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Sample records for randomised assessor-blind comparative

  1. Non-contact low-frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single-centre, assessor-blinded, randomised controlled trial.

    PubMed

    White, Judith; Ivins, Nicola; Wilkes, Antony; Carolan-Rees, Grace; Harding, Keith G

    2016-10-01

    'Hard-to-heal' wounds are those which fail to heal with standard therapy in an orderly and timely manner and may warrant the use of advanced treatments such as non-contact low-frequency ultrasound (NLFU) therapy. This evaluator-blinded, single-site, randomised controlled trial, compared NLFU in addition to UK standard of care [SOC: (NLFU + SOC)] three times a week, with SOC alone at least once a week. Patients with chronic venous leg ulcers were eligible to participate. All 36 randomised patients completed treatment (17 NLFU + SOC, 19 SOC), and baseline demographics were comparable between groups. NLFU + SOC patients showed a -47% (SD: 38%) change in wound area; SOC, -39% (38%) change; and difference, -7·4% [95% confidence intervals (CIs) -33·4-18·6; P = 0·565]. The median number of infections per patient was two in both arms of the study and change in quality of life (QoL) scores was not significant (P = 0·490). NLFU + SOC patients reported a substantial mean (SD) reduction in pain score of -14·4 (14·9) points, SOC patients' pain scores reduced by -5·3 (14·8); the difference was -9·1 (P = 0·078). Results demonstrated the importance of high-quality wound care. Outcome measures favoured NLFU + SOC over SOC, but the differences were not statistically significant. A larger sample size and longer follow-up may reveal NLFU-related improvements not identified in this study.

  2. A randomised, assessor blind, parallel group comparative efficacy trial of three products for the treatment of head lice in children - melaleuca oil and lavender oil, pyrethrins and piperonyl butoxide, and a "suffocation" product

    PubMed Central

    2010-01-01

    Background There are many different types of pediculicides available OTC in Australia. In this study we compare the efficacy and safety of three topical pediculicides: a pediculicide containing melaleuca oil (tea tree oil) and lavender oil (TTO/LO); a head lice "suffocation" product; and a product containing pyrethrins and piperonyl butoxide (P/PB). Method This study was a randomised, assessor-blind, comparative, parallel study of 123 subjects with live head lice. The head lice products were applied according to the manufacturer's instructions (the TTO/LO product and the "suffocation" product were applied three times at weekly intervals according to manufacturers instructions (on Day 0, Day 7 and Day 14) and the P/PB product was applied twice according to manufacturers instructions (on Day 0 and Day 7)). The presence or absence of live lice one day following the last treatment was determined. Results The percentage of subjects who were louse-free one day after the last treatment with the product containing tea tree oil and lavender oil (41/42; 97.6%) and the head lice "suffocation" product (40/41, 97.6%) was significantly higher compared to the percentage of subjects who were louse-free one day after the last treatment with the product containing pyrethrins and piperonyl butoxide (10/40, 25.0%; adj. p < 0.0001). Conclusion The high efficacy of the TTO/LO product and the head lice "suffocation" product offers an alternative to the pyrethrins-based product. Trial Registration The study was entered into the Australian/New Zealand Clinical Trial Registry, ACTRN12610000179033. PMID:20727129

  3. An ex vivo, assessor blind, randomised, parallel group, comparative efficacy trial of the ovicidal activity of three pediculicides after a single application - melaleuca oil and lavender oil, eucalyptus oil and lemon tea tree oil, and a "suffocation" pediculicide

    PubMed Central

    2011-01-01

    Background There are two components to the clinical efficacy of pediculicides: (i) efficacy against the crawling-stages (lousicidal efficacy); and (ii) efficacy against the eggs (ovicidal efficacy). Lousicidal efficacy and ovicidal efficacy are confounded in clinical trials. Here we report on a trial that was specially designed to rank the clinical ovicidal efficacy of pediculicides. Eggs were collected, pre-treatment and post-treatment, from subjects with different types of hair, different coloured hair and hair of different length. Method Subjects with at least 20 live eggs of Pediculus capitis (head lice) were randomised to one of three treatment-groups: a melaleuca oil (commonly called tea tree oil) and lavender oil pediculicide (TTO/LO); a eucalyptus oil and lemon tea tree oil pediculicide (EO/LTTO); or a "suffocation" pediculicide. Pre-treatment: 10 to 22 live eggs were taken from the head by cutting the single hair with the live egg attached, before the treatment (total of 1,062 eggs). Treatment: The subjects then received a single treatment of one of the three pediculicides, according to the manufacturers' instructions. Post-treatment: 10 to 41 treated live eggs were taken from the head by cutting the single hair with the egg attached (total of 1,183 eggs). Eggs were incubated for 14 days. The proportion of eggs that had hatched after 14 days in the pre-treatment group was compared with the proportion of eggs that hatched in the post-treatment group. The primary outcome measure was % ovicidal efficacy for each of the three pediculicides. Results 722 subjects were examined for the presence of eggs of head lice. 92 of these subjects were recruited and randomly assigned to: the "suffocation" pediculicide (n = 31); the melaleuca oil and lavender oil pediculicide (n = 31); and the eucalyptus oil and lemon tea tree oil pediculicide (n = 30 subjects). The group treated with eucalyptus oil and lemon tea tree oil had an ovicidal efficacy of 3.3% (SD 16%) whereas the

  4. An ex vivo, assessor blind, randomised, parallel group, comparative efficacy trial of the ovicidal activity of three pediculicides after a single application--melaleuca oil and lavender oil, eucalyptus oil and lemon tea tree oil, and a "suffocation" pediculicide.

    PubMed

    Barker, Stephen C; Altman, Phillip M

    2011-08-24

    There are two components to the clinical efficacy of pediculicides: (i) efficacy against the crawling-stages (lousicidal efficacy); and (ii) efficacy against the eggs (ovicidal efficacy). Lousicidal efficacy and ovicidal efficacy are confounded in clinical trials. Here we report on a trial that was specially designed to rank the clinical ovicidal efficacy of pediculicides. Eggs were collected, pre-treatment and post-treatment, from subjects with different types of hair, different coloured hair and hair of different length. Subjects with at least 20 live eggs of Pediculus capitis (head lice) were randomised to one of three treatment-groups: a melaleuca oil (commonly called tea tree oil) and lavender oil pediculicide (TTO/LO); a eucalyptus oil and lemon tea tree oil pediculicide (EO/LTTO); or a "suffocation" pediculicide. Pre-treatment: 10 to 22 live eggs were taken from the head by cutting the single hair with the live egg attached, before the treatment (total of 1,062 eggs). The subjects then received a single treatment of one of the three pediculicides, according to the manufacturers' instructions. Post-treatment: 10 to 41 treated live eggs were taken from the head by cutting the single hair with the egg attached (total of 1,183 eggs). Eggs were incubated for 14 days. The proportion of eggs that had hatched after 14 days in the pre-treatment group was compared with the proportion of eggs that hatched in the post-treatment group. The primary outcome measure was % ovicidal efficacy for each of the three pediculicides. 722 subjects were examined for the presence of eggs of head lice. 92 of these subjects were recruited and randomly assigned to: the "suffocation" pediculicide (n = 31); the melaleuca oil and lavender oil pediculicide (n = 31); and the eucalyptus oil and lemon tea tree oil pediculicide (n = 30 subjects). The group treated with eucalyptus oil and lemon tea tree oil had an ovicidal efficacy of 3.3% (SD 16%) whereas the group treated with melaleuca oil and

  5. Comparison of phenothrin mousse, phenothrin lotion, and wet-combing for treatment of head louse infestation in the UK: a pragmatic randomised, controlled, assessor blind trial

    PubMed Central

    Burgess, Ian F.; Brown, Christine M.; Nair, Pat

    2014-01-01

    In this investigation of effectiveness of an alternative pediculicide dosage form, we recruited 228 children and 50 adult participants from Bedfordshire, UK, to a randomised, controlled, assessor blind trial comparing two insecticide products with mechanical removal of lice as a control group.  Participants using insecticide were treated with either the investigative 0.5% phenothrin mousse, for 30 minutes, or 0.2% phenothrin lotion, for 2 hours as the reference product.  Both treatments were applied only once, followed by shampoo washing.  Those treated by wet-combing with conditioner were combed 4 times over 12 days.  Parents/carers carried out the treatments to mimic normal consumer use.  The outcome measure was the absence of lice, 14 days after treatment for the insecticides, and up to 14 days after completion of combing.  Intention to treat analysis of the outcomes for 275 participants showed success for phenothrin mousse in 21/105 (20.0%), in 23/107 (21.5%) for phenothrin lotion, and in 12/63 (19.1%) for wet-combing.  People receiving mousse were 1.07 (95% CI, 0.63 to 1.81) times more likely to still have lice after treatment compared with those treated with lotion. The group of participants who received the wet combing treatment were 1.13 (95% CI, 0.61 to 2.11) times more likely to still have lice after the treatment.  None of the treatments was significantly (p < 0.05) more effective than any other. This study was carried out in an area where moderate resistance to phenothrin was demonstrated after the study by using a bioassay.  Analysis of post treatment assessments found that failure of insecticides to kill louse eggs had influenced the outcome. PMID:25254106

  6. Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial.

    PubMed

    Lavender, Tina; Furber, Christine; Campbell, Malcolm; Victor, Suresh; Roberts, Ian; Bedwell, Carol; Cork, Michael J

    2012-06-01

    Some national guidelines recommend the use of water alone for napkin cleansing. Yet, there is a readiness, amongst many parents, to use baby wipes. Evidence from randomised controlled trials, of the effect of baby wipes on newborn skin integrity is lacking. We conducted a study to examine the hypothesis that the use of a specifically formulated cleansing wipe on the napkin area of newborn infants (<1 month) has an equivalent effect on skin hydration when compared with using cotton wool and water (usual care). A prospective, assessor-blinded, randomised controlled equivalence trial was conducted during 2010. Healthy, term babies (n=280), recruited within 48 hours of birth, were randomly assigned to have their napkin area cleansed with an alcohol-free baby wipe (140 babies) or cotton wool and water (140 babies). Primary outcome was change in hydration from within 48 hours of birth to 4 weeks post-birth. Secondary outcomes comprised changes in trans-epidermal water loss, skin surface pH and erythema, presence of microbial skin contaminants/irritants at 4 weeks and napkin dermatitis reported by midwife at 4 weeks and mother during the 4 weeks. Complete hydration data were obtained for 254 (90.7 %) babies. Wipes were shown to be equivalent to water and cotton wool in terms of skin hydration (intention-to-treat analysis: wipes 65.4 (SD 12.4) vs. water 63.5 (14.2), p=0.47, 95% CI -2.5 to 4.2; per protocol analysis: wipes 64.6 (12.4) vs. water 63.6 (14.3), p=0.53, 95% CI -2.4 to 4.2). No significant differences were found in the secondary outcomes, except for maternal-reported napkin dermatitis, which was higher in the water group (p=0.025 for complete responses). Baby wipes had an equivalent effect on skin hydration when compared with cotton wool and water. We found no evidence of any adverse effects of using these wipes. These findings offer reassurance to parents who choose to use baby wipes and to health professionals who support their use. Current Controlled Trials

  7. Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial

    PubMed Central

    2012-01-01

    Background Some national guidelines recommend the use of water alone for napkin cleansing. Yet, there is a readiness, amongst many parents, to use baby wipes. Evidence from randomised controlled trials, of the effect of baby wipes on newborn skin integrity is lacking. We conducted a study to examine the hypothesis that the use of a specifically formulated cleansing wipe on the napkin area of newborn infants (<1 month) has an equivalent effect on skin hydration when compared with using cotton wool and water (usual care). Methods A prospective, assessor-blinded, randomised controlled equivalence trial was conducted during 2010. Healthy, term babies (n = 280), recruited within 48 hours of birth, were randomly assigned to have their napkin area cleansed with an alcohol-free baby wipe (140 babies) or cotton wool and water (140 babies). Primary outcome was change in hydration from within 48 hours of birth to 4 weeks post-birth. Secondary outcomes comprised changes in trans-epidermal water loss, skin surface pH and erythema, presence of microbial skin contaminants/irritants at 4 weeks and napkin dermatitis reported by midwife at 4 weeks and mother during the 4 weeks. Results Complete hydration data were obtained for 254 (90.7 %) babies. Wipes were shown to be equivalent to water and cotton wool in terms of skin hydration (intention-to-treat analysis: wipes 65.4 (SD 12.4) vs. water 63.5 (14.2), p = 0.47, 95 % CI -2.5 to 4.2; per protocol analysis: wipes 64.6 (12.4) vs. water 63.6 (14.3), p = 0.53, 95 % CI -2.4 to 4.2). No significant differences were found in the secondary outcomes, except for maternal-reported napkin dermatitis, which was higher in the water group (p = 0.025 for complete responses). Conclusions Baby wipes had an equivalent effect on skin hydration when compared with cotton wool and water. We found no evidence of any adverse effects of using these wipes. These findings offer reassurance to parents who choose to use baby

  8. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

    PubMed Central

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large

  9. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial.

    PubMed

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-11-01

    Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)-the best evidence-based treatment for insomnia-has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18-65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted

  10. Injury risk in runners using standard or motion control shoes: a randomised controlled trial with participant and assessor blinding.

    PubMed

    Malisoux, Laurent; Chambon, Nicolas; Delattre, Nicolas; Gueguen, Nils; Urhausen, Axel; Theisen, Daniel

    2016-04-01

    This randomised controlled trial investigated if the usage of running shoes with a motion control system modifies injury risk in regular leisure-time runners compared to standard shoes, and if this influence depends on foot morphology. Recreational runners (n=372) were given either the motion control or the standard version of a regular running shoe model and were followed up for 6 months regarding running activity and injury. Foot morphology was analysed using the Foot Posture Index method. Cox regression analyses were used to compare injury risk between the two groups, based on HRs and their 95% CIs, controlling for potential confounders. Stratified analyses were conducted to evaluate the effect of motion control system in runners with supinated, neutral and pronated feet. The overall injury risk was lower among the participants who had received motion control shoes (HR=0.55; 95% CI 0.36 to 0.85) compared to those receiving standard shoes. This positive effect was only observed in the stratum of runners with pronated feet (n=94; HR=0.34; 95% CI 0.13 to 0.84); there was no difference in runners with neutral (n=218; HR=0.78; 95% CI 0.44 to 1.37) or supinated feet (n=60; HR=0.59; 95% CI 0.20 to 1.73). Runners with pronated feet using standard shoes had a higher injury risk compared to those with neutral feet (HR=1.80; 95% CI 1.01 to 3.22). The overall injury risk was lower in participants who had received motion control shoes. Based on secondary analysis, those with pronated feet may benefit most from this shoe type. 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/

  11. Injury risk in runners using standard or motion control shoes: a randomised controlled trial with participant and assessor blinding

    PubMed Central

    Malisoux, Laurent; Chambon, Nicolas; Delattre, Nicolas; Gueguen, Nils; Urhausen, Axel; Theisen, Daniel

    2016-01-01

    Background/aim This randomised controlled trial investigated if the usage of running shoes with a motion control system modifies injury risk in regular leisure-time runners compared to standard shoes, and if this influence depends on foot morphology. Methods Recreational runners (n=372) were given either the motion control or the standard version of a regular running shoe model and were followed up for 6 months regarding running activity and injury. Foot morphology was analysed using the Foot Posture Index method. Cox regression analyses were used to compare injury risk between the two groups, based on HRs and their 95% CIs, controlling for potential confounders. Stratified analyses were conducted to evaluate the effect of motion control system in runners with supinated, neutral and pronated feet. Results The overall injury risk was lower among the participants who had received motion control shoes (HR=0.55; 95% CI 0.36 to 0.85) compared to those receiving standard shoes. This positive effect was only observed in the stratum of runners with pronated feet (n=94; HR=0.34; 95% CI 0.13 to 0.84); there was no difference in runners with neutral (n=218; HR=0.78; 95% CI 0.44 to 1.37) or supinated feet (n=60; HR=0.59; 95% CI 0.20 to 1.73). Runners with pronated feet using standard shoes had a higher injury risk compared to those with neutral feet (HR=1.80; 95% CI 1.01 to 3.22). Conclusions The overall injury risk was lower in participants who had received motion control shoes. Based on secondary analysis, those with pronated feet may benefit most from this shoe type. PMID:26746907

  12. Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP) Trial)

    PubMed Central

    McDonough, SM; Liddle, SD; Hunter, R; Walsh, DM; Glasgow, P; Gormley, G; Hurley, D; Delitto, A; Park, J; Bradbury, I; Baxter, GD

    2008-01-01

    Background Evidence supports the use of exercise for chronic low back pain (CLBP); however, adherence is often poor due to ongoing pain. Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts. It may be a useful adjunct to exercise in managing CLBP; however, there is only limited evidence to support its use with this patient group. Methods/Design This study was designed to test the feasibility of an assessor-blind randomised controlled trial which assess the effects on clinical outcomes and exercise adherence of adding manual auricular acupuncture to a personalised and supervised exercise programme (PEP) for CLBP. No sample size calculation has been carried out as this study aims to identify CLBP referral rates within the catchment area of the study site. The researchers aim to recruit four cohorts of n = 20 participants to facilitate a power analysis for a future randomised controlled trial. A computer generated random allocation sequence will be prepared centrally and used to allocate participants by cohort to one of the following interventions: 1) six weeks of PEP plus manual auricular acupuncture; 2) six weeks of PEP alone. Both groups will also complete a further six weeks of self-paced exercise with telephone follow-up support. In addition to a baseline and exit questionnaire at the beginning and end of the study, the following outcomes will be collected at baseline, and after 7, 13 and 25 weeks: pain frequency and bothersomeness, back-specific function, objective assessment and recall of physical activity, use of analgesia, perceived self-efficacy, fear avoidance beliefs, and beliefs about the consequences of back pain. Since this is a feasibility study, significance tests will not be presented, and treatment effects will be represented by point estimates and confidence intervals. For each outcome variable, analysis of covariance will be performed on the data, conditioning on

  13. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial.

    PubMed

    Allingstrup, Matilde Jo; Kondrup, Jens; Wiis, Jørgen; Claudius, Casper; Pedersen, Ulf Gøttrup; Hein-Rasmussen, Rikke; Bjerregaard, Mads Rye; Steensen, Morten; Jensen, Tom Hartvig; Lange, Theis; Madsen, Martin Bruun; Møller, Morten Hylander; Perner, Anders

    2017-09-22

    We assessed the effects of early goal-directed nutrition (EGDN) vs. standard nutritional care in adult intensive care unit (ICU) patients. We randomised acutely admitted, mechanically ventilated ICU patients expected to stay longer than 3 days in the ICU. In the EGDN group we estimated nutritional requirements by indirect calorimetry and 24-h urinary urea aiming at covering 100% of requirements from the first full trial day using enteral and parenteral nutrition. In the standard of care group we aimed at providing 25 kcal/kg/day by enteral nutrition. If this was not met by day 7, patients were supplemented with parenteral nutrition. The primary outcome was physical component summary (PCS) score of SF-36 at 6 months. We performed multiple imputation for data of the non-responders. We randomised 203 patients and included 199 in the intention-to-treat analyses; baseline variables were reasonably balanced between the two groups. The EGDN group had less negative energy (p < 0.001) and protein (p < 0.001) balances in the ICU as compared to the standard of care group. The PCS score at 6 months did not differ between the two groups (mean difference 0.0, 95% CI -5.9 to 5.8, p = 0.99); neither did mortality, rates of organ failures, serious adverse reactions or infections in the ICU, length of ICU or hospital stay, or days alive without life support at 90 days. EGDN did not appear to affect physical quality of life at 6 months or other important outcomes as compared to standard nutrition care in acutely admitted, mechanically ventilated, adult ICU patients. Clinicaltrials.gov identifier no. NCT01372176.

  14. Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial

    PubMed Central

    Ried-Larsen, Mathias; Hansen, Katrine B; Johansen, Mette Y; Pedersen, Maria; Zacho, Morten; Hansen, Louise S; Kofoed, Katja; Thomsen, Katja; Jensen, Mette S; Nielsen, Rasmus O; MacDonald, Chris; Langberg, Henning; Vaag, Allan A; Pedersen, Bente K; Karstoft, Kristian

    2015-01-01

    Introduction Current pharmacological therapies in patients with type 2 diabetes (T2D) are challenged by lack of sustainability and borderline firm evidence of real long-term health benefits. Accordingly, lifestyle intervention remains the corner stone in the management of T2D. However, there is a lack of knowledge regarding the optimal intervention programmes in T2D ensuring both compliance as well as long-term health outcomes. Our objective is to assess the effects of an intensive lifestyle intervention (the U-TURN intervention) on glycaemic control in patients with T2D. Our hypothesis is that intensive lifestyle changes are equally effective as standard diabetes care, including pharmacological treatment in maintaining glycaemic control (ie, glycated haemoglobin (HbA1c)) in patients with T2D. Furthermore, we expect that intensive lifestyle changes will decrease the need for antidiabetic medications. Methods and analysis The study is an assessor-blinded, parallel group and a 1-year randomised trial. The primary outcome is change in glycaemic control (HbA1c), with the key secondary outcome being reductions in antidiabetic medication. Participants will be patients with T2D (T2D duration <10 years) without complications who are randomised into an intensive lifestyle intervention (U-TURN) or a standard care intervention in a 2:1 fashion. Both groups will be exposed to the same standardised, blinded, target-driven pharmacological treatment and can thus maintain, increase, reduce or discontinue the pharmacological treatment. The decision is based on the standardised algorithm. The U-TURN intervention consists of increased training and basal physical activity level, and an antidiabetic diet including an intended weight loss. The standard care group as well as the U-TURN group is offered individual diabetes management counselling on top of the pharmacological treatment. Ethics and dissemination This study has been approved by the Scientific Ethical Committee at the

  15. A comparison of two stretching programs for hamstring muscles: A randomized controlled assessor-blinded study.

    PubMed

    Demoulin, Christophe; Wolfs, Sébastien; Chevalier, Madeline; Granado, Caroline; Grosdent, Stéphanie; Depas, Yannick; Roussel, Nathalie; Hage, Renaud; Vanderthommen, Marc

    2016-01-01

    Most parameters regarding hamstring flexibility training programs have been investigated; however, the joint (i.e. hip or knee) on which the stretching should preferentially be focused needs to be further explored. This randomized controlled assessor-blinded study aimed to investigate the influence of this parameter. We randomly assigned 111 asymptomatic participants with tight hamstring muscles in three groups: a control group and two groups following a different home-based 8-week (five 10-minute sessions per week) hamstring stretching program (i.e. stretching performed by flexing the hip while keeping the knee extended [SH] or by first flexing the hip with a flexed knee and then extending the knee [SK]). Range of motion (ROM) of hip flexion and knee extension were measured before and after the stretching program by means of the straight leg raising test and the passive knee extension angle test, respectively. Eighty-nine participants completed the study. A significant increase in ROM was observed at post-test. Analyses showed significant group-by-time interactions for changes regarding all outcomes. Whereas the increase in hip flexion and knee extension ROM was higher in the stretching groups than in the CG (especially for the SH group p < 0.05), no differences between the two stretching groups were observed (p > 0.05). In conclusion, the fact that both stretching programs resulted in similar results suggests no influence of the joint at which the stretching is focused upon, as assessed by the straight leg raising and knee extension angle tests.

  16. Manual and manipulative therapy in addition to rehabilitation for osteoarthritis of the knee: assessor-blind randomized pilot trial.

    PubMed

    Dwyer, Lauren; Parkin-Smith, Gregory F; Brantingham, James W; Korporaal, Charmaine; Cassa, Tammy K; Globe, Gary; Bonnefin, Debra; Tong, Victor

    2015-01-01

    The purpose of this study was to examine the methodological integrity, sample size requirements, and short-term preliminary clinical outcomes of manual and manipulative therapy (MMT) in addition to a rehabilitation program for symptomatic knee osteoarthritis (OA). This was a pilot study of an assessor-blinded, randomized, parallel-group trial in 2 independent university-based outpatient clinics. Participants with knee OA were randomized to 3 groups: 6 MMT sessions alone, training in rehabilitation followed by a home rehabilitation program alone, or MMT plus the same rehabilitation program, respectively. Six MMT treatment sessions (provided by a chiropractic intern under supervision or by an experienced chiropractor) were provided to participants over the 4-week treatment period. The primary outcome was a description of the research methodology and sample size estimation for a confirmatory study. The secondary outcome was the short-term preliminary clinical outcomes. Data were collected at baseline and 5weeks using the Western Ontario and McMasters Osteoarthritis Index questionnaire, goniometry for knee flexion/extension, and the McMaster Overall Therapy Effectiveness inventory. Analysis of variance was used to compare differences between groups. Eighty-three patients were randomly allocated to 1 of the 3 groups (27, 28, and 28, respectively). Despite 5 dropouts, the data from 78 participants were available for analysis with 10% of scores missing. A minimum of 462 patients is required for a confirmatory 3-arm trial including the respective interventions, accounting for cluster effects and a 20% dropout rate. Statistically significant and clinically meaningful changes in scores from baseline to week 5 were found for all groups for the Western Ontario and McMasters Osteoarthritis Index (P ≤ .008), with a greater change in scores for MMT and MMT plus rehabilitation. Between-group comparison did not reveal statistically significant differences between group scores at

  17. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection.

    PubMed

    Adegnika, Ayola A; Zinsou, Jeannot F; Issifou, Saadou; Ateba-Ngoa, Ulysse; Kassa, Roland F; Feugap, Eliane N; Honkpehedji, Yabo J; Dejon Agobe, Jean-Claude; Kenguele, Hilaire M; Massinga-Loembe, Marguerite; Agnandji, Selidji T; Mordmüller, Benjamin; Ramharter, Michael; Yazdanbakhsh, Maria; Kremsner, Peter G; Lell, Bertrand

    2014-05-01

    In many regions where soil-transmitted helminth infections are endemic, single-dose albendazole is used in mass drug administration programs to control infections. There are little data on the efficacy of the standard single-dose administration compared to that of alternative regimens. We conducted a randomized, controlled, assessor-blinded clinical trial to determine the efficacies of standard and extended albendazole treatment against soil-transmitted helminth infection in Gabon. A total of 175 children were included. Adequate cure rates and egg reduction rates above 85% were found with a single dose of albendazole for Ascaris infection, 85% (95% confidence interval [CI], 73, 96) and 93.8% (CI, 87.6, 100), respectively, while two doses were necessary for hookworm infestation (92% [CI, 78, 100] and 92% [CI, 78, 100], respectively). However, while a 3-day regimen was not sufficient to cure Trichuris (cure rate, 83% [CI, 73, 93]), this regimen reduced the number of eggs up to 90.6% (CI, 83.1, 100). The rate ratios of two- and three-dose regimens compared to a single-dose treatment were 1.7 (CI, 1.1, 2.5) and 2.1 (CI, 1.5, 2.9) for Trichuris and 1.7 (CI, 1.0, 2.9) and 1.7 (CI, 1.0, 2.9) for hookworm. Albendazole was safe and well tolerated in all regimens. A single-dose albendazole treatment considerably reduces Ascaris infection but has only a moderate effect on hookworm and Trichuris infections. The single-dose option may still be the preferred regimen because it balances efficacy, safety, and compliance during mass drug administration, keeping in mind that asymptomatic low-level helminth carriage may also have beneficial effects. (This study has been registered at ClinicalTrials.gov under registration number NCT01192802.).

  18. Randomized, Controlled, Assessor-Blind Clinical Trial To Assess the Efficacy of Single- versus Repeated-Dose Albendazole To Treat Ascaris lumbricoides, Trichuris trichiura, and Hookworm Infection

    PubMed Central

    Zinsou, Jeannot F.; Issifou, Saadou; Ateba-Ngoa, Ulysse; Kassa, Roland F.; Feugap, Eliane N.; Honkpehedji, Yabo J.; Dejon Agobe, Jean-Claude; Kenguele, Hilaire M.; Massinga-Loembe, Marguerite; Agnandji, Selidji T.; Mordmüller, Benjamin; Ramharter, Michael; Yazdanbakhsh, Maria; Kremsner, Peter G.; Lell, Bertrand

    2014-01-01

    In many regions where soil-transmitted helminth infections are endemic, single-dose albendazole is used in mass drug administration programs to control infections. There are little data on the efficacy of the standard single-dose administration compared to that of alternative regimens. We conducted a randomized, controlled, assessor-blinded clinical trial to determine the efficacies of standard and extended albendazole treatment against soil-transmitted helminth infection in Gabon. A total of 175 children were included. Adequate cure rates and egg reduction rates above 85% were found with a single dose of albendazole for Ascaris infection, 85% (95% confidence interval [CI], 73, 96) and 93.8% (CI, 87.6, 100), respectively, while two doses were necessary for hookworm infestation (92% [CI, 78, 100] and 92% [CI, 78, 100], respectively). However, while a 3-day regimen was not sufficient to cure Trichuris (cure rate, 83% [CI, 73, 93]), this regimen reduced the number of eggs up to 90.6% (CI, 83.1, 100). The rate ratios of two- and three-dose regimens compared to a single-dose treatment were 1.7 (CI, 1.1, 2.5) and 2.1 (CI, 1.5, 2.9) for Trichuris and 1.7 (CI, 1.0, 2.9) and 1.7 (CI, 1.0, 2.9) for hookworm. Albendazole was safe and well tolerated in all regimens. A single-dose albendazole treatment considerably reduces Ascaris infection but has only a moderate effect on hookworm and Trichuris infections. The single-dose option may still be the preferred regimen because it balances efficacy, safety, and compliance during mass drug administration, keeping in mind that asymptomatic low-level helminth carriage may also have beneficial effects. (This study has been registered at ClinicalTrials.gov under registration number NCT01192802.) PMID:24550339

  19. Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial.

    PubMed

    Soto, Roy; Jahr, Jonathan S; Pavlin, Janet; Sabo, Daniel; Philip, Beverly K; Egan, Talmage D; Rowe, Everton; de Bie, Joris; Woo, Tiffany

    Complex surgical procedures are increasingly performed in an outpatient setting, with emphasis on rapid recovery and case turnover. In this study, the combination of rocuronium for neuromuscular blockade (NMB) reversed by single-dose sugammadex was compared with succinylcholine followed by spontaneous recovery in outpatient surgery. This multicenter, randomized, safety assessor-blinded study enrolled adults undergoing a short elective outpatient surgical procedure requiring NMB and tracheal intubation. Patients were randomized to NMB with either rocuronium 0.6 mg/kg for tracheal intubation with incremental doses of rocuronium 0.15 mg/kg and subsequent reversal with sugammadex 4.0 mg/kg at 1-2 posttetanic counts or succinylcholine 1.0 mg/kg for intubation with spontaneous recovery. The primary efficacy end point was the time from sugammadex administration to recovery of the train-of-four ratio to 0.9; for succinylcholine, time from administration to recovery of the first twitch (T1) to 90% was assessed. From 167 patients enrolled, 150 received treatment. The all-subjects-treated population comprised 70 patients in the rocuronium-sugammadex group and 80 in the succinylcholine group. Geometric mean (95% confidence interval) time from the start of sugammadex administration to recovery of the train-of-four ratio to 0.9 was 1.8 (1.6-2.0) minutes. Geometric mean (95% confidence interval) time from succinylcholine administration to recovery of T1 to 90% was 10.8 (10.1-11.5) minutes. Health outcome variables were similar between the groups. Adverse events were reported in 87.1% and 93.8% of patients for rocuronium-sugammadex and succinylcholine, respectively. In conclusion, rocuronium for intubation followed by sugammadex for reversal of NMB offers a viable treatment option in outpatient surgery without prolonging recovery duration or jeopardizing safety.

  20. Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

    PubMed Central

    2011-01-01

    Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation) and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged <24 hours were randomly assigned to bathing with water and cotton wool (W) or with a cleaning product (CP). A minimum of bathing 3 times per week was advocated. Groups were stratified according to family history of atopic eczema. Transepidermal water loss (TEWL), stratum corneum hydration and skin surface pH were measured within 24 hours of birth and at 4 and 8 weeks post birth. Measurements were taken on the thigh, forearm and abdomen. Women also completed questionnaires and diaries to record bathing practices and medical treatments. Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI) for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data

  1. Effects of Pilates-Based Core Stability Training in Ambulant People With Multiple Sclerosis: Multicenter, Assessor-Blinded, Randomized Controlled Trial.

    PubMed

    Fox, Esther E; Hough, Alan D; Creanor, Siobhan; Gear, Margaret; Freeman, Jennifer A

    2016-08-01

    Pilates exercise is often undertaken by people with multiple sclerosis (MS) who have balance and mobility difficulties. The primary aim of the study was to compare the effects of 12 weeks of Pilates exercises with relaxation on balance and mobility. Secondary aims were: (1) to compare standardized exercises with relaxation and (2) to compare Pilates exercises with standardized exercises. A multicenter, assessor-blinded, randomized controlled trial was conducted. Participants with Expanded Disability Status Scale scores of 4.0 to 6.5 were randomly allocated to groups receiving 12 weeks of Pilates exercises, standardized exercises, or relaxation. Assessments were undertaken at baseline and weeks 12 and 16 (primary outcome measure: 10-Meter Timed Walk Test [10MTW]). One hundred participants (mean age=54 years, 74% female) were randomized to study groups. Six participants relapsed (withdrew from the study), leaving 94 participants for intention-to-treat analysis. There was no significant difference in mean 10MTW measurements between the Pilates and relaxation groups. At 12 weeks, there was a mean reduction of 4.2 seconds for the standardized exercise group compared with the relaxation group (95% confidence interval [relaxation group minus standardized exercise group measurements]=0.0, 8.4) and a mean reduction of 3.7 seconds for the Pilates group compared with the standardized exercise group (95% confidence interval [Pilates group minus standardized exercise group measurements]=-0.4 to 7.8). At 16 weeks, mean 10MTW times for the standardized exercise group remained quicker than those for the Pilates and relaxation groups, although the differences were nonsignificant. There were no significant differences between the Pilates and relaxation groups for any secondary outcome measure. In this study, therapists were limited to a standardized basket of exercises that may have affected the study outcomes. Furthermore, choosing measures such as posturography to assess balance

  2. Tocopheryl acetate 20% spray for elimination of head louse infestation: a randomised controlled trial comparing with 1% permethrin creme rinse

    PubMed Central

    2013-01-01

    Background Tocopheryl acetate is viscous oily fluid used in a range of preparations for skin and scalp care in Italy. Observational and in vitro data have suggested a high level of efficacy against head louse infestation. The purpose of this investigation was to confirm the activity of tocopheryl acetate in a clinical setting in comparison with a standard widely used preparation. Methods A spray formulation containing tocopheryl acetate 20% in cyclomethicone was compared with permethrin 1% creme rinse for treatment of head louse infestation in a randomised, assessor blind, trial. Forty-five people were treated on two occasions 7 days apart. The spray was applied to dry hair for 20 minutes then washed. Participants treated with permethrin washed their hair and towel dried it before treatment for 10 minutes. Assessments were made by dry detection combing 1, 6, 9, and 14 days after first treatment. Results The tocopheryl acetate 20% spray was significantly (p = 0.033) more effective than permethrin 1%, using intention to treat worst case analysis, in which there were 13/23 (56.5%) successful treatments for tocopheryl acetate compared with 5/22 (22.7%) for permethrin. After unprecedented issues of re-infestation within households had been taken into account the underlying cure rate was 17/23 (73.9%) for tocopheryl acetate compared with 5/22 (22.7%), Odds Ratio 9.63 (95% CI, 2.46 to 37.68) (p < 0.001). Conclusions The tocopheryl acetate spray was significantly more effective than the permethrin product, was cosmetically acceptable, and not affected by current problems with resistance. Trial registration Current Controlled Trials ISRCTN45553737. PMID:24004959

  3. GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial.

    PubMed

    Ebert, David Daniel; Lehr, Dirk; Baumeister, Harald; Boß, Leif; Riper, Heleen; Cuijpers, Pim; Reins, Jo Annika; Buntrock, Claudia; Berking, Matthias

    2014-01-30

    Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT. A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n=128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation. This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD. German Clinical Trial Registration (DRKS): DRKS00005025.

  4. Use of a urea, arginine and carnosine cream versus a standard emollient glycerol cream for treatment of severe xerosis of the feet in patients with type 2 diabetes: a randomized, 8 month, assessor-blinded, controlled trial.

    PubMed

    Federici, Adalberto; Federici, Giovanni; Milani, Massimo

    2015-06-01

    No long-term data are available regarding the effects of emollients in treating severe foot skin xerosis in patients with diabetes. We evaluated the efficacy of 8 month urea, arginine and carnosine cream (UC) in comparison with a glycerin-based emollient cream (SEC) in type 2 patients with diabetes who had severe foot xerosis. We assessed the effect of UC and SEC on skin hydration in a randomized, assessor-blinded study in 50 patients treated with UC (N = 25) or SEC (N = 25) for 32 weeks with a twice daily application. Primary outcomes were a 9 point Xerosis Assessment Scale (XAS) score and a 4 point Overall Cutaneous Score (OCS), evaluated at baseline and after 4, 12 and 32 weeks. Skin hydration and desquamation were also objectively evaluated by means of a bio-impedance skin analysis device (Hydr8 * ) at baseline and at week 32. UC induced greater hydration than SEC (p = 0.001) with a 91% reduction at week 32 in XAS score vs. baseline. After 4 weeks, compared with the SEC treated group, the XAS score in the UC treated group was significantly lower. OCS was reduced by 27% from baseline to end of the study in the UC group, and increased by 8% in the SEC group (p = 0.02; between groups). At month 8, skin hydration and desquamation evaluated by the digital skin analysis system statistically improved in UC treated subjects in comparison with baseline and SEC group values. This study was not double-blind. In order to overcome this problem we performed an assessor-blinded evaluation of the primary endpoints and used an objective measurement tool for skin hydration and desquamation assessment. Using a urea, arginine and carnosine cream for 8 months increases skin hydration and improves skin dryness in type 2 diabetic patients in comparison with a glycerol-based emollient cream, with a greater efficacy observed as early as 4 weeks into treatment.

  5. Olive Oil, Sunflower Oil or no Oil for Baby Dry Skin or Massage: A Pilot, Assessor-blinded, Randomized Controlled Trial (the Oil in Baby SkincaRE [OBSeRvE] Study).

    PubMed

    Cooke, Alison; Cork, Michael J; Victor, Suresh; Campbell, Malcolm; Danby, Simon; Chittock, John; Lavender, Tina

    2016-03-01

    Topical oils on baby skin may contribute to development of childhood atopic eczema. A pilot, assessor-blinded, randomized controlled trial assessed feasibility of a definitive trial investigating their impact in neonates. One-hundred and fifteen healthy, full-term neonates were randomly assigned to olive oil, sunflower oil or no oil, twice daily for 4 weeks, stratified by family history of atopic eczema. We measured spectral profile of lipid lamellae, trans-epidermal water loss (TEWL), stratum corneum hydration and pH and recorded clinical observations, at baseline, and 4 weeks post-birth. Recruitment was challenging (recruitment 11.1%; retention 80%), protocol adherence reasonable (79-100%). Both oil groups had significantly improved hydration but significantly less improvement in lipid lamellae structure compared to the no oil group. There were no significant differences in TEWL, pH or erythema/skin scores. The study was not powered for clinical significance, but until further research is conducted, caution should be exercised when recommending oils for neonatal skin.

  6. Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial.

    PubMed

    Ingwersen, Kim G; Christensen, Robin; Sørensen, Lilli; Jørgensen, Hans Ri; Jensen, Steen Lund; Rasmussen, Sten; Søgaard, Karen; Juul-Kristensen, Birgit

    2015-01-27

    Shoulder pain is the third most common musculoskeletal disorder, often affecting people's daily living and work capacity. The most common shoulder disorder is the subacromial impingement syndrome (SIS) which, among other pathophysiological changes, is often characterised by rotator cuff tendinopathy. Exercise is often considered the primary treatment option for rotator cuff tendinopathy, but there is no consensus on which exercise strategy is the most effective. As eccentric and high-load strength training have been shown to have a positive effect on patella and Achilles tendinopathy, the aim of this trial is to compare the efficacy of progressive high-load exercises with traditional low-load exercises in patients with rotator cuff tendinopathy. The current study is a randomised, participant- and assessor-blinded, controlled multicentre trial. A total of 260 patients with rotator cuff tendinopathy will be recruited from three outpatient shoulder departments in Denmark, and randomised to either 12 weeks of progressive high-load strength training or to general low-load exercises. Patients will receive six individually guided exercise sessions with a physiotherapist and perform home-based exercises three times a week. The primary outcome measure will be change from baseline to 12 weeks in the patient-reported outcome Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Previous studies of exercise treatment for SIS have not differentiated between subgroups of SIS and have often had methodological flaws, making it difficult to specifically design target treatment for patients diagnosed with SIS. Therefore, it was considered important to focus on a subgroup such as tendinopathy, with a specific tailored intervention strategy based on evidence from other regions of the body, and to clearly describe the intervention in a methodologically strong study. The trial was registered with Clinicaltrials.gov ( NCT01984203 ) on 31 October 2013.

  7. Clinical efficacy of formula-based bifrontal versus right unilateral electroconvulsive therapy (ECT) in the treatment of major depression among elderly patients: a pragmatic, randomized, assessor-blinded, controlled trial.

    PubMed

    Bjølseth, Tor Magne; Engedal, Knut; Benth, Jūratė Šaltytė; Dybedal, Gro Strømnes; Gaarden, Torfinn Lødøen; Tanum, Lars

    2015-04-01

    No prior study has compared the efficacy of bifrontal (BF) vs right unilateral (RUL) electroconvulsive therapy (ECT) by including the subgroup that is most likely to receive it: only elderly patients with major depression (MD). This single-site, randomized, assessor-blinded, controlled trial was conducted from 2009 to 2013. Seventy-three elderly patients with MD, unipolar and bipolar, were treated with a course of formula-based BF ECT or RUL ECT. The 17-item Hamilton Rating Scale for Depression (HRSD17) was used to measure efficacy. Safety was assessed with the Mini Mental State Examination (MMSE). Both electrode placements resulted in highly significant downward trends in symptom severity (all p<0.001), with a non-significant difference between methods (p=0.703). At the end of the ECT course, response rates for the BF and RUL group were 63.9% and 67.6%, respectively. Short-term remission, defined as an HRSD17 score≤7, was achieved in 14 (38.9%) patients in the BF group and 19 (51.4%) patients in the RUL group. Global cognitive function, as measured by the MMSE, did not deteriorate in the two treatment groups. The small number of subjects may have led to reduced power to detect real differences. The MMSE is not sufficient to ascertain the negative effect of ECT on cognition. This study indicates that formula-based BF and RUL ECT are equally efficacious, and that remission rates of formula-based dosing are lower than those previously reported for titrated dosing, in a clinical sample of elderly patients with MD. ClinicalTrials.gov NCT01559324. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  8. Lessons from randomised direct comparative trials.

    PubMed

    Achiron, Anat; Fredrikson, Sten

    2009-02-01

    For over a decade, four immunomodulatory therapies have been available for the treatment of relapsing remitting multiple sclerosis. However, few direct comparative data were available to facilitate the choice of treatment. This choice has been influenced by the perception that interferon-beta preparations have greater efficacy than glatiramer acetate, due to apparently more rapid and robust reduction of gadolinium-enhancing lesions seen on magnetic resonance imaging in the pivotal trials of these agents. This situation has changed in the last year, with the outcomes of three randomised clinical trials comparing the efficacy and safety of glatiramer acetate with that of a high-dose interferon-beta in relapsing remitting multiple sclerosis. These are the REGARD, BEYOND and BECOME trials. In the REGARD trial, 764 patients were randomised to treatment with either interferon-beta 1a sc 44 microg or glatiramer acetate for 96 weeks; no significant difference in the time to first relapse was observed. The largest of the three comparative studies, the BEYOND trial, compared treatment with interferon-beta 1b sc 500 microg, interferon-beta 1b sc 250 microg or glatiramer acetate for two years in 2,244 patients. The hazard ratio for multiple relapses was close to unity for comparisons between all groups, indicating equivalent efficacy in all three treatment arms. Relapse rates (around 0.3 relapses/year) in all these studies were much lower than anticipated and lower than those reported a decade previously in the pivotal trials of beta-interferons and glatiramer acetate. No unexpected safety issues were identified in any of these studies. The completion of these direct comparative studies has considerably enriched the clinical evidence database by contributing large numbers of patients. This provides an invaluable contribution for helping the physician make an informed choice about treatment. The results of the direct comparative studies provide evidence that glatiramer acetate

  9. Exercise, education, manual-therapy and taping compared to education for patellofemoral osteoarthritis: a blinded, randomised clinical trial.

    PubMed

    Crossley, K M; Vicenzino, B; Lentzos, J; Schache, A G; Pandy, M G; Ozturk, H; Hinman, R S

    2015-09-01

    Patellofemoral joint osteoarthritis (PFJ OA) contributes considerably to knee OA symptoms. This study aimed to determine the efficacy of a PFJ-targeted exercise, education manual-therapy and taping program compared to OA education alone, in participants with PFJ OA. A randomised, participant-blinded and assessor-blinded clinical trial was conducted in primary-care physiotherapy. 92 people aged ≥40 years with symptomatic and radiographic PFJ OA participated. Physiotherapists delivered the PFJ-targeted exercise, education, manual-therapy and taping program, or the OA-education (control condition) in eight sessions over 12 weeks. Primary outcomes at 3-month (primary) and 9-month follow-up: (1) patient-perceived global rating of change (2) pain visual analogue scale (VAS) (100 mm); and (3) activities of daily living (ADL) subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS). 81 people (88%) completed the 3-month follow-up and data analysed on an intention-to-treat basis. Between-group baseline similarity for participant characteristics was observed. The exercise, education, manual-therapy and taping program resulted in more people reporting much improvement (20/44) than the OA-education group (5/48) (number needed to treat 3 (95% confidence interval (CI) 2 to 5)) and greater pain reduction (mean difference: -15.2 mm, 95% CI -27.0 to -3.4). No significant effects on ADL were observed (5.8; 95% CI -0.6 to 12.1). At 9 months there were no significant effects for self-report of improvement, pain (-10.5 mm, 95% CI -22.7 to 1.8) or ADL (3.0, 95% CI -3.7 to 9.7). Exercise, education, manual-therapy and taping can be recommended to improve short-term patient rating of change and pain severity. However over 9-months, both options were equivalent. Australian New Zealand Clinical Trials Registry (ACTRN12608000288325): https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82878. Copyright © 2015 Osteoarthritis Research Society International. Published

  10. What is the effect of regular group exercise on maternal psychological outcomes and common pregnancy complaints? An assessor blinded RCT.

    PubMed

    Haakstad, Lene A H; Torset, Beate; Bø, Kari

    2016-01-01

    to examine the effects of supervised group exercise on maternal psychological outcomes and commonly reported pregnancy complaints. an observer-blinded randomized controlled trial. Norwegian School of Sport Sciences, Oslo, Norway. 105 sedentary, nulliparous pregnant women, mean age 30.7(± 4.0) years, pre-pregnancy BMI 23.8 (± 4.3), were assigned to either exercise (n=52) or control group (n= 53) at mean gestation week 17.7 (± 4.2). the exercise intervention followed ACOG guidelines and included a 60 minutes general fitness class, with 40 minutes of endurance training/aerobic and 20 minutes of strength training and stretching/relaxation, performed at least twice per week for a minimum of 12 weeks. outcome measures were assessed through standardized interviews pre- and post-intervention (gestation week 36.6, ± 0.9), and included psychological variables related to quality of life, well-being, body image and pregnancy depression, as well as assessment of 13 commonly reported pregnancy complaints. post-intervention, using intention to treat (ITT) analysis, women randomized to exercise rated their health significantly better compared to women in the control group (p=0.02) and reported less fatigue related to everyday activities (p=0.04). Women with complete exercise adherence (≥ 24 sessions) had significantly better scores on measurements of feelings related to sadness, hopelessness and anxiety (p<0.01), compared to the control group. Contradictory, the control group reported higher life enjoyment (p<0.01). There were no significant group differences in body-image or pregnancy depression. With respect to analysing pregnancy complaints according to ITT, no differences between the groups were found. A comparison of the women who attended ≥ 19 (80%, n=21) or ≥ 24 (100%, n=14) exercise sessions with the control-participants, showed that fewer women in the exercise group reported nausea/vomiting and numbness/poor circulation in legs. KEY CONCLUSION AND IMPLICATION

  11. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    PubMed Central

    2013-01-01

    Background Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Methods/design Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t

  12. Randomised Controlled Trial of a Parenting Intervention in the Voluntary Sector for Reducing Child Conduct Problems: Outcomes and Mechanisms of Change

    ERIC Educational Resources Information Center

    Gardner, Frances; Burton, Jennifer; Klimes, Ivana

    2006-01-01

    Background: To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children. Methods: Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems,…

  13. Randomised Controlled Trial of a Parenting Intervention in the Voluntary Sector for Reducing Child Conduct Problems: Outcomes and Mechanisms of Change

    ERIC Educational Resources Information Center

    Gardner, Frances; Burton, Jennifer; Klimes, Ivana

    2006-01-01

    Background: To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children. Methods: Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems,…

  14. The 24-hour skin hydration and barrier function effects of a hyaluronic 1%, glycerin 5%, and Centella asiatica stem cells extract moisturizing fluid: an intra-subject, randomized, assessor-blinded study

    PubMed Central

    Milani, Massimo; Sparavigna, Adele

    2017-01-01

    Introduction Moisturizing products are commonly used to improve hydration in skin dryness conditions. However, some topical hydrating products could have negative effects on skin barrier function. In addition, hydrating effects of moisturizers are not commonly evaluated up to 24 hours after a single application. Hyaluronic acid (HA) and glycerin are very well-known substances able to improve skin hydration. Centella asiatica extract (CAE) could exert lenitive, anti-inflammatory and reepithelialization actions. Furthermore, CAE could inhibit hyaluronidase enzyme activity, therefore prolonging the effect of HA. A fluid containing HA 1%, glycerin 5% and stem cells CAE has been recently developed (Jaluronius CS [JCS] fluid). Study aim To evaluate and compare the 24-hour effects of JCS fluid on skin hydration and on transepidermal water loss (TEWL) in healthy subjects in comparison with the control site. Subjects and methods Twenty healthy women, mean age 40 years, were enrolled in an intra-subject (right vs left), randomized, assessor-blinded, controlled, 1-day trial. The primary end points were the skin hydration and TEWL, evaluated at the volar surface of the forearm and in standardized conditions (temperature- and humidity-controlled room: 23°C and 30% of humidity) using a corneometer and a vapometer device at baseline, 1, 8 and 24 hours after JCS fluid application. Measurements were performed by an operator blinded for the treatments. Results Skin hydration after 24 hours was significantly higher (P=0.001; Mann–Whitney U test) in the JCS-treated area in comparison with the control site. JCS induced a significant (P=0.0001) increase in skin hydration at each evaluation time (+59% after 1 hour, +48% after 8 hours and +29% after 24 hours) in comparison with both baseline (P=0.0001) and non-treated control site (P=0.001). TEWL after 24 hours was significantly lower (P=0.049; Mann–Whitney U test) in the JCS-treated area in comparison with the control site (13±4

  15. The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive–behavioural therapy

    PubMed Central

    Murphy, Glynis H.; Shepstone, Lee; Wilson, Edward C.F.; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

    2016-01-01

    Background There is a growing interest in using cognitive–behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. Aims To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Method Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. Results The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence. PMID:27703772

  16. The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive-behavioural therapy.

    PubMed

    Langdon, Peter E; Murphy, Glynis H; Shepstone, Lee; Wilson, Edward C F; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

    2016-03-01

    There is a growing interest in using cognitive-behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. None. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

  17. ‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    PubMed Central

    2012-01-01

    Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Discussion Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. Trial registration ClinicalTrials: NCT01070134 PMID:23253305

  18. Ballistic strength training compared with usual care for improving mobility following traumatic brain injury: protocol for a randomised, controlled trial.

    PubMed

    Williams, Gavin; Ada, Louise; Hassett, Leanne; Morris, Meg E; Clark, Ross; Bryant, Adam L; Olver, John

    2016-07-01

    will occur only if participants can perform the exercises ballistically. The control group will have their three 60-minute sessions of usual physiotherapy intervention (balance, strength, stretch, cardiovascular fitness, gait) standardised so that all participants have equivalent therapy time. Both groups will continue to receive usual rehabilitation. The primary outcome will be mobility, measured using the High Level Mobility Assessment Tool. The secondary outcomes will be walking speed, muscle strength, balance and health-related quality of life. Walking speed will be measured using the 10-m walking test. Strength will be measured by a 6 repetition maximum, seated, single leg press test. Balance will be measured as the single limb support time. Health-related quality of life will be measured using the Assessment of Quality of Life. Outcomes will be measured at baseline (0 months), at completion of the intervention phase (3 months), and 3 months after cessation of intervention (6 months). Baseline measures will be completed prior to randomisation. Assessors blinded to group allocation will perform all measures. Baseline characteristics of participants will be determined according to group, using descriptive statistics. The proportion of patients compliant with the intervention will be calculated according to group and compared using Fisher's exact test. Compliance with the intervention will be defined as those who have satisfactorily completed at least 80% of the allocated sessions (29 of 36 sessions). The between-group difference for all outcomes will be estimated using analysis of covariance, adjusting for baseline High Level Mobility Assessment Tool score, age, gender and length of post-traumatic amnesia. Analyses will be conducted on an intention-to-treat basis. Strength training in neurological rehabilitation is highly topical because muscle weakness has been identified as the primary impairment leading to mobility limitations in many neurological populations

  19. Novel Noxipoint Therapy versus Conventional Physical Therapy for Chronic Neck and Shoulder Pain: Multicentre Randomised Controlled Trials

    PubMed Central

    Koo, Charles C.; Lin, Ray S.; Wang, Tyng-Guey; Tsauo, Jau-Yih; Yang, Pan-Chyr; Yen, Chen-Tung; Biswal, Sandip

    2015-01-01

    As chronic pain affects 115 million people and costs $600B annually in the US alone, effective noninvasive nonpharmacological remedies are desirable. The purpose of this study was to determine the efficacy and the generalisability of Noxipoint therapy (NT), a novel electrotherapy characterised by site-specific stimulation, intensity-and-submodality-specific settings and a immobilization period, for chronic neck and shoulder pain. Ninety-seven heavily pretreated severe chronic neck/shoulder pain patients were recruited; 34 and 44 patients were randomly allocated to different treatment arms in two patient-and-assessor-blinded, randomised controlled studies. The participants received NT or conventional physical therapy including transcutaneous electrical nerve stimulation (PT-TENS) for three to six 90-minute sessions. In Study One, NT improved chronic pain (−89.6%, Brief Pain Inventory, p < 0.0001, 95% confidence interval), function (+77.4%, range of motion) and quality of life (+88.1%) at follow-up (from 4 weeks to 5 months), whereas PT-TENS resulted in no significant changes in these parameters. Study Two demonstrated similar advantages of NT over PT-TENS and the generalisability of NT. NT-like treatments in a randomised rat study showed a similar reduction in chronic hypersensitivity (−81%, p < 0.01) compared with sham treatments. NT substantially reduces chronic neck and shoulder pain, restores function, and improves quality of life in a sustained manner. PMID:26552835

  20. Does central venous oxygen saturation-directed fluid therapy affect postoperative morbidity after colorectal surgery? A randomized assessor-blinded controlled trial.

    PubMed

    Jammer, Ib; Ulvik, Atle; Erichsen, Christian; Lødemel, Olav; Ostgaard, Gro

    2010-11-01

    The optimal amount and method for monitoring intravenous fluid in surgical patients is unresolved. Central venous oxygen saturation (Scvo2) has been used to guide therapy and predict outcome in high-risk and intensive-care patients. The aim of this prospective, randomized trial was to compare the rate of postoperative complications in patients receiving fluid therapy guided by Scvo2 and those treated with a traditional effluent fluid scheme. Patients undergoing open colorectal and lower intestinal surgery (n = 241) were randomized to the Scvo2 group or the control group. The Scvo2 group received perioperatively crystalloid infusion 100 ml/h. When Scvo2 was less than 75%, a bolus of 3 ml/kg hydroxyethyl starch was given. The bolus was repeated if Scvo2 increased by 1 percentage point or more. The control group was maintained with crystalloid 800 ml/h and given extra fluid if there were clinical signs of hypovolemia. The participating surgeon, unaware of the group allocation, registered complications within day 30. Until 8:00 am on the first postoperative day, the Scvo2 group had received 3,869 ± 992 ml (mean ± SD) intravenous fluid compared with 6,491 ± 1,649 ml in the control group. Increase in weight was 0.8 ± 1.8 kg and 2.5 ± 1.6 kg in the two groups, respectively. The postoperative complication rate was 42% in both groups. Clinical outcomes among patients receiving Scvo2-guided perioperative fluid therapy were similar to those for patients treated with a traditional fluid regimen. Limitations in study design prevent full interpretation of these findings, and further large trials of this treatment algorithm are still required.

  1. The SHED-IT community trial study protocol: a randomised controlled trial of weight loss programs for overweight and obese men

    PubMed Central

    2010-01-01

    Background Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men. Methods and Design The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40 (kg/m2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT (Self-Help, Exercise and Diet using Internet Technology) study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category (overweight, obese class I, obese class II) and randomised to one of three groups: (1) SHED-IT Resources - provision of materials (DVD, handbooks, pedometer, tape measure) with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary

  2. Taping across the upper trapezius muscle reduces activity during a standardized typing task - an assessor-blinded randomized cross-over study.

    PubMed

    Takasaki, Hiroshi; Delbridge, Blane Michael; Johnston, Venerina

    2015-02-01

    Clinically, taping is believed to alter muscle activity. The purpose of this study was to investigate: (1) whether taping across the upper trapezius (UT) muscle influenced the level of UT and lower trapezius (LT) muscle activity and the ratio of these activities (UT/LT ratio) during a static typing task; and (2) if the activity of these muscles varied with the application of tensioned taping. Forty-two healthy participants performed a 15-min typing task on three separate occasions under one of three conditions: taping applied perpendicular to the UT fibers with tension; taping without tension; and no taping. Activity of the UT and LT muscles was assessed using surface electromyography. Between conditions, significant differences were found in the change of the normalized amplitude in the UT activity (p=.027) and UT/LT ratio (p=.024) but not in the LT activity (p=.93). Compared with the no taping condition, the UT activity was less in both the tensioned taping (p=.009) and the non-tensioned taping (p=.004). There was no difference between the two taping conditions in the change of the UT (p=.91) activity and the UT/LT ratio (p=.92). In conclusion, both tensioned and non-tensioned taping across the UT muscle reduces its activity during a typing task.

  3. Effect of a High-Intensity Exercise Program on Physical Function and Mental Health in Nursing Home Residents with Dementia: An Assessor Blinded Randomized Controlled Trial

    PubMed Central

    Telenius, Elisabeth Wiken; Engedal, Knut; Bergland, Astrid

    2015-01-01

    Background Dementia is among the leading causes of functional loss and disability in older adults. Research has demonstrated that nursing home patients without dementia can improve their function in activities of daily living, strength, balance and mental well being by physical exercise. The evidence on effect of physical exercise among nursing home patients with dementia is scarce and ambiguous. Thus, the primary objective of this study was to investigate the effect of a high intensity functional exercise program on the performance of balance in nursing home residents with dementia. The secondary objective was to examine the effect of this exercise on muscle strength, mobility, activities of daily living, quality of life and neuropsychiatric symptoms. Design and Methods This single blinded randomized controlled trial was conducted among 170 persons with dementia living in nursing homes. Mean age was 86.7 years (SD = 7.4) and 74% were women. The participants were randomly allocated to an intervention (n = 87) or a control group (n = 83). The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities. Results The intervention group improved the score on Bergs Balance Scale by 2.9 points, which was significantly more than the control group who improved by 1.2 points (p = 0.02). Having exercised 12 times or more was significantly associated with improved strength after intervention (p<0.05). The level of apathy was lower in the exercise group after the intervention, compared to the control group (p = 0.048). Conclusion The results from our study indicate that a high intensity functional exercise program improved balance and muscle strength as well as reduced apathy in nursing home patients with dementia. Trial Registration ClinicalTrials.gov NCT02262104 PMID:25974049

  4. Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years.

    PubMed

    Willett, Keith; Keene, David J; Morgan, Lesley; Gray, Bridget; Handley, Robert; Chesser, Tim; Pallister, Ian; Tutton, Elizabeth; Knox, Christopher; Lall, Ranjit; Briggs, Andrew; Lamb, Sarah E

    2014-03-12

    Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery. This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud & Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10 weeks post treatment. This

  5. Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

    PubMed Central

    2014-01-01

    Background Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery. Methods/Design This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud & Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10

  6. Balance training reduces fear of falling and improves dynamic balance and isometric strength in institutionalised older people: a randomised trial.

    PubMed

    Gusi, Narcis; Carmelo Adsuar, Jose; Corzo, Hector; Del Pozo-Cruz, Borja; Olivares, Pedro R; Parraca, Jose A

    2012-01-01

    What is the effect of a balance training protocol with the Biodex Balance System in institutionalised older people with fear of falling? Randomised controlled trial with concealed allocation and assessor blinding. Forty older people who lived in a nursing home and had fear of falling. The experimental group completed a 12-week balance training protocol based on balancing/rebalancing training with the Biodex Balance System, with two sessions per week. During the training period, participants in both groups received the same multidisciplinary care (such as physiotherapy, occupational therapy and nursing) that they usually received in the nursing home. The primary outcome was fear of falling (Falls Efficacy Scale International questionnaire). Secondary outcomes were dynamic balance (Fall Risk Test) and isometric strength (torque of knee flexor and extensor isometric strength measured with an isokinetic dynamometer). Outcome measures were taken before and after the training program protocol. Compared to the control group, the exercise group had significantly greater improvements at 12 weeks in fear of falling (by 8 points, 95% CI 4 to 12), in dynamic balance (by 2 degrees, 95% CI 1 to 3), and in isometric strength of the knee flexors (by 7Nm, 95% CI 3 to 11) and knee extensors (by 7Nm, 95% CI 1 to 13). The training program was feasible and effective in reducing fear of falling and improving dynamic balance and isometric strength in institutionalised older people with fear of falling. ISRCTN21695765. Copyright © 2012 Australian Physiotherapy Association. Published by .. All rights reserved.

  7. The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial

    PubMed Central

    Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachael; Leurent, Baptiste; Sweeting, Michael J; Touquet, Robin; Greene, Linda; Tyrer, Peter; Ward, Helen; Lingford-Hughes, Anne

    2015-01-01

    Objectives To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics. Methods Two-arm, parallel group, assessor blind, pragmatic, randomised controlled trial. 802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment. Brief advice consisted of feedback on alcohol and health, written information and an offer of an appointment with an Alcohol Health Worker. Control participants received a leaflet on health and lifestyle. The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation. The main secondary outcome was unprotected sex during this period. Results Among the 402 randomised to brief advice, 397 (99%) received it. The adjusted mean difference in alcohol consumption at 6 months was −2.33 units per week (95% CI −4.69 to 0.03, p=0.053) among those in the active compared to the control arm of the trial. Unprotected sex was reported by 154 (53%) of those who received brief advice, and 178 (59%) controls (adjusted OR=0.89, 95% CI 0.63 to 1.25, p=0.496). There were no significant differences in costs between study groups at 6 months. Conclusions Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. Trial registration number Current Controlled Trials ISRCTN 99963322. PMID:24936090

  8. Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial.

