Proton pump inhibitors (PPIs) are among the most commonly used medications in the world. Developed for the treatment and prevention of acid-mediated upper gastrointestinal conditions, these agents ...are being used increasingly for indications where their benefits are less certain. PPI overprescription imposes an economic cost and contributes to polypharmacy. In addition, PPI use has been increasingly linked to a number of adverse events (PPI-associated adverse events PAAEs). Therefore, de-prescribing of PPIs is an important strategy to lower pill burden while reducing real costs and theoretical risks. The purpose of this clinical update was to provide Best Practice Advice (BPA) statements about how to approach PPI de-prescribing in ambulatory patients.
Our guiding principle was that, although PPIs are generally safe, patients should not use any medication when there is not a reasonable expectation of benefit based on scientific evidence or prior treatment response. Prescribers are responsible for determining whether PPI use is absolutely or conditionally indicated and, when uncertainty exists, to incorporate patient perspectives into PPI decision making. We collaboratively outlined a high-level “process map” of the conceptual approach to de-prescribing PPIs in a clinical setting. We identified the following 3 key domains that required BPA guidance: documentation of PPI indication; identifying suitable candidates for consideration of de-prescribing; and optimizing successful de-prescribing. Co-authors drafted 1 or more potential BPAs, supported by literature review, for each domain. All co-authors reviewed, edited, and selected or rejected draft BPAs for inclusion in the final list submitted to the American Gastroenterological Association Governing Board. Because this was not a systematic review, we did not carry out a formal rating of the quality of evidence or strength of the presented considerations.
Best Practice Advice Statements
All patients taking a PPI should have a regular review of the ongoing indications for use and documentation of that indication. This review should be the responsibility of the patient’s primary care provider.
All patients without a definitive indication for chronic PPI should be considered for trial of de-prescribing.
Most patients with an indication for chronic PPI use who take twice-daily dosing should be considered for step down to once-daily PPI.
Patients with complicated gastroesophageal reflux disease, such as those with a history of severe erosive esophagitis, esophageal ulcer, or peptic stricture, should generally not be considered for PPI discontinuation.
Patients with known Barrett’s esophagus, eosinophilic esophagitis, or idiopathic pulmonary fibrosis should generally not be considered for a trial of de-prescribing.
PPI users should be assessed for upper gastrointestinal bleeding risk using an evidence-based strategy before de-prescribing.
Patients at high risk for upper gastrointestinal bleeding should not be considered for PPI de-prescribing.
Patients who discontinue long-term PPI therapy should be advised that they may develop transient upper gastrointestinal symptoms due to rebound acid hypersecretion.
When de-prescribing PPIs, either dose tapering or abrupt discontinuation can be considered.
The decision to discontinue PPIs should be based solely on the lack of an indication for PPI use, and not because of concern for PAAEs. The presence of a PAAE or a history of a PAAE in a current PPI user is not an independent indication for PPI withdrawal. Similarly, the presence of underlying risk factors for the development of an adverse event associated with PPI use should also not be an independent indication for PPI withdrawal.
Randomized controlled trials (RCTs) have yielded varying estimates of the benefit of flexible sigmoidoscopy (FS) screening for colorectal cancer (CRC). Our objective was to more precisely estimate ...the effect of FS-based screening on the incidence and mortality of CRC by performing a meta-analysis of published RCTs.
Medline and Embase databases were searched for eligible articles published between 1966 and 28 May 2012. After screening 3,319 citations and 29 potentially relevant articles, two reviewers identified five RCTs evaluating the effect of FS screening on the incidence and mortality of CRC. The reviewers independently extracted relevant data; discrepancies were resolved by consensus. The quality of included studies was assessed using criteria set out by the Evidence-Based Gastroenterology Steering Group. Random effects meta-analysis was performed. The five RCTs meeting eligibility criteria were determined to be of high methodologic quality and enrolled 416,159 total subjects. Four European studies compared FS to no screening and one study from the United States compared FS to usual care. By intention to treat analysis, FS-based screening was associated with an 18% relative risk reduction in the incidence of CRC (0.82, 95% CI 0.73-0.91, p<0.001, number needed to screen NNS to prevent one case of CRC = 361), a 33% reduction in the incidence of left-sided CRC (RR 0.67, 95% CI 0.59-0.76, p<0.001, NNS = 332), and a 28% reduction in the mortality of CRC (relative risk RR 0.72, 95% CI 0.65-0.80, p<0.001, NNS = 850). The efficacy estimate, the amount of benefit for those who actually adhered to the recommended treatment, suggested that FS screening reduced CRC incidence by 32% (p<0.001), and CRC-related mortality by 50% (p<0.001). Limitations of this meta-analysis include heterogeneity in the design of the included trials, absence of studies from Africa, Asia, or South America, and lack of studies comparing FS with colonoscopy or stool-based testing.
