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1.
Health Technol Assess ; 23(27): 1-166, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31217069

RESUMO

BACKGROUND: Balance, mobility impairments and falls are common problems for people with multiple sclerosis (MS). Our ongoing research has led to the development of Balance Right in MS (BRiMS), a 13-week home- and group-based exercise and education programme intended to improve balance and encourage safer mobility. OBJECTIVE: This feasibility trial aimed to obtain the necessary data and operational experience to finalise the planning of a future definitive multicentre randomised controlled trial. DESIGN: Randomised controlled feasibility trial. Participants were block randomised 1 : 1. Researcher-blinded assessments were scheduled at baseline and at 15 and 27 weeks post randomisation. As is appropriate in a feasibility trial, statistical analyses were descriptive rather than involving formal/inferential comparisons. The qualitative elements utilised template analysis as the chosen analytical framework. SETTING: Four sites across the UK. PARTICIPANTS: Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥ 4.0 and ≤ 7.0 points and a self-report of two or more falls in the preceding 6 months. INTERVENTIONS: Intervention - manualised 13-week education and exercise programme (BRiMS) plus usual care. Comparator - usual care alone. MAIN OUTCOME MEASURES: Trial feasibility, proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data. RESULTS: A total of 56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0-6.5 points) were recruited in 5 months; 30 were block randomised to the intervention group. The demographic and clinical data were broadly comparable at baseline; however, the intervention group scored worse on the majority of baseline outcome measures. Eleven participants (19.6%) withdrew or were lost to follow-up. Worsening of MS-related symptoms unrelated to the trial was the most common reason (n = 5) for withdrawal. Potential primary and secondary outcomes and economic data had completion rates of > 98% for all those assessed. However, the overall return rate for the patient-reported falls diary was 62%. After adjusting for baseline score, the differences between the groups (intervention compared with usual care) at week 27 for the potential primary outcomes were MS Walking Scale (12-item) version 2 -7.7 [95% confidence interval (CI) -17.2 to 1.8], MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical 0.6 (95% CI -7.8 to 9) and MSIS-29vs2 psychological -0.4 (95% CI -9.9 to 9) (negative score indicates improvement). After the removal of one outlier, a total of 715 falls were self-reported over the 27-week trial period, with substantial variation between individuals (range 0-93 falls). Of these 715 falls, 101 (14%) were reported as injurious. Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted physical and behavioural changes that they perceived to result from undertaking BRiMS. Engagement varied, influenced by a range of condition- and context-related factors. Suggestions to improve the utility and accessibility of BRiMS were highlighted. CONCLUSIONS: The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria. Challenges were experienced in some areas of data collection, such as completion of daily diaries. FUTURE WORK: Further development of BRiMS is required to address logistical issues and enhance user-satisfaction and adherence. Following this, a definitive trial to assess the clinical effectiveness and cost-effectiveness of the BRiMS intervention is warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13587999. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.

2.
BMJ Open ; 9(5): e025006, 2019 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-31133577

RESUMO

INTRODUCTION: Incidence of autistic traits, mental health problems, stress and poor coping is high among family members of children with autism. These problems are coupled with challenging behaviour among children with autism. Current treatment for these families is disjointed and costly. The need for whole family support is supported by the National Institute for Health and Care Excellence recommendations, developments regarding children's service provision, research and requests by families of children with autism. Despite evidence that family therapies can provide benefits to these families, efficacy has not been subject to a randomised controlled trial. Systemic Autism-related Family Enabling (SAFE) is a new family therapy intervention designed specifically for families of children with autism. We aim to establish the feasibility of running a fully powered randomised controlled trial to evaluate SAFE. METHODS AND ANALYSIS: Families of children with autism aged 3-16 years will be invited to participate. Consenting participants will be randomised 2:1 to either SAFE+support as usual or support as usual alone. The proposed primary outcome measure for the main trial will be the Systemic CORE 15. Participants will also complete proposed secondary outcome measures, indexing changes in child behaviour, child-parent attachment, anxiety and depression. Generic health economic outcome measures (EuroQol 5 dimensions and Child Health Utility 9 Dimensions) will also provide data on the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline and 32 weeks post-allocation. Data on ability to identify, recruit, randomise, retain and collect data from families, acceptability of outcome measures, adherence of therapists and families to the intervention, appropriateness of resource use questionnaires and effectiveness of training will be collected for feasibility analysis. Qualitative data will also explore acceptability of SAFE and reasons for declining and withdrawing from the study. ETHICS AND DISSEMINATION: The current trial protocol received ethical approval from the South West-Exeter Research Ethics Committee (Ref: 17/SW/0192). The findings of the trial will be disseminated in collaboration with our Family Consultation Group and other partners. Findings will be shared locally, nationally and internationally through events, conferences and published papers. TRIAL REGISTRATION NUMBER: ISCTRN83964946 (Pre-results) IRAS 213527.


