Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial

Scales, Charles D.; Desai, Alana; Harper, Jonathan D.; Lai, H. Henry; Maalouf, Naim M.; Reese, Peter P.; Tasian, Gregory E.; Al‐Khalidi, Hussein R.; Kırkalı, Ziya; Wessells, Hunter

doi:10.1053/j.ajkd.2020.09.016

Cited by 20 publications

(15 citation statements)

References 31 publications

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“…24 Hence, clinical trials are in progress to prospectively evaluate the efficacy and safety of prescribed water intake for the secondary prevention of chronic diseases. [25][26][27] Whether recommending water intake in healthcare 27 or prescribing water intake in a clinical research trial it is important to understand the circumstances that could result in water intoxication. 5 17 Recently, a comprehensive narrative review on the pathogenesis of overhydration was published, 28 and therefore, the primary aim of this study was to perform a systematic review to determine the characteristics (demographics, comorbidities, volume of water consumed) associated with water intoxication.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

Clinical characteristics and outcomes of hyponatraemia associated with oral water intake in adults: a systematic review

et al. 2021

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IntroductionExcessive water intake is rarely associated with life-threatening hyponatraemia. The aim of this study was to determine the clinical characteristics and outcomes of hyponatraemia associated with excess water intake.MethodsThis review was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All studies (case reports, observational or interventional studies) reporting excess water intake and hyponatraemia in adults (1946–2019) were included.ResultsA total of 2970 articles were identified and 177 were included (88.7% case reports), consisting of 590 patients. The mean age was 46±16 years (95% CI 44 to 48 years), 47% female, 52% had a chronic psychiatric disorder and 31% had no underlying condition. The median volume of water consumed and serum sodium at presentation was 8 L/day (95% CI 8.9 to 12.2 L/day) and 118 mmol/L (95% CI 116 to 118 mmol/L), respectively. The motivator for increased water consumption was psychogenic polydipsia (55%); iatrogenic (13%); exercise (12%); habitual/dipsogenic polydipsia (7%) and other reasons (13%). The clinical features on presentation were severe in 53% (seizures, coma); moderate in 35% (confusion, vomiting, agitation) and mild in 5% (dizziness, lethargy, cognitive deficit) and not reported in 5% of studies. Treatment was supportive in 41% of studies (fluid restriction, treatment of the underlying cause, emergency care), and isotonic and hypertonic saline was used in 18% and 28% of cases, respectively. Treatment-related complications included osmotic demyelination (3%) and rhabdomyolysis (7%), and death occurred in 13% of cases.ConclusionWater intoxication is associated with significant morbidity and mortality and requires daily intake to substantially exceed population-based recommendations. The limitations of this analysis are the low quality and high risk of bias of the included studies.PROSPERO registration numberA pre-existing protocol in the international prospective register of systematic reviews was updated to incorporate any new amendments and reregistered at http://www.crd.york.ac.uk/PROSPERO (registration no. CRD42019129809).

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Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

Clinical characteristics and outcomes of hyponatraemia associated with oral water intake in adults: a systematic review

et al. 2021

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“…As part of the ongoing PUSH (Prevention of Urinary Stones with Hydration) study, Scales et al use daily financial loss-framed incentives ($1.50) to nudge patients with urolithiasis toward adequate hydration with the aim of decreasing stone recurrence. 15 This aligns an immediate reward with a positive behavior. Notably, this study aims to evaluate whether financial incentives can provide a foundation for long-term habit formation by tapering financial incentives to “low-touch” incentives such as daily text reminders.…”

Section: Discussionmentioning

confidence: 93%

“…The tendency to be more motivated to avoid losses than acquire equivalent gains Daily loss-framed financial incentive of $1.50 for meeting fluid intake prescription in the ongoing PUSH study (Scales et al, 2021 15 ) Social norms…”

Section: Loss Aversionmentioning

confidence: 99%

“…29 The PUSH trial also aims to leverage loss aversion to incentivize behavioral change: the daily incentive will be delivered in a loss frame, meaning that participants will have a monthly deposit into their account and each day's allocation will be deducted if the hydration goal is not met. 15 Loss-framed incentives have had mixed results in the general medical literature. Some studies suggest that loss-framed incentives are better utilized for disease-detection behaviors such as breast selfexamination, while gain-framed incentives are better utilized for preventive behaviors such as skin cancer prevention.…”