    PubMed

    Cohen, Marc M; Smit, De Villiers; Andrianopoulos, Nick; Ben-Meir, Michael; Taylor, David McD; Parker, Shefton J; Xue, Chalie C; Cameron, Peter A

    2017-06-19

    This study aimed to assess analgesia provided by acupuncture, alone or in combination with pharmacotherapy, to patients presenting to emergency departments with acute low back pain, migraine or ankle sprain. A pragmatic, multicentre, randomised, assessor-blinded, equivalence and non-inferiority trial of analgesia, comparing acupuncture alone, acupuncture plus pharmacotherapy, and pharmacotherapy alone for alleviating pain in the emergency department. Setting, participants: Patients presenting to emergency departments in one of four tertiary hospitals in Melbourne with acute low back pain, migraine, or ankle sprain, and with a pain score on a 10-point verbal numerical rating scale (VNRS) of at least 4. The primary outcome measure was pain at one hour (T1). Clinically relevant pain relief was defined as achieving a VNRS score below 4, and statistically relevant pain relief as a reduction in VNRS score of greater than 2 units. 1964 patients were assessed between January 2010 and December 2011; 528 patients with acute low back pain (270 patients), migraine (92) or ankle sprain (166) were randomised to acupuncture alone (177 patients), acupuncture plus pharmacotherapy (178) or pharmacotherapy alone (173). Equivalence and non-inferiority of treatment groups was found overall and for the low back pain and ankle sprain groups in both intention-to-treat and per protocol (PP) analyses, except in the PP equivalence testing of the ankle sprain group. 15.6% of patients had clinically relevant pain relief and 36.9% had statistically relevant pain relief at T1; there were no between-group differences. The effectiveness of acupuncture in providing acute analgesia for patients with back pain and ankle sprain was comparable with that of pharmacotherapy. Acupuncture is a safe and acceptable form of analgesia, but none of the examined therapies provided optimal acute analgesia. More effective options are needed. Australian New Zealand Clinical Trials Registry, ACTRN12609000989246.

  9. A community-based strength training programme increases muscle strength and physical activity in young people with Down syndrome: a randomised controlled trial.

    PubMed

    Shields, Nora; Taylor, Nicholas F; Wee, Elin; Wollersheim, Dennis; O'Shea, Simone D; Fernhall, Bo

    2013-12-01

    This randomised controlled trial investigated the effects of a student-led progressive resistance training (PRT) programme in adolescents and young adults with Down syndrome. Sixty-eight young people with Down syndrome (30 female, 38 male; mean age 17.9±2.6 years) and mild to moderate intellectual disability were randomly allocated to a PRT programme (n=34) or a social group (n=34). Participants in the PRT group trained twice a week for 10 weeks at a community gymnasium with a physiotherapy student mentor using pin-loaded weight machines. Participants in the social group completed a 10-week programme of social activities also with a student mentor once a week for 90 min. Work performance, muscle strength and physical activity levels were assessed at weeks 0, 11 and 24 by an assessor blind to group allocation. Data were analysed using ANCOVA with baseline measures as covariate. Participants attended 92% of their scheduled sessions. There was no difference between the groups on work task performance. The PRT group increased their upper and lower limb strength at week 11 compared to the control group, but only their lower limb muscle strength at week 24. There was a significant difference in physical activity levels in favour of the PRT group at week 24 but not at week 11. PRT using a student mentor model helps young people with Down syndrome become stronger and more physically active but its effect on work task performance is unclear. Copyright © 2013 Elsevier Ltd. All rights reserved.

  10. A student-led progressive resistance training program increases lower limb muscle strength in adolescents with Down syndrome: a randomised controlled trial.

    PubMed

    Shields, Nora; Taylor, Nicholas F

    2010-01-01

    Does progressive resistance training improve muscle strength and physical function in adolescents with Down syndrome? Randomised controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. 23 adolescents with Down syndrome (17 boys, 6 girls; mean age 15.6 +/- 1.6 years) were randomly assigned to either an experimental group (n = 11) or a control group (n = 12). The intervention was a student-led progressive resistance training program, comprising 6 exercises using weight machines performed twice a week for 10 weeks. Participants completed 3 sets of 12 repetitions of each exercise or until they reached fatigue. The intervention took place in a community gymnasium. The control group continued with their usual activities. The outcomes measured at baseline and immediately after the intervention phase were muscle strength (1 repetition maximum), a timed stairs test, and the grocery shelving task. The experimental group attended 90% of their scheduled sessions. They demonstrated improvement in lower limb muscle strength compared to the control group (MD 36 kg, 95% CI 15 to 58). There were no significant differences between the groups for upper limb muscle strength or physical function measures. No major adverse events were recorded. Progressive resistance training is a feasible and safe exercise option that can improve lower limb muscle strength in adolescents with Down syndrome. ACTRN12608000261314.

  11. Double-dorsal versus single-volar digital subcutaneous anaesthetic injection for finger injuries in the emergency department: A randomised controlled trial.

    PubMed

    Martin, Shane P; Chu, Kevin H; Mahmoud, Ibrahim; Greenslade, Jaimi H; Brown, Anthony F T

    2016-04-01

    The objective of this present study is to compare pain associated with the double-dorsal versus a single-volar subcutaneous injection in the provision of digital anaesthesia for finger injuries presenting to the ED. A randomised controlled trial from November 2012 to January 2014 at a single adult tertiary-referral hospital. ED patients with finger injuries requiring digital anaesthesia was randomised to either the double-dorsal or a single-volar subcutaneous injection technique. The primary outcome was patient reported injection pain measured on a 100 mm visual analogue scale with the assessor blinded to the injection technique. The secondary outcome was success of anaesthesia defined as ability to perform the assessment and treatment without further anaesthetic supplementation after 5 min. Eighty-six patients were enrolled. Median (IQR) age was 34 (24-47) years and 79% were men. The majority (66.3%) had distal phalanx injuries. Forty patients were randomised to the double-dorsal and 46 to a single-volar subcutaneous injection technique. The mean (standard deviation) pain score of the double-dorsal injection was 39.1 (24.2) and a single-volar injection was 37.3 (24.5) with a difference of 1.8 (95% CI -8.8 to 12.3). Digital anaesthesia was successful in 64.9% of the double-dorsal and 71.7% of the single-volar subcutaneous injections, a difference of 6.8% (95% CI -12.7 to 26.3). In ED patients with finger injuries requiring digital anaesthesia, both the double-dorsal or single-volar subcutaneous injection techniques have similar pain of injection and success rates of anaesthesia. Single-volar injection appears suitable alternative to the commonly performed double-dorsal injection in the ED. © 2016 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  12. The PRICE study (Protection Rest Ice Compression Elevation): design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain [ISRCTN13903946].

    PubMed

    Bleakley, Chris M; O'Connor, Seán; Tully, Mark A; Rocke, Laurence G; Macauley, Domnhall C; McDonough, Suzanne M

    2007-12-19

    Cryotherapy (the application of ice for therapeutic purposes) is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury. Despite its widespread clinical use, the precise physiological responses to therapeutic cooling have not been fully elucidated, and effective evidence-based treatment protocols are yet to be established. Intermittent ice applications are thought to exert a significant analgesic effect. This could facilitate earlier therapeutic exercise after injury, potentially allowing for a quicker return to activity. The primary aim of the forthcoming study is therefore to examine the safety and effectiveness of combining intermittent ice applications with periods of therapeutic exercise in the first week after an acute ankle sprain. The study is a randomised controlled trial. 120 subjects with an acute grade I or grade II ankle sprain will be recruited from Accident & Emergency and a University based Sports Injury Clinic. Subjects will be randomised under strict double-blind conditions to either a standard cryotherapy (intermittent ice applications with compression) or cryokinetic treatment group (intermittent ice applications with compression and therapeutic exercise). After the first week, treatment will be standardised across groups. Assessor blinding will be maintained throughout the trial. Primary outcome will be function, assessed using the Lower Extremity Functional Scale (LEFS). Additional outcomes will include pain (10 cm Visual Analogue Scale), swelling (modified figure-of-eight method) and activity levels (activPALtrade mark physical activity monitor, PAL Technologies, Glasgow, UK). Diagnostic Ultrasound (Episcan-1-200 high frequency ultrasound scanning system, Longport International Ltd, PA) will also be used to assess the degree of soft tissue injury. After baseline assessment subjects will be followed up at 1, 2, 3 & 4 weeks post injury. All data will be analysed using repeated measures

  13. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. Methods/design A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. Discussion The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. Trial registration NCT01086930 (12th March 2010) ACTRN12609000695202 (12th August 2009) PMID:21235821

  14. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial.

    PubMed

    Harvey, Lisa A; Dunlop, Sarah A; Churilov, Leonid; Hsueh, Ya-Seng Arthur; Galea, Mary P

    2011-01-17

    Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009).

  15. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    PubMed

    French, Helen P; Cusack, Tara; Brennan, Aisling; White, Breon; Gilsenan, Clare; Fitzpatrick, Martina; O'Connell, Paul; Kane, David; Fitzgerald, Oliver; McCarthy, Geraldine M

    2009-01-19

    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. 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. 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 results will contribute to the evidence base regarding the clinical

  16. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

    PubMed Central

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-01-01

    Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer

  17. Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU: protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients. Methods/Design The Transfusion Requirements in Septic Shock (TRISS) trial is a multicenter trial with assessor-blinded outcome assessment, randomising 1,000 patients with septic shock in 30 Scandinavian ICUs to receive transfusion with pre-storage leuko-depleted RBC suspended in saline-adenine-glucose and mannitol (SAGM) at haemoglobin level (Hb) of 7 g/dl or 9 g/dl, stratified by the presence of haematological malignancy and centre. The primary outcome measure is 90-day mortality. Secondary outcome measures are organ failure, ischaemic events, severe adverse reactions (SARs: anaphylactic reaction, acute haemolytic reaction and transfusion-related circulatory overload, and acute lung injury) and mortality at 28 days, 6 months and 1 year. The sample size will enable us to detect a 9% absolute difference in 90-day mortality assuming a 45% event rate with a type 1 error rate of 5% and power of 80%. An interim analysis will be performed after 500 patients, and the Data Monitoring and Safety Committee will recommend the trial be stopped if a group difference in 90-day mortality with P ≤0.001 is present at this point. Discussion The TRISS trial may bridge the gap between clinical practice and the lack of efficacy and safety data on RBC transfusion in septic shock patients. The effect of restrictive versus liberal RBC transfusion strategy on mortality, organ failure, ischaemic events and SARs will be evaluated. Trial registration ClinicalTrials.gov: NCT01485315. Registration date 30 November 2011. First patient was randomised 3 December 2011. PMID:23702006

  18. Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial.

    PubMed

    George, Anne; Mathews, Jiji E; Sam, Dibu; Beck, Manisha; Benjamin, Santosh J; Abraham, Anuja; Antonisamy, Balevendra; Jana, Atanu K; Thomas, Nihal

    2015-02-01

    Two oral hypoglycaemic agents, metformin and glibenclamide, have been compared with insulin in separate large randomised controlled trials and have been found to be as effective as insulin in gestational diabetes. However, very few trials have compared metformin with glibenclamide. Of 159 South Indian women with fasting glucose ≥5.5 mmol/l and ≤7.2 mmol/l and/or 2-h post-prandial value ≥6.7 mmol/l and ≤13.9 mmol/l after medical nutritional therapy consented to be randomised to receive either glibenclamide or metformin. 80 women received glibenclamide and 79 received metformin. Neonatal outcomes were assessed by neonatologists who were unaware that the mother was part of a study and were recorded by assessors blinded to the medication the mother was given. The primary outcome was a composite of neonatal outcomes namely macrosomia, hypoglycaemia, need for phototherapy, respiratory distress, stillbirth or neonatal death and birth trauma. Secondary outcomes were birthweight, maternal glycaemic control, pregnancy induced hypertension, preterm birth, need for induction of labour, mode of delivery and complications of delivery. Baseline characteristics were similar but for the higher fasting triglyceride levels in women on metformin. The primary outcome was seen in 35% of the glibenclamide group and 18.9% of the metformin group [95% CI 16.1 (2.5, 29.7); P = 0.02]. The difference in outcome related to a higher rate of neonatal hypoglycaemia in the glibenclamide group (12.5%) versus none in the metformin group [95% CI 12.5(5.3, 19.7); P = 0.001]. Secondary outcomes in both groups were similar. In a south Indian population with gestational diabetes, metformin was associated with better neonatal outcomes than glibenclamide. © 2015 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  19. Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial.

    PubMed

    Griffin, Damian; Parsons, Nick; Shaw, Ewart; Kulikov, Yuri; Hutchinson, Charles; Thorogood, Margaret; Lamb, Sarah E

    2014-07-24

    To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures. Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial). 22 tertiary referral hospitals, United Kingdom. 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment. The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat. 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference -7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8). Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541. © Griffin et al 2014.

  20. Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial.

    PubMed

    Haran, Mark J; Cameron, Ian D; Ivers, Rebecca Q; Simpson, Judy M; Lee, Bonsan B; Tanzer, Michael; Porwal, Mamta; Kwan, Marcella M S; Severino, Connie; Lord, Stephen R

    2010-05-25

    To determine whether the provision of single lens distance glasses to older wearers of multifocal glasses reduces falls. Parallel randomised controlled trial stratified by recruitment site and source of referral, with 13 months' follow-up and outcome assessors blinded to group allocation. Community recruitment and treatment room assessments in Sydney and Illawarra regions of NSW, Australia. 606 regular wearers of multifocal glasses (mean age 80 (SD 7) years). Inclusion criteria included increased risk of falls (fall in previous year or timed up and go test >15 seconds) and outdoor use of multifocal glasses at least three times a week. Provision of single lens distance glasses with recommendations for wearing them for walking and outdoor activities compared with usual care. Number of falls and injuries resulting from falls during follow-up. Single lens glasses were provided to 275 (90%) of the 305 intervention group participants within two months; 162 (54%) of the intervention group reported satisfactory use of distance glasses for walking and outdoor activities for at least 7/12 months after dispensing. In the 299 intervention and 298 control participants available to follow-up, the intervention resulted in an 8% reduction in falls (incidence rate ratio 0.92, 95% confidence interval 0.73 to 1.16). Pre-planned sub-group analyses showed that the intervention was effective in significantly reducing all falls (incidence rate ratio 0.60, 0.42 to 0.87), outside falls, and injurious falls in people who regularly took part in outside activities. A significant increase in outside falls occurred in people in the intervention group who took part in little outside activity. With appropriate counselling, provision of single lens glasses for older wearers of multifocal glasses who take part in regular outdoor activities is an effective falls prevention strategy. The intervention may be harmful, however, in multifocal glasses wearers with low levels of outdoor activity. Clinical

  1. Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU: protocol for a randomised controlled trial.

    PubMed

    Holst, Lars B; Haase, Nicolai; Wetterslev, Jørn; Wernerman, Jan; Aneman, Anders; Guttormsen, Anne B; Johansson, Pär I; Karlsson, Sari; Klemenzson, Gudmundur; Winding, Robert; Nebrich, Lars; Albeck, Carsten; Vang, Marianne L; Bülow, Hans-Henrik; Elkjær, Jeanie M; Nielsen, Jane S; Kirkegaard, Peter; Nibro, Helle; Lindhardt, Anne; Strange, Ditte; Thormar, Katrin; Poulsen, Lone M; Berezowicz, Pawel; Bådstøløkken, Per M; Strand, Kristian; Cronhjort, Maria; Haunstrup, Elsebeth; Rian, Omar; Oldner, Anders; Bendtsen, Asger; Iversen, Susanne; Langva, Jørn-Åge; Johansen, Rasmus B; Nielsen, Niklas; Pettilä, Ville; Reinikainen, Matti; Keld, Dorte; Leivdal, Siv; Breider, Jan-Michael; Tjäder, Inga; Reiter, Nanna; Gøttrup, Ulf; White, Jonathan; Wiis, Jørgen; Andersen, Lasse Høgh; Steensen, Morten; Perner, Anders

    2013-05-23

    Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients. The Transfusion Requirements in Septic Shock (TRISS) trial is a multicenter trial with assessor-blinded outcome assessment, randomising 1,000 patients with septic shock in 30 Scandinavian ICUs to receive transfusion with pre-storage leuko-depleted RBC suspended in saline-adenine-glucose and mannitol (SAGM) at haemoglobin level (Hb) of 7 g/dl or 9 g/dl, stratified by the presence of haematological malignancy and centre. The primary outcome measure is 90-day mortality. Secondary outcome measures are organ failure, ischaemic events, severe adverse reactions (SARs: anaphylactic reaction, acute haemolytic reaction and transfusion-related circulatory overload, and acute lung injury) and mortality at 28 days, 6 months and 1 year.The sample size will enable us to detect a 9% absolute difference in 90-day mortality assuming a 45% event rate with a type 1 error rate of 5% and power of 80%. An interim analysis will be performed after 500 patients, and the Data Monitoring and Safety Committee will recommend the trial be stopped if a group difference in 90-day mortality with P ≤0.001 is present at this point. The TRISS trial may bridge the gap between clinical practice and the lack of efficacy and safety data on RBC transfusion in septic shock patients. The effect of restrictive versus liberal RBC transfusion strategy on mortality, organ failure, ischaemic events and SARs will be evaluated.

  2. The PRICE study (Protection Rest Ice Compression Elevation): design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain [ISRCTN13903946

    PubMed Central

    Bleakley, Chris M; O'Connor, Seán; Tully, Mark A; Rocke, Laurence G; MacAuley, Domnhall C; McDonough, Suzanne M

    2007-01-01

    Background Cryotherapy (the application of ice for therapeutic purposes) is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury. Despite its widespread clinical use, the precise physiological responses to therapeutic cooling have not been fully elucidated, and effective evidence-based treatment protocols are yet to be established. Intermittent ice applications are thought to exert a significant analgesic effect. This could facilitate earlier therapeutic exercise after injury, potentially allowing for a quicker return to activity. The primary aim of the forthcoming study is therefore to examine the safety and effectiveness of combining intermittent ice applications with periods of therapeutic exercise in the first week after an acute ankle sprain. Methods/Design The study is a randomised controlled trial. 120 subjects with an acute grade I or grade II ankle sprain will be recruited from Accident & Emergency and a University based Sports Injury Clinic. Subjects will be randomised under strict double-blind conditions to either a standard cryotherapy (intermittent ice applications with compression) or cryokinetic treatment group (intermittent ice applications with compression and therapeutic exercise). After the first week, treatment will be standardised across groups. Assessor blinding will be maintained throughout the trial. Primary outcome will be function, assessed using the Lower Extremity Functional Scale (LEFS). Additional outcomes will include pain (10 cm Visual Analogue Scale), swelling (modified figure-of-eight method) and activity levels (activPAL™ physical activity monitor, PAL Technologies, Glasgow, UK). Diagnostic Ultrasound (Episcan-1-200 high frequency ultrasound scanning system, Longport International Ltd, PA) will also be used to assess the degree of soft tissue injury. After baseline assessment subjects will be followed up at 1, 2, 3 & 4 weeks post injury. All data will be analysed using

  3. A pragmatic randomised multi-centre trial of multifamily and single family therapy for adolescent anorexia nervosa.

    PubMed

    Eisler, Ivan; Simic, Mima; Hodsoll, John; Asen, Eia; Berelowitz, Mark; Connan, Frances; Ellis, Gladys; Hugo, Pippa; Schmidt, Ulrike; Treasure, Janet; Yi, Irene; Landau, Sabine

    2016-11-24

    Considerable progress has been made in recent years in developing effective treatments for child and adolescent anorexia nervosa, with a general consensus in the field that eating disorders focussed family therapy (often referred to as Maudsley Family Therapy or Family Based Treatment) currently offers the most promising outcomes. Nevertheless, a significant number do not respond well and additional treatment developments are needed to improve outcomes. Multifamily therapy is a promising treatment that has attracted considerable interest and we report the results of the first randomised controlled trial of multifamily therapy for adolescent anorexia nervosa. The study was a pragmatic multicentre randomised controlled superiority trial comparing two outpatient eating disorder focussed family interventions - multifamily therapy (MFT-AN) and single family therapy (FT-AN). A total of 169 adolescents with a DSM-IV diagnosis of anorexia nervosa or eating disorder not otherwise specified (restricting type) were randomised to the two treatments using computer generated blocks of random sizes to ensure balanced numbers in the trial arms. Independent assessors, blind to the allocation, completed evaluations at baseline, 3 months, 12 months (end of treatment) and 18 months. Both treatment groups showed clinically significant improvements with just under 60% achieving a good or intermediate outcome (on the Morgan-Russell scales) at the end of treatment in the FT-AN group and more than 75% in the MFT-AN group - a statistically significant benefit in favour of the multifamily intervention (OR = 2.55 95%; CI 1.17, 5.52; p = 0.019). At follow-up (18 months post baseline) there was relatively little change compared to end of treatment although the difference in primary outcome between the treatments was no longer statistically significant. Clinically significant gains in weight were accompanied by improvements in mood and eating disorder psychopathology. Approximately

  4. A randomised clinical trial comparing 2% econazole and 5% natamycin for the treatment of fungal keratitis

    PubMed Central

    Prajna, N V; John, R K; Nirmalan, P K; Lalitha, P; Srinivasan, M

    2003-01-01

    Aim: To compare 2% econazole and 5% natamycin in the management of fungal keratitis. Methods: A randomised clinical trial was performed using 2% econazole or 5% natamycin as the two treatment arms on patients presenting with culture positive fungal keratitis to the cornea service at Aravind Eye Care System, Madurai, India. Results: 116 patients were recruited, and 112 continued in the study. There were no significant differences between the two arms at baseline or for success (defined as a healed or healing ulcer) at final visit (p = 0.79). Conclusions: 2% Econazole appears to be as effective as 5% natamycin for the management of fungal keratitis. PMID:14507756

  5. A randomised clinical trial comparing 2% econazole and 5% natamycin for the treatment of fungal keratitis.

    PubMed

    Prajna, N V; John, R K; Nirmalan, P K; Lalitha, P; Srinivasan, M

    2003-10-01

    To compare 2% econazole and 5% natamycin in the management of fungal keratitis. A randomised clinical trial was performed using 2% econazole or 5% natamycin as the two treatment arms on patients presenting with culture positive fungal keratitis to the cornea service at Aravind Eye Care System, Madurai, India. 116 patients were recruited, and 112 continued in the study. There were no significant differences between the two arms at baseline or for success (defined as a healed or healing ulcer) at final visit (p = 0.79). 2% Econazole appears to be as effective as 5% natamycin for the management of fungal keratitis.

  6. A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial.

    PubMed

    Saxon, David; Ashley, Kate; Bishop-Edwards, Lindsey; Connell, Janice; Harrison, Phillippa; Ohlsen, Sally; Hardy, Gillian E; Kellett, Stephen; Mukuria, Clara; Mank, Toni; Bower, Peter; Bradburn, Mike; Brazier, John; Elliott, Robert; Gabriel, Lynne; King, Michael; Pilling, Stephen; Shaw, Sue; Waller, Glenn; Barkham, Michael

    2017-03-01

    NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required. PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per

  7. Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

    PubMed

    Molt, Mats; Toksvig-Larsen, Sören

    2014-10-01

    The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

  8. Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640

    PubMed Central

    Buchbinder, Rachelle; Osborne, Richard H; Ebeling, Peter R; Wark, John D; Mitchell, Peter; Wriedt, Chris J; Wengier, Lainie; Connell, David; Graves, Stephen E; Staples, Margaret P; Murphy, Bridie

    2008-01-01

    Background Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years. Design A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms (< and ≥ 6 weeks), gender and treating radiologist and randomly allocated to either the treatment or placebo. Outcomes will be assessed at baseline, 1 week, 1, 3, 6, 12 and 24 months. Outcome measures include overall, night and rest pain on 10 cm visual analogue scales, quality of life measured by the Assessment of Quality of Life, Osteoporosis Quality of Life and EQ-5D questionnaires; participant perceived recovery on a 7-point ordinal scale ranging from 'a great deal worse' to 'a great deal better'; disability measured by the

  9. Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial.

    PubMed

    Kim, Joo-Hee; Jung, Hyun Jung; Kim, Tae-Hun; Lee, Seunghoon; Kim, Jung-Eun; Kang, Kyung-Won; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Shin, Mi-Suk; Shin, Kyung-Min; Jung, Hee-Jung; Lee, Seung-Deok; Hong, Kwon-Eui; Choi, Sun-Mi

    2013-09-22

    Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture. This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit. This pilot multicentre

  10. A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol

    PubMed Central

    2012-01-01

    Background Knee osteoarthritis (OA) is a prevalent chronic musculoskeletal condition with no cure. Pain is the primary symptom and results from a complex interaction between structural changes, physical impairments and psychological factors. Much evidence supports the use of strengthening exercises to improve pain and physical function in this patient population. There is also a growing body of research examining the effects of psychologist-delivered pain coping skills training (PCST) particularly in other chronic pain conditions. Though typically provided separately, there are symptom, resource and personnel advantages of exercise and PCST being delivered together by a single healthcare professional. Physiotherapists are a logical choice to be trained to deliver a PCST intervention as they already have expertise in administering exercise for knee OA and are cognisant of the need for a biopsychosocial approach to management. No studies to date have examined the effects of an integrated exercise and PCST program delivered solely by physiotherapists in this population. The primary aim of this multisite randomised controlled trial is to investigate whether an integrated 12-week PCST and exercise treatment program delivered by physiotherapists is more efficacious than either program alone in treating pain and physical function in individuals with knee OA. Methods/design This will be an assessor-blinded, 3-arm randomised controlled trial of a 12-week intervention involving 10 physiotherapy visits together with home practice. Participants with symptomatic and radiographic knee OA will be recruited from the community in two cities in Australia and randomized into one of three groups: exercise alone, PCST alone, or integrated PCST and exercise. Randomisation will be stratified by city (Melbourne or Brisbane) and gender. Primary outcomes are overall average pain in the past week measured by a Visual Analogue Scale and physical function measured by the Western Ontario and Mc

  11. A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol.

    PubMed

    Bennell, Kim L; Ahamed, Yasmin; Bryant, Christina; Jull, Gwendolen; Hunt, Michael A; Kenardy, Justin; Forbes, Andrew; Harris, Anthony; Nicholas, Michael; Metcalf, Ben; Egerton, Thorlene; Keefe, Francis J

    2012-07-24

    Knee osteoarthritis (OA) is a prevalent chronic musculoskeletal condition with no cure. Pain is the primary symptom and results from a complex interaction between structural changes, physical impairments and psychological factors. Much evidence supports the use of strengthening exercises to improve pain and physical function in this patient population. There is also a growing body of research examining the effects of psychologist-delivered pain coping skills training (PCST) particularly in other chronic pain conditions. Though typically provided separately, there are symptom, resource and personnel advantages of exercise and PCST being delivered together by a single healthcare professional. Physiotherapists are a logical choice to be trained to deliver a PCST intervention as they already have expertise in administering exercise for knee OA and are cognisant of the need for a biopsychosocial approach to management. No studies to date have examined the effects of an integrated exercise and PCST program delivered solely by physiotherapists in this population. The primary aim of this multisite randomised controlled trial is to investigate whether an integrated 12-week PCST and exercise treatment program delivered by physiotherapists is more efficacious than either program alone in treating pain and physical function in individuals with knee OA. This will be an assessor-blinded, 3-arm randomised controlled trial of a 12-week intervention involving 10 physiotherapy visits together with home practice. Participants with symptomatic and radiographic knee OA will be recruited from the community in two cities in Australia and randomized into one of three groups: exercise alone, PCST alone, or integrated PCST and exercise. Randomisation will be stratified by city (Melbourne or Brisbane) and gender. Primary outcomes are overall average pain in the past week measured by a Visual Analogue Scale and physical function measured by the Western Ontario and McMaster Universities

  12. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering

    PubMed Central

    Mittal, Geeta; Gupta, Kanchan; Katyal, Sunil; Kaushal, Sandeep

    2014-01-01

    Background and Aims: Dexmedetomidine (α2 adrenergic agonist) has been used for prevention of post anaesthesia shivering. Its use for the treatment of post-spinal anaesthesia shivering has not been evaluated. The aim of this study was to evaluate and compare the efficacy, haemodynamic and adverse effects of dexmedetomidine with those of tramadol, when used for control of post-spinal anaesthesia shivering. Methods: A prospective, randomised, and double-blind study was conducted in 50 American Society of Anaesthesiologists Grade I and II patients of either gender, aged between 18 and 65 years, scheduled for various surgical procedures under spinal anaesthesia. The patients were randomised in two groups of 25 patients each to receive either dexmedetomidine 0.5 μg/kg or tramadol 0.5 mg/kg as a slow intravenous bolus. Grade of shivering, onset of shivering, time for cessation of shivering, recurrence, response rate, and adverse effects were observed at scheduled intervals. Unpaired t-test was used for analysing the data. Results: Time taken for cessation of shivering was significantly less with dexmedetomidine when compared to tramadol. Nausea and vomiting was observed only in tramadol group (28% and; 20% respectively). There was not much difference in the sedation profile of both the drugs. Conclusion: We conclude that although both drugs are effective, the time taken for cessation of shivering is less with dexmedetomidine when compared to tramadol. Moreover, dexmedetomidine has negligible adverse effects, whereas tramadol is associated with significant nausea and vomiting. PMID:25024466

  13. The effects of the Bowen technique on hamstring flexibility over time: a randomised controlled trial.

    PubMed

    Marr, Michelle; Baker, Julian; Lambon, Nicky; Perry, Jo

    2011-07-01

    The hamstring muscles are regularly implicated in recurrent injuries, movement dysfunction and low back pain. Links between limited flexibility and development of neuromusculoskeletal symptoms are frequently reported. The Bowen Technique is used to treat many conditions including lack of flexibility. The study set out to investigate the effect of the Bowen Technique on hamstring flexibility over time. An assessor-blind, prospective, randomised controlled trial was performed on 120 asymptomatic volunteers. Participants were randomly allocated into a control group or Bowen group. Three flexibility measurements occurred over one week, using an active knee extension test. The intervention group received a single Bowen treatment. A repeated measures univariate analysis of variance, across both groups for the three time periods, revealed significant within-subject and between-subject differences for the Bowen group. Continuing increases in flexibility levels were observed over one week. No significant change over time was noted for the control group.

  14. Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial

    PubMed Central

    2013-01-01

    Background The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care. Methods/designs This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck

  15. Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial.

    PubMed

    Lee, Seunghoon; Kim, Kun Hyung; Kim, Tae-Hun; Kim, Jung-Eun; Kim, Joo-Hee; Kang, Jung Won; Kang, Kyung-Won; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Shin, Mi-Suk; Hong, Kwon-Eui; Song, Ho-Sueb; Choi, Jin-Bong; Kim, Hyung-Jun; Choi, Sun-Mi

    2013-03-13

    The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care. This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical

  16. Group therapy for adolescents with repeated self harm: randomised controlled trial with economic evaluation.

    PubMed

    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 (<4%). On all outcomes the trial cohort as a whole showed significant improvement from baseline to follow-up. On the primary outcome of frequency of 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

  17. Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy.

    PubMed

    Andersen, L L; Zobbe, V; Ottesen, B; Gluud, C; Tabor, A; Gimbel, H

    2015-05-01

    To compare the rates of urinary incontinence (UI) and other complications of subtotal abdominal hysterectomy (SAH) with total abdominal hysterectomy (TAH) at 5 years after surgery. Randomised clinical trial with central, computer-generated randomisation. Danish multi-centre trial performed in 11 departments of gynaecology. Women referred with benign uterine diseases scheduled for abdominal hysterectomy. Women were randomised to either SAH (n = 161) or TAH (n = 158). Follow-up data were collected from participants using postal questionnaires sent out 5 years after surgery. Complications of hysterectomy were further examined by scrutinising registered discharge summaries following hospitalisation. Intention-to-treat and per-protocol analyses were conducted. Potential bias caused by missing data was handled using multiple imputation. The primary outcome was UI. Secondary outcomes included constipation, prolapse of the vaginal vault or cervical stump, satisfaction with sexual life, pelvic pain, postoperative complications and vaginal bleeding. The response rate was 234/319 (73.4%). A significantly higher proportion of respondents had urinary incontinence 5 years after SAH 34/113 (30.1%) than TAH 21/119 (17.6%) (RR 1.71, 95% confidence interval 1.06-2.75, P = 0.026). This difference reduced after multiple imputation to account for missing data (RR 1.37, 95% confidence interval 0.99-1.89, P = 0.052). Eleven of the 101 women (11%) in the SAH group still experienced vaginal bleeding. No other differences were found between the two types of abdominal hysterectomy. A smaller proportion of women suffered from UI after TAH than after SAH 5 years postoperatively. Around one in ten women continued to experience vaginal bleeding 5 years after SAH. © 2014 Royal College of Obstetricians and Gynaecologists.

  18. Comparison of long-pulsed alexandrite and Nd:YAG lasers, individually and in combination, for leg hair reduction: an assessor-blinded, randomized trial with 18 months of follow-up.

    PubMed

    Davoudi, Seyyed Masoud; Behnia, Fereydoun; Gorouhi, Farzam; Keshavarz, Saeed; Nassiri Kashani, Mansour; Rashighi Firoozabadi, Mehdi; Firooz, Alireza

    2008-10-01

    To compare the long-term effectiveness and safety of long-pulsed Nd:YAG and alexandrite lasers, individually and in combination, in long-term leg hair reduction. Randomized, single-center, within-participant, investigator-blinded, active-controlled clinical trial. Private skin laser center. Twenty individuals aged 16 to 50 years with skin phototypes III and IV. The medial and lateral sides of each participant's legs were randomly assigned to receive 1 of the following laser treatments: (1) long-pulsed 1064-nm Nd:YAG laser (12-mm spot size); (2) long-pulsed 755-nm alexandrite laser (12-mm spot size); (3) long-pulsed 755-nm alexandrite laser (18-mm spot size); and (4) a combination of long-pulsed 1064-nm Nd:YAG laser and long-pulsed 755-nm alexandrite laser (treatments 1 and 2). Identified areas were treated for a total of 4 sessions at 8-week intervals. Hair reduction from baseline based on hair counting with digital photography by 2 blinded assessors, 8 and 18 months after the last treatment session. Fifteen participants completed the trial. The mean (SD) hair reduction 18 months after the last treatment, as measured by the assessors from digital photographs, were 75.9% (19.0%) for the 12-mm spot size alexandrite laser, 84.3% (12.4%) for the 18-mm spot size alexandrite laser, 73.6% (11.4%) for the Nd:YAG laser, and 77.8% (15.9%) for the combination therapy (analysis of variance, P > .05). The incidence of adverse effects (hyperpigmentation) and pain severity were significantly greater in areas that received combination therapy (P = .001). After 18 months of follow-up, alexandrite and Nd:YAG lasers were efficacious for leg hair removal. Combination therapy did not have any additional benefit and caused more adverse effects.

  19. Effectiveness of a behavioural intervention to prevent excessive weight gain during infancy (The Baby Milk Trial): study protocol for a randomised controlled trial.

    PubMed

    Lakshman, Rajalakshmi; Whittle, Fiona; Hardeman, Wendy; Suhrcke, Marc; Wilson, Ed; Griffin, Simon; Ong, Ken K

    2015-10-06

    Infancy is a period of rapid growth and habit formation and hence could be a critical period for obesity prevention. Excess weight gain during infancy is associated with later obesity and formula-fed babies are more likely to gain excess weight compared to breastfed babies. The primary trial outcome is a change in the weight standard deviation score from birth to 1 year. We will recruit 650 to 700 parents who introduce formula-milk feeds within 14 weeks of their baby's birth to a single (assessor) blind, parallel group, individually randomised controlled trial. The focus of the intervention is the caregiver (usually the mother), and the focus of the primary outcome is the infant. The intervention group will receive the behavioural intervention, which aims to reduce formula-milk intake, promote responsive feeding and healthy weaning, and prevent excessive weight gain during infancy. The intervention is based on Social Cognitive Theory and action planning ('implementation intentions'). It consists of three components: (1) a motivational component to strengthen parents' motivation to follow the Baby Milk feeding guidelines, (2) an action planning component to help translate motivation into action, and (3) a coping planning component to help parents deal with difficult situations. It will be delivered by trained facilitators (research nurses) over 6 months through three face-to-face contacts, two telephone contacts and written materials. The control group will have the same number of contacts with facilitators, and general issues about feeding will be discussed. Anthropometric outcomes will be measured by trained research staff, blind to group allocation, at baseline, 6 months and 12 months following standard operating procedures. Validated questionnaires will assess milk intake, temperament, appetite, sleep, maternal quality of life and maternal psychological factors. A 4-day food diary will be completed at 8 months. The results of the trial will help to inform infant

  20. Betamethasone valerate dressing is non-inferior to calcipotriol–betamethasone dipropionate ointment in the treatment of patients with mild-to-moderate chronic plaque psoriasis: results of a randomized assessor-blinded multicentre trial

    PubMed Central

    Ortonne, J-P; Esposito, M; Chimenti, S; Kapińska-Mrowiecka, M; Grodzińska, A; Naldi, L; Frangione, V

    2014-01-01

    Background A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP). Methods This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol–betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients’ quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group. Results Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a −0.288 (95% CI: −0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group. Conflicts of interest Centro Studi GISED, the centre led by LN, received a grant from IBSA Institut Biochimique SA. VF is an employee of IBSA Institut Biochimique SA. PMID:24256460

  1. Betamethasone valerate dressing is non-inferior to calcipotriol-betamethasone dipropionate ointment in the treatment of patients with mild-to-moderate chronic plaque psoriasis: results of a randomized assessor-blinded multicentre trial.

    PubMed

    Ortonne, J-P; Esposito, M; Chimenti, S; Kapińska-Mrowiecka, M; Grodzińska, A; Naldi, L; Frangione, V

    2014-09-01

    A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP). This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol-betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients' quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group. Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a -0.288 (95% CI: -0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group. BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP. Both treatments significantly improve patients' psoriasis and QoL. © 2013 Laboratoires Genevrier/IBSA Institut Biochimique SA (Switzerland). Journal of the European Academy of

  2. Sacroiliac joint pain: Prospective, randomised, experimental and comparative study of thermal radiofrequency with sacroiliac joint block.

    PubMed

    Cánovas Martínez, L; Orduña Valls, J; Paramés Mosquera, E; Lamelas Rodríguez, L; Rojas Gil, S; Domínguez García, M

    2016-05-01

    To compare the analgesic effects between the blockade and bipolar thermal radiofrequency in the treatment of sacroiliac joint pain. Prospective, randomised and experimental study conducted on 60 patients selected in the two hospitals over a period of nine months, who had intense sacroiliac joint pain (Visual Analogue Scale [VAS]>6) that lasted more than 3 months. Patients were randomised into three groups (n=20): Group A (two intra-articular sacroiliac injections of local anaesthetic/corticosteroid guided by ultrasound in 7 days). Group B: conventional bipolar radiofrequency "palisade". Target points were the lateral branch nerves of S1, S2, and S3, distance needles 1cm. Group C: modified bipolar radiofrequency "palisade" (needle distance >1cm). Patients were evaluated at one month, three months, and one year. Demographic data, VAS reduction, and side effects of the techniques were assessed. One month after the treatment, pain reduction was >50% in the three groups P<.001. Three and 12 months after the technique, the patients of the group A did not have a significant reduction in pain. At 3 months, almost 50% patients of the group B referred to improvement of the pain (P=.03), and <25% at 12 months, and those results were statistically significant (P=.01) compared to the baseline. Group C showed an improvement of 50% at 3 and 12 months (P<.001). All patients completed the study. Bipolar radiofrequency "palisade", especially when the distance between the needles was increased, was more effective and lasted longer, compared to join block and steroids, in relieving pain sacroiliac joint. Copyright © 2015 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

  3. Pressure ulcers--randomised controlled trial comparing hydrocolloid and saline gauze dressings.

    PubMed

    Chang, K W; Alsagoff, S; Ong, K T; Sim, P H

    1998-12-01

    An open comparative randomised study comparing the performance of hydrocolloid dressings (DuoDERM CGF) to saline gauze dressings in the treatment of pressure ulcers was done to evaluate the overall dressing performance, wound healing and cost effectiveness. Thirty-four subjects were enrolled at the University Hospital, Kuala Lumpur over a 643 days period. Inclusion criteria were Stage II or III pressure ulcers, at least 18 years of age and written informed consent. Only one pressure ulcer per subject was enrolled in the study. Patients with infected pressure ulcers, diabetes mellitus, an immuno-compromised status and known sensitivity to the study dressings were excluded. Subjects who met the enrollment criteria were randomised to one of the two dressing regimes. They were expected to participate in the study for a maximum of eight weeks or until the pressure ulcer healed, which ever occurred first. Overall subject age averaged 58 years and the mean duration of pressure ulcer existence was about 1 month. Twenty-one of the thirty-four ulcers enrolled were stage II and thirteen were stage III. The majority of the ulcers (88%) were located in the sacral area and seventeen subjects (50%) were incontinent. In the evaluation of dressing performance in terms of adherence to wound bed, exudate handling ability, overall comfort and pain during dressing removal; all favoured the hydrocolloid dressing by a statistically significant margin (p < 0.001). Subjects assigned the hydrocolloid dressing experienced a mean 34% reduction from their baseline surface area measurement compared to a mean 9% increase by subjects assigned gauze dressings. This was not statistically significant (p = 0.2318). In cost evaluation of the study products, there was no statistical significance in the total cost of wound management per subject. When only labour time and cost was evaluated, there was a statistically significant advantage towards hydrocolloid dressings.

  4. Comparative analysis between minimal access versus traditional accesses in carpal tunnel syndrome: a perspective randomised study.

    PubMed

    Tarallo, Mauro; Fino, Pasquale; Sorvillo, Valentina; Parisi, Paola; Scuderi, Nicolò

    2014-02-01

    Carpal tunnel decompression with division of the transverse carpal ligament has been a highly successful procedure for the treatment of carpal tunnel syndrome. The standard longitudinal incision technique, with a long curvilinear incision, has been the optimal treatment procedure for surgical decompression of the median nerve, for many surgeons. The aim of this study was to compare the traditional open carpal tunnel release (TOCTR) technique with the minimal-access carpal tunnel release (MACTR) technique for the treatment of carpal tunnel syndrome (CTS), presenting our experience. A total of 120 patients eligible for carpal tunnel decompression were recruited into the study. The patients were randomised for treatment allocation, at a 1:1 ratio, resulting in 60 patients in group A, treated by standard TOCTR, and 60 patients in group B, treated by MACTR. To evaluate patients' outcomes we used the Boston Carpal Tunnel (BCT) questionnaire; the formed scar was evaluated according to the Vancouver scale and short- and long-term complications. Statistical analysis was performed by the chi-squared test and analysis of variance (ANOVA); Excel was the program used. In our series, there was no complication related to the surgical intervention of any injury to nerve, artery or tendon structures. In each section of the BCT questionnaire, patients in group B had significantly better results than patients in group A at both 6 and 12 months' follow-up (p < 0.001). For the Vancouver scar scale, there was a significant difference between two groups' scores; group B patients had significant improvements compared with group A patients. In our perspective randomised study, MACTR showed statistically significant improvement compared to TOCTR. The patient tolerance is reasonably high and the procedure is compatible with the current minimal invasive trend in surgery. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All

  5. Knee joint distraction compared with total knee arthroplasty: a randomised controlled trial.

    PubMed

    van der Woude, J A D; Wiegant, K; van Heerwaarden, R J; Spruijt, S; Emans, P J; Mastbergen, S C; Lafeber, F P J G

    2017-01-01

    Knee joint distraction (KJD) is a relatively new, knee-joint preserving procedure with the goal of delaying total knee arthroplasty (TKA) in young and middle-aged patients. We present a randomised controlled trial comparing the two. The 60 patients ≤ 65 years with end-stage knee osteoarthritis were randomised to either KJD (n = 20) or TKA (n = 40). Outcomes were assessed at baseline, three, six, nine, and 12 months. In the KJD group, the joint space width (JSW) was radiologically assessed, representing a surrogate marker of cartilage thickness. In total 56 patients completed their allocated treatment (TKA = 36, KJD = 20). All patient reported outcome measures improved significantly over one year (p < 0.02) in both groups. At one year, the TKA group showed a greater improvement in only one of the 16 patient-related outcome measures assessed (p = 0.034). Outcome Measures in Rheumatology-Osteoarthritis Research Society International clinical response was 83% after TKA and 80% after KJD. A total of 12 patients (60%) in the KJD group sustained pin track infections. In the KJD group both mean minimum (0.9 mm, standard deviation (sd) 1.1) and mean JSW (1.2 mm, sd 1.1) increased significantly (p = 0.004 and p = 0.0003). In relatively young patients with end-stage knee osteoarthritis, KJD did not demonstrate inferiority of outcomes at one year when compared with TKA. However, there is a high incidence of pin track infection associated with KJD. Cite this article: Bone Joint J 2017;99-B:51-8. ©2017 The British Editorial Society of Bone & Joint Surgery.

  6. Extracapsular cataract extraction compared with small incision surgery by phacoemulsification: a randomised trial

    PubMed Central

    Minassian, D; Rosen, P; Dart, J; Reidy, A; Desai, P; Sidhu, M

    2001-01-01

    BACKGROUND—Cataract extraction constitutes the largest surgical workload in ophthalmic units throughout the world. Extracapsular cataract extraction (ECCE), through a large incision, with insertion of an intraocular lens has been the most widely used method from 1982 until recently. Technological advances have led to the increasing use of phacoemulsification (Phako) to emulsify and remove the lens The technique requires a smaller incision, but requires substantial capital investment in theatre equipment. In this randomised trial we assessed the clinical outcomes and carried out an economic evaluation of the two procedures.
METHODS—In this two centre randomised trial, 232 patients with age related cataract received ECCE, and 244 received small incision surgery by Phako. The main comparative outcomes were visual acuity, refraction, and complication rates. Resource use was monitored in the two trial centres and in an independent comparator centre. Costs calculated included average cost per procedure, at each stage of follow up.
RESULTS—Phako was found to be clinically superior. Surgical complications and capsule opacity within 1 year after surgery were significantly less frequent, and a higher proportion achieved an unaided visual acuity of 6/9 or better (<0.2 logMAR) in the Phako group. Postoperative astigmatism was more stable in Phako. The average cost of a cataract operation and postoperative care within the trial was similar for the two procedures. With the input of additional spectacles for corrected vision at 6 months after surgery, the average cost per procedure was £359.89 for Phako and £367.57 for ECCE.
CONCLUSION—Phako is clinically superior to ECCE and is cost effective.

 PMID:11423457

  7. Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): a multicentre, parallel-group, randomised controlled trial.

    PubMed

    Wright, Stephen E; Thomas, Kirsty; Watson, Gillian; Baker, Catherine; Bryant, Andrew; Chadwick, Thomas J; Shen, Jing; Wood, Ruth; Wilkinson, Jennifer; Mansfield, Leigh; Stafford, Victoria; Wade, Clare; Furneval, Julie; Henderson, Andrea; Hugill, Keith; Howard, Philip; Roy, Alistair; Bonner, Stephen; Baudouin, Simon

    2017-08-05

    Early physical rehabilitation in the intensive care unit (ICU) has been shown to improve short-term clinical outcomes but long-term benefit has not been proven and the optimum intensity of rehabilitation is not known. We conducted a randomised, parallel-group, allocation-concealed, assessor-blinded, controlled trial in patients who had received at least 48 hours of invasive or non-invasive ventilation. Participants were randomised in a 1:1 ratio, stratified by admitting ICU, admission type and level of independence. The intervention group had a target of 90 min physical rehabilitation per day, the control group a target of 30 min per day (both Monday to Friday). The primary outcome was the Physical Component Summary (PCS) measure of SF-36 at 6 months. We recruited 308 participants over 34 months: 150 assigned to the intervention and 158 to the control group. The intervention group received a median (IQR) of 161 (67-273) min of physical rehabilitation on ICU compared with 86 (31-139) min in the control group. At 6 months, 62 participants in the intervention group and 54 participants in the control group contributed primary outcome data. In the intervention group, 43 had died, 11 had withdrawn and 34 were lost to follow-up, while in the control group, 56 had died, 5 had withdrawn and 43 were lost to follow-up. There was no difference in the primary outcome at 6 months, mean (SD) PCS 37 (12.2) in the intervention group and 37 (11.3) in the control group. In this study, ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation. ISRCTN 20436833. © 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.

  8. ACCESS HD pilot: A randomised feasibility trial Comparing Catheters with fistulas in Elderly patientS Starting haemodialysis

    PubMed Central

    Quinn, Robert; Ravani, Pietro

    2016-01-01

    Introduction The selection of the type of vascular access for haemodialysis is an important intervention question. However, only observational studies are available to inform decision-making in this area, and they are at high risk of selection bias. While a clinical trial comparing the effects of the 2 most frequently chosen strategies for haemodialysis access (fistulas and catheters) on patient important and ‘hard’ clinical end points is needed, the feasibility of such a trial is uncertain. Methods and analysis This open-label pilot randomised controlled trial will test the feasibility and safety of randomising elderly people (≥65 years) who start haemodialysis with a central venous catheter (the most common initial type of haemodialysis access), and are eligible to receive a fistula, to a catheter-based strategy (comparator) or to a fistula-based strategy (intervention). We will enrol 100 patients at 10 centres across Canada. Participants assigned to the catheter-strategy arm will continue to use catheters; participants assigned to the fistula-strategy arm will receive a surgical attempt at fistula creation. The inclusion criteria are designed to minimise the risk of protocol violation and attrition. The primary outcome is feasibility, which we will assess by measuring: (1) the proportion of participants deemed eligible for the trial who consent to randomisation; and (2) the proportion of participants randomised to the intervention who receive the fistula surgery within 90 days of randomisation. Secondary outcomes will include safety outcomes, the reasons people and healthcare providers may not accept randomisation, and the reasons sites may not adhere to the trial protocol. Ethics and dissemination The Conjoint Health Research Ethics Board at the University of Calgary approved the study protocol. We will submit the results of this feasibility study in a peer-reviewed journal. Trial registration number NCT02675569, Pre-results. PMID:27884849

  9. A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs.

    PubMed

    Cristaudo, Adam; Nayak, Arun; Martin, Sarah; Adib, Reza; Martin, Ian

    2015-05-01

    The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15 × 10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15 × 10 cm folding slit mesh with absorbable tacks (Group 2), a partially-absorbable 15 × 10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15 × 10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partially-absorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods.

  10. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial

    PubMed Central

    French, Helen P; Cusack, Tara; Brennan, Aisling; White, Breon; Gilsenan, Clare; Fitzpatrick, Martina; O'Connell, Paul; Kane, David; FitzGerald, Oliver; McCarthy, Geraldine M

    2009-01-01

    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 results will contribute

  11. How Often Do Comparative Randomised Controlled Trials in the Field of Eczema Fail to Directly Compare the Treatments Being Tested?

    PubMed

    Ratib, Sonia; Wilkes, Sally R; Nankervis, Helen; Thomas, Kim S; Williams, Hywel C

    2015-06-17

    The objective of the study was to identify all parallel design randomised controlled trials (RCTs) comparing treatments for eczema in recent dermatology literature that have failed to report a between-group analysis. The GREAT database (www.greatdatabase.org.uk) was searched to identify parallel group RCTs comparing two or more interventions published in the English language in the last decade, 2004 to 2013. The primary outcome was the number of studies that had not reported a between-group analysis for any of the outcomes. Where possible we re-analysed the data to determine whether a between-group analysis would have given a different conclusion to that reported. Out of a total of 304 RCTs in the study period, 173 (56.9%) met the inclusion criteria. Of the 173 eligible studies, 12 (6.9%) had not conducted a between-group analysis for any of the reported outcomes. There was no clear improvement over time. Five of the eight studies that were re-analysed yielded non-significant between-group differences yet reported significant within-group comparisons. All but one of the 12 studies implied that the experimental intervention was successful despite not undertaking any between-group comparisons. Although the proportion of all RCTs that fail to report an appropriate between-group analysis is small, the fact that any scientist who purports to compare one treatment against another then chooses to omit the key comparison statistic is worrying.

  12. A randomised controlled trial comparing a dilating vaginal speculum with a conventional bivalve speculum.

    PubMed

    Thomas, A; Weisberg, E; Lieberman, D; Fraser, I S

    2001-11-01

    Cervical smears are traditionally taken with the aid of a metal or disposable plastic bivalve speculum. Many women complain of discomfort with these specula. This study compares the efficacy and women's experiences of a new 'dilating speculum' called the Veda-scope, with a conventional metal bivalve speculum (Pederson). The aims of this study were: to determine whether the Veda-scope provides adequate visualisation of the cervix and vaginal walls and an adequate cervical cytology specimen; and to compare user acceptability and women's levels of comfort between the Veda-scope and the bivalve speculum. Sixty-four women were randomised to be examined with the Veda-scope and 60 with the bivalve speculum, by one of two operators. Each woman completed a questionnaire that included subjective views of their previous cervical smear experiences, and acceptability of the examination at the study consultation. Cytologists were blinded as to which speculum was used for cervical sampling. Of women examined, 7-83% of women found Veda-scope examinations comfortable, compared to 38-62% of women who found examinations with the bivalve comfortable; 94% of the women preferred the 'comfort' of the Veda-scope. The Veda-scope was as good as the bivalve speculum in providing samples for cytological analysis following the initial learning curve, and also provided markedly superior magnified views of the cervix and vaginal fornices.

  13. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children.

    PubMed

    Lee, J-R; Kim, M-S; Kim, J-T; Byon, H-J; Park, Y-H; Kim, H-S; Kim, C-S

    2012-06-01

    We performed a prospective, randomised trial comparing the i-gel(TM) with the LMA Classic(TM) in children undergoing general anaesthesia. Ninety-nine healthy patients were randomly assigned to either the i-gel or the LMA Classic. The outcomes measured were airway leak pressure, ease of insertion, time taken for insertion, fibreoptic examination and complications. Median (IQR [range]) time to successful device placement was shorter with the i-gel (17.0 (13.8-20.0 [10.0-20.0]) s) compared with the LMA Classic (21.0 (17.5-25.0 [15.0-70.0]) s, p = 0.002). There was no significant difference in oropharyngeal leak pressure between the two devices. A good fibreoptic view of the glottis was obtained in 74% of the i-gel group and in 43% of the LMA Classic group (p < 0.001). There were no significant complications. In conclusion, the i-gel provided a similar leak pressure, but a shorter insertion time and improved glottic view compared with the LMA Classic in children.

  14. Comparative pathology of breast cancer in a randomised trial of screening.

    PubMed

    Anderson, T J; Lamb, J; Donnan, P; Alexander, F E; Huggins, A; Muir, B B; Kirkpatrick, A E; Chetty, U; Hepburn, W; Smith, A

    1991-07-01

    In the Edinburgh Randomised Breast Screening Project (EBSP) to December 1988 there were 500 cancers in the study population invited to screening and 340 cancers identified in the control population. The size and negative lymph node status characteristics of invasive cancers from the two populations were significantly different (P less than 0.05). The cancers detected by screening were predominantly 'early stage', with 16% noninvasive (PTIS) and 42% invasive stage I (pT1 node negative), whereas cancers were frequently 'late stage' (more than pT2) and inoperable in nonattenders (44%) and controls (36%). Grouped according to customary size ranges of invasive cancers, the proportion of cases lymph node positive differed in those screen detected compared with controls, but the benefit in favour of screen detection was not constant. In comparisons of cancers detected at prevalence and incidence screens, as a test of conformity with screening theory, no significant differences were apparent according to size and lymph node status, yet the characteristics of histological type of cancer discriminated significantly (P less than 0.05). When these same histological characteristics were used to compare survival, the capacity to separate invasive cancers into two groups having good and poor survival probabilities was evident, with a significant improvement for the screen detected poor survival group compared with controls (P less than 0.05).

  15. Comparing socially disadvantaged smokers who agree and decline to participate in a randomised smoking cessation trial

    PubMed Central

    Bonevski, Billie; Twyman, Laura; Paul, Chris; D'Este, Catherine; West, Robert; Siahpush, Mohammad; Oldmeadow, Christopher; Palazzi, Kerrin; Bryant, Jamie; Guillaumier, Ashleigh

    2015-01-01

    Objectives This study examined sociodemographic, smoking and psychosocial characteristics associated with consent to participate in a smoking cessation trial for socially disadvantaged smokers. Design Baseline data were collected prior to seeking consent for the Call it Quits, a randomised controlled trial. Setting An Australian social and community service organisation. Sociodemographic, smoking and psychosocial characteristics were compared between smokers who agreed or declined to participate. Participants Of the 584 smokers invited to participate, 431 (74%) consented and 153 (26%) declined. Results Logistic regression modelling indicates the ORs of participation were twice as high for those reporting ‘high’ motivation to quit compared to the ‘moderate’ motivation group, and five times higher than the ‘low’ motivation group (p=0.007). The ORs of consenting were higher for those with a preference for gradual reduction in cigarettes in quit attempts compared with ‘no preference’. The ORs were lower for those reporting ‘don't know’ regarding their enjoyment of smoking compared to ‘not at all’ enjoying smoking, and reporting that fewer of their family or friends smoked compared to ‘most or all’. Conclusions This study is the first to examine the characteristics of socially disadvantaged smokers who consent or decline to participate in a smoking cessation trial. Low-income smokers who are motivated to quit, are not enjoying smoking, had family or friends who smoked, and who are interested in gradual cessation approaches may be more likely to participate in a smoking cessation trial. Trial registration number ISRCTN85202510. PMID:26369799

  16. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

    PubMed

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-08-31

    Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology

  17. COSMOS: COmparing Standard Maternity care with One-to-one midwifery Support: a randomised controlled trial

    PubMed Central

    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

  18. Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared with hospital

    PubMed Central

    Corwin, Paul; Toop, Les; McGeoch, Graham; Than, Martin; Wynn-Thomas, Simon; Wells, J Elisabeth; Dawson, Robin; Abernethy, Paul; Pithie, Alan; Chambers, Stephen; Fletcher, Lynn; Richards, Dee

    2005-01-01

    Objectives To compare the efficacy, safety, and acceptability of treatment with intravenous antibiotics for cellulitis at home and in hospital. Design Prospective randomised controlled trial. Setting Christchurch, New Zealand. Participants 200 patients presenting or referred to the only emergency department in Christchurch who were thought to require intravenous antibiotic treatment for cellulitis and who did not have any contraindications to home care were randomly assigned to receive treatment either at home or in hospital. Main outcome measures Days to no advancement of cellulitis was the primary outcome measure. Days on intravenous and oral antibiotics, days in hospital or in the home care programme, complications, degree of functioning and pain, and satisfaction with site of care were also recorded. Results The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis, with a mean of 1.50 days (SD 0.11) for the group receiving treatment at home and 1.49 days (SD 0.10) for the group receiving treatment in hospital (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). None of the other outcome measures differed significantly except for patients' satisfaction, which was greater in patients treated at home. Conclusions Treatment of cellulitis requiring intravenous antibiotics can be safely delivered at home. Patients prefer home treatment, but in this study only about one third of patients presenting at hospital for intravenous treatment of cellulitis were considered suitable for home treatment. PMID:15604157

  19. Diffuse diabetic macular oedema treated by intravitreal triamcinolone acetonide: a comparative, non-randomised study

    PubMed Central

    Jonas, J B; Akkoyun, I; Kreissig, I; Degenring, R F

    2005-01-01

    Aim: To report on visual outcome of patients receiving an intravitreal injection of triamcinolone acetonide for treatment of diffuse diabetic macular oedema. Methods: Prospective, comparative, non-randomised clinical interventional study included 136 patients with diffuse diabetic macular oedema. Patients of the study group (97 eyes) received an intravitreal injection of 20–25 mg of triamcinolone acetonide and no other retinal treatment. Patients of the control group (69 eyes) received focal or panretinal laser treatment if indicated. Mean (standard deviation) follow up was 8.4 (SD 6.0) months (range 1.03–25.2 months). Results: Visual acuity (VA) increased significantly (p<0.001) in the study group with 66 (68%) eyes gaining in VA by at least two Snellen lines. In the control group, VA did not change significantly during the first 4 months of follow up, and decreased significantly (p<0.001) towards the end of the follow up. Difference in change of best VA was significant (p<0.001) between both groups. Correspondingly, the number of patients with VA improvement of two or more Snellen lines and visual loss of two or more Snellen lines, respectively, was significantly (p<0.001) higher and lower, respectively, in the study group. Conclusions: Intravitreal triamcinolone acetonide can temporarily increase VA in some patients with diffuse diabetic macular oedema. PMID:15722313

  20. [Randomised clinical trial to compare two tracheotomy care methods in an Intensive Care Unit].

    PubMed

    Fernández-García, C; Alonso-Rodríguez, A; Wensell-Fernández, A; Martínez-Camblor, P; Suárez-Mier, M B; Arenas Fernández, J; Linares Gutiérrez, B; Clavero Ballester, N

    2016-01-01

    Tracheotomy is a common technique in Intensive Care Units (ICU). It is known that nursing care during and after that procedure is directly related to its success, by reducing the possible complications to a minimum, such as the stoma infection, and contributing to a favourable outcome in critical patients. To compare the use of polyhexanide (PLX) versus saline+povidone iodine (PY) as antiseptics and infection incidence in tracheostomies performed in Intensive Care Units. A 2-year, experimental, randomised, open-label trial carried out in a multidiscipline ICU with 32 beds. The study was approved by the Research Ethics Committee of Principality of Asturias. The overall infection rate observed for every hundred patients was 1.34 (95% CI; 0.81-2.01), with 1.46 when using PLX and 1.21 for PY (P=.685). In spite of the experimental treatment (PLX) was shown to be effective in other types of wounds in our study. No significant differences were found between this technique and the standard one. Since there is no national registry of tracheotomy- associated infections, it is not possible to know whether the rate observed is within the usual parameters. Copyright © 2015 Elsevier España, S.L.U. y SEEIUC. All rights reserved.

  1. Randomised controlled trial comparing oral and intravenous paracetamol (acetaminophen) plasma levels when given as preoperative analgesia.

    PubMed

    van der Westhuizen, J; Kuo, P Y; Reed, P W; Holder, K

    2011-03-01

    Gastric absorption of oral paracetamol (acetaminophen) may be unreliable perioperatively in the starved and stressed patient. We compared plasma concentrations of parenteral paracetamol given preoperatively and oral paracetamol when given as premedication. Patients scheduled for elective ear; nose and throat surgery or orthopaedic surgery were randomised to receive either oral or intravenous paracetamol as preoperative medication. The oral dose was given 30 minutes before induction of anaesthesia and the intravenous dose given pre-induction. All patients were given a standardised anaesthetic by the same specialist anaesthetist who took blood for paracetamol concentrations 30 minutes after the first dose and then at 30 minute intervals for 240 minutes. Therapeutic concentrations of paracetamol were reached in 96% of patients who had received the drug parenterally, and 67% of patients who had received it orally. Maximum median plasma concentrations were 19 mg.l(-1) (interquartile range 15 to 23 mg.l(-1)) and 13 mg.l(-1) (interquartile range 0 to 18 mg.l(-1)) for the intravenous and oral group respectively. The difference between intravenous and oral groups was less marked after 150 minutes but the intravenous preparation gave higher plasma concentrations throughout the study period. It can be concluded that paracetamol gives more reliable therapeutic plasma concentrations when given intravenously.