Assuntos
Transtorno Autístico/psicologia , Cuidadores/psicologia , Saúde da Família , Terapia Familiar/métodos , Estresse Psicológico , Adaptação Psicológica , Adulto , Criança , Feminino , Humanos , Masculino , Sistemas de Apoio Psicossocial , Ensaios Clínicos Controlados Aleatórios como Assunto , Estresse Psicológico/psicologia , Estresse Psicológico/terapia
3.
BMJ Open ; 9(2): e026882, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30772866

RESUMO

INTRODUCTION: Patients presenting to emergency departments (EDs) with epistaxis uncontrolled by subsequent simple first aid measures or application of topical vasoconstrictors will typically undergo anterior nasal packing. Packing is effective, but can be extremely painful and unpleasant and patients usually need hospital admission. Tranexamic acid (TXA) is a cheap, safe, readily available antifibrinolytic agent known to be beneficial in a variety of clinical settings where uncontrolled bleeding may be a problem. Anecdotal evidence suggests that topical TXA may be of value in persistent epistaxis; however, further evaluation is required. METHODS AND ANALYSIS: This is a multicentre, double-blind, parallel group, randomised, controlled trial comparing the use of topical intranasal TXA with indistinguishable placebo in adults presenting to UK EDs with persistent atraumatic epistaxis. Follow-up is at 1 week by structured telephone review. The primary outcome measure is the subsequent need for anterior nasal packing in the ED. Key secondary outcomes include the need for hospital admission, blood transfusion and/or further treatment for epistaxis during the index ED attendance. Recruiting 450 patients will provide 90% power to demonstrate an absolute reduction in packing rate from 95% to 85%. An improvement of this magnitude would be of significant benefit to patients and healthcare providers and justify a change to standard practice. Given the low cost of TXA and its short administration time, a full economic evaluation is not being undertaken. ETHICS AND DISSEMINATION: The study has been approved by the South West-Bristol Research Ethics Committee (reference 17/SW/0010). We aim to publish the findings in a high impact, international peer-reviewed journal. Results will also be shared with the Hereditary Haemorrhagic Telangiectasia foundation and telangiectasia UK for dissemination through appropriate related forums. TRIAL REGISTRATION NUMBER: ISRCTN34153772 and EudraCT No: 2016-001530-10.


Assuntos
Antifibrinolíticos/administração & dosagem , Serviço Hospitalar de Emergência , Epistaxe/tratamento farmacológico , Ácido Tranexâmico/administração & dosagem , Administração Intranasal , Administração Tópica , Método Duplo-Cego , Tamponamento Interno/métodos , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
4.
Emerg Med J ; 36(1): 27-31, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30504456

RESUMO

BACKGROUND: The Valsalva manoeuvre (VM) is used to treat supraventricular tachycardia (SVT) by inducing a vagal response (drop in HR). There is debate as to the best position in which to carry out the VM and how the strain should be delivered in practice. We aimed to compare vagal responses induced with supine and modified VMs using strains delivered with a standardised manometer or novel Valsalva Assist Device (VAD), a simple device to provide resistance to exhalation. METHODS: We conducted a repeated measures randomised trial of four VMs (two supine VM and two modified VMs), in healthy adult volunteers, with strains delivered using an adapted sphygmomanometer (manometer) or a VAD. Changes in HR, pressure and duration of strain and adverse events were monitored and compared between the techniques and devices. The trial was approved by the University of Exeter Medical School Research ethics committee. RESULTS: 75 healthy participants aged 19-55 years were recruited over a 4-month period. A mixed-effects linear regression showed the modified VM resulted in a 3.8 beats per min (bpm) greater drop in HR compared with the supine VM (p=0.002, 95% CI 2.2 to 5.4). VM strains produced by the VAD were of a similar pressure but of slightly shorter duration and resulted in a 1.9 bpm smaller drop in HR compared with the manometer (p=0.01, 95% CI 0.4 to 3.4). There were no differences in adverse events. CONCLUSIONS: Modified VM was associated with a greater drop in HR than a supine VM with no increase in adverse events in healthy volunteers. The VAD can be used to safely generate the recommended VM strain pressure, but produced a smaller drop in HR compared with a manometer and requires modification to enable the recommended strain duration to be achieved consistently. TRIAL REGISTRATION NUMBER: NCT03298880.


Assuntos
Desenho de Equipamento/normas , Frequência Cardíaca/fisiologia , Estimulação do Nervo Vago/instrumentação , Manobra de Valsalva/fisiologia , Adulto , Feminino , Voluntários Saudáveis , Humanos , Masculino , Pessoa de Meia-Idade , Decúbito Dorsal/fisiologia , Nervo Vago/fisiologia , Estimulação do Nervo Vago/métodos
5.
BMJ Open ; 8(11): e024108, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-30389760

