scholarly journals Does perioperative ketamine have a role in the prevention of chronic postsurgical pain: the ROCKet trial

2017 ◽  
Vol 11 (4) ◽  
pp. 166-168 ◽  
Author(s):  
Stephan A Schug ◽  
Philip Peyton
Keyword(s):  
Controlled Trial ◽  
Cochrane Review ◽  
Postsurgical Pain ◽  
Pharmacological Prevention ◽  
Surgical Pain ◽  
Increased Risk ◽  
Chronic Postsurgical Pain ◽  
Zealand College ◽  
Chronic Post Surgical Pain ◽  
Randomised Controlled

Identifying operations and individuals with an increased risk of chronic postsurgical pain (CPSP) has led to significant interest in interventions with the potential to achieve primary prevention of this condition. Pharmacological prevention remains controversial with a Cochrane review identifying perioperative ketamine administration as the only intervention with possible benefit although, with only small, heterogeneous studies, the authors called for a large randomised controlled trial (RCT) to confirm the validity of this result. In response to these data, a group of researchers from Australia and Hong Kong designed the ROCKet trial – Reduction Of Chronic Post-surgical Pain with Ketamine, endorsed by the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network (CTN).

scholarly journals How important is the relative balance of fat and carbohydrate as sources of energy in relation to health?

2015 ◽  
Vol 75 (2) ◽  
pp. 147-153 ◽  
Author(s):  
Thomas A. B. Sanders
Keyword(s):  
Controlled Trial ◽  
Dietary Guidelines ◽  
Partial Replacement ◽  
Current Evidence ◽  
Added Sugar ◽  
Increased Risk ◽  
Total Fat ◽  
Randomised Controlled ◽  
Refined Carbohydrates ◽  
The Impact

Both the intake of fat, especially saturated trans fatty acids, and refined carbohydrates, particularly sugar, have been linked to increased risk of obesity, diabetes and CVD. Dietary guidelines are generally similar throughout the world, restrict both intake of SFA and added sugar to no more than 10 and 35 % energy for total fat and recommend 50 % energy from carbohydrates being derived from unrefined cereals, tubers, fruit and vegetables. Current evidence favours partial replacement of SFA with PUFA with regard to risk of CVD. The translation of these macronutrient targets into food-based dietary guidelines is more complex because some high-fat foods play an important part in meeting nutrient requirements as well as influencing the risk of chronic disease. Some of the recent controversies surrounding the significance of sugar and the type of fat in the diet are discussed. Finally, data from a recently published randomised controlled trial are presented to show the impact of following current dietary guidelines on cardiovascular risk and nutrient intake compared with a traditional UK diet.

scholarly journals P001 IS PROPHYLACTIC MESH IS ROUTINELY REQUIRED FOR STOMA CONSTRUCTION? IDENTIFICATION OF THE ‘TARGET GROUP’

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Ahmed Hassan ◽  
Wei Toh ◽  
James Ayathamattam ◽  
Zachary Thomas ◽  
Ondrej Ryska
Keyword(s):  
Controlled Trial ◽  
Cost Benefit ◽  
Prophylactic Mesh ◽  
Nice Guidelines ◽  
Prophylactic Measures ◽  
Increased Risk ◽  
End Colostomy ◽  
Randomised Controlled

Abstract Background Evidence to support routine prophylactic mesh insertion during stoma construction is conflicting. The PREVENT randomised controlled trial (RCT) suggested lower incidence of parastomal hernia (PSH) with prophylactic mesh but with no quality of life or cost benefit. Another two RCTs has shown no prophylactic benefit (STOMAMESH & STOMA-const). Although European Hernia guidelines recommends routine prophylactic mesh in end-colostomy, NICE guidelines suggest mesh on individual basis not routinely. Aim To identify the group with higher risk to develop a symptomatic PSH when prophylactic mesh should be considered Material and Methods A single center retrospective review of all stoma formed. Younger patient than 18 years and patients who had less than 6 months’ follow-up were excluded. Development of PSH was confirmed by radiological evidence or direct intra-operative visualization Results 194 patients between January 2015 till December 2019 were included with mean follow-up of 15.7±13.5 months where 91 patients developed PSH. On multivariate analysis, older age (>65) (OR 2.3, 95% CI 1.08 – 4.99, p 0.03) and Obesity (OR 5.8, 95% CI 2.53 – 13.57, p 0.00) were risk factors of developing PSH. Among the PSH group, 28 were symptomatic (31%). Symptomatic subgroup had higher ASA (ASA >2) than asymptomatic subgroup (50% Vs 27%, p 0.05) Conclusions Obese patients older than 65 years are at increased risk of PSH. IF their ASA >2 this PSH is likely to become symptomatic. This is the group who should benefit the most from prophylactic measures including mesh insertion and should be targeted for future trials

scholarly journals Effects of injectable progestogen contraception versus the copper intrauterine device on HIV acquisition: sub-study of a pragmatic randomised controlled trial

