Optimizing clinical nutrition research: the role of adaptive and pragmatic trials

Orsso, Camila E.; Ford, Katherine L.; Kiss, Nicole; Trujillo, Elaine B.; Spees, Colleen K.; Hamilton-Reeves, Jill M.; Prado, Carla M.

doi:10.1038/s41430-023-01330-7

Cited by 4 publications

(3 citation statements)

References 97 publications

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“…The semipragmatic approach to the dietary intervention provided insight into the feasibility of implementing dietary change in this population and aligns with strategies to optimize clinical nutrition research. 65 This strength is coupled with the limitation that a lack of a placebo-controlled and/or blinded approach may have induced contamination in our 1.0 g/kg/day group. Future trials could consider the incorporation of a more standardized approach to increased protein intake (e.g.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of two levels of protein intake in patients with colorectal cancer: findings from the Protein Recommendation to Increase Muscle (PRIMe) randomized controlled pilot trial

Ford,

Sawyer,

Ghosh

et al. 2024

ESMO Open

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Section: Discussionmentioning

confidence: 99%

Feasibility of two levels of protein intake in patients with colorectal cancer: findings from the Protein Recommendation to Increase Muscle (PRIMe) randomized controlled pilot trial

Ford,

Sawyer,

Ghosh

et al. 2024

ESMO Open

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“…Examples of potential limitations of PCTs include the lack of a doubleblinded design, which increases chance of biases; confounding factors that are challenging to control; treatment contamination that can occur across varying treatment arms; less precise outcome measurements which might contribute to measurement errors; the need for appropriately powered sample sizes to be collected; statistical analysis that can often be more challenging and complex; additional time may be needed for protocol development and ethics approvals given the complexity of study and varied stakeholder involvement; and trials that involve experimental medications may require necessary additional regulatory approvals for proposed treatments (Orsso et al, 2023;Patsopoulos, 2011).…”

Section: Challenges Associated With Pragmatic Trials and Consideratio...mentioning

confidence: 99%

“…In addition, samples used in trials have historically been homogeneous and focused on Caucasian females (Burnette et al, 2022), limiting generalizability of the findings. A synthesis and broad summary of challenges and barriers relevant to RCT design and implementation for children and youth with EDs drawn from the published literature has been provided in Table 1 (Halmi et al, 2005;Hébert et al, 2016;Kafantaris et al, 2011;Kaye et al, 2001;Norris et al, 2007;Norris et al, 2010;Orsso et al, 2023;Tasca et al, 2012).…”

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confidence: 99%

Pragmatic clinical trials to advance research in children and adolescents with eating disorders

Norris,

Spettigue,

Obeid

2024

Intl J Eating Disorders

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ObjectiveTo discuss the utility of pragmatic clinical trials (PCTs) to help advance research in eating disorders (EDs).MethodsWe describe challenges associated with traditional explanatory research trials and examine PCTs as an alternative, including a review of the PRECIS‐2 tool.ResultsThere are many challenges associated with the design and completion of traditional RCTs within the field of EDs. Pragmatic clinical trials are studies that closely align with conditions available in everyday practice and focus on outcomes that are relevant to patients and clinicians. Results of PCTS maximize applicability and generalizability to clinical settings.DiscussionAvailable therapies established for the treatment of EDs provide remission rates that rarely exceed 50%, implying a need for additional research on new or adjunctive treatments. In addition to a general overview of PCTs, we draw upon published literature and our own experiences involving adjunctive olanzapine for the treatment of children and youth with anorexia nervosa to help highlight challenges associated with randomized controlled trial (RCT) design and implementation, and offer pragmatic suggestions that would allow patients greater choice in treatment trials, while at the same time capturing outcomes that are most likely to advance treatment efforts.ConclusionsPragmatic clinical trials provide alternatives to RCT design that can help bolster research in EDs that aims to explore real‐world effects of interventions.Public SignificanceAvailable therapies established for the treatment of eating disorders (EDs) in children and adolescents provide remission rates that rarely exceed 50%, implying a need for additional research on new or adjunctive treatments. In this article, we discuss the utility of pragmatic trials to help promote research that can help advance knowledge that is relevant to clinical care settings.

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Post‐diagnosis dietary factors, supplement use and colorectal cancer prognosis: A Global Cancer Update Programme (CUP Global) systematic literature review and meta‐analysis

Chan,

Cariolou,

Markozannes

et al. 2024

Intl Journal of Cancer

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The role of diet in colorectal cancer prognosis is not well understood and specific lifestyle recommendations are lacking. We searched for randomised controlled trials (RCTs) and longitudinal observational studies on post‐diagnosis dietary factors, supplement use and colorectal cancer survival outcomes in PubMed and Embase from inception until 28th February 2022. Random‐effects dose–response meta‐analyses were conducted when at least three studies had sufficient information. The evidence was interpreted and graded by the CUP Global independent Expert Committee on Cancer Survivorship and Expert Panel. Five RCTs and 35 observational studies were included (30,242 cases, over 8700 all‐cause and 2100 colorectal cancer deaths, 3700 progression, recurrence, or disease‐free events). Meta‐analyses, including 3–10 observational studies each, were conducted for: whole grains, nuts/peanuts, red and processed meat, dairy products, sugary drinks, artificially sweetened beverages, coffee, alcohol, dietary glycaemic load/index, insulin load/index, marine omega‐3 polyunsaturated fatty acids, supplemental calcium, circulating 25‐hydroxyvitamin D (25[OH]D) and all‐cause mortality; for alcohol, supplemental calcium, circulating 25(OH)D and colorectal cancer‐specific mortality; and for circulating 25(OH)D and recurrence/disease‐free survival. The overall evidence was graded as ‘limited’. The inverse associations between healthy dietary and/or lifestyle patterns (including diets that comprised plant‐based foods), whole grains, total, caffeinated, or decaffeinated coffee and all‐cause mortality and the positive associations between unhealthy dietary patterns, sugary drinks and all‐cause mortality provided ‘limited—suggestive’ evidence. All other exposure‐outcome associations provided ‘limited—no conclusion’ evidence. Additional, well‐conducted cohort studies and carefully designed RCTs are needed to develop specific lifestyle recommendations for colorectal cancer survivors.

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Optimizing clinical nutrition research: the role of adaptive and pragmatic trials

Cited by 4 publications

References 97 publications

Feasibility of two levels of protein intake in patients with colorectal cancer: findings from the Protein Recommendation to Increase Muscle (PRIMe) randomized controlled pilot trial

Feasibility of two levels of protein intake in patients with colorectal cancer: findings from the Protein Recommendation to Increase Muscle (PRIMe) randomized controlled pilot trial

Pragmatic clinical trials to advance research in children and adolescents with eating disorders

Post‐diagnosis dietary factors, supplement use and colorectal cancer prognosis: A Global Cancer Update Programme (CUP Global) systematic literature review and meta‐analysis

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