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Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial.

ABSTRACT: Background: New clinical trials in cancer cachexia are essential, and outcome measures with high responsiveness to detect meaningful changes are crucial. This secondary analysis from a multimodal intervention trial estimates sensitivity to change and between treatment effect sizes (ESs) of outcome measures associated with body composition, physical function, metabolism, and trial intervention. Methods: The study was a multicenter, open-label, randomized pilot study investigating the feasibility of a 6-week multimodal intervention [exercise, non-steroidal anti-inflammatory drugs, and oral nutritional supplements containing polyunsaturated fatty acids (n-3 PUFAs)] vs. standard cancer care in non-operable non-small-cell lung cancer and advanced pancreatic cancer. Body composition measures from computerized tomography scans and circulating biomarkers were analyzed. Results: Forty-six patients were randomized, and the analysis included 22 and 18 patients in the treatment and control groups, respectively. The between-group ESs were high for body weight (ES = 1.2, p < 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64-1.37, p < 0.05 for all), and moderate for serum C-reactive protein (ES = 0.53, p = 0.12). Analysis within the multimodal treatment group showed high sensitivity to change for adiponectin (ES = 0.86, p = 0.001) and n-3 PUFAs (ES > 0.8, p < 0.05 for all) and moderate for 25-OH vitamin D (ES = 0.49, p = 0.03). In the control group, a moderate sensitivity to change for body weight (ES = -0.84, p = 0.002) and muscle mass (ES = -0.67, p = 0.016) and a high sensitivity to change for plasma levels of 25-OH vitamin D (ES = -0.88, p = 0.002) were found. Conclusion: Demonstrating high sensitivity to change and between treatment ES and body composition measures, body weight still stands out as a clinical and relevant outcome measure in cancer cachexia. Body composition and physical function measures clearly are important to address but demand large sample sizes to detect treatment group differences. Trial registration: ClinicalTrials.gov identifier: NCT01419145.

SUBMITTER: Balstad TR

PROVIDER: S-EPMC7874039 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial.

Balstad Trude R TR Brunelli Cinzia C Pettersen Caroline H CH Schønberg Svanhild A SA Skorpen Frank F Fallon Marie M Kaasa Stein S Bye Asta A Laird Barry J A BJA Stene Guro B GB Solheim Tora S TS

Frontiers in nutrition 20210114

<b>Background:</b> New clinical trials in cancer cachexia are essential, and outcome measures with high responsiveness to detect meaningful changes are crucial. This secondary analysis from a multimodal intervention trial estimates sensitivity to change and between treatment effect sizes (ESs) of outcome measures associated with body composition, physical function, metabolism, and trial intervention. <b>Methods:</b> The study was a multicenter, open-label, randomized pilot study investigating th ...[more]

PMID: 33585533

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Project description:Currently, there are no standardized treatments for cachexia or severe wasting. There is a growing consensus advocating multimodal interventions to address the complex pathogenesis and metabolic alterations in these conditions. This review examined multimodal treatments intended to alleviate and/or stabilize cachexia and severe wasting. The objectives of this review were to 1) identify multimodal interventions for the treatment of cachexia or associated wasting syndromes in patients with a chronic illness, 2) assess the quality of these studies, and 3) assess the effectiveness of multimodal interventions. Electronic databases including PubMed, MEDLINE, EMBASE, Scopus, Web of Science, Cochrane Library, CINAHL, PEDro, OpenGrey, and clinicaltrials.org were systematically searched using both text words and MeSH (medical subject heading) terms. The literature revealed a dearth of large, well-conducted trials in this area. Fourteen trials (n = 5 cancer, n = 5 chronic obstructive pulmonary disease, n = 4 chronic kidney disease) were included in this review. A total of 1026 patients were included across all studies; sample size ranged between 21 and 138 patients. Baseline and follow-up data were collected between 6 wk and 24 mo. All demonstrated some improvement in favor of the treatment groups, in relevant measures of body composition, nutrition, biomarkers, and functionality; however, caution should be applied due to the heterogenous nature of the interventions and small sample sizes. Overall, the evidence from this review supports the role of multimodal interventions in the treatment of severe wasting. However, randomized controlled trials with a powered sample size and sufficiently lengthy interaction period are necessary to assess if multimodal interventions are effective forms of therapy for improving body composition and nutritional and physical status in patients with cachexia and wasting. The protocol for this review is registered with Prospero (ID: CRD42019124374).

