Core outcome set for clinical studies of postoperative ileus after intestinal surgery.
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ABSTRACT:
SUBMITTER: Tripartite Gastrointestinal Recovery Post-operative IIeus Group
PROVIDER: S-EPMC10364764 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
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Core outcome set for clinical studies of postoperative ileus after intestinal surgery.
The British journal of surgery 20220501 6
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Project description:AimAdhesive 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.MethodsThe 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.ResultsIn 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.ConclusionThis 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.
| S-EPMC9796004 | biostudies-literature
Project description:BackgroundAppropriate outcome selection is essential if research is to guide decision-making and inform policy. Systematic reviews of the clinical, cosmetic and patient-reported outcomes of reconstructive breast surgery, however, have demonstrated marked heterogeneity, and results from individual studies cannot be compared or combined. Use of a core outcome set may improve the situation. The BRAVO study developed a core outcome set for reconstructive breast surgery.MethodsA long list of outcomes identified from systematic reviews and stakeholder interviews was used to inform a questionnaire survey. Key stakeholders defined as individuals involved in decision-making for reconstructive breast surgery, including patients, breast and plastic surgeons, specialist nurses and psychologists, were sampled purposively and sent the questionnaire (round 1). This asked them to rate the importance of each outcome on a 9-point Likert scale from 1 (not important) to 9 (extremely important). The proportion of respondents rating each item as very important (score 7-9) was calculated. This was fed back to participants in a second questionnaire (round 2). Respondents were asked to reprioritize outcomes based on the feedback received. Items considered very important after round 2 were discussed at consensus meetings, where the core outcome set was agreed.ResultsA total of 148 items were combined into 34 domains within six categories. Some 303 participants (51·4 per cent) (215 (49·5 per cent) of 434 patients; 88 (56·4 per cent) of 156 professionals) completed and returned the round 1 questionnaire, and 259 (85·5 per cent) reprioritized outcomes in round 2. Fifteen items were excluded based on questionnaire scores and 19 were carried forward to the consensus meetings, where a core outcome set containing 11 key outcomes was agreed.ConclusionThe BRAVO study has used robust consensus methodology to develop a core outcome set for reconstructive breast surgery. Widespread adoption by the reconstructive community will improve the quality of outcome assessment in effectiveness studies. Future work will evaluate how these key outcomes should best be measured.
| S-EPMC5034747 | biostudies-literature
Project description:Complex regional pain syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers, and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations. The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. "What is the clinical presentation and course of CRPS, and what factors influence it?" was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as follows: pain, disease severity, participation and physical function, emotional and psychological function, self-efficacy, catastrophizing, and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and 1 clinician-reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally.
| S-EPMC5438049 | biostudies-literature
Project description:ImportanceVasa previa, although a rare condition affecting 0.46 per 1000 pregnancies, results in high rates of fetal and neonatal mortality and morbidity. Widespread use of a core outcome set and reporting checklist may enable data harmonization, enhance evidence synthesis, and ensure prioritization of patient-important outcomes in clinical practice, future research, and clinical practice guidelines.ObjectiveTo develop a core outcome set for studies on vasa previa that includes perinatal screening, diagnosis, and management of vasa previa.Design, setting, and participantsThis survey study involved a 2-round international and cross-disciplinary Delphi survey and virtual consensus meetings conducted between March 14, 2021, and October 4, 2022. Health care professionals (HCPs) and health service users (HSUs) were invited to participate in the development of the core outcome set.ExposurePerinatal screening, diagnosis, and management of vasa previa.Main outcome and measuresCore outcomes and reporting checklist items for future studies on vasa previa were developed using Delphi surveys, small group discussions, and a consensus meeting.ResultsAn international group of 204 participants, comprising 115 HSUs and 89 HCPs representing 27 countries, rated 67 outcomes identified through a systematic review and qualitative interviews in a 2-round online Delphi survey. Through virtual small group discussions and a consensus meeting, 13 core outcomes were identified: pregnancy outcome (live birth, fetal loss [miscarriage or stillbirth], or neonatal death), severe neonatal morbidity, fetal/neonatal blood loss, neonatal intensive care unit admission for >24 hours, gestational age at birth, third trimester confirmation of vasa previa diagnosis, neurocognitive and developmental outcomes, mode of birth, maternal death or severe morbidity, maternal quality of life, duration of antepartum admission, and antepartum or peripartum hemorrhage. A 22-item reporting checklist was simultaneously developed to include important items in studies on vasa previa when possible and/or relevant.Conclusions and relevanceThe core outcome set and reporting checklist for vasa previa are hoped to encourage researchers to incorporate patient-important outcomes in future studies to enable data harmonization, improve evidence synthesis, and facilitate the development of clinical practice guidelines for this rare and highly lethal condition for which timely diagnosis and management may prevent fetal and maternal morbidity and mortality.