2017 ◽  
Vol 43 (3) ◽  
pp. 175-180 ◽  
Author(s):  
G Justus Hofmeyr ◽  
Mandisa Singata-Madliki ◽  
Theresa A Lawrie ◽  
Eduardo Bergel ◽  
Marleen Temmerman
Keyword(s):  
Randomised Controlled Trial ◽  
South African ◽  
Pregnancy Termination ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Randomised Trial ◽  
Contraceptive Device ◽  
Increased Risk ◽  
Hiv Acquisition ◽  
Randomised Controlled

BackgroundEvidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception.MethodsWithin the context of a South African programme to increase women's access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article.ResultsHIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59;p=0.7).ConclusionsThis sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision.Trial registration numberPan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).

scholarly journals CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e021000 ◽  
Author(s):  
Dan Siskind ◽  
Nadia Friend ◽  
Anthony Russell ◽  
John J McGrath ◽  
Carmen Lim ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Body Weight ◽  
Weight Gain ◽  
Controlled Trial ◽  
Adjunctive Treatment ◽  
Double Blind ◽  
Human Research Ethics ◽  
Increased Risk ◽  
Point Body ◽  
Randomised Controlled

IntroductionClozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation.Methods and analysisA 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on clozapine will be randomised to placebo or metformin (variable dose, up to 2 g/day). The primary outcome is comparative end point body weight, between the placebo and metformin groups. Secondary outcomes are comparative rates of conversion to T2DM, alteration of metabolic syndrome parameters, proportion gaining >5% body weight and changes in diet and appetite. We will additionally examine biomarkers associated with change in weight among trial participants.Ethics and disseminationEthics approval was granted by the Metro South Human Research Ethics Committee HREC/17/QPAH/538-SSA/17/QPAH/565. We plan to submit a manuscript of the results to a peer-reviewed journal, and present results at conferences, consumer forums and hospital grand rounds.Trial registration numberACTRN12617001547336; Pre-results.

scholarly journals P146 Undertaking an integrated nurse led review (INCLUDE) for patients with inflammatory conditions: does it change management of morbidities?

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Samantha Hider ◽  
Annabelle Machin ◽  
Milica Bucknall ◽  
Kendra Cooke ◽  
Clare Jinks ◽  
...  
Keyword(s):  
Primary Care ◽  
Medical Record ◽  
Controlled Trial ◽  
Management Plan ◽  
Lipid Lowering ◽  
Cvd Risk ◽  
Inflammatory Conditions ◽  
Increased Risk ◽  
Comorbidity Burden ◽  
Randomised Controlled

Abstract Background People with inflammatory rheumatological conditions (IRCs), including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), polymyalgia rheumatica (PMR) and giant cell arteritis (GCA), are at an increased risk of common comorbidities, such as cardiovascular disease (CVD), osteoporosis and mood problems, which result in poorer patient outcomes. The INCLUDE study assessed the feasibility of conducting a randomised controlled trial (RCT) of a nurse-led, holistic, integrated review in primary care. Methods A pilot cluster RCT was delivered across four general practices. Patients with a Read code for an IRC were recruited by postal invitation. In intervention practices (n = 2), eligible patients were invited to attend a nurse-delivered INCLUDE review - an integrated consultation assessing CVD risk (QRisk2), bone health (FRAX) and mood (PHQ2 and GAD2), using a study-specific computerised template. Patients received an individualized patient management plan, including signposting to additional services as appropriate. Medical record review was undertaken (in consenting participants) at 12 months. We compared primary care contacts (which include consultations, letters and test results) and prescribing rates (of antihypertensives, lipid-lowering, osteoporosis and antidepressant/anxiety medication) at baseline and 12 months. Results 333 patients participated in the study. The mean (SD) age was 68.2 (13.4) years and 200 (60%) were female. Of these 172 (52%) had RA and 88 (26%) had PMR. 154 (46%) reported high blood pressure, 70 (21%) existing anxiety/depression and 37 (11%) osteoporosis. Medical record data was available for 299/333 participants. Participants in intervention practices had more primary care contacts (mean 29 vs 22). Over the 12-month follow-up, there was higher prescribing of all medication classes in participants in intervention practices (see Table), particularly so for osteoporosis medication (baseline 29% vs 12 month 46%). Conclusion Nurse-delivered integrated reviews for patients with IRCs identified a significant comorbidity burden. Practices undertaking these reviews had higher prescribing rates at 12 months following treatment of previously un-identified conditions, suggesting that patients with IRCs would benefit from an integrated care review to identify and manage common morbidities. Disclosures S. Hider None. A. Machin None. M. Bucknall None. K. Cooke None. C. Jinks None. E. Healey None. A. Finney None. K. Cooke None. S. Wathall None. C. Mallen None. C. Chew-Graham None.

