| 1. |
- 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. |
- Caneiro, J. P., et al.
(författare)
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From Fear to Safety : A Roadmap to Recovery from Musculoskeletal Pain
- 2022
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Ingår i: Physical Therapy. - : Oxford University Press. - 0031-9023 .- 1538-6724. ; 102:2
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Tidskriftsartikel (refereegranskat)abstract
- Contemporary conceptualizations of pain emphasize its protective function. The meaning assigned to pain drives cognitive, emotional, and behavioral responses. When pain is threatening, and a person lacks control over their pain experience, it can become distressing, self-perpetuating, and disabling. Although the pathway to disability is well established, the pathway to recovery is less researched and understood. This Perspective draws on recent data on the lived experience of people with pain-related fear to discuss both fear and safety learning processes and their implications for recovery for people living with pain. Recovery is here defined as achievement of control over pain, as well as improvement in functional capacity and quality of life. Based on the common-sense model, this Perspective proposes a framework utilizing cognitive functional therapy to promote safety learning. A process is described in which experiential learning combined with "sense making" disrupts a person's unhelpful cognitive representation and behavioral and emotional response to pain, leading them on a journey to recovery. This framework incorporates principles of inhibitory processing that are fundamental to pain-related fear and safety learning.
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| 3. |
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| 4. |
- 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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| 5. |
- Shadbolt, Cade, et al.
(författare)
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Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery
- 2023
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 6, s. 1-10
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE: Discontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear.OBJECTIVES: To examine the rate of delayed completion, incomplete enrollment, and discontinuation among randomized clinical trials in surgical populations and the duration of delays and extent of recruiting shortfalls among these trials.DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study examined randomized clinical trials in surgical populations registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2014. Analysis was conducted between October 27, 2021, and June 30, 2022.MAIN OUTCOMES AND MEASURES: The main outcomes were the percentages of trials completed on time or with full enrollment. Delays and recruiting shortfalls were identified by comparing projected enrollment and study timeframes prespecified at the time of registration with the actual study duration and enrollment reported on completion or discontinuation. Absolute and relative differences between planned and actual trial conduct were presented for discontinued trials and those completed with delays or recruiting shortfalls.RESULTS: In total, 2542 randomized clinical trials in surgical populations were included in the study sample, of which 370 (14.6%; 95% CI, 13.2%-15.9%) were completed both on time and with full enrollment. Approximately 1 in 5 trials (20.4%; 95% CI, 18.9%-22.0%) were completed within their planned timeframe, and 1166 trials (45.9%; 95% CI, 43.9%-47.8%) met their prespecified enrollment target. The median delay among completed trials was 12.2 months (IQR, 5.1-24.3 months) or 66.7% (IQR, 30.1%-135.8%) longer than planned. Among completed trials that did not meet their prespecified enrollment target, the median recruiting shortfall was equivalent to 31.0% (IQR, 12.7%-55.5%) of the planned study sample. A total of 546 trials (21.5%; 95% CI, 19.9%-23.1%) were discontinued. The median time to discontinuation was 26.4 months (IQR, 15.2-45.7 months), and the median recruiting shortfall among discontinued trials was equivalent to 92.7% (IQR, 65.0%-100.0%) of the trial's prespecified enrollment target.CONCLUSIONS AND RELEVANCE: This cross-sectional study found that delayed completion, recruiting shortfalls, and untimely discontinuation were common among surgical trials. These findings highlight the importance of ensuring that investigators and funders do not overestimate the feasibility of planned trials.
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