This meta-analysis of randomized controlled trials demonstrates that FS-based screening significantly reduces the incidence and mortality of colorectal cancer in average-risk patients.
Machine learning (ML) algorithms provide effective ways to build prediction models using longitudinal information given their capacity to incorporate numerous predictor variables without compromising ...the accuracy of the risk prediction. Clinical risk prediction models in chronic hepatitis C virus (CHC) can be challenging due to non-linear nature of disease progression. We developed and compared two ML algorithms to predict cirrhosis development in a large CHC-infected cohort using longitudinal data.
We used national Veterans Health Administration (VHA) data to identify CHC patients in care between 2000-2016. The primary outcome was cirrhosis development ascertained by two consecutive aspartate aminotransferase (AST)-to-platelet ratio indexes (APRIs) > 2 after time zero given the infrequency of liver biopsy in clinical practice and that APRI is a validated non-invasive biomarker of fibrosis in CHC. We excluded those with initial APRI > 2 or pre-existing diagnosis of cirrhosis, hepatocellular carcinoma or hepatic decompensation. Enrollment was defined as the date of the first APRI. Time zero was defined as 2 years after enrollment. Cross-sectional (CS) models used predictors at or closest before time zero as a comparison. Longitudinal models used CS predictors plus longitudinal summary variables (maximum, minimum, maximum of slope, minimum of slope and total variation) between enrollment and time zero. Covariates included demographics, labs, and body mass index. Model performance was evaluated using concordance and area under the receiver operating curve (AuROC). A total of 72,683 individuals with CHC were analyzed with the cohort having a mean age of 52.8, 96.8% male and 53% white. There are 11,616 individuals (16%) who met the primary outcome over a mean follow-up of 7 years. We found superior predictive performance for the longitudinal Cox model compared to the CS Cox model (concordance 0.764 vs 0.746), and for the longitudinal boosted-survival-tree model compared to the linear Cox model (concordance 0.774 vs 0.764). The accuracy of the longitudinal models at 1,3,5 years after time zero also showed superior performance compared to the CS model, based on AuROC.
Boosted-survival-tree based models using longitudinal information are statistically superior to cross-sectional or linear models for predicting development of cirrhosis in CHC, though all four models were highly accurate. Similar statistical methods could be applied to predict outcomes in other non-linear chronic disease states.
Low-value care-the use of unnecessary and potentially harmful health care services-accounted for roughly $200 billion in wasteful spending in the United States in 2011. In 2012 the ABIM Foundation ...and Consumer Reports launched the Choosing Wisely® campaign, inspired by the idea that professional societies and health care providers should take the lead in defining and motivating efforts to reduce the use of low-value care. But decreases in that use have been slow in coming. We discuss the campaign's significant accomplishments in the past five years and summarize the work that is needed to fulfill the promise of Choosing Wisely. We focus on innovations in three main areas: identifying high-priority clinical targets, developing theory-based interventions, and evaluating interventions in ways that are clinically meaningful.
Little is known about how reports on the adverse effects of proton pump inhibitors (PPIs) impact patients' perceptions of these drugs and medication use. We sought to determine patients' level of ...concern about PPI adverse effects and its association with attempts to discontinue these drugs.