  2. Comparing conventional gauze therapy to vacuum-assisted closure wound therapy: a prospective randomised trial.

    PubMed

    Mouës, C M; van den Bemd, G J C M; Heule, F; Hovius, S E R

    2007-01-01

    Vacuum-assisted closure wound therapy (vacuum therapy) has been used in our department since 1997 as a tool to bridge the period between debridement and definite surgical closure in full-thickness wounds. We performed a prospective randomised clinical trial to compare the efficacy of vacuum therapy to conventional moist gauze therapy in this stage of wound treatment. Treatment efficacy was assessed by semi-quantitative scoring of the wound conditions (signs of rubor, calor, exudate and fibrinous slough) and by wound surface area measurements. Tissue biopsies were performed to quantify the bacterial load. Besides this, the duration until 'ready for surgical therapy' and complications encountered during therapy and postoperatively were recorded. Fifty-four patients were included (vacuum n=29, conventional n=25). With vacuum therapy, healthier wound conditions were observed. Furthermore, a tendency towards a shorter duration of therapy was found, which was most prominent in late-treated wounds. In addition, the wound surface area reduced significantly faster with vacuum therapy. Surprisingly, these results were obtained without a decrease in the number of bacteria colonising the wound. Complications were minor, except for one case of septicaemia and one case of increased tissue necrosis, which compelled us to stop vacuum therapy. For the treatment of full-thickness wounds, vacuum therapy has proven to be a valid wound healing modality.

  3. A study protocol of a randomised controlled trial to investigate if a community based strength training programme improves work task performance in young adults with Down syndrome.

    PubMed

    Shields, Nora; Taylor, Nicholas F; Fernhall, Bo

    2010-03-25

    Muscle strength is important for young people with Down syndrome as they make the transition to adulthood, because their workplace activities typically emphasise physical rather than cognitive skills. Muscle strength is reduced up to 50% in people with Down syndrome compared to their peers without disability. Progressive resistance training improves muscle strength and endurance in people with Down syndrome. However, there is no evidence on whether it has an effect on work task performance or physical activity levels. The aim of this study is to investigate if a student-led community-based progressive resistance training programme can improve these outcomes in adolescents and young adults with Down syndrome. A randomised controlled trial will compare progressive resistance training with a control group undertaking a social programme. Seventy adolescents and young adults with Down syndrome aged 14-22 years and mild to moderate intellectual disability will be randomly allocated to the intervention or control group using a concealed method. The intervention group will complete a 10-week, twice a week, student-led progressive resistance training programme at a local community gymnasium. The student mentors will be undergraduate physiotherapy students. The control group will complete an arts/social programme with a student mentor once a week for 90 minutes also for 10 weeks to control for the social aspect of the intervention. Work task performance (box stacking, pail carry), muscle strength (1 repetition maximum for chest and leg press) and physical activity (frequency, duration, intensity over 7-days) will be assessed at baseline (Week 0), following the intervention (Week 11), and at 3 months post intervention (Week 24) by an assessor blind to group allocation. Data will be analysed using ANCOVA with baseline measures as covariates. This paper outlines the study protocol for a randomised controlled trial on the effects of progressive resistance training on work task

  4. Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.

    PubMed

    Bucci, Sandra; Barrowclough, Christine; Ainsworth, John; Morris, Rohan; Berry, Katherine; Machin, Matthew; Emsley, Richard; Lewis, Shon; Edge, Dawn; Buchan, Iain; Haddock, Gillian

    2015-09-10

    Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to

  5. A randomised experiment comparing low-cost ultrasound gel alternative with commercial gel.

    PubMed

    Riguzzi, Christine; Binkowski, Allison; Butterfield, Mike; Sani, Farhad; Teismann, Nathan; Fahimi, Jahan

    2017-04-01

    Point-of-care ultrasound is a portable, relatively low-cost imaging modality with great potential utility in low-resource settings. However, commercially produced ultrasound gel is often cost-prohibitive and unavailable. We investigated whether images obtained using an alternative cornstarch-based gel would be of comparable quality with those using commercial gel. This was a blinded, randomised, cross-over study comparing commercially produced ultrasound gel with home-made cornstarch-based gel. Ultrasound-trained faculty obtained three video clips with each gel type from patients at one urban ED. The clips were evaluated by a radiologist and an ultrasound-trained emergency physician. Images were assessed in terms of overall adequacy (dichotomous) and quality, resolution and detail using a rating scale (0-10). All sonographers and physicians reviewing the images were blinded to the type of gel used. Thirty-four patients were enrolled in the study, producing 204 separate images (102 with each gel). The cornstarch gel clips were deemed accurate in 70.6% (95% CI 63.9% to 76.5%) of the scans, as compared with 65.2% (95% CI 58.4% to 71.4%) of those using commercial gel. There was no difference between the two groups with respect to image detail, resolution or quality. Images produced using the cornstarch-based alternative ultrasound gel were of similar quality to those using commercial gel. The low cost and easy preparation of the cornstarch-based gel make it an attractive coupling medium for use in low-resource settings. 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/.

  6. Effectiveness of functional hand splinting and the cognitive orientation to occupational performance (CO-OP) approach in children with cerebral palsy and brain injury: two randomised controlled trial protocols

    PubMed Central

    2014-01-01

    Background Cerebral palsy (CP) and brain injury (BI) are common conditions that have devastating effects on a child’s ability to use their hands. Hand splinting and task-specific training are two interventions that are often used to address deficits in upper limb skills, both in isolation or concurrently. The aim of this paper is to describe the method to be used to conduct two randomised controlled trials (RCT) investigating (a) the immediate effect of functional hand splints, and (b) the effect of functional hand splints used concurrently with task-specific training compared to functional hand splints alone, and to task-specific training alone in children with CP and BI. The Cognitive Orientation to Occupational Performance (CO-OP) approach will be the task-specific training approach used. Methods/Design Two concurrent trials; a two group, parallel design, RCT with a sample size of 30 participants (15 per group); and a three group, parallel design, assessor blinded, RCT with a sample size of 45 participants (15 per group). Inclusion criteria: age 4-15 years; diagnosis of CP or BI; Manual Abilities Classification System (MACS) level I – IV; hand function goals; impaired hand function; the cognitive, language and behavioural ability to participate in CO-OP. Participants will be randomly allocated to one of 3 groups; (1) functional hand splint only (n=15); (2) functional hand splint combined with task-specific training (n=15); (3) task-specific training only (n=15). Allocation concealment will be achieved using sequentially numbered, sealed opaque envelopes opened by an off-site officer after baseline measures. Treatment will be provided for a period of 2 weeks, with outcome measures taken at baseline, 1 hour after randomisation, 2 weeks and 10 weeks. The functional hand splint will be a wrist cock-up splint (+/- thumb support or supination strap). Task-specific training will involve 10 sessions of CO-OP provided in a group of 2-4 children. Primary outcome

  7. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    PubMed

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  8. A randomised trial comparing genotypic and virtual phenotypic interpretation of HIV drug resistance: the CREST study.

    PubMed

    Hales, Gillian; Birch, Chris; Crowe, Suzanne; Workman, Cassy; Hoy, Jennifer F; Law, Matthew G; Kelleher, Anthony D; Lincoln, Douglas; Emery, Sean

    2006-07-28

    The aim of this study was to compare the efficacy of different HIV drug resistance test reports (genotype and virtual phenotype) in patients who were changing their antiretroviral therapy (ART). Randomised, open-label trial with 48-week followup. The study was conducted in a network of primary healthcare sites in Australia and New Zealand. Patients failing current ART with plasma HIV RNA > 2000 copies/mL who wished to change their current ART were eligible. Subjects were required to be > 18 years of age, previously treated with ART, have no intercurrent illnesses requiring active therapy, and to have provided written informed consent. Eligible subjects were randomly assigned to receive a genotype (group A) or genotype plus virtual phenotype (group B) prior to selection of their new antiretroviral regimen. Patient groups were compared for patterns of ART selection and surrogate outcomes (plasma viral load and CD4 counts) on an intention-to-treat basis over a 48-week period. Three hundred and twenty seven patients completing >or= one month of followup were included in these analyses. Resistance tests were the primary means by which ART regimens were selected (group A: 64%, group B: 62%; p = 0.32). At 48 weeks, there were no significant differences between the groups for mean change from baseline plasma HIV RNA (group A: 0.68 log copies/mL, group B: 0.58 log copies/mL; p = 0.23) and mean change from baseline CD4+ cell count (group A: 37 cells/mm(3), group B: 50 cells/mm(3); p = 0.28). In the absence of clear demonstrated benefits arising from the use of the virtual phenotype interpretation, this study suggests resistance testing using genotyping linked to a reliable interpretive algorithm is adequate for the management of HIV infection.

  9. Randomised trial comparing hand expression with breast pumping for mothers of term newborns feeding poorly

    PubMed Central

    Flaherman, Valerie J; Gay, Barbara; Scott, Cheryl; Avins, Andrew; Lee, Kathryn A; Newman, Thomas B

    2016-01-01

    Objective Breast pumping or hand expression may be recommended when newborns latch or suck poorly. A recent trial found worse outcomes among mothers who used a breast pump in the early postpartum period. The objective of this study was to compare bilateral electric breast pumping to hand expression among mothers of healthy term infants feeding poorly at 12–36 h after birth. Design Randomised controlled trial. Setting Well-baby nursery and postpartum unit. Patients 68 mothers of newborns 12–36 h old who were latching or sucking poorly were randomly assigned to either 15 min of bilateral electric pumping or 15 min of hand expression. Mainoutcome measures Milk transfer, maternal pain, breastfeeding confidence and breast milk expression experience (BMEE) immediately after the intervention, and breastfeeding rates at 2 months after birth. Results The median volume of expressed milk (range) was 0.5 (0–5) ml for hand expressing mothers and 1 (0–40) ml for pumping mothers (p=0.07). Maternal pain, breastfeeding confidence and BMEE did not differ by intervention. At 2 months, mothers assigned to hand expression were more likely to be breastfeeding (96.1%) than mothers assigned to breast pumping (72.7%) (p=0.02). Conclusions Hand expression in the early postpartum period appears to improve eventual breastfeeding rates at 2 months after birth compared with breast pumping, but further research is needed to confirm this. However, in circumstances where either pumping or hand expression would be appropriate for healthy term infants 12–36 h old feeding poorly, providers should consider recommending hand expression. PMID:21747129

  10. Protocol for the PREHAB study—Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial

    PubMed Central

    Stammers, Andrew N; Kehler, D Scott; Afilalo, Jonathan; Avery, Lorraine J; Bagshaw, Sean M; Grocott, Hilary P; Légaré, Jean-Francois; Logsetty, Sarvesh; Metge, Colleen; Nguyen, Thang; Rockwood, Kenneth; Sareen, Jitender; Sawatzky, Jo-Ann; Tangri, Navdeep; Giacomantonio, Nicholas; Hassan, Ansar; Duhamel, Todd A; Arora, Rakesh C

    2015-01-01

    Introduction Frailty is a geriatric syndrome characterised by reductions in muscle mass, strength, endurance and activity level. The frailty syndrome, prevalent in 25–50% of patients undergoing cardiac surgery, is associated with increased rates of mortality and major morbidity as well as function decline postoperatively. This trial will compare a preoperative, interdisciplinary exercise and health promotion intervention to current standard of care (StanC) for elective coronary artery bypass and valvular surgery patients for the purpose of determining if the intervention improves 3-month and 12-month clinical outcomes among a population of frail patients waiting for elective cardiac surgery. Methods and analysis This is a multicentre, randomised, open end point, controlled trial using assessor blinding and intent-to-treat analysis. Two-hundred and forty-four elective cardiac surgical patients will be recruited and randomised to receive either StanC or StanC plus an 8-week exercise and education intervention at a certified medical fitness facility. Patients will attend two weekly sessions and aerobic exercise will be prescribed at 40–60% of heart rate reserve. Data collection will occur at baseline, 1–2 weeks preoperatively, and at 3 and 12 months postoperatively. The primary outcome of the trial will be the proportion of patients requiring a hospital length of stay greater than 7 days. Potential impact of study The healthcare team is faced with an increasingly complex older adult patient population. As such, this trial aims to provide novel evidence supporting a health intervention to ensure that frail, older adult patients thrive after undergoing cardiac surgery. Ethics and dissemination Trial results will be published in peer-reviewed journals, and presented at national and international scientific meetings. The University of Manitoba Health Research Ethics Board has approved the study protocol V.1.3, dated 11 August 2014 (H2014:208). Trial

  11. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2).

    PubMed

    Delcourt, C; Huang, Y; Wang, J; Heeley, E; Lindley, R; Stapf, C; Tzourio, C; Arima, H; Parsons, M; Sun, J; Neal, B; Chalmers, J; Anderson, C

    2010-04-01

    The INTERACT pilot study demonstrated the feasibility of the protocol, safety of early intensive blood pressure lowering and effects on haematoma expansion within 6 h of onset of intracerebral haemorrhage. This article describes the design of the second, main phase, INTERACT2. To compare the effects of a management strategy of early intensive blood pressure lowering with a more conservative guideline-based blood pressure management policy in patients with acute intracerebral hemorrhage. INTERACT2 is a prospective, randomized, open label, assessor-blinded end-point (PROBE). Patients with a systolic blood pressure greater than 150 mmHg and no definite indication for or contraindication to blood pressure-lowering treatment are centrally randomised to either of two treatment groups within 6 h onset of intracerebral haemorrhage. Those allocated to intensive blood pressure lowering will receive primarily intravenous, hypotensive agents to achieve a systolic blood pressure target of <140 mmHg within 1 h of randomisation and to maintain this level for up to 7 days in hospital. The control group will receive blood pressure-lowering treatment to a target systolic blood pressure of <180 mmHg. Both groups are to receive similar acute stroke unit care, therapy and active management. Oral antihypertensive therapy is recommended in patients before hospital discharge with a long-term systolic blood pressure goal of 140 mmHg according to secondary stroke prevention guidelines. A projected 2800 subjects are to be enrolled from approximately 140 centres worldwide to provide 90% power (alpha 0.05) to detect a 14% difference in the risk of death and dependency between the groups, which equates to one or more cases of a poor outcome prevented in every 15 patients treated. The primary outcome is the combined end-point of death and dependency according to the modified Rankin Scale at 90 days. The secondary outcomes are the separate components of the primary end-point in patients treated

  12. Assessment of the quality of reporting in randomised controlled trials of acupuncture in the Korean literature using the CONSORT statement and STRICTA guidelines

    PubMed Central

    Kim, Kun Hyung; Kang, Jung Won; Lee, Myeong Soo; Lee, Jae-Dong

    2014-01-01

    Objectives This study aims to assess the completeness of reporting of randomised controlled trials (RCTs) of acupuncture in the Korean literature. Design Systematic review. Methods We searched 12 Korean databases and 7 Korean journals to identify eligible RCTs of acupuncture published from 1996 to July 2011. We used the Consolidated Standards of Reporting Trials (CONSORT) checklist for parallel RCTs and the revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to assess the quality of reporting in Korean RCTs. We compared the completeness of reporting of CONSORT and STRICTA items in RCTs published in two time periods (1996–2004 referred to as the early period and 2005–2011 referred to as the late period). Results We analysed 146 eligible RCTs using the CONSORT statement concerning RCTs of both needling and non-needling acupuncture and the STRICTA guidelines for 90 trials of needling acupuncture. Among the 103 RCTs in the late period, the proportion of RCTs that completely reported the CONSORT items of outcome definition (15.5%), sample size calculation (2.9%), randomisation (56%), allocation concealment (5.8%), implementation of allocation (11.7%), outcome assessor blinding (20.3%), flow of participants (25.2%), number of participants analysed (19.4%), ancillary analyses (0.0%), adverse events (24.3%), generalisability of findings (1.9%) and overall evidence (32.0%) remained small. Among the 61 RCTs of needling acupuncture in the late period, the STRICTA items of setting/context (24.6%) and practitioner background (27.9%) showed incomplete reporting. The completeness of reporting improved over time in several CONSORT and STRICTA items. Conclusions The completeness of reporting of Korean RCTs of acupuncture was suboptimal according to the CONSORT and revised STRICTA statements. Trial authors and journal editors should use the CONSORT statement and STRICTA guidelines for transparent reporting in Korean RCTs of acupuncture. The

  13. A randomised controlled trial to compare methods of milk expression after preterm delivery.

    PubMed

    Jones, E; Dimmock, P W; Spencer, S A

    2001-09-01

    Primary: to compare sequential and simultaneous breast pumping on volume of milk expressed and its fat content. Secondary: to measure the effect of breast massage on milk volume and fat content. Sequential randomised controlled trial. Neonatal intensive care unit, North Staffordshire Hospital NHS Trust. Data on 36 women were analysed; 19 women used simultaneous pumping and 17 used sequential pumping. Women were randomly allocated to use either simultaneous (both breasts simultaneously) or sequential (one breast then the other) milk expression. Stratification was used to ensure that the groups were balanced for parity and gestation. A crossover design was used for massage, with patients acting as their own controls. Women were randomly allocated to receive either massage or non-massage first. Volume of milk expressed per expression and its fat content (estimated by the creamatocrit method). Milk yield per expression was: sequential pumping with no massage, 51.32 g (95% confidence interval (CI) 56.57 to 46.07); sequential pumping with massage, 78.71 g (95% CI 85.19 to 72.24); simultaneous pumping with no massage, 87.69 g (95% CI 96.80 to 78.57); simultaneous pumping with massage, 125.08 g (95% CI 140.43 to 109.74). The fat concentration in the milk was not affected by the increase in volume achieved by the interventions. The results are unequivocal and show that simultaneous pumping is more effective at producing milk than sequential pumping and that breast massage has an additive effect, improving milk production in both groups. As frequent and efficient milk removal is essential for continued production of milk, mothers of preterm infants wishing to express milk for their sick babies should be taught these techniques.

  14. A randomised controlled trial comparing two schedules of antenatal visits: the antenatal care project.

    PubMed Central

    Sikorski, J.; Wilson, J.; Clement, S.; Das, S.; Smeeton, N.

    1996-01-01

    OBJECTIVE--To compare the clinical and psychological effectiveness of the traditional British antenatal visit schedule (traditional care) with a reduced schedule of visits (new style care) for low risk women, together with maternal and professional satisfaction with care. DESIGN--Randomised controlled trial. SETTING--Places in south east London providing antenatal care for women receiving shared care and planning to deliver in one of three hospitals or at home. SUBJECT--2794 women at low risk fulfilling the trial's inclusion criteria between June 1993 and July 1994. MAIN OUTCOME MEASURES--Measures of fetal and maternal morbidity, health service use, psychosocial outcomes, and maternal and professional satisfaction. RESULTS--Pregnant women allocated to new style care had fewer day admissions (0.8 v 1.0; P=0.002) and ultrasound scans (1.6 v 1.7; P=0.003) and were less often suspected of carrying fetuses that were small for gestational age (odds ratio 0.73; 95% confidence interval 0.54 to 0.99). They also had some poorer psychosocial outcomes; for example, they were more worried about fetal wellbeing antenatally and coping with the baby postnatally, and they had more negative attitudes to their babies, both in pregnancy and postnatally. These women were also more dissatisfied with the number of visits they received (odds ratio 2.50; 2.00 to 3.11). CONCLUSIONS--Patterns of antenatal care involving fewer routine visits for women at low risk may lead to reduced psychosocial effectiveness and dissatisfaction with frequency of visits. The number of antenatal day admissions and ultrasound scans performed may also be reduced. For the variables reported, the visit schedules studied are similar in their clinical effectiveness. Uncertainty remains as to the clinical effectiveness of reduced visit schedules for rare pregnancy problems. PMID:8595286

  15. Prospective, randomised controlled trial comparing Versajet™ hydrosurgery and conventional debridement of partial thickness paediatric burns.

    PubMed

    Hyland, Ela J; D'Cruz, Rachel; Menon, Seema; Chan, Queenie; Harvey, John G; Lawrence, Torey; La Hei, Erik; Holland, Andrew J A

    2015-06-01

    Conventional surgical debridement of burn wounds consists of tangential excision of eschar using a knife or dermabrasion until viable dermis or punctate bleeding occurs. The Versajet™ (Smith and Nephew, St. Petersburg, FL, USA) hydrosurgery system has also been advocated for burn wound debridement, with the suggestion that enhanced preservation of dermal tissue might reduce subsequent scarring. A prospective randomised controlled trial was undertaken comparing Versajet™ to conventional debridement. After excluding those with facial burns, 61 children ≤16 years of age undergoing debridement and skin grafting for partial thickness burns were recruited. Adequacy of debridement was assessed by 2mm punch biopsies taken pre- and post-debridement. Surgical time, percentage graft take at day 10, time to healing, post-operative infection and scarring at 3 and 6 months were assessed. Thirty-one children underwent conventional debridement and 30 debridement using Versajet™. There was a significant difference in the amount of viable dermal preservation between the two groups (p=0.02), with more viable tissue lost in the conventional group (median 325 μm) versus the Versajet™ group (median 35 μm). There was no significant difference between graft take at day 10 (p=0.9), post-operative wound infection (p=0.5), duration of surgery (p=0.6) or time to healing after grafting (p=0.6). Despite better dermal preservation in the Versajet™ group, there was no significant difference between scarring at 3 or 6 months (p=1.0, 0.1). These findings suggest that Versajet™ hydrosurgery appears a more precise method of burn wound debridement. Although dermal preservation may be a factor in reducing subsequent hypertrophic scarring, there were no significant differences found between scarring at 3 or 6 months after-injury. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  16. A cluster randomised trial of cloth masks compared with medical masks in healthcare workers

    PubMed Central

    MacIntyre, C Raina; Seale, Holly; Dung, Tham Chi; Hien, Nguyen Tran; Nga, Phan Thi; Chughtai, Abrar Ahmad; Rahman, Bayzidur; Dwyer, Dominic E; Wang, Quanyi

    2015-01-01

    Objective The aim of this study was to compare the efficacy of cloth masks to medical masks in hospital healthcare workers (HCWs). The null hypothesis is that there is no difference between medical masks and cloth masks. Setting 14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam. Participants 1607 hospital HCWs aged ≥18 years working full-time in selected high-risk wards. Intervention Hospital wards were randomised to: medical masks, cloth masks or a control group (usual practice, which included mask wearing). Participants used the mask on every shift for 4 consecutive weeks. Main outcome measure Clinical respiratory illness (CRI), influenza-like illness (ILI) and laboratory-confirmed respiratory virus infection. Results The rates of all infection outcomes were highest in the cloth mask arm, with the rate of ILI statistically significantly higher in the cloth mask arm (relative risk (RR)=13.00, 95% CI 1.69 to 100.07) compared with the medical mask arm. Cloth masks also had significantly higher rates of ILI compared with the control arm. An analysis by mask use showed ILI (RR=6.64, 95% CI 1.45 to 28.65) and laboratory-confirmed virus (RR=1.72, 95% CI 1.01 to 2.94) were significantly higher in the cloth masks group compared with the medical masks group. Penetration of cloth masks by particles was almost 97% and medical masks 44%. Conclusions This study is the first RCT of cloth masks, and the results caution against the use of cloth masks. This is an important finding to inform occupational health and safety. Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection. Further research is needed to inform the widespread use of cloth masks globally. However, as a precautionary measure, cloth masks should not be recommended for HCWs, particularly in high-risk situations, and guidelines need to be updated. Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12610000887077. PMID

  17. Comparison of foam swabs and toothbrushes as oral hygiene interventions in mechanically ventilated patients: a randomised split mouth study

    PubMed Central

    Marino, Paola J; Hannigan, Ailish; Haywood, Sean; Cole, Jade M; Palmer, Nicki; Emanuel, Charlotte; Kinsella, Tracey; Lewis, Michael A O; Wise, Matt P

    2016-01-01

    Introduction During critical illness, dental plaque may serve as a reservoir of respiratory pathogens. This study compared the effectiveness of toothbrushing with a small-headed toothbrush or a foam-headed swab in mechanically ventilated patients. Methods This was a randomised, assessor-blinded, split-mouth trial, performed at a single critical care unit. Adult, orally intubated patients with >20 teeth, where >24 hours of mechanical ventilation was expected were included. Teeth were cleaned 12-hourly using a foam swab or toothbrush (each randomly assigned to one side of the mouth). Cleaning efficacy was based on plaque scores, gingival index and microbial plaque counts. Results High initial plaque (mean=2.1 (SD 0.45)) and gingival (mean=2.0 (SD 0.54)) scores were recorded for 21 patients. A significant reduction compared with initial plaque index occurred using both toothbrushes (mean change=−1.26, 95% CI −1.57 to −0.95; p<0.001) and foam swabs (mean change=−1.28, 95% CI −1.54 to −1.01; p<0.001). There was significant reduction in gingival index over time using toothbrushes (mean change=−0.92; 95% CI −1.19 to −0.64; p<0.001) and foam swabs (mean change=−0.85; 95% CI −1.10 to −0.61; p<0.001). Differences between cleaning methods were not statistically significant (p=0.12 for change in gingival index; p=0.24 for change in plaque index). There was no significant change in bacterial dental plaque counts between toothbrushing (mean change 3.7×104 colony-forming units (CFUs); minimum to maximum (−2.5×1010 CFUs, 8.7×107 CFUs)) and foam swabs (mean change 9×104 CFUs; minimum to maximum (−3.1×1010 CFUs, 3.0×107 CFUs)). Conclusions Patients admitted to adult intensive care had poor oral health, which improved after brushing with a toothbrush or foam swab. Both interventions were equally effective at removing plaque and reducing gingival inflammation. Trial registration number NCT01154257; Pre-results. PMID:27843549

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

    PubMed

    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.

  19. Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme.

    PubMed

    Regge, Daniele; Iussich, Gabriella; Segnan, Nereo; Correale, Loredana; Hassan, Cesare; Arrigoni, Arrigo; Asnaghi, Roberto; Bestagini, Piero; Bulighin, Gianmarco; Cassinis, Maria Carla; Ederle, Andrea; Ferraris, Andrea; Galatola, Giovanni; Gallo, Teresa; Gandini, Giovanni; Garretti, Licia; Martina, Maria Cristina; Molinar, Daniela; Montemezzi, Stefania; Morra, Lia; Motton, Massimiliano; Occhipinti, Pietro; Pinali, Lucia; Soardi, Gian Alberto; Senore, Carlo

    2017-08-01

    The role of CT colonography (CTC) as a colorectal cancer (CRC) screening test is uncertain. The aim of our trial was to compare participation and detection rate (DR) with sigmoidoscopy (flexible sigmoidoscopy (FS)) and CTC in a screening setting. We conducted two randomised clinical trials (RCTs). (1) Participation RCT: individuals, aged 58 years, living in Turin (Italy), were randomly assigned to be invited to FS or CTC screening; (2) detection RCT: residents in northern Italy, aged 58-60, giving their consent to recruitment, were randomly allocated to CTC or FS. Polyps ≥6 mm at CTC, or 'high-risk' distal lesions at FS, were referred for colonoscopy (TC). Participation rate (proportion of invitees examined); DR of advanced adenomas or CRC (advanced neoplasia (AN)). Participation was 30.4% (298/980) for CTC and 27.4% (267/976) for FS (relative risk (RR) 1.1; 95% CI 0.98 to 1.29). Among men, participation was higher with CTC than with FS (34.1% vs 26.5%, p=0.011). In the detection RCT, 2673 subjects had FS and 2595 had CTC: the AN DR was 4.8% (127/2673, including 9 CRCs) with FS and 5.1% (133/2595, including 10 CRCs) with CTC (RR 1.08; 95% CI 0.85 to 1.37). Distal AN DR was 3.9% (109/2673) with FS and 2.9% (76/2595) with CTC (RR 0.72; 95% CI 0.54 to 0.96); proximal AN DR was 1.2% (34/2595) for FS vs 2.7% (69/2595) for CTC (RR 2.06; 95% CI 1.37 to 3.10). Participation and DR for FS and CTC were comparable. AN DR was twice as high in the proximal colon and lower in the distal colon with CTC than with FS. Men were more likely to participate in CTC screening. NCT01739608; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  20. Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial

    PubMed Central

    Haran, Mark J; Cameron, Ian D; Ivers, Rebecca Q; Simpson, Judy M; Lee, Bonsan B; Tanzer, Michael; Porwal, Mamta; Kwan, Marcella M S; Severino, Connie

    2010-01-01

    Objective To determine whether the provision of single lens distance glasses to older wearers of multifocal glasses reduces falls. Design Parallel randomised controlled trial stratified by recruitment site and source of referral, with 13 months’ follow-up and outcome assessors blinded to group allocation. Setting Community recruitment and treatment room assessments in Sydney and Illawarra regions of NSW, Australia. Participants 606 regular wearers of multifocal glasses (mean age 80 (SD 7) years). Inclusion criteria included increased risk of falls (fall in previous year or timed up and go test >15 seconds) and outdoor use of multifocal glasses at least three times a week. Interventions Provision of single lens distance glasses with recommendations for wearing them for walking and outdoor activities compared with usual care. Main outcome measures Number of falls and injuries resulting from falls during follow-up. Results Single lens glasses were provided to 275 (90%) of the 305 intervention group participants within two months; 162 (54%) of the intervention group reported satisfactory use of distance glasses for walking and outdoor activities for at least 7/12 months after dispensing. In the 299 intervention and 298 control participants available to follow-up, the intervention resulted in an 8% reduction in falls (incidence rate ratio 0.92, 95% confidence interval 0.73 to 1.16). Pre-planned sub-group analyses showed that the intervention was effective in significantly reducing all falls (incidence rate ratio 0.60, 0.42 to 0.87), outside falls, and injurious falls in people who regularly took part in outside activities. A significant increase in outside falls occurred in people in the intervention group who took part in little outside activity. Conclusions With appropriate counselling, provision of single lens glasses for older wearers of multifocal glasses who take part in regular outdoor activities is an effective falls prevention strategy. The intervention may

  1. A randomised, double-blinded study comparing giving etoricoxib vs. placebo to female patients with fibromyalgia.

    PubMed

    Mahagna, H; Amital, D; Amital, H

    2016-02-01

    Current therapeutic approaches to fibromyalgia syndrome (FMS) do not provide satisfactory pain control to a high percentage of patients. This unmet need constantly fuels the pursuit for new modalities for pain relief. This randomised, double-blind, controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS. In this double-blind, placebo-controlled study, female patients were randomised to receive either 90 mg etoricoxib once daily or placebo for 6 weeks. Several physical and mental parameters were assessed throughout the study. The primary end-point was the response to treatment, defined as ≥ 30% reduction in the average Brief Pain Inventory score. Secondary outcomes were changes in the Fibromyalgia Impact Questionnaire, SF-36 Quality of Life assessment questionnaire and Hamilton rating scales for anxiety and depression. Overall, 73 patients were recruited. Although many outcome measures improved throughout the study, no difference was recorded between the etoricoxib- and placebo-treated groups. The Brief Pain Inventory, Fibromyalgia Impact Questionnaire, The Hamilton Anxiety and Depression scores did not differ between the two groups. This is the first randomised, double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS. Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects. © 2016 John Wiley & Sons Ltd.

  2. Comparing medical versus surgical termination of pregnancy at 13-20 weeks of gestation: a randomised controlled trial.

    PubMed

    Kelly, T; Suddes, J; Howel, D; Hewison, J; Robson, S

    2010-11-01

    To compare the psychological impact, acceptability and clinical effectiveness of medical versus surgical termination of pregnancy (TOP) at 13-20 weeks of gestation. Randomised trial. Large UK tertiary centre. Women accepted for TOP at 13-20 weeks of gestation. Medical TOP (MTOP) using mifepristone and misoprostol or surgical TOP (STOP) by vacuum aspiration at <15 weeks of gestation, and by dilatation and evacuation at 15 or more weeks of gestation. Distress 2 weeks after TOP, measured by the impact of events scale (IES), and acceptability, measured by the proportion of women who would opt for the same procedure again. One hundred and twenty two women were randomised: 60 to the MTOP group and 62 to the STOP group. Twelve women opted to continue their pregnancy. Follow-up rates were low (n=66/110; 60%). At 2 weeks post-procedure there was no difference in total IES score between groups. However, compared with women undergoing STOP, women undergoing MTOP had a higher score on the IES intrusion subscale (mean difference 6.6; 95% CI 1.4-11.8), and a higher score on the general health questionnaire (GHQ) (P=0.033). Women found STOP more acceptable: compared with MTOP, more women would opt for the same procedure again (100% versus 53%, P≤0.001), and fewer women found the experience to be worse than expected (0% versus 53%, P=0.001). Women who had MTOP experienced more bleeding (P=0.003), more pain on the day of the procedure (P=0.008), and more days of pain (P=0.020). Of the 107 women who declined to participate, 58 (67%) preferred a STOP. Randomised trials of women requesting midtrimester TOP are challenging. Women found STOP less painful and more acceptable than MTOP. © 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.

  3. 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

    PubMed Central

    2011-01-01

    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 PMID:21774823

  4. 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.

    PubMed

    Huf, Gisele; Coutinho, Evandro S F; Ferreira, Marco A V; Ferreira, Silvana; Mello, Flavia; Adams, Clive E

    2011-07-20

    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. 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.

  5. Comparing individual and group intervention for psychological adjustment in people with multiple sclerosis: a feasibility randomised controlled trial.

    PubMed

    das Nair, Roshan; Kontou, Eirini; Smale, Kathryn; Barker, Alex; Lincoln, Nadina B

    2016-12-01

    To modify a published group intervention for adjustment to multiple sclerosis (MS) to suit an individual format, and to assess the feasibility of a randomised controlled trial (RCT) to compare individual and group intervention for people with multiple sclerosis and low mood. Feasibility randomised controlled trial. Participants were recruited through healthcare professionals at a hospital-based multiple sclerosis service and the MS Society. People with multiple sclerosis. Adjustment to multiple sclerosis in individual or group delivery format. Participants completed mood and quality of life assessments at baseline and at four-month follow-up. Measures of feasibility included: recruitment rate, acceptability of randomisation and the intervention (content and format), and whether the intervention could be adapted for individual delivery. Participants were screened for inclusion using the General Health Questionnaire-12 and Hospital Anxiety and Depression Scale, and were randomly allocated to receive either individual or group intervention, with the same content. Twenty-one participants were recruited (mean age 48.5 years, SD 10.5) and were randomly allocated to individual (n=11) or group (n=10) intervention. Of those offered individual treatment, nine (82%) completed all six sessions. Of those allocated to group intervention, two (20%) attended all six sessions and three (30%) attended five sessions. There were no statistically significant differences between the groups on the outcome measures of mood and quality of life. The intervention could be provided on an individual basis and the trial design was feasible. There were lower attendance rates at group sessions compared to individual sessions. © The Author(s) 2015.

  6. New method of preoxygenation for orotracheal intubation in patients with hypoxaemic acute respiratory failure in the intensive care unit, non-invasive ventilation combined with apnoeic oxygenation by high flow nasal oxygen: the randomised OPTINIV study protocol

    PubMed Central

    Jaber, Samir; Molinari, Nicolas; De Jong, Audrey

    2016-01-01

    Introduction Tracheal intubation in the intensive care unit (ICU) is associated with severe life-threatening complications including severe hypoxaemia. Preoxygenation before intubation has been recommended in order to decrease such complications. Non-invasive ventilation (NIV)-assisted preoxygenation allows increased oxygen saturation during the intubation procedure, by applying a positive end-expiratory pressure (PEEP) to prevent alveolar derecruitment. However, the NIV mask has to be taken off after preoxygenation to allow the passage of the tube through the mouth. The patient with hypoxaemia does not receive oxygen during this period, at risk of major hypoxaemia. High-flow nasal cannula oxygen therapy (HFNC) has a potential for apnoeic oxygenation during the apnoea period following the preoxygenation with NIV. Whether application of HFNC combined with NIV is more effective at reducing oxygen desaturation during the intubation procedure compared with NIV alone for preoxygenation in patients with hypoxaemia in the ICU with acute respiratory failure remains to be established. Methods and analysis The HFNC combined to NIV for decreasing oxygen desaturation during the intubation procedure in patients with hypoxaemia in the ICU (OPTINIV) trial is an investigator-initiated monocentre randomised controlled two-arm trial with assessor-blinded outcome assessment. The OPTINIV trial randomises 50 patients with hypoxaemia requiring orotracheal intubation for acute respiratory failure to receive NIV (pressure support=10, PEEP=5, fractional inspired oxygen (FiO2)=100%) combined with HFNC (flow=60 L/min, FiO2=100%, interventional group) or NIV alone (reference group) for preoxygenation. The primary outcome is lowest oxygen saturation during the intubation procedure. Secondary outcomes are intubation-related complications, quality of preoxygenation and ICU mortality. Ethics and dissemination The study project has been approved by the appropriate ethics committee (CPP Sud

  7. A randomised trial comparing the clinical effectiveness of different emergency department healthcare professionals in soft tissue injury management

    PubMed Central

    McClellan, Carey Middleton; Cramp, Fiona; Powell, Jane; Benger, Jonathan Richard

    2012-01-01

    Objectives To evaluate the clinical effectiveness of soft tissue injury management by emergency nurse practitioners (ENPs) and extended scope physiotherapists (ESPs) compared to the routine care provided by doctors in a UK emergency department (ED). Design Randomised, pragmatic trial of equivalence. Setting One adult ED in England. Participants 372 patients were randomised; 126 to the ESP group, 123 to the ENP group and 123 to the doctor group. Participants were adults (older than 16 years) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups. Patients were excluded if they had any of the following: injury greater than 72 hours old; systemic disease; dislocated joints; recent surgery; unable to give informed consent (eg, dementia), open wounds; major deformities; opiate analgesia required; concurrent chest/rib injury; neurovascular deficits and associated fracture. Interventions Patients were randomised to treatment by ESPs, ENPs or routine care provided by doctors (of all grades). Main outcome measures Upper-limb and lower-limb functional scores, quality of life, physical well-being, preference-based health measures and the number of days off work. Results The clinical outcomes of soft tissue injury treated by ESPs and ENPs in the ED were equivalent to routine care provided by doctors. Conclusions As all groups were clinically equivalent it is other factors such as cost, workforce sustainability, service provision and skill mix that become important. This result validates the role of the ENP, which is becoming established as an integral part of minor injuries care, and demonstrates that the ESP should be considered as part of the clinical skill mix without detriment to outcomes. ISRCTN-ISRCTN trials register number 70891354. PMID:23144256

  8. A randomised trial comparing the clinical effectiveness of different emergency department healthcare professionals in soft tissue injury management.

    PubMed

    McClellan, Carey Middleton; Cramp, Fiona; Powell, Jane; Benger, Jonathan Richard

    2012-01-01

    To evaluate the clinical effectiveness of soft tissue injury management by emergency nurse practitioners (ENPs) and extended scope physiotherapists (ESPs) compared to the routine care provided by doctors in a UK emergency department (ED). Randomised, pragmatic trial of equivalence. One adult ED in England. 372 patients were randomised; 126 to the ESP group, 123 to the ENP group and 123 to the doctor group. Participants were adults (older than 16 years) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups. Patients were excluded if they had any of the following: injury greater than 72 hours old; systemic disease; dislocated joints; recent surgery; unable to give informed consent (eg, dementia), open wounds; major deformities; opiate analgesia required; concurrent chest/rib injury; neurovascular deficits and associated fracture. Patients were randomised to treatment by ESPs, ENPs or routine care provided by doctors (of all grades). Upper-limb and lower-limb functional scores, quality of life, physical well-being, preference-based health measures and the number of days off work. The clinical outcomes of soft tissue injury treated by ESPs and ENPs in the ED were equivalent to routine care provided by doctors. As all groups were clinically equivalent it is other factors such as cost, workforce sustainability, service provision and skill mix that become important. This result validates the role of the ENP, which is becoming established as an integral part of minor injuries care, and demonstrates that the ESP should be considered as part of the clinical skill mix without detriment to outcomes. ISRCTN-ISRCTN TRIALS REGISTER NUMBER: 70891354.

  9. The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration ClinicalTrials.gov: NCT01057173 PMID:23302232

  10. Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin

    PubMed Central

    Tancawan, Archiel Launch; Pato, Maria Noemi; Abidin, Khamiza Zainol; Asari, A. S. Mohd; Thong, Tran Xuan; Kochhar, Puja; Muganurmath, Chandra; Twynholm, Monique; Barker, Keith

    2015-01-01

    Background. Treatment of odontogenic infections includes surgical drainage and adjunctive antibiotics. This study was designed to generate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections. Methods. This was a phase IV, randomised, observer blind study; 472 subjects were randomised to receive amoxicillin/clavulanic acid (875 mg/125 mg BID, n = 235) or clindamycin (150 mg QID, n = 237) for 5 or 7 days based on clinical response. The primary endpoint was percentage of subjects achieving clinical success (composite measure of pain, swelling, fever, and additional antimicrobial therapy required) at the end of treatment. Results. The upper limit of two-sided 95% confidence interval for the treatment difference between the study arms (7.7%) was within protocol specified noninferiority margin of 10%, thus demonstrating noninferiority of amoxicillin/clavulanic acid to clindamycin. Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm. Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity. Conclusion. Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT02141217. PMID:26300919

  11. Randomised clinical trial comparing melatonin 3 mg, amitriptyline 25 mg and placebo for migraine prevention

    PubMed Central

    Gonçalves, Andre Leite; Martini Ferreira, Adriana; Ribeiro, Reinaldo Teixeira; Zukerman, Eliova; Cipolla-Neto, José; Peres, Mario Fernando Prieto

    2016-01-01

    Introduction Melatonin has been studied in headache disorders. Amitriptyline is efficacious for migraine prevention, but its unfavourable side effect profile limits its use. Methods A randomised, double-blind, placebo-controlled study was carried out. Men and women, aged 18–65 years, with migraine with or without aura, experiencing 2–8 attacks per month, were enrolled. After a 4-week baseline phase, 196 participants were randomised to placebo, amitriptyline 25 mg or melatonin 3 mg, and 178 took a study medication and were followed for 3 months (12 weeks). The primary outcome was the number of migraine headache days per month at baseline versus last month. Secondary end points were responder rate, migraine intensity, duration and analgesic use. Tolerability was also compared between groups. Results Mean headache frequency reduction was 2.7 migraine headache days in the melatonin group, 2.2 for amitriptyline and 1.1 for placebo. Melatonin significantly reduced headache frequency compared with placebo (p=0.009), but not to amitriptyline (p=0.19). Melatonin was superior to amitriptyline in the percentage of patients with a greater than 50% reduction in migraine frequency. Melatonin was better tolerated than amitriptyline. Weight loss was found in the melatonin group, a slight weight gain in placebo and significantly for amitriptyline users. Conclusions Melatonin 3 mg is better than placebo for migraine prevention, more tolerable than amitriptyline and as effective as amitriptyline 25 mg. PMID:27165014

  12. Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: A Randomised Study Comparing Efficacy and Tolerability versus Clindamycin.

    PubMed

    Tancawan, Archiel Launch; Pato, Maria Noemi; Abidin, Khamiza Zainol; Asari, A S Mohd; Thong, Tran Xuan; Kochhar, Puja; Muganurmath, Chandra; Twynholm, Monique; Barker, Keith

    2015-01-01

    Background. Treatment of odontogenic infections includes surgical drainage and adjunctive antibiotics. This study was designed to generate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections. Methods. This was a phase IV, randomised, observer blind study; 472 subjects were randomised to receive amoxicillin/clavulanic acid (875 mg/125 mg BID, n = 235) or clindamycin (150 mg QID, n = 237) for 5 or 7 days based on clinical response. The primary endpoint was percentage of subjects achieving clinical success (composite measure of pain, swelling, fever, and additional antimicrobial therapy required) at the end of treatment. Results. The upper limit of two-sided 95% confidence interval for the treatment difference between the study arms (7.7%) was within protocol specified noninferiority margin of 10%, thus demonstrating noninferiority of amoxicillin/clavulanic acid to clindamycin. Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm. Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity. Conclusion. Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT02141217.

  13. The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone. Methods/Design A prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle. Discussion By enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to

  14. The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial.

    PubMed

    Brauer, Sandra G; Hayward, Kathryn S; Carson, Richard G; Cresswell, Andrew G; Barker, Ruth N

    2013-07-02

    Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone. A prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle. By enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to improve recovery of upper limb function

  15. Treatment of external genital warts: a randomised clinical trial comparing podophyllin, cryotherapy, and electrodesiccation.

    PubMed Central

    Stone, K M; Becker, T M; Hadgu, A; Kraus, S J

    1990-01-01

    Four hundred and fifty patients were enrolled into a randomised clinical trial in a public sexually transmitted diseases clinic to evaluate the efficacy of podophyllin, cryotherapy, and electrodesiccation for treatment of external genital warts. Complete clearance of warts was observed in 41%, 79%, and 94% of patients who received up to six weekly treatments of podophyllin, cryotherapy, and electrodesiccation, respectively. Relapses occurred in 25% of all patients, yielding 3 month clearance rates of 17%, 55%, and 71% for podophyllin, cryotherapy, and electrodesiccation, respectively. Wart volume and duration did not influence treatment outcome. Response to therapy was greater in women than in men, and did not differ by treatment modality. Electrodesiccation and cryotherapy were more effective than podophyllin for the treatment of external genital warts, but none of these three treatments were highly successful. PMID:2179111

  16. A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women.

    PubMed

    Shen, S; Zhou, Y; Xu, Y; Zhang, B; Duan, X; Huang, R; Li, B; Shi, Y; Shao, Z; Liao, H; Jiang, J; Shen, N; Zhang, J; Yu, C; Jiang, H; Li, S; Han, S; Ma, J; Sun, Q

    2015-03-17

    Chinese women tend to have small and dense breasts and ultrasound is a common method for breast cancer screening in China. However, its efficacy and cost comparing with mammography has not been evaluated in randomised trials. At 14 breast centres across China during 2008-2010, 13 339 high-risk women aged 30-65 years were randomised to be screened by mammography alone, ultrasound alone, or by both methods at enrollment and 1-year follow-up. A total of 12 519 and 8692 women underwent the initial and second screenings, respectively. Among the 30 cancers (of which 15 were stage 0/I) detected, 5 (0.72/1000) were in the mammography group, 11 (1.51/1000) in the ultrasound group, and 14 (2.02/1000) in the combined group (P=0.12). In the combined group, ultrasound detected all the 14 cancers, whereas mammography detected 8, making ultrasound more sensitive (100 vs 57.1%, P=0.04) with a better diagnostic accuracy (0.999 vs 0.766, P=0.01). There was no difference between mammography and ultrasound in specificity (100 vs 99.9%, P=0.51) and positive predictive value (72.7 vs 70.0%; P=0.87). To detect one cancer, the costs of ultrasound, mammography, and combined modality were $7876, $45 253, and $21 599, respectively. Ultrasound is superior to mammography for breast cancer screening in high-risk Chinese women.

  17. A randomised trial comparing endometrial resection and abdominal hysterectomy for the treatment of menorrhagia.

    PubMed Central

    Gannon, M J; Holt, E M; Fairbank, J; Fitzgerald, M; Milne, M A; Crystal, A M; Greenhalf, J O

    1991-01-01

    OBJECTIVE--To determine the advantages and disadvantages of endometrial resection and abdominal hysterectomy for the surgical treatment of women with menorrhagia. DESIGN--Randomised study of two treatment groups with a minimum follow up of nine months. SETTING--Royal Berkshire Hospital, Reading. SUBJECTS--51 of 78 menorrhagic women without pelvic pathology who were on the waiting list for abdominal hysterectomy. TREATMENT--Endometrial resection or abdominal hysterectomy (according to randomisation). Endometrial resections were performed by an experienced hysteroscopic surgeon; hysterectomies were performed by two other gynaecological surgeons. MAIN OUTCOME MEASURES--Length of operating time, hospitalisation, recovery; cost of surgery; short term results of endometrial resection. RESULTS--Operating time was shorter for endometrial resection (median 30 (range 20-47) minutes) than for hysterectomy (50 (39-74) minutes). The hospital stay for endometrial resection (median 1 (range 1-3) days) was less than for hysterectomy (7 (5-12) days). Recovery after endometrial resection (median 16 (range 5-62) days) was shorter than after hysterectomy (58 (11-125) days). The cost was 407 pounds for endometrial resection and 1270 pounds for abdominal hysterectomy. Four women (16%) who did not have an acceptable improvement in symptoms after endometrial resection had repeat resections. No woman has required hysterectomy during a mean follow up of one year. CONCLUSION--For women with menorrhagia who have no pelvic pathology endometrial resection is a useful alternative to abdominal hysterectomy, with many short term benefits. Larger numbers and a longer follow up are needed to estimate the incidence of complications and the long term efficacy of endometrial resection. PMID:1760601

  18. A randomised double blind comparative study of low level laser therapy following surgical extraction of lower third molar teeth.

    PubMed

    Fernando, S; Hill, C M; Walker, R

    1993-06-01

    A randomised, double blind comparative study was undertaken to assess the efficacy of low level laser therapy in the reduction of postoperative pain and swelling in patients undergoing the extraction of bilaterally impacted mandibular third molar teeth. Healing of the sockets was also compared after 1 week. A group of 64 patients had one randomly-selected operation side treated with a semi-conductor laser and the other side with an apparently identical but non-operating model. Complete data were obtained from 52 of the 64 patients. The results showed that there was no evidence of a difference in pain and swelling on the third day after operation between laser and placebo sides. There was no difference between the two sides when they were assessed for healing 7 days after surgery.

  19. Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial.

    PubMed

    Costa, Matthew L; Achten, Juul; Parsons, Nick R; Rangan, Amar; Griffin, Damian; Tubeuf, Sandy; Lamb, Sarah E

    2014-08-05

    To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius. A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation. 18 trauma centres in the United Kingdom. 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction. Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws. validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient's experience of pain and disability to give a score out of 100. disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery. The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was -1.3, 95% confidence interval -4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group. Contrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with

  20. Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial

    PubMed Central

    Achten, Juul; Parsons, Nick R; Rangan, Amar; Griffin, Damian; Tubeuf, Sandy; Lamb, Sarah E

    2014-01-01

    Objectives To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius. Design A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation. Setting 18 trauma centres in the United Kingdom. Participants 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction. Interventions Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws. Main outcome measures Primary outcome measure: validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient’s experience of pain and disability to give a score out of 100. Secondary outcomes: disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery. Results The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was −1.3, 95% confidence interval −4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group. Conclusions Contrary to the existing literature, and against the rapidly increasing use of locking plate

  1. INCITE: A randomised trial comparing constraint induced movement therapy and bimanual training in children with congenital hemiplegia

    PubMed Central

    2010-01-01

    Background Congenital hemiplegia is the most common form of cerebral palsy (CP) accounting for 1 in 1300 live births. These children have limitations in capacity to use the impaired upper limb and bimanual coordination deficits which impact on daily activities and participation in home, school and community life. There are currently two diverse intensive therapy approaches. Traditional therapy has adopted a bimanual approach (BIM training) and recently, constraint induced movement therapy (CIMT) has emerged as a promising unimanual approach. Uncertainty remains about the efficacy of these interventions and characteristics of best responders. This study aims to compare the efficacy of CIMT to BIM training to improve outcomes across the ICF for school children with congenital hemiplegia. Methods/Design A matched pairs randomised comparison design will be used with children matched by age, gender, side of hemiplegia and level of upper limb function. Based on power calculations a sample size of 52 children (26 matched pairs) will be recruited. Children will be randomised within pairs to receive either CIMT or BIM training. Both interventions will use an intensive activity based day camp model, with groups receiving the same dosage of intervention delivered in the same environment (total 60 hours over 10 days). A novel circus theme will be used to enhance motivation. Groups will be compared at baseline, then at 3, 26 and 52 weeks following intervention. Severity of congenital hemiplegia will be classified according to brain structure (MRI and white matter fibre tracking), cortical excitability using Transcranial Magnetic Stimulation (TMS), functional use of the hand in everyday tasks (Manual Ability Classification System) and Gross Motor Function Classification System (GMFCS). Outcomes will address neurovascular changes (functional MRI, functional connectivity), and brain (re)organisation (TMS), body structure and function (range of motion, spasticity, strength and

  2. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

    PubMed Central

    MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

    2013-01-01

    Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

  3. A randomised control study comparing the Infant Flow Driver with nasal continuous positive airway pressure in preterm infants

    PubMed Central

    Mazzella, M; Bellini, C; Calevo, M; Campone, F; Massocco, D; Mezzano, P; Zullino, E; Scopesi, F; Arioni, C; Bonacci, W; Serra, G

    2001-01-01

    OBJECTIVE—To compare the effectiveness of the Infant Flow Driver (IFD) with single prong nasal continuous positive airway pressure (nCPAP) in preterm neonates affected by respiratory distress syndrome.
DESIGN—Randomised controlled study.
PATIENTS—Between September 1997 and March 1999, 36 preterm infants who were eligible for CPAP treatment were randomly selected for either nCPAP or IFD and studied prospectively for changes in oxygen requirement and/or respiratory rate. The requirement for mechanical ventilation, complications of treatment, and effects on mid-term outcome were also evaluated.
RESULTS—Use of the IFD had a significantly beneficial effect on both oxygen requirement and respiratory rate (p < 0.0001) when compared with nCPAP. Moreover, O2 requirement and respiratory rate were significantly decreased by four hours (p < 0.001 and p < 0.03 respectively). The probability of remaining supplementary oxygen free over the first 48 hours of treatment was significantly higher in patients treated with the IFD than with nCPAP (p < 0.02). IFD treated patients had a higher success (weaning) rate (94% v 72%) and shorter duration of treatment (49.3 (31) v 56 (29.7) hours respectively; mean (SD)), although the difference was not significant.
CONCLUSIONS—IFD appears to be a feasible device for managing respiratory distress syndrome in preterm infants, and benefits may be had with regard to oxygen requirement and respiratory rate when compared with nCPAP. The trend towards reduced requirement for mechanical ventilation, shorter clinical recovery time, and shorter duration of treatment requires further evaluation in a multicentre randomised clinical trial.

 PMID:11517199

  4. A French multicenter randomised trial comparing two dose-regimens of prothrombin complex concentrates in urgent anticoagulation reversal

    PubMed Central

    2013-01-01

    Introduction Prothrombin complex concentrates (PCC) are haemostatic blood preparations indicated for urgent anticoagulation reversal, though the optimal dose for effective reversal is still under debate. The latest generation of PCCs include four coagulation factors, the so-called 4-factor PCC. The aim of this study was to compare the efficacy and safety of two doses, 25 and 40 IU/kg, of 4-factor PCC in vitamin K antagonist (VKA) associated intracranial haemorrhage. Methods We performed a phase III, prospective, randomised, open-label study including patients with objectively diagnosed VKA-associated intracranial haemorrhage between November 2008 and April 2011 in 22 centres in France. Patients were randomised to receive 25 or 40 IU/kg of 4-factor PCC. The primary endpoint was the international normalised ratio (INR) 10 minutes after the end of 4-factor PCC infusion. Secondary endpoints were changes in coagulation factors, global clinical outcomes and incidence of adverse events (AEs). Results A total of 59 patients were randomised: 29 in the 25 IU/kg and 30 in the 40 IU/kg group. Baseline demographics and clinical characteristics were comparable between the groups. The mean INR was significantly reduced to 1.2 - and ≤1.5 in all patients of both groups - 10 minutes after 4-factor PCC infusion. The INR in the 40 IU/kg group was significantly lower than in the 25 IU/kg group 10 minutes (P = 0.001), 1 hour (P = 0.001) and 3 hours (P = 0.02) after infusion. The 40 IU/kg dose was also effective in replacing coagulation factors such as PT (P = 0.038), FII (P = 0.001), FX (P <0.001), protein C (P = 0.002) and protein S (0.043), 10 minutes after infusion. However, no differences were found in haematoma volume or global clinical outcomes between the groups. Incidence of death and thrombotic events was similar between the groups. Conclusions Rapid infusion of both doses of 4-factor PCC achieved an INR of 1.5 or less in all patients with a lower INR observed in the 40 IU

  5. Sublingual vitamin B12 compared to intramuscular injection in patients with type 2 diabetes treated with metformin: a randomised trial.

    PubMed

    Parry-Strong, Amber; Langdana, Fali; Haeusler, Sylvan; Weatherall, Mark; Krebs, Jeremy

    2016-06-10

    MAIM: To compare a single 1mg intramuscular hydroxocobalamin injection with a 3-month course of 1mg/day sublingual methylcobalamin supplements on serum vitamin B12 concentrations in participants withtype 2 diabetes treated with metformin. Participants on metformin treatment with vitamin B12 concentrations below 220pmol/L were recruited through hospital diabetes clinics and primary care practices. They were randomised to receive either the injection or sublingual treatment. The primary outcome was serum vitamin B12 level after 3 months adjusted for baseline assessed by analysis of covariance (ANCOVA). The trial was registered on the Australia New Zealand Clinical Trial registry (ACTRN12612001108808). A total of 34 participants were randomised; 19 to the tablet, and 15 to the injection. The mean (SD) age, duration of diabetes, and duration of metformin use were, 64.2 (7.3) years, 13.7 (6.4) years, and 11.6 (5.0) years, respectively. After 3 months, the mean (SD) vitamin B12 was 372.1 (103.3) pmol/L in the tablet group (n=19) compared to 251.7 (106.8) pmol/L in the injection group (n=15), ANCOVA estimated difference -119.4 (95% CI -191.2 to -47.6), p=0.002. After 6 months, the mean (SD) serum B12 was 258.8 (58.7) pmol/L in the tablet group (n=17) and 241.9 (40.1) pmol/L in the injection group (n=15); ANCOVA estimated difference -15.2 (95% CI -50.3 to 19.8), p=0.38. Higher metformin dose was associated with lower serum B12 at 3 months, but not at baseline or 6 months. Decreased serum vitamin B12 level in patients with type 2 diabetes who are treated with metformin can be corrected through treatment with either hydroxocobalamin injections or methylcobalamin sublingual supplements.

  6. Comparative effect sizes in randomised trials from less developed and more developed countries: meta-epidemiological assessment.

    PubMed

    Panagiotou, Orestis A; Contopoulos-Ioannidis, Despina G; Ioannidis, John P A

    2013-02-12

    To compare treatment effects from randomised trials conducted in more developed versus less developed countries. Meta-epidemiological study. Cochrane Database of Systematic Reviews (August 2012). Meta-analyses with mortality outcomes including data from at least one randomised trial conducted in a less developed country and one in a more developed country. Relative risk estimates of more versus less developed countries were compared by calculating the relative relative risks for each topic and the summary relative relative risks across all topics. Similar analyses were performed for the primary binary outcome of each topic. 139 meta-analyses with mortality outcomes were eligible. No nominally significant differences between more developed and less developed countries were found for 128 (92%) meta-analyses. However, differences were beyond chance in 11 (8%) cases, always showing more favourable treatment effects in trials from less developed countries. The summary relative relative risk was 1.12 (95% confidence interval 1.06 to 1.18; P<0.001; I(2)=0%), suggesting significantly more favourable mortality effects in trials from less developed countries. Results were similar for meta-analyses with nominally significant treatment effects for mortality (1.15), meta-analyses with recent trials (1.14), and when excluding trials from less developed countries that subsequently became more developed (1.12). For the primary binary outcomes (127 meta-analyses), 20 topics had differences in treatment effects beyond chance (more favourable in less developed countries in 15/20 cases). Trials from less developed countries in a few cases show significantly more favourable treatment effects than trials in more developed countries and, on average, treatment effects are more favourable in less developed countries. These discrepancies may reflect biases in reporting or study design as well as genuine differences in baseline risk or treatment implementation and should be considers when

  7. Randomised controlled trial comparing effectiveness and acceptability of an early discharge, hospital at home scheme with acute hospital care

    PubMed Central

    Richards, Suzanne H; Coast, Joanna; Gunnell, David J; Peters, Tim J; Pounsford, John; Darlow, Mary-Anne

    1998-01-01

    Objective: To compare effectiveness and acceptability of early discharge to a hospital at home scheme with that of routine discharge from acute hospital. Design: Pragmatic randomised controlled trial. Setting: Acute hospital wards and community in north of Bristol, with a catchment population of about 224 000 people. Subjects: 241 hospitalised but medically stable elderly patients who fulfilled criteria for early discharge to hospital at home scheme and who consented to participate. Interventions: Patients’ received hospital at home care or routine hospital care. Main outcome measures: Patients’ quality of life, satisfaction, and physical functioning assessed at 4 weeks and 3 months after randomisation to treatment; length of stay in hospital and in hospital at home scheme after randomisation; mortality at 3 months. Results: There were no significant differences in patient mortality, quality of life, and physical functioning between the two arms of the trial at 4 weeks or 3 months. Only one of 11 measures of patient satisfaction was significantly different: hospital at home patients perceived higher levels of involvement in decisions. Length of stay for those receiving routine hospital care was 62% (95% confidence interval 51% to 75%) of length of stay in hospital at home scheme. Conclusions: The early discharge hospital at home scheme was similar to routine hospital discharge in terms of effectiveness and acceptability. Increased length of stay associated with the scheme must be interpreted with caution because of different organisational characteristics of the services. Key messages Pressure on hospital beds, the increasing age of the population, and high costs associated with acute hospital care have fuelled the search for alternatives to inpatient hospital care There were no significant differences between early discharge to hospital at home scheme and routine hospital care in terms of patient quality of life, physical functioning, and most measures of

  8. Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - The SOSTRA trial protocol

    PubMed Central

    2011-01-01

    Background Children with attention deficit hyperactivity disorder (ADHD) are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions. Methods/Design The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms. Discussion We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone. Trial registration ClinicalTrials (NCT): NCT00937469 PMID:21255399

  9. Effects of continuous positive airway pressure on neurocognitive architecture and function in patients with obstructive sleep apnoea: study protocol for a multicentre randomised controlled trial.

