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
Lobatto, D.J.; Vlieland, T.P.M.V.; Hout, W.B. van den; Vries, F. de; Vries, A.F. de; Schutte, P.J.; ... ; Furth, W.R. van 2020
Objective Discharge policies concerning hospitalization after endoscopic pituitary tumor surgery are highly variable. A few studies support fast-track discharge; however, this is not commonplace.... Show moreObjective Discharge policies concerning hospitalization after endoscopic pituitary tumor surgery are highly variable. A few studies support fast-track discharge; however, this is not commonplace. Our goal was to report the transition to and evaluate the feasibility, safety, clinical- and patient-reported outcomes and costs of fast-track care in pituitary surgery. Methods This observational study included 155 patients undergoing pituitary surgery between December 2016 and December 2018. Fast-track care consisted of planned discharge 2-3 days after surgery, followed by daily surveillance by a case manager. All outcomes were compared with patients not eligible for fast-track discharge. The total group (fast-track and non-fast-track) was compared with historic controls (N = 307). Results A total of 79/155 patients (51%) were considered eligible for fast-track discharge, of whom 69 (87%) were discharged within 3 days. The total group was discharged more often within 3 days compared with historic controls (49 vs. 20%, p < 0.001), the total length of stay did not differ (5.3 vs. 5.7 days, p = 0.363). Although the total group had more readmissions compared with historic controls (17 vs. 10%, p = 0.002), no life-threatening complications occurred after discharge. On average, clinical- and patient-reported outcomes improved over time, both in the fast-track and non-fast-track groups. The mean overall costs within 30 days after surgery did not differ between the total group euro 9992 (SD euro 4562) and historic controls euro 9818 (SD euro 3488) (p = 0.649). Conclusion A stratified fast-track care trajectory with enhanced postoperative outpatient surveillance after pituitary tumor surgery is safe and feasible. As expected, costs of the fast-track were lower than the non-fast-track group, however we could not prove overall cost-effectiveness compared with the historic controls. 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
Lobatto, D.J.; Najafabadi, A.H.Z.; Vries, F. de; Andela, C.D.; Hout, W.B. van den; Pereira, A.M.; ... ; Biermasz, N.R. 2019
PurposeNon-functioning pituitary adenomas (NFPA) have a substantial impact on patients' health status, yet research on the extent of healthcare utilization and costs among these patients is scarce.... Show morePurposeNon-functioning pituitary adenomas (NFPA) have a substantial impact on patients' health status, yet research on the extent of healthcare utilization and costs among these patients is scarce. The objective was to determine healthcare usage, associated costs, and their determinants among patients treated for an NFPA.MethodsIn a cross-sectional study, 167 patients treated for an NFPA completed four validated questionnaires. Annual healthcare utilization and associated costs were assessed through the medical consumption questionnaire (MTA iMCQ). In addition, the Leiden Bother and Needs Questionnaire for pituitary patients (LBNQ-Pituitary), Short Form-36 (SF-36), and EuroQol (EQ-5D) were administered. Furthermore, age, sex, endocrine status, treatment, and duration of follow-up were extracted from the medical records. Associations were analyzed using logistic/linear regression.ResultsAnnual healthcare utilization included: consultation of an endocrinologist (95% of patients), neurosurgeon (14%), and/or ophthalmologist (58%). Fourteen percent of patients had 1 hospitalization(s) and 11% 1 emergency room visit(s). Mean overall annual healthcare costs were Euro 3040 (SD 6498), highest expenditures included medication (31%), inpatient care (28%), and specialist care (17%). Factors associated with higher healthcare utilization and costs were greater self-perceived disease bother and need for support, worse mental and physical health status, younger age, and living alone.ConclusionHealthcare usage and costs among patients treated for an NFPA are substantial and were associated with self-perceived health status, disease bother, and healthcare needs rather than endocrine status, treatment, or duration of follow-up. These findings suggest that targeted interventions addressing disease bother and unmet needs in the chronic phase are needed. Show less
Pieterse, A.H.; Kunneman, M.; Hout, W.B. van den; Baas-Thijssen, M.; Geijsen, E.D.; Ceha, H.M.; ... ; Stiggelbout, A.M. 2019
PurposeNon-functioning pituitary adenomas (NFPA) have a substantial impact on patients’ healthstatus, yet research on the extent of healthcare utilization and costs among these patients isscarce.... Show morePurposeNon-functioning pituitary adenomas (NFPA) have a substantial impact on patients’ healthstatus, yet research on the extent of healthcare utilization and costs among these patients isscarce. The objective was to determine healthcare usage, associated costs, and theirdeterminants among patients treated for an NFPA.MethodsIn a cross-sectional study, 167 patients treated for an NFPA completed four validatedquestionnaires. Annual healthcare utilization and associated costs were assessed through themedical consumption questionnaire (MTA iMCQ). In addition, the Leiden Bother and NeedsQuestionnaire for pituitary patients (LBNQ-Pituitary), Short Form-36 (SF-36), and EuroQol(EQ-5D) were administered. Furthermore, age, sex, endocrine status, treatment, and durationof follow-up were extracted from the medical records. Associations were analyzed usinglogistic/linear regression.ResultsAnnual healthcare utilization included: consultation of an endocrinologist (95% of patients),neurosurgeon (14%), and/or ophthalmologist (58%). Fourteen percent of patients had ≥1hospitalization(s) and 11% ≥1 emergency room visit(s). Mean overall annual healthcare costswere € 3040 (SD 6498), highest expenditures included medication (31%), inpatient care(28%), and specialist care (17%). Factors associated with higher healthcare utilization andcosts were greater self-perceived disease bother and need for support, worse mental andphysical health status, younger age, and living alone.ConclusionHealthcare usage and costs among patients treated for an NFPA are substantial and were associated with self-perceived health status, disease bother, and healthcare needs rather thanendocrine status, treatment, or duration of follow-up. These findings suggest that targetedinterventions addressing disease bother and unmet needs in the chronic phase are needed. Show less
Lobatto, D.J.; Steffens, A.N.V.; Najafabadi, A.H.Z.; Andela, C.D.; Pereira, A.M.; Hout, W.B. van den; ... ; Furth, W.R. van 2018
