Objective:Acknowledging study limitations in a scientific publication is a crucial element in scientific transparency and progress. However, limitation reporting is often inadequate. Natural language processing (NLP) methods could support automated reporting checks, improving research transparency. In this study, our objective was to develop a dataset and NLP methods to detect and categorize self-acknowledged limitations (e.g., sample size, blinding) reported in randomized controlled trial (RCT) publications.Methods:We created a data model of limitation types in RCT studies and annotated a corpus of 200 full-text RCT publications using this data model. We fine-tuned BERT-based sentence classification models to recognize the limitation sentences and their types. To address the small size of the annotated corpus, we experimented with data augmentation approaches, including Easy Data Augmentation (EDA) and Prompt-Based Data Augmentation (PromDA). We applied the best-performing model to a set of about 12K RCT publications to characterize self-acknowledged limitations at larger scale.Results:Our data model consists of 15 categories and 24 sub-categories (e.g., Population and its sub-category DiagnosticCriteria). We annotated 1090 instances of limitation types in 952 sentences (4.8 limitation sentences and 5.5 limitation types per article). A fine-tuned PubMedBERT model for limitation sentence classification improved upon our earlier model by about 1.5 absolute percentage points in F1 score (0.821 vs. 0.8) with statistical significance (). Our best-performing limitation type classification model, PubMedBERT fine-tuning with PromDA (Output View), achieved an F1 score of 0.7, improving upon the vanilla PubMedBERT model by 2.7 percentage points, with statistical significance ().Conclusion:The model could support automated screening tools which can be used by journals to draw the authors’ attention to reporting issues. Automatic extraction of limitations from RCT publications could benefit peer review and evidence synthesis, and support advanced methods to search and aggregate the evidence from the clinical trial literature.
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Background: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. Methods: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges. Results: The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including patients, leading to excluding two of the eight units from participation. This resulted in failing to include a similar number of patients in the control condition versus the intervention condition. Data on outcomes routinely collected in the electronic patient records were not accessible during the study, and appeared to be often missing during analyses. Conclusions: The stepped wedge, cluster randomized trial poses specific risks in the design and execution of research in real-life settings of which researchers should be aware to prevent negative consequences impacting the validity of their results. Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial. Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review, flexibility, a spacious time schedule, the availability of substantial capacity in the research team and early checks on the data availability and quality.
ObjectiveTo determine the effect of a multidisciplinary lifestyle program in patients with RA with low–moderate disease activity.MethodsIn the ‘Plants for Joints’ (PFJ) parallel-arm, assessor-blind randomized controlled trial, patients with RA and 28-joint DAS (DAS28) ≥2.6 and ≤5.1 were randomized to the PFJ or control group. The PFJ group followed a 16-week lifestyle program based on a whole-food plant-based diet, physical activity and stress management. The control group received usual care. Medication was kept stable 3 months before and during the trial whenever possible. We hypothesized that PFJ would lower disease activity (DAS28). Secondary outcomes included anthropometric, metabolic and patient-reported measures. An intention-to-treat analysis with a linear mixed model adjusted for baseline values was used to analyse between-group differences.ResultsOf the 83 people randomized, 77 completed the study. Participants were 92% female with mean (S.D.) age of 55 (12) years, BMI of 26 (4) kg/m2 and mean DAS28 of 3.8 (0.7). After 16 weeks the PFJ group had a mean 0.9-point greater improvement of DAS28 vs the control group (95% CI 0.4, 1.3; P < 0.0001). The PFJ intervention led to greater decreases in body weight (difference –3.9 kg), fat mass (–2.8 kg), waist circumference (–3 cm), HbA1c (–1.3 mmol/mol) and low-density lipoprotein (–0.32 mmol/l), whereas patient-reported outcome measures, blood pressure, glucose and other lipids did not change.ConclusionThe 16-week PFJ multidisciplinary lifestyle program substantially decreased disease activity and improved metabolic status in people with RA with low–moderate disease activity.Trial RegistrationInternational Clinical Trials Registry Platform; https://www.who.int/clinical-trials-registry-platform; NL7800.
Meestal is er geen specifieke oorzaak te vinden voor nekpijn. Fysiotherapie richt zich daarom op algemene zaken, zoals spierkracht en beweeglijkheid. We onderzoeken of er effectieve behandelingen zijn voor subgroepen met niet-specifieke nekpijn. Met deze inzichten kunnen we fysiotherapie verbeteren.Doel We willen inzicht krijgen in effectieve behandelingen bij subgroepen patiënten met niet-specifieke nekpijn. Dit leidt uiteindelijk tot kostenvermindering voor de maatschappij en een sneller en beter herstel van de patiënten. Resultaten Dit onderzoek loopt nog. Na afronding vind je hier een samenvatting van alle resultaten. Tot nu toe is duidelijk geworden dat de volgende behandelingen effectief kunnen zijn bij patiënten met niet-specifieke nekpijn: Behandelingen gericht op kracht en uithoudingsvermogen. Behandelingen gericht op coördinatie met gebruik van visuele feedback. Een voorbeeld hiervan is patiënten met een laserlamp een parcours laten uitvoeren op een scherm. De resultaten van het onderzoek worden verwerkt in het bachelor- en masteronderwijs en cursussen binnen het werkveld. Looptijd 01 december 2015 - 01 december 2020 Aanpak Dit onderzoek bestaat uit verschillende delen: We onderzoeken wat er vanuit wetenschappelijk onderzoek al bekend is over de relatie tussen beperking in activiteit en een passende behandeling. We voeren een Delphi-studie uit onder deskundigen naar het behandelen van mensen met niet-specifieke nekpijn. We vragen ze naar een overeenstemming over de relatie tussen beperking in activiteit en een algemene behandeling, zoals het trainen van spierkracht. We onderzoeken of beweegoefeningen en/of manipulaties, als meest onderzochte behandelingen bij mensen met nekpijn, zo zijn beschreven dat we het kunnen hergebruiken. In de laatste studie onderzoeken we of beweegoefeningen en/of manipulaties effectief zijn in het herstellen van de beweeglijkheid. Het gaat hierbij om een subgroep van mensen met nekpijn die ook beperkt zijn in hun beweeglijkheid. Rapporten tot nu toe: The clinical reasoning process in randomized clinical trials with patients with non-specific neck pain is incomplete: A systematic review. Maissan F, Pool J, de Raaij E, Mollema J, Ostelo R, Wittink H. Musculoskelet Sci Pract. 2018 Jun;35:8-17 Clinical reasoning in unimodal interventions in patients with non-specific neck pain in daily physiotherapy practice, a Delphi study. Maissan F, Pool J, Stutterheim E, Wittink H, Ostelo R., Musculoskelet Sci Pract. 2018 Oct;37:8-16
