scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review (Preprint)

2019 ◽  
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

BACKGROUND Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. OBJECTIVE This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. METHODS To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. RESULTS Scoping review and pilot data extraction are under way, and the results are expected by March 2020. CONCLUSIONS It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. CLINICALTRIAL PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15309

scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review

10.2196/15309 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15309
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

Background Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. Objective This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. Methods To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. Results Scoping review and pilot data extraction are under way, and the results are expected by March 2020. Conclusions It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. Trial Registration PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 International Registered Report Identifier (IRRID) DERR1-10.2196/15309

scholarly journals Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031151 ◽  
Author(s):  
Karin A Wasmann ◽  
Pieta Wijsman ◽  
Susan van Dieren ◽  
Willem Bemelman ◽  
Christianne Buskens
Keyword(s):  
Systematic Review ◽  
External Validity ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Internal Validity ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Meta Analyses ◽  
Lost To Follow Up

ObjectiveRandomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients’ preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.DesignSystematic review and meta-analyses.Data sourcesMEDLINE, Embase, PsycINFO and the Cochrane Library.Eligibility criteria for selecting studiesRPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.Data extraction and synthesisTwo independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.ResultsIn total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%–100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%–99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI −0.178 to 0.364, p=0.502).ConclusionsPatients’ preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.PROSPERO registration numberCRD42019094438.

scholarly journals A Systematic Review of Postoperative Pain Outcome Measurements Utilised in Regional Anesthesia Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
E. Pushpanathan ◽  
T. Setty ◽  
B. Carvalho ◽  
P. Sultan
Keyword(s):  
Systematic Review ◽  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Regional Anesthesia ◽  
Outcome Measures ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Pain Outcome ◽  
Meta Analyses

Introduction. Regional anesthesia is a rapidly growing subspecialty. There are few published meta-analyses exploring pain outcome measures utilised in regional anesthesia randomized controlled trials (RCTs), which may be due to heterogeneity in outcomes assessed. This systematic review explores postoperative pain outcomes utilised in regional anesthesia RCTs. Methods. A literature search was performed using three databases (Medline, Embase, and CINAHL). Regional anesthesia RCTs with postoperative pain as a primary outcome were included if written in English and published in one of the top 20 impact factor journals between 2005 and 2017. Study quality was assessed using the Cochrane Collaboration’s tool for assessing risk of bias. Results. From the 31 included articles, 15 different outcome measures in total were used to assess postoperative pain. The most commonly (16/31) used outcome measures were verbal numerical grading of pain out of 10, total opioid consumption, and visual analogue scale 10 cm (VAS). The need for analgesia was used as an outcome measure where studies did not use a pain rating score. Ten studies reported pain scores on activity and 27/31 studies utilised ≥2 pain outcomes. Time of measurement of pain score also varied with a total of 51 different time points used in total. Conclusion. Analysis of the articles demonstrated heterogeneity and inconsistency in choice of pain outcome and time of measurement within regional anesthesia studies. Identification of these pain outcomes utilised can help to create a definitive list of core outcomes, which may guide future researchers when designing such studies.

Postamputation Residual Limb Pain Severity and Prevalence: A Systematic Review and Meta-Analysis

2021 ◽  
pp. 229255032110196
Author(s):  
Adam G. Evans ◽  
Sara C. Chaker ◽  
Gabrielle E. Curran ◽  
Mauricio A. Downer ◽  
Patrick E. Assi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Pain Severity ◽  
Residual Limb ◽  
Limb Pain ◽  
Residual Limb Pain ◽  
Pain Prevalence ◽  
Meta Analyses ◽  
Extremity Amputation

