BackgroundFrameworks used in research impact evaluation studies vary widely and it remains unclear which methods are most appropriate for evaluating research impact in the field of surgical... Show moreBackgroundFrameworks used in research impact evaluation studies vary widely and it remains unclear which methods are most appropriate for evaluating research impact in the field of surgical research. Therefore, we aimed to identify and review the methods used to assess the impact of surgical intervention trials on healthcare and to identify determinants for surgical impact.MethodsWe searched journal databases up to March 10, 2020 for papers assessing the impact of surgical effectiveness trials on healthcare. Two researchers independently screened the papers for eligibility and performed a Risk of Bias assessment. Characteristics of both impact papers and trial papers were summarized. Univariate analyses were performed to identify determinants for finding research impact, which was defined as a change in healthcare practice.ResultsSixty-one impact assessments were performed in 37 included impact papers. Some surgical trial papers were evaluated in more than one impact paper, which provides a total of 38 evaluated trial papers. Most impact papers were published after 2010 (n = 29). Medical records (n = 10), administrative databases (n = 22), and physician's opinion through surveys (n = 5) were used for data collection. Those data were analyzed purely descriptively (n = 3), comparing data before and after publication (n = 29), or through time series analyses (n = 5). Significant healthcare impact was observed 49 times and more often in more recent publications. Having impact was positively associated with using medical records or administrative databases (ref.: surveys), a longer timeframe for impact evaluation and more months between the publication of the trial paper and the impact paper, data collection in North America (ref.: Europe), no economic evaluation of the intervention, finding no significant difference in surgical outcomes, and suggesting de-implementation in the original trial paper.Conclusions and implicationsResearch impact evaluation receives growing interest, but still a small number of impact papers per year was identified. The analysis showed that characteristics of both surgical trial papers and impact papers were associated with finding research impact. We advise to collect data from either medical records or administrative databases, with an evaluation time frame of at least 4 years since trial publication Show less
Importance Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the... Show moreImportance Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited. Objective To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD. Design, Setting, and Participants The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019. Interventions In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%). Main Outcomes and Measures The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs. Results Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, -1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were euro119 (US $143.94) per patient in the prehydration group compared with euro0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar. Conclusions and Relevance Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure. Show less
Swart, N.M.; Oudenaarde, K. van; Bierma-Zeinstra, S.M.A.; Bloem, H.J.L.; Hout, W.B. van den; Algra, P.R.; ... ; Luijsterburg, P.A.J. 2019
Background: Hip fracture is a common injury in the geriatric population. Despite surgical repair and subsequent rehabilitation programmes, functional recovery is often limited, particularly in... Show moreBackground: Hip fracture is a common injury in the geriatric population. Despite surgical repair and subsequent rehabilitation programmes, functional recovery is often limited, particularly in individuals with multi-morbidity. This leads to high care dependency and subsequent use of healthcare services. Fear of falling has a negative influence on recovery after hip fracture, due to avoidance of activity and subsequent restriction in mobility. Although fear of falling is highly prevalent after hip fracture, no structured treatment programme is currently available. This trial will evaluate whether targeted treatment of fear of falling in geriatric rehabilitation after hip fracture using a multi-component cognitive behavioural intervention (FIT-HIP), is feasible and (cost) effective in reducing fear of falling and associated activity restriction and thereby improves physical functioning.Methods/design: This multicentre cluster randomised controlled trial will be conducted among older patients with hip fracture and fear of falling who are admitted to a multidisciplinary inpatient geriatric rehabilitation programme in eleven post-acute geriatric rehabilitation units. Fifteen participants will be recruited from each site. Recruitment sites will be allocated by computer randomisation to either the control group, receiving usual care, or to the intervention group receiving the FIT-HIP intervention in addition to usual care. The FIT-HIP intervention is conducted by physiotherapists and will be embedded in usual care. It consists of various elements of cognitive behavioural therapy, including guided exposure to feared activities (that are avoided by the participants). Participants and outcome assessors are blinded to group allocation. Follow-up measurements will be performed at 3 and 6 months after discharge from geriatric rehabilitation. (Cost)-effectiveness and feasibility of the intervention will be evaluated. Primary outcome measures are fear of falling and mobility.Discussion: Targeted treatment of fear of falling may improve recovery and physical and social functioning after hip fracture, thereby offering benefits for patients and reducing healthcare costs. Results of this study will provide insight into whether fear of falling is modifiable in the (geriatric) rehabilitation after hip fracture and whether the intervention is feasible.Trial registration: Netherlands Trial Register: NTR 5695 Show less
Vries, E.F. de; Rabelink, T.J.; Hout, W.B. van den 2016