    PubMed

    Xu, Huajun; Wang, Hui; Guan, Jian; Yi, Hongliang; Qian, Yingjun; Zou, Jianyin; Xia, Yunyan; Fu, Yiqun; Li, Xinyi; Jiao, Xiao; Huang, Hengye; Dong, Pin; Yu, Ziwei; Yang, Jun; Xiang, Mingliang; Li, Jiping; Chen, Yanqing; Wang, Peihua; Sun, Yizhou; Li, Yuehua; Zheng, Xiaojian; Jia, Wei; Yin, Shankai

    2017-05-25

    Many clinical studies have indicated that obstructive sleep apnoea (OSA), the most common chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous positive airway pressure (CPAP) has some neurocognitive protective effects against the adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture and function remain unclear. Therefore, this multicentre trial was designed to investigate whether and when neurocognitive architecture and function in patients with OSA can be improved by CPAP treatment and to explore the role of gut microbiota in improving neurocognitive function during treatment. This study will be a multicentre, randomised, controlled trial with allocation concealment and assessor blinding. A total of 148 eligible patients with moderate to severe OSA will be enrolled from five sleep centres and randomised to receive CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive function, structure and function of brain regions, gut microbiota, metabolites, biochemical variables, electrocardiography, echocardiography, pulmonary function and arterial stiffness will be assessed at baseline before randomisation and at 3, 6 and 12 months. This study has been approved by the Medical Ethics Committee of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (approval number 2015-79). The results from this study will be published in peer-reviewed journals and at relevant conferences. NCT02886156; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. A multicentre randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injections

    PubMed Central

    Deyle, Gail D; Gill, Norman W; Rhon, Daniel I; Allen, Chris S; Allison, Stephen C; Hando, Ben R; Petersen, Evan J; Dusenberry, Douglas I; Bellamy, Nicholas

    2016-01-01

    Introduction Corticosteroid injections (CSIs) are commonly used as an initial or a primary intervention for knee osteoarthritis (OA). Consistent evidence indicates CSIs offer symptom relief with conflicting reports regarding long-term efficacy. Physical therapy (PT) offers a non-invasive alternative. There is moderate evidence suggesting short-term and long-term symptom relief and functional improvement with PT interventions. Patients with knee OA are more commonly prescribed CSI than PT prior to total joint replacement. UnitedHealthcare and Military Health System data show substantially more total knee replacement patients receive preoperative CSI than PT. There are no studies comparing CSI to a PT approach in individuals with knee OA. The primary objective of this study is to compare the effectiveness of CSI to PT in individuals with knee OA at 1, 2 and 12 months. Methods and analysis We plan to recruit 156 participants meeting established knee OA criteria. Following informed consent, participants will be randomised to receive either CSI or PT. All participants will receive instruction on recommended exercise and weight control strategies plus usual medical care. The CSI intervention consisting of 3 injections and the PT intervention consisting of 8–12 sessions will be spaced over 12 months. Measures of the dependent variables (DVs) will occur at baseline, 4 weeks, 8 weeks, 6 months and 12 months post enrolment. This pragmatic, randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (CSI and PT) and time with five levels from baseline to 1 year. The primary DV is the Western Ontario & McMaster Universities Arthritis Index (WOMAC). We will also compare healthcare utilisation between the 2 groups. Ethics and Dissemination The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The authors intend to publish the results in a peer-reviewed source. Trial Registration

  11. A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women

    PubMed Central

    Shen, S; Zhou, Y; Xu, Y; Zhang, B; Duan, X; Huang, R; Li, B; Shi, Y; Shao, Z; Liao, H; Jiang, J; Shen, N; Zhang, J; Yu, C; Jiang, H; Li, S; Han, S; Ma, J; Sun, Q

    2015-01-01

    Background: Chinese women tend to have small and dense breasts and ultrasound is a common method for breast cancer screening in China. However, its efficacy and cost comparing with mammography has not been evaluated in randomised trials. Methods: At 14 breast centres across China during 2008–2010, 13 339 high-risk women aged 30–65 years were randomised to be screened by mammography alone, ultrasound alone, or by both methods at enrolment and 1-year follow-up. Results: A total of 12 519 and 8692 women underwent the initial and second screenings, respectively. Among the 30 cancers (of which 15 were stage 0/I) detected, 5 (0.72/1000) were in the mammography group, 11 (1.51/1000) in the ultrasound group, and 14 (2.02/1000) in the combined group (P=0.12). In the combined group, ultrasound detected all the 14 cancers, whereas mammography detected 8, making ultrasound more sensitive (100 vs 57.1%, P=0.04) with a better diagnostic accuracy (0.999 vs 0.766, P=0.01). There was no difference between mammography and ultrasound in specificity (100 vs 99.9%, P=0.51) and positive predictive value (72.7 vs 70.0% P=0.87). To detect one cancer, the costs of ultrasound, mammography, and combined modality were $7876, $45 253, and $21 599, respectively. Conclusions: Ultrasound is superior to mammography for breast cancer screening in high-risk Chinese women. PMID:25668012

  12. Comparing clinical quality indicators for asthma management in children with outcome measures used in randomised controlled trials: a protocol.

    PubMed

    Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B; Coiera, Enrico

    2015-09-08

    Clinical quality indicators are necessary to monitor the performance of healthcare services. The development of indicators should, wherever possible, be based on research evidence to minimise the risk of bias which may be introduced during their development, because of logistic, ethical or financial constraints alone. The development of automated methods to identify the evidence base for candidate indicators should improve the process of indicator development. The objective of this study is to explore the relationship between clinical quality indicators for asthma management in children with outcome and process measurements extracted from randomised controlled clinical trial reports. National-level indicators for asthma management in children will be extracted from the National Quality Measures Clearinghouse (NQMC) database and the National Institute for Health and Care Excellence (NICE) quality standards. Outcome measures will be extracted from published English language randomised controlled trial (RCT) reports for asthma management in children aged below 12 years. The two sets of measures will be compared to assess any overlap. The study will provide insights into the relationship between clinical quality indicators and measurements in RCTs. This study will also yield a list of measurements used in RCTs for asthma management in children, and will find RCT evidence for indicators used in practice. Ethical approval is not necessary because this study will not include patient data. Findings will be disseminated through peer-reviewed publications. 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.

  13. Protocol for "Seal or Varnish?" (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay.

    PubMed

    Chestnutt, Ivor Gordon; Chadwick, Barbara Lesley; Hutchings, Simon; Playle, Rebecca; Pickles, Timothy; Lisles, Catherine; Kirkby, Nigel; Morgan, Maria Zeta; Hunter, Lindsay; Hodell, Ceri; Withers, Beverely; Murphy, Simon; Morgan-Trimmer, Sarah; Fitzsimmons, Deborah; Phillips, Ceri; Nuttall, Jacqueline; Hood, Kerenza

    2012-11-20

    Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6-7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools

  14. Increasing compliance with protective eyewear to reduce ocular injuries in stone-quarry workers in Tamil Nadu, India: a pragmatic, cluster randomised trial of a single education session versus an enhanced education package delivered over six months.

    PubMed

    Adams, James S K; Raju, Renu; Solomon, Victor; Samuel, Prasanna; Dutta, Amit K; Rose, Jeyanth S; Tharyan, Prathap

    2013-01-01

    To evaluate the efficacy of standard education versus enhanced education in increasing compliance with protective eyewear to prevent ocular injuries in stone-quarry workers. Pragmatic, allocation concealed, participant and outcome assessor blinded, cluster randomised trial. Six stone-quarries around Vellore, Tamil Nadu, South India. 204 consenting adult stone quarry workers. Protective eyewear plus enhanced education (one education session, plus 11 sessions of group education, individual discussions, and educational plays over six months) versus protective eyewear plus standard education (one education session and 5 follow up visits). The primary outcomes were observer-rated compliance with protective eyewear and reduction in incidence of ocular injuries (slit-lamp examination by an observer blinded to allocation status) at three and six months. Analysis was by intention to treat. Quarries and participants were similar at enrolment. All quarries; 92/103 (90%) of workers in three quarries given enhanced intervention, and 91/101 workers (89%) in three quarries given standard education, completed six months follow up. Compared to standard education, enhanced education significantly increased compliance with protective eyewear by 16% (95% CI 3-28%) at three months (OR 2.1; 95% CI 1.2-3.8); and by 25% (95% CI 11-35%) at six months (OR 2.7; 95% CI 1.5-4.8). Protective eyewear and enhanced education reduced the incidence of eye injuries at three months by 16% (95% CI 7-24%); and standard education by 13% (95% CI 4-22%), compared to the three months before interventions. The cumulative reduction over baseline in eye injuries at the six months was greater with enhanced education (12% decrease; 95% CI 3-21%) than with standard education (7% decrease; 95% CI 17% decrease to 3% increase). However, this incidence did not differ significantly between intervention arms at three months (OR 0.7% 95% CI 0.3-2.1); and at six months (OR 0.8; 95% CI 0.4-1.5). Provision of appropriate

  15. A randomised controlled trial comparing Mediwrap heat retention and forced air warming for maintaining normothermia in thoracic surgery.

    PubMed

    Rathinam, Sridhar; Annam, Venkatesh; Steyn, Richard; Raghuraman, Govindan

    2009-07-01

    Hypothermia is one of the common complications in the perioperative period. Currently, normothermia is maintained with forced air warming (FAW) or passive heat retention methods. We compared the efficacy of the Mediwrap blanket with FAW in maintaining normothermia during intra-operative period in thoracic surgery in a prospective randomised controlled trial on 30 patients. Core temperature was measured at 30-min intervals in the perioperative period and the time taken to attain baseline in the postoperative periods in the two groups was compared. There was no difference in core temperatures between the groups during pre- and intra-operative period, with mean+/-S.D. final core temperatures of 36.2+/-0.6 degrees C with Mediwrap and 36+/-0.9 degrees C with the FAW blanket. However, the postoperative core temperatures were significantly higher in the Mediwrap group. The time required to reach baseline temperature was lower in the Mediwrap group with a mean+/-S.D. of 66+/-66 min as compared to 161+/-108 min in the FAW group. The Mediwrap blanket is as effective as the FAW blanket in maintaining core body temperature during thoracotomy when applied thirty minutes before the surgery.

  16. A randomised controlled trial comparing skin closure in total knee arthroplasty in the same knee: nylon sutures versus skin staples

    PubMed Central

    Iamthanaporn, K.; Hongnaparak, T.; Tangtrakulwanich, B.

    2016-01-01

    Objectives Nylon sutures and skin staples are used commonly in total knee arthroplasty (TKA) surgical wound closure. However, there is no study that compares the wound healing efficacy and patient satisfaction scores of both techniques in the same knee. Methods We randomised 70 patients who underwent primary TKA into two groups. In one group of 34 patients, the skin at the upper half of the wound was closed with skin staples and the lower half of the wound was closed with simple interrupted nylon sutures. In the other group of 36 patients, the skin at the upper half of the wound was closed with nylon stitches and the lower half of the wound was closed with skin staples. We recorded the wound closure time, pain score at the time of stitch removal, wound complication rate, patient satisfaction score, and the Hollander wound evaluation score at the post-operative periods of five days, 14 days, six weeks, three months, and six months. Each half wound was analysed separately. Results The mean patient body mass index was 26.8 kg/m2 (standard deviation 6.3). A total of 70 nylon stitched wounds and 70 skin stapled wounds were analysed. There were no significant differences in wound complication rates, patient satisfaction score, and the Hollander wound evaluation score between both types of wounds (p > 0.05). The wound closure time for skin stapled wounds was significantly lower than the nylon stitched wounds (p < 0.001). However, the skin stapled wounds had a significantly higher pain score at the time of stitch removal (p < 0.001). Conclusion Skin staples and nylon stitches had comparable results with respect to wound healing and patient satisfaction in TKA wound closure in non-obese patients. The benefit of skin staples over nylon stitches was a decrease in operative time, but was more painful upon removal. Cite this article: V. Yuenyongviwat. A randomised controlled trial comparing skin closure in total knee arthroplasty in the same knee: nylon sutures versus skin

  17. Flutrimazole shampoo 1% versus ketoconazole shampoo 2% in the treatment of pityriasis versicolor. A randomised double-blind comparative trial.

    PubMed

    Rigopoulos, D; Gregoriou, S; Kontochristopoulos, G; Ifantides, A; Katsambas, A

    2007-05-01

    Flutrimazole is an imidazole derivative that has been proven to be efficient in superficial skin fungal infections. The aim of this randomised double-blind study was to compare for the first time, the efficiency and safety of flutrimazole 1% shampoo versus ketoconazole 2% shampoo in the treatment of tinea versicolor. Study population consisted of 60 patients with pityriasis versicolor diagnosed clinically and through direct microscopy and culture. Patients were randomly assigned to two groups: one instructed to apply flutrimazole shampoo 1% and one instructed to apply ketoconazole shampoo 2% both on head and body for 14 days. Patients were re-evaluated 14 days after the end of treatment clinically and through direct microscopy and culture. Twenty-one of 26 patients (80.8%) in the ketoconazole and 22 of 29 patients (75.9%) in the flutrimazole group had both visual healing and negative mycological evaluation. Comparison of the response between the two groups with the Yates' corrected chi-square was found statistically not significant (chi(2) = 0.19, d.f. = 1, P = 0.91). None of the patients in the two groups reported any adverse effects. Fourteen (53%) patients in the ketoconazole group and 23 (79%) in the flutrimazole group assessed the shampoos as cosmetically acceptable regarding texture, smell and foam properties. Flutrimazole shampoo 1% appears to present efficacy comparable with ketoconazole 2% in the treatment of tinea versicolor.

  18. A multicentre randomised trial comparing octreotide and injection sclerotherapy in the management and outcome of acute variceal haemorrhage

    PubMed Central

    Jenkins, S; Shields, R; Davies, M; Elias, E; Turnbull, A; Bassendine, M; James, O; Iredale, J; Vyas, S; Arthur, M; Kingsnorth, A; Sutton, R

    1997-01-01

    Background—Few studies have compared vasoactive drugs with endoscopic sclerotherapy in the control of acute variceal haemorrhage. Octreotide is widely used for this purpose, but its value remains undetermined. 
Aims—To compare octreotide with endoscopic sclerotherapy for acute variceal haemorrhage. 
Patients—Consecutive patients with acute variceal haemorrhage. 
Methods—Patients were randomised at endoscopy to receive either a 48 hour intravenous infusion of 50 µg/h octreotide (n=73), or emergency sclerotherapy (n=77). 
Results—Overall control of bleeding and mortality was not significantly different between octreotide (85%, 62 patients) and sclerotherapy (82%, 63 patients) over the 48 hour trial period (relative risk of rebleeding 0.83; 95% confidence interval (CI) 0.38 to 1.82), irrespective of Child's grading or active bleeding at endoscopy. One major complication was observed in the sclerotherapy group (aspiration) and two in the octreotide group (pulmonary oedema, severe paralytic ileus). During 60 days of follow up there was an overall trend towards an increased mortality in the octreotide group which was not statistically significant (relative risk of dying at 60 days 1.91, 95% CI 0.97 to 3.78, p=0.06). 
Conclusions—The results of this study indicate that intravenous octreotide is as effective as injection sclerotherapy in the control of acute variceal bleeding, but further controlled trials are necessary to evaluate the safety of this treatment. 

 Keywords: variceal haemorrhage; octreotide; injection sclerotherapy PMID:9391254

  19. Massage reduced severity of pain during labour: a randomised trial.

    PubMed

    Silva Gallo, Rubneide Barreto; Santana, Licia Santos; Jorge Ferreira, Cristine Homsi; Marcolin, Alessandra Cristina; Polineto, Omero Benedicto; Duarte, Geraldo; Quintana, Silvana Maria

    2013-06-01

    Does massage relieve pain in the active phase of labour? Randomised trial with concealed allocation, assessor blinding for some outcomes, and intention-to-treat analysis. 46 women pregnant at ≥ 37 weeks gestation with a single fetus, with spontaneous onset of labour, 4-5cm of cervical dilation, intact ovular membranes, and no use of medication after admission to hospital. Experimental group participants received a 30-min lumbar massage by a physiotherapist during the active phase of labour. A physiotherapist attended control group participants for the same period but only answered questions. Both groups received routine perinatal care. The primary outcome was pain severity measured on a 100mm visual analogue scale. Secondary outcomes included the Short Form McGill Pain Questionnaire, pain location, and time to analgesic medication use. After labour, a blinded researcher also recorded duration of labour, route of delivery, neonatal outcomes, and the participant's satisfaction with the physiotherapist during labour. At the end of the intervention, pain severity was 52mm (SD 20) in the experimental group and 72mm (SD 15) in control group, which was significantly different with a mean difference of 20mm (95% CI 10 to 31). The groups did not differ significantly on the other pain-related outcome measures. Obstetric outcomes were also similar between the groups except the duration of labour, which was 6.8hr (SD 1.6) in the experimental group and 5.7hr (SD 1.5) in the control group, mean difference 1.1hr (95% CI 0.2 to 2.0). Patients in both groups were satisfied with the care provided by the physiotherapist. Massage reduced the severity of pain in labour, despite not changing its characteristics and location. Copyright © 2013 Australian Physiotherapy Association. Published by .. All rights reserved.

  20. A randomised clinical trial to assess satisfaction with the levonorgestrel- releasing intrauterine system inserted at caesarean section compared to postpartum placement.

    PubMed

    Braniff, Kathleen; Gomez, Edmund; Muller, Reinhold

    2015-06-01

    Insertion of levonorgestrel-releasing intrauterine system (LNG-IUS) at caesarean section (CS) provides contraception prior to resumption of ovulation or sexual activity. Patient satisfaction with insertion at CS has not previously been studied. The aim of this study was to compare patient satisfaction with LNG-IUS inserted at the time of lower uterine segment CS to six weeks postpartum. Open-label randomised controlled trial. Women booked for elective CS were randomised to LNG-IUS insertion either at the time of CS (study group) or at six weeks postpartum (control group). The primary outcome measure was patient satisfaction. Outcomes were measured at six weeks, three months and six months postpartum. Forty-eight women were randomised into two treatment groups. Twenty-five women were randomised to have LNG-IUS inserted at the time of CS, 23 of whom had the planned intervention and two had the LNG-IUS inserted postpartum. Twenty-three women were randomised to the control group, four of whom withdrew prior to treatment. The 44 remaining women contributed to data analysis. Patient satisfaction was high and similar in both groups. At six months postpartum, 90.5% of the study group were very satisfied or somewhat satisfied compared with 88.2% of the control group. Patient satisfaction is high with LNG-IUS insertion at CS and not different to that with delayed insertion. LNG-IUS insertion may be an option for women who find postpartum contraception difficult to access. © 2015 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology published by Wiley Publishing Asia Pty Ltd on behalf of Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  1. Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial

    PubMed Central

    Barnhoorn, Karlijn J; van de Meent, Henk; van Dongen, Robert T M; Klomp, Frank P; Groenewoud, Hans; Samwel, Han; Nijhuis-van der Sanden, Maria W G; Frölke, Jan Paul M; Staal, J Bart

    2015-01-01

    Objective To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. Setting The study was conducted at a level 1 trauma centre in the Netherlands. Participants 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. Interventions Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. Measurements Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score—Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. Results The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI −1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. Conclusions We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. Trial registration numbers NCT00817128 and NTR 2090. PMID:26628523

  2. Intravenous salbutamol bolus compared with an aminophylline infusion in children with severe asthma: a randomised controlled trial

    PubMed Central

    Roberts, G; Newsom, D; Gomez, K; Raffles, A; Saglani, S; Begent, J; Lachman, P; Sloper, K; Buchdahl, R; Habel, A

    2003-01-01

    Background: The relative efficacies of aminophylline and salbutamol in severe acute childhood asthma are currently unclear. A single bolus of salbutamol was compared with a continuous aminophylline infusion in children with severe asthma in a randomised double blind study. Methods: Children aged 1–16 years with acute severe asthma were enrolled if they showed little improvement with three nebulisers (combined salbutamol and ipratropium) administered over an hour and systemic steroids. Subjects were randomised to receive either a short intravenous bolus of salbutamol (15 µg/kg over 20 minutes) followed by a saline infusion or an aminophylline infusion (5 mg/kg over 20 minutes) followed by 0.9 mg/kg/h. Results: Forty four subjects were enrolled, with 18 randomly allocated to receive salbutamol and 26 to receive aminophylline. The groups were well matched at baseline. An intention to treat analysis showed that there was no statistically significant difference in the asthma severity score (ASS) at 2 hours between the two groups (median (IQR) 6 (6, 8) and 6.5 (5, 8) for salbutamol and aminophylline respectively, p=0.93). A similar improvement in ASS to 2 hours was seen in the two groups (mean difference –0.08, 95% CI –0.97 to 0.80), there was a trend (p=0.07) towards a longer duration of oxygen therapy in the salbutamol group (17.8 hours (95% CI 8.5 to 37.5) v 7.0 hours (95% CI 3.4 to 14.2)), and a significantly (p=0.02) longer length of hospital stay in the salbutamol group (85.4 (95% CI 66.1 to 110.2) hours v 57.3 hours (95% CI 45.6 to 72.0)). There was no significant difference in adverse events between the two groups. Conclusions: This study suggests that, in severe childhood asthma, there is no significant difference in the effectiveness of a bolus of salbutamol and an aminophylline infusion in the first 2 hours of treatment. Overall, the aminophylline infusion was superior as it significantly reduced the length of stay in hospital. PMID:12668792

  3. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis.

    PubMed

    Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Kwan, Ben C H; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

    2014-11-06

    Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients' remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The trial results will be published in peer-reviewed journals

  4. A multicentre randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injections.

    PubMed

    Deyle, Gail D; Gill, Norman W; Rhon, Daniel I; Allen, Chris S; Allison, Stephen C; Hando, Ben R; Petersen, Evan J; Dusenberry, Douglas I; Bellamy, Nicholas

    2016-03-31

    Corticosteroid injections (CSIs) are commonly used as an initial or a primary intervention for knee osteoarthritis (OA). Consistent evidence indicates CSIs offer symptom relief with conflicting reports regarding long-term efficacy. Physical therapy (PT) offers a non-invasive alternative. There is moderate evidence suggesting short-term and long-term symptom relief and functional improvement with PT interventions. Patients with knee OA are more commonly prescribed CSI than PT prior to total joint replacement. UnitedHealthcare and Military Health System data show substantially more total knee replacement patients receive preoperative CSI than PT. There are no studies comparing CSI to a PT approach in individuals with knee OA. The primary objective of this study is to compare the effectiveness of CSI to PT in individuals with knee OA at 1, 2 and 12 months. We plan to recruit 156 participants meeting established knee OA criteria. Following informed consent, participants will be randomised to receive either CSI or PT. All participants will receive instruction on recommended exercise and weight control strategies plus usual medical care. The CSI intervention consisting of 3 injections and the PT intervention consisting of 8-12 sessions will be spaced over 12 months. Measures of the dependent variables (DVs) will occur at baseline, 4 weeks, 8 weeks, 6 months and 12 months post enrolment. This pragmatic, randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (CSI and PT) and time with five levels from baseline to 1 year. The primary DV is the Western Ontario & McMaster Universities Arthritis Index (WOMAC). We will also compare healthcare utilisation between the 2 groups. The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The authors intend to publish the results in a peer-reviewed source. NCT01427153. Published by the BMJ Publishing Group Limited. For permission to use (where not

  5. A randomised controlled trial comparing sugammadex and neostigmine at different depths of neuromuscular blockade in patients undergoing laparoscopic surgery.

    PubMed

    Geldner, G; Niskanen, M; Laurila, P; Mizikov, V; Hübler, M; Beck, G; Rietbergen, H; Nicolayenko, E

    2012-09-01

    Deep neuromuscular blockade during certain surgical procedures may improve operating conditions. Sugammadex can be used to reverse deep neuromuscular blockade without waiting for spontaneous recovery. This randomised study compared recovery times from neuromuscular blockade induced by rocuronium 0.6 mg.kg(-1), using sugammadex 4 mg.kg(-1) administered at 1-2 post-tetanic count (deep blockade) or neostigmine 50 μg.kg(-1) (plus atropine 10 μg.kg(-1)) administered at the re-appearance of the second twitch of a train-of-four stimulation (moderate blockade), in patients undergoing laparoscopic surgery. The primary efficacy variable was the time from the start of sugammadex/neostigmine administration to recovery of the train-of-four ratio to 0.9. Patients receiving sugammadex recovered 3.4 times faster than patients receiving neostigmine (geometric mean (95% CI) recovery times of 2.4 (2.1-2.7) and 8.4 (7.2-9.8) min, respectively, p<0.0001). Moreover, 94% (62/66) of sugammadex-treated patients recovered within 5 min, vs 20% (13/65) of neostigmine-treated patients, despite the difference in the depth of neuromuscular blockade at the time of administration of both drugs. The ability to provide deep neuromuscular blockade throughout the procedure but still permit reversal at the end of surgery may enable improved surgical access and an enhanced visual field.

  6. Suction assisted pulse lavage: randomised controlled studies comparing its efficacy with conventional dressings in healing of chronic wounds.

    PubMed

    Shetty, Rahul; Barreto, Elvino; Paul, Kingsly M

    2014-02-01

    Chronic, open, non-healing wounds pose a continual challenge in medicine as the treatment is variable and there are no documented consistent responses. Although wound aetiologies vary and there are a number of factors that affect chronic wound pathogenesis, wound ischaemia and bacterial colonisation of wounds are the chief concerns among them. Conventionally, pulse lavage has been used primarily as a wound debriding device. To address both the critical factors of wound ischaemia and bacterial burden, a couple of technical points were proposed and applied in this study. The objective of our study was to evaluate pulse lavage therapy's ability to improve the healing rate of chronic wounds compared to that of the traditional saline-wet-to-moist dressings. The study period was from 1 August 2010 to 31 January 2012 and was conducted in our institution. Thirty patients with 31 chronic, non-healing wounds were enrolled in the study after obtaining proper consent. Subjects were randomised (15 patients each) to the pulse lavage group and the control group. Patients in the test group were subjected to irrigation of their wounds with pulsed lavage at 10 to 15 psi pressure. In the control group, wound was closed by applying moist betadine saline gauze dressings after cleaning with saline. Wounds treated with pulse lavage system significantly reduced in size, had better control of bacterial contamination and had overall faster healing rates. Efficacy of pulse lavage can be increased by correct method of administration of the irrigant.

  7. A prospective randomised trial to compare the efficacy of povidone-iodine 10% and chlorhexidine 2% for skin disinfection

    PubMed Central

    Kulkarni, Atul P; Awode, Rishikesh M

    2013-01-01

    Context: Infectious complications of invasive procedures affect patient outcomes adversely. Choice of antiseptic solution at the time of insertion is one of the major factors affecting their incidence. Aims: This study was undertaken to compare efficacy of chlorhexidine 2% and povidone iodine 10% for skin disinfection prior to placement of epidural and central venous catheters (CVCs). Settings and Design: A prospective randomised trial in the operating rooms of a tertiary referral cancer centre. Methods: Sixty consecutive adult patients undergoing elective oncosurgery requiring placement of epidural and CVCs were enrolled. Paired skin swabs were collected before and after application of the antiseptic solution. The samples were incubated in McConkey's media and blood agar at 35°C for up to 24 h. Any bacterial growth was graded as: <10 colonies - poor growth, 10-50 colonies - moderate growth and >50 colonies as heavy growth. Data on demographics and antibiotic prophylaxis and costs was collected for all patients. Statistical Analysis: Student's t-test and Mann-Whitney tests were used to analyse data, P<0.05 was considered significant. Results: Demographics and antibiotic prophylaxis use was similar in both groups. Before application of antiseptic solution, a variety of micro-organisms were grown from most patients with growth ranging from none-heavy. No organism was grown after application of either antiseptic solution from any patient. Conclusions: We found no differences between 2% chlorhexidine and 10% povidone-iodine for skin disinfection in regard to costs, efficacy or side-effects. PMID:23983286

  8. Comparative palatability of two veterinary dewormers (Milpro® and Milbemax®): a blinded randomised crossover cat study

    PubMed Central

    Bernachon, N.; McGahie, D.; Corvaisier, D.; Benizeau, E.; Crastes, N.; Chaix, G.

    2014-01-01

    Background The combination of milbemycin oxime–praziquantel is widely used against the most common tapeworms and roundworms affecting cats. New veterinary presentations of this combination have recently been approved. Objective The objective of this study was to compare the palatability of two products using this combination, Milpro® and Milbemax®. Methods In all, 20 adult cats and 20 kittens were offered each product according to a randomisation table using a blinded crossover design. Prehension from the bowl, prehension from the hand and total consumption were assessed. Results Both presentations were very well tolerated in adult cats and kittens. Total prehension in adult cats and kittens was 100 and 45 per cent, respectively, for Milpro®, and 95 and 30 per cent, respectively, for Milbemax®. The percentages of adult cats and kittens which swallowed the pill after taking it into their mouth (total spontaneous consumption) were respectively 40 and 45 per cent for Milpro®, and 35 and 20 per cent for Milbemax®. Conclusion In this study, both presentations were highly attractive to cats and their respective coatings successfully covered the unpleasant odour of praziquantel, which usually repels cats. These results indicate that the palatability of Milpro® is at least as good as Milbemax® and both tablets are well accepted by adult cats and kittens. PMID:26392882

  9. Comparative palatability of two veterinary dewormers (Milpro(®) and Milbemax(®)): a blinded randomised crossover cat study.

    PubMed

    Bernachon, N; McGahie, D; Corvaisier, D; Benizeau, E; Crastes, N; Chaix, G

    2014-01-01

    The combination of milbemycin oxime-praziquantel is widely used against the most common tapeworms and roundworms affecting cats. New veterinary presentations of this combination have recently been approved. The objective of this study was to compare the palatability of two products using this combination, Milpro(®) and Milbemax(®). In all, 20 adult cats and 20 kittens were offered each product according to a randomisation table using a blinded crossover design. Prehension from the bowl, prehension from the hand and total consumption were assessed. Both presentations were very well tolerated in adult cats and kittens. Total prehension in adult cats and kittens was 100 and 45 per cent, respectively, for Milpro(®), and 95 and 30 per cent, respectively, for Milbemax(®). The percentages of adult cats and kittens which swallowed the pill after taking it into their mouth (total spontaneous consumption) were respectively 40 and 45 per cent for Milpro(®), and 35 and 20 per cent for Milbemax(®). In this study, both presentations were highly attractive to cats and their respective coatings successfully covered the unpleasant odour of praziquantel, which usually repels cats. These results indicate that the palatability of Milpro(®) is at least as good as Milbemax(®) and both tablets are well accepted by adult cats and kittens.

  10. Effect of atrial antitachycardia pacing treatments in patients with an atrial defibrillator: randomised study comparing subthreshold and nominal pacing outputs

    PubMed Central

    Mitchell, A R J; Spurrell, P A R; Cheatle, L; Sulke, N

    2002-01-01

    Objective: To assess the true efficacy of antitachycardia pacing on spontaneous persistent atrial fibrillation in patients with an implanted atrial defibrillator, by comparing the effects of nominal pacing treatment with subthreshold pacing treatment. Design: The effects of antitachycardia pacing and burst 50 Hz atrial pacing on spontaneous atrial arrhythmias were evaluated six months after implantation of a Medtronic Jewel AF® atrial defibrillator. Setting: Cardiology department in a district general hospital. Patients: 15 patients with persistent atrial fibrillation. Interventions: Patients were randomised to either “nominal” output pacing treatment or surface ECG and endocardial electrogram proven subthreshold “sham” pacing treatment for three months, and then crossed over to the alternative treatment for a further three months. Results: During the nominal output phase, 31 episodes of atrial fibrillation were treated with 53 bursts of 50 Hz pacing, 98 sequences of ramp atrial pacing, and 61 sequences of burst atrial pacing. Atrial fibrillation was not pace terminated during any episode. Thirty one episodes of atrial tachycardia were treated with 19 bursts of 50 Hz atrial pacing, 103 sequences of ramp atrial pacing, and 38 sequences of burst atrial pacing. Termination of atrial tachycardia was observed in 17 episodes. During the “sham” pacing period, no episodes were terminated by any pacing treatment. Conclusion: Atrial antitachycardia pacing treatments are ineffective at terminating persistent atrial fibrillation but may be useful in terminating episodes of atrial tachycardia or flutter, thus reducing the burden of arrhythmia. PMID:11997413

  11. Crotaline snake bite in the Ecuadorian Amazon: randomised double blind comparative trial of three South American polyspecific antivenoms.

    PubMed

    Smalligan, Roger; Cole, Judy; Brito, Narcissa; Laing, Gavin D; Mertz, Bruce L; Manock, Steven; Maudlin, Jeffrey; Quist, Brad; Holland, Gary; Nelson, Stephen; Lalloo, David G; Rivadeneira, Gonzalo; Barragan, Maria Elena; Dolley, Daniel; Eddleston, Michael; Warrell, David A; Theakston, R David G

    2004-11-13

    To compare the efficacy and safety of three polyspecific antivenoms for bites by pit vipers. Randomised double blind comparative trial of three antivenoms. Shell, Pastaza, southeastern Ecuador. 210 patients with incoagulable blood were recruited from 221 consecutive patients admitted with snake bite between January 1997 and December 2001. One of three antivenoms manufactured in Brazil, Colombia, and Ecuador, chosen for their preclinical potency against Ecuadorian venoms. Permanent restoration of blood coagulability after 6 and 24 hours. The snakes responsible for the bites were identified in 187 cases: 109 patients (58%) were bitten by Bothrops atrox, 68 (36%) by B bilineatus, and 10 (5%) by B taeniatus, B brazili, or Lachesis muta. Eighty seven patients (41%) received Colombian antivenom, 82 (39%) received Brazilian antivenom, but only 41 (20%) received Ecuadorian antivenom because the supply was exhausted. Two patients died, and 10 developed local necrosis. All antivenoms achieved the primary end point of permanently restoring blood coagulability by 6 or 24 hours after the start of treatment in > 40% of patients. Colombian antivenom, however, was the most effective after initial doses of 20 ml (two vials), < 70 ml, and any initial dose at both 6 and 24 hours. An initial dose of 20 ml of Colombian antivenom permanently restored blood coagulability in 64% (46/72) of patients after 6 hours (P = 0.054 compared with the other two antivenoms) and an initial dose of < 70 ml was effective at 6 hours (65%, P = 0.045) and 24 hours (99%, P = 0.06). Early anaphylactoid reactions were common (53%, 73%, and 19%, respectively, for Brazilian, Colombian, and Ecuadorian antivenoms, P < 0.0001) but only three reactions were severe and none was fatal. All three antivenoms can be recommended for the treatment of snakebites in this region, though the reactogenicity of Brazilian and Colombian antivenoms is a cause for concern.

  12. Cost utility analysis of co-prescribed heroin compared with methadone maintenance treatment in heroin addicts in two randomised trials

    PubMed Central

    Dijkgraaf, Marcel G W; van der Zanden, Bart P; de Borgie, Corianne A J M; Blanken, Peter; van Ree, Jan M; van den Brink, Wim

    2005-01-01

    Objective To determine the cost utility of medical co-prescription of heroin compared with methadone maintenance treatment for chronic, treatment resistant heroin addicts. Design Cost utility analysis of two pooled open label randomised controlled trials. Setting Methadone maintenance programmes in six cities in the Netherlands. Participants 430 heroin addicts. Interventions Inhalable or injectable heroin prescribed over 12 months. Methadone (maximum 150 mg a day) plus heroin (maximum 1000 mg a day) compared with methadone alone (maximum 150 mg a day). Psychosocial treatment was offered throughout. Main outcome measures One year costs estimated from a societal perspective. Quality adjusted life years (QALYs) based on responses to the EuroQol EQ-5D at baseline and during the treatment period. Results Co-prescription of heroin was associated with 0.058 more QALYs per patient per year (95% confidence interval 0.016 to 0.099) and a mean saving of €12 793 (£8793, $16 122) (€1083 to €25 229) per patient per year. The higher programme costs (€16 222; lower 95% confidence limit €15 084) were compensated for by lower costs of law enforcement (- €4129; upper 95% confidence limit - €486) and damage to victims of crime (- €25 374; upper 95% confidence limit - €16 625). The results were robust for the use of national EQ-5D tariffs and for the exclusion of the initial implementation costs of heroin treatment. Completion of treatment is essential; having participated in any abstinence treatment in the past is not. Conclusions Co-prescription of heroin is cost effective compared with treatment with methadone alone for chronic, treatment resistant heroin addicts. PMID:15933353

  13. A Randomised, Open-label, Comparative Study of Tranexamic Acid Microinjections and Tranexamic Acid with Microneedling in Patients with Melasma

    PubMed Central

    Budamakuntla, Leelavathy; Loganathan, Eswari; Suresh, Deepak Hurkudli; Shanmugam, Sharavana; Suryanarayan, Shwetha; Dongare, Aparna; Venkataramiah, Lakshmi Dammaningala; Prabhu, Namitha

    2013-01-01

    Background: Melasma is a common cause of facial hyperpigmentation with significant cosmetic deformity. Although several treatment modalities are available, none is satisfactory. Aim: To compare the therapeutic efficacy and safety of tranexamic acid (TA) microinjections versus tranexamic acid with microneedling in melasma. Materials and Methods: This is a prospective, randomised, open-label study with a sample size of 60; 30 in each treatment arms. Thirty patients were administered with localised microinjections of TA in one arm, and other 30 with TA with microneedling. The procedure was done at monthly intervals (0, 4 and 8 weeks) and followed up for three consecutive months. Clinical images were taken at each visit including modified Melasma Area Severity Index MASI scoring, patient global assessment and physician global assessment to assess the clinical response. Results: In the microinjection group, there was 35.72% improvement in the MASI score compared to 44.41% in the microneedling group, at the end of third follow-up visit. Six patients (26.09%) in the microinjections group, as compared to 12 patients (41.38%) in the microneedling group, showed more than 50% improvement. However, there were no major adverse events observed in both the treatment groups. Conclusions: On the basis of these results, TA can be used as potentially a new, effective, safe and promising therapeutic agent in melasma. The medication is easily available and affordable. Better therapeutic response to treatment in the microneedling group could be attributed to the deeper and uniform delivery of the medication through microchannels created by microneedling. PMID:24163529

  14. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma.

    PubMed

    Babaei Jandaghi, Ali; Lebady, Mohammadkazem; Zamani, Athar-Alsadat; Heidarzadeh, Abtin; Monfared, Ali; Pourghorban, Ramin

    2017-01-01

    To compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy. This is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated. The procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006). Renal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  15. Randomised comparative study of adenotonsillectomy by conventional and coblation method for children with obstructive sleep apnoea.

    PubMed

    Paramasivan, Vijaya Krishnan; Arumugam, Senthil Vadivu; Kameswaran, Mohan

    2012-06-01

    Adenotonsillectomy is one of the most common surgical procedures throughout the world for children in otolaryngology. One of the current indications for adenotonsillectomy is adenotonsillar hypertrophy causing Obstructive Sleep Apnoea (OSA). The choice of surgical tools and technique affects the outcome and morbidity due to adenotonsillectomy. To assess the efficacy and safety of coblation adenotonsillectomy as compared to dissection method. To evaluate the morbidity and to study complications associated with each procedure. This prospective and comparative study of dissection and coblation method of adenotonsillectomy was conducted in our institute, Madras ENT Research Foundation, Chennai over a period of 6 months. 50 cases of children with OSA age group between 5 and 12 years were randomly selected for each group and studied. Duration of surgical procedure, blood loss, post operative pain, post operative reactionary and secondary bleeding was noted and compared. Operative time was more in dissection method compared to coblation technique. Blunt dissection tonsillectomy was associated with greater blood loss than coblation tonsillectomy. Post operative pain was more in dissection method and it was less in coblation technique. Post operative bleeding in both the techniques were found to be minimal. We conclude that the use of coblation for adenotonsillectomy may have several advantages over standard methods for the treatment of children with Obstructive Sleep Apnoea. It is highly efficacious, practical and safe with less morbidity and less complications. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  16. A randomised trial comparing the antibacterial effects of dentine primers against bacteria in natural root caries.

    PubMed

    Rolland, S L; McCabe, J F; Imazato, S; Walls, A W G

    2011-01-01

    As people are living longer and retaining their teeth into old age, root caries is an increasingly significant problem. A minimally invasive treatment strategy, involving sealing the root caries lesion with an antibacterial resin sealant, could be highly beneficial. The aim of this study was to compare the antibacterial properties of the primers of two proprietary dentine bonding agents, Clearfil SE Bond (SE; Kuraray Medical, Japan) and Clearfil Protect Bond (PB; Kuraray Medical), which contains the antibacterial monomer methacryloyloxydodecylpyridinium bromide. Fifty-two root caries lesions were identified and randomly assigned to a primer. The lesion was cleaned, isolated, sampled with a sharp spoon excavator, a primer applied and a second sample taken. Samples were transported in fastidious anaerobe broth, vortex-dispersed and serial dilutions inoculated onto selective agars. Reduction in colony-forming units (CFU, %) after primer application was calculated for both primers for bacterial growth on each selective agar and compared to a hypothesised mean of 100% (one-sample t test, p < 0.05). No significant differences between primers were seen, indicating efficient bacterial elimination by both materials. Comparing percent reduction between SE and PB for each agar (Mann-Whitney test, p < 0.05), a significantly greater CFU reduction by PB was seen for streptococci but not other bacteria. More lesions exhibited bacterial growth and several lesions demonstrated marked bacterial growth after treatment with SE compared with PB. Therefore, PB appears to exhibit superior antimicrobial properties, particularly against streptococci. Both primers are highly antibacterial towards root caries bacteria and may therefore be suitable for minimally invasive treatment.

  17. Exercise augmentation compared to usual care for post traumatic stress disorder: a randomised controlled trial (the REAP study: Randomised Exercise Augmentation for PTSD).

    PubMed

    Rosenbaum, Simon; Nguyen, Dang; Lenehan, Tom; Tiedemann, Anne; van der Ploeg, Hidde P; Sherrington, Catherine

    2011-07-22

    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. 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, pharmaceutical interventions and group therapy. This

  18. Exercise augmentation compared to usual care for Post Traumatic Stress Disorder: A Randomised Controlled Trial (The REAP study: Randomised Exercise Augmentation for PTSD)

    PubMed Central

    2011-01-01

    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, pharmaceutical

  19. Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus

    PubMed Central

    2014-01-01

    randomised by central fax randomisation. Primary endpoint is mean HbA1c after 24 months of treatment. Secondary endpoints are change in FEV1% predicted and change in BMI-Z-score. Discussion There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia. The results regarding BMI after 6 months and 12 months showed an improvement for the insulin treated patients and were inconsistent for those treated with repaglinide. HbA1c and lung function (FEV1%pred) were unchanged for either group. The authors compared the changes -12 months to baseline and baseline to +12 months separately for each group. Therefore a direct comparison of the effect of repaglinide versus insulin on BMI, HbA1c and FEV1%pred was not presented. According to our protocol, we will directly compare treatment effects (HbA1c, BMI, FEV1%pred) in between both groups. The actual Cochrane report regarding “Insulin and oral agents for managing CFRD” stated that further studies are needed to establish whether there is clear benefit for hypoglycemic agents. We expect that the results of our study will help to address this clinical need. Trial registration ClinicalTrials.gov Identifier: NCT00662714 PMID:24620855

  20. Bacterial overgrowth during treatment with omeprazole compared with cimetidine: a prospective randomised double blind study.

    PubMed Central

    Thorens, J; Froehlich, F; Schwizer, W; Saraga, E; Bille, J; Gyr, K; Duroux, P; Nicolet, M; Pignatelli, B; Blum, A L; Gonvers, J J; Fried, M

    1996-01-01

    BACKGROUND: Gastric and duodenal bacterial overgrowth frequently occurs in conditions where diminished acid secretion is present. Omeprazole inhibits acid secretion more effectively than cimetidine and might therefore more frequently cause bacterial overgrowth. AIM: This controlled prospective study compared the incidence of gastric and duodenal bacterial overgrowth in patients treated with omeprazole or cimetidine. METHODS: 47 outpatients with peptic disease were randomly assigned to a four week treatment regimen with omeprazole 20 mg or cimetidine 800 mg daily. Gastric and duodenal juice were obtained during upper gastrointestinal endoscopy and plated for anaerobic and aerobic organisms. RESULTS: Bacterial overgrowth (> or = 10(5) cfu/ml) was present in 53% of the patients receiving omeprazole and in 17% receiving cimetidine (p < 0.05). The mean (SEM) number of gastric and duodenal bacterial counts was 6.0 (0.2) and 5.0 (0.2) respectively in the omeprazole group and 4.0 (0.2) and 4.0 (0.1) in the cimetidine group (p < 0.001 and < 0.01; respectively). Faecal type bacteria were found in 30% of the patients with bacterial overgrowth. Basal gastric pH was higher in patients treated with omeprazole compared with cimetidine (4.2 (0.5) versus 2.0 (0.2); p < 0.001) and in patients with bacterial overgrowth compared with those without bacterial overgrowth (5.1 (0.6) versus 2.0 (0.1); p < 0.0001). The nitrate, nitrite, and nitrosamine values in gastric juice did not increase after treatment with either cimetidine or omeprazole. Serum concentrations of vitamin B12, beta carotene, and albumin were similar before and after treatment with both drugs. CONCLUSIONS: These results show that the incidence of gastric and duodenal bacterial overgrowth is considerably higher in patients treated with omeprazole compared with cimetidine. This can be explained by more pronounced inhibition of gastric acid secretion. No patient developed signs of malabsorption or an increase of N

  1. A prospective, randomised, cross-over trial comparing two standard polyvinyl chloride tracheal tubes. Are all the tubes the same?

    PubMed

    Serna, M B; Valdivia, A; Dosset, C; Ivars, C; Martin-Pacetti, M A

    2016-01-01

    A randomised study was conducted on the number of attempts made during the conventional endotracheal intubation of a mannequin using two polyvinyl (PVC) tracheal tubes, apparently similar but from different manufactures: INTERSURGICAL (IS; Intersurgical S.L., Madrid, Spain) and Mallinckrodt (ML; Mallinkrodt Medical S.A., Madrid, Spain). A total of 26 anaesthesiologists, in randomly established order (generated by Epidat 3.1) intubated a mannequin twice using a different tube each time. The tubes were masked by painting them to prevent recognition. The main outcome of the study was to compare the number of attempts needed to complete the manoeuvre for each tube. Data on intubation time and failed intubations were also collected. The number of attempts with the ML tube was significantly lower than with the IS tube. Intubation was completed on the first attempt with the ML tube in 93.3% of cases, while using the IS tube the percentage fell to 30.8% (Fisher exact test, P<.001). The time required to complete the manoeuvre was greater with the IS tube (median 10.8seconds, interquartile range 6-22) than with the ML tube (median 4.4seconds, interquartile range 3.5 to 6.3). The PVC tube from the ML manufacturer was superior when compared with the IS, the latter was also associated with a larger number of attempts to complete intubation using a conventional Macintosh blade. Copyright © 2015 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. Acute hamstring injuries in Swedish elite sprinters and jumpers: a prospective randomised controlled clinical trial comparing two rehabilitation protocols.

    PubMed

    Askling, Carl M; Tengvar, Magnus; Tarassova, Olga; Thorstensson, Alf

    2014-04-01

    Hamstring strain is a common injury in sprinters and jumpers, and therefore time to return to sport and secondary prevention become of particular concern. To compare the effectiveness of two rehabilitation protocols after acute hamstring injury in Swedish elite sprinters and jumpers by evaluating time needed to return to full participation in the training process. Prospective randomised comparison of two rehabilitation protocols. Fifty-six Swedish elite sprinters and jumpers with acute hamstring injury, verified by MRI, were randomly assigned to one of two rehabilitation protocols. Twenty-eight athletes were assigned to a protocol emphasising lengthening exercises, L-protocol, and 28 athletes to a protocol consisting of conventional exercises, C-protocol. The outcome measure was the number of days to return to full training. Re-injuries were registered during a period of 12 months after return. Time to return was significantly shorter for the athletes in the L-protocol, mean 49 days (1SD±26, range 18-107 days), compared with the C-protocol, mean 86 days (1SD±34, range 26-140 days). Irrespective of protocol, hamstring injuries where the proximal free tendon was involved took a significantly longer time to return than injuries that did not involve the free tendon, L-protocol: mean 73 vs 31 days and C-protocol: mean 116 vs 63 days, respectively. Two reinjuries were registered, both in the C-protocol. A rehabilitation protocol emphasising lengthening type of exercises is more effective than a protocol containing conventional exercises in promoting time to return in Swedish elite sprinters and jumpers.

  3. A randomised trial to compare Truview PCD(®), C-MAC(®) and Macintosh laryngoscopes in paediatric airway management.

    PubMed

    Singh, Ranju; Kumar, Nishant; Jain, Aruna

    2017-06-01

    To evaluate and compare the Truview PCD and C-MAC laryngoscopes to the standard Macintosh laryngoscope in paediatric patients. One hundred and fifty ASA I-II patients in the age group of 1-6 years (10-20 kg) scheduled for elective surgery were randomised into three equal groups for laryngoscopy and intubation with either Truview PCD (Group T), C-MAC (Group C) or Macintosh (Group M) laryngoscopes under general anaesthesia. Percentage of glottic opening (POGO) score, application of external laryngeal manoeuvre, time to intubation, number of attempts at intubation, failed intubations, episodes of desaturation and trauma caused were recorded and statistically analysed. A p value of <0.05 was taken as significant. POGO scores were significantly better with Truview PCD as compared with C-MAC and Macintosh laryngoscopes (94.7 ± 12.9/82 ± 25.0/85.1 ± 17.1; p < 0.01). There were no failed attempts, episodes of desaturation or trauma in any of the patients. The mean intubation time taken was 19.2 s in group T, 12.3 s in group C and 10.7 s in group M, respectively. There is a statistically significant difference among groups (p < 0.01). Eight patients in group T, 21 out of 50 patients in group C and 19 out of 50 patients in group M needed OELM, respectively. There is significant difference among the groups (p < 0.01) CONCLUSION: Using Truview PCD to assist intubation offers excellent view field of glottic opening after OLEM and the mean time taken is less than 20 s. The Truview PCD tool is suitable for paediatric patients. Copyright © 2017. Published by Elsevier B.V.

  4. Puncture technique and postural postdural puncture headache. A randomised, double-blind study comparing transverse and parallel puncture.

    PubMed

    Flaatten, H; Thorsen, T; Askeland, B; Finne, M; Rosland, J; Hansen, T; Rønhovde, K; Wisborg, T

    1998-11-01

    This clinical study was conducted in order to investigate the effect of two different orientations of the bevel during dural puncture on development of postural postdural puncture headache (PPDPH). Two hundred and eighteen patients aged 18 to 50 years scheduled for minor non-obstetric surgery using spinal anaesthesia (SA) were included in this randomised, double-blind study. Dural puncture was performed using a 0.42 mm O.D. (27-g) Quincke spinal needle with the orientation of the bevel parallel or transverse relative to the longitudinal axis of the dural cylinder. All patients were blinded with regard to the puncture technique, and so was the anaesthesiologist performing a telephone interview 5 to 7 days postoperatively. The occurrence and duration of headache, backache and other complaints were recorded. Headache was classified as PPDPH or non-PPDPH, and intensity of the headache was registered using a numerical rating scale (NRS) from 0 to 10. Two hundred and twelve patients with a mean age of 35.3 years completed the study, 106 in each group. The two groups were comparable with regard to mean age, sex, local anaesthetics used and surgical procedure performed. Headache occurred in 44 patients postoperatively. PPDPH was diagnosed in 4/106 patients (3.8%) in the parallel group and 24/106 (22.6%) in the transverse group (P < 0.0002). Postoperative backache occurred in 31 and 20 patients (parallel compared to transverse) (NS). Dural puncture with the bevel of the needle transverse to the longitudinal axis of the dural cylinder gave significantly more cases of PPDPH than puncture with the bevel parallel to this axis even when using a 27-g Quincke needle. When using Quincke bevelled needles care must be taken to assure that the orientation of the bevel is parallel to the longitudinal axis of the dural sac.

  5. The effectiveness of salicylic acid plasters compared with ‘usual’ scalpel debridement of corns: a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Corns are a common foot problem and surveys have indicated that between 14-48% of people suffer from them. Many of these will seek podiatry treatment, however there is little evidence to indicate which current treatments provide long term resolution. This study compared ‘usual’ treatment (enucleation with a scalpel) with the application of 40% salicylic acid plasters to corns to investigate which is the most effective in terms of clinical, economic and patient-centred outcomes. Methods A parallel-group randomised controlled trial was carried out in two centres where adults who presented with one or more corns and who met the inclusion criteria were allocated to either ‘usual’ scalpel debridement or corn plaster treatment. All participants had measurements of corn size, pain using a 100 mm visual analogue scale (VAS) and health-related quality of life (EQ-5D) measures by an independent podiatrist, blind to treatment allocation at baseline, 3, 6, 9 and 12 months. Results 202 participants were randomised to receive scalpel debridement or corn plaster treatment (101 in each group). At 3 months 34% (32/95) of corns had completely resolved in the corn plaster group compared with 21% (20/94) in the scalpel group (p = 0.044), and 83% (79/95) had reduced in size in the corn plaster group compared with 56% (53/94) in the scalpel group (p < 0.001). At 12 months, time to corn recurrence was longer in the corn plaster group (p < 0.001). Pain from the corns was significantly lower in the corn plaster group at 3 months (p < 0.001) and EQ-5D scores changed (improved), from baseline, by 0.09 (SD ±0.31) and 0.01 (SD ±0.25) points in the corn plaster and scalpel groups respectively (p = 0.056). By month 12, EQ-5D scores had changed by 0.12 and −0.05 in the corn plaster and scalpel groups respectively (p = 0.005). The EQ-5D, VAS scores and the four domains of the Foot Disability Scale were similar in both groups at 3 and 12

  6. Open comparative randomised study of moclobemide versus amitriptyline in major depressive illness (DSM IIIR) in Nigeria.

    PubMed

    Ononye, F; Sijuola, O A; Chukwuani, C M; Mume, O C; Makanjuola, R O

    2000-01-01

    In a multi-centre study, 60 patients (20 males and 40 females aged 43 +/- 15 and 37 +/- 15 years respectively) with a DSM-IIIR diagnosis of major depressive disorders were randomly assigned to treatment with either Moclobemide (maximum dose 600 mg per day) or Amitriptyline (maximum dose 150 mg per day) for eight weeks. Patients were evaluated pretreatment and over the 8 weeks treatment period using Hamilton Depression Rating Scale (HDRS) and the clinical global impressions (CGI). The Adverse Drug Effects Schedule, clinical, haematological and biochemical status were also evaluated pre, during and post treatment. Of the 60 patients enrolled for the study 54 were found evaluable for efficacy whilst all 60 were evaluated for safety (Adverse Event). On the HDRS and CGI scale there was no significant difference in the therapeutic outcome between the two treatment groups. In the overall clinical assessment rating at the end of treatment 94.1% of patients in the Moclobemide group were rated 'very good to good' and 94.4% with Amitriptyline. Moclobemide appeared to have a slightly better safety profile, the incidence of adverse event was 9.0% compared to 19.0% with Amitriptyline. The drop out rate was 16.7% and 26.7% for moclobemide and amitriptyline respectively. These differences were however not statistically significant. It was therefore concluded that moclobemide is an effective and safe alternative to amitriptyline, with attractive potential for out patients management of depressive illness.

  7. Comparative randomised trial of high and conventional doses of praziquantel in the treatment of schistosomiasis mansoni.

    PubMed

    Queiroz, Leonardo C de; Drummond, Sandra C; Matos, Maria Laura M de; Paiva, Mariana B S; Batista, Thaís S; Kansaon, Ahraby Z M; Antunes, Carlos Maurício de F; Lambertucci, José Roberto

    2010-07-01

    The efficacy of oral praziquantel in the treatment of schistosomiasis has been considered low by most public health institutions. In this paper, we compared the efficacy of two dosages of praziquantel (80 mg/kg vs. 50 mg/kg) in patients with chronic schistosomiasis mansoni. Two hundred eighty-eight patients with schistosomiasis from a community in Brazil were randomly divided into two groups: 145 patients (Group 1) received 80 mg/kg body weight of oral praziquantel divided in two equal doses with 1 h interval and 143 patients (Group 2) received 50 mg/kg body weight of oral praziquantel. To keep the study masked, patients in Group 2 received placebo 1 h after the first dose. All patients were subjected to clinical and ultrasonographic examination. Cure assessment was performed by repeating two stool examinations, by a quantitative method, at 30, 90 and 180 days after treatment. The morbidity of schistosomiasis was low, with a few cases of light periportal thickening and 16 cases of mild splenomegaly. The cure rates were 89.7% for Group 1 and 83.9% for Group 2. There was no difference in the efficacy of both therapeutic dosages of praziquantel assayed. The adverse reactions were more frequent with higher dosage.

  8. C-MAC videolaryngoscope compared with direct laryngoscopy for rapid sequence intubation in an emergency department: A randomised clinical trial.

    PubMed

    Sulser, Simon; Ubmann, Dirk; Schlaepfer, Martin; Brueesch, Martin; Goliasch, Georg; Seifert, Burkhardt; Spahn, Donat R; Ruetzler, Kurt

    2016-12-01

    Airway management in the emergency room can be challenging when patients suffer from life-threatening conditions. Mental stress, ignorance of the patient's medical history, potential cervical injury or immobilisation and the presence of vomit and/or blood may also contribute to a difficult airway. Videolaryngoscopes have been introduced into clinical practice to visualise the airway and ultimately increase the success rate of airway management. The aim of this study was to test the hypothesis that the C-MAC videolaryngoscope improves first-attempt intubation success rate compared with direct laryngoscopy in patients undergoing emergency rapid sequence intubation in the emergency room setting. A randomised clinical trial. Emergency Department of the University Hospital, Zurich, Switzerland. With approval of the local ethics committee, we prospectively enrolled 150 patients between 18 and 99 years of age requiring emergency rapid sequence intubation in the emergency room of the University Hospital Zurich. Patients were randomised (1 : 1) to undergo tracheal intubation using the C-MAC videolaryngoscope or by direct laryngoscopy. Owing to ethical considerations, patients who had sustained maxillo-facial trauma, immobilised cervical spine, known difficult airway or ongoing cardiopulmonary resuscitation were excluded from our study. All intubations were performed by one of three very experienced anaesthesia consultants. First-attempt success rate served as our primary outcome parameter. Secondary outcome parameters were time to intubation; total number of intubation attempts; Cormack and Lehane score; inadvertent oesophageal intubation; ease of intubation; complications including violations of the teeth, injury/bleeding of the larynx/pharynx and aspiration/regurgitation of gastric contents; necessity of using further alternative airway devices for successful intubation; maximum decrease of oxygen saturation and technical problems with the device. A total of 150

  9. Comparative effectiveness of Pilates and yoga group exercise interventions for chronic mechanical neck pain: quasi-randomised parallel controlled study.

    PubMed

    Dunleavy, K; Kava, K; Goldberg, A; Malek, M H; Talley, S A; Tutag-Lehr, V; Hildreth, J

    2016-09-01

    To determine the effectiveness of Pilates and yoga group exercise interventions for individuals with chronic neck pain (CNP). Quasi-randomised parallel controlled study. Community, university and private practice settings in four locations. Fifty-six individuals with CNP scoring ≥3/10 on the numeric pain rating scale for >3 months (controls n=17, Pilates n=20, yoga n=19). Exercise participants completed 12 small-group sessions with modifications and progressions supervised by a physiotherapist. The primary outcome measure was the Neck Disability Index (NDI). Secondary outcomes were pain ratings, range of movement and postural measurements collected at baseline, 6 weeks and 12 weeks. Follow-up was performed 6 weeks after completion of the exercise classes (Week 18). NDI decreased significantly in the Pilates {baseline: 11.1 [standard deviation (SD) 4.3] vs Week 12: 6.8 (SD 4.3); mean difference -4.3 (95% confidence interval -1.64 to -6.7); P<0.001} and yoga groups [baseline: 12.8 (SD 7.4) vs Week 12: 8.1 (SD 5.6); mean difference -4.7 (95% confidence interval -2.1 to -7.4); P<0.00], with no change in the control group. Pain ratings also improved significantly. Moderate-to-large effect sizes (0.7 to 1.8) and low numbers needed to treat were found. There were no differences in outcomes between the exercise groups or associated adverse effects. No improvements in range of movement or posture were found. Pilates and yoga group exercise interventions with appropriate modifications and supervision were safe and equally effective for decreasing disability and pain compared with the control group for individuals with mild-to-moderate CNP. Physiotherapists may consider including these approaches in a plan of care. ClinicalTrials.gov NCT01999283. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  10. A randomised, placebo controlled, comparative trial of the gastrointestinal safety and efficacy of AZD3582 versus naproxen in osteoarthritis

    PubMed Central

    Lohmander, L; McKeith, D; Svensson, O; Malmenas, M; Bolin, L; Kalla, A; Genti, G; Szechinski, J; Ramos-Remus, C; t for

    2005-01-01

    Objective: To evaluate the gastrointestinal safety and efficacy of the COX inhibiting nitric oxide donator AZD3582 in patients with hip or knee osteoarthritis. Methods: 970 patients were randomised (7:7:2) to AZD3582 750 mg twice daily, naproxen 500 mg twice daily, or placebo twice daily in a double blind study. The primary end point was the six week incidence of endoscopic gastroduodenal ulcers (diameter ⩾3 mm). Overall damage measured on the Lanza scale was a secondary end point. Safety and tolerability assessments included endoscopic upper gastrointestinal erosions and the gastrointestinal symptom rating scale (GSRS). Efficacy was primarily assessed by WOMAC. Results: The incidence of ulcers with AZD3582 was 9.7% and with naproxen 13.7% (p = 0.07, NS), v 0% on placebo. The incidence of Lanza scores >2 was higher with naproxen (43.7%) than with AZD3582 (32.2%) (p<0.001). Compared with baseline, significantly fewer ulcers and erosions developed in stomach and stomach/duodenum combined, and fewer erosions developed in stomach, duodenum, and both combined on AZD3582 than on naproxen. GSRS reflux and abdominal pain subscale scores were lower for AZD3582 than for naproxen but there was no difference for indigestion, constipation, and diarrhoea. AZD3582 was as effective as naproxen at improving WOMAC scores. Both agents were well tolerated, with no significant effects on blood pressure. Conclusions: At doses with similar efficacy in relieving osteoarthritis symptoms, the primary end point of six week endoscopic gastroduodenal ulcer incidence was not significantly different between AZD3582 and naproxen. Most secondary endoscopic gastrointestinal end points favoured AZD3582. PMID:15345500

  11. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement.

    PubMed

    Karthikeyan, S; Kwong, H T; Upadhyay, P K; Parsons, N; Drew, S J; Griffin, D

    2010-01-01

    We have carried out a prospective double-blind randomised controlled trial to compare the efficacy of a single subacromial injection of the non-steroidal anti-inflammatory drug, tenoxicam, with a single injection of methylprednisolone in patients with subacromial impingement. A total of 58 patients were randomly allocated into two groups. Group A received 40 mg of methylprednisolone and group B 20 mg of tenoxicam as a subacromial injection along with lignocaine. The Constant-Murley shoulder score was used as the primary outcome measure and the Disability of Arm, Shoulder and Hand (DASH) and the Oxford Shoulder Score (OSS) as secondary measures. Six weeks after injection the improvement in the Constant-Murley score was significantly greater in the methylprednisolone group (p = 0.003) than in the tenoxicam group. The improvement in the DASH score was greater in the steroid group and the difference was statistically significant and consistent two (p < 0.01), four (p < 0.01) and six weeks (p < 0.020) after the injection. The improvement in the OSS was consistently greater in the steroid group than in the tenoxicam group. Although the difference was statistically significant at two (p < 0.001) and four (p = 0.003) weeks after the injection, it was not at six weeks (p = 0.055). Subacromial injection of tenoxicam does not offer an equivalent outcome to subacromial injection of corticosteroid at six weeks. Corticosteroid is significantly better than tenoxicam for improving shoulder function in tendonitis of the rotator cuff after six weeks.