RESUMO

INTRODUCTION: Ovarian cancer is the leading cause of death from gynaecological cancer, with more than 7000 new cases registered in the UK in 2014. In patients suitable for surgery, the National Institute of Health and Care Excellence guidance for treatment recommends surgical resection of all macroscopic tumour, followed by chemotherapy. The surgical procedure can be extensive and associated with substantial blood loss which is conventionally replaced with a donor blood transfusion. While often necessary and lifesaving, the use of donor blood is associated with increased risks of complications and adverse surgical outcomes. Intraoperative cell salvage (ICS) is a blood conservation strategy in which red cells collected from blood lost during surgery are returned to the patient thus minimising the use of donor blood. This is the protocol for a feasibility randomised controlled trial with an embedded qualitative study and feasibility economic evaluation. If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of ICS reinfusion versus donor blood transfusion in ovarian cancer surgery. METHODS AND ANALYSIS: Sixty adult women scheduled for primary or interval ovarian cancer surgery at participating UK National Health Service Trusts will be recruited and individually randomised in a 1:1 ratio to receive ICS reinfusion or donor blood (as required) during surgery. Participants will be followed up by telephone at 30 days postoperatively for adverse events monitoring and by postal questionnaire at 6 weeks and 3 monthly thereafter, to capture quality of life and resource use data. Qualitative interviews will capture participants' and clinicians' experiences of the study. ETHICS AND DISSEMINATION: This study has been granted ethical approval by the South West-Exeter Research Ethics Committee (ref: 16/SW/0256). Results will be disseminated via peer-reviewed publications and will inform the design of a larger trial. TRIAL REGISTRATION NUMBER: ISRCTN19517317.


Assuntos
Transfusão de Sangue/métodos , Procedimentos Cirúrgicos de Citorredução , Recuperação de Sangue Operatório/métodos , Neoplasias Ovarianas/cirurgia , Ovariectomia , Perda Sanguínea Cirúrgica , Transfusão de Sangue/economia , Transfusão de Sangue Autóloga , Análise Custo-Benefício , Estudos de Viabilidade , Feminino , Humanos , Recuperação de Sangue Operatório/economia , Pesquisa Qualitativa , Qualidade de Vida , Transplante Homólogo
6.
J Orthod ; 44(1): 3-7, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-28248619

RESUMO

OBJECTIVES: Pain is a common side effect of orthodontic treatment. An objective of this study, part of a large previously reported RCT on pain and analgesic use, was to determine the effect of anxiety on perceived pain and use of analgesia. METHODS: 1000 patients aged 11-17 years, undergoing upper and lower fixed appliance treatment in nine hospital departments were recruited into this two-arm parallel design randomised controlled trial. One arm was given sugar-free chewing gum and the other arm ibuprofen for pain relief. Neither the clinicians nor patients were blinded to assignment. In addition to recording pain experience and analgesic use for 3 days following appliance placement and first archwire change, each patient recorded their level of anxiety immediately following the fitting of the appliance and the first archwire change. RESULTS: 419 chewing gum group (84%) and 407 ibuprofen group (83%) questionnaires were returned following appliance placement, and 343 chewing gum group (70%) and 341 ibuprofen group (71%) questionnaires were returned following the first archwire change. The mean anxiety scores following fitting of the appliance and first archwire change were 2.7 (SD 2.1) and 1.6 (SD 1.8), respectively. There were weak but significant positive associations between anxiety scores and pain scores. Multi-level modelling produced a coefficient for anxiety of 0.23 (95% CI 0.17-0.28) for appliance placement, suggesting a small rise (0.23) on the 11-point pain scale for a one-point increase on the corresponding anxiety scale. Following archwire change, the corresponding coefficient was 0.32 (0.24-0.39). For ibuprofen use, again simple analyses suggested a relationship with anxiety. Multi-level logistic modelling produced an odds ratio for ibuprofen use of 1.11 (95% CI 1.07-1.15) at appliance placement and 1.21 (1.10-1.33) at the first archwire change. There was a 10-20% increase in the odds of using ibuprofen for each one-point increase on the anxiety scale. No such relationship was found between anxiety and chewing gum use. There were no adverse effects or harms reported during the trial. Approvals were granted by the Research Ethics Committee (08/H0106/139), R&D and MHRA (Eudract 2008-005522-36) and the trial was registered on the ISRCTN (79884739) and NIHR (6631) portfolios. Support was provided by the British Orthodontic Society Foundation. CONCLUSIONS: There was a weak positive correlation between anxiety reported and pain experienced following both the initial fitting of the fixed appliances and at the subsequent archwire change. Patients that were more anxious tended to take more ibuprofen for their pain relief.


Assuntos
Goma de Mascar , Ibuprofeno , Adolescente , Ansiedade , Criança , Humanos , Dor , Sociedades Odontológicas
8.
Am J Orthod Dentofacial Orthop ; 150(2): 220-7, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27476354

