Objectives: We have developed two Dutch questionnaires to assess the shared decision-making (SDM) process in oncology; the iSHAREpatient and iSHAREphysician. In this study, we aimed to determine:... Show moreObjectives: We have developed two Dutch questionnaires to assess the shared decision-making (SDM) process in oncology; the iSHAREpatient and iSHAREphysician. In this study, we aimed to determine: scores, construct validity, test-retest agreement (iSHAREpatient), and inter-rater (iSHAREpatient-iSHAREphysician) agreement. Methods: Physicians from seven Dutch hospitals recruited cancer patients, and completed the iSHAREphysician and SDM-Questionnaire-physician version. Their patients completed the: iSHAREpatient, nine-item SDM-Questionnaire, Decisional Conflict Scale, Combined Outcome Measure for Risk communication And treatment Decision-making Effectiveness, and five-item Perceived Efficacy in Patient-Physician Interactions. We formulated, respectively, one (iSHAREphysician) and 10 (iSHAREpatient) a priori hypotheses regarding correlations between the iSHARE questionnaires and questionnaires assessing related constructs. To assess test-retest agreement patients completed the iSHAREpatient again 1-2 weeks later. Results: In total, 151 treatment decision-making processes with unique patients were rated. Dimension and total iSHARE scores were high both in patients and physicians. The hypothesis on the iSHAREphysician and 9/10 hypotheses on the iSHAREpatient were confirmed. Test-retest and inter-rater agreement were >.60 for most items. Conclusions: The iSHARE questionnaires show high scores, have good construct validity, substantial test-retest agreement, and moderate inter-rater agreement. Practice implications: Results from the iSHARE questionnaires can inform both physician- and patient-directed efforts to improve SDM in clinical practice. Show less
Mekke, S.; Roshani, H.; Zanten, P. van; Palacios, L.G.; Egberts, J.; Hendriks, N.; ... ; Buddingh, T. 2021
Introduction: Controversy exists over whether transurethral resection of the prostate (TURP) in men with bladder stones prevents recurrence of stone formation and facilitates stone discharge. We... Show moreIntroduction: Controversy exists over whether transurethral resection of the prostate (TURP) in men with bladder stones prevents recurrence of stone formation and facilitates stone discharge. We sought to evaluate whether TURP in patients who underwent cystolithotripsy led to a lower recurrence of bladder stones for which a re-cystolithotripsy was necessary.Methods: Patients (n=127) who underwent transurethral cystolithotripsy with (n=38) or without simultaneous TURP (n=89) between January 2009 and December 2013 were retrospectively included in five centers in the Netherlands. Median followup was 48 months. The primary endpoint was to compare the relative risk between both groups for re-cystolithotripsy due to recurrent bladder stones. Secondary outcomes were the relative risk of urinary retention, the need for a (re-)TURP and the average time until recurrence.Results: Patients who underwent a cystolithotripsy with a simultaneous TURP had a lower need for re-cystolithotripsy, resulting in a risk reduction of 72%. (relative risk [RR] 0.28 [0.07-1.13], p=0.06, number needed to treat [NNT]=7). The length of in hospital stay (3.4 vs. 1.6 days, p=0.04) and operative time (58 vs. 33 minutes, p<0.01) was longer when a TURP was performed. There was no significant difference in complication rate, occurrence of urinary retention, reTURP, and re-admission. Eighty-one percent of patients who did not undergo a TURP remained free of bladder stone recurrence. Due to the retrospective nature of the study, essential data concerning prostate volume and micturition analysis was lacking.Conclusions: A simultaneous TURP in patients who underwent a cystolithotripsy showed a trend towards a protective effect on the need for re-cystolithotripsy. Show less
Weltings, S.; Buddingh, K.T.; Diepen, D.C. van; Pelger, R.C.M.; Putter, H.; Rad, M.; ... ; Roshani, H. 2020