  12. A randomised controlled trial comparing meat-based with human cadaveric models for teaching ultrasound-guided regional anaesthesia.

    PubMed

    Chuan, A; Lim, Y C; Aneja, H; Duce, N A; Appleyard, R; Forrest, K; Royse, C F

    2016-08-01

    The aim of this prospective, blinded, randomised controlled study was to compare novices' acquisition of the technical skills of ultrasound-guided regional anaesthesia using either a meat phantom model or fresh-frozen human cadavers. The primary outcome was the time taken to successfully perform an ultrasound-guided sciatic nerve block on a cadaver; secondary outcomes were the cumulative score of errors, and best image quality of the sciatic nerve achieved. After training, the median (IQR [range]) time taken to perform the block was 311(164-390 [68-600]) s in the meat model trained group and 210 (174-354 [85-600]) s in the fresh-frozen cadaver trained group (p = 0.24). Participants made a median (IQR [range]) of 18 (14-33 [8-55]) and 15 (12-22 [8-44]) errors in the two groups respectively (p = 0.39). The image quality score was also not different, with a median (IQR [range]) of 62.5 (59.4-65.6 [25.0-100.0])% vs 62.5 (62.5-75.0 [25.0-87.5])% respectively (p = 0.58). The training and deliberate feedback improved all participants' block performance, the median (IQR [range]) times being 310 (206-532 [110-600]) s before and 240 (174-354 [85-600]) s after training (p = 0.02). We conclude that novices taught ultrasound scanning and needle guidance skills using an inexpensive and easily constructed meat model perform similarly to those trained on a cadaveric model. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

  13. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial.

    PubMed

    van den Bergh, B; Blankestijn, J; van der Ploeg, T; Tuinzing, D B; Forouzanfar, T

    2015-06-01

    A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of IMFS with the use of arch bars in the treatment of mandibular condyle fractures. The study population consisted of 50 patients (mean age: 31.8 years). Twenty-four (48%) patients were allocated in the IMFS group. Twenty-six (52%) patients were assigned to the arch bars group. In total 188 IMF-screws were used (5-12 screws per patient, mean 7.83 screws per patient). All pain scores were lower in the IMFS group. Three patients developed a malocclusion (IFMS-group: one patient, arch bars-group: two patients). Mean surgical time was significantly shorter in the IMFS group (59 vs. 126 min; p<0.001). There were no needlestick injuries (0%) in the IMFS group and eight (30.7%) in the arch bars group (p=0.003). One IMF-screw fractured on insertion (0.53%), one (0.53%) screw was inserted into a root. Six (3.2%) screws loosened spontaneously in four patients. Mucosal disturbances were seen in 22 patients, equally divided over both groups. Considering the advantages and the disadvantages of IMFS, and observing the results of this study, the authors conclude that IMFS provide a superior method for IMF. IMFS are safer for the patients and surgeons. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  14. High Platelet Reactivity in Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: Randomised Controlled Trial Comparing Prasugrel and Clopidogrel

    PubMed Central

    Geisler, Tobias; Booth, Jean; Tavlaki, Elli; Karathanos, Athanasios; Müller, Karin; Droppa, Michal; Gawaz, Meinrad; Yanez-Lopez, Monica; Davidson, Simon J.; Stables, Rod H.; Banya, Winston; Zaman, Azfar; Flather, Marcus; Dalby, Miles

    2015-01-01

    Background Prasugrel is more effective than clopidogrel in reducing platelet aggregation in acute coronary syndromes. Data available on prasugrel reloading in clopidogrel treated patients with high residual platelet reactivity (HRPR) i.e. poor responders, is limited. Objectives To determine the effects of prasugrel loading on platelet function in patients on clopidogrel and high platelet reactivity undergoing percutaneous coronary intervention for acute coronary syndrome (ACS). Patients Patients with ACS on clopidogrel who were scheduled for PCI found to have a platelet reactivity ≥40 AUC with the Multiplate Analyzer, i.e. “poor responders” were randomised to prasugrel (60 mg loading and 10 mg maintenance dose) or clopidogrel (600 mg reloading and 150 mg maintenance dose). The primary outcome measure was proportion of patients with platelet reactivity <40 AUC 4 hours after loading with study medication, and also at one hour (secondary outcome). 44 patients were enrolled and the study was terminated early as clopidogrel use decreased sharply due to introduction of newer P2Y12 inhibitors. Results At 4 hours after study medication 100% of patients treated with prasugrel compared to 91% of those treated with clopidogrel had platelet reactivity <40 AUC (p = 0.49), while at 1 hour the proportions were 95% and 64% respectively (p = 0.02). Mean platelet reactivity at 4 and 1 hours after study medication in prasugrel and clopidogrel groups respectively were 12 versus 22 (p = 0.005) and 19 versus 34 (p = 0.01) respectively. Conclusions Routine platelet function testing identifies patients with high residual platelet reactivity (“poor responders”) on clopidogrel. A strategy of prasugrel rather than clopidogrel reloading results in earlier and more sustained suppression of platelet reactivity. Future trials need to identify if this translates into clinical benefit. Trial Registration ClinicalTrials.gov NCT01339026 PMID:26317618

  15. Definition of efficiency in vacuum therapy--a randomised controlled trial comparing with V.A.C. Therapy.

    PubMed

    Wild, Thomas; Stremitzer, Stefan; Budzanowski, Annita; Hoelzenbein, Thomas; Ludwig, Claudia; Ohrenberger, Gerald

    2008-12-01

    Redon drains are still used to suction wounds for vacuum sealing. Vacuum-assisted closure (V.A.C.((R)); Kinetic Concepts Inc, San Antonio, TX) is a computer-controlled therapy system for delivering topical negative pressure therapy. The efficiency of V.A.C. in the treatment of pressure ulcers was prospectively studied in a randomised controlled trial in which patients with pressure ulcers were randomly assigned to negative pressure wound therapy (NPWT) using either V.A.C. or Redon bottles. The target parameters were absolute and relative proportion of wound area consists of granulation tissue, fibrin and necrosis. Other outcome measures were the number of dressing changes and time invested using each system. The study was terminated after a post hoc analysis after inclusion of ten patients because of the significantly better results when using V.A.C., and the substantially larger care effort needed in the Redon group compared with the V.A.C. group. An increase in surface granulation tissue of 54% was observed in the V.A.C. group, and a reduction in the Redon group (P = 0.001). The Redon group showed an increase in fibrin tissue at the wound base of 21.8%, whereas in the V.A.C group, a 27% reduction was observed (P = 0.035). Necrosis was reduced in the V.A.C. group, but this difference did not reach significance. Redon bottles are not a good alternative for V.A.C. therapy for delivering NPWT.

  16. The ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self-harm: study protocol for a randomised controlled trial.

    PubMed

    Hatcher, Simon; Sharon, Cynthia; House, Allan; Collings, Sunny; Parag, Varsha; Collins, Nicola

    2011-05-26

    People who present to hospital after intentionally harming themselves pose a common and important problem. Previous reviews of interventions have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and regular written communications after the self-harm attempt may be an effective treatment. This protocol describes a large pragmatic trial of a package of measures which include problem solving therapy, regular written communication, patient support, cultural assessment, improved access to primary care and a risk management strategy in people who present to hospital after self-harm using a novel design. We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enroll a large representative cohort of patients. The main outcome will be hospital attendance following repetition of self-harm, in the 12 months after recruitment with secondary outcomes of self reported self-harm, hopelessness, anxiety, depression, quality of life, social function and hospital use at three months and one year. A strength of the study is that it is a pragmatic trial which aims to recruit large numbers and does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. However the primary analysis is a true intention to treat analysis of everyone randomised which includes both those who consent and do not consent to participate in the study. This provides information about how the intervention will work in practice in a representative population which is a major advance in this study compared to what has been done before. Australia and New Zealand Clinical

  17. Protocol for the Arterial Revascularisation Trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation [ISRCTN46552265

    PubMed Central

    Taggart, David P; Lees, Belinda; Gray, Alastair; Altman, Douglas G; Flather, Marcus; Channon, Keith

    2006-01-01

    Background Standard coronary artery bypass graft surgery uses a single internal mammary artery and supplemental vein or radial artery grafts. Several observational studies have suggested a survival benefit with two internal mammary artery grafts compared to a single internal mammary artery graft, but this has not been tested in a randomised trial. The Arterial Revascularisation Trial is a Medical Research Council and British Heart Foundation funded, multi-centre international trial comparing single internal mammary artery grafting versus bilateral internal mammary artery grafting. Methods/Design Twenty centres in the UK, Australia, Poland and Brazil are planning to randomise 3000 coronary artery bypass graft surgery patients to single or bilateral internal mammary artery grafting. Supplemental grafts may be either saphenous vein or radial artery. Coronary artery bypass grafting can be performed as an on-pump or off-pump procedure. The primary outcome is survival at 10 years and secondary end-points include clinical events, quality of life and cost effectiveness. The effect of age, left ventricular function, diabetes, number of grafts, vein grafts and off-pump surgery are pre-specified subgroups. Discussion The Arterial Revascularisation Trial is one of the first randomised trials to evaluate the effects on survival and other clinical outcomes of single internal mammary artery grafting versus bilateral internal mammary artery grafting, and will help to establish the best approach for patients requiring coronary artery bypass graft surgery. PMID:16573820

  18. Employment status five years after a randomised controlled trial comparing multidisciplinary and brief intervention in employees on sick leave due to low back pain.

    PubMed

    Pedersen, Pernille; Nielsen, Claus Vinther; Jensen, Ole Kudsk; Jensen, Chris; Labriola, Merete

    2017-08-01

    To evaluate differences in employment status, during a five-year follow-up period in patients on sick leave due to low back pain who had participated in a trial comparing a brief and a multidisciplinary intervention. From 2004 to 2008, 535 patients were referred to the Spine Centre at the Regional Hospital in Silkeborg if they had been on sick leave for 3-16 weeks due to low back pain. All patients underwent a clinical examination by a rehabilitation physician and a physiotherapist, and were randomised to either the brief intervention or the multidisciplinary intervention. The outcome was employment status from randomisation to five years of follow-up and was measured by the mean number of weeks in four different groups of employment status (sequence analysis) and a fraction of the number of weeks working (work participation score) that were accumulated over the years. A total of 231 patients were randomised to the brief intervention and 233 patients to the multidisciplinary intervention. No statistically significant differences in the mean weeks spent within the different employment statuses were found between the two intervention groups. After five years of follow-up, participants in the multidisciplinary intervention had a 19% higher risk of not having a work participation score above 75% compared to participants in the brief intervention. After five years of follow-up no differences in employment status were found between participants in the brief and the multidisciplinary intervention.

  19. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

    PubMed Central

    Tullberg, Tycho; Branth, Björn; Olerud, Claes; Tropp, Hans

    2009-01-01

    The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21–55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The

  20. Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

    PubMed Central

    Varadhan, Krishna K; Neal, Keith R

    2012-01-01

    Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789

  1. Localised application of vibration improves passive knee extension in women with apparent reduced hamstring extensibility: a randomised trial.

    PubMed

    Bakhtiary, Amir Hoshang; Fatemi, Elham; Khalili, Mohammad Amozade; Ghorbani, Raheb

    2011-01-01

    Does the localised application of vibration over the hamstrings improve hamstring extensibility? Randomised controlled trial with concealed allocation, intention-to-treat analysis, and assessor blinding. 30 non-athletic females (aged 18-22 yrs) with limited hamstring extensibility bilaterally. The experimental group received 3 sessions of localised application of vibration per week for 8 weeks. At each session, 3 sets of vibration were applied over the left and right hamstring muscles. The control group continued their usual daily activities. Both groups were asked to perform no specific exercises during the 8-week intervention period. Hamstring muscle extensibility was measured bilaterally at baseline and at the end of the 8-week intervention period by measuring passive knee extension in supine with 90 deg of hip flexion. At baseline, the mean lack of knee extension was 27 deg (SD 9) in the experimental group and 24 deg (SD 8) in the control group. At 8 weeks, this had changed to 13 deg (SD 5) in the experimental group and 23 deg (SD 9) in the control group. This was a significant treatment effect: mean between-group difference of 13 deg (95% CI 11 to 16). An 8-week regimen of localised application of vibration over the hamstring muscles significantly reduces knee extension lack in women with reduced range on the passive knee extension test. Copyright © 2011 Australian Physiotherapy Association. Published by .. All rights reserved.

  2. Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview

    PubMed Central

    Golder, Su; Loke, Yoon K.; Bland, Martin

    2011-01-01

    Background There is considerable debate as to the relative merits of using randomised controlled trial (RCT) data as opposed to observational data in systematic reviews of adverse effects. This meta-analysis of meta-analyses aimed to assess the level of agreement or disagreement in the estimates of harm derived from meta-analysis of RCTs as compared to meta-analysis of observational studies. Methods and Findings Searches were carried out in ten databases in addition to reference checking, contacting experts, citation searches, and hand-searching key journals, conference proceedings, and Web sites. Studies were included where a pooled relative measure of an adverse effect (odds ratio or risk ratio) from RCTs could be directly compared, using the ratio of odds ratios, with the pooled estimate for the same adverse effect arising from observational studies. Nineteen studies, yielding 58 meta-analyses, were identified for inclusion. The pooled ratio of odds ratios of RCTs compared to observational studies was estimated to be 1.03 (95% confidence interval 0.93–1.15). There was less discrepancy with larger studies. The symmetric funnel plot suggests that there is no consistent difference between risk estimates from meta-analysis of RCT data and those from meta-analysis of observational studies. In almost all instances, the estimates of harm from meta-analyses of the different study designs had 95% confidence intervals that overlapped (54/58, 93%). In terms of statistical significance, in nearly two-thirds (37/58, 64%), the results agreed (both studies showing a significant increase or significant decrease or both showing no significant difference). In only one meta-analysis about one adverse effect was there opposing statistical significance. Conclusions Empirical evidence from this overview indicates that there is no difference on average in the risk estimate of adverse effects of an intervention derived from meta-analyses of RCTs and meta-analyses of observational

  3. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates.

    PubMed

    Kaltenbach, T; Friedland, S; Soetikno, R

    2008-10-01

    Colonoscopy, the "gold standard" screening test for colorectal cancer (CRC), has known diagnostic limitations. Advances in endoscope technology have focused on improving mucosal visualisation. In addition to increased angle of view and resolution features, recent colonoscopes have non-white-light optics, such as narrow band imaging (NBI), to enhance image contrast. We aimed to study the neoplasia diagnostic characteristics of NBI, by comparing the neoplasm miss rate when the colonoscopy was performed under NBI versus white light (WL). Randomised controlled trial. US Veterans hospital. Elective colonoscopy adults. We randomly assigned patients to undergo a colonoscopic examination using NBI or WL. All patients underwent a second examination using WL, as the reference standard. The primary end point was the difference in the neoplasm miss rate, and secondary outcome was the neoplasm detection rate. In 276 tandem colonoscopy patients, there was no significant difference of miss or detection rates between NBI or WL colonoscopy techniques. Of the 135 patients in the NBI group, 17 patients (12.6%; 95% confidence interval (CI) 7.5 to 19.4%) had a missed neoplasm, as compared with 17 of the 141 patients (12.1%; 95% CI 7.2 to 18.6%) in the WL group, with a miss rate risk difference of 0.5% (95% CI -7.2 to 8.3). 130 patients (47%) had at least one neoplasm. Missed lesions with NBI showed similar characteristics to those missed with WL. All missed neoplasms were tubular adenomas, the majority (78%) was < or = 5 mm and none were larger than 1 cm (one-sided 95% CI up to 1%). Nonpolypoid lesions represented 35% (13/37) of missed neoplasms. NBI did not improve the colorectal neoplasm miss rate compared to WL; the miss rate for advanced adenomas was less than 1% and for all adenomas was 12%. The neoplasm detection rates were similar high using NBI or WL; almost a half the study patients had at least one adenoma. Clinicaltrials.gov identifier: NCT00628147.

  4. SMART: physical activity and cerebral metabolism in older people: study protocol for a randomised controlled trial.

    PubMed

    Fleckenstein, Johannes; Matura, Silke; Engeroff, Tobias; Füzéki, Eszter; Tesky, Valentina A; Pilatus, Ulrich; Hattingen, Elke; Deichmann, Ralf; Vogt, Lutz; Banzer, Winfried; Pantel, Johannes

    2015-04-11

    Physical activity exerts a variety of long-term health benefits in older adults. In particular, it is assumed to be a protective factor against cognitive decline and dementia. Randomised controlled assessor blinded 2-armed trial (n = 60) to explore the exercise- induced neuroprotective and metabolic effects on the brain in cognitively healthy older adults. Participants (age ≥ 65), recruited within the setting of assisted living facilities and newspaper advertisements are allocated to a 12-week individualised aerobic exercise programme intervention or a 12-week waiting control group. Total follow-up is 24 weeks. The main outcome is the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging reflecting changes of cerebral N-acetyl-aspartate and of markers of neuronal energy reserve. Imaging also measures changes in cortical grey matter volume. Secondary outcomes include a broad range of psychometric (cognition) and movement-related parameters such as nutrition, history of physical activity, history of pain and functional diagnostics. Participants are allocated to either the intervention or control group using a computer-generated randomisation sequence. The exercise physiologist in charge of training opens sealed and opaque envelopes and informs participants about group allocation. For organisational reasons, he schedules the participants for upcoming assessments and exercise in groups of five. All assessors and study personal other than exercise physiologists are blinded. Magnetic Resonance Spectroscopic Imaging gives a deeper insight into mechanisms of exercise-induced changes in brain metabolism. As follow-up lasts for 6 months, this study is able to explore the mid-term cerebral metabolic effects of physical activity assuming that an individually tailored aerobic ergometer training has the potential to counteract brain ageing. NCT02343029 (clinicaltrials.gov; 12 January 2015).

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

    PubMed

    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 < 0.001], BMI [-1.38 kg · m(‒)(2), P < 0.001], BMI-Z [-0.5 z-scores, P < 0.001], sit and reach [+3.0 cm, P < 0.001], standing jump [+0.1 m, P = 0.021] and shuttle run [+10.3 laps, P = 0.019]. Retention rate was 82.3%. All programme sessions were delivered and participants' mean satisfaction scores ranged from 4.2 to 4.6 out of 5. The findings demonstrate that CrossFit Teens™ is a feasible and efficacious programme for improving health-related fitness in adolescents.

  6. Inspiratory muscle training to enhance recovery from mechanical ventilation: a randomised trial

    PubMed Central

    Bissett, Bernie M; Leditschke, I Anne; Neeman, Teresa; Boots, Robert; Paratz, Jennifer

    2016-01-01

    Background In patients who have been mechanically ventilated, inspiratory muscles remain weak and fatigable following ventilatory weaning, which may contribute to dyspnoea and limited functional recovery. Inspiratory muscle training may improve inspiratory muscle strength and endurance following weaning, potentially improving dyspnoea and quality of life in this patient group. Methods We conducted a randomised trial with assessor-blinding and intention-to-treat analysis. Following 48 hours of successful weaning, 70 participants (mechanically ventilated ≥7 days) were randomised to receive inspiratory muscle training once daily 5 days/week for 2 weeks in addition to usual care, or usual care (control). Primary endpoints were inspiratory muscle strength and fatigue resistance index (FRI) 2 weeks following enrolment. Secondary endpoints included dyspnoea, physical function and quality of life, post-intensive care length of stay and in-hospital mortality. Results 34 participants were randomly allocated to the training group and 36 to control. The training group demonstrated greater improvements in inspiratory strength (training: 17%, control: 6%, mean difference: 11%, p=0.02). There were no statistically significant differences in FRI (0.03 vs 0.02, p=0.81), physical function (0.25 vs 0.25, p=0.97) or dyspnoea (−0.5 vs 0.2, p=0.22). Improvement in quality of life was greater in the training group (14% vs 2%, mean difference 12%, p=0.03). In-hospital mortality was higher in the training group (4 vs 0, 12% vs 0%, p=0.051). Conclusions Inspiratory muscle training following successful weaning increases inspiratory muscle strength and quality of life, but we cannot confidently rule out an associated increased risk of in-hospital mortality. Trial registration number ACTRN12610001089022, results. PMID:27257003

  7. Platelets for neonatal transfusion - study 2: a randomised controlled trial to compare two different platelet count thresholds for prophylactic platelet transfusion to preterm neonates.

    PubMed

    Curley, Anna; Venkatesh, Vidheya; Stanworth, Simon; Clarke, Paul; Watts, Timothy; New, Helen; Willoughby, Karen; Khan, Rizwan; Muthukumar, Priya; Deary, Alison

    2014-01-01

    Neonatal thrombocytopenia is a common and important clinical problem in preterm neonates. A trial assessing clinically relevant outcomes in relation to the different platelet count thresholds used to trigger transfusion has never been undertaken in preterm neonates with severe thrombocytopenia. Platelets for Neonatal Transfusion - Study 2 (PlaNeT-2) aims to assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in current standard practice in reducing the proportion of patients who have a major bleed or die up to study day 28. PlaNeT-2 is a two-stage, randomised, parallel-group, superiority trial. PlaNet-2 compares clinical outcomes in preterm neonates (<34 weeks' gestation at birth) randomised to receive prophylactic platelet transfusions to maintain platelet counts at or above either 25 × 10(9)/l or 50 × 10(9)/l. The primary outcome measure is the proportion of patients who either die or experience a major bleed up to and including study day 28. A total of 660 infants will be randomised. This trial will help define optimal platelet transfusion support for severely thrombocytopenic preterm neonates by evaluating the risks and benefits of two different prophylactic neonatal platelet transfusion thresholds. © 2014 S. Karger AG, Basel.

  8. Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: The Multicentre Venefit™ versus ClariVein® for varicose veins trial.

    PubMed

    Bootun, R; Lane, T R A; Dharmarajah, B; Lim, C S; Najem, M; Renton, S; Sritharan, K; Davies, A H

    2016-02-01

    Endovenous techniques are, at present, the recommended choice for truncal vein treatment. However, the thermal techniques require tumescent anaesthesia, which can be uncomfortable during administration. Non-tumescent, non-thermal techniques would, therefore, have potential benefits. This randomised controlled trial is being carried out to compare the degree of pain that patients experience while receiving mechanochemical ablation or radiofrequency ablation. The early results of this randomised controlled trial are reported here. Patients attending for the treatment of primary varicose veins were randomised to receive mechanochemical ablation (ClariVein®) or radiofrequency ablation (Covidien® Venefit™). The most symptomatic limb was randomised. The primary outcome measure was intra-procedural pain using a validated visual analogue scale. The secondary outcome measures were change in quality of life and clinical scores, time to return to normal activities and work as well as the occlusion rate. One-hundred and nineteen patients have been randomised (60 in the mechanochemical ablation group). Baseline characteristics were similar. Maximum pain score was significantly lower in the mechanochemical ablation group (19.3 mm, standard deviation ±19 mm) compared to the radiofrequency ablation group (34.5 mm ± 23 mm; p < 0.001). Average pain score was also significantly lower in the mechanochemical ablation group (13.4 mm ± 16 mm) compared to the radiofrequency ablation group (24.4 mm ± 18 mm; p = 0.001). Sixty-six percent attended follow-up at one month, and the complete or proximal occlusion rates were 92% for both groups. At one month, the clinical and quality of life scores for both groups had similar improvements. Early results show that the mechanochemical ablation is less painful than the radiofrequency ablation procedure. Clinical and quality of life scores were similarly improved at one month. The long-term data including

  9. A 1-year randomised controlled trial comparing zirconia versus metal-ceramic implant supported single-tooth restorations.

    PubMed

    Hosseini, Mandana; Worsaae, Nils; Schiodt, Morten; Gotfredsen, Klaus

    2011-01-01

    To compare the biological, technical and aesthetic outcomes of single implant-supported all-ceramic versus metal-ceramic crowns. Thirty-six patients with premolar agenesis were randomly treated with 38 all-ceramic (AC) and 37 metal-ceramic (MC) implant-supported single-tooth restorations. A quasi-randomisation of consecutively included restorations in patients with one or more implants was used, i.e. a combination of parallel group (for 13 patients with one restoration) and split-mouth (for 23 patients with ≥2 restorations). All patients were recalled for baseline and 1-year followup examinations. Biological and technical outcomes, including complications, were clinically and radiographically registered. The Copenhagen Index Score and visual analogue scale (VAS) score were used to assess professional and patient-reported aesthetic outcomes, respectively, by blinded assessors. One-year after loading, no patient dropped out and no implant failed, though one MC restoration had to be remade. The marginal bone loss was not significantly different between AC and MC restorations (AC: mean 0.08 mm, SD 0.25; MC: mean 0.10 mm, SD 0.17). Seven out of 10 inflammatory reactions were registered at AC restorations. Two technical complications, one loss of retention and one chipping of veneering porcelain were recorded at two metal-ceramic crowns. The marginal adaptation of the all-ceramic crowns was significantly less optimal than the metal-ceramic crowns (P = 0.014). The professional-reported colour match of all-ceramic crowns was significantly better than metal-ceramic crowns (P = 0.031), but other aesthetic parameters as well as the VAS scores demonstrated no statistically significant difference between AC and MC restorations. Marginal bone loss and the aesthetic outcomes were not significantly different between AC and MC restorations in this short-term follow-up study, though inflammatory reactions in the peri-implant mucosa as well as less optimal marginal adaptation were

  10. Burden of colonoscopy compared to non-cathartic CT-colonography in a colorectal cancer screening programme: randomised controlled trial.

    PubMed

    de Wijkerslooth, Thomas R; de Haan, Margriet C; Stoop, Esther M; Bossuyt, Patrick M; Thomeer, Maarten; Essink-Bot, Marie-Louise; van Leerdam, Monique E; Fockens, Paul; Kuipers, Ernst J; Stoker, Jaap; Dekker, Evelien

    2012-11-01

    CT-colonography has been suggested to be less burdensome for primary colorectal cancer (CRC) screening than colonoscopy. To compare the expected and perceived burden of both in a randomised trial. 8844 Dutch citizens aged 50-74 years were randomly invited for CRC screening with colonoscopy (n=5924) or CT-colonography (n=2920). Colonoscopy was performed after full colon lavage, or CT-colonography after limited bowel preparation (non-cathartic). All invitees were asked to complete the expected burden questionnaire before the procedure. All participants were invited to complete the perceived burden questionnaire 14 days later. Mean scores were calculated on 5-point scales. Expected burden: 2111 (36%) colonoscopy and 1199 (41%) CT-colonography invitees completed the expected burden questionnaire. Colonoscopy invitees expected the bowel preparation and screening procedure to be more burdensome than CT-colonography invitees: mean scores 3.0±1.1 vs 2.3±0.9 (p<0.001) and 3.1±1.1 vs 2.2±0.9 (p<0.001). Perceived burden: 1009/1276 (79%) colonoscopy and 801/982 (82%) CT-colonography participants completed the perceived burden questionnaire. The full screening procedure was reported as more burdensome in CT-colonography than in colonoscopy: 1.8±0.9 vs 2.0±0.9 (p<0.001). Drinking the bowel preparation resulted in a higher burden score in colonoscopy (3.0±1.3 vs 1.7±1.0, p<0.001) while related bowel movements were scored more burdensome in CT-colonography (2.0±1.0 vs 2.2±1.1, p<0.001). Most participants would probably or definitely take part in a next screening round: 96% for colonoscopy and 93% for CT-colonography (p=0.99). In a CRC screening programme, colonoscopy invitees expected the screening procedure and bowel preparation to be more burdensome than CT-colonography invitees. In participants, CT-colonography was scored as more burdensome than colonoscopy. Intended participation in a next screening round was comparable.

  11. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study.

    PubMed

    Van Damme, Pierre; Arnou, Robert; Kafeja, Froukje; Fiquet, Anne; Richard, Patrick; Thomas, Stéphane; Meghlaoui, Gilles; Samson, Sandrine Isabelle; Ledesma, Emilio

    2010-05-26

    Although seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an intradermal vaccination route. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly. Elderly volunteers (age > or = 65 years) were randomised to receive a single dose of trivalent seasonal influenza vaccine: either a split-virion vaccine containing 15 microg haemagglutinin [HA]/strain/0.1-ml dose administered intradermally, or a subunit vaccine (15 microg HA/strain/0.5-ml dose) adjuvanted with MF59C.1 and administered intramuscularly. Blood samples were taken before and 21 +/- 3 days post-vaccination. Anti-HA antibody titres were assessed using haemagglutination inhibition (HI) and single radial haemolysis (SRH) methods. We aimed to show that the intradermal vaccine was non-inferior to the adjuvanted vaccine. A total of 795 participants were enrolled (intradermal vaccine n = 398; adjuvanted vaccine n = 397). Non-inferiority of the intradermal vaccine was demonstrated for the A/H1N1 and B strains, but not for the A/H3N2 strain (upper bound of the 95% CI = 1.53) using the HI method, and for all three strains by the SRH method. A post-hoc analysis of covariance to adjust for baseline antibody titres demonstrated the non-inferiority of the intradermal vaccine by HI and SRH methods for all three strains. Both vaccines were, in general, well tolerated; the incidence of injection-site reactions was higher for the intradermal (70.1%) than the adjuvanted vaccine (33.8%) but these reactions were mild and of short duration. The immunogenicity and safety of the intradermal seasonal influenza vaccine in the elderly was comparable with that of the adjuvanted vaccine. Intradermal vaccination to target the immune properties of the skin appears to be an

  12. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study

    PubMed Central

    2010-01-01

    Background Although seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an intradermal vaccination route. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly. Methods Elderly volunteers (age ≥ 65 years) were randomised to receive a single dose of trivalent seasonal influenza vaccine: either a split-virion vaccine containing 15 μg haemagglutinin [HA]/strain/0.1-ml dose administered intradermally, or a subunit vaccine (15 μg HA/strain/0.5-ml dose) adjuvanted with MF59C.1 and administered intramuscularly. Blood samples were taken before and 21 ± 3 days post-vaccination. Anti-HA antibody titres were assessed using haemagglutination inhibition (HI) and single radial haemolysis (SRH) methods. We aimed to show that the intradermal vaccine was non-inferior to the adjuvanted vaccine. Results A total of 795 participants were enrolled (intradermal vaccine n = 398; adjuvanted vaccine n = 397). Non-inferiority of the intradermal vaccine was demonstrated for the A/H1N1 and B strains, but not for the A/H3N2 strain (upper bound of the 95% CI = 1.53) using the HI method, and for all three strains by the SRH method. A post-hoc analysis of covariance to adjust for baseline antibody titres demonstrated the non-inferiority of the intradermal vaccine by HI and SRH methods for all three strains. Both vaccines were, in general, well tolerated; the incidence of injection-site reactions was higher for the intradermal (70.1%) than the adjuvanted vaccine (33.8%) but these reactions were mild and of short duration. Conclusions The immunogenicity and safety of the intradermal seasonal influenza vaccine in the elderly was comparable with that of the adjuvanted vaccine. Intradermal vaccination to target the immune properties of

  13. A multinational randomised study comparing didactic lectures with case scenario in a severe sepsis medical simulation course.

    PubMed

    Li, Chih-Huang; Kuan, Win-Sen; Mahadevan, Malcolm; Daniel-Underwood, Lynda; Chiu, Te-Fa; Nguyen, H Bryant

    2012-07-01

    Medical simulation has been used to teach critical illness in a variety of settings. This study examined the effect of didactic lectures compared with simulated case scenario in a medical simulation course on the early management of severe sepsis. A prospective multicentre randomised study was performed enrolling resident physicians in emergency medicine from four hospitals in Asia. Participants were randomly assigned to a course that included didactic lectures followed by a skills workshop and simulated case scenario (lecture-first) or to a course that included a skills workshop and simulated case scenario followed by didactic lectures (simulation-first). A pre-test was given to the participants at the beginning of the course, post-test 1 was given after the didactic lectures or simulated case scenario depending on the study group assignment, then a final post-test 2 was given at the end of the course. Performance on the simulated case scenario was evaluated with a performance task checklist. 98 participants were enrolled in the study. Post-test 2 scores were significantly higher than pre-test scores in all participants (80.8 ± 12.0% vs 65.4 ± 12.2%, p<0.01). There was no difference in pre-test scores between the two study groups. The lecture-first group had significantly higher post-test 1 scores than the simulation-first group (78.8 ± 10.6% vs 71.6 ± 12.6%, p<0.01). There was no difference in post-test 2 scores between the two groups. The simulated case scenario task performance completion was 90.8% (95% CI 86.6% to 95.0%) in the lecture-first group compared with 83.8% (95% CI 79.5% to 88.1%) in the simulation-first group (p=0.02). A medical simulation course can improve resident physician knowledge in the early management of severe sepsis. Such a course should include a comprehensive curriculum that includes didactic lectures followed by simulation experience.

  14. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy

    PubMed Central

    Emery, Paul; Vencovský, Jiří; Sylwestrzak, Anna; Leszczyński, Piotr; Porawska, Wieslawa; Baranauskaite, Asta; Tseluyko, Vira; Zhdan, Vyacheslav M; Stasiuk, Barbara; Milasiene, Roma; Barrera Rodriguez, Aaron Alejandro; Cheong, Soo Yeon; Ghil, Jeehoon

    2017-01-01

    Objectives To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. Methods This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. Results 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was −9.41% to 4.98%, which is completely contained within the predefined equivalence margin of −15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). Conclusions SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. Trial registration numbers NCT01895309, EudraCT 2012-005026-30. PMID:26150601

  15. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy.

    PubMed

    Emery, Paul; Vencovský, Jiří; Sylwestrzak, Anna; Leszczyński, Piotr; Porawska, Wieslawa; Baranauskaite, Asta; Tseluyko, Vira; Zhdan, Vyacheslav M; Stasiuk, Barbara; Milasiene, Roma; Barrera Rodriguez, Aaron Alejandro; Cheong, Soo Yeon; Ghil, Jeehoon

    2017-01-01

    To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. NCT01895309, EudraCT 2012-005026-30. 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. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    PubMed Central

    2012-01-01

    Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health education for young

  17. Randomised clinical study comparing the effectiveness and physiological effects of hypertonic and isotonic polyethylene glycol solutions for bowel cleansing

    PubMed Central

    Yamano, Hiro-o; Matsushita, Hiro-o; Yoshikawa, Kenjiro; Takagi, Ryo; Harada, Eiji; Tanaka, Yoshihito; Nakaoka, Michiko; Himori, Ryogo; Yoshida, Yuko; Satou, Kentarou; Imai, Yasushi

    2016-01-01

    Objectives Bowel cleansing is necessary before colonoscopy, but is a burden to patients because of the long cleansing time and large dose volume. A low-volume (2 L) hypertonic polyethylene glycol-ascorbic acid solution (PEG-Asc) has been introduced, but its possible dehydration effects have not been quantitatively studied. We compared the efficacy and safety including the dehydration risk between hypertonic PEG-Asc and isotonic PEG regimens. Design This was an observer-blinded randomised study. Participants (n=310) were allocated to receive 1 of 3 regimens on the day of colonoscopy: PEG-Asc (1.5 L) and water (0.75 L) dosed with 1 split (PEG-Asc-S) or 4 splits (PEG-Asc-M), or PEG-electrolyte solution (PEG-ES; 2.25 L) dosed with no split. Dehydration was analysed by measuring haematocrit (Ht). Results The cleansing time using the hypertonic PEG-Asc-S (3.33±0.48 hours) was significantly longer than that with isotonic PEG-ES (3.05±0.56 hours; p<0.001). PEG-Asc-M (3.00±0.53 hours) did not have this same disadvantage. Successful cleansing was achieved in more than 94% of participants using each of the 3 regimens. The percentage changes in Ht from baseline (before dosing) to the end of dosing with PEG-Asc-S (3.53±3.32%) and PEG-Asc-M (4.11±3.07%) were significantly greater than that with PEG-ES (1.31±3.01%). Conclusions These 3 lower volume regimens were efficacious and had no serious adverse effects. Even patients cleansed with isotonic PEG-ES showed significant physiological dehydration at the end of dosing. The four-split PEG-Asc-M regimen is recommended because of its shorter cleansing time without causing serious nausea. Trial registration number UMIN000013103; Results. PMID:27547443

  18. A multicentre randomised controlled trial comparing elective and selective caesarean section for the delivery of the preterm breech infant.

    PubMed

    Penn, Zoe J; Steer, Philip J; Grant, Adrian

    2014-12-01

    To determine the optimum mode of delivery for women in preterm breech labour at a gestational age of 26 to 32 weeks. A multicentre randomised controlled trial. Twenty-six hospitals in England, UK. Women with a singleton breech fetus in spontaneous preterm labour between 26 and 32 completed weeks of gestation, with no clear indication for a caesarean section or vaginal breech delivery. Random allocation to either 'intention to delivery vaginally' or 'intention to deliver by caesarean section'. Perinatal mortality, neonatal morbidity, maternal morbidity and gestation at delivery. The trial was closed after 17 months because of low recruitment, by which time substantial numbers of women had been in the eligible gestation period. Thirteen women from six hospitals were recruited. One infant, randomised to and delivered vaginally, was stillborn. Three fetal presentations were cephalic at delivery despite a diagnosis of breech presentation at trial entry. No formal statistical analysis was performed due to the small numbers. No conclusions about the optimum mode of delivery for women in preterm labour with a fetus presenting by the breech can be drawn from this trial. The low accrual rate was due to clinicians' reluctance to randomise eligible women, reflecting the circumstances and nature of the trial. © RCOG 1996 British Journal of Obstetrics and Gynaecology.

  19. Effect of Baduanjin exercise on cognitive function in older adults with mild cognitive impairment: study protocol for a randomised controlled trial

    PubMed Central

    Zheng, Guohua; Huang, Maomao; Li, Shuzhen; Li, Moyi; Xia, Rui; Zhou, Wenji; Tao, Jing; Chen, Lidian

    2016-01-01

    Introduction Mild cognitive impairment (MCI) is an intermediate stage between the cognitive changes of normal aging and dementia characterised by a reduction in memory and/or other cognitive processes. An increasing number of studies have indicated that regular physical activity/exercise may have beneficial association with cognitive function of older adults with or without cognitive impairment. As a traditional Chinese Qigong exercise, Baduanjin may be even more beneficial in promoting cognitive ability in older adults with MCI, but the evidence is still insufficient. The main purpose of this study is to investigate the effect of Baduanjin exercise on neuropsychological outcomes of community-dwelling older adults with MCI, and to explore its mechanism of action from neuroimaging based on functional MRI (fMRI) and cerebrovascular function. Methods and analysis The design of this study is a randomised, controlled trial with three parallel groups in a 1:1:1 allocation ratio with allocation concealment and assessor blinding. A total of 135 participants will be enrolled and randomised to the 24-week Baduanjin exercise intervention, 24-week brisk walking intervention and 24-week usual physical activity control group. Global cognitive function and the specific domains of cognition (memory, processing speed, executive function, attention and verbal learning and memory) will be assessed at baseline and 9, 17, 25 and 37 weeks after randomisation, while the structure and function of brain regions related to cognitive function and haemodynamic variables of the brain will be measured by fMRI and transcranial Doppler, respectively, at baseline and 25 and 37 weeks after randomisation. Ethics and dissemination Ethics approval was given by the Medical Ethics Committee of the Second People's Hospital of Fujian Province (approval number 2014-KL045-02). The findings will be disseminated through peer-reviewed publications and at scientific conferences. Trial registration number

  20. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

    PubMed

    Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

    2015-12-15

    Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

  1. Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial

    PubMed Central

    Hwang, Man-Suk; Heo, Kwang-Ho; Cho, Hyun-Woo; Shin, Byung-Cheul; Lee, Hyeon-Yeop; Heo, In; Kim, Nam-Kwen; Choi, Byung-Kwan; Son, Dong-Wuk; Hwang, Eui-Hyoung

    2015-01-01

    Introduction Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described. Methods and analysis This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment. Ethics and dissemination Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250. PMID:25652804

  2. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

    PubMed Central

    2010-01-01

    Summary Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events

  3. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    PubMed

    Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L; Bonati, Leo H; van der Worp, H Bart; de Borst, Gert J; Lo, T Hauw; Gaines, Peter; Dorman, Paul J; Macdonald, Sumaira; Lyrer, Philippe A; Hendriks, Johanna M; McCollum, Charles; Nederkoorn, Paul J; Brown, Martin M

    2010-03-20

    Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006). Risks of any

  4. An urea, arginine and carnosine based cream (Ureadin Rx Db ISDIN) shows greater efficacy in the treatment of severe xerosis of the feet in Type 2 diabetic patients in comparison with glycerol-based emollient cream. A randomized, assessor-blinded, controlled trial

    PubMed Central

    2012-01-01

    Background Xerosis is a common skin disorder frequently observed in diabetic patients. An effective hydration of foot skin in diabetics is a relevant preventive strategy in order to maintain a healthy foot. Urea is considered an effective hydrating and emollient topical product. The aim of the present study was to evaluate the efficacy of topical urea 5% with arginine and carnosine (Ureadin Rx Db, ISDIN Spain) (UC) in comparison with glycerol-based emollient topical product (Dexeryl, Pierre Fabre) (EC), in Type 2 diabetic patients. Methods We assessed the effect of UC on skin hydration in a randomized, evaluator-blinded comparative study in 40 type II diabetic patients, aged 40–75 years, treated with UC or the comparator for 28 days with a twice-daily application. The principal outcomes were the Dryness Area Severity Index (DASI) Score and the Visual Analogue Score (VAS) for skin dryness evaluated at baseline and at the end of study period by an investigator unaware of treatment allocation. Results UC induced significantly greater hydration than EC with an 89% reduction in DASI score (from 1.6 to 0.2; p < 0.001) in comparison with baseline values. After 4 weeks, compared with the control group, DASI score in UC treated group was significantly lower (0.2 vs. 1.0; p = 0.048). VAS score (high values mean better hydration) significantly increased in both groups during treatment. VAS score at the end of treatment period was significantly higher in UC group in comparison with EC group (9.8 vs. 8.2; p = 0.05). Conclusion Application of urea 5%, arginine and carnosine cream increases skin hydration and alleviates the condition of skin dryness in Type 2 diabetic patients in comparison with a control glycerol-based emollient product. (Dutch Trials Register trial number 3328). PMID:23009311

  5. Retraction statement: Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers.

    PubMed

    2015-09-01

    The following article from Journal of Clinical Nursing, 'Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers' by Georgina Gethin and Seamus Cowman published online on 25 August 2008 in Wiley Online Library (wileyonlinelibrary.com) and in Volume 18, pp. 466-474, has been retracted by agreement between the journal Editor-in-Chief, the authors and John Wiley & Sons, Ltd. The retraction has been agreed due to errors in the data analysis which affect the article's findings.

  6. Comparative effects of TV watching, recreational computer use, and sedentary video game play on spontaneous energy intake in male children. A randomised crossover trial.

    PubMed

    Marsh, Samantha; Ni Mhurchu, Cliona; Jiang, Yannan; Maddison, Ralph

    2014-06-01

    To compare the effects of three screen-based sedentary behaviours on acute energy intake (EI) in children. Normal-weight males aged 9-13 years participated in a randomised crossover trial conducted in a laboratory setting between November 2012 and February 2013 in Auckland, New Zealand. EI during an ad libitum meal was compared for three 1-hour conditions: (1) television (TV) watching, (2) sedentary video game (VG) play, and (3) recreational computer use. The primary endpoint was total EI from food and drink. Mixed regression models were used to evaluate the treatment conditions adjusting for age, BMI, and appetite at baseline. A total of 20 participants were randomised and all completed the three conditions. Total EI from food and drink in the TV, computer, and VG conditions was estimated at 820 (SE 73.15), 685 (SE 73.33), and 696 (SE 73.16) kcal, respectively, with EI being significantly greater in the TV versus computer condition (+135; P = 0.04), a trend towards greater intake in the TV versus VG condition (+124; P = 0.06), but not significantly different between the computer and VG conditions (-10; P = 0.87). TV watching was associated with greater EI compared with computer use, and a trend towards greater EI compared with VG play.

  7. A randomised pilot study comparing 13 G vacuum-assisted biopsy and conventional 14 G core needle biopsy of axillary lymph nodes in women with breast cancer.

    PubMed

    Maxwell, A J; Bundred, N J; Harvey, J; Hunt, R; Morris, J; Lim, Y Y

    2016-06-01

    To compare the acceptability, safety, and feasibility of vacuum-assisted biopsy (VAB) and core needle biopsy (CNB) of axillary lymph nodes in women with breast cancer. This parallel, non-blinded, randomised study was approved by the National Research Ethics Service. Following written informed consent, women with abnormal appearing axillary lymph nodes and radiologically malignant breast masses were randomised 1:1 to lymph node sampling under local anaesthetic with either 14 G CNB or 13 G VAB in a single UK centre. Primary outcomes were study uptake rate and patient willingness to undergo a repeat procedure if necessary. Procedure duration, immediate and post-procedure pain scores, diagnostic yield, complications, and surgical histopathology were recorded. Ninety-five women were approached; 81 (85.3%) consented and were randomised. Forty underwent CNB; 40 underwent VAB; one was excluded. Median age was 57 years. The median procedure time was 2 minutes for both techniques. The median number of samples obtained was three for CNB and four for VAB. Median pain scores for the procedure and first 3 days were 1/10 and 1/10 for CNB and 1/10 and 2/10 for VAB (p=0.11 and 0.04). More women were prepared to undergo repeat CNB compared to VAB, but the difference was not significant (38/39 versus 33/39; p=0.11). Two patients developed a haematoma after VAB. One CNB and six VABs failed to yield adequate tissue (p=0.11), but the sensitivity was similar at 79% and 78%. Study uptake was high. Acceptability of the two procedures was similar, but VAB was associated with more post-procedure pain. The sensitivity appears to be similar. Copyright © 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

  8. Developmental outcomes in early compared with delayed surgery for glue ear up to age 7 years: a randomised controlled trial.

    PubMed

    Hall, A J; Maw, A R; Steer, C D

    2009-02-01

    To investigate whether early versus delayed surgery for children severely affected by otitis media with effusion (OME) results in improved performance on developmental tests up to age 7 years. Follow-up of a randomised controlled trial. University of Bristol. One hundred and eighty-two children (mean age 35 months) with persistent OME, hearing loss and speech, language or behaviour problems who were originally eligible and randomised to either early surgery or delayed surgery after a period of watchful waiting were followed-up as part of the Avon Longitudinal Study of Parents and Children (ALSPAC) at age 4 1/2 and 7-8 years. Measures included behaviour, language, educational attainment tests, hearing, reading, cognition and coordination. Of the original randomised trial, 88 of 92 of the early surgery and 74 of 90 of the watchful waiting group were still participating in ALSPAC. Analysis was by intention to treat. At age 4 1/2 years there were significant differences in teacher assessment of language (adj OR 3.45, 95% CI: 1.42-8.39) and writing (adj OR 3.74, 95% CI: 1.51-9.27), in favour of early surgery. At age 7-8 years, there was a significant difference on teacher report of emotional problems (adj OR 4.11, 95% CI: 1.15-14.64) in favour of early surgery. There were no other significant differences. Early surgery for the child severely affected by OME may be associated with subtle benefits at age 4 1/2 years. This may continue to 7-8 years but the small study size makes it difficult to distinguish these effects from chance. A larger study is recommended.

  9. Randomised controlled trial comparing European standard class 1 to class 2 compression stockings for ulcer recurrence and patient compliance.

    PubMed

    Clarke-Moloney, Mary; Keane, Niamh; O'Connor, Veronica; Ryan, Mary Anna; Meagher, Helen; Grace, Pierce A; Kavanagh, Eamon; Walsh, Stewart R; Burke, Paul E

    2014-08-01

    The aim of this study was to determine the rate of venous ulcer recurrence and the level of compliance in patients wearing European class 1 or class 2 compression stockings. A total of 100 patients with healed venous leg ulcers were recruited, and were randomised to either class 1 (n = 50) or class 2 (n = 50) compression stockings. Follow-up was at 1 week, 3, 6, 9 and 12 months to monitor ulcer recurrence and compliance. Patients had a duplex scan to identify the source of venous incompetence. The rate of ulcer recurrence after 12 months was 16·1%, and the difference in recurrence rate between classes was not statistically significant (P = 0·287) although greater numbers in class 1 developed a recurrence. Participants (88·9%) were compliant; non-compliant patients were at a significantly greater risk of recurrence (P≤ 0·0001). Thirteen patients had both superficial and deep incompetence; those randomised to class 1 stockings (n = 4) developed ulcer recurrence. Patients with a history of multiple episodes of ulceration were more likely to develop a recurrence (P = 0·001). The lowest venous ulcer recurrence rates were seen in patients who were compliant with hosiery regardless of the compression level. Patients with both superficial and deep incompetence had a lower rate of recurrence with class 2 compression.

  10. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial

    PubMed Central

    Kallesøe, Karen Hansen; Schröder, Andreas; Wicksell, Rikard K; Fink, Per; Ørnbøl, Eva; Rask, Charlotte Ulrikka

    2016-01-01

    Introduction Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). Methods and analysis A total of 120 adolescents aged 15–19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. Ethics and dissemination The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. Discussion This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a

  11. Use of the learning conversation improves instructor confidence in life support training: An open randomised controlled cross-over trial comparing teaching feedback mechanisms.

    PubMed

    Baldwin, Lydia J L; Jones, Christopher M; Hulme, Jonathan; Owen, Andrew

    2015-11-01

    Feedback is vital for the effective delivery of skills-based education. We sought to compare the sandwich technique and learning conversation structured methods of feedback delivery in competency-based basic life support (BLS) training. Open randomised crossover study undertaken between October 2014 and March 2015 at the University of Birmingham, United Kingdom. Six-hundred and forty healthcare students undertaking a European Resuscitation Council (ERC) BLS course were enrolled, each of whom was randomised to receive teaching using either the sandwich technique or the learning conversation. Fifty-eight instructors were randomised to initially teach using either the learning conversation or sandwich technique, prior to crossing-over and teaching with the alternative technique after a pre-defined time period. Outcome measures included skill acquisition as measured by an end-of-course competency assessment, instructors' perception of teaching with each feedback technique and candidates' perception of the feedback they were provided with. Scores assigned to use of the learning conversation by instructors were significantly more favourable than for the sandwich technique across all but two assessed domains relating to instructor perception of the feedback technique, including all skills-based domains. No difference was seen in either assessment pass rates (80.9% sandwich technique vs. 77.2% learning conversation; OR 1.2, 95% CI 0.85-1.84; p=0.29) or any domain relating to candidates' perception of their teaching technique. This is the first direct comparison of two feedback techniques in clinical medical education using both quantitative and qualitative methodology. The learning conversation is preferred by instructors providing competency-based life support training and is perceived to favour skills acquisition. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. Risk of extrapyramidal side effects comparing continuous vs. bolus intravenous metoclopramide administration: a systematic review and meta-analysis of randomised controlled trials.

    PubMed

    Cavero-Redondo, Iván; Álvarez-Bueno, Celia; Pozuelo-Carrascosa, Diana P; Díez-Fernández, Ana; Notario-Pacheco, Blanca

    2015-12-01

    To provide evidence about whether intravenous metoclopramide continuous infusion is associated with fewer extrapyramidal side effects than bolus infusion. Many studies have described the effects produced by the administration of metoclopramide, as a continuous intravenous infusion or intravenous bolus directly, but there is a lack of consensus about the best administration of this drug to minimise extrapyramidal side effects. A meta-analysis was conducted. The search data base was conducted in: Cochrane Library, PubMed, Web of Knowledge and Scopus, to collect randomised controlled trials examining the association between extrapyramidal side effects and intravenous metoclopramide continuous or bolus infusion. Meta-analyses were conducted for the eligible randomised controlled trials by Comprehensive Meta-Analysis. Risk difference and 95% CIs were calculated with the Cochran's Q-statistic, and heterogeneity was assessed with the I(2) test. Eleven randomised controlled trials were included. Meta-analysis showed that continuous intravenous infusion of metoclopramide produced less extrapyramidal side effects (8%; 95% CI, 5-11%; p < 0·001; I(2) = 65%). These improvements were particularly strong in studies scored ≥3 in the Jadad scale (12%; 95% CI, 3-24%; I(2) = 0%), in emergency patients (12%; 95% CI, 2-25%; I(2) = 0%), in patients who used concomitant drugs (9%; 95% CI, 5-12%; I(2) = 80%) and when observation (8%; 95% CI, 5-14%; I(2) = 69%) or analogue scale (7%; 95% CI, 1-13%; I(2) = 64%) were used to quantify the number of extrapyramidal reactions in patients. Compared with bolus administration, continuous intravenous infusion of metoclopramide reduces the appearance of extrapyramidal side effects. Continuous infusion is an effective intervention to reduce in patients discomfort caused by the extrapyramidal side effects of metoclopramide. Clinicians also reduce the time spent on alleviating these unwanted effects. © 2015 John Wiley & Sons Ltd.

  13. A Randomised Controlled Trial Comparing the Impact of Yoga and Physical Education on the Emotional and Behavioural Functioning of Middle School Children

    PubMed Central

    Haden, Sara C.; Daly, Leslie; Hagins, Marshall

    2014-01-01

    Background Yoga programs geared for school children have become more widespread, but research regarding its impact on children is lacking. Several studies have reported positive outcomes, though there is a need for more randomised controlled trials. Objectives To determine the effects of yoga on children’s emotional and behavioural functioning when compared with physical education (PE) classes. Methods Thirty middle school children were randomised to participate in either a school-based Ashtanga-informed yoga or PE class three times a week for 12 weeks. Emotional (i.e. affect, self-perceptions) and behavioural (i.e. internalising and externalising problems, aggression) functioning were measured pre and post-intervention. Results There were no significant changes between groups in self-reported positive affect, global self-worth, aggression indices or parent reports of their children’s externalising and internalising problems. However, negative affect increased for those children participating in yoga when compared to the PE program. Conclusions In general, findings suggest that yoga and PE classes do not differentially impact on middle school children’s emotional and behavioural functioning. However, children reported experiencing increased negative emotions after receiving yoga while children in the PE group reported a decrease in these feelings. Implications of these results and potential directions for future research on children’s yoga are discussed. PMID:25147479

  14. Early results of a randomised trial comparing Prolene and VyproII-mesh in endoscopic extraperitoneal inguinal hernia repair (TEP) of recurrent unilateral hernias.

    PubMed

    Heikkinen, T; Wollert, S; Osterberg, J; Smedberg, S; Bringman, S

    2006-03-01

    The purpose of this study was to compare a lightweight mesh to a standard polypropylene hernia mesh in endoscopic extraperitoneal hernioplasty in recurrent hernias. A total of 140 men with recurrent unilateral inguinal hernias were randomised to a totally extraperitoneal endoscopic hernioplasty (TEP) with Prolene or VyproII in a single-blinded multi-center trial. The randomisation and all data handling were performed through the Internet. 137 patients were operated as allocated. Follow-up was completed in 88% of the patients. The median operation times were 55 (24-125) min and 53.5 (21-123) min for the Prolene and VyproII groups, respectively. The meshes had comparable results in the surgeon's assessment of the handling of the mesh, return to work, return to daily activities, complications, postoperative pain and quality of life during the first 8 weeks of rehabilitation, except in General Health (GH) SF-36, where the VyproII-group had a significantly better score (P=0.045). The use of Prolene and VyproII-meshes in endoscopic repair of recurrent inguinal hernia seems to result in similar short-term outcomes and quality of life.

  15. A Randomised Controlled Trial Comparing the Impact of Yoga and Physical Education on the Emotional and Behavioural Functioning of Middle School Children.

    PubMed

    Haden, Sara C; Daly, Leslie; Hagins, Marshall

    2014-09-01

    Yoga programs geared for school children have become more widespread, but research regarding its impact on children is lacking. Several studies have reported positive outcomes, though there is a need for more randomised controlled trials. To determine the effects of yoga on children's emotional and behavioural functioning when compared with physical education (PE) classes. Thirty middle school children were randomised to participate in either a school-based Ashtanga-informed yoga or PE class three times a week for 12 weeks. Emotional (i.e. affect, self-perceptions) and behavioural (i.e. internalising and externalising problems, aggression) functioning were measured pre and post-intervention. There were no significant changes between groups in self-reported positive affect, global self-worth, aggression indices or parent reports of their children's externalising and internalising problems. However, negative affect increased for those children participating in yoga when compared to the PE program. In general, findings suggest that yoga and PE classes do not differentially impact on middle school children's emotional and behavioural functioning. However, children reported experiencing increased negative emotions after receiving yoga while children in the PE group reported a decrease in these feelings. Implications of these results and potential directions for future research on children's yoga are discussed.

  16. Randomised trial of the effects of four weeks of daily stretch on extensibility of hamstring muscles in people with spinal cord injuries.

    PubMed

    Harvey, Lisa A; Byak, Adrian J; Ostrovskaya, Marsha; Glinsky, Joanne; Katte, Lyndall; Herbert, Robert D

    2003-01-01

    The aim of this assessor-blind randomised controlled trial was to determine the effect of four weeks of 30 minute stretches each weekday on extensibility of the hamstring muscles in people with recent spinal cord injuries. A consecutive sample of 16 spinal cord-injured patients with no or minimal voluntary motor power in the lower limbs and insufficient hamstring muscle extensibility to enable optimal long sitting were recruited. Subjects' legs were randomly allocated to experimental and control conditions. The hamstring muscles of the experimental leg of each subject were stretched with a 30 Nm torque at the hip for 30 minutes each weekday for four weeks. The hamstring muscles of the contralateral leg were not stretched during this period. Extensibility of the hamstring muscles (hip flexion range of motion with knee extended, measured with a 48 Nm torque at the hip) of both legs was measured by a blinded assessor at the commencement of the study and one day after the completion of the four-week stretch period. Changes in hamstring muscle extensibility from initial to final measurements were calculated. The effect of stretching was expressed as the mean difference in these changes between stretched and non-stretched legs. The mean effect of stretching was 1 degree (95% CI -2 to 5 degrees). Four weeks of 30 minute stretches each weekday does not affect the extensibility of the hamstring muscle in people with spinal cord injuries.

  17. Effects of aerobic exercise on brain metabolism and grey matter volume in older adults: results of the randomised controlled SMART trial

    PubMed Central

    Matura, S; Fleckenstein, J; Deichmann, R; Engeroff, T; Füzéki, E; Hattingen, E; Hellweg, R; Lienerth, B; Pilatus, U; Schwarz, S; Tesky, V A; Vogt, L; Banzer, W; Pantel, J

    2017-01-01

    There is mounting evidence that aerobic exercise has a positive effect on cognitive functions in older adults. To date, little is known about the neurometabolic and molecular mechanisms underlying this positive effect. The present study used magnetic resonance spectroscopy and quantitative MRI to systematically explore the effects of physical activity on human brain metabolism and grey matter (GM) volume in healthy aging. This is a randomised controlled assessor-blinded two-armed trial (n=53) to explore exercise-induced neuroprotective and metabolic effects on the brain in cognitively healthy older adults. Participants (age >65) were allocated to a 12-week individualised aerobic exercise programme intervention (n=29) or a 12-week waiting control group (n=24). The main outcomes were the change in cerebral metabolism and its association to brain-derived neurotrophic factor (BDNF) levels as well as changes in GM volume. We found that cerebral choline concentrations remained stable after 12 weeks of aerobic exercise in the intervention group, whereas they increased in the waiting control group. No effect of training was seen on cerebral N-acetyl-aspartate concentrations, nor on markers of neuronal energy reserve or BDNF levels. Further, we observed no change in cortical GM volume in response to aerobic exercise. The finding of stable choline concentrations in the intervention group over the 3 month period might indicate a neuroprotective effect of aerobic exercise. Choline might constitute a valid marker for an effect of aerobic exercise on cerebral metabolism in healthy aging.

  18. A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

    PubMed Central

    2010-01-01

    Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640 PMID:20515467

  19. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial.

    PubMed

    Santana, Licia Santos; Gallo, Rubneide Barreto Silva; Ferreira, Cristine Homsi Jorge; Duarte, Geraldo; Quintana, Silvana Maria; Marcolin, Alessandra Cristina

    2016-01-01

    In the active phase of the first stage of labour, does transcutaneous electrical nerve stimulation (TENS) relieve pain or change its location? Does TENS delay the request for neuraxial analgesia during labour? Does TENS produce any harmful effects in the mother or the foetus? Are women in labour satisfied with the care provided? Randomised trial with concealed allocation, assessor blinding for some outcomes, and intention-to-treat analysis. Forty-six low-risk, primigravida parturients with a gestational age > 37 weeks, cervical dilation of 4cm, and without the use of any medications from hospital admission until randomisation. The principal investigator applied TENS to the experimental group for 30minutes starting at the beginning of the active phase of labour. A second investigator assessed the outcomes in both the control and experimental groups. Both groups received routine perinatal care. The primary outcome was pain severity after the intervention period, which was assessed using the 100-mm visual analogue scale. Secondary outcomes included: pain location, duration of the active phase of labour, time to pharmacological labour analgesia, mode of birth, neonatal outcomes, and the participant's satisfaction with the care provided. After the intervention, a significant mean difference in change in pain of 15mm was observed favouring the experimental group (95% CI 2 to 27). The application of TENS did not alter the location or distribution of the pain. The mean time to pharmacological analgesia after the intervention was 5.0hours (95% CI 4.1 to 5.9) longer in the experimental group. The intervention did not significantly impact the other maternal and neonatal outcomes. Participants in both groups were satisfied with the care provided during labour. TENS produces a significant decrease in pain during labour and postpones the need for pharmacological analgesia for pain relief. NCT01600495. Copyright © 2015. Published by Elsevier B.V.

  20. Acupuncture treatment for ischaemic stroke in young adults: protocol for a randomised, sham-controlled clinical trial

    PubMed Central

    Chen, Lifang; Fang, Jianqiao; Jin, Xiaoming; Keeler, Crystal Lynn; Gao, Hong; Fang, Zhen; Chen, Qin

    2016-01-01

    Introduction Stroke in young adults is not uncommon. Although the overall incidence of stroke has been recently declining, the incidence of stroke in young adults is increasing. Traditional vascular risk factors are the main cause of young ischaemic stroke. Acupuncture has been shown to benefit stroke rehabilitation and ameliorate the risk factors for stroke. The aims of this study were to determine whether acupuncture treatment will be effective in improving the activities of daily living (ADL), motor function and quality of life (QOL) in patients of young ischaemic stroke, and in preventing stroke recurrence by controlling blood pressure, lipids and body weight. Methods and analysis In this randomised, sham-controlled, participant-blinded and assessor-blinded clinical trial, 120 patients between 18 and 45 years of age with a recent (within 1 month) ischaemic stroke will be randomised for an 8-week acupuncture or sham acupuncture treatment. The primary outcome will be the Barthel Index for ADL. The secondary outcomes will include the Fugl-Meyer Assessment for motor function; the World Health Organization Quality of Life BREF (WHOQOL-BREF) for QOL; and risk factors that are measured by ambulatory blood pressure, the fasting serum lipid, body mass index and waist circumference. Incidence of adverse events and long-term mortality and recurrence rate during a 10-year and 30-year follow-up will also be investigated. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University. Protocol V.3 was approved in June 2013. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone during follow-up calls enquiring on the patient's post-study health status. Trial registration number ChiCTR-TRC- 13003317; Pre-results. PMID:26739742

  1. A feasibility study of a randomised controlled trial comparing fall prevention using exercise with or without the support of motivational interviewing

    PubMed Central

    Arkkukangas, Marina; Johnson, Susanna Tuvemo; Hellström, Karin; Söderlund, Anne; Eriksson, Staffan; Johansson, Ann-Christin

    2015-01-01

    Objective The aim of this investigation was to study the feasibility of a randomised controlled trial (RCT) based on a multicentre fall prevention intervention including exercise with or without motivational interviewing compared to standard care in community-living people 75 years and older. Method The feasibility of a three-armed, randomised controlled trial was evaluated according to the following: process, resources, management by questionnaire, and treatment outcomes. The outcome measures were fall frequency, physical performance and falls self-efficacy evaluated after three months. Twelve physiotherapists conducted the measurements and treatments and responded to the questionnaire. The first 45 participants recruited to the ongoing RCT were included: 16 individuals in the Otago Exercise Program group (OEP), 16 individuals in the OEP combined with motivational interviewing group (MI), and 13 individuals in the control group. The study was conducted from November 2012 to December 2013. Results The feasibility of the study process, resources and management reached the set goals in most aspects; however, the set goal regarding the MI guide and planned exercise for the participating older people was not completely reached. No significant differences were found between the groups regarding the outcome measures. Conclusion This study confirmed the acceptable feasibility for the study protocol in the ongoing RCT. PMID:26844061

  2. Comparing the effectiveness of video self-instruction versus traditional classroom instruction targeted at cardiopulmonary resuscitation skills for laypersons: a prospective randomised controlled trial.