RESUMO

INTRODUCTION: The aim of this randomized trial was to investigate the effect of the use of a sugar-free chewing gum vs ibuprofen on reported pain in orthodontic patients. METHODS: This was a 2-arm parallel design randomized controlled trial in 9 sites in the southwest of England. Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances were recruited and randomly allocated to an experimental chewing gum group or a control ibuprofen group. Eligibility criteria included patients undergoing fixed maxillary and mandibular appliance therapy, aged 11 to 17 years, and able to use ibuprofen and chewing gum. The primary outcome measure was pain experienced after appliance placement using a mean of 3 recordings on a scale of 0 to 10. Secondary outcome measures were pain experienced in the subsequent 3 days, pain after the first archwire change, ibuprofen use, and appliance breakages. Pain scores were recorded with a questionnaire and posted to a collection center by each patient. Randomization was by means of a central telephone service and comprised computer-generated random numbers used to generate a sequential allocation list, with permuted blocks of variable size (2 and 4) and stratified by center. Neither the clinicians nor the patients were blinded to the intervention. Patients in the control group were permitted to use ibuprofen only, and patients in the experimental group were allowed to use ibuprofen if they did not get sufficient analgesia from the chewing gum. Data were analyzed using the principle of intention to treat with multilevel modeling to reflect the structured nature of the data (scores within patient within site). RESULTS: One thousand patients were recruited and randomized in a ratio of 1:1 to the chewing gum and ibuprofen (control) groups. The male-to-female ratios were similar in the groups. The pain questionnaire response rates were good at approximately 84% and 83% after appliance placement (chewing gum group, 419; ibuprofen group, 407) and 70% and 71% after the first archwire change (chewing gum group, 343; ibuprofen group, 341). The primary outcomes were similar for the 2 groups: mean pain scores, 4.31 in the chewing gum group and 4.17 in the ibuprofen group; difference, 0.14 (95% CI, -0.13 to 0.41). There was a suggestion that the relative pain scores for the 2 groups changed over time, with the chewing gum group experiencing slightly more pain on the day of bond-up and less on the subsequent 3 days; however, the differences had no clinical importance. There were no significant differences for the period after archwire change. The reported use of ibuprofen was less in the chewing gum group than in the ibuprofen group; after appliance placement, the mean numbers of occasions that ibuprofen was used were 2.1 in the chewing gum group and 3.0 in the ibuprofen group (adjusted difference, -0.96 [95% CI, -0.75 to -1.17; P <0.001]); after archwire change, the figures were 0.8 and 1.5 occasions (difference, -0.65 [-0.44 to -0.86; P <0.001]). After appliance placement and the first archwire change, there was no clinically or statistically significant difference in appliance breakages between the chewing gum and ibuprofen groups after either bond-up (7% and 8.8%, respectively) or the first archwire change (4.2% and 5.5%, respectively). No adverse events were reported. CONCLUSIONS: The use of a sugar-free chewing gum may reduce the level of ibuprofen usage but has no clinically or statistically significant effect on bond failures. REGISTRATION: International Standard Randomised Controlled Trial Number (79884739) and National Institute of Health Research (6631) portfolios. FUNDING: This research was supported by an award by the British Orthodontic Society Foundation.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Goma de Mascar , Ibuprofeno/uso terapêutico , Braquetes Ortodônticos/efeitos adversos , Fios Ortodônticos/efeitos adversos , Manejo da Dor/métodos , Técnicas de Movimentação Dentária/instrumentação , Adolescente , Criança , Inglaterra , Falha de Equipamento , Feminino , Humanos , Masculino , Mastigação/fisiologia , Medição da Dor , Resultado do Tratamento
9.
Lancet ; 386(10005): 1747-53, 2015 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-26314489

RESUMO

BACKGROUND: The Valsalva manoeuvre is an internationally recommended treatment for supraventricular tachycardia, but cardioversion is rare in practice (5-20%), necessitating the use of other treatments including adenosine, which patients often find unpleasant. We assessed whether a postural modification to the Valsalva manoeuvre could improve its effectiveness. METHODS: We did a randomised controlled, parallel-group trial at emergency departments in England. We randomly allocated adults presenting with supraventricular tachycardia (excluding atrial fibrillation and flutter) in a 1:1 ratio to undergo a modified Valsalva manoeuvre (done semi-recumbent with supine repositioning and passive leg raise immediately after the Valsalva strain), or a standard semi-recumbent Valsalva manoeuvre. A 40 mm Hg pressure, 15 s standardised strain was used in both groups. Randomisation, stratified by centre, was done centrally and independently, with allocation with serially numbered, opaque, sealed, tamper-evident envelopes. Patients and treating clinicians were not masked to allocation. The primary outcome was return to sinus rhythm at 1 min after intervention, determined by the treating clinician and electrocardiogram and confirmed by an investigator masked to treatment allocation. This study is registered with Current Controlled Trials (ISRCTN67937027). FINDINGS: We enrolled 433 participants between Jan 11, 2013, and Dec 29, 2014. Excluding second attendance by five participants, 214 participants in each group were included in the intention-to-treat analysis. 37 (17%) of 214 participants assigned to standard Valsalva manoeuvre achieved sinus rhythm compared with 93 (43%) of 214 in the modified Valsalva manoeuvre group (adjusted odds ratio 3·7 (95% CI 2·3-5·8; p<0·0001). We recorded no serious adverse events. INTERPRETATION: In patients with supraventricular tachycardia, a modified Valsalva manoeuvre with leg elevation and supine positioning at the end of the strain should be considered as a routine first treatment, and can be taught to patients. FUNDING: National Institute for Health Research.