Background: Individuals with an extremity amputation are predisposed to persistent pain that reduces their quality of life. Residual limb pain is defined as pain that is felt in the limb after amputation. Methods: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review of 5 databases from inception to June 2020 was performed and is registered under the PROSPERO ID: CRD42020199297. Included studies were clinical trials with residual limb pain assessed at a minimum follow-up of 1 week. Meta-analyses of residual limb pain prevalence and severity were performed with subgroups of extremity and amputation etiology. Results: Twenty clinical trials met criteria and reported on a total of 1347 patients. Mean patient ages ranged from 38 to 77. Residual limb pain prevalence at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, respectively, was 50%, 11%, 23%, 27%, 22%, and 24%. Mean residual limb pain severity at the 6 months or longer follow-up was 4.19 out of 10 for cancer amputations, 2.70 for traumatic amputations, 0.47 for vasculopathy amputations, 1.01 for lower extremity amputations, and 3.56 for upper extremity amputations. Conclusions: Residual limb pain severity varies according to the etiology of amputation and is more common after upper extremity amputation than lower extremity amputations. The most severe pain is reported by patients undergoing amputations due to cancer, followed by traumatic amputations, while vascular amputation patients report lower pain severity. Promising methods of reducing long-term pain are preoperative pain control, nerve or epidural blocks, use of memantine, calcitonin-containing blocks, and prophylactic nerve coaptations.

Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment

2018 ◽  
Vol 61 (4) ◽  
pp. 811-819 ◽  
Author(s):  
Mark Onslow ◽  
Mark Jones ◽  
Sue O'Brian ◽  
Ann Packman ◽  
Ross Menzies ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Trials ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Analysis Of Covariance ◽  
Data Sets ◽  
Randomized Controlled ◽  
Absolute Agreement

Purpose This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Method Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland–Altman plots, analysis of covariance, and Spearman rho correlations. Results Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. Conclusion There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

scholarly journals Sarcopenia Is Associated with Mortality in Adults: A Systematic Review and Meta-Analysis

Gerontology ◽  
2021 ◽  
pp. 1-16
Author(s):  
Jane Xu ◽  
Ching S. Wan ◽  
Kiriakos Ktoris ◽  
Esmee M. Reijnierse ◽  
Andrea B. Maier
Keyword(s):  
Systematic Review ◽  
Working Group ◽  
Meta Analysis ◽  
Nursing Home Residents ◽  
Community Dwelling ◽  
Risk Of Mortality ◽  
European Working ◽  
Subgroup Analyses ◽  
Meta Analyses

<b><i>Background:</i></b> Sarcopenia can predispose individuals to falls, fractures, hospitalization, and mortality. The prevalence of sarcopenia depends on the population studied and the definition used for the diagnosis. <b><i>Objective:</i></b> This systematic review and meta-analysis aimed to investigate the association between sarcopenia and mortality and if it is dependent on the population and sarcopenia definition. <b><i>Methods:</i></b> A systematic search was conducted in MEDLINE, EMBASE, and Cochrane from 1 January 2010 to 6 April 2020 for articles relating to sarcopenia and mortality. Articles were included if they met the following criteria – cohorts with a mean or median age ≥18 years and either of the following sarcopenia definitions: Asian Working Group for Sarcopenia (AWGS and AWGS2019), European Working Group on Sarcopenia in Older People (EWGSOP and EWGSOP2), Foundation for the National Institutes of Health (FNIH), International Working Group for Sarcopenia (IWGS), or Sarcopenia Definition and Outcomes Consortium (SDOC). Hazard ratios (HR) and odds ratios (OR) were pooled separately in meta-analyses using a random-effects model, stratified by population (community-dwelling adults, outpatients, inpatients, and nursing home residents). Subgroup analyses were performed for sarcopenia definition and follow-up period. <b><i>Results:</i></b> Out of 3,025 articles, 57 articles were included in the systematic review and 56 in the meta-analysis (42,108 participants, mean age of 49.4 ± 11.7 to 86.6 ± 1.0 years, 40.3% females). Overall, sarcopenia was associated with a significantly higher risk of mortality (HR: 2.00 [95% CI: 1.71, 2.34]; OR: 2.35 [95% CI: 1.64, 3.37]), which was independent of population, sarcopenia definition, and follow-up period in subgroup analyses. <b><i>Conclusions:</i></b> Sarcopenia is associated with a significantly higher risk of mortality, independent of population and sarcopenia definition, which highlights the need for screening and early diagnosis in all populations.

scholarly journals A protocol for the systematic review and meta-analysis of thigmotactic behaviour in the open field test in rodent models associated with persistent pain

