Clinical trial designs in anaesthesia

2017 ◽  
Author(s):  
Simon J. Howell
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Control Group ◽  
Or Groups ◽  
Related Quality ◽  
Health Related ◽  
Economic Analyses ◽  
Surrogate Measures ◽  
The Impact

A clinical trial is a research study that assigns people or groups to different interventions and compares the impact of these on health outcomes. This chapter examines the design and delivery of clinical trials in anaesthesia and perioperative medicine covering the issues outlined below. The features of a high-quality clinical trial include well-defined inclusion and exclusion criteria, a control group, randomization, and blinding. Outcome measures may be broadly divided into counting the number of people who experience an outcome and taking measurements on people. The outcome measures selected for a clinical trial reflect the purpose of the study and may include ‘true’ clinical measures such as major postoperative complications or surrogate measures such as the results of a biochemical test. Outcome measures may be combined in a composite outcome. Assessment of health-related quality of life using a tool such as the SF-36 questionnaire is an important aspect of many clinical trials in its own right and also informs the economic analyses that may be embedded in a trial. Determining the number for recruits needed for a clinical trial requires both clinical and statistical insight and judgement. The analysis of a clinical trial requires a similarly sophisticated approach that takes into account the objectives of the study and balances the need for appropriate subgroup analyses with the risk of false-positive results. The safe and effective management of a clinical trial requires rigorous organizational discipline and an understanding of the ethical and regulatory structures that govern clinical research.

scholarly journals Methodological Characteristics of Clinical Trials: Impact of Mandatory Trial Registration

2019 ◽  
Vol 22 ◽  
pp. 131-141
Author(s):  
Ashish Kumar Kakkar ◽  
Biswa Mohan Padhy ◽  
Sudhir Chandra Sarangi ◽  
Yogendra Kumar Gupta
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Statistical Methods ◽  
Quality Characteristics ◽  
Allocation Concealment ◽  
Trial Registration ◽  
Control Group ◽  
Study Protocols ◽  
The Impact

Purpose: Numerous studies across multiple specialties have evaluated the impact of trial registration on quality of study reports and found significant improvements over several domains. However, the impact of mandatory trial registration on the quality of clinical trial protocols remains hitherto unexplored. Methods: We carried out a retrospective cohort study of clinical trial applications submitted to drug regulatory authority of India for initial review with the objective of comparing methodological characteristics of their protocols. Since trial registration was made mandatory in the country in June 2009, we selected two study periods as between January 2007 to May 2009 (Period I) and July 2009 to December 2011 (Period II). Seventy-five protocols were randomly selected using a computer-generated list for each study period, making a total of 150 protocols. Data on twelve key methodological characteristics were collected including clearly defined primary outcomes, randomization, blinding, use of control group, statistical methods, handling of withdrawals amongst others. Results: More than 3/4th of the trial applications in the two study periods were for new chemical entities and nearly 90% were pharmaceutical industry sponsored studies. Comparing the period before and after implementation of mandatory trial registration, description of clearly defined trial outcomes improved from nearly 42% to 80% (p<0.001), sample size justifications increased from 38% to 70% (p<0.001) and use of allocation concealment improved from 24% to 49% (p=0.001). Marked improvement was also noted for blinding, description of statistical methods and handling of withdrawals and dropouts. Remaining characteristics did not change significantly between the two study periods. The mean cumulative scores for the study protocols improved significantly from 7± 0.296 in the first period to 8.93± 0.346 (p<0.001) in the second period. Conclusions: Our study found a significant improvement in the methodological quality characteristics of the protocols particularly in elements related to minimization of bias and statistical methods, which could be attributed to mandatory trial registration. Overall, the significant improvement was limited to global clinical trials, and room for improvement was noted for two quality characteristics – proportion of randomized studies and trials adequately describing the generation of allocation sequence.

Improvement in Migraine-Specific Quality of Life in A Clinical Trial of Rizatriptan

Cephalalgia ◽  
1997 ◽  
Vol 17 (8) ◽  
pp. 867-872 ◽  
Author(s):  
NC Santanello ◽  
AB Polis ◽  
SL Hartmaier ◽  
MS Kramer ◽  
GA Block ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Functional Disability ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Test Statistic ◽  
Related Quality ◽  
Health Related ◽  
The Impact

A validated migraine-specific questionnaire (24-h Migraine Quality of Life Questionnaire1: 24-h MQoLQ) was used to assess the impact of migraine and migraine therapy on health related quality of life during an acute migraine attack. Male and female migraineurs aged 18-55 years were randomized to placebo ( n = 41), rizatriptan 2.5 mg ( n = 47), 5 mg ( n = 74), or 10 mg ( n = 85) in a triple-blind, placebo-controlled clinical trial. Rizatriptan 5 mg and 10 mg were significantly more efficacious than placebo on pain relief and functional disability. After accounting, for multiple comparisons to placebo, rizatriptan 10 mg showed significantly better responses compared to placebo on three of five domains of 24-h MQoLQ (social functioning, migraine symptoms, and feelings/concerns). The O'Brien's Rank Sum Test statistic showed a statistically significant overall difference on the 24-h MQoLQ between the 10 mg rizatriptan and placebo groups ( p = 0.005) and for the overall close trend ( p 0.001).

