Journal of evaluation in clinical practice
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Randomized Controlled Trial Observational Study
Nursing staff perspectives of continuous remote vital signs monitoring on surgical wards: Theory elicitation for a realist evaluation.
Continuous remote monitoring (CRM) provides a novel solution to the challenges of monitoring patients' vital signs in hospital, but the results of quantitative studies have been mixed. Acceptance by staff is a crucial determinant of the success of healthcare technologies and may explain these discrepancies. Drawing on the approach of realist evaluation, this paper aims to identify theories about how, why and in what conditions nursing staff perceptions vary regarding the CRM of patients' vital signs. ⋯ Theories regarding nursing staff engagement with remote monitoring are numerous, varied and contradictory. The theories elicited in this initial phase will be refined during interviews with the nursing staff involved with the RCT.
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Randomized Controlled Trial
Distinctive aspects of consent in pilot and feasibility studies.
Prior to a main randomized clinical trial, investigators often carry out a pilot or feasibility study in order to test certain trial processes or estimate key statistical parameters, so as to optimize the design of the main trial and/or determine whether it can feasibly be run. Pilot studies reflect the design of the intended main trial, whereas feasibility studies may not do so, and may not involve allocation to different treatments. Testing relative clinical effectiveness is not considered an appropriate aim of pilot or feasibility studies. ⋯ Equipoise may also be particularly challenging to grasp in the context of a pilot study. The consent process in pilot and feasibility studies requires a particular focus, and careful communication, if it is to carry the appropriate moral weight. There are corresponding implications for the process of ethical approval.
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Randomized Controlled Trial
Assessing the impact of medication management review service for females diagnosed with depression and anxiety: A randomized control trial.
Study participants (n = 73; mean age = 41.8 [SD = 16.27]) had 177 TRPs identified, with 2.42(SD = 1.06) TRPs per patient. At baseline, only 54.8% of the participants reported to be adherent to their treatment, and no significant differences were found between the groups. At follow-up, a significant decline in the number of TRPs was found for the active versus control group (active: 0.58[SD = 0.64], control: 1.78[SD = 1.13], P < .001). A significantly higher proportion of adherent patients was identified in the active (88.9%) versus control group (51.4%), P < .001. Significant improvements in the depression (P < .001) and anxiety (P = .003) scores were detected for the active versus control group. ⋯ The MMR service led to a significant decrease in the number of TRPs, improved adherence, depression, and anxiety scores for females diagnosed with depression and anxiety.
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Randomized Controlled Trial
Perioperative analgesia with parecoxib sodium improves postoperative pain and immune function in patients undergoing hepatectomy for hepatocellular carcinoma.
Acute postoperative pain can result in immune dysfunction, which can be partly mitigated by efficient pain management. Opioids that have been widely applied to analgesia have been shown to suppress immune function, which has a negative impact on the treatment of patients with cancer. This study investigated the effects of perioperative fentanyl analgesia alone or in combination with parecoxib sodium on postoperative pain, immune function, and prognosis in patients undergoing hepatectomy of hepatocellular carcinoma (HCC). ⋯ The present study indicated that perioperative analgesia of parecoxib sodium combined with patient-controlled analgesic fentanyl resulted in better preserved immune function with enhancement of the analgesic efficacy to fentanyl alone of HCC patients undergoing hepatectomy and helped postpone postoperative tumour recurrence.
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Randomized Controlled Trial
Unconditional and conditional monetary incentives to increase response to mailed questionnaires: A randomized controlled study within a trial (SWAT).
High response rates to research questionnaires can help to ensure results are more representative of the population studied and provide increased statistical power, on which the study may have been predicated. Improving speed and quality of response can reduce costs. ⋯ Unconditional monetary incentives can produce a transitory greater likelihood of mailed questionnaire response in a clinical trial participant group, consistent with the direction of effect in other settings. However, this could have been a chance finding. The use of multiple strategies to promote response may have created a ceiling effect. This strategy has potential to reduce administrative and postage costs, weighed against the cost of incentives used, but could risk compromising the completeness of data.