2021 ◽  
Vol 5 (1) ◽  
pp. e100135
Author(s):  
Xue Ying Zhang ◽  
Jan Vollert ◽  
Emily S Sena ◽  
Andrew SC Rice ◽  
Nadia Soliman
Keyword(s):  
Systematic Review ◽  
Outcome Measure ◽  
Meta Analysis ◽  
Persistent Pain ◽  
Effect Sizes ◽  
Bias Assessment ◽  
Animal Pain ◽  
Trim And Fill ◽  
Meta Analyses ◽  
The Impact

ObjectiveThigmotaxis is an innate predator avoidance behaviour of rodents and is enhanced when animals are under stress. It is characterised by the preference of a rodent to seek shelter, rather than expose itself to the aversive open area. The behaviour has been proposed to be a measurable construct that can address the impact of pain on rodent behaviour. This systematic review will assess whether thigmotaxis can be influenced by experimental persistent pain and attenuated by pharmacological interventions in rodents.Search strategyWe will conduct search on three electronic databases to identify studies in which thigmotaxis was used as an outcome measure contextualised to a rodent model associated with persistent pain. All studies published until the date of the search will be considered.Screening and annotationTwo independent reviewers will screen studies based on the order of (1) titles and abstracts, and (2) full texts.Data management and reportingFor meta-analysis, we will extract thigmotactic behavioural data and calculate effect sizes. Effect sizes will be combined using a random-effects model. We will assess heterogeneity and identify sources of heterogeneity. A risk-of-bias assessment will be conducted to evaluate study quality. Publication bias will be assessed using funnel plots, Egger’s regression and trim-and-fill analysis. We will also extract stimulus-evoked limb withdrawal data to assess its correlation with thigmotaxis in the same animals. The evidence obtained will provide a comprehensive understanding of the strengths and limitations of using thigmotactic outcome measure in animal pain research so that future experimental designs can be optimised. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines and disseminate the review findings through publication and conference presentation.

scholarly journals Effectiveness of e-cigarettes in smoking cessation: a systematic review and meta-analysis

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Oberndorfer ◽  
I Grabovac ◽  
S Haider ◽  
T E Dorner
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Meta Analysis ◽  
Current Evidence ◽  
Promising Alternative ◽  
Quality Of Evidence ◽  
Different Populations ◽  
Meta Analyses

Abstract Background Reports of the effectiveness of e-cigarettes (ECs) for smoking cessation vary across different studies making implementation recommendations hard to attain. We performed a systematic review and meta-analysis to synthesise the current evidence regarding the effectiveness of ECs for smoking cessation. Methods PubMed, PsycInfo and Embase databases were searched for randomized controlled trials comparing nicotine ECs with non-nicotine ECs or with established smoking cessation interventions (nicotine replacement therapy (NRT) and or counselling) published between 01/01/2014 and 01/05/2019. Data from eligible studies were extracted and used for random-effects meta-analyses. Results Our literature review yielded 13190 publications with 10 studies being identified as eligible for systematic review, covering 8362 participants, and 8 for meta-analyses (n = 30 - 6006). Using the last follow-up of eligible studies, the proportion of smokers achieving abstinence was 1.67 [95CI:0.99 - 2.81] times higher in nicotine EC users compared to non-nicotine EC users. The proportion of abstinent smokers was 1.69 [95CI:1.25 - 2.27] times higher in EC users compared to participants receiving NRT. EC users showed a 2.70 [95CI:1.15 - 6.30] times higher proportion of abstinent smokers in comparison to participants solely receiving counselling. Conclusions Our analysis showed modest effects of nicotine-ECs compared to non-nicotine ECs. When compared to NRT or counselling, results suggest that nicotine EC may be more effective for smoking cessation. As ECs also help maintaining routinized behaviour and social aspects of smoking, we hypothesise that this may explain their advantage as a tool for smoking cessation. However, given the small number of included studies, different populations, heterogeneous designs, and the overall moderate to low quality of evidence, it is not possible to offer clear recommendations. More comparable data is needed to strengthen confidence in the quality of evidence. Key messages The number of previous studies assessing the effectiveness of ECs for smoking cessation is limited. Further, comparability of these studies is restricted, weakening the quality of evidence. Although current evidence on the effectiveness of ECs for smoking cessation is inconclusive, our meta-analyses suggest that ECs could be a promising alternative tool in attempts to achieve abstinence.

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