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This paper identifies and explores issues of medication, the elderly, and the problems in securing and using evidence from randomised control trials. Demographic and health care data are presented. While the elderly are a significant set of consumers of medicines, there is a lack of published evidence, in control trial format, on which medications are better for elderly patients. Even if all the trial evidence on a new drug was published before the drug was put on the market, as recently recommended, there are serious issues to consider in securing and using evidence from clinical trials. This paper indicates ten problems in securing and using evidence from randomised control trials. Three examples of randomised control trials involving the elderly are given. While it is easier to call for improvements in the evidence base than to achieve improvements, this paper argues that improvements are fundamentally necessary. This is because if no significant improvement comes through on the evidence base, we will never know if we are providing the elderly with the cost‐effective care and attention that they deserve.

The chapter considers the ethical problems engendered by random assignment and privacy concerns in randomised controlled experiments and cluster randomised trials. The particular focus is on procedural, legislative and technical approaches to reducing or avoiding the problems. Examples are given from a variety of disciplines including health and education, though the main emphasis is on research in crime and delinquency.

Diabetic foot ulcers are associated with considerable morbidity, mortality and costs to the NHS. This paper describes a review of publications reporting randomised controlled trials examining the clinical effectiveness of interventions for diabetic foot ulcers for 1986–1996. Only 23 studies were identified that described randomised controlled trials and, of these, only 4 fulfilled three criteria shown to influence reliability of results: adequate description of randomisation, double blinding and description of withdrawals and drop‐outs. No cost‐effectiveness studies conducted alongside trials were identified from the searches. This shortage of rigorous trials highlights the need for more well designed research in the prevention and treatment of diabetic foot ulcers to determine clinical effectiveness as well as relative cost‐effectiveness.

To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.

Interventional “before‐after” study in 51 units (38 surgical and 13 anaesthetic) in nine hospitals participating in a RCT in the greater Copenhagen area; 27 of the units also underwent international accreditation.

The proportion of units with guidelines increased from 24/51 (47 percent) units before to 38/51 (75 percent) units after the trial. Among the 27 units without guidelines before the trial, significantly more accredited units compared to non‐accredited units had a guideline after the trial (9/10 (90 percent) compared to 5/17 (29 percent). The quality of the systematic development scale and the clinical scales improved significantly after the trial in both accredited units (both p<0.001) and in non‐accredited units (both p<0.02). The improvement of the systematic development scale was significantly higher in accredited than in non‐accredited units (p<0.01).

The combination of conducting both the DIPOM Trial and international accreditation led to a significant improvement of both dissemination and quality of guidelines on perioperative diabetic care.

Randomised controlled trials (RCTs) are considered the bedrock of evidence‐based practice. However, they raise important issues about participant recruitment and the ethics of group allocation. In this article we report relevant literature on how participants with learning disabilities and other stakeholders experience RCTs. Five quantitative studies have been published, one reporting on the views of people with learning disabilities and the remainder on carers' views. Despite the methodological limitations of the studies, carers appear to have a positive experience of RCT participation, and people with learning disabilities are able to understand certain aspects of research methods. We conclude that stakeholders are not hostile to RCTs, but the therapeutic misconception may affect their experiences. Further research is required to investigate interventions that might help promote RCTs in learning disabilities.

The aim of this randomised intervention study was to test the use of two counselling styles in reducing alcohol consumption in offenders who were hazardous drinkers and who had been charged with alcohol‐related offences. An additional aim was to evaluate the research process itself before embarking on a larger trial. Participants were recruited from a police custody suite in the south east of England and randomised to receive either a motivational interviewing brief intervention (MIBI) or a standard brief intervention (BI). The Alcohol Use Disorder Identification Test (AUDIT) was used to screen offenders for hazardous drinking. Participants were asked to complete a second AUDIT 12 weeks later. Two hundred offenders with alcohol‐related offences were screened over a 10‐month period. Of these, 182 were alcohol dependent and were therefore excluded from the study. Of the 18 who were eligible to enter the study, six refused to participate. Five were randomised to the MIBI group and seven into the BI group (BI). The mean age of the MIBI group was 25 (SD±3.86) years and the mean age of the BI group was 32.4 (SD±7.9). Audit scores were significantly lower at time 2 compared to time 1 for both intervention groups (t(11) = 17.60; p < 0.05). There was no significant difference between the different intervention groups.

This study aims to evaluate and summarize the effectiveness of cognitive behavioral therapy (CBT) and internet-based CBT (ICBT) interventions on relapse prevention and severity of symptoms among individuals with major depressive disorder (MDD). CBT is one of the most used and suggested interventions to manage MDD, whereas ICBT is a novel effective proposed approach.

The review was conducted following the preferred reporting items for systematic review and meta-analysis protocol. A comprehensive and extensive search was performed to identify and evaluate the relevant studies about the effectiveness of CBT and ICBT on relapse prevention and severity of symptoms among patients with MDD.

A total of eight research studies met the inclusion criteria and were included in this systematic review. RCT studies were conducted to assess and evaluate the effectiveness of CBT and ICBT on relapse prevention and severity of symptoms among patients with MDD. It has been found that CBT is a well-supported and evidently based effective psychotherapy for managing depressive symptoms and reducing the relapse and readmission rate among patients diagnosed with MDD. The ICBT demonstrated greater improvements in depressive symptoms during major depressive episodes among patients with MDDS. The ICBT program had good acceptability and satisfaction among participants in different countries.