Section: Loss Aversionmentioning

confidence: 99%

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Behavioral Economics in Urology: A Scoping Review

et al. 2022

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Purpose:Behavioral economics is the study of human behavior in the context of irrationality, self-control and self-interest. It has been leveraged in a variety of ways in health care, including efforts to decrease smoking, encourage weight loss and promote medication adherence. Concepts from this field can be used to help urologists better understand and improve behavior-dependent clinical outcomes. Our objective in this scoping review was to assess the current state of behavioral economics in the urological literature.Materials and Methods:We conducted a scoping review of behavioral economic research in urology by performing a broad search in MEDLINE®, Embase® and Scopus® databases from inception to August 30, 2021. Abstracts were screened, assessed for relevancy and selected for full-text review. A qualitative synthesis of selected manuscripts was then performed.Results:A total of 1,855 articles were identified. Sixty-one articles were selected for full-text review. Of those, 13 were selected for qualitative synthesis. The selected articles included reports of prospective trials (6), ongoing prospective trial methods (1), abstracts without a published manuscript (4) and commentaries (2). A variety of topics were covered: prostate cancer (5), resident education (2), hematuria (1), incontinence (1), surgical costs (1), care pathways (1), nephrolithiasis (1) and bladder cancer (1).Conclusions:There is a very limited number of articles, and even fewer trials, in urology that leverage behavioral economic concepts. Given this, and the successful application of behavioral economics in other medical disciplines, there is a need for behavioral economic informed urological interventions and well-designed trials to evaluate behavioral economics outcomes in urology.

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“…To reduce variation inherent to ultrasound, all PKIDS site investigators agreed to adopt with minor modifications the standardised ultrasound protocol that was developed for the Urinary Stone Disease Research Network (USDRN) Prevention of Urinary Stones with Hydration trial (online supplemental figure 1). 23 Stone clearance is defined as the absence of any stone of >4 mm. This cut point was chosen because ultrasound overestimates stone size by 2 mm, and 2 mm is a commonly used conservative size for clinically insignificant stone fragments measured by CT 24–26.…”

Section: Methodsmentioning

confidence: 99%

Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial

et al. 2022

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Introduction The strength of the evidence base for the comparative effectiveness of three common surgical modalities for paediatric nephrolithiasis (ureteroscopy, shockwave lithotripsy and percutaneous nephrolithotomy) and its relevance to patients and caregivers are insufficient. We describe the methods and rationale for the Pediatric KIDney Stone (PKIDS) Care Improvement Network Trial with the aim to compare effectiveness of surgical modalities in paediatric nephrolithiasis based on stone clearance and lived patient experiences. This protocol serves as a patient-centred alternative to randomised controlled trials for interventions where clinical equipoise is lacking. Methods and analysis The PKIDS is a collaborative learning organisation composed of 26 hospitals that is conducting a prospective pragmatic clinical trial comparing the effectiveness of ureteroscopy, shockwave lithotripsy and percutaneous nephrolithotomy for youth aged 8–21 years with kidney and/or ureteral stones. Embedded within clinical care, the PKIDS trial will collect granular patient-level, surgeon-level and institution-level data, with a goal enrolment of 1290 participants over a 21-month period. The primary study outcome is stone clearance, defined as absence of a residual calculus of >4 mm on postoperative ultrasound. Secondary outcomes include patient-reported physical, emotional and social health outcomes (primarily using the Patient-Reported Outcome Measurement Information System), analgesic use and healthcare resource use. Timing and content of secondary outcomes assessments were set based on feedback from patient partners. Heterogeneity of treatment effect for stone clearance and patient-reported outcomes by participant and stone characteristics will be assessed. Ethics and dissemination This study is approved by the central institutional review board with reliance across participating sites. Participating stakeholders will review results and contribute to development dissemination at regional, national and international meetings. Trial registration number NCT04285658; Pre-results.

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Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial

Cited by 20 publications

References 31 publications

Clinical characteristics and outcomes of hyponatraemia associated with oral water intake in adults: a systematic review

Clinical characteristics and outcomes of hyponatraemia associated with oral water intake in adults: a systematic review

Behavioral Economics in Urology: A Scoping Review

Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial

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