A randomized clinical trial of total parenteral nutrition in malnourished surgical patients: the rationale and impact of previous clinical trials and pilot study on protocol design
Abstract
The rationale for a large-scale clinical trial of preoperative total parenteral nutrition (TPN) is described in the context of previous clinical trials that have attempted to demonstrate reduction of operative morbidity with preoperative TPN. Defects in study design or execution potentially compromising the validity of these studies are analyzed. Results of a single-institution pilot study performed during the planning phase of the multiinstitutional preoperative TPN trial are presented. This literature review and pilot study provided the data necessary to permit appropriate design of many critical elements in the protocol for the clinical trial including sample size, eligibility criteria, duration and intensity of treatment regimens, and end-point criteria. The rationale underlying critical decisions in protocol design are presented in detail to allow more meaningful interpretation of the results of the clinical trial.
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In 2009, the use of 10-point analog scales was proposed to assess food intake in both in- and out-patients.
“In 2009, the use of 10-point analog scales was proposed to 1756 assess food intake in both in- and out-patients”
From ESPEN guideline on hospital nutrition (2021) · cites this paper as [239]
The 10-point visual analog scale for food intake could help to identify hospitalized patients at risk of malnutrition, with 81% of those with a score <7 being at high nutritional risk according to the Nutritional Risk Index.
“Moreover, the 10-point visual analog scale 1760 for food intake could help to identify hospitalized patients at risk of malnutrition with 81% of 1761 those with a score <7 were at high nutritional risk [239] according to the Nutritional Risk Index 1762 (NRI) [241].”
From ESPEN guideline on hospital nutrition (2021) · cites this paper as [239]
Another semi-quantitative way of assessing food intake could be the use of a 10-point analog visual scale for food intake.
“Another semi-quantitative way of assessing food intake could be the use of a 10-point analog 1755 visual scale for food intake [239].”
From ESPEN guideline on hospital nutrition (2021) · cites this paper as [239]
The 10-point analog scale is feasible, easy to use, and extremely well correlated with daily energy intake assessed by the 3-day dietary record, especially in malnourished patients.
“as it is feasible, easy to use, and extremely well 1757 correlated with daily energy intake assessed by the 3-day dietary record, especially in 1758 malnourished patients [239].”
From ESPEN guideline on hospital nutrition (2021) · cites this paper as [239]
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Levitt, D., & Levitt, M. (2016) · International Journal of General Medicine · doi:10.2147/ijgm.s102819 · Cited by 763 · see citing works
Malnutrition Screening and Assessment
Serón-Arbeloa, C., Labarta-Monzón, L., Puzo-Foncillas, J., Mallor-Bonet, T., Lafita-López, A., Bueno-Vidales, N., & Montoro-Huguet, M. (2022) · doi:10.20944/preprints202205.0071.v1 · Cited by 312
ESPEN guideline on hospital nutrition
Thibault, R., Abbasoglu, O., Ioannou, E., Meija, L., Ottens-Oussoren, K., Pichard, C., Rothenberg, E., Rubin, D., Siljamäki-Ojansuu, U., Vaillant, M.-F., et al. (2021) · Clinical Nutrition · doi:10.1016/j.clnu.2021.09.039 · Cited by 259 · see citing works
Trujillo, E. B., Kadakia, K. C., Thomson, C., Zhang, F. F., Livinski, A., Pollard, K., Mattox, T., Tucker, A., Williams, V., Walsh, D., et al. (2024) · Journal of Parenteral and Enteral Nutrition · doi:10.1002/jpen.2688 · Cited by 67 · see citing works
- Authors
- Buzby, G., Williford, W., Peterson, O., Crosby, L., Page, C., Reinhardt, G., & Mullen, J.
- Affiliations
- Philadelphia VA Medical Center (US)
- Venue
- The American Journal of Clinical Nutrition
- Publisher
- Elsevier BV
- Published
- 1988-02
- Volume
- 47
- Issue
- 2
- Pages
- 357-365
- ISSN
- 0002-9165 (ISSN-L)
- OpenAlex
- W2142691724
- Cited by
- 293
- References
- 0
- Citations by year
- 2026: 12 · 2025: 12 · 2024: 20 · 2023: 26 · 2022: 12 · 2021: 21 · 2020: 17 · 2019: 7 · 2018: 6 · 2017: 6 · 2016: 6 · 2015: 4 · 2014: 6 · 2013: 9 · 2012: 10
- FWCI
- 4.69
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Clinical Nutrition (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
- Health Sciences › Medicine › Surgery › Enhanced Recovery After Surgery
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Keywords
- total parenteral nutrition, protocol design, pilot study, sample size determination, eligibility criteria, surgical morbidity, research validity
- MeSH terms
- Clinical Trials as Topic, Humans, Nutrition Disorders, Parenteral Nutrition, Total, Pilot Projects, Postoperative Complications, Preoperative Care, Prospective Studies, Random Allocation, Research Design, Surgical Procedures, Operative
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