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Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012.

ABSTRACT: BACKGROUND:Low back pain is a common health complaint resulting in substantial economic burden. Each year, upwards of 20 randomised controlled trials (RCTs) evaluating interventions for non-specific low back pain are published. Use of the term non-specific low back pain has been criticised on the grounds of encouraging heterogeneity and hampering interpretation of findings due to possible heterogeneous causes, challenging meta-analyses. We explored selection criteria used in trials of treatments for nsLBP. METHODS:A systematic review of English-language reports of RCTs in nsLBP population samples, published between 2006 and 2012, identified from MEDLINE, EMBASE, and the Cochrane Library databases, using a mixed-methods approach to analysis. Study inclusion and exclusion criteria were extracted, thematically categorised, and then descriptive statistics were used to summarise the prevalence by emerging category. RESULTS:We included 168 studies. Two inclusion themes (anatomical area, and symptoms and signs) were identified. Anatomical area was most reported as between costal margins and gluteal folds (n =?8, 5%), while low back pain (n =?150, 89%) with or without referred leg pain (n =?27, 16%) was the most reported symptom. Exclusion criteria comprised 21 themes. Previous or scheduled surgery (n =?84, 50%), pregnancy (n =?81, 48%), malignancy (n =?78, 46%), trauma (n =?63, 37%) and psychological conditions (n =?58, 34%) were the most common. Sub-themes of exclusion criteria mostly related to neurological signs and symptoms: nerve root compromise (n =?44, 26%), neurological signs (n =?34, 20%) or disc herniation (n =?30, 18%). Specific conditions that were most often exclusion criteria were spondylolisthesis (n =?35, 21%), spinal stenosis (n =?31, 18%) or osteoporosis (n =?27, 16%). CONCLUSION:RCTs of interventions for non-specific low back pain have incorporated diverse inclusion and exclusion criteria. Guidance on standardisation of inclusion and exclusion criteria for nsLBP trials will increase clinical homogeneity, facilitating greater interpretation of between-trial comparisons and meta-analyses. We propose a template for reporting inclusion and exclusion criteria.

SUBMITTER: Amundsen PA

PROVIDER: S-EPMC5898037 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012.

Amundsen Pål André PA Evans David W DW Rajendran Dévan D Bright Philip P Bjørkli Tom T Eldridge Sandra S Buchbinder Rachelle R Underwood Martin M Froud Robert R

BMC musculoskeletal disorders 20180412 1

<h4>Background</h4>Low back pain is a common health complaint resulting in substantial economic burden. Each year, upwards of 20 randomised controlled trials (RCTs) evaluating interventions for non-specific low back pain are published. Use of the term non-specific low back pain has been criticised on the grounds of encouraging heterogeneity and hampering interpretation of findings due to possible heterogeneous causes, challenging meta-analyses. We explored selection criteria used in trials of tr ...[more]

PMID: 29650015

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Project description:BackgroundControl-arm mortality varies between acute respiratory distress syndrome (ARDS) RCTs.MethodsWe systematically reviewed ARDS RCTs that commenced recruitment after publication of the American-European Consensus (AECC) definition (MEDLINE, Embase, and Cochrane central register of controlled trials; January 1994 to October 2020). We assessed concordance of RCT inclusion criteria to ARDS consensus definitions and whether exclusion criteria are strongly or poorly justified. We estimated the proportion of between-trial difference in control-arm 28-day mortality explained by the inclusion criteria and RCT design characteristics using meta-regression.ResultsA literature search identified 43 709 records. One hundred and fifty ARDS RCTs were included; 146/150 (97.3%) RCTs defined ARDS inclusion criteria using AECC/Berlin definitions. Deviations from consensus definitions, primarily aimed at improving ARDS diagnostic certainty, frequently related to duration of hypoxaemia (117/146; 80.1%). Exclusion criteria could be grouped by rationale for selection into strongly or poorly justified criteria. Common poorly justified exclusions included pregnancy related, age, and comorbidities (infectious/immunosuppression, hepatic, renal, and human immunodeficiency virus/acquired immunodeficiency syndrome). Control-arm 28-day mortality varied between ARDS RCTs (mean: 29.8% [95% confidence interval: 27.0-32.7%; I2=88.8%; τ2=0.02; P<0.01]), and differed significantly between RCTs with different Pao2:FiO2 ratio inclusion thresholds (26.6-39.9 kPa vs <26.6 kPa; P<0.01). In a meta-regression model, inclusion criteria and RCT design characteristics accounted for 30.6% of between-trial difference (P<0.01).ConclusionsIn most ARDS RCTs, consensus definitions are modified to use as inclusion criteria. Between-RCT mortality differences are mostly explained by the Pao2:FiO2 ratio threshold within the consensus definitions. An exclusion criteria framework can be applied when designing and reporting exclusion criteria in future ARDS RCTs.