Assuntos
Postura , Taquicardia Supraventricular/terapia , Manobra de Valsalva , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Postura/fisiologia , Decúbito Dorsal/fisiologia , Taquicardia Supraventricular/fisiopatologia , Resultado do Tratamento , Manobra de Valsalva/fisiologia
10.
BMJ ; 350: h3147, 2015 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-26094712

RESUMO

OBJECTIVE: To determine whether patient controlled analgesia (PCA) is better than routine care in providing effective analgesia for patients presenting to emergency departments with moderate to severe non-traumatic abdominal pain. DESIGN: Pragmatic, multicentre, parallel group, randomised controlled trial SETTING: Five English hospitals. PARTICIPANTS: 200 adults (66% (n=130) female), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe non-traumatic abdominal pain and were expected to be admitted to hospital for at least 12 hours. INTERVENTIONS: Patient controlled analgesia or nurse titrated analgesia (treatment as usual). MAIN OUTCOME MEASURES: The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant's hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate or severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. RESULTS: 196 participants were included in the primary analyses (99 allocated to PCA and 97 to treatment as usual). Mean total pain experienced was 35.3 (SD 25.8) in the PCA group compared with 47.3 (24.7) in the treatment as usual group. The adjusted between group difference was 6.3 (95% confidence interval 0.7 to 11.9). Participants in the PCA group received significantly more morphine (mean 36.1 (SD 22.4) v 23.6 (13.1) mg; mean difference 12.3 (95% confidence interval 7.2 to 17.4) mg), spent less of the study period in moderate or severe pain (32.6% v 46.9%; mean difference 14.5% (5.6% to 23.5%)), and were more likely to be perfectly or very satisfied with the management of their pain (83% (73/88) v 66% (57/87); adjusted odds ratio 2.56 (1.25 to 5.23)) in comparison with participants in the treatment as usual group. CONCLUSIONS: Significant reductions in pain can be achieved by PCA compared with treatment as usual in patients presenting to the emergency department with non-traumatic abdominal pain. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.


Assuntos
Dor Abdominal/terapia , Analgesia Controlada pelo Paciente , Tratamento de Emergência , Manejo da Dor/métodos , Adolescente , Adulto , Idoso , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
11.
BMJ ; 350: h2988, 2015 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-26094763

RESUMO

OBJECTIVE: To determine whether patient controlled analgesia (PCA) is better than routine care in patients presenting to emergency departments with moderate to severe pain from traumatic injuries. DESIGN: Pragmatic, multicentre, parallel group, randomised controlled trial. SETTING: Five English hospitals. PARTICIPANTS: 200 adults (71% (n = 142) male), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe pain from traumatic injuries and were expected to be admitted to hospital for at least 12 hours. INTERVENTIONS: PCA (n = 99) or nurse titrated analgesia (treatment as usual; n = 101). MAIN OUTCOME MEASURES: The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant's hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate/severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. RESULTS: 200 participants were included in the primary analyses. Mean total pain experienced was 47.2 (SD 21.9) for the treatment as usual group and 44.0 (24.0) for the PCA group. Adjusted analyses indicated slightly (but not statistically significantly) lower total pain experienced in the PCA group than in the routine care group (mean difference 2.7, 95% confidence interval -2.4 to 7.8). Participants allocated to PCA used more morphine in total than did participants in the treatment as usual group (mean 44.3 (23.2) v 27.2 (18.2) mg; mean difference 17.0, 11.3 to 22.7). PCA participants spent, on average, less time in moderate/severe pain (36.2% (31.0) v 44.1% (31.6)), but the difference was not statistically significant. A higher proportion of PCA participants reported being perfectly or very satisfied compared with the treatment as usual group (86% (78/91) v 76% (74/98)), but this was also not statistically significant. CONCLUSIONS: PCA provided no statistically significant reduction in pain compared with routine care for emergency department patients with traumatic injuries. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.


Assuntos
Analgesia Controlada pelo Paciente , Tratamento de Emergência , Manejo da Dor/métodos , Dor/etiologia , Ferimentos e Lesões/complicações , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
13.
Am J Orthod Dentofacial Orthop ; 145(5): 569-78, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24785921

RESUMO

INTRODUCTION: The aim of this study was to compare the time to initial alignment and extraction space closure using conventional brackets and active and passive self-ligating brackets. METHODS: One hundred adolescent patients 11 to 18 years of age undergoing maxillary and mandibular fixed appliance therapy after the extraction of 4 premolars were randomized with stratification of 2 age ranges (11-14 and 15-18 years) and 3 maxillomandibular plane angles (high, medium, and low) with an allocation ratio of 1:2:2. Restrictions were applied using a block size of 10. Allocation was to 1 of 3 treatment groups: conventional brackets, active self-ligating, or passive self-ligating brackets. All subjects were treated with the same archwire sequence and space-closing mechanics in a district general hospital setting. The trial was a 3-arm parallel design. Labial-segment alignment and space closure were measured on study models taken every 12 weeks throughout treatment. All measurements were made by 1 operator who was blinded to bracket type. The patients and other operators were not blinded to bracket type during treatment. RESULTS: Ninety-eight patients were followed to completion of treatment (conventional, n = 20; active self-ligating brackets, n = 37; passive self-ligating brackets, n = 41). The data were analyzed using linear mixed models and demonstrated a significant effect of bracket type on the time to initial alignment (P = 0.001), which was shorter with the conventional brackets than either of the self-ligating brackets. Sidak's adjustment showed no significant difference in effect size (the difference in average response in millimeters) between the active and passive self-ligating brackets (the results are presented as effect size, 95% confidence intervals, probabilities, and intraclass correlation coefficients) (-0.42 [-1.32, 0.48], 0.600, 0.15), but the conventional bracket was significantly different from both of these (-1.98 [-3.19, -0.76], 0.001, 0.15; and -1.56 [-2.79, -0.32], 0.001, 0.15). There was no statistically significant difference between any of the 3 bracket types with respect to space closure. Space-closure times were shorter in the mandible, except for the Damon 3MX bracket (Ormco, Orange, Calif), where active and total space-closure times were shorter in the maxilla. No adverse events were recorded in the trial. CONCLUSIONS: Time to initial alignment was significantly shorter for the conventional bracket than for either the active or passive self-ligating brackets. There was no statistically significant difference in passive, active, or total space-closure times among the 3 brackets under investigation.