Impact of sialendoscopy on improving health related quality of life in patients suffering from radioiodineinduced xerostomia

2018 ◽  
Vol 57 (04) ◽  
pp. 160-167 ◽  
Author(s):  
Sabine Haufe ◽  
Ralph Hohenberger ◽  
Matti Hein ◽  
Clemens Kratochwil ◽  
Hendrik Rathke ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Salivary Gland ◽  
Common Side Effect ◽  
Control Group ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Summary Introduction: Xerostomia following radioiodine therapy (RIT) in patients suffering from differentiated thyroid cancer is a common side effect in 2 % to 67 % of patients treated with radioiodine (I-131). In order to evaluate the impact of sialendoscopy on health related quality of life (HRQOL) in patients suffering from therapy induced sialadenitis and xerostomia, we analyzed findings from two dedicated questionnaires (Xerostomy Questionnaire XQ and Xerostomy Inventory XI) in patients before and three months after sialendoscopy. Procedures: In total, 12 patients suffering from differentiated thyroid carcinoma (10 women and 2 men) were evaluated. All patients had experienced conservative management. Patients were offered a sialendoscopy procedure if no major contradictions were present. Patients who denied the procedure formed the control group. Pre- and (three months) postoperative HRQOL was measured with the Patient Reported Outcome Measures (PROM) Xerostomia Questionnaire (XQ) and the Xerostomia Inventory (XI), as well as by a pre- and post-interventional salivary gland scintigram. Patients were graded according to their sialendoscopical findings. Results: Interventional group presented with significant improvements in HRQOL measurements regarding XQ and XI-scores three months postoperatively. Control group showed no significant changes in the XQ or the XI scores. Number of RIT and cumulative activity of I-131 did not correlate with higher disease grade in regards to sialendoscopical findings nor did it correlate with higher XQand XI scores. Pre- and post-interventional salivary gland scintigram stated that parotid glands are more severely damaged than submandibular glands (SMG), but no significant scintigraphically changes could be detected after sialendoscopy. Conclusion: Sialendoscopy in patients suffering from therapy induced sialadenitis and xerostomia seems to be beneficial when evaluating the impact on HRQOL. Functional parameters measured by salivary gland scintigram did not show significant changes in post-interventional scintigrams.

Does telerehabilitation result in inferior clinical outcomes compared with in-person care for the management of chronic musculoskeletal spinal conditions in the tertiary hospital setting? A non-randomised pilot clinical trial

2019 ◽  
pp. 1357633X1988726 ◽  
Author(s):  
Michelle A Cottrell ◽  
Shaun P O'Leary ◽  
Maree Raymer ◽  
Anne J Hill ◽  
Tracy Comans ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Clinical Outcomes ◽  
Pain Severity ◽  
Control Group ◽  
Health Related Quality ◽  
Significant Group ◽  
Related Quality ◽  
Health Related

Introduction Clinical guidelines recommend multidisciplinary non-surgical management for most musculoskeletal spinal conditions. Access to such services continues to be a barrier for many individuals residing outside metropolitan regions. The primary aim of this study was to determine whether clinical outcomes achieved via telerehabilitation are as good as those achieved via in-person care. Methods A non-randomised pilot clinical trial was undertaken where eligible patients chose to access treatment either via telerehabilitation or in-person (control group). Outcome measures for pain-related disability, pain severity and health-related quality of life were recorded at baseline, 3-, 6- and 9-months. Secondary outcomes included patient satisfaction and technical disruptions. Results Seventy-one patients were recruited (telerehabilitation, n = 51; control group, n = 20). Patient characteristics did not differ at baseline and clinically meaningful improvements for pain-related disability and health-related quality of life were observed in both groups. Non-inferiority of telerehabilitation could not be claimed for any clinical outcome measure. There were no significant group-by-time interactions observed for either pain-related disability ( p = 0.706), pain severity ( p = 0.187) or health-related quality of life ( p = 0.425) measures. The telerehabilitation group reported significantly higher levels of treatment satisfaction (median: 97 vs. 76.5; p = 0.021); 7.9% of telerehabilitation appointments were not completed due to technical disruptions. Discussion Findings indicate patients with chronic musculoskeletal spinal conditions can achieve clinically meaningful improvements in their condition when accessing care via telerehabilitation. Telerehabilitation should be considered for individuals unable to access relevant in-person services; however non-inferiority remains inconclusive and requires further exploration.