Project description:Clinical trials are essential parts of a medical study process, but studies are often cancelled due to a lack of participants. Clinical Trial Recruitment Support Systems are systems that help to increase the number of participants by seeking more suitable subjects. The software ATLAS (developed by Observational Health Data Sciences and Informatics) can support the launch of a clinical trial by building cohorts of patients who fulfill certain criteria. The correct use of medical classification systems aiming at clearly defined inclusion and exclusion criteria in the studies is an important pillar of this software. The aim of this investigation was to determine whether ATLAS can be used in a Clinical Trial Recruitment Support System to portray the eligibility criteria of clinical studies. Our analysis considered the number of criteria feasible for integration with ATLAS and identified its strengths and weaknesses. Additionally, we investigated whether nonrepresentable criteria were associated with the utilized terminology systems. We analyzed ATLAS using 223 objective eligibility criteria from 30 randomly selected trials conducted in the last 10 years. In the next step, we selected appropriate ICD, OPS, LOINC, or ATC codes to feed the software. We classified each criterion and study based on its implementation capability in the software, ensuring a clear and logical progression of information. Based on our observations, 51% of the analyzed inclusion criteria were fully implemented in ATLAS. Within our selected example set, 10% of the studies were classified as fully portrayable, and 73% were portrayed to some extent. Additionally, we conducted an evaluation of the software regarding its technical limitations and interaction with medical classification systems. To improve and expand the scope of criteria within a cohort definition in a practical setting, it is recommended to work closely with personnel involved in the study to define the criteria precisely and to carefully select terminology systems. The chosen criteria should be combined according to the specific setting. Additional work is needed to specify the significance and amount of the extracted criteria.

Project description:BACKGROUND:Hospital-acquired and ventilator-associated pneumonia (HAP/VAP) are often selected for randomized clinical trials (RCTs) aiming at new drug approval. Guidelines for the design of such RCTs have been repeatedly updated by regulatory agencies. We hypothesized that large variability in the enrolled populations, the endpoints assessed and the HAP/VAP definition criteria may impact the results of these studies, and addressed this through a systematic review of HAP/VAP RCTs. METHODS:A search (Pubmed-Embase-ICAAC-ECCMID) of all RCTs published between 1994 and 2016 comparing antimicrobial treatment for HAP/VAP in the intensive care unit was conducted. The populations enrolled, inclusion/exclusion criteria, statistical design and endpoints assessed were recorded. All unpublished RCTs recorded on the ClinicalTrials.gov registry were also screened. RESULTS:From the 93 abstracts reviewed, 39 potentially relevant studies were inspected, leading to 27 studies being included. As expected, illness severity or the proportion with VAP (27-100%) differed greatly among the enrolled populations. The HAP/VAP definition used various clinical and biological criteria, and only 55% of studies required a microbiological sample. The mandatory duration of prior hospital stay was variable; the mechanical ventilation duration was an inclusion criterion in only 41% of VAP studies. Nine studies had non-inferiority design, but nine studies (33%) did not have a pre-specified statistical hypothesis. Clinical cure was the primary endpoint in 24 studies, but was recorded in several populations or as the co-primary endpoint in 13 studies. The definition of clinical cure and the timing of its assessment greatly differed. This variability slightly improved over time but remained significant in the 13 registered but currently unpublished RCTs that we screened. CONCLUSION:Our study provides a description of populations and endpoints of RCTs evaluating antimicrobials for treatment of HAP/VAP in the ICU. There was significant heterogeneity in enrollment criteria, endpoints and statistical design, which may influence the ability of studies to demonstrate differences between studied drugs.

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Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012.

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Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012.

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