Assuntos
Desenho de Aparelho Ortodôntico , Braquetes Ortodônticos , Fechamento de Espaço Ortodôntico/instrumentação , Técnicas de Movimentação Dentária/instrumentação , Adolescente , Dente Pré-Molar/cirurgia , Cefalometria/métodos , Criança , Cobre/química , Ligas Dentárias/química , Elastômeros , Feminino , Seguimentos , Humanos , Masculino , Mandíbula/patologia , Maxila/patologia , Níquel/química , Fios Ortodônticos , Aço Inoxidável/química , Fatores de Tempo , Titânio/química , Extração Dentária
14.
BMJ Open ; 4(3): e004525, 2014 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-24622951

RESUMO

INTRODUCTION: The Valsalva manoeuvre (VM) is a recommended first-line physical treatment for patients with re-entrant supraventricular tachycardia (SVT), but is often ineffective in standard practice. A failed VM is typically followed by treatment with intravenous adenosine, which patients often find unpleasant. VM effectiveness might be improved by a modification to posture which exaggerates the manoeuvre's vagal response and reduces the need for further emergency treatment. METHODS AND ANALYSIS: This is a multicentre randomised controlled clinical trial in 10 UK emergency departments (EDs). It compares a standard VM with a modified VM incorporating leg elevation and a supine posture after a standardised strain in stable adult patients presenting to the ED with SVT. The primary outcome measure is return to sinus rhythm on a 12-lead ECG. Secondary outcome measures include the need for treatment with adenosine or other antiarrhythmic treatments and the time patients spend in the ED. We plan to recruit approximately 372 patients, with 80% power to demonstrate an absolute improvement in cardioversion rate of 12%. An improvement of this magnitude through the use of a modified VM would be of significant benefit to patients and healthcare providers, and justify a change to standard practice. ETHICS AND DISSEMINATION: The study has been approved by the South West-Exeter Research Ethics Committee (REC reference 12/SW/0281). The trial will be published in an international peer reviewed journal. Study findings will be sent to the European and International resuscitation councils to inform future revisions of arrhythmia management guidelines. RESULTS: The trial will also be disseminated at international conferences and to patients through the Arrhythmia Alliance, a patient support charity. REGISTRATION: The study is registered with Current Controlled Trials (ISRCTN67937027) and has been adopted by the National Institute for Health Research (NIHR) Clinical Research Network.


Assuntos
Postura , Taquicardia Supraventricular/terapia , Manobra de Valsalva , Adenosina/uso terapêutico , Adolescente , Adulto , Antiarrítmicos/uso terapêutico , Eletrocardiografia , Humanos , Taquicardia Supraventricular/tratamento farmacológico , Adulto Jovem
15.
BMJ Open ; 3(2)2013.
Artigo em Inglês | MEDLINE | ID: mdl-23418302

RESUMO

INTRODUCTION: Pain is the commonest reason that patients present to an emergency department (ED), but it is often not treated effectively. Patient controlled analgesia (PCA) is used in other hospital settings but there is little evidence to support its use in emergency patients. We describe two randomised trials aiming to compare PCA to nurse titrated analgesia (routine care) in adult patients who present to the ED requiring intravenous opioid analgesia for the treatment of moderate to severe pain and are subsequently admitted to hospital. METHODS AND ANALYSIS: Two prospective multi-centre open-label randomised trials of PCA versus routine care in emergency department patients who require intravenous opioid analgesia followed by admission to hospital; one trial involving patients with traumatic musculoskeletal injuries and the second involving patients with non-traumatic abdominal pain. In each trial, 200 participants will be randomised to receive either routine care or PCA, and followed for the first 12 h of their hospital stay. The primary outcome measure is hourly pain score recorded by the participant using a visual analogue scale (VAS) over the 12 h study period, with the primary statistical analyses based on the area under the curve of these pain scores. Secondary outcomes include total opioid use, side effects, time spent asleep, patient satisfaction, length of hospital stay and incremental cost effectiveness ratio. ETHICS AND DISSEMINATION: The study is approved by the South Central-Southampton A Research Ethics Committee (REC reference 11/SC/0151). Data collection will be completed by August 2013, with statistical analyses starting after all final data queries are resolved. Dissemination plans include presentations at local, national and international scientific meetings held by relevant Colleges and societies. Publications should be ready for submission during 2014. A lay summary of the results will be available to study participants on request, and disseminated via a publically accessible website. REGISTRATION DETAILS: The study is registered with the European Clinical Trials Database (EudraCT Number: 2011-000194-31) and is on the ISCRTN register (ISRCTN25343280).