scholarly journals Effect of episodic tension-type headache on the health-related quality of life in employees of a Brazilian public hospital

2004 ◽  
Vol 62 (3b) ◽  
pp. 769-773 ◽  
Author(s):  
Hilton Mariano Silva Jr ◽  
Roberta P. Garbelini ◽  
Simone O. Teixeira ◽  
Carlos A. Bordini ◽  
José G. Speciali
Keyword(s):  
Public Hospital ◽  
Bodily Pain ◽  
Tension Type Headache ◽  
Control Group ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
The Difference ◽  
Type Headache ◽  
The Impact

OBJECTIVE: To evaluate the impact of ETTH on HRQoL in a sample of employees of a Brazilian public hospital. METHOD: Three hundred and sixty Mário Gatti Hospital employees were asked about headache occurrence in the previous 6 months and completed a SF-36 and a pain questionnaires concerning impact of pain (0 to 10 scale) on daily activities, work efficiency, leisure and social activities in previous six months. Two groups were studied: 1. Episodic Tension-type headache group: 127 employees - 81 (63.8%) female and 46 (36.2%), male. 2. Control group: 124, 71 (57.3%) female and 53 (42.7%) male. RESULTS: ETTH had lowers scores than control in all domains of SF-36; in vitality and bodily pain the difference was statistically significant. CONCLUSION: Our results indicate that ETTH suffers have impact on HRQoL predominantly in vitality. Psychological factors associated to pain may explain this finding.

International Perspective on Health-Related Quality-of-Life Research in Cancer Clinical Trials: The European Organisation for Research and Treatment of Cancer Experience

2007 ◽  
Vol 25 (32) ◽  
pp. 5082-5086 ◽  
Author(s):  
Andrew Bottomley ◽  
Neil K. Aaronson
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase Iii ◽  
Cancer Clinical Trials ◽  
Health Related Quality ◽  
European Organisation ◽  
Related Quality ◽  
Health Related

Over recent decades, health-related quality of life (HRQOL) research has been increasingly integrated into cancer clinical trials. The purpose of this review is to examine the overall approach taken towards clinical trial–based HRQOL investigations within the European Organisation for Research and Treatment of Cancer (EORTC). This article reports a literature review of clinical trial–based HRQOL investigations and provides selective examples of HRQOL studies in phase III clinical trials in various disease sites. The findings of this review highlight that, historically, assessing HRQOL was a challenge. However, as EORTC has become more experienced in the assessment of HRQOL and has developed a portfolio of appropriate tools, HRQOL has become a more accepted end point in large-scale trials. The trials reviewed in this article show that, in general, HRQOL data do provide information that can both inform clinicians about the effectiveness of the treatments and also serve as an invaluable source of information for patients to make informed decisions regarding the treatment choice.

scholarly journals The Influence of Friction on Design of the Type of Bracket and Its Relation to OHRQoL in Patients Who Use Multi-Bracket Appliances: A Randomized Clinical Trial

Medicina ◽  
2021 ◽  
Vol 57 (2) ◽  
pp. 171
Author(s):  
Adriana González-Sáez ◽  
Laura Antonio-Zancajo ◽  
Javier Montero ◽  
Alberto Albaladejo ◽  
María Melo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Oral Health ◽  
Randomized Clinical Trial ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Bonferroni Test ◽  
The Impact

Background and objectives: The aim of this study was to evaluate the influence of friction on design of the type of bracket, patients’ perception of pain and the impact on their oral health-related quality of life. Materials and Methods: A randomized clinical trial was carried out with 90 patients (62.2% women and 37.8% men) with three kinds of fixed multi-bracket appliances: Conventional (GC), fixed multi-bracket low friction (GS) and self-ligating (GA). The VAS (Visual Analogue Scale) was used to determine pain during the first seven days of treatment at different points in time. The patients were also given the OHIP-14 (Oral Health Impact Profile) questionnaire to analyse their oral health-related quality of life (OHRQoL) after the first 30 days of treatment. The ANOVA test was used for the analysis of the variables and the post hoc Bonferroni test for the comparison between groups. Results: Maximum pain was observed between one and two days after the start of treatment. The GC group showed the greatest degree of pain, with maximum values (4.5 ± 2.0) at 24 h. The self-ligation brackets show lower impact on patients’ oral health-related quality of life (0.8 ± 2.2, p < 0.01). Conclusions: Friction in the type of bracket influences pain and the Oral Health-Related Quality of Life of patients who use multi-bracket fixed orthodontics.

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