Project description:While force-velocity-power characteristics of resistance exercises, such as bench presses and squats, have been well documented, little attention has been paid to load, force, and power-velocity relationships in exercises engaging core muscles. Given that power produced during lifting tasks or trunk rotations plays an important role in most sport-specific and daily life activities, its measurement should represent an important part of the test battery in both athletes and the general population. The aim of this scoping review was 1) to map the literature related to testing methods assessing core muscle strength and stability in sport and rehabilitation, chiefly studies with particular focus on force-velocity-power characteristics of exercises involving the use of core muscles, 2) and to identify gaps in existing studies and suggest further research in this field. The literature search was conducted on Cochrane Library databases, Scopus, Web of Science, PubMed and MEDLINE, which was completed by SpringerLink, Google Scholar and Elsevier. The inclusion criteria were met in 37 articles. Results revealed that among a variety of studies investigating the core stability and core strength in sport and rehabilitation, only few of them analyzed force-velocity-power characteristics of exercises involving the use of core muscles. Most of them evaluated maximal isometric strength of the core and its endurance. However, there are some studies that assessed muscle power during lifting tasks at different loads performed either with free weights or using the Smith machine. Similarly, power and velocity were assessed during trunk rotations performed with different weights when standing or sitting. Nevertheless, there is still scant research investigating the power-velocity and force-velocity relationship during exercises engaging core muscles in able-bodied and para athletes with different demands on stability and strength of the core. Therefore, more research is needed to address this gap in the literature and aim research at assessing strength and power-related measures within cross-sectional and intervention studies. A better understanding of the power-force-velocity profiles during exercises with high demands on the core musculature has implications for designing sport training and rehabilitation programs for enhancement of athletes' performance and/or decrease their risk of back pain.

Project description:OBJECTIVES:To develop outcome measures to assess practical management of primary surgical wounds and patient experience. DESIGN:Mixed methods, including qualitative interviews and data extraction from published randomised controlled trials (RCTs). SETTING:Two university-teaching NHS hospitals and three district NHS hospitals in the South West and Midlands regions of England. PARTICIPANTS:Sixty-four patients and 15 healthcare professionals from abdominal general surgical specialities and obstetrics (caesarean section). METHODS:Measures were developed according to standard guidelines to identify issues relevant to patients' experiences of surgical wounds and dressings, including analysis of existing RCT outcomes and semi-structured interviews. These were written into provisional questionnaire items for a single outcome measure. Cognitive interviews with patients and healthcare professionals assessed face validity, acceptability and relevance. Findings from interviews were regularly shared with the study team who suggested amendments to modify and reword items to improve understanding before further iterative testing with patients and healthcare professionals. RESULTS:Analyses of existing RCT outcomes and interviews produced a total of 69 issues. Pretesting and iterative revision established the need for two separate measures. One measure addresses healthcare professionals' experience of wound management in two key areas: exudate and its impact, and allergic reactions to the dressing. The other measure addresses patients' experience of wounds in seven key areas: wound comfort, dressing removal, dressings to protect the wound, impact on daily activities, ease of movement, anxiety about the wound and satisfaction with dressing. Each measure took less than five?min to complete and both were understood and acceptable to patients and healthcare professionals. CONCLUSION:This in-depth study has developed two measures to assess practical management of primary surgical wounds and patient experience. Further work to test their validity, reliability and application to other settings is now required. TRIAL REGISTRATION NUMBER:HTA - 12/200/04; Pre-results.

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Dataset Information

Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial.

Publications

Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial.

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