Essential statistical principles of clinical trials of pain treatments

Dworkin, Robert H.; Evans, Scott; Mbowe, Omar; McDermott, Michael P.

doi:10.1097/pr9.0000000000000863

Cited by 25 publications

(18 citation statements)

References 193 publications

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“…9,11,12 The FDA recently recognized that comparing an experimental treatment with an established drug in a noninferiority study, to mimic realworld scenarios, can sometimes be considered sufficient to determine the new treatment's efficacy. 25 A crossover design, in which every participant receives the active treatment in sequence, 31,73 can also assist in recruitment and retention. This design may be especially valuable when recruitment of large samples is not possible, as in studies of rare forms of chronic pain.…”

Section: Effect Of Placebomentioning

confidence: 99%

Recruitment and retention for chronic pain clinical trials: a narrative review

Kennedy¹,

Nelson²,

Jerome³

et al. 2022

PR9

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Section: Effect Of Placebomentioning

confidence: 99%

Recruitment and retention for chronic pain clinical trials: a narrative review

Kennedy¹,

Nelson²,

Jerome³

et al. 2022

PR9

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“…A permuted block randomisation design with a random block size of 4 and 6 and an 1:1 allocation ratio will be applied and evaluated in the pilot study in order to allocate participants to either the intervention or control group 68–70. A computer-generated randomisation schedule will be created using a random number table to allocate participants to one of the two treatment arms; intervention group (IPRP supplemented by eVIS) or control group (IPRP with daily patient reports in PATRON).…”

Section: Methods and Analysismentioning

confidence: 99%

Effectiveness of the eVISualisation of physical activity and pain intervention (eVIS) in Swedish Interdisciplinary Pain Rehabilitation Programmes: study protocol for a registry-based randomised controlled clinical trial

et al. 2022

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IntroductionLiving with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programmes (IPRP) is considered superior to single-treatment measures in patients with chronic pain. Despite this, effects emerge suboptimal and more than 20% of patients deteriorate in patient-reported physical health outcomes after IPRP. A novel e-Health intervention, eVISualisation (eVIS) of physical activity and pain, was systematically developed to facilitate individualisation of physical activity levels. By adding elements of data collection, visualisation and communication of objectively measured physical activity and patient-reported outcomes (pain intensity, interference of pain, pharmaceutical consumption) to existing treatment modalities in IPRP, the IPRP team acquires prerequisites to adapt advice and physical activity prescriptions and to evaluate set activity goals. The overall aim is twofold. First, the aim is to evaluate the feasibility of the subsequent registry-based randomised controlled clinical trial (R-RCT). Second, the aim is to prospectively evaluate the effectiveness of the eVIS-intervention as a supplement to IPRP on our defined primary (physical health) and secondary outcomes.Methods and analysisIn the R-RCT, recruitment of 400 patients with chronic pain will be performed at 15 IPRP units. A random allocation to either IPRP + eVIS or to control group that will receive IPRP only will be performed. Data from the initial 30 participants completing the study period (6 months) will be included in a pilot study, where key feasibility outcomes (recruitment, randomisation, implementation, treatment integrity, data collection procedure, preliminary outcome measures) will be evaluated. Outcome variables will be extracted from the web application Pain And TRaining ON-line (PATRON) and from six national registries. Multivariate statistics and repeated measure analyses will be performed. Quality-adjusted life years and incremental cost-effectiveness ratio will be calculated for cost-effectiveness evaluation.Ethics/disseminationThe Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-reviewed journals.Trial registration numberNCT05009459. Protocol V.1.

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“…The study was conducted as an experimental post-test only control group design, with the following two-step research implementation: Step 1, optimization - validation by spectrometric technique, and Step 2, detecting the presence of tetracycline in animal carcass using RTD [ 18 - 20 ]. Detection of tetracycline in meat was calculated using Eq.…”

Section: Methodsmentioning

confidence: 99%

Designing prototype rapid test device at qualitative performance to detect residue of tetracycline in chicken carcass

2022

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Background and Aim: Human health problems due as a microbial resistance or tumors and cancers because consumption of the carcasses containing residues of tetracycline are main global problems in the context of fight against antimicrobial resistance phenomena. Explanation of the sustainable development goals, particularly point 3, is well recognized that all animal products for human consumption must be safe to live a healthy life. This study aimed to design a prototype of rapid test devices (RTD) based on principles of precipitate to obtain a specific color change after the process of reactions as an indicator to determine tetracycline residues in the carcass. Materials and Methods: Five samples of tetracycline-containing poultry carcasses using artificial add the tetracycline at pharmaceutics grade were examined using a prototype of a strong reaction solution for tetracycline fixation based on the concept bonded by ion Fe(III) at atom O in position atom C-1 at the ring of tetracycline and ion N+ as the functional branch of tetracycline. RTD detection was evaluated using a yellow color presentation and an absorbance spectrometric technique at a wavelength of 273 nm. Results: The following chemicals were used to create the best-fixed tetracycline residue: HCl and H2SO4 dissolved in H2O, chromatographic grade of 0.1 N and 0.5 N of HNO3, and 1% Fe (III) Cl. The RTD had a higher limit of detection (LOD) than the ultraviolet-visible spectrophotometer. Conclusion: The results of this study revealed that RTD, as constructed in this study, can be used to detect residue at LOD 44.764 μg/mL during 120 min of exposure through a light-emitting diode at 980 nm wavelength (p<0.05). The necessity for using RTD was because of the apparent limitations of conventional devices.

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Essential statistical principles of clinical trials of pain treatments

Cited by 25 publications

References 193 publications

Recruitment and retention for chronic pain clinical trials: a narrative review

Recruitment and retention for chronic pain clinical trials: a narrative review

Effectiveness of the eVISualisation of physical activity and pain intervention (eVIS) in Swedish Interdisciplinary Pain Rehabilitation Programmes: study protocol for a registry-based randomised controlled clinical trial

Designing prototype rapid test device at qualitative performance to detect residue of tetracycline in chicken carcass

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