Purpose To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic. Methods We conducted a placebo-controlled, multicenter, double-blind... Show morePurpose To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic. Methods We conducted a placebo-controlled, multicenter, double-blind randomized clinical trial (RCT) including 128 patients with renal colic (confirmed by ultrasound or CT-scan). Patients were randomized to receive either continuous IV butylscopolamine 100 mg/24 h or placebo (saline). Primary outcome is the amount of opioid escape medication used, measured in doses administered. Secondary outcomes are pain measured on a Numeric Rating Scale (NRS), side effects, and time of drug administration. Non-inferiority was assessed using linear regression with robust standard errors, with non-inferiority limit set at 0.5 units of escape medication. Results Median number of doses of escape medication was one in both groups. The number of extra doses in the placebo group compared with the butylscopolamine group was 0.05, with a 95% robust confidence interval (CI) of 0.38-0.47. Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04). No differences in secondary endpoints were seen between the groups. Conclusion Placebo is non-inferior to continuous IV butylscopolamine for pain relief in patients with renal colic. Based on this study and previous evidence, there is no role for continuous butylscopolamine IV in the treatment of renal colic. Trial NL7819 Show less
Weltings, S.; Buddingh, K.T.; Diepen, D.C. van; Pelger, R.C.M.; Putter, H.; Rad, M.; ... ; Roshani, H. 2020
Purpose To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic. Methods We conducted a placebo-controlled, multicenter, double-blind... Show morePurpose To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic. Methods We conducted a placebo-controlled, multicenter, double-blind randomized clinical trial (RCT) including 128 patients with renal colic (confirmed by ultrasound or CT-scan). Patients were randomized to receive either continuous IV butylscopolamine 100 mg/24 h or placebo (saline). Primary outcome is the amount of opioid escape medication used, measured in doses administered. Secondary outcomes are pain measured on a Numeric Rating Scale (NRS), side effects, and time of drug administration. Non-inferiority was assessed using linear regression with robust standard errors, with non-inferiority limit set at 0.5 units of escape medication. Results Median number of doses of escape medication was one in both groups. The number of extra doses in the placebo group compared with the butylscopolamine group was 0.05, with a 95% robust confidence interval (CI) of 0.38-0.47. Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04). No differences in secondary endpoints were seen between the groups. Conclusion Placebo is non-inferior to continuous IV butylscopolamine for pain relief in patients with renal colic. Based on this study and previous evidence, there is no role for continuous butylscopolamine IV in the treatment of renal colic. Trial NL7819 Show less
INTRODUCTION AND OBJECTIVES:Nephrolithiasis has a multifactorial etiology, wherein, besides metabolic factors, the anatomy of the pelvicalyceal system might play a role. Using 3D-reconstructions of... Show moreINTRODUCTION AND OBJECTIVES:Nephrolithiasis has a multifactorial etiology, wherein, besides metabolic factors, the anatomy of the pelvicalyceal system might play a role. Using 3D-reconstructions of CT-urography (CT-U), we studied the morphometric properties of pelvicalyceal anatomy affecting kidney stone formation and compared those with existing literature on their effect on minimally invasive treatment techniques for renal calculi.METHODS: CT-U's were made between 01-01-2017 and 30-09-2018. Patients were chronologically included in two groups: a nephrolithiasis group when ≥ 1 calculus was present on the CT-U and a control group of patients with both the absence of calculi on the CT-U and no medical history of urolithiasis. Patients with a medical history of diseases leading to higher risks on urolithiasis were excluded. In the nephrolithiasis group affected kidneys were measured. In the control group, left and right kidneys were alternately measured.RESULTS: Twenty kidneys were measured in both groups. Mean calyceopelvic tract width was significantly larger in the lower segments of affected kidneys (3.9 vs. 2.7 mm). No significant differences between the groups were found in number of calyces, infundibular length, infundibular width, calyceopelvic angle, upper-lower angle and diameters of the pelvis. Transversal calyceal orientation in hours was significantly smaller in the upper and lower segments of the nephrolithiasis group (7.69 vs. 8.52 and 8.08 vs. 9.09 h), corresponding with more dorsally located calyces in stone-forming kidneys.CONCLUSION: Pelvicalyceal anatomy differs between stone-forming and non-stone-forming kidneys. Understanding the pelvicalyceal system and etiology of stone formation can improve development of endourological techniques. Show less