16.
J Neurol Neurosurg Psychiatry ; 82(11): 1232-8, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-21856692

RESUMO

OBJECTIVES: To compare the effectiveness of an exercise programme with usual care in people with Parkinson's disease (PD) who have a history of falls. DESIGN: Pragmatic randomised controlled trial. SETTING: Recruitment was from three primary and four secondary care organisations, and PD support groups in South West England. The intervention was delivered in community settings. PARTICIPANTS: People with PD, with a history of two or more falls in the previous year, who were able to mobilise independently. INTERVENTION: 10 week, physiotherapy led, group delivered strength and balance training programme with supplementary home exercises (intervention) or usual care (control). MAIN OUTCOME MEASURE: Number of falls during the (a) 10 week intervention period and (b) the 10 week follow-up period. RESULTS: 130 people were recruited and randomised (64 to the intervention; 66 to usual care). Seven participants (5.4%) did not complete the study. The incidence rate ratio for falls was 0.68 (95% CI 0.43 to 1.07, p=0.10) during the intervention period and 0.74 (95% CI 0.41 to 1.33, p=0.31) during the follow-up period. Statistically significant between group differences were observed in Berg balance, Falls Efficacy Scale-International scores and recreational physical activity levels. CONCLUSIONS: The study did not demonstrate a statistically significant between group difference in falls although the difference could be considered clinically significant. However, a type 2 error cannot be ruled out. The findings from this trial add to the evidence base for physiotherapy and exercise in the management of people with PD. Trial registration ISRCTN50793425.


Assuntos
Acidentes por Quedas/prevenção & controle , Terapia por Exercício/métodos , Doença de Parkinson/terapia , Idoso , Idoso de 80 Anos ou mais , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modalidades de Fisioterapia , Qualidade de Vida , Resultado do Tratamento
17.
Circ J ; 75(1): 67-72, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21127382

RESUMO

BACKGROUND: This retrospective cohort study evaluated whether long term outcome of atrial resynchronisation therapy using bi-atrial pacing (BiaP) to treat atrial fibrillation (AF) was effective in patients deemed unfit for left atrial (LA) ablation procedures. METHODS AND RESULTS: The patient population comprised 2 groups: those deemed suitable for left LA ablation (n=14) and those who were not (n = 17). Both groups underwent BiaP and outcomes were evaluated by comparing symptoms, AF duration, admissions and antiarrhythmic drugs (AAD) for an equal period of time pre and post implantation. Median follow-up was 24 months (range 8-66 months) for the unsuitable group and 31 months (range 7-84 months) for the suitable group. Efficacy in reduction of both AF and symptoms was similar (P = 0.44) in both groups (unsuitable group: 13/17; suitable group: 8/14). There was significant improvement in median AF episodes/week pre and post BiaP in both groups (unsuitable group AF reduction: 5 days/week, P = 0.001; suitable group AF reduction: 4.9 days/week, P = 0.03); the improvement was similar in both groups (P = 0.33). There was a significant reduction in the median number of admissions for AF in both groups (unsuitable group: P = 0.003; suitable group: P = 0.01) and this reduction was also similar (P = 0.70). The median number of AAD was also reduced to a similar degree (P = 0.83) in both groups (suitable group: P = 0.004; unsuitable group: P = 0.001). CONCLUSIONS: Atrial resynchronisation therapy is effective in the long term management of drug-resistant AF in patients unsuitable for LA ablation, leading to significant reductions in symptoms, AF duration, admissions and AAD.


Assuntos
Antiarrítmicos/uso terapêutico , Fibrilação Atrial/terapia , Terapia de Ressincronização Cardíaca , Ablação por Cateter , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/cirurgia , Terapia de Ressincronização Cardíaca/efeitos adversos , Ablação por Cateter/efeitos adversos , Resistência a Medicamentos , Inglaterra , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Recidiva , Estudos Retrospectivos , Medição de Risco , Fatores de Tempo , Resultado do Tratamento
18.
Ann Surg ; 252(6): 966-71, 2010 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-21107106

RESUMO

OBJECTIVE: To investigate the rate of type 2 diabetes remission after gastric bypass and banding and establish the mechanism leading to remission of type 2 diabetes after bariatric surgery. SUMMARY BACKGROUND DATA: Glycemic control in type 2 diabetic patients is improved after bariatric surgery. METHODS: In study 1, 34 obese type 2 diabetic patients undergoing either gastric bypass or gastric banding were followed up for 36 months. Remission of diabetes was defined as patients not requiring hypoglycemic medication, fasting glucose below 7 mmol/L, 2 hour glucose after oral glucose tolerance test below 11.1 mmol/L, and glycated haemoglobin (HbA1c) <6%. In study 2, 41 obese type 2 diabetic patients undergoing either bypass, banding, or very low calorie diet were followed up for 42 days. Insulin resistance (HOMA-IR), insulin production, and glucagon-like peptide 1 (GLP-1) responses after a standard meal were measured. RESULTS: In study 1, HbA1c as a marker of glycemic control improved by 2.9% after gastric bypass and 1.9% after gastric banding at latest follow-up (P < 0.001 for both groups). Despite similar weight loss, 72% (16/22) of bypass and 17% (2/12) of banding patients (P = 0.001) fulfilled the definition of remission at latest follow-up. In study 2, within days, only bypass patients had improved insulin resistance, insulin production, and GLP-1 responses (all P < 0.05). CONCLUSIONS: With gastric bypass, type 2 diabetes can be improved and even rapidly put into a state of remission irrespective of weight loss. Improved insulin resistance within the first week after surgery remains unexplained, but increased insulin production in the first week after surgery may be explained by the enhanced postprandial GLP-1 responses.


