Estimating the Effect of Preventable Treatment Discontinuation on Health Outcomes

Brookhart, M. Alan; Reams, Diane; Dluzniewski, PJ; Kshirsagar, Abhijit V.; Walsh, Liron; Bradbury, BD

doi:10.1097/ede.0000000000000766

Cited by 5 publications

(7 citation statements)

References 29 publications

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“…In a similar study on the effect of preventable treatment discontinuation, medically indicated treatment discontinuation was not considered "preventable." 14 Because contraindications for rotavirus vaccination are very rare, 42,43 the bias resulting from the occurrence of these events during follow-up is likely small. Second, our study was conducted under the assumption of no interference (i.e., the potential outcomes of one individual are assumed to be unaffected by the exposure of other individuals).…”

Section: Discussionmentioning

confidence: 99%

“…10 The general approach has been used to study the effect of dynamic treatment regimens, [11][12][13] and to study the population attributable effect of preventing treatment discontinuation. 14 Here, we apply the approach in the context of a study of various RV schedules for the prevention of acute gastroenteritis -related hospitalization and emergency department (ED) visits during early childhood. The effectiveness of full-and partial-series completion with the two-dose monovalent RV, Rotarix (RV1; GlaxoSmithKline Biologicals, Rixensart, Belgium), and the three-dose pentavalent RV, RotaTeq (RV5; Merck & Co., Inc., Whitehouse Station, New Jersey, USA), have been well-established.…”

Section: Introductionmentioning

confidence: 99%

“…10 The general approach has been used to study the effect of dynamic treatment regimens, 11–13 and to study the population attributable effect of preventing treatment discontinuation. 14…”

Section: Introductionmentioning

confidence: 99%

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Estimating the Effectiveness of Rotavirus Vaccine Schedules

et al. 2021

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“…The increasing availability of RWD is further enhanced by the growing sophistication of epidemiologic and statistical methods, such as causal inference. [15][16][17][18][19][20][21] TARGET-NEURO was developed to address the current gaps in research on patients with chronic neurological diseases and capitalize upon the potential medical and health insights that data in EHR systems can provide. The overarching goal of TARGET-NEURO is to characterize the natural history of patients with chronic neurological diseases (i.e.…”

Section: Introductionmentioning

confidence: 99%

Design and Rationale for a Real-World Observational Cohort of Patients Living with Progressive Neurological Disease and their care partners: TARGET-NEURO Study

Fowler

Boustani

Meadows

et al. 2023

Preprint

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Background Progressive neurological diseases, such as Alzheimer’s disease and related dementias, Parkinson’s disease, and multiple sclerosis, are leading causes of disability and mortality. Chronic neurological diseases typically develop and progress over many years. Safety and effectiveness data, from long-term real-world sources are needed to guide therapeutic decision making and effectively measure pragmatic trials, and what matters most to patients and their care partners. The increasing availability of data from electronic health records is further enhanced by the growing sophistication of epidemiologic and statistical methods, such as causal inference. Methods A longitudinal, observational study, TARGET-NEURO, will characterize the natural history of chronic neurological diseases in real world populations, observe practice patterns, directly evaluate patient and care partner experiences and understand the effectiveness and long-term safety of treatments. TARGET-NEURO is a cooperative consortium of centers treating patients with chronic neurological diseases, enrolling over one million participants across three cohorts: 1) Engaged, 2) Disease, and 3) Age. Selection for the Disease cohort is based upon diagnosis codes. Those who consent to completing patient-reported outcomes with optional consent for biospecimen collection, will be enrolled into the Engaged cohort. Care partners are also eligible to participate in surveys. The Age cohort includes adults at least 60 years old, regardless of diagnoses. Conclusions TARGET-NEURO establishes a large, robust database from participants in both academic medical centers and community practice settings to address important clinical questions. The outcomes can support improved understanding of how different patients progress in their disease and how trajectories vary based on sociodemographic factors, co-morbidities and risk factors. The results can support novel prevention and screening strategies, earlier and more precise diagnoses, and appropriate and equitable use of therapies. Trial registration Clinicaltrials.gov identification number: NCT05796037

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“…It directly reduces PTH levels with an additional resultant effect of decreasing serum calcium and phosphorus levels [12, 13]. As with most chronically administered medications, the putative benefits of cinacalcet therapy are thought to manifest when patients are taking it consistently as prescribed, and consequently, the benefits of cinacalcet may not be fully realized when not remaining on therapy [14].…”

Section: Introductionmentioning

confidence: 99%

Predictors of cinacalcet discontinuation and reinitiation in hemodialysis patients: results from 7 European countries

et al. 2019

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Background The putative benefits of cinacalcet therapy for management of secondary hyperparathyroidism (SHPT) are thought to be most manifested when patients are taking it consistently and as prescribed. Real-world descriptions of cinacalcet prescription discontinuation and reinitiation in European hemodialysis patients are lacking. To address this knowledge gap, we used Dialysis Outcomes and Practice Patterns Study (DOPPS) data, based on dialysis facility medical records, from seven European countries to estimate rates and predictors of cinacalcet prescription discontinuation and reinitiation in hemodialysis patients and to describe the trajectories of CKD-MBD laboratory values after discontinuation. Methods Cox regression analyses were used to predict (1) cinacalcet discontinuation among 613 patients with ≥3 consecutive months without cinacalcet prescription immediately prior to a new cinacalcet prescription and (2) cinacalcet reinitiation among 415 patients with a newly discontinued cinacalcet prescription immediately after ≥3 consecutive months of prescribed use. Results Cinacalcet was discontinued in 21 and 35% of new users after 6 and 12 months, respectively. Cinacalcet was reinitiated in 38 and 49% of newly-discontinued users after 6 and 12 months, respectively. Predictors of discontinuation included lower parathyroid hormone (PTH) in the previous month (< 150 pg/ml vs. 150–299, HR = 2.57 [95% CI: 1.52–4.33]) and lower serum calcium in the previous month (< 8.4 mg/dl vs. 8.4–10.19, HR = 1.67 [95% CI: 1.08–2.59]). Predictors of reinitiation included higher PTH in the previous month (300–599 pg/ml vs. 150–299, HR = 1.88 [95% CI = 1.19–2.97]; 600+ pg/ml, HR = 3.02 [95% CI = 1.92–4.76]). After cinacalcet discontinuation, mean serum PTH increased from 408 to 510 pg/ml, mean serum calcium briefly rose from 9.12 to 9.22 mg/dl before declining to 9.06 mg/dl, and mean serum phosphorus showed little change. Conclusions Nephrologist discontinuation of cinacalcet therapy is common in European countries. Additional research is needed to identify optimal cinacalcet treatment strategies for SHPT management, including comparisons of intermittent cinacalcet therapy versus sustained treatment with reduced dose or frequency. Electronic supplementary material The online version of this article (10.1186/s12882-019-1355-5) contains supplementary material, which is available to authorized users.

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Estimating the Effect of Preventable Treatment Discontinuation on Health Outcomes

Cited by 5 publications

References 29 publications

Estimating the Effectiveness of Rotavirus Vaccine Schedules

Estimating the Effectiveness of Rotavirus Vaccine Schedules

Design and Rationale for a Real-World Observational Cohort of Patients Living with Progressive Neurological Disease and their care partners: TARGET-NEURO Study

Predictors of cinacalcet discontinuation and reinitiation in hemodialysis patients: results from 7 European countries

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