scholarly journals A Feasibility Study of the Mistletoe and Breast Cancer (MAB) Trial: A Protocol for a Randomised Double-blind Controlled Trial

2020 ◽  
Author(s):  
Susan Bryant ◽  
Lorna Duncan ◽  
Gene Feder ◽  
Alyson Huntley
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Cochrane Review ◽  
Double Blind ◽  
Randomised Controlled ◽  
The Uk ◽  
Mistletoe Therapy

Abstract Background: A Cochrane review of mistletoe therapy concludes that there is some evidence that mistletoe extracts may offer benefits on measures of quality of life during chemotherapy for breast cancer, but these results need replication. Our aim was to test the feasibility of a placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. Methods/design: A placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer. There will be three arms (groups) in the trial: Iscador M, Iscador P, with physiological saline as the placebo. The aim is to recruit 45 adult patients with a new diagnosis of early or locally advanced breast cancer, up to 12 weeks following definitive breast surgery whose standard treatment plan includes chemotherapy with or without radiotherapy. They will be taught to administer the MAB therapies subcutaneously and will titrate up to their optimal dose. MAB therapy will continue throughout their standard chemotherapy and radiotherapy and one month beyond. The main outcome of the MAB study is the feasibility of conducting such a trial within the NHS in order to inform a future fully powered investigative trial. Feasibility will be measured through recruitment, retention and patient experience using clinical research forms, patient diaries, cancer-related questionnaires and qualitative interviews conducted with both patients and oncology staff.Discussion: This trial is the first of its kind in the UK. Currently mistletoe therapy is mostly available through private practice in the UK. Completion of this feasibility study will support applications for further funding for a fully powered randomised controlled trial which will measure effectiveness and cost-effectiveness of this herbal therapy.

scholarly journals Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Gretchen Bjornstad ◽  
Kath Wilkinson ◽  
Beth Cuffe-Fuller ◽  
Katharine Fitzpatrick ◽  
Aleksandra Borek ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Trial Design ◽  
Controlled Trial ◽  
Well Being ◽  
Online Resources ◽  
Disabled Children ◽  
Link Type ◽  
Increased Risk ◽  
Randomised Controlled

Abstract Background Parent carers of disabled children are at increased risk of mental and physical health problems. They often experience challenges to maintaining good health which have implications for their well-being and their ability to care for their children. In response to these needs, researchers and parent carers developed the Healthy Parent Carers (HPC) programme. It is a peer-led, group-based intervention that promotes behaviours associated with health and well-being. The aims of this trial are to assess the acceptability of the HPC programme and the feasibility of its delivery in the community and to assess the feasibility and acceptability of the design of the definitive trial to evaluate the programme’s effectiveness and cost-effectiveness. Methods We will establish six research sites and train facilitators to deliver the manualised intervention. Parent carers of children with special educational needs and disabilities will be individually randomised, stratified by group delivery site, to either take part in a group programme and online resources (intervention) or to receive access to the online resources only (control). Measures of mental health; well-being; health-related quality of life; health behaviours; patient activation; protective factors such as resilience, social connections, and practical support; and use of health care, social care, and wider societal resources will be collected before randomisation (baseline), immediately post-intervention, and 6 months later. Recruitment of participants, adherence to the programme, and the dose received will be assessed. Group sessions will be audio-recorded to evaluate the fidelity of delivery and participant engagement. Participants’ and facilitators’ feedback on the programme content and delivery, their experience, and the acceptability of the outcome measures and trial design will be collected through feedback forms, interviews, and focus groups. Discussion This trial will assess whether the programme delivery and evaluative trial design are feasible, to inform whether to progress to a definitive randomised controlled trial to test the effectiveness and cost-effectiveness of the Healthy Parent Carers programme. Trial registration ISRCTN, ISRCTN151144652, registered on 25 October 2018; ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

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