scholarly journals A feasibility randomised controlled trial to evaluate the role of computed tomography in adults with atypical right iliac fossa pain

2019 ◽  
Vol 101 (8) ◽  
pp. 546-551
Author(s):  
R Jones ◽  
D Olatunbode ◽  
J Dean ◽  
B Hall ◽  
D Harji ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Randomised Controlled Trial ◽  
Diagnostic Accuracy ◽  
Standard Care ◽  
Controlled Trial ◽  
Iliac Fossa ◽  
Randomised Trial ◽  
Final Analysis ◽  
Right Iliac Fossa Pain ◽  
Randomised Controlled

Background In patients with right iliac fossa pain, the need for surgery is largely determined by the likelihood of appendicitis. Patients often undergo ultrasound scanning despite a low diagnostic accuracy for appendicitis. This study aimed to determine the feasibility of a larger trial of computed tomography in the evaluation of patients with atypical right iliac fossa pain. Materials and methods A single-centre, unblinded, parallel randomised controlled trial of computed tomography in the assessment of patients with atypical right iliac fossa pain. After a retrospective evaluation, standard care was defined as serial examination with or without ultrasound. Atypical right iliac fossa pain was defined as no firm diagnosis after initial senior review. Simple descriptions of the risks and benefits of computed tomography were devised for patients to consider. Primary objectives were to assess feasibility and acceptability of the study procedures. Results A total of 71 patients were invited to participate and 68 were randomised. Final analysis included 31 participants in the standard care arm and 33 in the computed tomography arm, with comparable demographics. Computed tomography was associated with superior diagnostic accuracy, with 100% positive and negative predictive value. The proportion of scans that positively influenced management was 73% for computed tomography and 0% for ultrasound. In the computed tomography arm, there was a trend towards a shorter length of stay (2.3 vs 3.1 days) and a lower negative laparoscopy rate (2 of 11 vs 4 of 9). Conclusion A large randomised trial to evaluate the use of unenhanced computed tomography in atypical right iliac fossa pain appears feasible and justified.

scholarly journals Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection

2015 ◽  
Vol 46 (2) ◽  
pp. 456-463 ◽  
Author(s):  
Clare E. Hooper ◽  
Anthony J. Edey ◽  
Anthony Wallis ◽  
Amelia O. Clive ◽  
Anna Morley ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Hospital Stay ◽  
Standard Care ◽  
Best Practice ◽  
Controlled Trial ◽  
Saline Irrigation ◽  
Pleural Infection ◽  
Randomised Controlled

Pleural infection is increasing in incidence. Despite optimal medical management, up to 30% of patients will die or require surgery. Case reports suggest that irrigation of the pleural space with saline may be beneficial.A randomised controlled pilot study in which saline pleural irrigation (three times per day for 3 days) plus best-practice management was compared with best-practice management alone was performed in patients with pleural infection requiring chest-tube drainage. The primary outcome was percentage change in computed tomography pleural fluid volume from day 0 to day 3. Secondary outcomes included surgical referral rate, hospital stay and adverse events.35 patients were randomised. Patients receiving saline irrigation had a significantly greater reduction in pleural collection volume on computed tomography compared to those receiving standard care (median (interquartile range) 32.3% (19.6–43.7%) reduction versus 15.3% (−5.5–28%) reduction) (p<0.04). Significantly fewer patients in the irrigation group were referred for surgery (OR 7.1, 95% CI 1.23–41.0; p=0.03). There was no difference in length of hospital stay, fall in C-reactive protein, white cell count or procalcitonin or adverse events between the treatment groups, and no serious complications were documented.Saline irrigation improves pleural fluid drainage and reduces referrals for surgery in pleural infection. A large multicentre randomised controlled trial is now warranted to evaluate its effects further.

scholarly journals Methods for delivering the UK's multi-centre prison-based naloxone-on-release pilot randomised trial (N-ALIVE): Europe's largest prison-based randomised controlled trial

2017 ◽  
Vol 37 (4) ◽  
pp. 487-498 ◽  
Author(s):  
Angela Mary Meade ◽  
Sheila Macdonald Bird ◽  
John Strang ◽  
Tracey Pepple ◽  
Laura Lea Nichols ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Randomised Controlled

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).

A randomised controlled trial of intrapleural balloon intercostal chest drains to prevent drain displacement

2021 ◽  
pp. 2101753
Author(s):  
Rachel M Mercer ◽  
Eleanor Mishra ◽  
Radhika Banka ◽  
John P Corcoran ◽  
Cyrus Daneshvar ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Standard Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Problem ◽  
Outcome Data ◽  
Chest Drain ◽  
Drain Removal ◽  
Randomised Controlled

BackgroundChest drain displacement is a common clinical problem, occurring in 9–42% of cases and results in treatment failure or additional pleural procedures conferring unnecessary risk. A novel chest drain with an integrated intrapleural balloon may reduce the risk of displacement.MethodsProspective randomised controlled trial comparing the balloon drain to standard care (12 F chest drain with no balloon) with the primary outcome of objectively-defined unintentional or accidental chest drain displacement.Results267 patients were randomised (primary outcome data available in 257, 96.2%). Displacement occurred less frequently using the balloon drain (displacement 5/128, 3.9%; standard care displacement 13/129, 10.1%) but this was not statistically significant (Odds Ratio (OR) for drain displacement 0.36, 95% CI 0.13 to 1.0, χ2 1df=2.87, p=0.09). Adjusted analysis to account for minimisation factors and use of drain sutures demonstrated balloon drains were independently associated with reduced drain fall out rate (adjusted OR 0.27, 95% CI 0.08 to 0.87, p=0.028). Adverse events were higher in the balloon arm than the standard care arm (balloon drain 59/131, 45.0%; standard care 18/132, 13.6%; χ2 1df=31.3, p<0.0001).ConclusionBalloon drains reduce displacement compared with standard drains independent of the use of sutures but are associated with increased adverse events specifically during drain removal. The potential benefits of the novel drain should be weighed against the risks, but may be considered in practices where sutures are not routinely used.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

scholarly journals Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Antenatal Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
The World ◽  
Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

Sign in / Sign up

Export Citation Format

Share Document