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- Bunzli, Samantha, et al.
(författare)
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Placebo Surgery Controlled Trials : Do They Achieve What They Set Out To Do? A Systematic Review
- 2021
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Ingår i: Annals of Surgery. - 1528-1140. ; 273:6, s. 1102-1107
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).
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| 2. |
- Calderoni, Francesco, et al.
(författare)
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Recruitment into Organized Crime : An Agent-Based Approach Testing the Impact of Different Policies
- 2022
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Ingår i: Journal of quantitative criminology. - : SPRINGER/PLENUM PUBLISHERS. - 0748-4518 .- 1573-7799. ; 38:1, s. 197-237
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Tidskriftsartikel (refereegranskat)abstract
- Objectives We test the effects of four policy scenarios on recruitment into organized crime. The policy scenarios target (i) organized crime leaders and (ii) facilitators for imprisonment, (iii) provide educational and welfare support to children and their mothers while separating them from organized-crime fathers, and (iv) increase educational and social support to at-risk schoolchildren. Methods We developed a novel agent-based model drawing on theories of peer effects (differential association, social learning), social embeddedness of organized crime, and the general theory of crime. Agents are simultaneously embedded in multiple social networks (household, kinship, school, work, friends, and co-offending) and possess heterogeneous individual attributes. Relational and individual attributes determine the probability of offending. Co-offending with organized crime members determines recruitment into the criminal group. All the main parameters are calibrated on data from Palermo or Sicily (Italy). We test the effect of the four policy scenarios against a baseline no-intervention scenario on the number of newly recruited and total organized crime members using Generalized Estimating Equations models. Results The simulations generate realistic outcomes, with relatively stable organized crime membership and crime rates. All simulated policy interventions reduce the total number of members, whereas all but primary socialization reduce newly recruited members. The intensity of the effects, however, varies across dependent variables and models. Conclusions Agent-based models effectively enable to develop theoretically driven and empirically calibrated simulations of organized crime. The simulations can fill the gaps in evaluation research in the field of organized crime and allow us to test different policies in different environmental contexts.
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| 3. |
- Castelnuovo, Gianluca, et al.
(författare)
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What Is the Role of the Placebo Effect for Pain Relief in Neurorehabilitation? : Clinical Implications From the Italian Consensus Conference on Pain in Neurorehabilitation
- 2018
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Ingår i: Frontiers in Neurology. - : Frontiers Media SA. - 1664-2295. ; 9
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Forskningsöversikt (refereegranskat)abstract
- Background: It is increasingly acknowledged that the outcomes of medical treatments are influenced by the context of the clinical encounter through the mechanisms of the placebo effect. The phenomenon of placebo analgesia might be exploited to maximize the efficacy of neurorehabilitation treatments. Since its intensity varies across neurological disorders, the Italian Consensus Conference on Pain in Neurorehabilitation (ICCP) summarized the studies on this field to provide guidance on its use.Methods: A review of the existing reviews and meta-analyses was performed to assess the magnitude of the placebo effect in disorders that may undergo neurorehabilitation treatment. The search was performed on Pubmed using placebo, pain, and the names of neurological disorders as keywords. Methodological quality was assessed using a pre-existing checklist. Data about the magnitude of the placebo effect were extracted from the included reviews and were commented in a narrative form.Results: 11 articles were included in this review. Placebo treatments showed weak effects in central neuropathic pain (pain reduction from 0.44 to 0.66 on a 0-10 scale) and moderate effects in postherpetic neuralgia (1.16), in diabetic peripheral neuropathy (1.45), and in pain associated to HIV (1.82). Moderate effects were also found on pain due to fibromyalgia and migraine; only weak short-term effects were found in complex regional pain syndrome. Confounding variables might have influenced these results.Clinical implications: These estimates should be interpreted with caution, but underscore that the placebo effect can be exploited in neurorehabilitation programs. It is not necessary to conceal its use from the patient. Knowledge of placebo mechanisms can be used to shape the doctor-patient relationship, to reduce the use of analgesic drugs and to train the patient to become an active agent of the therapy.
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| 5. |
- Schilling, Chris, et al.
(författare)
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An Economic Model for Estimating Trial Costs with an Application to Placebo Surgery Trials
- 2023
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Ingår i: Applied Health Economics and Health Policy. - : Springer Science and Business Media LLC. - 1175-5652 .- 1179-1896. ; 21:2, s. 263-273
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Tidskriftsartikel (refereegranskat)abstract
- Background and Objective: Waste in clinical trials remains rife. We developed an economic model to predict the cost of trials based on input costs, duration, power, number of sites, recruitment eligibility and consenting rates. Methods: We parameterised the model for three proxy placebo-controlled surgical trials using data from a systematic review, a bespoke cost survey, and from the literature. We used the model to compare target and actual trial performance for (i) a trial that was completed on time but with more sites, (ii) a trial that completed after a time extension, and (iii) an incomplete trial. Results: Successful trials more accurately anticipated the true recruitment rate that they achieved and those that overestimated this were most likely to fail. The costs of overestimating recruitment rates were dramatic: all proxy trials had significantly higher costs than planned, with additional funding of at least AUD$600,000 (50% above budget) required for trials that completed after adding more sites or more time, and over AUD$2 million (260% above budget) for incomplete trials. Conclusions: This model shows the trade-offs between time and cost, or both, when recruitment is lower than anticipated. Greater consideration is needed to improve trial planning, reviewing, and funding of these trials to avoid costly overruns and incomplete trials.
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