The current status of clinical trials in emergency gastrointestinal surgery: A systematic analysis of contemporary clinical trials

Milton, Amelia; Drake, Thomas M; Lee, Matthew J.

doi:10.1097/ta.0000000000002123

Cited by 3 publications

(3 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although it is recognized that the evidence base for emergency surgery should be improved by way of high‐quality RCTs 37,38 , there is a long‐standing issue of unrepresentative samples contained within clinical research 39 . This affects both interpretation and comparison of results.…”

Section: Discussionmentioning

confidence: 99%

Variation in descriptors of patient characteristics in randomized clinical trials of peptic ulcer repair: a systematic review

Lee

Coe

O'Donoghue³

et al. 2020

British Journal of Surgery

View full text Add to dashboard Cite

Background: The ability to compare findings across surgical research is important. Inadequate description of participants, interventions or outcomes could lead to bias and inaccurate assessment of findings. The aim of this study was to assess consistency of description of participants using studies comparing laparoscopic and open repair of peptic ulcer as an example. Methods: This systematic review is reported in line with the PRISMA checklist. Searches of MEDLINE and Embase databases were performed to identify studies comparing laparoscopic and open repair of perforated peptic ulcer in adults, published in the English language. Manuscripts were dual-screened for eligibility. Full texts were retrieved and dual-screened for inclusion. Data extracted from studies included descriptors of participants in studies from tables and text. Descriptors were categorized into conceptual domains by the research team, and coverage of each domain by study was tabulated. Results: Searches identified 2018 studies. After screening, 37 full texts were retrieved and 23 studies were included in the final synthesis. A total of 76 unique descriptors were identified. These were classified into demographics (11 descriptors), vital signs (9 descriptors), disease-specific characteristics (10 descriptors), presentation and pathway factors (4 descriptors), risk factors (8 descriptors), laboratory tests (14 descriptors) and baseline health (28 descriptors). The number of descriptors in a single study ranged from three to 31. All studies reported at least one demographic descriptor. Laboratory tests was the least frequently described domain. Conclusion: Study participants are described inconsistently in studies of a single example surgical condition.

show abstract

Section: Discussionmentioning

confidence: 99%

Variation in descriptors of patient characteristics in randomized clinical trials of peptic ulcer repair: a systematic review

Lee

Coe

O'Donoghue³

et al. 2020

British Journal of Surgery

View full text Add to dashboard Cite

show abstract

“…Although the importance of RCTs in the advancement of the evidence base has been established [90], there is also increasing recognition that participants in clinical research are not representative of the wider population. In recent years there has been an emphasis on the ethnic and racial disparities of participants involved in research [91,92].…”

Section: Discussionmentioning

confidence: 99%

A systematic review of participant descriptors reported in studies of adhesive small bowel obstruction

Rashid,

Kumar,

Lee

2024

Colorectal Disease

Self Cite

View full text Add to dashboard Cite

AimReporting of participant descriptors in studies of adhesive small bowel obstruction (ASBO) can help identify characteristics associated with favourable outcomes and allow comparison with other studies and real‐world clinical populations. The aim was to identify the pattern of participant descriptors reported in studies assessing interventions for ASBO.MethodThis systematic review was registered with PROSPERO (CRD42021281031) and reported in line with the PRISMA checklist. Systematic searches of Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were undertaken to identify studies assessing operative and non‐operative interventions for adults with ASBO. Studies were dual screened for inclusion. Descriptors were categorised into conceptual domains by the research team.ResultsSearches identified 2648 studies, of which 73 were included. A total of 156 unique descriptors were identified. On average, studies reported 12 descriptors. The most frequently reported descriptors were sex, age, SBO aetiology, history of abdominal surgery, BMI and ASA classification. The highest number of descriptors in a single study was 34, compared to the lowest number of descriptors which was one. Pathway factors were the least frequently described domain. Overall, 37 descriptors were reported in just one study.ConclusionThere is a lack of consistency in participant descriptors reported in studies of SBO. Furthermore, a significant proportion of the descriptors were used infrequently. This makes it challenging to assess whether study participants are representative of the wider population. Further work is required to develop a Core Descriptor Set to standardise the reporting of patient characteristics and reduce heterogeneity between studies.

show abstract

“…The quality of randomised data and outcomes reporting in ASBO is limited [ 7 , 8 , 9 ]. The most recent trials in ASBO focus on the use of water soluble contrast agents [ 10 ], or laparoscopic surgery [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

A core outcome set for clinical studies of adhesive small bowel obstruction

Lee¹,

Chapman²,

Blackwell³

et al. 2022

Colorectal Disease

Self Cite

View full text Add to dashboard Cite

Aim: Adhesive small bowel obstruction (ASBO) is a common surgical emergency condition. Research in the field is plentiful; however, inconsistency in outcome reporting makes comparisons challenging. The aim of this study was to define a core outcome set (COS) for studies of ASBO. Methods:The long list of outcomes was identified through systematic review, and focus groups across different geographical regions. A modified Delphi consensus exercise of three rounds was undertaken with stakeholder groups (patients and clinicians). Items were rated on a 9-point Likert scale. Items exceeding 70% rating at 7-9 were passed to the consensus meeting. New item proposals were invited in round 1. Individualised feedback on prior voting compared to other participants was provided. An international consensus meeting was convened to ratify the final COS. Results:In round 1, 56 items were rated by 118 respondents. A total of 18 items reached consensus, and respondents proposed an additional 10 items. Round 2 was completed by 90 respondents, and nine items achieved consensus. In round 3, 80 surveys were completed; one item achieved consensus, and five borderline items were identified. The final COS included 26 outcomes, mapped to the following domains: Interventions, need for stoma, septic complications, return of gut function, patient reported outcomes, and recurrence of obstruction, as well as mortality, failure to rescue, and time to resolution. Conclusion:This COS should be used in future studies in the treatment of adhesive SBO. Further studies to define a core measurement set are needed to identify the optimum tools to measure each outcome.

show abstract

The current status of clinical trials in emergency gastrointestinal surgery: A systematic analysis of contemporary clinical trials

Abstract: This is a repository copy of The current status of clinical trials in emergency gastrointestinal surgery. A systematic analysis of contemporary clinical trials.

Cited by 3 publications

References 13 publications

Variation in descriptors of patient characteristics in randomized clinical trials of peptic ulcer repair: a systematic review

Variation in descriptors of patient characteristics in randomized clinical trials of peptic ulcer repair: a systematic review

A systematic review of participant descriptors reported in studies of adhesive small bowel obstruction

A core outcome set for clinical studies of adhesive small bowel obstruction

Contact Info

Product

Resources

About