Assuntos
Diabetes Mellitus Tipo 2/cirurgia , Derivação Gástrica , Gastroplastia , Obesidade Mórbida/cirurgia , Adulto , Glicemia , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Hemoglobina A Glicada , Humanos , Pessoa de Meia-Idade , Obesidade Mórbida/complicações , Indução de Remissão , Resultado do Tratamento
19.
Clin Exp Ophthalmol ; 38(7): 678-82, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20456437

RESUMO

BACKGROUND: To compare the efficacy and tolerance of three prostaglandin analogues, bimatoprost, latanoprost and travoprost in patients with previously untreated open-angle glaucoma and ocular hypertension. METHODS: Prospective randomized single (investigator) masked comparative clinical trial at the Taunton and Somerset NHS Hospital, Taunton, UK. Newly diagnosed, treatment naïve glaucoma/ocular hypertension patients were recruited. Patients were randomized into three groups to receive one of the three prostaglandin analogues. Intraocular pressure (IOP) was measured before starting treatment and after 2 and 6 months of treatment. The IOP reduction and the tolerance profile of each drug were compared. The data were analysed on the basis of intention to treat, using analysis of covariance comparing IOP in the three groups at 2 and 6 months, adjusting for baseline IOP. Tolerance levels were compared using Kruskal-Wallis test. RESULTS: Of the 122 patients, 40 patients were given bimatoprost, 42 received latanoprost and 40 had travoprost. At 2 months, there was a significant difference between the three treatment groups (P = 0.013) with bimatoprost achieving a greater reduction in IOP than the other two drops. However, at 6 months, the difference was not statistically significant (P = 0.13). There was no significant difference in the tolerance profile. CONCLUSION: All the three topical prostaglandin analogues are effective at lowering IOP, but bimatoprost was found to be most effective in the initial phase of the trial, and there was no statistically significant difference in the efficacy, among the three prostaglandin analogue eye drops after 6 months of treatment.


Assuntos
Amidas/uso terapêutico , Cloprostenol/análogos & derivados , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Baixa Tensão/tratamento farmacológico , Hipertensão Ocular/tratamento farmacológico , Prostaglandinas F Sintéticas/uso terapêutico , Prostaglandinas Sintéticas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Amidas/efeitos adversos , Bimatoprost , Cloprostenol/efeitos adversos , Cloprostenol/uso terapêutico , Feminino , Seguimentos , Humanos , Pressão Intraocular/efeitos dos fármacos , Latanoprosta , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/fisiopatologia , Prostaglandinas F Sintéticas/efeitos adversos , Prostaglandinas Sintéticas/efeitos adversos , Travoprost
20.
Br J Gen Pract ; 60(571): 101-5, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20132703

RESUMO

BACKGROUND: National Institute for Health and Clinical Excellence (NICE) guidance to treat otitis media in older children immediately with antibiotics only if they have ear discharge is based on limited evidence. AIM: To determine the clinical significance and outcome of ear discharge in children with acute otitis media, in routine clinical practice. DESIGN OF STUDY: Observational cohort study of children with acute otitis media comparing those with and without ear discharge at presentation. SETTING: Primary care in East Somerset. METHOD: Two hundred and fifty-six children aged 6 months to 10 years were recruited from primary care. Clinical features and other characteristics were recorded at presentation. Follow-up was undertaken at 2 weeks and 3 months. RESULTS: Children with otitis media who present with ear discharge are much more likely to be treated with antibiotics irrespective of age (adjusted odds ratio 15, 95% confidence interval [CI] = 3 to 66). Most with discharge have proven bacterial infection (58%, 95% CI = 42 to 72%). They have a more severe systemic illness, with higher axillary temperature (80% increase in odds of ear discharge for each additional degree centigrade, P = 0.02), pulse rate (9% increase in odds for each extra beat, P<0.001), and Yale score (mean 10.5 versus 9.0, P = 0.003). They may also have an increased likelihood of adverse outcome (adjusted odds ratio of pain at 1 week 2.9; further episodes of acute otitis media 3.3; hearing difficulty at 3 months 4.7; all P<0.10). CONCLUSION: Ear discharge defines a group of children with otitis media who are sicker and may be at higher risk of adverse outcome. NICE guidance to treat them with antibiotics is supported.


Assuntos
Antibacterianos/uso terapêutico , Otite Média com Derrame/tratamento farmacológico , Doença Aguda , Criança , Pré-Escolar , Estudos de Coortes , Medicina de Família e Comunidade , Feminino , Fidelidade a Diretrizes , Humanos , Lactente , Masculino , Otite Média com Derrame/microbiologia , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Fatores de Risco , Resultado do Tratamento
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