| S-EPMC11920838 | biostudies-literature
Project description:Abstract Background Following abdominal surgery, postoperative ileus is a common complication significantly increasing patient morbidity and cost of hospital admission. This is the first systematic review aimed at determining the average global hospital cost per patient associated with postoperative ileus. Methods A systematic search of electronic databases was performed from January 2000 to March 2023. Studies included compared patients undergoing abdominal surgery who developed postoperative ileus to those who did not, focusing on costing data. The primary outcome was the total cost of inpatient stay. Risk of bias was assessed using the Newcastle–Ottawa assessment tool. Summary meta-analysis was performed. Results Of the 2071 studies identified, 88 papers were assessed for full eligibility. The systematic review included nine studies (2005–2022), investigating 1 860 889 patients undergoing general, colorectal, gynaecological and urological surgery. These studies showed significant variations in the definition of postoperative ileus. Six studies were eligible for meta-analysis showing an increase of €8233 (95 per cent c.i. (5176 to 11 290), P < 0.0001, I2 = 95.5 per cent) per patient with postoperative ileus resulting in a 66.3 per cent increase in total hospital costs (95 per cent c.i. (34.8 to 97.9), P < 0.0001, I2 = 98.4 per cent). However, there was significant bias between studies. Five colorectal-surgery-specific studies showed an increase of €7242 (95 per cent c.i. (4502 to 9983), P < 0.0001, I2 = 86.0 per cent) per patient with postoperative ileus resulting in a 57.3 per cent increase in total hospital costs (95 per cent c.i. (36.3 to 78.3), P < 0.0001, I2 = 85.7 per cent). Conclusion The global financial burden of postoperative ileus following abdominal surgery is significant. While further multicentre data using a uniform postoperative ileus definition would be useful, reducing the incidence and impact of postoperative ileus are a priority to mitigate healthcare-related costs, and improve patient outcomes. This is the first meta-analysis demonstrating the financial burden of postoperative ileus following abdominal surgery. We show in our paper that there is an increase of €8233 (95 per cent c.i. (5176–11 290), P < 0.0001, I2 = 95.5 per cent) per patient with postoperative ileus or a 66.3 per cent increase in total hospital costs (95 per cent c.i. (34.8–97.9), P < 0.0001, I2 = 98.4 per cent).
| S-EPMC10289829 | biostudies-literature
Project description:BackgroundInvasive off- or on-pump cardiac surgery (elective and emergency procedures, excluding transplants are routinely performed to treat complications of ischaemic heart disease. Randomised controlled trials (RCT) evaluate the effectiveness of treatments in the setting of cardiac surgery. However, the impact of RCTs is weakened by heterogeneity in outcome measuring and reporting, which hinders comparison across trials. Core outcome sets (COS, a set of outcomes that should be measured and reported, as a minimum, in clinical trials for a specific clinical field) help reduce this problem. In light of the above, we developed a COS for cardiac surgery effectiveness trials.MethodsPotential core outcomes were identified a priori by analysing data on 371 RCTs of 58,253 patients. We reached consensus on core outcomes in an international three-round eDelphi exercise. Outcomes for which at least 60% of the participants chose the response option "no" and less than 20% chose the response option "yes" were excluded.ResultsEighty-six participants from 23 different countries involving adult cardiac patients, cardiac surgeons, anaesthesiologists, nursing staff and researchers contributed to this eDelphi. The panel reached consensus on four core outcomes: 1) Measure of mortality, 2) Measure of quality of life, 3) Measure of hospitalisation and 4) Measure of cerebrovascular complication to be included in adult cardiac surgery trials.ConclusionThis study used robust research methodology to develop a minimum core outcome set for clinical trials evaluating the effectiveness of treatments in the setting of cardiac surgery. As a next step, appropriate outcome measurement instruments have to be selected.