Despite the significant findings from this systematic review, certain limitations should be acknowledged. First, it is important to note that all the studies included in this review were exclusively conducted in the English language, potentially limiting the generalizability of the findings to non-English speaking populations. Second, the number of research studies incorporated in this systematic review was relatively limited, which may have resulted in a narrower scope of analysis. Finally, a few studies within the selected research had small sample sizes, which could potentially impact the precision and reliability of the overall conclusions drawn from this review. The authors recommend that nurses working in psychiatric units should use CBT interventions with patients with MDD.

This paper, a review of the literature gives an overview of CBT and ICBT interventions to reduce the severity of depressive symptoms and prevent patients’ relapse and rehospitalization and shows that CBT interventions are effective on relapse prevention among patients with MDD. In addition, there is still no standardized protocol to apply the CBT intervention in the scope of reducing the severity of depressive symptoms and preventing depression relapse among patients with major depressive disorder. Further research is needed to confirm the findings of this review. Future research is also needed to find out the most effective form and contents of CBT and ICBT interventions for MDD.

CBT is a psychological intervention that has been recommended by the literature for the treatment of major depressive disorder (MDD). It is a widely recognized and accepted approach that combines cognitive and behavioral techniques to assist individuals overcome their depressive symptoms and improve their overall mental well-being. This would speculate that effectiveness associated with several aspects and combinations of different approaches in CBT interventions and the impact of different delivery models are essential for clinical practice and appropriate selection of the interventional combinations.

This systematic review focuses on the various studies that explore the effectiveness of face-to-face CBT and ICBT in reducing depressive symptoms among patients with major depressive disorder. These studies were conducted in different countries such as Iran, Australia, Pennsylvania and the USA.

The authors performed a systematic review and meta-analysis of all published randomized controlled trials with the aim to determine and quantify the anti-hyperglycemic effects of glutamine (Gln) in acute and chronic clinical settings.

The authors conducted a comprehensive search of all randomized clinical trials performed up to December 2018, to identify those investigating the impact of Gln supplementation on fasting blood sugar (FBS), insulin levels and homeostatic model assessment-insulin resistance (HOMA-IR) via ISI Web of Science, Cochrane library PubMed and SCOPUS databases. A meta-analysis of eligible studies was conducted using random effects model to estimate the pooled effect size. Fractional polynomial modeling was used to explore the dose–response relationships between Gln supplementation and diabetic indices.

The results of the present meta-analysis suggest that of Gln supplementation had a significant effect on FBS (weighted mean difference (WMD): –2.868 mg/dl, 95 per cent CI: –5.467, –0.269, p = 0.031). However, the authors failed to observe that Gln supplementation affected insulin levels (WMD: 1.06 units, 95 per cent CI: –1.13, 3.26, p = 0.34) and HOMA-IR (WMD: 0.001 units, 95 per cent CI: –2.031, 2.029, p = 0.999). Subgroup analyses showed that the highest decrease in FBS levels was observed when the duration of intervention was less than two weeks (WMD: –4.064 mg/dl, 95 per cent CI: –7.428, –0.700, p = 0.01) and when Gln was applied via infusion (WMD: –5.334 mg/dl, 95 per cent CI: –10.48, 0.17, p = 0.04).

The results from this meta-analysis show that Gln supplementation did not have a significant effect on insulin levels and HOMA-IR. However, it did significantly reduce the levels of FBS, obtaining a higher effect when the duration of the intervention period was less than two weeks.

Randomised controlled trial (RCT) methodology is viewed as the gold standard in evaluating the impact of interventions. Recruitment problems present one threat to the validity of RCTs, yet the barriers to recruitment are poorly understood. The purpose of this study is to identify obstacles to recruitment in a personality disorder (PD) treatment trial, with a view to suggesting ways of overcoming these obstacles.

A discussion group of 13 staff involved in the trial was held to identify barriers to recruitment. The information was subject to thematic analysis.

Eight themes were identified, and three overarching themes: reluctance to diagnose and preference for treating symptoms; increasing the burden and jeopardising other services; and lack of confidence in treatment and in treatment as usual.

Suggestions for minimising recruitment obstacles include careful site selection and protocol negotiation; education and training about PD; continued promotion of both research in general and the specific trial; and assurances about good research practice.

Recruitment is a common problem in RCTs, and the paper addresses this issue, not only in identifying obstacles to recruitment but also in offering suggestions to other trialists for minimising the obstacles.

In recent years, a wide range of psychosocial health interventions have been implemented among military service members and their families. However, there are questions over the evaluative rigor of these interventions. We conducted a systematic review of this literature, rating each relevant study (k = 111) on five evaluative rigor scales (type of control group, approach to participant assignment, outcome quality, number of measurement time points, and follow-up distality). The most frequently coded values on three of the five scales (control group type, participant assignment, and follow-up distality) were those indicating the lowest level of operationally defined rigor. Logistic regression results indicate that the evaluative rigor of intervention studies has largely remained consistent over time, with exceptions indicating that rigor has decreased. Analyses among seven military sub-populations indicate that interventions conducted among soldiers completing basic training, soldiers returning from combat deployment, and combat veterans have had, on average, the greatest evaluative rigor. However, variability in mean scores across evaluative rigor scales within sub-populations highlights the unique methodological hurdles common to different military settings. Recommendations for better standardizing the intervention evaluation process are discussed.