This study is an online survey of US adults who use PPIs for gastroesophageal reflux disease. Topics included awareness of and concern about PPI adverse effects, prior discussion with providers, and attempts to stop PPI because of concern about adverse effects. For the primary analysis, we used logistic regression to identify associations between having attempted to stop PPI and concern about PPI-related adverse effects, a provider's recommendation to stop, risk of upper gastrointestinal bleeding (UGIB), age, and gender.
Among 755 patient participants, mean age was 49 years (s.d. 16), 71% were women, and 24% were at high risk of UGIB. Twenty percent of patients were able to write in ≥1 reported adverse effect, and 46% endorsed awareness of ≥1 adverse effect when presented with a list, most commonly chronic kidney disease (17%). Thirty-three percent of patients were slightly concerned, 32% somewhat concerned, and 14% extremely concerned about adverse effects. Twenty-four percent of patients had discussed PPI risks and benefits with a provider, and 9% had been recommended to stop. Thirty-nine percent had attempted to stop their PPI, most (83%) without a provider recommendation. Factors associated with an attempt at stopping PPI included: (i) provider recommendation to stop (odds ratio OR 3.26 1.82-5.83); (ii) concern about adverse effects (OR 5.13 2.77-9.51 for slightly, 12.0 6.51-22.2 for somewhat, and 19.4 9.75-38.7 for extremely concerned); and (iii) female gender (OR 1.64 1.12-2.39). Patients at high risk of UGIB were as likely to have attempted to stop as others (OR 0.98 0.66-1.44).
Concern about PPIs is common and strongly associated with attempts at discontinuation, even without a provider's recommendation. Notably, individuals at high risk of UGIB, who benefit from PPIs, were equally likely to have tried stopping PPIs as others. Providers should proactively discuss the risks and benefits of PPIs with their patients, who may otherwise make unwise decisions about PPI management on their own.
To systematically review available data on the effect of daily medication dosing frequency on medication adherence in chronic disease states, as assessed by precise medication event monitoring ...systems (MEMS).
Systematic review of relevant literature published between January 1986 and August 2007.
Four electronic databases were searched to identify appropriate studies. Study selection criteria included prospective study design, patient population with quiescent chronic disease, medication intervention prescribed to each treatment arm for at least 6 weeks, and the use of MEMS to measure adherence. Data were extracted on the chronic disease being treated, the frequency of medication dosing, and the proportion of days with correct number of doses.
Twenty studies met the selection criteria. All studies reported higher adherence rates in patients using less frequently dosed medications, and these differences were statistically significant (P <.05) in 75% (15 of 20) of studies. For 5 of 6 studies comparing once-daily versus thrice-daily dosing, patients receiving once-daily dosing had 22% to 41% more adherent days compared with patients receiving thrice-daily dosing. For studies comparing once-daily versus twice-daily dosing, patients receiving once-daily dosing had 2% to 44% more adherent days compared with patients receiving twice-daily dosing, with most studies clustering around 13% to 26%.
Patients are more compliant with once-daily compared with twice-daily or thrice-daily treatment regimens.
Bowel preparation is inadequate in a large proportion of colonoscopies, leading to multiple clinical and economic harms. While most patients receive some form of education before colonoscopy, there ...is no consensus on the best approach.
This systematic review aimed to evaluate the efficacy of patient education interventions to improve bowel preparation.
We searched the Cochrane Database, CINAHL, EMBASE, Ovid, and Web of Science. Inclusion criteria were: (1) a patient education intervention; (2) a primary aim of improving bowel preparation; (3) a validated bowel preparation scale; (4) a prospective design; (5) a concurrent control group; and, (6) adult participants. Study validity was assessed using a modified Downs and Black scale.
1,080 abstracts were screened. Seven full text studies met inclusion criteria, including 2,660 patients. These studies evaluated multiple delivery platforms, including paper-based interventions (three studies), videos (two studies), re-education telephone calls the day before colonoscopy (one study), and in-person education by physicians (one study). Bowel preparation significantly improved with the intervention in all but one study. All but one study were done in a single center. Validity scores ranged from 13 to 24 (maximum 27). Four of five abstracts and research letters that met inclusion criteria also showed improvements in bowel preparation. Statistical and clinical heterogeneity precluded meta-analysis.