| S-EPMC5667757 | biostudies-literature
Project description:BackgroundPostoperative ileus is a major complication for persons undergoing abdominal surgery. Daikenchuto, a Japanese traditional medicine (Kampo), is a drug that may reduce postoperative ileus.ObjectivesTo assess the efficacy and safety of Daikenchuto for reducing prolonged postoperative ileus in persons undergoing elective abdominal surgery.Search methodsWe searched the following databases on 3 July 2017: CENTRAL, MEDLINE, Embase, ICHUSHI, WHO (World Health Organization) International Clinical Trials Registry Platform (ICTRP), EU Crinical Trials registry (EU-CTR), UMIN Clinical Trials Registry (UMIN-CTR), ClinicalTrials.gov, The Japan Society for Oriental Medicine (JSOM), American Society of Clinical Oncology (ASCO), Society of American Gastrointestinal and Endscopic Surgeons (SAGES). We set no limitations on language or date of publication.Selection criteriaWe included randomised controlled trials (RCTs) comparing Daikenchuto with any control condition in adults, 18 years of age or older, undergoing elective abdominal surgery.Data collection and analysisWe applied standard methodological procedures expected by Cochrane. Two review authors independently reviewed the articles identified by literature searches, extracted data, and assessed risk of bias of the included studies using the Cochrane software Review Manager 5.Main resultsWe included seven RCTs with a total of 1202 participants. Overall, we judged the risk of bias as low in four studies and high in three studies. We are uncertain whether Daikenchuto reduced time to first flatus (mean difference (MD) -11.32 hours, 95% confidence interval (CI) -17.45 to -5.19; two RCTs, 83 participants; very low-quality evidence), or time to first bowel movement (MD -9.44 hours, 95% CI -22.22 to 3.35; four RCTs, 500 participants; very low-quality evidence) following surgery. There was little or no difference in time to resumption of regular solid food following surgery (MD 3.64 hours, 95% CI -24.45 to 31.74; two RCTs, 258 participants; low-quality evidence). There were no adverse events in either arm of the five RCTs that reported on drug-related adverse events (risk difference (RD) 0.00, 95% CI -0.02 to 0.02, 568 participants, low-quality evidence). We are uncertain of the effect of Daikenchuto on patient satisfaction (MD 0.09, 95% CI -0.19 to 0.37; one RCT, 81 participants; very low-quality of evidence). There was little or no difference in the incidence of any re-interventions for postoperative ileus before leaving hospital (risk ratio (RR) 0.99, 95% CI 0.06 to 15.62; one RCT, 207 participants; moderate-quality evidence), or length of hospital stay (MD -0.49 days, 95% CI -1.21 to 0.22; three RCTs, 292 participants; low-quality evidence).Authors' conclusionsEvidence from current literature was unclear whether Daikenchuto reduced postoperative ileus in patients undergoing elective abdominal surgery, due to the small number of participants in the meta-analyses. Very low-quality evidence means we are uncertain whether Daikenchuto improved postoperative flatus or bowel movement. Further well-designed and adequately powered studies are needed to assess the efficacy of Daikenchuto.
| S-EPMC6494569 | biostudies-literature
Project description:Study designRetrospective observational study of a cohort of consecutive patients.ObjectivesPostoperative ileus (POI) is associated with a variety of adverse effects. Although the incidence of and risk factors for POI following spinal surgery have been reported, the frequency and pathology of POI after spinal corrective surgery for adult spinal deformity (ASD) are still largely unknown. The study objectives were to: (1) clarify the prevalence and clinical significance of POI, (2) elucidate the risk factors for POI, (3) determine radiographically which preoperative and/or postoperative spinal parameters predominantly influence the risk of POI after spinal corrective surgery for ASD.MethodsWe included data from 144 consecutive patients who underwent spinal corrective surgery. Perioperative medical complications and clinical information were extracted from patient electronic medical records. Preoperative radiographic parameters and changes in radiographic parameters after surgery were compared between patients with and without POI. Multivariate logistic regression analyses were performed to clarify potential risk factors for POI.ResultsPOI developed in 25/144 (17.4%) patients and was the most common complication in the present study. The frequencies of smoking, gastroesophageal reflux disease, and lateral lumbar interbody fusion (LLIF), as well as the duration of surgery were significantly greater in the group with POI versus the group without POI. Among radiographic parameters, only the change in thoracolumbar kyphosis (TLK) from before to after surgery was significantly larger in the group with POI. Multivariate logistic regression analysis showed that male sex, LLIF and large changes in TLK from before to after surgery were significantly associated with the development of POI.ConclusionsThese results suggested that LLIF and large corrections in TLK were independent risk factors for POI after ASD surgery. When patients with ASD have large TLK preoperatively, and it is determined that a large correction is needed, physicians must be aware of the potential for occurrence of POI.
| S-EPMC9210243 | biostudies-literature
Project description:Background and aimStandardizing evaluative outcomes and their assessment facilitates comparisons between clinical studies and provides a basis for comparing direct effects of different treatment options. The aim of this study was to systematically review types of outcomes and measurement instruments used in studies regarding treatment options for slow-transit constipation (STC) in adults.MethodsIn this systematic review of the literature, we searched MEDLINE, Embase, and PsycINFO from inception through February 2018, for papers assessing any STC treatment in adult patients. Outcomes were systematically extracted and categorized in domains using the conceptual framework of the Outcome Measures in Rheumatology filter 2.0. Outcome reporting was stratified by decade of publication, intervention, and study type.ResultsForty-seven studies were included in this systematic review. Fifty-nine different types of outcomes were identified. The outcomes were structured in three core areas and 18 domains. The most commonly reported domains were defecation functions (94%), gastrointestinal transit (53%), and health-care service use (51%). The most frequently reported outcomes were defecation frequency (83%), health-related quality of life (43%), and adverse events and complications (43%). In 62% of the studies, no primary outcome was defined, whereas in two studies, more than one primary outcomes were selected. A wide diversity of measurement instruments was used to assess the reported outcomes.ConclusionOutcomes reported in studies on STC in adults are heterogeneous. A lack of standardization complicates comparisons between studies. Developing a core outcome set for STC in adults could contribute to standardization of outcome reporting in (future) studies.
| S-EPMC7027471 | biostudies-literature
Project description:Aims/hypothesisThe aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM).MethodsWe identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised.ResultsOur review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth).Conclusions/interpretationThis COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies.Trial registrationThis study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.
| S-EPMC7228989 | biostudies-literature