Background: The extensor tendons of the foot are crucial for maintaining the intricate movements and stability of the foot and ankle complex. Understanding these variations is essential for ...health-care professionals involved in foot-related pathologies. Aims and Objective: The study was conducted to identify and document variations in extensor tendons of the foot during routine dissection of human cadavers and to highlight their clinical significance. Materials and Methods: This was an observational study conducted in the Department of Anatomy, King George’s Medical University, Lucknow, India. Eight embalmed cadavers were examined, and the dorsum of the foot was dissected to explore the proximal and distal attachments of extensor muscles. Results: We observed unilateral variations in extensor tendons of the feet of three limbs during routine dissection. First case showed a bifurcation of extensor hallucis longus, giving tendons to great toe as well as 2nd toe. Second case showed a variation in extensor digitorum longus tendon of the 4th toe giving lateral and medial slips along with its main tendon. The medial slip further gave medial and lateral divisions to merge distally with the long tendons of 3rd and 4th toe, respectively. The third case depicted the bifurcation of extensor hallucis brevis to give tendinous slips to great toe and 2nd toe, respectively. Conclusion: Knowledge of these variations in extensor tendons of foot is crucial for accurate interpretation of diagnostic imaging, surgical planning, and optimizing treatment outcomes.
A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of ...treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed.
Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.
An essential component of the interpretation of results of randomized clinical trials of treatments for chronic pain involves the determination of their clinical importance or meaningfulness. This ...involves two distinct processes--interpreting the clinical importance of individual patient improvements and the clinical importance of group differences--which are frequently misunderstood. In this article, we first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. We then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors. The clinical importance of individual patient improvements can be determined by assessing what patients themselves consider meaningful improvement using well-described methods. In contrast, the clinical meaningfulness of group differences must be determined by a multi-factorial evaluation of the benefits and risks of the treatment and of other available treatments for the condition in light of the primary goals of therapy. Such determinations must be conducted on a case-by-case basis, and are ideally informed by patients and their significant others, clinicians, researchers, statisticians, and representatives of society at large.
What are the smallest worthwhile effects of nonsteroidal anti-inflammatory drugs (NSAIDs) for people with acute and chronic low back pain (LBP)? What is the smallest worthwhile effect of ...individualised exercise for people with chronic LBP compared with no intervention?
Benefit-harm trade-off study.
Participants were recruited by advertisement on social media and included if they were English-speaking adults in Australia who had non-specific LBP.
Pain intensity.
A total of 116 people with acute LBP and 230 people with chronic LBP were recruited. For acute LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 30% (IQR 10 to 40%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 27.5% (IQR 10 to 50%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of exercise additional to no intervention was a 20% (IQR 10 to 40%) reduction in pain intensity. There were small associations between baseline pain, duration of pain and level of exercise and the smallest worthwhile effect of NSAIDs for acute LBP. There were no other clear associations.
For people with LBP, the smallest worthwhile effect of exercise and NSAIDs additional to no intervention is approximately a 20 to 30% reduction in pain. These results can inform the interpretation of the effects of NSAIDs and exercise in randomised trials and meta-analyses, incorporating consumers’ perspectives. Further research on comparisons between different interventions and on other core LBP outcomes may inform decision-making.
OSF osf.io/3erjx/.
•We introduce a case replacement framework for sensitivity analysis of clinical trials.•The framework supports statements such as “The inference would change if xx of the treatment patients who ...experienced positive outcomes were replaced by hypothetical patients who did not receive a treatment.”•The framework complements the Fragility Index by accounting for the rarity of negative outcomes. For example, large case replacement is required when the Fragility Index is small but negative outcomes are rare.•The framework can be used for any threshold, including minimally important differences and statistical significance.•The framework applies to a broad set of models and research designs.
We apply a general case replacement framework for quantifying the robustness of causal inferences to characterize the uncertainty of findings from clinical trials.
We express the robustness of inferences as the amount of data that must be replaced to change the conclusion and relate this to the fragility of trial results used for dichotomous outcomes. We illustrate our approach in the context of an RCT of hydroxychloroquine on pneumonia in COVID-19 patients and a cumulative meta-analysis of the effect of antihypertensive treatments on stroke.
We developed the Robustness of an Inference to Replacement (RIR), which quantifies how many treatment cases with positive outcomes would have to be replaced with hypothetical patients who did not receive a treatment to change an inference. The RIR addresses known limitations of the Fragility Index by accounting for the observed rates of outcomes. It can be used for varying thresholds for inference, including clinical importance.
Because the RIR expresses uncertainty in terms of patient experiences, it is more relatable to stakeholders than P-values alone. It helps identify when results are statistically significant, but conclusions are not robust, while considering the rareness of events in the underlying data.
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