    PubMed

    Chung, C H; Siu, Axel Y C; Po, Lucia L K; Lam, C Y; Wong, Peter C Y

    2010-06-01

    To determine whether in the local lay Hong Kong population, video self-instruction about cardiopulmonary resuscitation has comparable results to traditional classroom instructions. Prospective randomised single-blind controlled trial. A first-aid training organisation in Hong Kong. Cantonese applicants for cardiopulmonary resuscitation courses aged between 18 and 70 years were recruited into the study. They were randomised into two groups. Those selected for self-learning were given a kit (consisting of a mini-manikin, a video compact disc, and an instruction manual) and sent home. The other group underwent usual classroom training. Both groups were examined together; the examiners remained blinded to the background training of the subjects. Those who passed were asked to come back for re-examination after 1 year. The examination passing rates initially and after 1 year. During a 1-year period between 1 April 2007 to 31 March 2008, 256 subjects were recruited into this study, 124 for self-learning and 132 for classroom training. The age range was 18 to 62 (mean, 39; standard deviation, 10) years. There was no significant difference in passing rate between the two groups at the initial examination or at the re-examination after 1 year. Notably, 28 (23%) of the participants of the self-learning group taught cardiopulmonary resuscitation to relatives and friends. Video self-learning resulted in cardiopulmonary resuscitation performance as good as traditional classroom training.

  3. Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial.

    PubMed

    Sahebjamee, Mahnaz; Mansourian, Arash; Hajimirzamohammad, Mohammad; Mohammad, Haji Mirza Mohammad; Zadeh, Mohsen Taghi; Bekhradi, Reza; Kazemian, Ali; Manifar, Soheila; Ashnagar, Sajjad; Doroudgar, Kiavash

    2015-01-01

    To compare the efficacy of an Aloe vera mouthwash with a benzydamine mouthwash in the alleviation of radiation- induced mucositis in head and neck cancer patients using a triple-blind, randomised controlled trial. Twenty-six eligible head and neck cancer patients who were to receive conventional radiation therapy at the radiation oncology department were randomised to receive an Aloe vera mouthwash or a benzydamine mouthwash. Mucositis severity was assessed during the course of radiation therapy using the WHO grading system. At baseline, there was no difference in the distribution of mucositis severity between the two groups. The mean interval between radiation therapy and onset of mucositis was similar for both groups (Aloe vera 15.69±7.77 days, benzydamine 15.85±12.96 days). The mean interval between the start of radiation therapy and the maximum severity of mucositis were was also similar in both the Aloe vera and benzydamine groups (Aloe vera 23.38±10.75 days, benzydamine 23.54±15.45 days). Mean changes of mucositis severity over time in both groups were statistically similar and the effect of both treatments did not change signficantly with time (p=0.09). Aloe vera mouthwash was as beneficial as benzydamine mouthwash in alleviating the severity of radiation-induced mucositis and showed no side effects. The Aloe vera mouthwash could be an alternative agent in the treatment of radiation-induced mucositis in patients with head and neck cancers.

  4. Effectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: study protocol for a randomised controlled trial

    PubMed Central

    Fairhall, Nicola; Kurrle, Susan E; Sherrington, Catherine; Lord, Stephen R; Lockwood, Keri; John, Beatrice; Monaghan, Noeline; Howard, Kirsten; Cameron, Ian D

    2015-01-01

    Introduction Frailty is a major concern due to its costly and widespread consequences, yet evidence of effective interventions to delay or reduce frailty is lacking. Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail. Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty. This study describes a randomised controlled trial that aims to evaluate the effectiveness of a multifactorial intervention on development of frailty in older people who are pre-frail. Methods and analysis A single centre randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. Two hundred and thirty people aged above 70 who meet the Cardiovascular Health Study frailty criteria for pre-frailty, reside in the community and are without severe cognitive impairment will be recruited. Participants will be randomised to receive a multifactorial intervention or usual care. The intervention group will receive a 12-month interdisciplinary intervention targeting identified characteristics of frailty and problems identified during geriatric assessment. Participants will be followed for a 12-month period. Primary outcome measures will be degree of frailty measured by the number of Cardiovascular Health Study frailty criteria present, and mobility measured with the Short Physical Performance Battery. Secondary outcomes will include measures of mobility, mood and use of health and community services. Ethics and dissemination The study was approved by the Northern Sydney Local Health District Health Research Ethics Committee (1207-213M). The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals. Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12613000043730. PMID:25667151

  5. Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial

    PubMed Central

    Chan, Kam Wa; Ip, Tai Pang; Kwong, Alfred Siu Kei; Lui, Sing Leung; Chan, Gary Chi Wang; Cowling, Benjamin John; Yiu, Wai Han; Wong, Dickson Wai Leong; Liu, Yang; Feng, Yibin; Tan, Kathryn Choon Beng; Chan, Loretta Yuk Yee; Leung, Joseph Chi Kam; Lai, Kar Neng; Tang, Sydney Chi Wai

    2016-01-01

    Introduction Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin–angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese–Western medicine protocol for the management of DN. Objective To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2–3 chronic kidney disease and macroalbuminuria. Methods and analysis This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-β1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015. Ethics and registration This protocol is approved by the Institutional

  6. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

    PubMed Central

    Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

    2015-01-01

    Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

  7. A comparative randomised controlled trial of the effects of brain wave vibration training, iyengar yoga, and mindfulness on mood, well-being, and salivary cortisol.

    PubMed

    Bowden, Deborah; Gaudry, Claire; An, Seung Chan; Gruzelier, John

    2012-01-01

    This randomised trial compared the effects of Brain Wave Vibration (BWV) training, which involves rhythmic yoga-like meditative exercises, with Iyengar yoga and Mindfulness. Iyengar provided a contrast for the physical components and mindfulness for the "mental" components of BWV. 35 healthy adults completed 10 75-minute classes of BWV, Iyengar, or Mindfulness over five weeks. Participants were assessed at pre- and postintervention for mood, sleep, mindfulness, absorption, health, memory, and salivary cortisol. Better overall mood and vitality followed both BWV and Iyengar training, while the BWV group alone had improved depression and sleep latency. Mindfulness produced a comparatively greater increase in absorption. All interventions improved stress and mindfulness, while no changes occurred in health, memory, or salivary cortisol. In conclusion, increased well-being followed training in all three practices, increased absorption was specific to Mindfulness, while BWV was unique in its benefits to depression and sleep latency, warranting further research.

  8. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial.

    PubMed

    Fang, Jianqiao; Chen, Lifang; Chen, Luni; Wang, Chao; Keeler, Crystal Lynn; Ma, Ruijie; Xu, Shouyu; Shen, Laihua; Bao, Yehua; Ji, Conghua

    2014-12-04

    Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks' follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events. Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status. Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  9. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial

    PubMed Central

    Fang, Jianqiao; Chen, Lifang; Chen, Luni; Wang, Chao; Keeler, Crystal Lynn; Ma, Ruijie; Xu, Shouyu; Shen, Laihua; Bao, Yehua; Ji, Conghua

    2014-01-01

    Introduction Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. Methods and analysis 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks’ follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events. Ethics and dissemination Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status. Trial registration number Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561 PMID:25475247

  10. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial.

    PubMed

    Reznik, Yves; Cohen, Ohad; Aronson, Ronnie; Conget, Ignacio; Runzis, Sarah; Castaneda, Javier; Lee, Scott W

    2014-10-04

    Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin targets and randomised controlled studies comparing the efficacy of pump treatment and multiple daily injections for lowering glucose in insulin-treated patients have yielded inconclusive results. We aimed to resolve this uncertainty with a randomised controlled trial (OpT2mise). We did this multicentre, controlled trial at 36 hospitals, tertiary care centres, and referal centres in Canada, Europe, Israel, South Africa, and the USA. Patients with type 2 diabetes who had poor glycaemic control despite multiple daily injections with insulin analogues were enrolled into a 2-month dose-optimisation run-in period. After the run-in period, patients with glycated haemoglobin of 8·0-12·0% (64-108 mmol/mol) were randomly assigned (1:1) by a computer-generated randomisation sequence (block size 2 with probability 0·75 and size 4 with probability 0·25) to pump treatment or to continue with multiple daily injections. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was change in mean glycated haemoglobin between baseline and end of the randomised phase for the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01182493. 495 of 590 screened patients entered the run-in phase and 331 were randomised (168 to pump treatment, 163 to multiple daily injections). Mean glycated haemoglobin at baseline was 9% (75 mmol/mol) in both groups. At 6 months, mean glycated haemoglobin had decreased by 1·1% (SD 1·2; 12 mmol/mol, SD 13) in the pump treatment group and 0·4% (SD 1·1; 4 mmol/mol, SD 12) in the multiple daily injection group, resulting in a between-group treatment difference of -0·7% (95% CI -0·9 to -0·4; -8 mmol/mol, 95% CI -10 to -4, p<0·0001). At the end of the study, the mean total daily insulin dose was 97 units (SD 56) with pump treatment versus 122 units (SD 68) for multiple daily injections (p<0·0001

  11. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China.

    PubMed

    Zhang, Hongyu; Huang, Shurong; Guo, Xiaolan; Zhao, Ningning; Lu, Yujing; Chen, Min; Li, Yingxia; Wu, Junqin; Huang, Lihua; Ma, Fenglan; Yang, Yuhong; Zhang, Xiaoli; Zhou, Xiaoyu; Guo, Renfei; Cai, Wenzhi

    2017-07-01

    the supine position is the most frequently offered for birth delivery in China and many other countries, but the hands-and-knees position is now gaining prominence with doctors in China. This study aims to examine the differences in maternal and neonatal outcomes among low-risk women who gave birth either in the hands-and-knees position or the supine position. a randomised controlled trial was conducted in 11 hospitals in China from May to December in 2012. In total, 1400 women were recruited and randomly allocated to either the experimental group (n=700, 446 completed the protocol) who delivered in hands-and-knees position and the control group (n=700, 440 completed the protocol) who delivered in supine position. Women who could not maintain the randomised position during the second stage of labour were allowed to withdraw from the study. The primary maternal outcome measured was rate of episiotomy. Secondary outcomes included degree of perineum laceration, rate of emergency caesarean section, rate of shoulder dystocia, and duration of labour, postpartum bleeding, neonatal Apgar score, and the rate of neonatal asphyxia. Because outcome data were only collected for women who gave birth in the randomised position, per-protocol analyses were used to compare groups. The primary outcome, episiotomy, was also compared between groups using logistic regression adjusting for maternal age,gestational age at birth, whether the woman was primiparous, the process of second stage of labour and birthweight. as compared with the control group, the experimental group had lower rates of episiotomy and second-degree perineum laceration (including episiotomy), and higher rates of intact perineum and first-degree perineum laceration, with a longer duration of second stage of labour. No significant differences were found in the amount of postpartum bleeding, shoulder dystocia, neonatal asphyxia and neonatal Apgar scores at 1minute and 5minutes. Adjusted for maternal age, gestational

  12. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial.

    PubMed

    Mas, Jean-Louis; Trinquart, Ludovic; Leys, Didier; Albucher, Jean-François; Rousseau, Hervé; Viguier, Alain; Bossavy, Jean-Pierre; Denis, Béatrice; Piquet, Philippe; Garnier, Pierre; Viader, Fausto; Touzé, Emmanuel; Julia, Pierre; Giroud, Maurice; Krause, Denis; Hosseini, Hassan; Becquemin, Jean-Pierre; Hinzelin, Grégoire; Houdart, Emmanuel; Hénon, Hilde; Neau, Jean-Philippe; Bracard, Serge; Onnient, Yannick; Padovani, Raymond; Chatellier, Gilles

    2008-10-01

    Carotid stenting is a potential alternative to carotid endarterectomy but whether this technique is as safe as surgery and whether the long-term protection against stroke is similar to that of surgery are unclear. We previously reported that in patients in the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the rate of any stroke or death within 30 days after the procedure was higher with stenting than with endarterectomy. We now report the results up to 4 years. In this follow-up study of a multicentre, randomised, open, assessor-blinded, non-inferiority trial, we compared outcome after stenting with outcome after endarterectomy in 527 patients who had carotid stenosis of at least 60% that had recently become symptomatic. The primary endpoint of the EVA-3S trial was the rate of any periprocedural stroke or death (ie, within 30 days after the procedure). The prespecified main secondary endpoint was a composite of any periprocedural stroke or death and any non-procedural ipsilateral stroke during up to 4 years of follow-up. Other trial outcomes were any stroke or periprocedural death, any stroke or death, and the above endpoints restricted to disabling or fatal strokes. This trial is registered with ClinicalTrials.gov, number NCT00190398. 262 patients were randomly assigned to endarterectomy and 265 to stenting. The cumulative probability of periprocedural stroke or death and non-procedural ipsilateral stroke after 4 years of follow-up was higher with stenting than with endarterectomy (11.1%vs 6.2%, hazard ratio [HR] 1.97, 95% CI 1.06-3.67; p=0.03). The HR for periprocedural disabling stroke or death and non-procedural fatal or disabling ipsilateral stroke was 2.00 (0.75-5.33; p=0.17). A hazard function analysis showed the 4-year differences in the cumulative probabilities of outcomes between stenting and endarterectomy were largely accounted for by the higher periprocedural (within 30 days of the procedure

  13. Ocular tolerability and efficacy of a cationic emulsion in patients with mild to moderate dry eye disease - a randomised comparative study.

    PubMed

    Amrane, M; Creuzot-Garcher, C; Robert, P-Y; Ismail, D; Garrigue, J-S; Pisella, P-J; Baudouin, C

    2014-10-01

    The purpose of this study was to compare the safety and efficacy of a new cationic emulsion (CE) with a formulation of polyvinyl alcohol and povidone (PVA-P) for the treatment of mild to moderate dry eye disease. This was a multicenter, open-label, comparative study. Patients were randomised to receive CE (Cationorm) or PVA-P (Refresh) (1:1). The following objective criteria were assessed to compare the two eye drops: tear Break-up Time (TBUT), Schirmer's test, lissamine green staining (Van Bijsterveld score), corneal fluorescein staining (Oxford scale) and oculopalpebral examination, on D7 and D28 (end of study). At these visits, ocular symptoms and safety were also assessed. Seventy-nine patients were randomised: CE: 44 patients; PVA-P: 35 patients. At D28, improvement was significantly better for TBUT [CE: 1.7 ± 2.4 s; PVA-P: 0.6 ± 1.8 s; P=0.015] and for the Van Bijsterveld score [CE: -1.4 ± 1.2; PVA-P: -0.9 ± 1.2; P=0.046] in the CE group. The same applied for the palpebral erythema score (P=0.023), overall efficacy assessed by the investigators (P<0.001), and symptoms not related to eye drop instillation (P=0.021). Improvement was observed from D7. No difference was observed between the two treatments with regard to ocular safety. These results suggest that in patients with mild to moderate dry eye, Cationorm, in addition to its moisturizing and lubricating properties, also helps stabilize the tear film due to its oily component. This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  14. Does hydrotherapy improve strength and physical function in patients with osteoarthritis—a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme

    PubMed Central

    Foley, A; Halbert, J; Hewitt, T; Crotty, M

    2003-01-01

    Objective: To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Design: Single blind, three arm, randomised controlled trial. Subjects: 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Methods: Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). Results: In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Conclusion: Functional gains were achieved with both exercise programmes compared with the control group. PMID:14644853

  15. The TOPSHOCK study: effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial.

    PubMed

    van der Worp, Henk; Zwerver, Johannes; van den Akker-Scheek, Inge; Diercks, Ron L

    2011-10-11

    Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. The TOPSHOCK study is the first randomised controlled trial that

  16. Does hydrotherapy improve strength and physical function in patients with osteoarthritis--a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme.

    PubMed

    Foley, A; Halbert, J; Hewitt, T; Crotty, M

    2003-12-01

    To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Single blind, three arm, randomised controlled trial. 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Functional gains were achieved with both exercise programmes compared with the control group.

  17. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed

    PubMed Central

    Dutton, Susan; Yu, Ly-Mee; Chan, An-Wen; Altman, Douglas G

    2010-01-01

    Objectives To examine the reporting characteristics and methodological details of randomised trials indexed in PubMed in 2000 and 2006 and assess whether the quality of reporting has improved after publication of the Consolidated Standards of Reporting Trials (CONSORT) Statement in 2001. Design Comparison of two cross sectional investigations. Study sample All primary reports of randomised trials indexed in PubMed in December 2000 (n=519) and December 2006 (n=616), including parallel group, crossover, cluster, factorial, and split body study designs. Main outcome measures The proportion of general and methodological items reported, stratified by year and study design. Risk ratios with 95% confidence intervals were calculated to represent changes in reporting between 2000 and 2006. Results The majority of trials were two arm (379/519 (73%) in 2000 v 468/616 (76%) in 2006) parallel group studies (383/519 (74%) v 477/616 (78%)) published in specialty journals (482/519 (93%) v 555/616 (90%)). In both 2000 and 2006, a median of 80 participants were recruited per trial for parallel group trials. The proportion of articles that reported drug trials decreased between 2000 and 2006 (from 393/519 (76%) to 356/616 (58%)), whereas the proportion of surgery trials increased (51/519 (10%) v 128/616 (21%)). There was an increase between 2000 and 2006 in the proportion of trial reports that included details of the primary outcome (risk ratio (RR) 1.18, 95% CI 1.04 to 1.33), sample size calculation (RR 1.66, 95% CI 1.40 to 1.95), and the methods of random sequence generation (RR 1.62, 95% CI 1.32 to 1.97) and allocation concealment (RR 1.40, 95% CI 1.11 to 1.76). There was no difference in the proportion of trials that provided specific details on who was blinded (RR 0.91, 95% CI 0.75 to 1.10). Conclusions Reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level. Without complete

  18. Intensive Patient Education Improves Glycaemic Control in Diabetes Compared to Conventional Education: A Randomised Controlled Trial in a Nigerian Tertiary Care Hospital

    PubMed Central

    Essien, Okon; Otu, Akaninyene; Umoh, Victor; Enang, Ofem; Hicks, Joseph Paul; Walley, John

    2017-01-01

    Background Diabetes is now a global epidemic, but most cases are now in low- and middle-income countries. Diabetes self-management education (DSME) is key to enabling patients to manage their chronic condition and can reduce the occurrence of costly and devastating complications. However, there is limited evidence on the effectiveness of different DSME programmes in resource limited settings. Methods We conducted an unblinded, parallel-group, individually-randomised controlled trial at the University of Calabar Teaching Hospital (Nigeria) to evaluate whether an intensive and systematic DSME programme, using structured guidelines, improved glycaemic control compared to the existing ad hoc patient education (clinical practice was unchanged). Eligible patients (≥18 years, HbA1c > 8.5% and physically able to participate) were randomly allocated by permuted block randomisation to participate for six months in either an intensive or conventional education group. The primary outcome was HbA1c (%) at six-months. Results We randomised 59 participants to each group and obtained six-month HbA1c outcomes from 53 and 51 participants in the intensive and conventional education groups, respectively. Intensive group participants had a mean six-month HbA1c (%) of 8.4 (95% CI: 8 to 8.9), while participants in the conventional education group had a mean six-month HbA1c (%) of 10.2 (95% CI: 9.8 to 10.7). The difference was statistically (P < 0.0001) and clinically significant, with intensive group participants having HbA1c outcomes on average -1.8 (95% CI: -2.4 to -1.2) percentage points lower than conventional group participants. Results were robust to adjustment for a range of covariates and multiple imputation of missing outcome data. Conclusions This study demonstrates the effectiveness of a structured, guideline-based DSME intervention in a LMIC setting versus a pragmatic comparator. The intervention is potentially replicable at other levels of the Nigerian healthcare system

  19. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

    PubMed

    Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

    2017-10-01

    ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Intensive Patient Education Improves Glycaemic Control in Diabetes Compared to Conventional Education: A Randomised Controlled Trial in a Nigerian Tertiary Care Hospital.

    PubMed

    Essien, Okon; Otu, Akaninyene; Umoh, Victor; Enang, Ofem; Hicks, Joseph Paul; Walley, John

    2017-01-01

    Diabetes is now a global epidemic, but most cases are now in low- and middle-income countries. Diabetes self-management education (DSME) is key to enabling patients to manage their chronic condition and can reduce the occurrence of costly and devastating complications. However, there is limited evidence on the effectiveness of different DSME programmes in resource limited settings. We conducted an unblinded, parallel-group, individually-randomised controlled trial at the University of Calabar Teaching Hospital (Nigeria) to evaluate whether an intensive and systematic DSME programme, using structured guidelines, improved glycaemic control compared to the existing ad hoc patient education (clinical practice was unchanged). Eligible patients (≥18 years, HbA1c > 8.5% and physically able to participate) were randomly allocated by permuted block randomisation to participate for six months in either an intensive or conventional education group. The primary outcome was HbA1c (%) at six-months. We randomised 59 participants to each group and obtained six-month HbA1c outcomes from 53 and 51 participants in the intensive and conventional education groups, respectively. Intensive group participants had a mean six-month HbA1c (%) of 8.4 (95% CI: 8 to 8.9), while participants in the conventional education group had a mean six-month HbA1c (%) of 10.2 (95% CI: 9.8 to 10.7). The difference was statistically (P < 0.0001) and clinically significant, with intensive group participants having HbA1c outcomes on average -1.8 (95% CI: -2.4 to -1.2) percentage points lower than conventional group participants. Results were robust to adjustment for a range of covariates and multiple imputation of missing outcome data. This study demonstrates the effectiveness of a structured, guideline-based DSME intervention in a LMIC setting versus a pragmatic comparator. The intervention is potentially replicable at other levels of the Nigerian healthcare system and in other LMICs, where nurses

  1. Five-year results of a randomised controlled trial comparing mobile and fixed bearings in total knee replacement.

    PubMed

    Breeman, S; Campbell, M K; Dakin, H; Fiddian, N; Fitzpatrick, R; Grant, A; Gray, A; Johnston, L; MacLennan, G S; Morris, R W; Murray, D W

    2013-04-01

    There is conflicting evidence about the merits of mobile bearings in total knee replacement, partly because most randomised controlled trials (RCTs) have not been adequately powered. We report the results of a multicentre RCT of mobile versus fixed bearings. This was part of the knee arthroplasty trial (KAT), where 539 patients were randomly allocated to mobile or fixed bearings and analysed on an intention-to-treat basis. The primary outcome measure was the Oxford Knee Score (OKS) plus secondary measures including Short Form-12, EuroQol EQ-5D, costs, cost-effectiveness and need for further surgery. There was no significant difference between the groups pre-operatively: mean OKS was 17.18 (sd 7.60) in the mobile-bearing group and 16.49 (sd 7.40) in the fixed-bearing group. At five years mean OKS was 33.19 (sd 16.68) and 33.65 (sd 9.68), respectively. There was no significant difference between trial groups in OKS at five years (-1.12 (95% confidence interval -2.77 to 0.52) or any of the other outcome measures. Furthermore, there was no significant difference in the proportion of patients with knee-related re-operations or in total costs. In this appropriately powered RCT, over the first five years after total knee replacement functional outcomes, re-operation rates and healthcare costs appear to be the same irrespective of whether a mobile or fixed bearing is used.

  2. The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia: a randomised controlled trial.

    PubMed

    Vink, A C; Zuidersma, M; Boersma, F; de Jonge, P; Zuidema, S U; Slaets, J P J

    2013-10-01

    This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. In a randomised controlled design, residents with dementia (n = 94) were allocated to either music therapy or recreational activities. Both music therapy and general activities were offered twice weekly for 4 months. Changes in agitation were measured with a modified Cohen-Mansfield Agitation Inventory (CMAI) at four intervals on each intervention day. A mixed model analysis was used to evaluate the effectiveness of music therapy, compared with general activities, on CMAI scores at 4 h after the intervention, controlled for CMAI scores at 1 h before the session and session number. Data were analysed for 77 residents (43 randomised to music therapy and 34 to general activities). In both groups, the intervention resulted in a decrease in agitated behaviours from 1 h before to 4 h after each session. This decrease was somewhat greater in the music therapy group than in the general activities group, but this difference was statistically not significant (F = 2.885, p = 0.090) and disappeared completely after adjustment for Global Deterioration Scale stage (F = 1.500; p = 0.222). Both music therapy and recreational activities lead to a short-term decrease in agitation, but there was no additional beneficial effect of music therapy over general activities. More research is required to provide insight in the effects of music therapy in reducing agitation in demented older people. Copyright © 2012 John Wiley & Sons, Ltd.

  3. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins.

    PubMed

    Davies, Huw Ob; Popplewell, Matthew; Darvall, Katy; Bate, Gareth; Bradbury, Andrew W

    2016-05-01

    The last 10 years have seen the introduction into everyday clinical practice of a wide range of novel non-surgical treatments for varicose veins. In July 2013, the UK National Institute for Health and Care Excellence recommended the following treatment hierarchy for varicose veins: endothermal ablation, ultrasound-guided foam sclerotherapy, surgery and compression hosiery. The aim of this paper is to review the randomised controlled trials that have compared endothermal ablation and ultrasound-guided foam sclerotherapy to determine if the level 1 evidence base still supports an "endothermal ablation first" strategy for the treatment of varicose veins. A PubMed and OVID literature search (until 31 January 2015) was performed and randomised controlled trials comparing endothermal ablation and ultrasound-guided foam sclerotherapy were obtained. Although anatomical success appeared higher with endothermal ablation than ultrasound-guided foam sclerotherapy, clinical success and patient-reported outcomes measures were similar. Morbidity and complication rates were very low and not significantly different between endothermal ablation and ultrasound-guided foam sclerotherapy. Ultrasound-guided foam sclerotherapy was consistently less expensive that endothermal ablation. All endovenous modalities appear to be successful and have a role in modern day practice. Although further work is required to optimise ultrasound-guided foam sclerotherapy technique to maximise anatomical success and minimise retreatment, the present level 1 evidence base shows there is no significant difference in clinical important outcomes between ultrasound-guided foam sclerotherapy and endothermal ablation. As ultrasound-guided foam sclerotherapy is less expensive, it is likely to be a more cost-effective option in most patients in most healthcare settings. Strict adherence to the treatment hierarchy recommended by National Institute for Health and Care Excellence seems unjustified. © The Author

  4. Intra-Operative Fluid Management in Adult Neurosurgical Patients Undergoing Intracranial Tumour Surgery: Randomised Control Trial Comparing Pulse Pressure Variance (PPV) and Central Venous Pressure (CVP)

    PubMed Central

    Salins, Serina Ruth; Kumar, Amar Nandha; Korula, Grace

    2016-01-01

    Introduction Fluid management in neurosurgery presents specific challenges to the anaesthesiologist. Dynamic para-meters like Pulse Pressure Variation (PPV) have been used successfully to guide fluid management. Aim To compare PPV against Central Venous Pressure (CVP) in neurosurgical patients to assess hemodynamic stability and perfusion status. Materials and Methods This was a single centre prospective randomised control trial at a tertiary care centre. A total of 60 patients undergoing intracranial tumour excision in supine and lateral positions were randomised to two groups (Group 1, CVP n=30), (Group 2, PPV n=30). Intra-operative fluid management was titrated to maintain baseline CVP in Group 1(5-10cm of water) and in Group 2 fluids were given to maintain PPV less than 13%. Acid base status, vital signs and blood loss were monitored. Results Although intra-operative hypotension and acid base changes were comparable between the groups, the patients in the CVP group had more episodes of hypotension requiring fluid boluses in the first 24 hours post surgery. {CVP group median (25, 75) 2400ml (1850, 3110) versus PPV group 2100ml (1350, 2200) p=0.03} The patients in the PPV group received more fluids than the CVP group which was clinically significant. {2250 ml (1500, 3000) versus 1500ml (1200, 2000) median (25, 75) (p=0.002)}. The blood loss was not significantly different between the groups The median blood loss in the CVP group was 600ml and in the PPV group was 850 ml; p value 0.09. Conclusion PPV can be used as a reliable index to guide fluid management in neurosurgical patients undergoing tumour excision surgery in supine and lateral positions and can effectively augment CVP as a guide to fluid management. Patients in PPV group had better hemodynamic stability and less post operative fluid requirement. PMID:27437329

  5. Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis

    PubMed Central

    Freeman, Daniel; Dunn, Graham; Startup, Helen; Pugh, Katherine; Cordwell, Jacinta; Mander, Helen; Černis, Emma; Wingham, Gail; Shirvell, Katherine; Kingdon, David

    2015-01-01

    Summary Background Worry might be a contributory causal factor in the occurrence of persecutory delusions in patients with psychotic disorders. Therefore we postulated that reducing worry with cognitive behaviour therapy (CBT) would reduce persecutory delusions. Methods For our two-arm, assessor-blinded, randomised controlled trial (Worry Intervention Trial [WIT]), we recruited patients aged 18–65 years with persistent persecutory delusions but non-affective psychosis from two centres: the Oxford Health National Health Service (NHS) Foundation Trust (Oxford, UK) and the Southern Health NHS Foundation Trust (Southampton, UK). The key inclusion criteria for participants were a score of at least 3 on the Psychotic Symptoms Rating Scale (PSYRATS) denoting a current persecutory delusion; that the delusion had persisted for at least 3 months; a clinical diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder; and a clinically significant level of worry. We randomly assigned (1:1) eligible patients, using a randomly permuted block procedure with variable block sizes and division by four strata, to either six sessions of worry-reduction CBT intervention done over 8 weeks added to standard care (the CBT-intervention group), or to standard care alone (the control group). The assessors were masked to patient allocations and did their assessments at week 0 (baseline), 8 weeks (end of treatment), and 24 weeks, follow-up. The primary outcomes were worry measured by the Penn State Worry Questionnaire (PSWQ) and delusions measured by the PSYRATS-delusion scale; we did the analyses in the intention-to-treat population, and also did a planned mediation analysis. This trial is registered with the ISRCTN Registry (number ISRCTN23197625) and is closed to new participants. Findings From Nov 1, 2011, to Sept 9, 2013, we recruited 150 eligible participants and randomly assigned 73 to the CBT intervention group, and 77 to the control group. 143 patients (95

  6. Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

    PubMed Central

    Metcalfe, Chris; Avery, Kerry; Berrisford, Richard; Barham, Paul; Noble, Sian M; Fernandez, Aida Moure; Hanna, George; Goldin, Robert; Elliott, Jackie; Wheatley, Timothy; Sanders, Grant; Hollowood, Andrew; Falk, Stephen; Titcomb, Dan; Streets, Christopher; Donovan, Jenny L; Blazeby, Jane M

    2016-01-01

    BACKGROUND Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. OBJECTIVES The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. DESIGN Pilot parallel three-arm randomised controlled trial nested within feasibility work. SETTING Two UK NHS departments of upper gastrointestinal surgery. PARTICIPANTS Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. INTERVENTIONS Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. MAIN OUTCOME MEASURE The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. RESULTS During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the

  7. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial.

    PubMed

    Kallesøe, Karen Hansen; Schröder, Andreas; Wicksell, Rikard K; Fink, Per; Ørnbøl, Eva; Rask, Charlotte Ulrikka

    2016-09-15

    Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). A total of 120 adolescents aged 15-19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS. NCT02346071; Pre-results. Published by the BMJ

  8. Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial

    PubMed Central

    Navani, Neal; Nankivell, Matthew; Lawrence, David R; Lock, Sara; Makker, Himender; Baldwin, David R; Stephens, Richard J; Parmar, Mahesh K; Spiro, Stephen G; Morris, Stephen; Janes, Sam M

    2015-01-01

    Summary Background The diagnosis and staging of lung cancer is an important process that identifies treatment options and guides disease prognosis. We aimed to assess endobronchial ultrasound-guided transbronchial needle aspiration as an initial investigation technique for patients with suspected lung cancer. Methods In this open-label, multicentre, pragmatic, randomised controlled trial, we recruited patients who had undergone a CT scan and had suspected stage I to IIIA lung cancer, from six UK centres and randomly assigned them to either endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) or conventional diagnosis and staging (CDS), for further investigation and staging. If a target node could not be accessed by EBUS-TBNA, then endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) was allowed as an alternative procedure. Randomisation was stratified according to the presence of mediastinal lymph nodes measuring 1 cm or more in the short axis and by recruiting centre. We used a telephone randomisation method with permuted blocks of four generated by a computer. Because of the nature of the intervention, masking of participants and consenting investigators was not possible. The primary endpoint was the time-to-treatment decision after completion of the diagnostic and staging investigations and analysis was by intention-to-diagnose. This trial is registered with ClinicalTrials.gov, number NCT00652769. Findings Between June 10, 2008, and July 4, 2011, we randomly allocated 133 patients to treatment: 66 to EBUS-TBNA and 67 to CDS (one later withdrew consent). Two patients from the EBUS-TBNA group underwent EUS-FNA. The median time to treatment decision was shorter with EBUS-TBNA (14 days; 95% CI 14–15) than with CDS (29 days; 23–35) resulting in a hazard ratio of 1·98, (1·39–2·82, p<0·0001). One patient in each group had a pneumothorax from a CT-guided biopsy sample; the patient from the CDS group needed intercostal drainage

  9. Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders

    PubMed Central

    2011-01-01

    Background Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups. Methods/Design A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to

  10. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only

    PubMed Central

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-01-01

    Background Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Methods Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score <9 (original definition), or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 (modified definition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. Results 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), p<0.01, Number needed to treat =6. 338 patients met the modified definition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. Conclusions This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care (original definition only). Confirmatory studies which also address non-compliance issues are needed. Trial registration number NCT00112398. PMID:25795741

  11. Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders.

    PubMed

    Hahne, Andrew J; Ford, Jon J; Surkitt, Luke D; Richards, Matthew C; Chan, Alexander Y P; Thompson, Sarah L; Hinman, Rana S; Taylor, Nicholas F

    2011-05-20

    Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups. A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to intention to treat principles

  12. IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases

    PubMed Central

    Galimberti, Viviana; Cole, Bernard F.; Zurrida, Stefano; Viale, Giuseppe; Luini, Alberto; Veronesi, Paolo; Baratella, Paola; Chifu, Camelia; Sargenti, Manuela; Intra, Mattia; Gentilini, Oreste; Mastropasqua, Mauro G.; Mazzarol, Giovanni; Massarut, Samuele; Garbay, Jean-Remi; Zgajnar, Janez; Galatius, Hanne; Recalcati, Angelo; Littlejohn, David; Bamert, Monika; Colleoni, Marco; Price, Karen N.; Regan, Meredith M.; Goldhirsch, Aron; Coates, Alan S.; Gelber, Richard D.; Veronesi, Umberto

    2014-01-01

    Background For breast cancer patients with a metastatic sentinel node (SN), axillary dissection (AD) has been standard treatment. However, for patients with minimal SN involvement, AD may be overtreatment. IBCSG Trial 23-01 was designed to determine whether no AD is non-inferior to AD in patients with one or more micrometastatic (≤2 mm) SNs and tumour ≤5 cm. Methods In this multicentre trial patients were randomised to AD or no AD. Eligibility was limited to patients with clinically-palpable axillary lymph node(s) and a primary tumour ≤ 5 cm who, after sentinel node biopsy, had one or more micrometastatic (≤ 2 mm) sentinel lymphs nodes with no extracapsular extension. The primary endpoint was disease-free survival (DFS). Non-inferiority was defined as a hazard ratio of <1·25 for no AD vs. AD. The analysis was intention to treat. Patients were randomly allocated in a 1:1 ratio to AD or no AD with stratification by centre and menopausal status. There was no attempt to blind the treatment assignment. The trial is registered with ClinicalTrials.gov, NCT00072293. Per protocol, disease and survival information continues to be collected yearly. Findings From 2001 to 2010, 934 patients were randomised; 931 were evaluable (464 in the AD group and 467 in the no AD group). After a median follow-up of 5·0 (IQR 3.6–7.3) years, there were 124 DFS events, including breast-cancer-related events in 95 patients (local, 18; contralateral breast, 12; regional, 6; and distant, 59), and other events in 29 (second malignancy, 26; death without prior cancer event, 3). Five-year DFS was 87·8% (95% CI 84·4%–91·2%) in the no AD group and 84·4% (95% CI 80·7%–88·1%) in the AD group (log-rank p=0·16) (HR no AD vs. AD=0·78, 95% CI 0·55–1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3–4) included 1 sensory neuropathy (grade 3), 3 lymphedema (2 grade 3 and 1 grade 4), and 3 motor neuropathy (grade 3), all in the AD group, and

  13. Surgical Trial In Traumatic intraCerebral Haemorrhage (STITCH): a randomised controlled trial of Early Surgery compared with Initial Conservative Treatment.

    PubMed Central

    Gregson, Barbara A; Rowan, Elise N; Francis, Richard; McNamee, Paul; Boyers, Dwayne; Mitchell, Patrick; McColl, Elaine; Chambers, Iain R; Unterberg, Andreas; Mendelow, A David

    2015-01-01

    BACKGROUND While it is accepted practice to remove extradural (EDH) and subdural haematomas (SDH) following traumatic brain injury, the role of surgery in parenchymal traumatic intracerebral haemorrhage (TICH) is controversial. There is no evidence to support Early Surgery in this condition. OBJECTIVES There have been a number of trials investigating surgery for spontaneous intracerebral haemorrhage but none for TICH. This study aimed to establish whether or not a policy of Early Surgery for TICH improves outcome compared with a policy of Initial Conservative Treatment. DESIGN This was an international multicentre pragmatic parallel group trial. Patients were randomised via an independent telephone/web-based randomisation service. SETTING Neurosurgical units in 59 hospitals in 20 countries registered to take part in the study. PARTICIPANTS The study planned to recruit 840 adult patients. Patients had to be within 48 hours of head injury with no more than two intracerebral haematomas greater than 10 ml. They did not have a SDH or EDH that required evacuation or any severe comorbidity that would mean they could not achieve a favourable outcome if they made a complete recovery from their head injury. INTERVENTIONS Patients were randomised to Early Surgery within 12 hours or to Initial Conservative Treatment with delayed evacuation if it became clinically appropriate. MAIN OUTCOME MEASURES The Extended Glasgow Outcome Scale (GOSE) was measured at 6 months via a postal questionnaire. The primary outcome was the traditional dichotomised split into favourable outcome (good recovery or moderate disability) and unfavourable outcome (severe disability, vegetative, dead). Secondary outcomes included mortality and an ordinal assessment of Glasgow Outcome Scale and Rankin Scale. RESULTS Patient recruitment began in December 2009 but was halted by the funding body because of low UK recruitment in September 2012. In total, 170 patients were randomised from 31 centres in 13

  14. A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin compared with standard therapy for the treatment of transverse myelitis in adults and children (STRIVE).

    PubMed

    Absoud, Michael; Brex, Peter; Ciccarelli, Olga; Diribe, Onyinye; Giovannoni, Gavin; Hellier, Jennifer; Howe, Rosemary; Holland, Rachel; Kelly, Joanna; McCrone, Paul; Murphy, Caroline; Palace, Jackie; Pickles, Andrew; Pike, Michael; Robertson, Neil; Jacob, Anu; Lim, Ming

    2017-05-01

    Transverse myelitis (TM) is an immune-mediated disorder of the spinal cord that affects adults and children and that causes motor, sensory and autonomic dysfunction. There is a prolonged recovery phase, which may continue for many years. Neuromyelitis optica (NMO) is an uncommon relapsing inflammatory central nervous system condition in which TM can be the first presenting symptom. As TM and NMO affect many patients in the prime of their working life, the disorder can impose a significant demand on health resources. There are currently no robust controlled trials in children or adults to inform the optimal treatment of TM. However, treatment with intravenous immunoglobulin (IVIG) is being effectively used in the management of a range of neurological conditions. Although other interventions such as plasma exchange (PLEX) in addition to intravenous (IV) methylprednisolone therapy can be beneficial in TM, PLEX is costly and technically challenging to deliver in the acute setting. IVIG is more readily accessible and less costly. To evaluate whether additional and early treatment with IVIG is of extra benefit in TM compared with standard therapy with IV steroids. A multicentre, single-blind, parallel-group randomised controlled trial of IVIG compared with standard therapy for the treatment of TM in adults and children. Patients aged ≥ 1 year diagnosed with either acute first-onset TM or first presentation of NMO. Target recruitment was 170 participants (85 participants per arm). Participants were randomised 1 : 1 to treatment with IV methylprednisolone only or treatment with IV methylprednisolone plus 2 g/kg of IVIG in divided doses within 5 days of the first commencement of steroid therapy. Primary outcome measure - American Spinal Injury Association (ASIA) Impairment Scale at 6 months post randomisation, with a good outcome defined by a two-grade change. Secondary and tertiary outcome measures - ASIA motor and sensory scales, Expanded Disability Status Scale

  15. Superior results with eccentric compared to concentric quadriceps training in patients with jumper's knee: a prospective randomised study

    PubMed Central

    Jonsson, P; Alfredson, H

    2005-01-01

    Background: A recent study reported promising clinical results using eccentric quadriceps training on a decline board to treat jumper's knee (patellar tendinosis). Methods: In this prospective study, athletes (mean age 25 years) with jumper's knee were randomised to treatment with either painful eccentric or painful concentric quadriceps training on a decline board. Fifteen exercises were repeated three times, twice daily, 7 days/week, for 12 weeks. All patients ceased sporting activities for the first 6 weeks. Age, height, weight, and duration of symptoms were similar between groups. Visual analogue scales (VAS; patient estimation of pain during exercise) and Victorian Institute of Sport Assessment (VISA) scores, before and after treatment, and patient satisfaction, were used for evaluation. Results: In the eccentric group, for 9/10 tendons patients were satisfied with treatment, VAS decreased from 73 to 23 (p<0.005), and VISA score increased from 41 to 83 (p<0.005). In the concentric group, for 9/9 tendons patients were not satisfied, and there were no significant differences in VAS (from 74 to 68, p<0.34) and VISA score (from 41 to 37, p<0.34). At follow up (mean 32.6 months), patients in the eccentric group were still satisfied and sports active, but all patients in the concentric group had been treated surgically or by sclerosing injections. Conclusions: In conclusion, eccentric, but not concentric, quadriceps training on a decline board, seems to reduce pain in jumper's knee. The study aimed to include 20 patients in each group, but was stopped at the half time control because of poor results achieved in the concentric group. PMID:16244196

  16. A randomised controlled trial comparing two methods of teaching medical students trauma and orthopaedics: traditional lectures versus the "donut round".

    PubMed

    Bulstrode, C; Gallagher, F A; Pilling, E L; Furniss, D; Proctor, R D

    2003-04-01

    To assess whether a new form of teaching, the 'donut round', is as good at imparting factual knowledge as interactive lectures in both the short-term and the long-term. Randomised controlled trial. University of Oxford Medical School. 106 fifth year clinical medical students taught half of their A&E/trauma course by donut round and half by lecture. The results of multiple choice questions (MCQs) divided according to how the material was taught. Three MCQ papers were set: one at the end of a four-week course, one approximately 10 weeks later and a final exam approximately 17 months after the first. At the first MCQ, the average result for questions taught by donut round was 41.0 (out of 50) and for those taught by conventional lecture was 40.1. At 10 weeks these averages fell to 36.3 and 37.3 and at 17 months they were 38.7 and 38.1, respectively. None of these pairs were significantly different. Ratios were calculated for each candidate by dividing their donut round score by their lecture score. The average ratios for the first, second and third MCQ papers were: 1.029, 1.007 and 1.027, respectively, and were not significantly different. The individual ratios of all candidates in all three MCQs were plotted against their equivalent total mark. The calculated linear regression showed a statistically significant advantage of donut rounds over lectures in those candidates who scored a total mark less than 89 (n=260, p=0.02). Donut rounds are at least as good as lectures in imparting factual knowledge and may provide a selective advantage to weaker students.

  17. Argentine tango dance compared to mindfulness meditation and a waiting-list control: a randomised trial for treating depression.

    PubMed

    Pinniger, Rosa; Brown, Rhonda F; Thorsteinsson, Einar B; McKinley, Patricia

    2012-12-01

    To determine whether tango dancing is as effective as mindfulness meditation in reducing symptoms of psychological stress, anxiety and depression, and in promoting well-being. This study employed analysis of covariance (ANCOVA) and multiple regression analysis. Ninety-seven people with self-declared depression were randomised into tango dance or mindfulness meditation classes, or to control/waiting-list. classes were conducted in a venue suitable for both activities in the metropolitan area of Sydney, Australia. Participants completed six-week programmes (1½h/week of tango or meditation). The outcome measures were assessed at pre-test and post-test. Depression, Anxiety and Stress Scale; The Self Esteem Scale; Satisfaction with Life Scale, and Mindful Attention Awareness Scale. Sixty-six participants completed the program and were included in the statistical analysis. Depression levels were significantly reduced in the tango (effect size d=0.50, p=.010), and meditation groups (effect size d=0.54, p=.025), relative to waiting-list controls. Stress levels were significantly reduced only in the tango group (effect size d=0.45, p=.022). Attending tango classes was a significant predictor for the increased levels of mindfulness R(2)=.10, adjusted R(2)=.07, F (2,59)=3.42, p=.039. Mindfulness-meditation and tango dance could be effective complementary adjuncts for the treatment of depression and/or inclusion in stress management programmes. Subsequent trials are called to explore the therapeutic mechanisms involved. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  18. Risk factors for low vision related functioning in the Mycotic Ulcer Treatment Trial: a randomised trial comparing natamycin with voriconazole.

    PubMed

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; Porco, Travis C; McLeod, Stephen D; Acharya, Nisha R; Keenan, Jeremy D; Lietman, Thomas M

    2016-07-01

    The Mycotic Ulcer Treatment Trial I (MUTT I) was a double-masked, multicentre, randomised controlled trial, which found that topical natamycin is superior to voriconazole for the treatment of filamentous fungal corneal ulcers. In this study, we determine risk factors for low vision-related quality of life in patients with fungal keratitis. The Indian visual function questionnaire (IND-VFQ) was administered to MUTT I study participants at 3 months. Associations between patient and ulcer characteristics and IND-VFQ subscale score were assessed using generalised estimating equations. 323 patients were enrolled in the trial, and 292 (90.4%) completed the IND-VFQ at 3 months. Out of a total possible score of 100, the average VFQ score for all participants was 81.3 (range 0-100, SD 23.6). After correcting for treatment arm, each logMAR line of worse baseline visual acuity in the affected eye resulted in an average 1.2 points decrease on VFQ at 3 months (95% CI -1.8 to 0.6, p<0.001). Those who required therapeutic penetrating keratoplasty had an average of 25.2 points decrease on VFQ after correcting for treatment arm (95% CI -31.8 to -18.5, p<0.001). Study participants who were unemployed had on average 28.5 points decrease on VFQ (95% CI -46.9 to -10.2, p=0.002) after correcting for treatment arm. Monocular vision loss from corneal opacity due to fungal keratitis reduced vision-related quality of life. Given the relatively high worldwide burden of corneal opacity, improving treatment outcomes of corneal infections should be a public health priority. Clinicaltrials.gov Identifier: NCT00996736. 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/.

  19. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial

    PubMed Central

    Fairbank, Jeremy; Frost, Helen; Wilson-MacDonald, James; Yu, Ly-Mee; Barker, Karen; Collins, Rory

    2005-01-01

    Objectives To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain. Design Multicentre randomised controlled trial. Setting 15 secondary care orthopaedic and rehabilitation centres across the United Kingdom. Participants 349 participants aged 18-55 with chronic low back pain of at least one year's duration who were considered candidates for spinal fusion. Intervention Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy. Main outcome measure The primary outcomes were the Oswestry disability index and the shuttle walking test measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure. Results 176 participants were assigned to surgery and 173 to rehabilitation. 284 (81%) provided follow-up data at 24 months. The mean Oswestry disability index changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group. The estimated mean difference between the groups was –4.1 (95% confidence interval –8.1 to –0.1, P = 0.045) in favour of surgery. No significant differences between the treatment groups were observed in the shuttle walking test or any of the other outcome measures. Conclusions Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation. PMID:15911537

  20. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial

    PubMed Central

    Castien, René F; van der Windt, Daniëlle AWM; Dekker, Joost; Mutsaers, Bert; Grooten, Anneke

    2009-01-01

    Background Patients with Chronic Tension Type Headache (CTTH) report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being) and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles. We present the design of a randomised clinical trial (RCT) evaluating the effectiveness of manual therapy (MT) compared to usual care by the general practitioner (GP) in patients with CTTH. Methods and design Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS). Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques), exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks. Discussion This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible. The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache. PMID:19216763

  1. A randomised trial comparing combination chemotherapy using mitomycin C, mitozantrone and methotrexate (3M) with vincristine, anthracycline and cyclophosphamide (VAC) in advanced breast cancer.

    PubMed Central

    Powles, T. J.; Jones, A. L.; Judson, I. R.; Hardy, J. R.; Ashley, S. E.

    1991-01-01

    This paper describes a randomised clinical trial in patients with advanced breast cancer, comparing the regimen 3M, mitomycin C 7-8 mg m-2 (day 1), mitozantrone 7-8 mg m-2 (day 1 and 21), methotrexate 35 mg m-2 (day 1 and 21) given on a 42 day cycle with a standard anthracycline containing regimen, VAC, vincristine 1.4 mg m-2 (day 1), anthracycline (adriamycin or epirubicin) 30 mg m-2 (day 1), cyclophosphamide 400 mg m-2 (day 1) given on a 21 day cycle. Of a total of 217 patients, 107 were randomised to 3M and 110 to VAC and a mean of 5.5 courses was given per patient. The overall response rate (complete and partial) was 53% (95% Confidence Limits (CL): 43-62%) for 3M and 49% (CL; 39-58%) for VAC. The response according to sites of metastases was the same for both treatment groups. Symptomatic toxicity including alopecia, neuropathy, vomiting (P less than 0.001) and nausea (P less than 0.01) were significantly less for 3M. Myelosuppression including leucopenia (P less than 0.001) and thrombocytopenia (P less than 0.001) was significantly greater with 3M at day 21, although there was no difference in nadir counts in patients at special risk of myelosuppression and there was no evidence of an increase in infective or bleeding complications. There was no significant difference in the duration of response to 3M (10 months, CL 6-15) and VAC (11 months, CL 7-12), nor in survival (3M, 8 months, CL 6-12; VAC, 10 months, CL 8-12). These results indicate that 3M is as effective as, but has significantly less symptomatic toxicity than, an anthracycline containing regimen for the treatment of advanced breast cancer. PMID:1892775

  2. The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

    PubMed

    Thompson, E A; Shaw, A; Nichol, J; Hollinghurst, S; Henderson, A J; Thompson, T; Sharp, D

    2011-07-01

    To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  3. Early multimodal rehabilitation following lumbar disc surgery: a randomised clinical trial comparing the effects of two exercise programmes on clinical outcome and lumbar multifidus muscle function.

    PubMed

    Hebert, Jeffrey J; Fritz, Julie M; Thackeray, Anne; Koppenhaver, Shane L; Teyhen, Deydre

    2015-01-01

    The optimal components of postoperative exercise programmes following single-level lumbar discectomy have not been identified. Facilitating lumbar multifidus (LM) function after discectomy may improve postoperative recovery. The aim of this study was to compare the clinical and muscle function outcomes of patients randomised to receive early multimodal rehabilitation following lumbar discectomy consisting of exercises targeting specific trunk muscles including the LM or general trunk exercises. We included participants aged 18 to 60 years who were scheduled to undergo single-level lumbar discectomy. After two postoperative weeks, participants were randomly assigned to receive an 8-week multimodal exercise programme including either general or specific trunk exercises. The primary outcome was pain-related disability (Oswestry Index). Secondary outcomes included low back and leg pain intensity (0-10 numeric pain rating scale), global change, sciatica frequency, sciatica bothersomeness and LM function measured with real-time ultrasound imaging. Treatment effects 10 weeks and 6 months after surgery were estimated with linear mixed models. 61 participants were randomised to receive a general trunk (n=32) or specific (n=29) exercise programme. There were no between-group differences in clinical or muscle function outcomes. Participants in both groups experienced improvements in most outcome measures. Following lumbar discectomy, multimodal rehabilitation programmes comprising specific or general trunk exercises have similar effects on clinical and muscle function outcomes. Local factors such as the individual patient characteristics identified by specific assessment findings, clinician expertise and patient preferences should direct therapy selection when considering the types of exercises tested in this trial for inclusion in rehabilitation programmes following lumbar disc surgery. Published by the BMJ Publishing Group Limited. For permission to use (where not

  4. Computer-mediated instructional video: a randomised controlled trial comparing a sequential and a segmented instructional video in surgical hand wash.

    PubMed

    Schittek Janda, M; Tani Botticelli, A; Mattheos, N; Nebel, D; Wagner, A; Nattestad, A; Attström, R

    2005-05-01

    Video-based instructions for clinical procedures have been used frequently during the preceding decades. To investigate in a randomised controlled trial the learning effectiveness of fragmented videos vs. the complete sequential video and to analyse the attitudes of the user towards video as a learning aid. An instructional video on surgical hand wash was produced. The video was available in two different forms in two separate web pages: one as a sequential video and one fragmented into eight short clips. Twenty-eight dental students in the second semester were randomised into an experimental (n = 15) and a control group (n = 13). The experimental group used the fragmented form of the video and the control group watched the complete one. The use of the videos was logged and the students were video taped whilst undertaking a test hand wash. The videos were analysed systematically and blindly by two independent clinicians. The students also performed a written test concerning learning outcome from the videos as well as they answered an attitude questionnaire. The students in the experimental group watched the video significantly longer than the control group. There were no significant differences between the groups with regard to the ratings and scores when performing the hand wash. The experimental group had significantly better results in the written test compared with those of the control group. There was no significant difference between the groups with regard to attitudes towards the use of video for learning, as measured by the Visual Analogue Scales. Most students in both groups expressed satisfaction with the use of video for learning. The students demonstrated positive attitudes and acceptable learning outcome from viewing CAL videos as a part of their pre-clinical training. Videos that are part of computer-based learning settings would ideally be presented to the students both as a segmented and as a whole video to give the students the option to choose the

  5. Preventing vitamin B12 deficiency in South Asian women of childbearing age: a randomised controlled trial comparing an oral vitamin B12 supplement with B12 dietary advice.

    PubMed

    Mearns, G J; Koziol-McLain, J; Obolonkin, V; Rush, E C

    2014-08-01

    To examine the effectiveness, acceptability and sustainability of interventions to reduce vitamin B12 (B12) deficiency in South Asian women before conception. A 6-month randomised controlled trial conducted in Auckland, New Zealand. Participants (62 South Asian women, 18-50 years old) were stratified by dietary practices, then randomised to three treatment groups: B12 Supplement (oral cyanocobalamin 6 μg/day) (n=21), Placebo (n=21), or B12 Dietary Advice (n=20). Primary outcome measures were changes in B12 biomarkers (serum B12 and holotranscobalamin (holoTC)) at 6 months. Dietary B12 intake was estimated from a B12 food-specific frequency questionnaire (B12FFQ). Intention-to-treat analysis was applied using 'last observation carried forward' method. Changes in B12 biomarkers by treatment were compared using analysis of variance. Pearson's correlations tested relationships between dietary B12 intake and B12 biomarkers. At baseline, 48% of women tested as insufficient or deficient in serum B12 (<222 pmol/l) and 51% as insufficient or deficient in holoTC (<45 pmol/l). B12 status was moderately correlated with dietary B12 intake (r=0.5, 95% confidence interval (CI) (0.3-0.7)) and 44% of women reported insufficient dietary intake (<2.4 μg/day). B12 Supplement was the only treatment group to record a significant increase in B12 biomarkers over 6 months: serum B12 by 30% (95% CI (11-48%)) and holoTC by 42% (12-72%). The prevalence of B12 insufficiency among Auckland South Asian women is high and moderately correlated with inadequate intake of foods that contain B12. Cyanocobalamin supplementation (6 μg/day) was associated with improved B12 biomarkers, with a potential to improve preconception B12 status in South Asian women.

  6. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers

    PubMed Central

    Zelen, Charles M; Serena, Thomas E; Snyder, Robert J

    2014-01-01

    The aim of this study is to determine if weekly application of dehydrated human amnion/chorion membrane allograft reduce time to heal more effectively than biweekly application for treatment of diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers of ≥ 4 weeks duration were included for the study. They were randomised to receive weekly or biweekly application of allograft in addition to a non-adherent, moist dressing with compressive wrapping. All wounds were offloaded. The primary study outcome was mean time to healing. Overall, during the 12-week study period, 92·5% (37/40) ulcers completely healed. Mean time to complete healing was 4·1 ± 2·9 versus 2·4 ± 1·8 weeks (P = 0·039) in the biweekly versus weekly groups, respectively. Complete healing occurred in 50% versus 90% by 4 weeks in the biweekly and weekly groups, respectively (P = 0·014). Number of grafts applied to healed wounds was similar at 2·4 ± 1·5 and 2·3 ± 1·8 for biweekly versus weekly groups, respectively (P = 0·841). These results validate previous studies showing that the allograft is an effective treatment for diabetic ulcers and show that wounds treated with weekly application heal more rapidly than with biweekly application. More rapid healing may decrease clinical operational costs and prevent long-term medical complications. PMID:24618401

  7. Randomised controlled trial comparing early home biofeedback physiotherapy with pelvic floor exercises for the treatment of third-degree tears (EBAPT Trial).

    PubMed

    Peirce, C; Murphy, C; Fitzpatrick, M; Cassidy, M; Daly, L; O'Connell, P R; O'Herlihy, C

    2013-09-01

    To compare early home biofeedback physiotherapy with pelvic floor exercises (PFEs) for the initial management of women sustaining a primary third-degree tear. Single centre, randomised trial. National Maternity Hospital, Dublin, Ireland. A total of 120 women sustaining a primary third-degree tear. Women were randomised in a one to three ratio: 30 to early postpartum home biofeedback physiotherapy and 90 to PFEs. Differences in anorectal manometry results, Cleveland Clinic continence scores and Rockwood faecal incontinence quality of life scale scores after 3 months of postpartum treatment. The mean anal resting pressure was 39 ± 13 mmHg in the early biofeedback physiotherapy group and 43 ± 17 mmHg in the PFE group. The mean anal squeeze pressure was 64 ± 17 mmHg in the biofeedback group and 62 ± 23 mmHg in the PFE group. There was no significant difference in anal resting and squeeze pressure values between the groups (P = 0.123 and P = 0.68, respectively). There were no differences in symptom score and quality of life measurements between the groups. This study demonstrates no added value in using early home biofeedback physiotherapy in the management of women sustaining third-degree tears. Poor compliance may have contributed because women found it difficult to designate time to using biofeedback. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

  8. Meta-analysis of randomised trials comparing a penicillin or cephalosporin with a macrolide or lincosamide in the treatment of cellulitis or erysipelas.

    PubMed

    Ferreira, Athena; Bolland, Mark J; Thomas, Mark G

    2016-10-01

    Beta-lactam antibiotics, such as penicillin, flucloxacillin or cephalexin, are widely considered first-line treatment for cellulitis and erysipelas, while macrolides and lincosamides, such as erythromycin, azithromycin or clindamycin, are widely considered second-line agents. We attempted to determine whether outcomes differed between patients treated either with a beta-lactam or with a macrolide or lincosamide. We conducted a meta-analysis of published trials in which patients with cellulitis or erysipelas were randomised to treatment either with a beta-lactam or with a macrolide or lincosamide. We searched PUBMED, EMBASE, MEDLINE and SCOPUS (up to March 2014) using the terms: cellulitis/erysipelas, penicillin/beta-lactam, macrolide/lincosamide, random*/controlled*/trial* as keywords. We included randomised trials that compared monotherapy with a beta-lactam with monotherapy with a macrolide or lincosamide for cellulitis or erysipelas. We identified 15 studies, 9 in patients with cellulitis or erysipelas and 6 in patients with various skin and soft tissue infections including cellulitis and erysipelas. The efficacy of treatment of cellulitis or erysipelas was similar with a beta-lactam [27/221 (12 %) not cured] and a macrolide or lincosamide [21/241 (9 %) not cured, RR 1.24, 95 % CI 0.72-2.41, p = 0.44]. Treatment efficacy was also similar for skin or soft tissue infections including cellulitis and erysipelas (RR 1.28, 95 % CI 0.96-1.69, p = 0.09). Risk of adverse effects was similar for beta-lactams [148/1295 (11 %) not cured] and macrolides or lincosamides [228/1737 (13 %) not cured, RR 0.86, 95 % CI 0.64-1.16, p = 0.31]. Treatment with a macrolide or lincosamide for cellulitis or erysipelas has a similar efficacy and incidence of adverse effects as treatment with a beta-lactam.