Compared to usual care, patient education interventions appear efficacious in improving the quality of bowel preparation. However, because of the small scale of the studies and individualized nature of the interventions, results of these studies may not be generalizable to other settings. Healthcare practices should consider systematically evaluating their current bowel preparation education methods before undertaking new interventions.
Background
Decreasing low-value colonoscopy is critical to optimizing access for high-need patients, particularly in resource-constrained environments such as those created by the COVID-19 pandemic. ...We hypothesized that rates of screening colonoscopy overuse would decline during COVID compared to pre-COVID due to enhanced procedural scrutiny and prioritization in the setting of constrained access.
Objective
To characterize impacts of COVID-19 on screening colonoscopy overuse
Design
Retrospective national cohort study using Veterans Health Administration administrative data
Participants
Veterans undergoing screening colonoscopy in Q4 2019 (pre-COVID) and Q4 2020 (COVID) at 109 endoscopy facilities
Main Measures
Rates of screening colonoscopy overuse
Key Results
18,376 screening colonoscopies were performed pre-COVID, 19% (3,641) of which met overuse criteria. While only 9,360 screening colonoscopies were performed in Q4 2020, 25% met overuse criteria. Overall change in median facility-level overuse during COVID compared to pre-COVID was 6% (95%CI 5%-7%), with significant variability across facilities (IQR: 2%-11%). Of colonoscopies meeting overuse criteria, the top reason for overuse in both periods was screening colonoscopy performed <9 years after previous screening procedure (55% pre-COVID, 49% during COVID). The largest shifts in overuse category were in screening procedures performed <9 years after prior screening colonoscopy (-6% decline COVID vs. pre-COVID) and screening procedures performed in patients below average-risk screening age (i.e., age <40 (5% increase COVID compared to pre-COVID), age 40-44 (4% increase COVID vs. pre-COVID)). Within facility performance was stable over time; 83/109 facilities changed their performance by <=1 quartile during COVID compared to pre-COVID.
Conclusions
Despite pandemic-related resource constraints and enhanced procedural scrutiny and prioritization in the setting of COVID-related backlogs, screening colonoscopy overuse rates remained roughly stable during COVID compared to pre-COVID, with continued variability across facilities. These data highlight the need for systematic and concerted efforts to address overuse, even in the face of strong external motivating factors.
Background
To prepare for colonoscopy, patients must consume a bowel purgative and travel from their home to the site of their procedure. The timing of bowel purgative ingestion predicts bowel ...preparation quality. Currently, it is not known if driving distance impacts bowel preparation quality or adenoma detection.
Objective
This study investigates the effect of driving distance on bowel preparation and adenoma detection.
Design
This is a cross-sectional retrospective analysis of outpatient screening colonoscopy procedures that were completed at an academic medical center.
Participants
A total of 5089 patients who completed screening colonoscopy across 3 procedure units were analyzed.
Main Measures
Description of bowel preparation was dichotomized to either adequate or inadequate. Patient residential addresses were converted into geographic coordinates for geospatial analysis of driving distance to their colonoscopy site.
Key Results
Median driving distance was 13.1 miles. Eighty-nine percent of patients had an adequate bowel preparation. The rate of adenoma detection was 37%. On multivariable logistic regression adjusting for age, sex, race, insurance, endoscopist, and site, increasing driving distance (10-mile increments) was negatively associated with adequate bowel preparation (odds ratio = 0.91; 95% confidence interval 0.85 to 0.97), while adenoma detection was positively associated with adequate bowel preparation (odds ratio = 1.53; 95% confidence interval 1.24 to 1.88) but not with driving distance (odds ratio = 1.02; 95% confidence interval 0.98 to 1.06). Driving distances of 30 miles or less were associated with adequate bowel preparation (odds ratio = 1.37; 95% confidence interval 1.09 to 1.72).
Conclusions
Increasing driving distance to screening colonoscopy was negatively associated with adequate bowel preparation but not adenoma detection. Among an academic medical center population, the likelihood of adequate bowel preparation was highest in patients traveling 30 miles or less to their screening colonoscopy. Patient driving distance to colonoscopy is an important consideration in optimizing screening colonoscopy quality.
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