BMC research notes
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Randomized Controlled Trial
To send or not to send: weighing the costs and benefits of mailing an advance letter to participants before a telephone survey.
A letter was mailed to half the participants (Letter = 137; No Letter = 138) of a 5-year follow-up survey regarding smoking cessation before attempting contact for a telephone interview. The primary outcome was the number of completed surveys per group (response rate). Secondary analyses of the number of telephone calls placed and a cost analysis were performed. ⋯ No conclusive effect was found on the response rates per group (59.1% Letter, 50.0% No Letter; p = 0.147). Additionally, a logistic regression, controlling for demographics, revealed that there was no direct effect of sending the letter on response rate (p = 0.369). Non-parametric analysis showed significantly fewer calls (U = 7962.5, z = - 2.274, p < 0.05 two-tailed) and significantly lower costs (U = 11112.00, z = 2.521, p < 0.05 two-tailed) in reaching participants in the Letter group. Mailing an advance letter to participants did not appear to effect response rates between the groups, even when controlling for demographics. However, further analysis examining the number of call attempts and the costs per group revealed the letter may have had other effects. These findings suggest that additional analyses may be merited when evaluating the effectiveness of methods to increase participation, such as an advance letter, especially in cases where the literature largely supports its effectual use. Trial registration ClinicalTrials.gov NCT03097445. Registered 31 March 2017.
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Randomized Controlled Trial
Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial.
We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status. ⋯ Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).
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Randomized Controlled Trial Comparative Study
Betamethasone gel compared with lidocaine jelly to reduce tracheal tube related postoperative airway symptoms: a randomized controlled trial.
Post-operative airway symptoms can be troublesome to patients following an uneventful general anesthesia with endotracheal intubation. In this study, we compared the effectiveness of lubricating an endotracheal tube with betamethasone gel or lidocaine jelly with using an unlubricated tube in reducing the incidence and severity of postoperative sore throat, hoarseness and cough. ⋯ Wide spread application of 0.05% betamethasone gel to lubricate the endotracheal tube significantly reduces the incidence and severity of sore throat at 24 h of extubation but not of hoarseness or cough.
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Randomized Controlled Trial
Feasibility and challenges of inpatient psychotherapy for psychosis: lessons learned from a veterans health administration pilot randomized controlled trial.
In large health care systems, decision regarding broad implementation of psychotherapies for inpatients with psychosis require substantial evidence regarding effectiveness and feasibility for implementation. It is important to recognize challenges in conducting research to inform such decisions, including difficulties in obtaining consent from and engaging inpatients with psychosis in research. We set out to conduct a feasibility and effectiveness Hybrid Type I pilot randomized controlled trial of acceptance and commitment therapy (ACT) and a semi-formative evaluation of barriers and facilitators to implementation. ⋯ Future studies should include (1) multi-stage informed consent processes to build trust and alleviate patient fears, (2) relaxation of restrictions associated with obtaining efficacy/effectiveness data, and (3) use of Hybrid Type II and III designs.
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Randomized Controlled Trial
Adding a transversus abdominis plane block to parenteral opioid for postoperative analgesia following trans-abdominal hysterectomy in a low resource setting: a prospective, randomised, double blind, controlled study.
The current gold standard treatment for acute postoperative pain after major abdominal surgery is multimodal analgesia using patient controlled analgesia delivery systems. Patient controlled analgesia systems are expensive and their routine use in very low income countries is not practical. The use of ultrasound in anaesthesia has made some regional anaesthesia blocks technically easy and safe to perform. This study aimed to determine whether adding an ultrasound guided transversus abdominis plane block as an adjunct to the current parenteral opioid based regimen would result in superior pain relief after a trans abdominal hysterectomy compared to using parenteral opioids alone. ⋯ The addition of a bupivacaine-dexamethasone transverse abdominis plane block to intramuscular opioid does produce superior acute post-operative pain relief following a hysterectomy. However a single-shot block has a limited duration of action, and we recommend a repeat block.