  9. The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol.

    PubMed

    Chesterton, Linda S; Dziedzic, Krysia S; van der Windt, Danielle A; Davenport, Graham; Myers, Helen L; Rathod, Trishna; Blagojevic-Bucknall, Milica; Jowet, Sue M; Burton, Claire; Roddy, Edward; Hay, Elaine M

    2016-10-06

    Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints. Secondary objectives are to determine specified comparative clinical outcomes and cost effectiveness of corticosteroid injection over 6 and 24 months. A multicentre, randomised, parallel group, clinical pragmatic trial will recruit 240 adults aged ≥18 years with mild to moderate CTS from GP Practices and Primary-Secondary Care Musculoskeletal Interface Clinics. Diagnosis will be by standardised clinical assessment. Participants will be randomised on an equal basis to receive either one injection of 20 mg Depo-Medrone or a night splint to be worn for 6 weeks. The primary outcome is the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. Secondary outcomes are the BCTQ symptom severity and function status subscales, symptom intensity, interrupted sleep, adherence to splinting, perceived benefit and satisfaction with treatment, work absence and reduction in work performance, EQ-5D-5L, referral to surgery and health utilisation costs. Participants will be assessed at baseline and followed up at 6 weeks, 6, 12 and 24 months. The primary analysis will use an intention to treat (ITT) approach and multiple imputation for missing data. The sample size was calculated to detect a 15 % greater improvement in the BTCQ overall score in the injection group compared to night-splinting at approximately 90 % power, 5 % two-tailed significance and allows for 15 % loss to follow-up. The trial makes an important

  10. Indoor Residual Spraying in Combination with Insecticide-Treated Nets Compared to Insecticide-Treated Nets Alone for Protection against Malaria: A Cluster Randomised Trial in Tanzania

    PubMed Central

    West, Philippa A.; Protopopoff, Natacha; Wright, Alexandra; Kivaju, Zuhura; Tigererwa, Robinson; Mosha, Franklin W.; Kisinza, William; Rowland, Mark; Kleinschmidt, Immo

    2014-01-01

    Background Insecticide-treated nets (ITNs) and indoor residual spraying (IRS) of houses provide effective malaria transmission control. There is conflicting evidence about whether it is more beneficial to provide both interventions in combination. A cluster randomised controlled trial was conducted to investigate whether the combination provides added protection compared to ITNs alone. Methods and Findings In northwest Tanzania, 50 clusters (village areas) were randomly allocated to ITNs only or ITNs and IRS. Dwellings in the ITN+IRS arm were sprayed with two rounds of bendiocarb in 2012. Plasmodium falciparum prevalence rate (PfPR) in children 0.5–14 y old (primary outcome) and anaemia in children <5 y old (secondary outcome) were compared between study arms using three cross-sectional household surveys in 2012. Entomological inoculation rate (secondary outcome) was compared between study arms. IRS coverage was approximately 90%. ITN use ranged from 36% to 50%. In intention-to-treat analysis, mean PfPR was 13% in the ITN+IRS arm and 26% in the ITN only arm, odds ratio = 0.43 (95% CI 0.19–0.97, n = 13,146). The strongest effect was observed in the peak transmission season, 6 mo after the first IRS. Subgroup analysis showed that ITN users were additionally protected if their houses were sprayed. Mean monthly entomological inoculation rate was non-significantly lower in the ITN+IRS arm than in the ITN only arm, rate ratio = 0.17 (95% CI 0.03–1.08). Conclusions This is the first randomised trial to our knowledge that reports significant added protection from combining IRS and ITNs compared to ITNs alone. The effect is likely to be attributable to IRS providing added protection to ITN users as well as compensating for inadequate ITN use. Policy makers should consider deploying IRS in combination with ITNs to control transmission if local ITN strategies on their own are insufficiently effective. Given the uncertain generalisability of these findings

  11. Strain-Counterstrain therapy combined with exercise is not more effective than exercise alone on pain and disability in people with acute low back pain: a randomised trial.

    PubMed

    Lewis, Cynan; Souvlis, Tina; Sterling, Michele

    2011-01-01

    Is Strain-Counterstrain treatment combined with exercise therapy more effective than exercise alone in reducing levels of pain and disability in people with acute low back pain? Randomised trial with concealed allocation, assessor blinding, and intention-to-treat analysis. 89 (55 female) participants between 18 and 55 years experiencing acute low back pain were randomised to experimental (n = 44) and control (n = 45) groups. Participants attended four treatments in two weeks. The experimental group received Strain-Counterstrain treatment and review of standardised exercises (abdominal bracing, knee to chest, and lumbar rotation). The control group performed the standardised exercises under supervision. Following the intervention period, all participants received exercise progression, manual therapy, and advice. The primary outcome was the modified Oswestry low back pain disability questionnaire, measured at 2 weeks (ie, end of treatment), 6 weeks, and 28 weeks. Secondary outcome measures included the SF-36, visual analogue scale pain ratings, and a 7-point global rating of change. The experimental intervention was not more effective than exercise alone in reducing levels of pain and disability. Mean between-group differences in change from baseline for the Oswestry Disability Index were 0 (95% CI -6 to 7) after treatment, -1 (95% CI -7 to 6) at 6 weeks, and 2 (95% CI -4 to 8) at 28 weeks. Other outcomes did not differ significantly between groups. There is no advantage in providing Strain- Counterstrain treatment to patients with acute low back pain, although further studies could examine whether a subset of these patients can benefit from the treatment. ACTRN 12609000084280. Copyright © 2011 Australian Physiotherapy Association. Published by .. All rights reserved.

  12. Effect of Schroth exercises on curve characteristics and clinical outcomes in adolescent idiopathic scoliosis: protocol for a multicentre randomised controlled trial.

    PubMed

    Schreiber, Sanja; Parent, Eric C; Hedden, Douglas M; Moreau, Marc; Hill, Doug; Lou, Edmond

    2014-12-01

    The promising results of Schroth scoliosis-specific exercises for adolescent idiopathic scoliosis found in low-quality studies will be strengthened by confirmation in a randomised controlled trial. 1. Are Schroth exercises combined with standard care for 6 months more effective than standard care alone in improving radiographic and clinical outcomes for adolescents with idiopathic scoliosis? 2. Will the outcomes of the control group (who will be offered Schroth therapy delayed by 6 months) improve after 6 months of Schroth therapy? 3. Are the effects maintained 6 months after discontinuing the supervised intervention? This is an assessor-blinded and statistician-blinded randomised controlled trial with transfer of the controls to the exercise group after 6 months. Two hundred and fifty-eight consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, treated with or without a brace, with curves between 10 and 45 deg Cobb and Risser sign ≤ 3 will be recruited from three scoliosis clinics. Combined with standard care, the Schroth group will receive five individual training sessions, followed by weekly group classes and daily home exercises for 6 months. Controls will only receive standard care consisting of observation or bracing, and will be offered Schroth therapy 6 months later. Curve severity (Cobb angle) and vertebral rotation will be assessed from radiographs at baseline, 6 and 12 months. Secondary clinical outcomes (back muscle endurance, surface topography measures of posture, and self-reported perceived spinal appearance and quality of life) will be assessed at baseline, and every 3 months until 1-year follow-up. Data will be analysed using intention-to-treat linear mixed models. The results will demonstrate whether Schroth exercises combined with standard of care can improve outcomes in adolescents with idiopathic scoliosis. This study has potential to influence clinical practice worldwide, where exercises are not routinely prescribed for

  13. The PULSE (Prevention Using LifeStyle Education) trial protocol: a randomised controlled trial of a Type 2 Diabetes Prevention programme for men.

    PubMed

    Aguiar, Elroy J; Morgan, Philip J; Collins, Clare E; Plotnikoff, Ronald C; Young, Myles D; Callister, Robin

    2014-09-01

    Intensive lifestyle interventions have been successful in reducing type 2 diabetes incidence. Whether intensive programmes requiring face-to-face contact, trained staff and access to facilities are feasible, on a larger scale, has been debated. The aim of this study is to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in men using an assessor-blinded, parallel-group, randomised controlled trial. The 'Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) Programme for Men' is a 6-month, self-administered, gender-tailored lifestyle intervention, with a multicomponent approach (weight loss, dietary modification, aerobic exercise and resistance training). Eligible men were aged 18-65 years, overweight/obese (BMI 25-40 kg·m(-2)) and at high-risk for type 2 diabetes (score ≥ 12, Australian diabetes risk tool). Men with diagnosed prediabetes were eligible, but those with type 1 and 2 diabetes were ineligible. Randomisation was stratified by age (<50 or ≥ 50 years) and BMI category (kg·m(-2): 25-29.9; 30-34.9; 35-40) to the intervention or wait-list control group. Data are collected at study entry (baseline), 3 and 6 months. The primary outcome is weight change at 6 months. Secondary outcomes include: fasting plasma glucose, HbA1C, waist circumference, body composition, blood pressure, diet quality, aerobic fitness, muscular fitness and physical activity. Generalised linear mixed models (intention-to-treat) will assess outcomes for treatment (intervention vs. control), time (baseline, 3 and 6-months) and the treatment-by-time interaction. The results will determine the efficacy of a type 2 diabetes prevention programme for men with potential for wide reach and dissemination. Australian New Zealand Clinical Trials Registry (ACTRN12612000721808). Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial

    PubMed Central

    Sun, Zhong-ren; Yue, Jin-huan; Tian, Hong-zhao; Zhang, Qin-hong

    2014-01-01

    Introduction The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. Methods/analysis This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ). Ethics/dissemination The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research. Trial registration number ChiCTR-TRC-13003911. PMID:25537784

  15. Efficacy, safety and tolerability of salbutamol + guaiphenesin + bromhexine (Ascoril) expectorant versus expectorants containing salbutamol and either guaiphenesin or bromhexine in productive cough: a randomised controlled comparative study.

    PubMed

    Prabhu Shankar, S; Chandrashekharan, S; Bolmall, Chandrashekhar S; Baliga, Vidyagauri

    2010-05-01

    Patients with acute bronchitis, acute exacerbations of chronic bronchitis and asthmatic bronchitis suffer from cough with tenacious bronchial secretions requiring expectorants in addition to bronchodilating therapy. The present one-week, multicentric, prospective, randomised, double-blind study compared the efficacy and tolerability of three expectorant formulations in 426 patients with productive cough associated with varied aetiology after approval by the institutional review boards. Selected patients received 7 days' treatment with either fixed dose combination (FDC) of salbutamol 2 mg + bromhexine HCI 8 mg + guaiphenesin 100 mg (group A) or salbutamol 2 mg+ guaiphenesin 100 mg expectorant (group B) or salbutamol 2 mg + bromhexine 8 mg (group C) thrice daily after obtaining their informed consent. In group A, there was improvement of symptoms in a larger number of patients and earlier onset of action in reducing cough frequency and severity and improving sputum characteristics as compared to the other two groups. More patients in group A reported excellent efficacy (44.4%) as compared to only 14.6% in Group B and 13% in Group C. Cough expectorant containing salbutamol + bromhexine +guaiphenesin could be the expectorant of choice in alleviating productive cough since it scored in terms of efficacy as well as tolerability over salbutamol with either bromhexine or guaiphenesin alone.

  16. A prospective randomised controlled trial comparing chronic groin pain and quality of life in lightweight versus heavyweight polypropylene mesh in laparoscopic inguinal hernia repair

    PubMed Central

    Prakash, Pradeep; Bansal, Virinder Kumar; Misra, Mahesh Chandra; Babu, Divya; Sagar, Rajesh; Krishna, Asuri; Kumar, Subodh; Rewari, Vimi; Subramaniam, Rajeshwari

    2016-01-01

    BACKGROUND: The aim of our study was to compare chronic groin pain and quality of life (QOL) after laparoscopic lightweight (LW) and heavyweight (HW) mesh repair for groin hernia. MATERIALS AND METHODS: One hundred and forty adult patients with uncomplicated inguinal hernia were randomised into HW mesh group or LW mesh group. Return to activity, chronic groin pain and recurrence rates were assessed. Short form-36 v2 health survey was used for QOL analysis. RESULTS: One hundred and thirty-one completed follow-up of 3 months, 66 in HW mesh group and 65 in LW mesh group. Early post-operative convalescence was better in LW mesh group in terms of early return to walking (P = 0.01) and driving (P = 0.05). The incidence of early post-operative pain, chronic groin pain and QOL and recurrences were comparable. CONCLUSION: Outcomes following laparoscopic inguinal hernia repair using HW and LW mesh are comparable in the short-term as well as long-term. PMID:27073309

  17. A randomised trial comparing the CEL-100 videolaryngoscope(TM) with the Macintosh laryngoscope blade for insertion of double-lumen tubes.

    PubMed

    Lin, W; Li, H; Liu, W; Cao, L; Tan, H; Zhong, Z

    2012-07-01

    We performed a randomised trial comparing the CEL-100 videolaryngoscope(TM) with the Macintosh laryngoscope blade in 170 patients undergoing double-lumen tube placement for thoracic surgery. Compared with the Macintosh laryngoscope blade, use of the CEL-100 resulted in significantly more patients with a Cormack and Lehane Grade-1 laryngeal view (90.4% vs 61.0%, p < 0.001), a higher rate of successful intubation on the first attempt (92.8% vs 79.3%, p = 0.012), a lower median (IQR [range]) intubation difficulty score (0 (0-0 [0-60]) vs 15 (0-30 [0-80]), p < 0.001), a higher incidence of correct positioning of the tube (90.3% vs 79.2%, p = 0.041) and significantly fewer patients requiring external laryngeal pressure (19.3% vs 32.9%, p = 0.046). Median (IQR [range]) time to successful intubation was 45 (38-55 [22-132]) s with the CEL-100 compared with 51 (40-61 [30-160] s using the Macintosh laryngoscope blade. We conclude that the CEL-100 videolaryngoscope is superior to the Macintosh laryngoscope blade for double-lumen tube insertion.

  18. A prospective, randomised controlled trial comparing ceramic-on-metal and metal-on-metal bearing surfaces in total hip replacement.

    PubMed

    Schouten, R; Malone, A A; Tiffen, C; Frampton, C M; Hooper, G

    2012-11-01

    In a double-blinded randomised controlled trial, 83 patients with primary osteoarthritis of the hip received either a ceramic-on-metal (CoM) or metal-on-metal (MoM) total hip replacement (THR). The implants differed only in the bearing surfaces used. The serum levels of cobalt and chromium and functional outcome scores were compared pre-operatively and at six and 12 months post-operatively. Data were available for 41 CoM and 36 MoM THRs (four patients were lost to follow-up, two received incorrect implants). The baseline characteristics of both cohorts were similar. Femoral head size measured 36 mm in all but two patients who had 28 mm heads. The mean serum cobalt and chromium levels increased in both groups, with no difference noted between groups at six months (cobalt p = 0.67, chromium p = 0.87) and 12 months (cobalt p = 0.76, chromium p = 0.76) post-operatively. Similarly, the mean Oxford hip scores, Western Ontario and McMaster Universities Osteoarthritis index and University of California, Los Angeles activity scores showed comparable improvement at 12 months. Our findings indicate that CoM and MoM couplings are associated with an equivalent increase in serum cobalt and chromium levels, and comparable functional outcome scores at six and 12-months follow-up.

  19. NEOCENT: a randomised feasibility and translational study comparing neoadjuvant endocrine therapy with chemotherapy in ER-rich postmenopausal primary breast cancer.

    PubMed

    Palmieri, C; Cleator, S; Kilburn, L S; Kim, S B; Ahn, S-H; Beresford, M; Gong, G; Mansi, J; Mallon, E; Reed, S; Mousa, K; Fallowfield, L; Cheang, M; Morden, J; Page, K; Guttery, D S; Rghebi, B; Primrose, L; Shaw, J A; Thompson, A M; Bliss, J M; Coombes, R C

    2014-12-01

    Neoadjuvant endocrine therapy is an alternative to chemotherapy for women with oestrogen receptor (ER)-positive early breast cancer (BC). We aimed to assess feasibility of recruiting patients to a study comparing chemotherapy versus endocrine therapy in postmenopausal women with ER-rich primary BC, and response as well as translational endpoints were assessed. Patients requiring neoadjuvant therapy were randomised to chemotherapy: 6 × 3-weekly cycles FE₁₀₀C or endocrine therapy: letrozole 2.5 mg, daily for 18-23 weeks. Primary endpoints were recruitment feasibility and tissue collection. Secondary endpoints included clinical, radiological and pathological response rates, quality of life and translational endpoints. 63/80 patients approached were eligible, of those 44 (70, 95% CI 57-81) were randomised. 12 (54.5, 95% CI 32.2-75.6) chemotherapy patients showed radiological objective response compared with 13 (59.1, 95% CI 36.4-79.3) letrozole patients. Compared with baseline, mean Ki-67 levels fell in both groups at days 2-4 and at surgery [fold change: 0.24 (95% CI 0.12-0.51) and 0.24; (95% CI 0.15-0.37), respectively]. Plasma total cfDNA levels rose from baseline to week 8 [fold change: chemotherapy 2.10 (95% CI 1.47-3.00), letrozole 1.47(95% CI 0.98-2.20)], and were maintained at surgery in the chemotherapy group [chemotherapy 2.63; 95% CI 1.56-4.41), letrozole 0.95 (95% CI 0.71-1.26)]. An increase in plasma let-7a miRNA was seen at surgery for patients with objective radiological response to chemotherapy. Recruitment and tissue collection endpoints were met; however, a larger trial was deemed unfeasible due to slow accrual. Both regimens were equally efficacious. Dynamic changes were seen in Ki-67 and circulating biomarkers in both groups with increases in cfDNA and let-7a miRNA persisting until surgery for chemotherapy patients.

  20. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study

    PubMed Central

    Fenaux, Pierre; Mufti, Ghulam J; Hellstrom-Lindberg, Eva; Santini, Valeria; Finelli, Carlo; Giagounidis, Aristoteles; Schoch, Robert; Gattermann, Norbert; Sanz, Guillermo; List, Alan; Gore, Steven D; Seymour, John F; Bennett, John M; Byrd, John; Backstrom, Jay; Zimmerman, Linda; McKenzie, David; Beach, C L; Silverman, Lewis R

    2014-01-01

    Summary Background Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens. Methods In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m² per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French–American–British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov, number NCT00071799. Findings Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21·1 months (IQR 15·1–26·9), median overall survival was 24·5 months (9·9–not reached) for the azacitidine group versus 15·0 months (5·6–24·1) for the conventional care group (hazard ratio 0·58; 95% CI 0·43–0·77; stratified log-rank p=0·0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50·8% (95% CI 42·1–58·8) of patients in the azacitidine group were alive compared with 26·2% (18·7–34·3) in the conventional care group (p<0·0001). Peripheral cytopenias were the most

  1. The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. Methods/design The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. Discussion The TOPSHOCK study is the

  2. Randomised controlled trial comparing ofatumumab to rituximab in children with steroid-dependent and calcineurin inhibitor-dependent idiopathic nephrotic syndrome: study protocol

    PubMed Central

    Ravani, Pietro; Bonanni, Alice; Ghiggeri, Gian Marco

    2017-01-01

    Introduction Oral steroids induce remission in about 90% of children with idiopathic nephrotic syndrome (INS), which is characterised by severe proteinuria and hypoalbuminaemia. Some children become steroid-dependent (SD) and require addition of calcineurin inhibitors (CNI) to maintain remission. Since these oral agents are toxic, alternative interventions are needed for long-term treatment. The anti-CD20 antibody rituximab has shown promising steroid-sparing properties in clinical trials, but benefits are less convincing in complicated forms of SD-INS. Ofatumumab, a new anti-CD20 antibody with stronger affinity to CD20, may be superior to rituximab in maintaining oral steroid-free and CNI-free disease remission in children with SD-INS. Methods and analysis This open-label, two-parallel-arm, controlled, phase II randomised clinical trial will enrol children with SD-INS maintained in remission with oral steroids and CNI. Children will be randomised to either ofatumumab or rituximab infusion. After infusion of either antibody, steroids will be maintained for 30 days and then tapered off by 0.3 mg/kg/week until complete withdrawal. 1 week after complete steroid withdrawal, CNI will be decreased by 50% and withdrawn within 2 additional weeks. We will enrol 140 children to detect as significant at the 2-sided p value of 0.01 with a power of >0.8, a reduction in the risk of 1-year relapse (primary end point) of at least 0.3 (ie, from 0.65 to 0.35; (risk ratio 0.54)) in the ofatumumab arm when compared with the rituximab arm. We will compare the amount of steroids required to maintain complete disease remission at 6 and 24 months, relapse-free period, relapse rate per year as secondary end points. Circulating cell populations will be studied as biomarkers or predictors of the anti-CD20 response. Ethics and dissemination The trial received ethics approval from the local ethics board. We will publish study results and present them at international scientific meetings

  3. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care

    PubMed Central

    Wiegersma, Marian; Panman, Chantal M C R; Kollen, Boudewijn J; Berger, Marjolein Y; Lisman-Van Leeuwen, Yvonne

    2014-01-01

    Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Design Randomised controlled trial. Setting Dutch primary care. Participants Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language. Interventions Pelvic floor muscle training versus watchful waiting. Main outcome measures The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients’ perceived change in symptoms. Results Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups. Conclusions Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points

  4. A randomised in situ trial, measuring the anti-erosive properties of a stannous-containing sodium fluoride dentifrice compared with a sodium fluoride/potassium nitrate dentifrice.

    PubMed

    Hooper, Susan; Seong, Joon; Macdonald, Emma; Claydon, Nicholas; Hellin, Nicola; Barker, Matthew L; He, Tao; West, Nicola X

    2014-03-01

    To determine if a stabilised, stannous-containing sodium fluoride dentifrice provides greater enamel protection in situ against intraoral dietary erosive challenges compared with a sodium fluoride/potassium nitrate dentifrice. A single-centre, investigator blind, randomised, supervised, two-treatment, non-brushing, four-period crossover in situ study was undertaken, with each test period being 15 days. Thirty-five healthy adult subjects were recruited to participate in the study, which included four erosive acid challenges per day. Subjects were randomised to product treatment, which included either: (1) a stannous-containing sodium fluoride dentifrice (Oral-B(®) Pro-Expert Sensitive) or (2) a sodium fluoride/potassium nitrate dentifrice (Sensodyne(®) Pronamel(®) ). Each study subject wore an intraoral appliance retaining two sterilised, polished human enamel samples for 6 hours/day. Subjects swished with an allocated dentifrice slurry twice a day and with 250 ml of orange juice for 10 minutes (25 ml/minute over a 10-minute period) four times per day. The primary and secondary outcomes for this study were enamel loss measured using contact profilometry at days 15 and 5, respectively, using parametric analysis methods. At day 15, a 38% lower enamel loss (P < 0.0001) was observed, with estimated medians of 2.03 μm (SE 0.247) and 3.30 μm (SE 0.379), in favour of the stannous-containing dentifrice. At day 5, specimens treated with the stannous-containing sodium fluoride dentifrice demonstrated 25% less enamel loss than those treated with the sodium fluoride/potassium nitrate dentifrice. Treatment differences at day 5 were also statistically significant (P < 0.05), with estimated medians of 1.37 μm (SE 0.177) and 1.83 μm (SE 0.223), respectively. Results of this in situ study suggest the stabilised, stannous-containing sodium fluoride dentifrice could be used to provide significantly greater protection to enamel from erosive acid challenge compared with that

  5. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

    PubMed Central

    Yoo, Dae Hyun; Suh, Chang-Hee; Shim, Seung Cheol; Jeka, Slawomir; Cons-Molina, Francisco Fidencio; Hrycaj, Pawel; Wiland, Piotr; Lee, Eun Young; Medina-Rodriguez, Francisco G; Shesternya, Pavel; Radominski, Sebastiao; Stanislav, Marina; Kovalenko, Volodymyr; Sheen, Dong Hyuk; Myasoutova, Leysan; Lim, Mie Jin; Choe, Jung-Yoon; Lee, Sang Joon; Lee, Sung Young; Kwon, Taek Sang; Park, Won

    2017-01-01

    Objective To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents. Methods In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration–time curve from time zero to last quantifiable concentration (AUC0–last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24. Results 103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%–125% (AUC0–last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles. Conclusions CT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety. Trial registration number NCT01534884. PMID:27624791

  6. A multicentric, open label, randomised, postmarketing efficacy study comparing multidose of lincomycin hydrochloride capsule 500 mg with multidose cefpodoxime proxetil tablet 200 mg in patients with tonsillitis, sinusitis.

    PubMed

    Kothadiya, Ajay

    2012-08-01

    Tonsillitis causes considerable short and medium term morbidity, and can be recurrent. Sinusitis can be acute (less than 4 weeks), subacute (4-8 weeks) or chronic (8 weeks or more). To study the comparative efficacy and safety of multidose treatments of lincomycin hydrochloride 500 mg capsules against cefpodoxime proxetil 200 mg tablets on its outcome in the Indian scenario are the aims and objective of the study. A total of 41 tonsillitis, sinusitis cases of either gender aged above 18 years were enrolled in the study. The diagnosis of sonsillitis, sinusitis was made based on examination of symptoms and throat swab. A randomised treatment of either lincomycin hydrochloride 500 mg capsules or cefpodoxime proxetil 200 mg tablets twice daily for five days alongwith other concomitant medications depending on related symptoms was given to 40 patients. At the end of study, all patients were re-evaluated and the response rate was assessed. The most common clinical symptoms were body temperature, headache, throat pain, postnasal discharge, mucopus, odynophagia, sinus tenderness, nasal congestion, pharyngeal congestion and tonsillar congestion. The overall response rate of lincomycin hydrochloride in all the symptoms except headache was more effective than cefpodoxime proxetil. Out of 100% (n = 20) patients in each group, 67.89% in lincomycin and 52.27% in cefpodoxime patients achieved complete relief, in all the clinical symptoms. The study suggests that lincomycin hydrochloride capsules, a conventional antibiotic indicates effective treatment for relief from tonsillitis and sinusitis, as compared to new third generation antibiotic.

  7. Comparative efficacy of active and passive distraction during restorative treatment in children using an iPad versus audiovisual eyeglasses: a randomised controlled trial.

    PubMed

    Attar, R H; Baghdadi, Z D

    2015-02-01

    This study aimed to compare the effects of two types of distraction techniques: passive, using audiovisual glasses (AV glasses), versus active, using an iPad, as an adjunct to local analgesia during vital pulp therapy in children. Pain behaviour, and heart rates from an exposure group (treatment with the aid of an iPad) and control group (treatment with the aid of AV glasses) were compared in a randomised, split-mouth design using the Wilcoxon signed rank test (pain and behaviour) and paired t test for heart rate scores at p 0.05. Children (39) (mean age 6.27 years) received the two treatment sessions. Generally, AV glasses had higher pain and behaviour scores than iPad. Pain results demonstrated marginal significant differences between the two distraction techniques during local analgesia administration (p 0.076) and caries removal (p 0.071). A significant difference between the two techniques during local analgesia administration only (p 0.017), in favour of an iPad. Average heart rates over the treatment intervals were lower among iPad group than those using AV glasses group. Patients preferred an iPad more than AV glasses (24 versus 15). Treatment sessions were significantly shorter for iPad. Active distraction using an iPad demonstrated better performance than passive distraction using AV glasses.

  8. 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.

    PubMed

    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

  9. Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations.

    PubMed

    Manchanda, Ranjit; Burnell, Matthew; Loggenberg, Kelly; Desai, Rakshit; Wardle, Jane; Sanderson, Saskia C; Gessler, Sue; Side, Lucy; Balogun, Nyala; Kumar, Ajith; Dorkins, Huw; Wallis, Yvonne; Chapman, Cyril; Tomlinson, Ian; Taylor, Rohan; Jacobs, Chris; Legood, Rosa; Raikou, Maria; McGuire, Alistair; Beller, Uziel; Menon, Usha; Jacobs, Ian

    2016-07-01

    Newer approaches to genetic counselling are required for population-based testing. We compare traditional face-to-face genetic counselling with a DVD-assisted approach for population-based BRCA1/2 testing. A cluster-randomised non-inferiority trial in the London Ashkenazi Jewish population. Ashkenazi Jewish men/women >18 years; exclusion criteria: (a) known BRCA1/2 mutation, (b) previous BRCA1/2 testing and (c) first-degree relative of BRCA1/2 carrier. Ashkenazi Jewish men/women underwent pre-test genetic counselling prior to BRCA1/2 testing in the Genetic Cancer Prediction through Population Screening trial (ISRCTN73338115). Genetic counselling clinics (clusters) were randomised to traditional counselling (TC) and DVD-based counselling (DVD-C) approaches. DVD-C involved a DVD presentation followed by shorter face-to-face genetic counselling. Outcome measures included genetic testing uptake, cancer risk perception, increase in knowledge, counselling time and satisfaction (Genetic Counselling Satisfaction Scale). Random-effects models adjusted for covariates compared outcomes between TC and DVD-C groups. One-sided 97.5% CI was used to determine non-inferiority. relevance, satisfaction, adequacy, emotional impact and improved understanding with the DVD; cost-minimisation analysis for TC and DVD-C approaches. 936 individuals (clusters=256, mean-size=3.6) were randomised to TC (n=527, clusters=134) and DVD-C (n=409, clusters=122) approaches. Groups were similar at baseline, mean age=53.9 (SD=15) years, women=66.8%, men=33.2%. DVD-C was non-inferior to TC for increase in knowledge (d=-0.07; lower 97.5% CI=-0.41), counselling satisfaction (d=-0.38, 97.5% CI=1.2) and risk perception (d=0.08; upper 97.5% CI=3.1). Group differences and CIs did not cross non-inferiority margins. DVD-C was equivalent to TC for uptake of genetic testing (d=-3%; lower/upper 97.5% CI -7.9%/1.7%) and superior for counselling time (20.4 (CI 18.7 to 22.2) min reduction (p<0.005)). 98% people

  10. Immunogenicity and safety of a novel monovalent high-dose inactivated poliovirus type 2 vaccine in infants: a comparative, observer-blind, randomised, controlled trial.

    PubMed

    Sáez-Llorens, Xavier; Clemens, Ralf; Leroux-Roels, Geert; Jimeno, José; Clemens, Sue Ann Costa; Weldon, William C; Oberste, M Steven; Molina, Natanael; Bandyopadhyay, Ananda S

    2016-03-01

    Following the proposed worldwide switch from trivalent oral poliovirus vaccine (tOPV) to bivalent types 1 and 3 OPV (bOPV) in 2016, inactivated poliovirus vaccine (IPV) will be the only source of protection against poliovirus type 2. With most countries opting for one dose of IPV in routine immunisation schedules during this transition because of cost and manufacturing constraints, optimisation of protection against all poliovirus types will be a priority of the global eradication programme. We assessed the immunogenicity and safety of a novel monovalent high-dose inactivated poliovirus type 2 vaccine (mIPV2HD) in infants. This observer-blind, comparative, randomised controlled trial was done in a single centre in Panama. We enrolled healthy infants who had not received any previous vaccination against poliovirus. Infants were randomly assigned (1:1) by computer-generated randomisation sequence to receive a single dose of either mIPV2HD or standard trivalent IPV given concurrently with a third dose of bOPV at 14 weeks of age. At 18 weeks, all infants were challenged with one dose of monovalent type 2 OPV (mOPV2). Primary endpoints were seroconversion and median antibody titres to type 2 poliovirus 4 weeks after vaccination with mIPV2HD or IPV; and safety (as determined by the proportion and nature of serious adverse events and important medical events for 8 weeks after vaccination). The primary immunogenicity analyses included all participants for whom a post-vaccination blood sample was available. All randomised participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02111135. Between April 14 and May 9, 2014, 233 children were enrolled and randomly assigned to receive mIPV2HD (117 infants) or IPV (116 infants). 4 weeks after vaccination with mIPV2HD or IPV, seroconversion to poliovirus type 2 was recorded in 107 (93·0%, 95% CI 86·8-96·9) of 115 infants in the mIPV2HD group compared with 86 (74·8%, 65·8

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

    PubMed

    Ijzelenberg, Wilhelmina; Hellemans, Irene M; van Tulder, Maurits W; Heymans, Martijn W; Rauwerda, Jan A; van Rossum, Albert C; Seidell, Jaap C

    2012-09-10

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

  12. Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults.

    PubMed

    Skou, Søren Thorgaard; Lind, Martin; Hölmich, Per; Jensen, Hans Peter; Jensen, Carsten; Afzal, Muhammad; Jørgensen, Uffe; Thorlund, Jonas Bloch

    2017-08-21

    Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears. This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18-40 years with a clinical history and symptoms consistent with a meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon will be randomly allocated to one of two groups (1:1 ratio). Participants randomised to surgery will undergo either arthroscopic partial meniscectomy or meniscal repair followed by standard postsurgical care, while participants allocated to exercise and education will undergo a 12-week individualised, supervised neuromuscular and strengthening exercise programme and patient education. The primary outcome will be difference in change from baseline to 12 months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, function in sports and recreation and quality of life (Knee Injury and Osteoarthritis Outcome Score (KOOS4)) supported by the individual subscale scores allowing clinical interpretation. Alongside, the RCT an observational cohort will follow patients aged 18-40 years with clinical suspicion of a meniscal tear, but not fully eligible or declining to participate in the trial. Results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Regional Committees on Health Research Ethics for Southern

  13. Comparing cognitive-behavioural psychotherapy and psychoeducation for non-specific symptoms associated with indoor air: a randomised control trial protocol

    PubMed Central

    Selinheimo, Sanna; Vuokko, Aki; Sainio, Markku; Karvala, Kirsi; Suojalehto, Hille; Järnefelt, Heli; Paunio, Tiina

    2016-01-01

    Introduction Indoor air-related conditions share similarities with other conditions that are characterised by medically unexplained symptoms (MUS)-a combination of non-specific symptoms that cannot be fully explained by structural bodily pathology. In cases of indoor air-related conditions, these symptoms are not fully explained by either medical conditions or the immunological–toxicological effects of environmental factors. The condition may be disabling, including a non-adaptive health behaviour. In this multifaceted phenomenon, psychosocial factors influence the experienced symptoms. Currently, there is no evidence of clinical management of symptoms, which are associated with the indoor environment and cannot be resolved by removing the triggering environmental factors. The aim of this study is to compare the effect of treatment-as-usual (TAU) and two psychosocial interventions on the quality of life, and the work ability of employees with non-specific indoor air-related symptomatology. Methods and analyses The aim of this ongoing randomised controlled trial is to recruit 60 participants, in collaboration with 5 occupational health service units. The main inclusion criterion is the presence of indoor air-related recurrent symptoms in ≥2 organ systems, which have no pathophysiological explanation. After baseline clinical investigations, participants are randomised into interventions, which all include TAU: cognitive-behavioural psychotherapy, psychoeducation and TAU (control condition). Health-related quality of life, measured using the 15D-scale, is the primary outcome. Secondary outcomes include somatic and psychiatric symptoms, occupational factors, and related underlying mechanisms (ie, cognitive functioning). Questionnaires are completed at baseline, at 3, 6 and 12-month follow-ups. Data collection will continue until 2017. The study will provide new information on the individual factors related to indoor air-associated symptoms, and on ways in which to

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

    PubMed Central

    2012-01-01

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

  15. Comparing three forms of early intervention for youth with borderline personality disorder (the MOBY study): study protocol for a randomised controlled trial.

    PubMed

    Chanen, Andrew; Jackson, Henry; Cotton, Sue M; Gleeson, John; Davey, Christopher G; Betts, Jennifer; Reid, Sophie; Thompson, Katherine; McCutcheon, Louise

    2015-10-21

    Borderline personality disorder is a severe mental disorder that usually has its onset in youth, but its diagnosis and treatment are often delayed. Psychosocial 'early intervention' is effective in improving symptoms and behaviours, but no trial has studied adaptive functioning as a primary outcome, even though this remains the major persistent impairment in this patient group. Also, the degree of complexity of treatment and requirements for implementation in mainstream health services are unclear. The primary aim of this trial is to evaluate the effectiveness of three forms of early intervention for borderline personality disorder in terms of adaptive functioning. Each treatment is defined by combining either a specialised or a general service delivery model with either an individual psychotherapy or a control psychotherapy condition. The study is a parallel-group, single-blind, randomised controlled trial, which has randomised permuted blocking, stratified by depression score, sex and age. The treatments are: (1) the specialised Helping Young People Early service model plus up to 16 sessions of individual cognitive analytic therapy; (2) the Helping Young People Early service plus up to 16 sessions of a control psychotherapy condition known as 'befriending'; (3) a general youth mental health care model plus up to 16 sessions of befriending. Participants will comprise 135 help-seeking youth aged 15-25 years with borderline personality disorder. After baseline assessment, staff blind to the study design and treatment group allocation will conduct assessments at 3, 6, 12 and 18 months. At the 12-month primary endpoint, the primary outcome is adaptive functioning (measures of social adjustment and interpersonal problems); secondary outcomes include measures of client satisfaction, borderline personality disorder features, depression and substance use. The results of this trial will help to clarify the comparative effectiveness of a specialised early intervention

  16. A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer

    PubMed Central

    Bramhall, S R; Schulz, J; Nemunaitis, J; Brown, P D; Baillet, M; Buckels, J A C

    2002-01-01

    Pancreatic cancer is the fifth most common cause of cancer death in the western world and the prognosis for unresectable disease remains poor. Recent advances in conventional chemotherapy and the development of novel ‘molecular’ treatment strategies with different toxicity profiles warrant investigation as combination treatment strategies. This randomised study in pancreatic cancer compares marimastat (orally administered matrix metalloproteinase inhibitor) in combination with gemcitabine to gemcitabine alone. Two hundred and thirty-nine patients with unresectable pancreatic cancer were randomised to receive gemcitabine (1000 mg m−2) in combination with either marimastat or placebo. The primary end-point was survival. Objective tumour response and duration of response, time to treatment failure and disease progression, quality of life and safety were also assessed. There was no significant difference in survival between gemcitabine and marimastat and gemcitabine and placebo (P=0.95 log-rank test). Median survival times were 165.5 and 164 days and 1-year survival was 18% and 17% respectively. There were no significant differences in overall response rates (11 and 16% respectively), progression-free survival (P=0.68 log-rank test) or time to treatment failure (P=0.70 log-rank test) between the treatment arms. The gemcitabine and marimastat combination was well tolerated with only 2.5% of patients withdrawn due to presumed marimastat toxicity. Grade 3 or 4 musculoskeletal toxicities were reported in only 4% of the marimastat treated patients, although 59% of marimastat treated patients reported some musculoskeletal events. The results of this study provide no evidence to support a combination of marimastat with gemcitabine in patients with advanced pancreatic cancer. The combination of marimastat with gemcitabine was well tolerated. Further studies of marimastat as a maintenance treatment following a response or stable disease on gemcitabine may be justified

  17. Effect of aqua-cycling on pain and physical functioning compared with usual care in patients with knee osteoarthritis: study protocol of a randomised controlled trial.

    PubMed

    Rewald, Stefanie; Mesters, Ilse; Lenssen, A F; Emans, Pieter J; Wijnen, Wiel; de Bie, Rob A

    2016-02-18

    Over the last decade aquatic exercise has become more and more popular. One of the latest trends is aqua-cycling, where participants sit on a water-resistant stationary bike and, while immersed chest deep in the water, combine continuous cycling with upper body exercises that utilise water resistance. Since stationary cycling and aquatic exercises are frequently recommended to patients with knee osteoarthritis, combining both would seem an obvious step, and an aqua-cycling exercise programme for patients with knee osteoarthritis has indeed been developed. This study protocol gives a detailed description of the exercise programme and the methodology of a study to compare this programme with treatment involving usual care only. The study is a single-blind, parallel-group, randomised controlled trial of Maastricht University Medical Centre+, the Netherlands. knee pain of four to seven on a 10-point pain rating scale; a Kellgren/Lawrence score between one to three; ability to cycle; good mental health; sufficient language skills; indication for physical therapy in conjunction with impairments due to OA. any contra-indication for aquatic exercise; planned total knee replacement; corticosteroid injection <3 months and/or hyaluronic acid injection <6 months; severe joint complaints (other than knee joint); symptomatic and radiological apparent hip OA; inflammatory joint diseases; inability to safely enter and exit the pool; fear of water. Participants will receive two 45-min moderate intense aqua-cycling sessions weekly over a period of 12 weeks in addition to usual care or usual care only. Usual care consists of an individual intervention plan comprising lifestyle recommendations, medication routine and referral to a physical therapist. Participants will be assessed at baseline, and at 12 and 24 weeks after baseline. The primary outcome is self-reported knee pain and physical functioning. Secondary outcomes are lower limb muscle strength, functional capacity, self

  18. Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol for the PATHS randomised controlled trial.

    PubMed

    Kwasnicka, Dominika; Vandelanotte, Corneel; Rebar, Amanda; Gardner, Benjamin; Short, Camille; Duncan, Mitch; Crook, Dawn; Hagger, Martin S

    2017-05-26

    Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals' physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ according to their focus on motivational, self-regulatory and/or habitual processes. Healthcare professionals (N = 192) will be recruited from four hospitals in Perth, Western Australia, via email lists, leaflets, and posters to participate in the four group randomised controlled trial. Participants will be randomised to one of four conditions: (1) education only (non-tailored information only), (2) education plus intervention components to enhance motivation, (3) education plus components to enhance motivation and self-regulation, and (4) education plus components to enhance motivation, self-regulation and habit formation. All intervention groups will receive a computer-tailored intervention administered via a web-based platform and will receive supporting text-messages containing tailored information, prompts and feedback relevant to each condition. All outcomes will be assessed at baseline, and at 3-month follow-up. The primary outcome assessed in this study is physical activity measured using activity monitors. Secondary outcomes include: quality of life, stress, anxiety, sleep, and absenteeism. Website engagement, retention, preferences and intervention fidelity will also be evaluated as well as potential mediators and moderators of intervention effect. This is the first study to examine a tailored

  19. Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial.

    PubMed

    Fan, Guang Sheng; Ren, Mulan; Di, Wen; Su, Ping; Chang, Qin; Wu, Shuying; Qin, Yun; Korver, Tjeerd; Marintcheva-Petrova, Maya; Yacik, Carol; McCrary Sisk, Christine; Wang, Guoqin

    2016-08-01

    The aim of the study was to assess the efficacy and tolerability of the monthly vaginal ring (NuvaRing; 15 μg ethinylestradiol [EE] and 120 μg etonogestrel per day) compared with a monophasic (21/7) combined oral contraceptive (COC) containing 30 μg EE and 3 mg drospirenone in healthy Chinese women aged 18-40 years. This was a phase III, open-label, randomised multicentre trial conducted in China. Participants received NuvaRing or COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-free/pill-free period). Contraceptive efficacy was assessed by in-treatment pregnancies and expressed by the Pearl Index (PI; number of pregnancies/100 woman-years of use). Cycle control was assessed by unscheduled (breakthrough) and absence of scheduled (withdrawal) bleeding events. Safety and tolerability were assessed throughout the study. Participants were randomised either to the NuvaRing (n = 732) or to the COC (n = 214); 588 (82.4%) and 182 (78.4%) participants, respectively, completed the study. There were 10 in-treatment pregnancies in the NuvaRing group (PI 1.92; 95% confidence interval [CI] 0.92, 3.53) and five in the COC group (PI 3.12; 95% CI 1.01, 7.29). Breakthrough bleeding/spotting ranged from 18.6% (Cycle 1) to 4.2% (Cycle 11) for NuvaRing and from 21.6% (Cycle 1) to 7.9% (Cycle 11) for COC. Absence of withdrawal bleeding ranged from 8.6% (Cycle 1) to 3.0% (Cycle 11) for NuvaRing and from 14.6% (Cycle 1) to 6.4% (Cycle 5) for COC. For NuvaRing and COC, respectively, 26.6% and 25.0% of participants had treatment-related adverse events, and 7.0% and 9.1% discontinued the study as a result. Once-monthly NuvaRing is efficacious and safe for use in Chinese women.

  20. A randomised trial to compare i-gel and ProSeal™ laryngeal mask airway for airway management in paediatric patients

    PubMed Central

    Nirupa, R; Gombar, Satinder; Ahuja, Vanita; Sharma, Preeti

    2016-01-01

    Background and Aims: i-gel™ is a newer supraglottic airway device with a unique non-inflatable cuff. We aimed to compare i-gel™ with ProSeal™ laryngeal mask airway (PLMA™) in children scheduled for surgery under general anaesthesia (GA) with controlled ventilation. Methods: This prospective, randomised controlled study was conducted in 100 surgical patients, aged 2–6 years of American Society of Anesthesiologists Physical Status I–II scheduled under GA. Patients were randomly allocated to receive either size 2 i-gel™ or PLMA™ as an airway device. The primary aim was oropharyngeal leak pressure assessed at 5 min following correct placement of the device. Secondary outcomes measured included number of attempts, ease of insertion, time of insertion, quality of initial airway, fibre-optic grading and effects on pulmonary mechanics. Statistical analysis was done using paired t-test and Chi-square test. Results: The demographic data were similar in both the groups. The oropharyngeal leak pressure in the i-gel™ group was 29.5 ± 2.5 cmH2 O as compared to 26.1 ± 3.8 cmH2 O in PLMA™ group (P = 0.002). The time taken for successful insertion in PLMA™ was longer as compared to i-gel (12.4 ± 2.7 vs. 10.2 ± 1.9 s, P = 0.007). The quality of initial airway was superior with i-gel™. The number of attempts, ease of insertion of supraglottic device, insertion of orogastric tube and pulmonary mechanics were similar in both the groups. Conclusion: Size 2 i-gel™ exhibited superior oropharyngeal leak pressure and quality of airway in paediatric patients with controlled ventilation as compared to PLMA™ although the pulmonary mechanics were similar. PMID:27761035

  1. Pain biology education and exercise classes compared to pain biology education alone for individuals with chronic low back pain: a pilot randomised controlled trial.

    PubMed

    Ryan, Cormac G; Gray, Heather G; Newton, Mary; Granat, Malcolm H

    2010-08-01

    The aim of this single-blind pilot RCT was to investigate the effect of pain biology education and group exercise classes compared to pain biology education alone for individuals with chronic low back pain (CLBP). Participants with CLBP were randomised to a pain biology education and group exercise classes group (EDEX) [n = 20] or a pain biology education only group (ED) [n = 18]. The primary outcome was pain (0-100 numerical rating scale), and self-reported function assessed using the Roland Morris Disability Questionnaire, measured at pre-intervention, post-intervention and three month follow up. Secondary outcome measures were pain self-efficacy, pain related fear, physical performance testing and free-living activity monitoring. Using a linear mixed model analysis, there was a statistically significant interaction effect between time and intervention for both pain (F[2,49] = 3.975, p < 0.05) and pain self-efficacy (F[2,51] = 4.011, p < 0.05) with more favourable results for the ED group. The effects levelled off at the three month follow up point. In the short term, pain biology education alone was more effective for pain and pain self-efficacy than a combination of pain biology education and group exercise classes. This pilot study highlights the need to investigate the combined effects of different interventions. Copyright 2010 Elsevier Ltd. All rights reserved.

  2. Meta-analysis of drop-out rates in randomised clinical trials, comparing typical and atypical antipsychotics in the treatment of schizophrenia.

    PubMed

    Martin, José Luis R; Pérez, Víctor; Sacristán, Montse; Rodríguez-Artalejo, Fernando; Martínez, Cristóbal; Alvarez, Enric

    2006-01-01

    To assess antipsychotic medication in the treatment of schizophrenia, based on trial drop-out rates. The studies included were randomised controlled trials that compared any of the four clinically best-established atypical antipsychotics (quetiapine, olanzapine, risperidone or clozapine) against either of two typical antipsychotics regarded as the gold standard (haloperidol or chlorpromazine). Meta-analysis indicated less risk of all-cause patient withdrawal from atypical medication trials where dosage was flexible, in both the short, relative risk (RR) 0.70 (95% CI 0.64-0.76), P<0.00001, and long term, RR 0.72 (0.65-0.80), P<0.00001. Similar results were observed for withdrawal due to adverse events, RR: 0.54 (0.41-0.72), P<0.0001. Nevertheless, the favourable effects of atypical medication disappeared in trials relying on fixed dosage. We detected a significant positive effect in terms of the outcome of treatment discontinuation for atypical versus typical medication, though only where the use of flexible rather than fixed doses (closer to an experimental control situation) was possible.

  3. A prospective randomised study comparing a GnRH-antagonist versus a GnRH-agonist short protocol for ovarian stimulation in patients referred for IVF.

    PubMed

    Gordts, S; Van Turnhout, C; Campo, R; Puttemans, P; Valkenburg, M; Gordts, S

    2012-01-01

    To compare two short protocols for ovarian stimulation in IVF cycles using an antagonist and an agonist short protocol. The outcomes studied were dosis rec FSH needed, days of stimulation, number of oocytes retrieved and pregnancy outcome. A prospective randomised study design. first or second IVF attempt in women younger than 40 years. In the agonist protocol (Suprefact®) nasal spray was used. In the antagonist protocol (Orgalutran)® was started as soon as at least 1 follicle of 12 mm was visualized on ultrasound. 160 cycles were included in the study: 80 in the antagonist group and 80 in the agonist group. A higher dosis of recombinant FSH (rec FSH) was used for stimulation in the antagonist group (1897 IU versus 1655 IU). Pregnancy rate per ET in the antagonist group was 37% with an ongoing pregnancy rate of 21%/ET and an -implantation rate of 22%; versus respectively 39%, 20% and 22% in the agonist treated group. Live birth rate per started cylce was 19% in the antagonist group versus 20% in the agonist group. This study shows that implantation rates, ongoing pregnancy rates and live birth rates are equal in both groups. An identical number of oocytes was retrieved, with no difference in duration of the stimulation although a higher dosis of rec FSH was needed in the antagonist group.

  4. A prospective randomised study comparing a GnRH-antagonist versus a GnRH-agonist short protocol for ovarian stimulation in patients referred for IVF

    PubMed Central

    Gordts, S.; Van Turnhout, C.; Campo, R.; Puttemans, P.; Valkenburg, M.; Gordts, S.

    2012-01-01

    Objective: To compare two short protocols for ovarian stimulation in IVF cycles using an antagonist and an agonist short protocol. The outcomes studied were dosis rec FSH needed, days of stimulation, number of oocytes retrieved and pregnancy outcome. Methods: A prospective randomised study design. Inclusion criteria: first or second IVF attempt in women younger than 40 years. In the agonist protocol (Suprefact®) nasal spray was used. In the antagonist protocol (Orgalutran)® was started as soon as at least 1 follicle of 12 mm was visualized on ultrasound. Results: 160 cycles were included in the study: 80 in the antagonist group and 80 in the agonist group. A higher dosis of recombinant FSH (rec FSH) was used for stimulation in the antagonist group (1897 IU versus 1655 IU). Pregnancy rate per ET in the antagonist group was 37% with an ongoing pregnancy rate of 21%/ET and an implantation rate of 22%; versus respectively 39%, 20% and 22% in the agonist treated group. Live birth rate per started cylce was 19% in the antagonist group versus 20% in the agonist group. Conclusion: This study shows that implantation rates, ongoing pregnancy rates and live birth rates are equal in both groups. An identical number of oocytes was retrieved, with no difference in duration of the stimulation although a higher dosis of rec FSH was needed in the antagonist group. PMID:24753894

  5. Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial.

    PubMed

    Tsukayama, Hiroshi; Yamashita, Hitoshi; Amagai, Hitoshi; Tanno, Yasuo

    2002-12-01

    The objective of this study was to compare the effectiveness of electroacupuncture and TENS for low back pain when the electroacupuncture is applied in a clinically realistic manner. The study was designed as an evaluator-blinded randomised controlled trial (RCT). The study was performed at the Tsukuba College of Technology Clinic in Japan. Twenty subjects, who suffered from low back pain (LBP) without sciatica, were recruited, using leaflets in Tsukuba city. Subjects were allocated to either an electroacupuncture (EA) group (10 patients) or a transcutaneous electrical nerve stimulation (TENS) group (10 patients). The procedure for EA was in accordance with standard practice at our clinic. The main outcome measures were a pain relief scale (100 mm visual analogue scale: VAS) and a LBP score recommended by the Japanese Orthopaedic Association (JOA Score). Mean VAS value during the 2-weeks experimental period of the EA group was significantly smaller than that of the TENS group (65 mm vs 86 mm; 95% CI, 4.126 - 37.953). JOA Score in the EA group improved significantly while that in the TENS group showed no change. Although some placebo effect may be included, EA appeared more useful than TENS in the short-term effect on low back pain. We suggest that more realistic acupuncture interventions based on standard practice should be employed in pragmatic RCTs.

  6. Randomised controlled trial comparing the Ambu® aScope™2 with a conventional fibreoptic bronchoscope in orotracheal intubation of anaesthetised adult patients.

    PubMed

    Chan, J K; Ng, I; Ang, J P; Koh, S M; Lee, K; Mezzavia, P; Morris, J; Loh, F; Segal, R

    2015-07-01

    Fibreoptic intubation remains an essential skill for anaesthetists to master. In addition to the reusable fibrescope, an alternative disposable videoscope is available (aScope(™)2, Ambu®, Ballerup, Denmark). A total of 60 anaesthetised adult patients were randomised to either having orotracheal intubation using the aScope 2 or a Karl Storz fibrescope. Intubations were performed by experienced operators who were familiar with both devices. The primary outcome was the Global Rating Scale score. Secondary outcomes included intubation success, number of intubation attempts and intubation time. Other subjective outcomes including practicality, useability and image quality were also recorded. There was no significant difference in the Global Rating Scale score, intubation success orintubation time between the aScope 2 or Karl Storz fibrescope. Global Rating Scale scores were three and two in the aScope 2 and Karl Storz groups respectively (P=0.14). All of the other subjective outcomes were similar between the two groups, except that operators found it easier to use the aScope 2 compared to the fibrescope. There was no significant difference in clinical performance between the aScope 2 and the Karl Storz fibreoptic bronchoscope. The aScope's practicality, disposability and recently improved version (aScope(™)3) potentially make it an acceptable alternative to the reusable fibrescope.

  7. A randomised controlled trial comparing graded exercise treatment and usual physiotherapy for patients with non-specific neck pain (the GET UP neck pain trial).

    PubMed

    McLean, Sionnadh M; Klaber Moffett, Jennifer A; Sharp, Donald M; Gardiner, Eric

    2013-06-01

    Evidence supports exercise-based interventions for the management of neck pain, however there is little evidence of its superiority over usual physiotherapy. This study investigated the effectiveness of a group neck and upper limb exercise programme (GET) compared with usual physiotherapy (UP) for patients with non-specific neck pain. A total of 151 adult patients were randomised to either GET or UP. The primary measure was the Northwick Park Neck pain Questionnaire (NPQ) score at six weeks, six months and 12 months. Mixed modelling identified no difference in neck pain and function between patients receiving GET and those receiving UP at any follow-up time point. Both interventions resulted in modest significant and clinically important improvements on the NPQ score with a change score of around 9% between baseline and 12 months. Both GET and UP are appropriate clinical interventions for patients with non-specific neck pain, however preferences for treatment and targeted strategies to address barriers to adherence may need to be considered in order to maximise the effectiveness of these approaches. Copyright © 2012 Elsevier Ltd. All rights reserved.

  8. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV) results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community), participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their best possible outcome and may

  9. A randomised controlled trial to compare the clinical and cost-effectiveness of prism glasses, visual search training and standard care in patients with hemianopia following stroke: a protocol.

    PubMed

    Rowe, F J; Barton, P G; Bedson, E; Breen, R; Conroy, E J; Cwiklinski, E; Dodridge, C; Drummond, A; Garcia-Finana, M; Howard, C; Johnson, S; MacIntosh, C; Noonan, C P; Pollock, A; Rockliffe, J; Sackley, C; Shipman, T

    2014-07-17

    Homonymous hemianopia is a common and disabling visual problem after stroke. Currently, prism glasses and visual scanning training are proposed to improve it. The aim of this trial is to determine the effectiveness of these interventions compared to standard care. The trial will be a multicentre three arm individually randomised controlled trial with independent assessment at 6 week, 12 week and 26 week post-randomisation. Recruitment will occur in hospital, outpatient and primary care settings in UK hospital trusts. A total of 105 patients with homonymous hemianopia and without ocular motility impairment, visual inattention or pre-existent visual field impairment will be randomised to one of three balanced groups. Randomisation lists will be stratified by site and hemianopia level (partial or complete) and created using simple block randomisation by an independent statistician. Allocations will be disclosed to patients by the treating clinician, maintaining blinding for outcome assessment. The primary outcome will be change in visual field assessment from baseline to 26 weeks. Secondary measures will include the Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual-5D and Short Form-12 questionnaires. Analysis will be by intention to treat. This study has been developed and supported by the UK Stroke Research Network Clinical Studies Group working with service users. Multicentre ethical approval was obtained through the North West 6 Research ethics committee (Reference 10/H1003/119). The trial is funded by the UK Stroke Association. Trial Registration: Current Controlled Trials ISRCTN05956042. Dissemination will consider usual scholarly options of conference presentation and journal publication in addition to patient and public dissemination with lay summaries and articles. Current Controlled Trials ISRCTN05956042. Published by the BMJ Publishing Group Limited. For permission to use (where

  10. A randomised controlled trial to compare the clinical and cost-effectiveness of prism glasses, visual search training and standard care in patients with hemianopia following stroke: a protocol

    PubMed Central

    Rowe, F J; Barton, P G; Bedson, E; Breen, R; Conroy, E J; Cwiklinski, E; Dodridge, C; Drummond, A; Garcia-Finana, M; Howard, C; Johnson, S; MacIntosh, C; Noonan, C P; Pollock, A; Rockliffe, J; Sackley, C; Shipman, T

    2014-01-01

    Introduction Homonymous hemianopia is a common and disabling visual problem after stroke. Currently, prism glasses and visual scanning training are proposed to improve it. The aim of this trial is to determine the effectiveness of these interventions compared to standard care. Methods and analysis The trial will be a multicentre three arm individually randomised controlled trial with independent assessment at 6 week, 12 week and 26 week post-randomisation. Recruitment will occur in hospital, outpatient and primary care settings in UK hospital trusts. A total of 105 patients with homonymous hemianopia and without ocular motility impairment, visual inattention or pre-existent visual field impairment will be randomised to one of three balanced groups. Randomisation lists will be stratified by site and hemianopia level (partial or complete) and created using simple block randomisation by an independent statistician. Allocations will be disclosed to patients by the treating clinician, maintaining blinding for outcome assessment. The primary outcome will be change in visual field assessment from baseline to 26 weeks. Secondary measures will include the Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual-5D and Short Form-12 questionnaires. Analysis will be by intention to treat. Ethics and dissemination This study has been developed and supported by the UK Stroke Research Network Clinical Studies Group working with service users. Multicentre ethical approval was obtained through the North West 6 Research ethics committee (Reference 10/H1003/119). The trial is funded by the UK Stroke Association. Trial Registration: Current Controlled Trials ISRCTN05956042. Dissemination will consider usual scholarly options of conference presentation and journal publication in addition to patient and public dissemination with lay summaries and articles. Trial Registration Current Controlled Trials ISRCTN05956042

  11. A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans.

    PubMed

    Jeong, I D; Camilleri, M; Shin, A; Iturrino, J; Boldingh, A; Busciglio, I; Burton, D; Ryks, M; Rhoten, D; Zinsmeister, A R

    2012-05-01

    Tapentadol is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor. In clinical trials, tapentadol provided somatic pain relief comparable to mu-opioids such as oxycodone, with significantly less gastrointestinal adverse effects. The acute effects of tapentadol on gastrointestinal and colonic transit are unclear. To compare acute effects of oral tapentadol and oxycodone on gastric, small bowel and colonic transit of solids in 38 healthy human subjects. In a randomised, parallel-group, double-blind, placebo-controlled study of the effects of identical-appearing tapentadol immediate release (IR), 75 mg t.d.s., or oxycodone IR, 5 mg t.d.s., for 48 h, we measured gastric (GE), small bowel (SBT measured as colonic filling at 6 h) and colonic transit by validated scintigraphy. Drug was commenced on the evening before the start of the transit test. The primary endpoints were overall colonic transit (geometric centre, GC) at 24 h and GE half-time (t1/2 ). ancova of transit data included gender or BMI as covariates. Adverse effects were summarised. At the doses tested, oxycodone and tapentadol significantly delayed GE t1/2 and SBT, but not overall colonic transit, compared to placebo. Transit profiles in all regions were not significantly different between oxycodone and tapentadol at the doses tested. Both oxycodone and tapentadol were associated with nausea and central effects attributable to central opiate effects. Tapentadol significantly delayed gastric emptying t1/2 and small bowel transit, similar to oxycodone. These data suggest that acute administration of tapentadol may not have significant advantages over standard mu-opioids, in terms of the potential to avoid upper gastrointestinal motor dysfunction. © 2012 Blackwell Publishing Ltd.

  12. A randomised crossover simulation study comparing the impact of chemical, biological, radiological or nuclear substance personal protection equipment on the performance of advanced life support interventions.

    PubMed

    Schumacher, J; Arlidge, J; Garnham, F; Ahmad, I

    2017-03-02

    Recent incidents involving chemical, biological, radiological and nuclear substances have stressed the importance of sufficient personal protection equipment for medical first-responders. Modern lightweight, battery-independent, suit ensembles may prove superior to the current protective suit used in the UK. This study compared the powered respiratory protective suit (PRPS ensemble) with a lightweight suit consisting of a SARATOGA(®) Multipurpose CBRN Protective Coverall Polyprotect 12 in conjunction with the Avon C50 Respirator/Avon CBRNF12CE filter canister and butyl rubber protective gloves (Polyprotect 12 ensemble). Thirty anaesthetists carried out a standardised resuscitation scenario either unprotected (control) or wearing the PRPS or Polyprotect 12 ensembles in a randomised, crossover simulation study. Treatment times for five simulated advanced life support interventions (application of monitoring; bag/mask ventilation; tracheal intubation; drug and fluid administration; and external pacing) were measured. Wearer comfort was also assessed for the two protective suits by questionnaire. All participants accomplished the treatment objectives of all study arms without adverse events. Total mean (SD) completion time for the five interventions was significantly longer for the PRPS compared with the Polyprotect 12 ensemble (204 (53) s vs. 149 (36) s, respectively; p < 0.0001). Participants rated mobility, noise, heat, vision, dexterity and speech intelligibility significantly better in the Polyprotect 12 ensemble compared with the PRPS ensemble. The combination of a lightweight Polyprotect 12 suit and an Avon C50 air-purifying respirator is preferable to the powered respiratory protective suit during simulated emergency life support, due to a combination of shorter task completion times and improved mobility, communication and dexterity.

  13. Northern Manhattan Hispanic Caregiver Intervention Effectiveness Study: protocol of a pragmatic randomised trial comparing the effectiveness of two established interventions for informal caregivers of persons with dementia

    PubMed Central

    Luchsinger, José A; Burgio, Louis; Mittelman, Mary; Dunner, Ilana; Levine, Jed A; Kong, Jian; Silver, Stephanie; Ramirez, Mildred; Teresi, Jeanne A

    2016-01-01

    Introduction The prevalence of dementia is increasing without a known cure, resulting in an increasing number of informal caregivers. Caring for a person with dementia results in increased stress and depressive symptoms. There are several behavioural interventions designed to alleviate stress and depressive symptoms in caregivers of persons with dementia with evidence of efficacy. Two of the best-known interventions are the New York University Caregiver Intervention (NYUCI) and the Resources for Enhancing Alzheimer's Caregivers Health (REACH). The effectiveness of the NYUCI and REACH has never been compared. There is also a paucity of data on which interventions are more effective in Hispanics in New York City. Thus, we proposed the Northern Manhattan Hispanic Caregiver intervention Effectiveness Study (NHiCE), a pragmatic clinical trial designed to compare the effectiveness of adaptations of the NYUCI and the REACH in informal Hispanic caregivers of persons with dementia in New York City. Methods and analysis NHiCE is a 6-month randomised controlled trial comparing the effectiveness of adaptations of the NYUCI and REACH among 200 Hispanic informal adult caregivers of persons with dementia. The planned number of sessions of the NYUCI and REACH are similar. The primary outcome measures are changes from baseline to 6 months in the Zarit Caregiver Burden Scale and Geriatric Depression Scale. Our primary approach to analyses will be intent-to-treat. The primary analyses will use mixed random effects models, and a full information maximum likelihood approach, with sensitivity analyses using generalised estimating equation. Ethics and dissemination NHiCE is approved by the Institutional Review Board of Columbia University Medical Center (protocol AAAM5150). A Data Safety Monitoring Board monitors the progress of the study. Dissemination will include reports of the characteristics of the study participants, as well as a report of the results of the clinical trial. Trial

  14. A randomised trial of the pharmacodynamic and pharmacokinetic effects of ticagrelor compared with clopidogrel in Hispanic patients with stable coronary artery disease.

    PubMed

    Price, Matthew J; Clavijo, Leonardo; Angiolillo, Dominick J; Carlson, Glenn; Caplan, Richard; Teng, Renli; Maya, Juan

    2015-01-01

    The objective was to compare the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ticagrelor with clopidogrel among subjects of Hispanic ethnicity, as the PD and PK effects of antiplatelet agents among Hispanics are not specifically known. This was a randomised, open-label, crossover PD/PK study of 40 Hispanic subjects with stable coronary artery disease (CAD). Subjects were allocated to either ticagrelor 180 mg loading dose (LD)/90 mg twice-daily maintenance dose (MD) followed by clopidogrel 600 mg LD/75 mg once-daily MD with an intervening washout period, or vice versa. The primary endpoint was on-treatment reactivity (OTR) at 2 h post-LD according to the VerifyNow P2Y12 test. OTR was significantly lower at 2 h post-LD with ticagrelor compared with clopidogrel (34 PRU vs. 201 PRU, least square means difference = -167 PRU [95 % CI, -197, -137], P < 0.001). OTR was also lower with ticagrelor at 30 min and 8 h post-LD (P < 0.001). The greater magnitude of antiplatelet effect with ticagrelor persisted after 7 days of MD (52 PRU [95 % CI, 30, 73] vs. 182 PRU [95 % CI, 160, 205], P < 0.001). Mean plasma concentration of ticagrelor and its active metabolite were greatest at 2 h post-LD, with similar levels at 2 h post-MD after 7 days of MD. Among Hispanic subjects with stable CAD, ticagrelor provides a more rapid onset of platelet inhibition and a significantly greater antiplatelet effect compared with clopidogrel during both the loading and maintenance phases of treatment.

  15. Efficacy and safety of mepivacaine compared with lidocaine in local anaesthesia in dentistry: a meta-analysis of randomised controlled trials.

    PubMed

    Su, Naichuan; Liu, Yan; Yang, Xianrui; Shi, Zongdao; Huang, Yi

    2014-04-01

    The objective of the study was to assess the efficacy and safety of mepivacaine compared with lidocaine used in local anaesthesia in dentistry. Medline, Cochrane Central Register of Controlled Trials, EMBASE, Chinese BioMedical Literature Database, China National Knowledge Infrastructure and WHO International Clinical Trials Registry Platform were searched electronically. Relevant journals and references of studies included were hand-searched for randomised controlled trials comparing mepivacaine with lidocaine in terms of efficacy and safety. Twenty-eight studies were included, of which 15 had low risk of bias and 13 had moderate risk of bias. In comparison with 2% lidocaine with 1:100,000 adrenaline, 3% mepivacaine showed a lower success rate (P = 0.05), a shorter onset time of pulpal anaesthesia (P = 0.0005), inferior pain control during injection phase and superior inhibition of heart rate increase (P < 0.0001). In contrast, 2% mepivacaine with 1:100,000 adrenaline gave a higher success rate (P < 0.00001), a similar onset time of pulpal anaesthesia (P = 0.34) and superior pain control during injection phase (P < 0.0001); 2% mepivacaine with 1:20,000 levonordefrin had the same success rate (P = 0.69) and similar onset time of pulpal anaesthesia (P = 0.90). In addition, 3% mepivacaine had shorter onset time (P = 0.004), same level of success rate (P = 0.28) and similar pain control during injection and postinjection compared with 2% lidocaine with 1:50,000 adrenaline. Given the efficacy and safety of the two solutions, 2% mepivacaine with vasoconstrictors is better than 2% lidocaine with vasoconstrictors in dental treatment. Meanwhile, 3% plain mepivacaine is better for patients with cardiac diseases. © 2014 FDI World Dental Federation.

  16. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for children at 18 months

    PubMed Central

    2007-01-01

    Objective To assess the long-term effects of in utero exposure to magnesium sulphate for children whose mothers had pre-eclampsia. Design Assessment at 18 months of age for children whose mothers were recruited to the Magpie Trial (recruitment 1998–2001 ISRCTN 86938761), which compared magnesium sulphate with placebo. Setting Follow-up of children born at 125 centres in 19 countries across five continents. Population A total of 6922 children were born to women randomised before delivery at follow-up centres. Of these, 2271 were not included for logistic reasons and 168 were excluded (101 at a centre where <20% were contacted, 40 whose death or disability was due to a problem at conception or embryogenesis and 27 whose parent/s opted out). Therefore, 4483 children were included in follow-up, of whom 3283 (73%) were contacted. Methods Assessment by questionnaire, with interview and neurodevelopmental testing of selected children. Main outcome measures Death or neurosensory disability at age of 18 months. Results Of those allocated magnesium sulphate, 245/1635 (15.0%) were dead or had neurosensory disability at 18 months compared with 233/1648 (14.1%) allocated placebo (relative risk [RR] 1.06, 95% CI 0.90–1.25), and of survivors, 19/1409 (1.3%) had neurosensory disability at 18 months compared with 27/1442 (1.9%) (RR 0.72, 95% CI 0.40–1.29). There were no substantial differences in causes of death or in the risk of individual impairments or disabilities. Conclusions The lower risk of eclampsia following prophylaxis with magnesium sulphate was not associated with a clear difference in the risk of death or disability for children at 18 months. PMID:17166221

  17. A non-randomised trial investigating the cost-effectiveness of Midwifery Group Practice compared with standard maternity care arrangements in one Australian hospital.

    PubMed

    Toohill, Jocelyn; Turkstra, Erika; Gamble, Jenny; Scuffham, Paul A

    2012-12-01

    to compare cost-effectiveness of two models of maternity service delivery: Midwifery Group Practice (MGP) at a birth centre and standard care (SC). a prospective non-randomised trial. an Australian metropolitan hospital. women at 36 weeks gestation were approached in the birth centre or hospital antenatal clinics between March and December 2008. Of 170 consecutive women who met birth centre eligibility criteria, 70% (n=119) were recruited to the study. Women (MGP n=52 or standard care n=50) were followed through to 6 weeks postpartum. Publically funded care costs were collected from women's diaries, handheld pregnancy health records, medical records and the hospital accounting system. health-care costs to the hospital and government. generalised linear models with covariates of age, nulliparity, private health insurance (yes/no) and household income category. women receiving MGP care were less likely to experience induction of labour, required fewer antenatal visits, received more postnatal care, and neonates were less likely to be admitted to special care nursery than those receiving standard care. Statistically significant lower costs were found for women and babies receiving MGP care compared with women receiving standard care during pregnancy, labour and birth and postpartum to 6 weeks. MGP resulted in lower costs for the hospital ($AUD4,696 vs. $AUD5,521 p<0.001) and the government ($AUD4,722 vs. $AUD5,641 p<0.001). When baby costs were excluded MGP care remained statistically significantly cheaper than standard care. for women at low-risk of birth complications, Midwifery Group Practice was cost effective, and women experienced fewer obstetric interventions compared with standard maternity care. The evidence suggests Midwifery Group Practice is safe and economically viable. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. Efficacy of low-level laser therapy applied at acupuncture points in knee osteoarthritis: a randomised double-blind comparative trial.

    PubMed

    Al Rashoud, A S; Abboud, R J; Wang, W; Wigderowitz, C

    2014-09-01

    To evaluate the efficacy of low-level laser therapy (LLLT) applied to acupuncture points on the knee joint in combination with exercise and advice in patients with knee osteoarthritis. Randomised, double-blind, comparative clinical trial. Forty-nine patients with knee osteoarthritis were assigned at random into two groups: active laser group (n=26) and placebo laser group (n=23). Using a gallium aluminium arsenide laser device, patients received either active or placebo LLLT at five acupuncture points on the affected knee during nine sessions. Patients were assessed using a visual analogue scale (VAS) and the Saudi Knee Function Scale (SKFS) at baseline, the fifth treatment session, the last treatment session, 6 weeks post intervention and 6 months post intervention. VAS scores showed a significant improvement in the active laser group compared with the placebo laser group at 6 weeks post intervention [mean difference -1.3, 95% confidence interval (CI) of the difference -2.4 to -0.3; P=0.014] and 6 months post intervention (mean difference -1.8, 95% CI of the difference -3.0 to -0.7; P=0.003) using the independent samples test. SKFS scores also showed a significant improvement in the active laser group compared with the placebo laser group at the last treatment session (median difference -15, 95% CI of the difference -27 to -2; P=0.035) and 6 months post intervention (median difference -21, 95% CI of the difference -34 to -7; P=0.006) using the Mann-Whitney U test. The results demonstrate that short-term application of LLLT to specific acupuncture points in association with exercise and advice is effective in reducing pain and improving quality of life in patients with knee osteoarthritis. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  19. Preventing Australian football injuries with a targeted neuromuscular control exercise programme: comparative injury rates from a training intervention delivered in a clustered randomised controlled trial

    PubMed Central

    Twomey, Dara M; Fortington, Lauren V; Doyle, Tim L A; Elliott, Bruce C; Akram, Muhammad; Lloyd, David G

    2016-01-01

    Background Exercise-based training programmes are commonly used to prevent sports injuries but programme effectiveness within community men's team sport is largely unknown. Objective To present the intention-to-treat analysis of injury outcomes from a clustered randomised controlled trial in community Australian football. Methods Players from 18 male, non-elite, community Australian football clubs across two states were randomly allocated to either a neuromuscular control (NMC) (intervention n=679 players) or standard-practice (control n=885 players) exercise training programme delivered as part of regular team training sessions (2× weekly for 8-week preseason and 18-week regular-season). All game-related injuries and hours of game participation were recorded. Generalised estimating equations, adjusted for clustering (club unit), were used to compute injury incidence rates (IIRs) for all injuries, lower limb injuries (LLIs) and knee injuries sustained during games. The IIRs were compared across groups with cluster-adjusted Injury Rate Ratios (IRRs). Results Overall, 773 game injuries were recorded. The lower limb was the most frequent body region injured, accounting for 50% of injuries overall, 96 (12%) of which were knee injuries. The NMC players had a reduced LLI rate compared with control players (IRR: 0.78 (95% CI 0.56 to 1.08), p=0.14.) The knee IIR was also reduced for NMC compared with control players (IRR: 0.50 (95% CI 0.24 to 1.05), p=0.07). Conclusions These intention-to-treat results indicate that positive outcomes can be achieved from targeted training programmes for reducing knee and LLI injury rates in men's community sport. While not statistically significant, reducing the knee injury rate by 50% and the LLI rate by 22% is still a clinically important outcome. Further injury reductions could be achieved with improved training attendance and participation in the programme. PMID:26399611

  20. Randomised trial comparing the recording ability of a novel, electronic emergency documentation system with the AHA paper cardiac arrest record.

    PubMed

    Grigg, Eliot; Palmer, Andrew; Grigg, Jeffrey; Oppenheimer, Peter; Wu, Tim; Roesler, Axel; Nair, Bala; Ross, Brian

    2014-10-01

    To evaluate the ability of an electronic system created at the University of Washington to accurately document prerecorded VF and pulseless electrical activity (PEA) cardiac arrest scenarios compared with the American Heart Association paper cardiac arrest record. 16 anaesthesiology residents were randomly assigned to view one of two prerecorded, simulated VF and PEA scenarios and asked to document the event with either the paper or electronic system. Each subject then repeated the process with the other video and documentation method. Five types of documentation errors were defined: (1) omission, (2) specification, (3) timing, (4) commission and (5) noise. The mean difference in errors between the paper and electronic methods was analysed using a single factor repeated measures ANOVA model. Compared with paper records, the electronic system omitted 6.3 fewer events (95% CI -10.1 to -2.5, p=0.003), which represents a 28% reduction in omission errors. Users recorded 2.9 fewer noise items (95% CI -5.3 to -0.6, p=0.003) when compared with paper, representing a 36% decrease in redundant or irrelevant information. The rate of timing (Δ=-3.2, 95% CI -9.3 to 3.0, p=0.286) and commission (Δ=-4.4, 95% CI -9.4 to 0.5, p=0.075) errors were similar between the electronic system and paper, while the rate of specification errors were about a third lower for the electronic system when compared with the paper record (Δ=-3.2, 95% CI -6.3 to -0.2, p=0.037). Compared with paper documentation, documentation with the electronic system captured 24% more critical information during a simulated medical emergency without loss in data quality. 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.

  1. Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial.

    PubMed

    Xhepa, Erion; Byrne, Robert A; Schulz, Stefanie; Helde, Sandra; Gewalt, Senta; Cassese, Salvatore; Linhardt, Maryam; Ibrahim, Tareq; Mehilli, Julinda; Hoppe, Katharina; Grupp, Katharina; Kufner, Sebastian; Böttiger, Corinna; Hoppmann, Petra; Burgdorf, Christof; Fusaro, Massimiliano; Ott, Ilka; Schneider, Simon; Hengstenberg, Christian; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan

    2014-06-01

    Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking. The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial is a prospective, randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis. The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications. Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD, EXOSEAL VCD or manual compression. The primary endpoint is the incidence of the composite of arterial access-related complications (haematoma ≥5 cm, pseudoaneurysm, arteriovenous fistula, access-site-related bleeding, acute ipsilateral leg ischaemia, the need for vascular surgical/interventional treatment or documented local infection) at 30 days after randomisation. According to power calculations based on non-inferiority hypothesis testing, enrolment of 4,500 patients is planned. The trial is registered at www.clinicaltrials.gov (study identifier: NCT01389375). The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise. The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications.

  2. Efficacy and safety of scorpion antivenom plus prazosin compared with prazosin alone for venomous scorpion (Mesobuthus tamulus) sting: randomised open label clinical trial

    PubMed Central

    2011-01-01

    Objective Envenomation by Mesobuthus tamulus scorpion sting can result in serious cardiovascular effects. Scorpion antivenom is a specific treatment for scorpion sting. Evidence for the benefit of scorpion antivenom and its efficacy compared with that of commonly used vasodilators, such as prazosin, is scarce. We assessed the efficacy of prazosin combined with scorpion antivenom, compared with prazosin alone, in individuals with autonomic storm caused by scorpion sting. Design Prospective, open label randomised controlled trial. Setting General hospital inpatients (Bawaskar Hospital and Research Centre Mahad Dist-Raigad Maharashtra, India). Participants Seventy patients with grade 2 scorpion envenomation, older than six months, with no cardiorespiratory or central nervous system abnormalities. Intervention Scorpion antivenom plus prazosin (n=35) or prazosin alone (n=35) assigned by block randomisation. Treatment was not masked. Analysis was by intention to treat. Main outcome measures The primary end point was the proportion of patients achieving resolution of the clinical syndrome (sweating, salivation, cool extremities, priapism, hypertension or hypotension, tachycardia) 10 hours after administration of study drugs. Secondary end points were time required for complete resolution of clinical syndrome, prevention of deterioration to higher grade, doses of prazosin required overall and within 10 hours, and adverse events. The study protocol was approved by the independent ethics committee of Mumbai. Results Mean (SD) recovery times in hours for the prazosin plus scorpion antivenom group compared with the prazosin alone groups were: sweating 3 (1.1) v 6.6 (2.6); salivation 1.9 (0.9) v 3 (1.9); priapism 4.7 (1.5) v 9.4 (1.5). Mean (SD) doses of prazosin in the groups were 2 (2.3) and 4 (3.5), respectively. 32 patients (91.4%, 95% confidence interval 76.9% to 97.8%) in the prazosin plus antivenom group showed complete resolution of the clinical syndrome within 10 hours

  3. Efficacy and safety of scorpion antivenom plus prazosin compared with prazosin alone for venomous scorpion (Mesobuthus tamulus) sting: randomised open label clinical trial.

    PubMed

    Bawaskar, Himmatrao Saluba; Bawaskar, Pramodini Himmatrao

    2011-01-05

    Envenomation by Mesobuthus tamulus scorpion sting can result in serious cardiovascular effects. Scorpion antivenom is a specific treatment for scorpion sting. Evidence for the benefit of scorpion antivenom and its efficacy compared with that of commonly used vasodilators, such as prazosin, is scarce. We assessed the efficacy of prazosin combined with scorpion antivenom, compared with prazosin alone, in individuals with autonomic storm caused by scorpion sting. Prospective, open label randomised controlled trial. General hospital inpatients (Bawaskar Hospital and Research Centre Mahad Dist-Raigad Maharashtra, India). Seventy patients with grade 2 scorpion envenomation, older than six months, with no cardiorespiratory or central nervous system abnormalities. Scorpion antivenom plus prazosin (n=35) or prazosin alone (n=35) assigned by block randomisation. Treatment was not masked. Analysis was by intention to treat. The primary end point was the proportion of patients achieving resolution of the clinical syndrome (sweating, salivation, cool extremities, priapism, hypertension or hypotension, tachycardia) 10 hours after administration of study drugs. Secondary end points were time required for complete resolution of clinical syndrome, prevention of deterioration to higher grade, doses of prazosin required overall and within 10 hours, and adverse events. The study protocol was approved by the independent ethics committee of Mumbai. Mean (SD) recovery times in hours for the prazosin plus scorpion antivenom group compared with the prazosin alone groups were: sweating 3 (1.1) v 6.6 (2.6); salivation 1.9 (0.9) v 3 (1.9); priapism 4.7 (1.5) v 9.4 (1.5). Mean (SD) doses of prazosin in the groups were 2 (2.3) and 4 (3.5), respectively. 32 patients (91.4%, 95% confidence interval 76.9% to 97.8%) in the prazosin plus antivenom group showed complete resolution of the clinical syndrome within 10 hours of administration of treatment compared with eight patients in the prazosin

  4. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    PubMed

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  5. Trimethopim-sulfamethoxazole compared with benzathine penicillin for treatment of impetigo in Aboriginal children: a pilot randomised controlled trial.

    PubMed

    Tong, Steven Y C; Andrews, Ross M; Kearns, Therese; Gundjirryirr, Rosalyn; McDonald, Malcolm I; Currie, Bart J; Carapetis, Jonathan R

    2010-03-01

    We conducted a pilot randomized controlled trial comparing trimethoprim-sulfamethoxazole to benzathine penicillin for treatment of impetigo in Aboriginal children. Treatment was successful in 7 of 7 children treated with trimethoprim-sulfamethoxazole and 5 of 6 treated with benzathine penicillin. Trimethoprim-sulfamethoxazole achieved microbiological clearance and healing of sores from which beta-hemolytic streptococci and community-associated methicillin-resistant Staphylococcus aureus were initially cultured.

  6. Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain)

    PubMed Central

    Dean, Sarah G; Poltawski, Leon; Forster, Anne; Taylor, Rod S; Spencer, Anne; James, Martin; Allison, Rhoda; Stevens, Shirley; Norris, Meriel; Shepherd, Anthony I; Calitri, Raff

    2016-01-01

    Introduction The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. Methods and analysis A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis. Ethics and dissemination National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data

  7. Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans

    PubMed Central

    Vesga, Boris; Hernandez, Hector; Higuera, Sergio; Gasior, Pawel; Echeveri, Dario; Delgado, Juan A; Dager, Antonio; Arana, Camilo; Simonton, Charles; Maehara, Akiko; Palmaz, Julio; Granada, Juan F

    2017-01-01

    Objective To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation. Background In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS). Methods A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis. Results At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75–95.52) compared with the MSG group (74.21%, 58.85–86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group. Conclusions MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents. Classifications BMS, OCT, clinical trials. PMID:28674616

  8. Long-term outcomes of provisional stenting compared with a two-stent strategy for bifurcation lesions: a meta-analysis of randomised trials.

    PubMed

    Nairooz, Ramez; Saad, Marwan; Elgendy, Islam Y; Mahmoud, Ahmed N; Habash, Fuad; Sardar, Partha; Anderson, David; Shavelle, David M; Abbott, J Dawn

    2017-09-01

    The optimal interventional technique for addressing coronary bifurcation lesions is debatable. Long-term clinical outcomes with provisional stenting (PS) compared with a two-stent (TS) strategy for bifurcation lesions are scarce. We aim to perform the first meta-analysis of randomised controlled trials (RCTs) to explore long-term outcomes comparing both strategies. An electronic search was performed for online databases until August 2016 for RCTs comparing PS with TS for bifurcation lesions reporting outcomes at 1 year of follow-up or more. Random effects model risk ratios (RRs) were calculated for outcomes of interest. Eight RCTs with a total of 2778 patients reported long-term clinical outcomes. At mean follow-up of 3.0±1.6 years, PS was associated with lower risk of all-cause mortality (RR=0.66; 95% CI 0.45 to 0.98; p=0.04) compared with TS for bifurcation lesions. No difference was observed with PS compared with TS regarding major adverse cardiac events (MACE), myocardial infarction (MI), target lesion revascularisation (TLR) or stent thrombosis (ST). In a sensitivity analysis limited to trials with follow-up duration ≥3 years, PS was associated with lower risk of all-cause mortality (RR=0.57; 95% CI 0.36 to 0.88; p=0.01), MACE (RR=0.71; 95% CI 0.52 to 0.97; p=0.03) and MI (RR=0.45; 95% CI 0.21 to 0.96; p=0.04) compared with TS, at mean follow-up of 4.6±0.7 years. The risk of TLR and ST remained similar with both strategies (RR=0.81; 95% CI 0.57 to 1.15; p=0.24; and RR=0.75; 95% CI 0.19 to 2.84; p=0.67 respectively). Meta-regression analyses identified increased risk of MACE with PS in patients presenting with acute coronary syndrome (p=0.05). PS may be associated with a long-term mortality benefit compared with a TS strategy for coronary bifurcation lesions. © 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.

  9. A prospective randomised comparative study of endoscopic band ligation versus injection sclerotherapy of bleeding internal haemorrhoids in patients with liver cirrhosis.

    PubMed

    Awad, Atif ElSayed; Soliman, Hanan Hamed; Saif, Sabry Abdel Latif Abou; Darwish, Abdel Monem Nooman; Mosaad, Samah; Elfert, Asem Ahmed

    2012-06-01

    Bleeding internal haemorrhoids are common and used to be treated surgically with too many complications. Endoscopic therapy is trying to take the lead. Sclerotherapy and rubber band ligation are the candidates to replace surgical therapy especially in patients with liver cirrhosis. The aim of this study was to compare endoscopic injection sclerotherapy (EIS) to endoscopic rubber band ligation (EBL) regarding effectiveness and complications in the treatment of bleeding internal haemorrhoids in Egyptian patients with liver cirrhosis. One hundred and twenty adult patients with liver cirrhosis and bleeding internal haemorrhoids were randomised into two equal groups; the first treated with EBL using Saeed multiband ligator, and the second with EIS using either ethanolamine oleate 5% or N-butyl cyanoacrylate. All groups were matched as regards age, sex, Child score and pre-procedure Doppler values. Patients were followed up clinically and with abdominal ultrasound/Doppler for 6 months. Endoscopic and endosonography/Doppler was done before and one month after the procedure. Pre and post-procedure data were recorded and analysed. Both techniques were highly effective in the control of bleeding from internal haemorrhoids with a low rebleeding [10% in the EBL group and 13.33% in the EIS group] and recurrence [20% in the EBL group 20% in the EIS group] rates. Child score had a positive correlation with rebleeding and recurrence in EIS group only. Pain score and need for analgesia were significantly higher while patient satisfaction was significantly lower in EIS compared to EBL [p<0.05]. No significant difference between ethanolamine and cyanoacrylate subgroups was found [p>0.05]. Both EBL and EIS were effective in the treatment of bleeding internal haemorrhoids in patients with liver cirrhosis. EBL had significantly less pain and higher patient satisfaction than EIS. EBL was also safer in patients with advanced cirrhosis. Copyright © 2012 Arab Journal of Gastroenterology

  10. Comparable effect of aliskiren or a diuretic added on an angiotensin II receptor blocker on augmentation index in hypertension: a multicentre, prospective, randomised study

    PubMed Central

    Miyoshi, Toru; Murakami, Takashi; Sakuragi, Satoru; Doi, Masayuki; Nanba, Seiji; Mima, Atsushi; Tominaga, Youkou; Oka, Takafumi; Kajikawa, Yutaka; Nakamura, Kazufumi; Ito, Hiroshi

    2017-01-01

    Background The effects of antihypertensive drug combination therapy on central blood pressure (BP) and augmentation index (AI) have not been fully elucidated. We investigated the effects of the direct renin inhibitor, aliskiren, or a diuretic added to an angiotensin II receptor blocker on AI in patients with essential hypertension. Methods A 24-week, prospective, multicentre, randomised, open-label study enrolled 103 patients already treated with valsartan. Participants were randomly allocated to receive either valsartan with aliskiren (V+A), or valsartan with trichlormethiazide (V+T). The primary outcome was the change in AI derived from radial artery tonometry. Secondary outcome measures included systolic and diastolic BP, cardio-ankle vascular index (CAVI, which reflects arterial stiffness) and urinary 8-hydroxydeoxyguanosine concentration. Results After 24 weeks, systolic and diastolic BP were significantly reduced in both groups to a broadly comparable extent. There was no significant difference in AI at the end of the study between the V+A group and the V+T group (between-group difference: −2.3%, 95% CI −6.9% to 2.2%, p=0.31). Central BP at the end of the study also did not differ between the two groups (p=0.62). There was no significant difference in the CAVI between the groups at the end of the study. Urinary 8-hydroxydeoxyguanosine concentration was significantly lower in the V+A group than in the V+T group (p<0.01), suggesting that V+A attenuated oxidative stress more than V+T. Conclusion The combination of valsartan and aliskiren had an effect on AI comparable with that of the combination of valsartan and trichlormethiazide. UMIN Clinical Trial Registration number UMIN000005726. PMID:28409014

  11. Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department

    PubMed Central

    Reynolds, Stacy L; Studnek, Jonathan R; Bryant, Kathleen; VanderHave, Kelly; Grossman, Eric; Moore, Charity G; Young, James; Hogg, Melanie; Runyon, Michael S

    2016-01-01

    Introduction Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. Methods and analysis This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4–17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. Ethics and dissemination This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. Trial registration number NCT02521415. PMID:27609854

  12. A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin.

    PubMed

    Djokic-Gallagher, Jasmina; Rosher, Phil; Oliveira, Gabriela; Walker, Jennine

    2017-07-04

    Healthcare professionals tend to recommend emollients based primarily on patient/consumer preference and cost, with cheaper options assumed to be therapeutically equivalent. The aim of this study was therefore to compare the effects on skin hydration of two emollients prescribed in the UK, Doublebase Dayleve™ gel (DELP) and a cheaper alternative, Zerobase Emollient™ cream (ZBC). This was a single-centre, randomised, double-blind, concurrent bi-lateral (within-patient) comparison in 18 females with atopic eczema and dry skin on their lower legs. DELP gel and ZBC cream were each applied to one lower leg twice daily for 4 days and on the morning only on day 5. The efficacy of both products was assessed by hydration measurements using a Corneometer CM825 probe (Courage-Khazaka Electronic). The measurements were made three times daily on days 1 to 5. The primary efficacy variable was the area under the curve (AUC) of the change from baseline corneometer readings over the 5 days. Skin hydration using DELP gel was significantly higher than using ZBC cream (p < 0.0001). The cumulative increase in skin hydration observed for DELP gel was substantial and long lasting. In contrast, for ZBC cream, there was no significant improvement of the cumulative skin hydration as measured by the AUC (p = 0.22). DELP gel achieved substantial, long-lasting and cumulative skin hydration, whilst ZBC cream achieved no measurable improvement in skin hydration compared to before treatment. Healthcare professionals should be aware that different emollients can perform differently. Dermal Laboratories Ltd. EudraCT number:2014-001026-16.

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

    PubMed Central

    2007-01-01

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

  14. Increased postprandial glycaemia, insulinemia, and lipidemia after 10 weeks’ sucrose-rich diet compared to an artificially sweetened diet: a randomised controlled trial

    PubMed Central

    Raben, Anne; Møller, Bente K.; Flint, Anne; Vasilaras, Tatjana H.; Christina Møller, A.; Juul Holst, Jens; Astrup, Arne

    2011-01-01

    Background The importance of exchanging sucrose for artificial sweeteners on risk factors for developing diabetes and cardiovascular diseases is not yet clear. Objective To investigate the effects of a diet high in sucrose versus a diet high in artificial sweeteners on fasting and postprandial metabolic profiles after 10 weeks. Design Healthy overweight subjects were randomised to consume drinks and foods sweetened with either sucrose (∼2 g/kg body weight) (n = 12) or artificial sweeteners (n = 11) as supplements to their usual diet. Supplements were similar on the two diets and consisted of beverages (∼80 weight%) and solid foods (yoghurts, marmalade, ice cream, stewed fruits). The rest of the diet was free of choice and ad libitum. Before (week 0) and after the intervention (week 10) fasting blood samples were drawn and in week 10, postprandial blood was sampled during an 8-hour meal test (breakfast and lunch). Results After 10 weeks postprandial glucose, insulin, lactate, triglyceride, leptin, glucagon, and GLP-1 were all significantly higher in the sucrose compared with the sweetener group. After adjusting for differences in body weight changes and fasting values (week 10), postprandial glucose, lactate, insulin, GIP, and GLP-1 were significantly higher and after further adjusting for differences in energy and sucrose intake, postprandial lactate, insulin, GIP, and GLP-1 levels were still significantly higher on the sucrose-rich diet. Conclusion A sucrose-rich diet consumed for 10 weeks resulted in significant elevations of postprandial glycaemia, insulinemia, and lipidemia compared to a diet rich in artificial sweeteners in slightly overweight healthy subjects. PMID:21799667

  15. Prospective, randomised study to compare empirical treatment versus targeted treatment on the basis of the urine antigen results in hospitalised patients with community-acquired pneumonia.

    PubMed

    Falguera, M; Ruiz-González, A; Schoenenberger, J A; Touzón, C; Gázquez, I; Galindo, C; Porcel, J M

    2010-02-01

    Recommendations for diagnostic testing in hospitalised patients with community-acquired pneumonia remain controversial. The aim of the present study was to evaluate the impact of a therapeutic strategy based on the microbiological results provided by urinary antigen tests for Streptococcus pneumoniae and Legionella pneumophila. For a 2-year period, hospitalised patients with community-acquired pneumonia were randomly assigned to receive either empirical treatment, according to international guidelines, or targeted treatment, on the basis of the results from antigen tests. Outcome parameters, monetary costs and antibiotic exposure levels were compared. Out of 194 enrolled patients, 177 were available for randomisation; 89 were assigned to empirical treatment and 88 were assigned to targeted treatment. Targeted treatment was associated with a slightly higher overall cost (euro 1657.00 vs euro 1617.20, p=0.28), reduction in the incidence of adverse events (9% vs 18%, p=0.12) and lower exposure to broad-spectrum antimicrobials (154.4 vs 183.3 defined daily doses per 100 patient days). No statistically significant differences in other outcome parameters were observed. Oral antibiotic treatment was started according to the results of antigen tests in 25 patients assigned to targeted treatment; these patients showed a statistically significant higher risk of clinical relapse as compared with the remaining population (12% vs 3%, p=0.04). The routine implementation of urine antigen detection tests does not carry substantial outcome-related or economic benefits to hospitalised patients with community-acquired pneumonia. Narrowing the antibiotic treatment according to the urine antigen results may in fact be associated with a higher risk of clinical relapse.

  16. Comparing the hydrosurgery system to conventional debridement techniques for the treatment of delayed healing wounds: a prospective, randomised clinical trial to investigate clinical efficacy and cost-effectiveness.

    PubMed

    Liu, Jing; Ko, Jason H; Secretov, Erwin; Huang, Eric; Chukwu, Christiana; West, Julie; Piserchia, Katherine; Galiano, Robert D

    2015-08-01

    In these uncertain times of high health care costs, clinicians are looking for cost-effective devices to employ in their everyday practices. In an effort to promote cost-effective and proper wound repair, the hydrosurgical device allows accurate debridement of only unwanted tissue while precisely conserving viable structures for eventual repair. This prospective, randomised study compared procedures using the hydrosurgery system (VERSAJET™) with conventional debridement in order to assess clinical efficacy and cost-effectiveness when treating subjects with chronic wounds. A total of 40 subjects were recruited. There was no difference in time to achieve stable wound closure between the treatment groups (P = 0·77). There were no significant differences between the two groups in terms of cost of the first operative procedure (P = 0·28), cost of surgical procedures during the study (P = 0·51), cost of study treatment (P = 0·29) or cost to achieve stable wound closure (P = 0·85). There were no differences in quantitative bacterial counts after debridement with either methods (P = 0·376). However, the time taken for the first excision procedure was significantly faster using the hydrosurgery system (VERSAJET) when compared with conventional debridement (P < 0·001). The total excision time for all procedures was significantly less for the Hydrosurgery group than for the conventional group (P = 0·005). Also, the Hydrosurgery group demonstrated significantly less intraoperative blood loss than conventional group for all procedures (P = 0·003). In this study, although there were no differences in time to stable wound closure or bacterial reduction between the two groups, the hydrosurgery system (VERSAJET) did offer advantages in terms of operative times and intraoperative blood loss and was cost-neutral, despite the handpiece cost.

  17. Comparative effects of A1 versus A2 beta-casein on gastrointestinal measures: a blinded randomised cross-over pilot study.

    PubMed

    Ho, S; Woodford, K; Kukuljan, S; Pal, S

    2014-09-01

    At present, there is debate about the gastrointestinal effects of A1-type beta-casein protein in cows' milk compared with the progenitor A2 type. In vitro and animal studies suggest that digestion of A1 but not A2 beta-casein affects gastrointestinal motility and inflammation through the release of beta-casomorphin-7. We aimed to evaluate differences in gastrointestinal effects in a human adult population between milk containing A1 versus A2 beta-casein. Forty-one females and males were recruited into this double-blinded, randomised 8-week cross-over study. Participants underwent a 2-week dairy washout (rice milk replaced dairy), followed by 2 weeks of milk (750 ml/day) that contained beta-casein of either A1 or A2 type before undergoing a second washout followed by a final 2 weeks of the alternative A1 or A2 type milk. The A1 beta-casein milk led to significantly higher stool consistency values (Bristol Stool Scale) compared with the A2 beta-casein milk. There was also a significant positive association between abdominal pain and stool consistency on the A1 diet (r=0.520, P=0.001), but not the A2 diet (r=-0.13, P=0.43). The difference between these two correlations (0.52 versus -0.13) was highly significant (P<0.001). Furthermore, some individuals may be susceptible to A1 beta-casein, as evidenced by higher faecal calprotectin values and associated intolerance measures. These preliminary results suggest differences in gastrointestinal responses in some adult humans consuming milk containing beta-casein of either the A1 or the A2 beta-casein type, but require confirmation in a larger study of participants with perceived intolerance to ordinary A1 beta-casein-containing milk.

  18. Comparative efficacy and safety of anticoagulant strategies for acute coronary syndromes. Comprehensive network meta-analysis of 42 randomised trials involving 117,353 patients.

    PubMed

    Navarese, Eliano Pio; Andreotti, Felicita; Kołodziejczak, Michalina; Schulze, Volker; Wolff, Georg; Dias, Sofia; Claessen, Bimmer; Brouwer, Marc; Tarantini, Giuseppe; Iliceto, Sabino; Brockmeyer, Maximilian; Kowalewski, Mariusz; Lin, Yingfeng; Eikelboom, John; Musumeci, Giuseppe; Lee, Leong; Lip, Gregory Y H; Valgimigli, Marco; Berti, Sergio; Kelm, Malte

    2015-11-01

    International guidelines differ in strengths of recommendation for anticoagulation strategies in acute coronary syndromes (ACS). We performed a comprehensive network meta-analysis (NMA) of randomised controlled trials (RCTs) to investigate the comparative efficacy and safety of parenteral anticoagulants in ACS. MEDLINE, Cochrane, EMBASE, Google Scholar, major cardiology websites, and abstracts/presentations were searched. Six treatments were identified: 1) unfractionated heparin (UFH) + glycoprotein IIb/IIIa inhibitor (GPI) [UFH+GPI], 2) UFH±GPI, 3) bivalirudin, 4) low-molecular-weight heparins (LMWHs), 5) otamixaban, and 6) fondaparinux. Prespecified outcomes (death, myocardial infarction [MI], revascularisation, major bleeding [MB], minor bleeding, and stent thrombosis [ST]) were evaluated up to 30 days. Forty-two RCTs involving 117,353 patients were included. No significant differences in mortality rates were found among strategies. Compared to UFH+GPI, bivalirudin reduced the odds of MB but increased the odds of ST and MI. LMWHs vs bivalirudin reduced MI risk at the price of MB excess. UFH±GPI significantly increased the odds of MI vs LMWHs, of ST vs UFH+GPI, and of MB vs bivalirudin. Reduced ST risk with otamixaban vs UFH±GPI and vs bivalirudin was offset by a marked 2.5- to four-fold MB excess. Fondaparinux showed an intermediate profile. Results for ST-segment elevation MI were consistent with the overall findings. Early anticoagulant strategies for ACS differ in efficacy and safety, with UFH+GPI and LMWHs reducing ischaemic but increasing bleeding risk, and bivalirudin reducing MB but increases MI and ST. The findings support individualised therapy based on patients' bleeding and ischaemic risks.

  19. A randomised controlled trial comparing incentive spirometry with the Acapella® device for physiotherapy after thoracoscopic lung resection surgery.

    PubMed

    Cho, Y J; Ryu, H; Lee, J; Park, I K; Kim, Y T; Lee, Y H; Lee, H; Hong, D M; Seo, J H; Bahk, J H; Jeon, Y

    2014-08-01

    Lung resection surgery has been associated with numerous postoperative complications. Seventy-eight patients scheduled for elective video-assisted thoracoscopic lung resection were randomly assigned to receive standard postoperative care with incentive spirometry or standard care plus positive vibratory expiratory pressure treatment using the Acapella(®) device. There was no significant difference between incentive spirometry and the Acapella device in the primary outcome, forced expiratory volume in 1 s, on the third postoperative day, mean (SD) 53% (16%) vs 59% (18%) respectively, p = 0.113. Patients treated with both devices simultaneously found incentive spirometry to be less comfortable compared with the Acapella device, using a numeric rating scale from 1 to 5 with lower scores indicating higher comfort, median (IQR [range]) 3 (2-3 [2-4]) vs 1 (1-2 [1-3]) respectively, p < 0.001. In addition, 37/39 patients (95%) stated a clear preference for the Acapella device. Postoperative treatment with the Acapella device did not improve pulmonary function after thoracoscopic lung resection surgery compared with incentive spirometry, but it may be more comfortable to use. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

  20. Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole.

    PubMed

    Bohbot, Jean-Marc; Vicaut, Eric; Fagnen, Didier; Brauman, Michel

    2010-01-01

    Multiple-dose metronidazole oral therapy is currently the reference treatment for bacterial vaginosis (BV). This double-blind, double-dummy, noninferiority study compared the efficacy of secnidazole, another nitroimidazole with pharmacokinetics allowing a single dose regimen, to this standard treatment. A total of 577 patients were randomized to receive metronidazole (500 mg, b.i.d for seven days) or secnidazole (2 g, once). Therapeutic cure at D28 was defined as the resolution of vaginal discharge, positive KOH whiff test, vaginal pH >4.5 and Nugent score >7 on Gram-stained vaginal fluid. According to this primary endpoint, the single-dose secnidazole regimen was shown to be at least as effective as the multiple-dose metronidazole regimen (60.1 % cured women vs 59.5% , 95% confidence interval with a noninferiority margin of 10%: [-0.082; 0.0094]). Safety profiles were comparable in both groups. The secnidazole regimen studied represents an effective, convenient therapeutic alternative that clinicians should consider in routine practice.

  1. Treatment of Bacterial Vaginosis: A Multicenter, Double-Blind, Double-Dummy, Randomised Phase III Study Comparing Secnidazole and Metronidazole

    PubMed Central

    Bohbot, Jean-Marc; Vicaut, Eric; Fagnen, Didier; Brauman, Michel

    2010-01-01

    Objective. Multiple-dose metronidazole oral therapy is currently the reference treatment for bacterial vaginosis (BV). This double-blind, double-dummy, noninferiority study compared the efficacy of secnidazole, another nitroimidazole with pharmacokinetics allowing a single dose regimen, to this standard treatment. Methods. A total of 577 patients were randomized to receive metronidazole (500 mg, b.i.d for seven days) or secnidazole (2 g, once). Therapeutic cure at D28 was defined as the resolution of vaginal discharge, positive KOH whiff test, vaginal pH >4.5 and Nugent score >7 on Gram-stained vaginal fluid. Results. According to this primary endpoint, the single-dose secnidazole regimen was shown to be at least as effective as the multiple-dose metronidazole regimen (60.1 % cured women vs 59.5% , 95% confidence interval with a noninferiority margin of 10%: [−0.082; 0.0094]). Safety profiles were comparable in both groups. Conclusion. The secnidazole regimen studied represents an effective, convenient therapeutic alternative that clinicians should consider in routine practice. PMID:20885970

  2. Randomised prospective study compares efficacy of five different stomach tubes for rumen fluid sampling in dairy cows.

    PubMed

    Steiner, S; Neidl, A; Linhart, N; Tichy, A; Gasteiner, J; Gallob, K; Baumgartner, W; Wittek, T

    2015-01-10

    The objective of the study was to compare the performance of five types of stomach tubes for rumen fluid sampling. Rumen fluid was sampled in rumen fistulated cows assigned to a 5×5 Latin square study design. The pH values of samples taken by stomach tubes and via fistulas were measured; the results were compared with indwelling sensor measurements. The practicability of the stomach tubes for regular use was tested in the field. Rumen fluid samples were obtained rapidly. Volumes for transfaunation could be obtained. The pH-values of samples taken with the four out of the five tubes (Dirksen, Geishauser, tube 4 and a simple water hose used with a gag) did not show significant differences to samples taken via rumen fistulas. Mean differences ranged between -0.02 and +0.09. Samples taken with tube 4 and the water hose showed also no significant differences to pH-sensor measurements. This study demonstrates that stomach tubes are suitable for rumen fluid sampling. Tube 4 seems to be the best probe for work in the field. It was well tolerated by the animals, saliva contamination is negligible. We, therefore, conclude that the evaluation of rumen acid base status in the field is possible. British Veterinary Association.

  3. The protocol for a randomised controlled trial comparing intermittent and graded exercise to usual care for chronic fatigue syndrome patients

    PubMed Central

    2013-01-01

    Background Chronic Fatigue Syndrome is a debilitating disorder with an unknown aetiology but suspected multifactorial origins. Common “triggers” include severe viral infections and emotional stress. Recent studies have also found evidence of immune dysfunction and elevated inflammatory cytokines in CFS patients, but there has been considerable variation in the outcome measures and magnitude of these studies. Currently, there is no cure for CFS but treatments include rest, specialist medical care, cognitive behavioural therapy, and graded (self-paced) exercise. To date, several studies have examined the efficacy of graded exercise with or without Cognitive Behavioural Therapy, with some success for patients. However, improvements in functional capacity have not necessarily correlated with improvements in immune function, fatigue or other symptoms. This 12-week pilot trial compares graded and intermittent exercise to normal care, measuring physiological outcomes, fatigue levels, immune function and wellness. Methods/design 90 patients aged between 16 to 60 years, who meet the diagnostic criteria for CFS and have been diagnosed by their medical practitioner, will be randomly recruited into groups consisting of Intermittent exercise, Graded exercise and usual care (Control). The outcomes will be measured pre-study (Week 0) and post-study (Week 13). Primary outcomes are VO2peak, anaerobic threshold, peak power, levels of fatigue, immune cell (CD3+CD4+, CD3+CD8+, CD19+, CD 16+CD56+) concentrations and activation. Secondary outcomes include onset of secondary CFS symptoms (e.g. fever, swollen lymph nodes), wellness, mood and sleep patterns. Primary analysis will be based on intention to treat using logistic regression models to compare treatments. Quantitative data will be analysed using repeated measures ANOVA with a linear model, and Cohen’s effect size. Qualitative data such as participants’ responses (e.g. changes in mood and other reactions) following the

  4. A randomised controlled trial comparing rocuronium priming, magnesium pre-treatment and a combination of the two methods.

    PubMed

    Kim, M H; Oh, A Y; Jeon, Y T; Hwang, J W; Do, S H

    2012-07-01

    We investigated whether magnesium sulphate combined with rocuronium priming shortens the onset of neuromuscular blockade, compared with these methods used alone. Ninety-two patients scheduled for general anaesthesia were randomly allocated to one of four groups: controls were given 0.6 mg.kg(-1) rocuronium; patients in the prime group were given 0.06 mg.kg(-1) rocuronium three minutes before a further dose of 0.54 mg.kg(-1) rocuronium; patients in the magnesium group were given an infusion of 50 mg.kg(-1) magnesium sulphate before rocuronium and patients in the magnesium and prime group were given both the magnesium sulphate and the priming dose of rocuronium. Tracheal intubation was attempted 40 s after the rocuronium injection. The time to onset of neuromuscular blockade was the primary outcome; duration of blockade and tracheal intubating conditions were also measured. The group allocation and study drugs were coded and concealed until statistical analyses were completed. The magnesium and prime group had the shortest mean (SD) onset time (55 (16)s; p < 0.001), and best tracheal intubating conditions (p < 0.05). No statistical difference was found for the duration of blockade. As for adverse events, a burning or heat sensation was reported in eight (35%) and six (26%) patients in the magnesium and magnesium and prime groups, respectively. The combination of magnesium sulphate and rocuronium priming accelerated the onset or neuromuscular blockade and improved rapid-sequence intubating conditions, compared with either magnesium sulphate or priming used alone. Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland.

  5. Neutral zone or conventional mandibular complete dentures: a randomised crossover trial comparing oral health-related quality of life.

    PubMed

    Geerts, G A V M

    2017-09-01

    There is widespread consensus that the neutral zone (NZ) concept contributes to improved stability for mandibular complete dentures (CDs). However, little is known about its impact on oral health-related quality of life (OHRQoL) of edentulous patients compared to conventionally (CV) manufactured dentures. In this prospective crossover trial, performed at the Oral Health Centre of the University of the Western Cape, CV and NZ mandibular dentures were made for each patient. Scores from the 20-item oral health impact profile (OHIP-20) for both types of dentures were compared with pre-treatment scores using paired t-tests. Treatment effect size (ES) was established. Associations of OHIP-20 scores and several patient variables (age, gender, period of edentulousness, quality of the denture-bearing tissue, denture dimensions, preference) were performed using the generalised linear model. Significance was set at P = 0·05. Records of thirty-five participants were included in the study (mean age of 62·3 years, range 47-85 years). There were highly significant differences between pre-treatment and both post-treatment OHIP-20 scores with t = 6·470 for CV and t = 6·713 for NZ. Treatment ES was large for both types of dentures (>0·8). Difference of ES between NZ and CV dentures was small (ES < 0·2). None of the patient variables showed significant associations with OHIP-20 scores of the two types of dentures, except for preference and NZ OHIP-20 scores. For this group of patients, both treatment methods improved OHRQoL significantly and patient-related factors did not influence impact on OHRQoL differently for both interventions. © 2017 John Wiley & Sons Ltd.

  6. Sodium Stibogluconate (SSG) & Paromomycin Combination Compared to SSG for Visceral Leishmaniasis in East Africa: A Randomised Controlled Trial

    PubMed Central

    Musa, Ahmed; Khalil, Eltahir; Hailu, Asrat; Olobo, Joseph; Balasegaram, Manica; Omollo, Raymond; Edwards, Tansy; Rashid, Juma; Mbui, Jane; Musa, Brima; Abuzaid, Abuzaid Abdalla; Ahmed, Osama; Fadlalla, Ahmed; El-Hassan, Ahmed; Mueller, Marius; Mucee, Geoffrey; Njoroge, Simon; Manduku, Veronica; Mutuma, Geoffrey; Apadet, Lilian; Lodenyo, Hudson; Mutea, Dedan; Kirigi, George; Yifru, Sisay; Mengistu, Getahun; Hurissa, Zewdu; Hailu, Workagegnehu; Weldegebreal, Teklu; Tafes, Hailemariam; Mekonnen, Yalemtsehay; Makonnen, Eyasu; Ndegwa, Serah; Sagaki, Patrick; Kimutai, Robert; Kesusu, Josephine; Owiti, Rhoda; Ellis, Sally; Wasunna, Monique

    2012-01-01

    Background Alternative treatments for visceral leishmaniasis (VL) are required in East Africa. Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India. Methods A multi-centre randomized-controlled trial (RCT) to compare efficacy and safety of PM (20 mg/kg/day for 21 days) and PM plus sodium stibogluconate (SSG) combination (PM, 15 mg/kg/day and SSG, 20 mg/kg/day for 17 days) with SSG (20 mg/kg/day for 30 days) for treatment of VL in East Africa. Patients aged 4–60 years with parasitologically confirmed VL were enrolled, excluding patients with contraindications. Primary and secondary efficacy outcomes were parasite clearance at 6-months follow-up and end of treatment, respectively. Safety was assessed mainly using adverse event (AE) data. Findings The PM versus SSG comparison enrolled 205 patients per arm with primary efficacy data available for 198 and 200 patients respectively. The SSG & PM versus SSG comparison enrolled 381 and 386 patients per arm respectively, with primary efficacy data available for 359 patients per arm. In Intention-to-Treat complete-case analyses, the efficacy of PM was significantly lower than SSG (84.3% versus 94.1%, difference = 9.7%, 95% confidence interval, CI: 3.6 to 15.7%, p = 0.002). The efficacy of SSG & PM was comparable to SSG (91.4% versus 93.9%, difference = 2.5%, 95% CI: −1.3 to 6.3%, p = 0.198). End of treatment efficacy results were very similar. There were no apparent differences in the safety profile of the three treatment regimens. Conclusion The 17 day SSG & PM combination treatment had a good safety profile and was similar in efficacy to the standard 30 day SSG treatment, suggesting suitability for VL treatment in East Africa. Clinical Trials Registration www.clinicaltrials.gov NCT00255567 PMID:22724029

  7. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project: An open-label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone [ISRCTN07752728

    PubMed Central

    Oldham, Nicola S; Wright, Nat MJ; Adams, Clive E; Sheard, Laura; Tompkins, Charlotte NE

    2004-01-01

    Background Heroin is a synthetic opioid with an extensive illicit market leading to large numbers of people becoming addicted. Heroin users often present to community treatment services requesting detoxification and in the UK various agents are used to control symptoms of withdrawal. Dissatisfaction with methadone detoxification [8] has lead to the use of clonidine, lofexidine, buprenorphine and dihydrocodeine; however, there remains limited evaluative research. In Leeds, a city of 700,000 people in the North of England, dihydrocodeine is the detoxification agent of choice. Sublingual buprenorphine, however, is being introduced. The comparative value of these two drugs for helping people successfully and comfortably withdraw from heroin has never been compared in a randomised trial. Additionally, there is a paucity of research evaluating interventions among drug users in the primary care setting. This study seeks to address this by randomising drug users presenting in primary care to receive either dihydrocodeine or buprenorphine. Methods/design The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project is a pragmatic randomised trial which will compare the open use of buprenorphine with dihydrocodeine for illicit opiate detoxification, in the UK primary care setting. The LEEDS project will involve consenting adults and will be run in specialist general practice surgeries throughout Leeds. The primary outcome will be the results of a urine opiate screening at the end of the detoxification regimen. Adverse effects and limited data to three and six months will be acquired. PMID:15117415

  8. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial.

    PubMed

    Kedhi, Elvin; Joesoef, Kaiyum Sheik; McFadden, Eugene; Wassing, Jochem; van Mieghem, Carlos; Goedhart, Dick; Smits, Pieter Cornelis

    2010-01-16

    Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice. We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041. Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0.69 [95% CI 0.50-0.95], p value for superiority=0.02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0.26 [0.11-0-64], p=0.002), myocardial infarction (25 [3%] vs 48 [5%], 0.52 [0.33-0.84], p=0.007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0.39 [0.24-0.64], p=0.0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0.005. The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. Unrestricted grants from Abbott Vascular and Boston Scientific. Copyright 2010 Elsevier Ltd. All rights

  9. Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

    PubMed Central

    2012-01-01

    Background According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period). Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300). Discussion This trial aims to

  10. IMPROVDENT: improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures.

    PubMed

    Gray, Janine C; Navarro-Coy, Nuria; Pavitt, Sue H; Hulme, Claire; Godfrey, Mary; Craddock, Helen L; Brunton, Paul A; Brown, Sarah; Dillon, Sean; Dukanovic, Gillian; Fernandez, Catherine; Wright, Jonathan; Collier, Howard; Swithenbank, Shirley; Lee, Carol; Hyde, T Paul

    2012-08-31

    According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65-74, 30% aged 75-84 and 47% aged >85 years are edentulous and require complete dentures. Patients' quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period).Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300). This trial aims to provide evidence on the costs and quality of dentures

  11. The VEPRO trial: A cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia

    PubMed Central

    Boutron, Isabelle; Touizer, Caroline; Pitrou, Isabelle; Roy, Carine; Ravaud, Philippe

    2008-01-01

    Background The aim of this trial was to compare the effectiveness of two generations of progressive lenses for presbyopia. Methods A multicenter cross-over randomized controlled trial performed in a primary care setting (5 optical dispensaries) was planned. Two categories of progressive lenses were compared: 1) a new-generation lens (i.e., VARILUX PANAMIC ORMA CRIZAL), which is expensive but a supposed improvement in comfort, and 2) an older-generation lens (i.e., VARILUX CONFORT ORMA CRIZAL), which is less expensive and is considered the reference lens. Patients were randomized to wear one generation of progressive lens for 4 weeks, then cross over to wear the other lens for 4 weeks, without knowing the sequence of lenses. Inclusion criteria were 1) age 43–60 years; 2) outpatients already wearing progressive lenses and referred to an optician ophthalmologist for optical correction prescription within the last 6 months; 3) receiving a correction of ≤3 dioptres in cases of associated myopia, hyperopia or astigmatism; 4) understanding and speaking French and able to answer a questionnaire; and 5) giving written consent to participate in the study. The primary outcome was patient preference for one progressive lens at week 8. Secondary outcomes were subjective measures of bifocal visual performance, including a) near visual acuity, b) visual field, c) kinetic visual skills, d) visual adaptability, e) visual comfort, and f) rapidity of adaptation. Results 127 patients were randomized to one of the lens groups. Two patients withdrew prematurely; 98.4% and 97.6% patients who wore the new versus older lenses, respectively, wore their progressive lenses every day during the 4-week period 1 and period 2. The number of participants in each of 5 centres varied from 16 (12.6%) to 35 (27.6%). 57.9% patients preferred the new-generation lenses, 36.5% the older-generation lenses, and 5.6% had no preference (p = 0.01). The two groups did not differ in any of the measures of

  12. A comparative study of efficacy and safety of azithromycin and ofloxacin in uncomplicated typhoid Fever: a randomised, open labelled study.

    PubMed

    Chandey, Manish; Multani, A S

    2012-12-01

    To compare the efficacy and safety of azithromycin with ofloxacin in patients with uncomplicated typhoid fever. Forty adult patients with bacteriologically or serologically diagnosed, uncomplicated typhoid fever were included from Medicine out-patient department at Government medical college, Amritsar, India. They were randomized into 2 groups of 20 patients each. Group I: patients received ofloxacin 200mg orally twice daily for 7 days. Group II: Patients received Azithromycin orally 1 gm on day 1 and then 500 mg daily from day 2 to day 6. The following parameters were noted a) fever clearance time b) cure rate c) adverse drug reaction d) recurrence of symptoms, if any, during 4 weeks follow up. Nineteen out of 20 patients from group I were cured with mean fever clearance time of 3.68 days while all 20 patients from group II were cured with mean fever clearance time of 3.65 days. No significant side effects were noted in any of the patients. No relapse was recorded in the present study in a follow up period of 4 weeks in both study groups. Both ofloxacin and Azithromycin are almost equally efficacious and safe in treatment of typhoid fever with no major adverse effect. Azithromycin is an effective alternative in conditions where ofloxacin is contraindicated i.e., children, pregnant women and quinolone resistant cases of typhoid fever.

  13. A randomised controlled trial to compare local with general anaesthesia for short-stay inguinal hernia repair.

    PubMed Central

    Teasdale, C.; McCrum, A. M.; Williams, N. B.; Horton, R. E.

    1982-01-01

    A series of 117 consecutive unselected patients with clinically reducible unilateral inguinal herniae were admitted for short-stay repair. Seven expressed a strong preference for one form of anaesthesia (6 general (GA)) local (LA) and 7 were unfit for GA; these were excluded from the trial. The remaining 103 patients were allocated at random to receive either LA or GA in order to compare the two methods of anaesthesia. The resulting groups (53 LA, 50 GA) were well matched for age and obesity. Perand postoperative symptoms were assessed with linear analogues self-assessment questionnaires. Statistically significant differences were demonstrated between the groups; those patients having LA were able to walk, eat, and pass urine earlier than those having GA, who experienced more nausea, vomiting, sore throat, and headache. The postoperative course and additional symptoms were otherwise similar. Forty-five LA patients experienced mild pain during the operation, but nevertheless 85% of the total group said they would consent to its use again. Ninety-three patients (90%) were discharged at 24 h. LA was applicable to all types of clinically reducible inguinal hernia and was an acceptable, safe, and satisfactory alternative to GA. PMID:7046604

  14. A randomised controlled trial comparing Triadcortyl with 10% glycerine-ichthammol in the initial treatment of severe acute otitis externa.

    PubMed

    Masood, Ajmal; Moumoulidis, Ioannis; Ray, Shalina; Chawla, Om; Panesar, Jaan

    2008-08-01

    Acute otitis externa is a common clinical condition accounting for a large proportion of patients attending the otolaryngology department, although milder cases are often managed in primary care. Treatment of the most severe forms of otitis externa involves aural toilet, followed by the application of a topical preparation, commonly in the form of an ear canal dressing. A prospective single-blind randomized controlled trial was performed to compare the efficacy of 10% glycerine-ichthammol (GI) solution and Triadcortyl (TAC) ointment, both applied as ear canal dressings, in the initial management of severe acute otitis externa. A total of 64 patients were studied. Both treatment modalities were proven efficacious in the treatment of severe acute otitis externa. Although there was a statistically significant improvement of pain parameters in the TAC group, we found no significant differences in clinical findings between the two groups. Therefore, it is recommended that GI dressing can be used instead of an antibiotic dressing as an initial treatment of severe acute otitis externa on the basis of cost, avoidance of resistance and toxicity.

  15. Randomised controlled multiple treatment comparison to provide a cost-effectiveness rationale for the selection of antimicrobial therapy in acne.

    PubMed

    Ozolins, M; Eady, E A; Avery, A; Cunliffe, W J; O'Neill, C; Simpson, N B; Williams, H C

    2005-01-01

    To determine the relative efficacy and cost-effectiveness of five of the most commonly used antimicrobial preparations for treating mild to moderate facial acne in the community; the propensity of each regimen to give rise to local and systemic adverse events; whether pre-existing bacterial resistance to the prescribed antibiotic resulted in reduced efficacy; and whether some antimicrobial regimens were less likely to give rise to resistant propionibacterial strains. This was a parallel group randomised assessor-blind controlled clinical trial. It was a pragmatic design with intention-to-treat analysis. All treatments were given for 18 weeks, after a 4-week treatment free period. Outcomes were measured at 0, 6, 12 and 18 weeks. Primary care practices and colleges in and around Nottingham and Leeds, and one practice in Stockton-on-Tees, England. Participants were 649 people aged 12--39 years, all with mild to moderate inflammatory acne of the face. Study participants were randomised into one of five groups: 500 mg oral oxytetracycline (non-proprietary) twice daily (b.d.) + topical vehicle control b.d.; 100 mg oral Minocin MR (minocycline) once daily (o.d.) + topical vehicle control b.d.; topical Benzamycin (3% erythromycin + 5% benzoyl peroxide) b.d. + oral placebo o.d.; topical Stiemycin (2% erythromycin) o.d. + topical Panoxyl Aquagel (5% benzoyl peroxide) o.d. + oral placebo o.d., and topical Panoxyl Aquagel (5% benzoyl peroxide) b.d. + oral placebo o.d. (the active comparator group). The two primary outcome measures were: (1) the proportion of patients with at least moderate self-assessed improvement as recorded on a six-point Likert scale, and (2) change in inflamed lesion count (red spots). The best response rates were seen with two of the topical regimens (erythromycin plus benzoyl peroxide administered separately o.d. or in a combined proprietary formulation b.d.), compared with benzoyl peroxide alone, oxytetracycline (500 mg b.d.) and minocycline (100 mg o

  16. Comparing Tuberculosis Diagnostic Yield in Smear/Culture and Xpert® MTB/RIF-Based Algorithms Using a Non-Randomised Stepped-Wedge Design

    PubMed Central

    Naidoo, Pren; Dunbar, Rory; Lombard, Carl; du Toit, Elizabeth; Caldwell, Judy; Detjen, Anne; Squire, S. Bertel; Enarson, Donald A.; Beyers, Nulda

    2016-01-01

    Setting Primary health services in Cape Town, South Africa. Study Aim To compare tuberculosis (TB) diagnostic yield in an existing smear/culture-based and a newly introduced Xpert® MTB/RIF-based algorithm. Methods TB diagnostic yield (the proportion of presumptive TB cases with a laboratory diagnosis of TB) was assessed using a non-randomised stepped-wedge design as sites transitioned to the Xpert® based algorithm. We identified the full sequence of sputum tests recorded in the electronic laboratory database for presumptive TB cases from 60 primary health sites during seven one-month time-points, six months apart. Differences in TB yield and temporal trends were estimated using a binomial regression model. Results TB yield was 20.9% (95% CI 19.9% to 22.0%) in the smear/culture-based algorithm compared to 17.9% (95%CI 16.4% to 19.5%) in the Xpert® based algorithm. There was a decline in TB yield over time with a mean risk difference of -0.9% (95% CI -1.2% to -0.6%) (p<0.001) per time-point. When estimates were adjusted for the temporal trend, TB yield was 19.1% (95% CI 17.6% to 20.5%) in the smear/culture-based algorithm compared to 19.3% (95% CI 17.7% to 20.9%) in the Xpert® based algorithm with a risk difference of 0.3% (95% CI -1.8% to 2.3%) (p = 0.796). Culture tests were undertaken for 35.5% of smear-negative compared to 17.9% of Xpert® negative low MDR-TB risk cases and for 82.6% of smear-negative compared to 40.5% of Xpert® negative high MDR-TB risk cases in respective algorithms. Conclusion Introduction of an Xpert® based algorithm did not produce the expected increase in TB diagnostic yield. Studies are required to assess whether improving adherence to the Xpert® negative algorithm for HIV-infected individuals will increase yield. In light of the high cost of Xpert®, a review of its role as a screening test for all presumptive TB cases may be warranted. PMID:26930400

  17. Prevention of heterotopic bone formation after total hip arthroplasty: a prospective randomised study comparing postoperative radiation therapy with indomethacin medication.