Standardized Treatment of Pulmonary Exacerbations (STOP) study: Physician treatment practices and outcomes for individuals with cystic fibrosis with pulmonary Exacerbations

West, Natalie E.; Beckett, Valeria; Jain, Raksha; Sanders, Don B.; Nick, Jerry A.; Heltshe, Sonya L.; Dasenbrook, Elliott C.; VanDevanter, Donald R.; Solomon, George M.; Goss, Christopher H.; Flume, Patrick A.

doi:10.1016/j.jcf.2017.04.003

Cited by 80 publications

(100 citation statements)

References 23 publications

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“…This would suggest that FEV 1 loss/recovery was not a primary motivating factor in their treatment, though we did not record whether other factors (e.g., worsening symptoms, new auscultatory findings) were driving the decision to treat. A recent report on PEx treated with oral antibiotics also noted that a similar proportion of patients were treated for a PEx despite having FEV 1 at baseline (23). Alternatively, this observation highlights a limitation of relying on intermittent measurements of FEV 1 , to determine the “baseline” lung function, as has been done in previous registry analyses (6, 7, 24).…”

Section: Discussionmentioning

confidence: 95%

Standardized Treatment of Pulmonary Exacerbations (STOP) study: Observations at the initiation of intravenous antibiotics for cystic fibrosis pulmonary exacerbations

Sanders

Solomon

Beckett

et al. 2017

Journal of Cystic Fibrosis

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Background The Standardized Treatment of Pulmonary Exacerbations (STOP) program has the intent of defining best practices in the treatment of pulmonary exacerbations (PEx) in patients with cystic fibrosis (CF). The objective of this analysis was to describe the clinical presentations of patients admitted for intravenous (IV) antibiotics and enrolled in a prospective observational PEx study as well as to understand physician treatment goals at the start of the intervention. Methods We enrolled adolescents and adults admitted to the hospital for a PEx treated with IV antibiotics. We recorded patient and PEx characteristics at the time of enrollment. We surveyed treating physicians on treatment goals as well as their willingness to enroll patients in various study designs. Additional demographic and clinical data were obtained from the CF Foundation Patient Registry. Results Of 220 patients enrolled, 56% were female, 19% were adolescents, and 71% were infected with P. aeruginosa. The mean (SD) FEV1 at enrollment was 51.1 (21.6) % predicted. Most patients (85%) experienced symptoms for ≥7 days before admission, 43% had received IV antibiotics within the previous 6 months, and 48% received oral and/or inhaled antibiotics prior to IV antibiotic initiation. Forty percent had ≥10% FEV1 decrease from their best value recorded in the previous 6 months, but for 20% of patients, their enrollment FEV1 was their best FEV1 recorded within the previous 6 months. Physicians reported that their primary treatment objectives were lung function recovery (53%) and improvement of symptoms (47%) of PEx. Most physicians stated they would enroll patients in studies involving 10-day (72%) or 14-day (87%), but not 7-day (29%), treatment regimens. Conclusions Based on the results of this study, prospective studies are feasible and physician willingness for interventional studies of PEx exists. Results of this observational study will help design future PEx trials.

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Section: Discussionmentioning

confidence: 95%

Standardized Treatment of Pulmonary Exacerbations (STOP) study: Observations at the initiation of intravenous antibiotics for cystic fibrosis pulmonary exacerbations

Sanders

Solomon

Beckett

et al. 2017

Journal of Cystic Fibrosis

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“…However, the median time between consecutive PEx treatments was over 7 months, so it is unlikely that clinicians treated these as linked events. Additionally, in surveys, the majority of treating physicians view PEx treatment as a success, even when FEV 1 has not returned to previous baseline values . Moreover, we excluded PEx episodes when a second PEx occurred prior to the best FEV 1 in the 3 months after the chosen PEx to try and isolate the effects of a single PEx treatment.…”

Section: Discussionmentioning

confidence: 99%

Poor recovery from cystic fibrosis pulmonary exacerbations is associated with poor long‐term outcomes

Sanders

Zhao

et al. 2017

Pediatric Pulmonology

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Rationale People with CF treated with IV antibiotics for a pulmonary exacerbation (PEx) frequently fail to recover to baseline FEV1. The long-term impact of these events has not been studied. Objectives To determine if a patient’s spirometric recovery after a PEx is associated with time to next PEx within 1 year, the spirometric recovery after the next PEx, and/or the number of PEx episodes in the next 3 years. Methods We used data from the CF Foundation Patient Registry from 2004–2011. We randomly selected one PEx per patient that met inclusion/exclusion criteria. Patients were defined as Non-Responders if their best FEV1 (in liters) recorded in the 3 months after the PEx was <90% of the best FEV1 (in liters) in the 6 months before the PEx. We compared Responders and Non-Responders using multivariable regression models. Results We randomly chose 13,954 PEx episodes that met inclusion/exclusion criteria. 2,762 (19.8%) patients were classified as Non-Responders. Non-Responders had a shorter median time to the next PEx, 235 (95% CI 218, 252) days, versus >365 days for Responders. Thirty-four percent of Non-Responders at the initial PEx were also Non-Reponders at the next PEx, versus 20% of Responders at the initial PEx. Non-Responders had more PEx episodes over the next 3 years, 4.99 (95% CI 4.84, 5.13), than Responders, 3.46 (95% CI 3.41, 3.51). Conclusions Poor recovery after a PEx is associated with a shorter time to the next PEx, increased risk of poor recovery at a second PEx, and more frequent subsequent PEx treatments.

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“…Risk factors for failure to return to baseline for PEx treated with IV antibiotics include familiar demographic and disease characteristics (poor nutritional status, infection with P. aeruginosa , Burkholderia cepacia, or methicillin‐resistant S. aureus , female gender, Medicaid insurance status) but certain modifiable aspects of treatment are notable: length of prodromal symptoms prior to treatment, depth of drop in ppFEV1 from baseline to treatment initiation, and outpatient versus inpatient treatment of PEx . Nonetheless, great variation exists across CF care programs regarding triggers of treatment, site of treatment (inpatient vs outpatient), as well as duration of treatment, choice of antibiotics, and use of adjunctive therapies (Figure ) …”

Section: Treatment Of Pulmonary Exacerbationsmentioning

confidence: 99%

“…The STOP2 trial, currently underway to determine the optimal length of antibiotic treatment in adults with PEx, provides a good model of how to proceed in this endeavor and shows the feasibility of the approach . A number of questions still remain, regarding the use of oral versus IV antibiotics (and which ones, and what duration), inpatient versus outpatient care, and use of adjunctive therapies (steroids, hypertonic saline, aerosolized antibiotics) …”

Section: Unanswered Questions In the Diagnosis And Management Of Pulmmentioning

confidence: 99%

Reevaluating approaches to cystic fibrosis pulmonary exacerbations

Schechter

2018

Pediatric Pulmonology

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Cystic Fibrosis (CF) lung disease is characterized by intermittent acute episodes of worsening signs, symptoms, and pulmonary function; these so-called pulmonary exacerbations (PEx) appear to be important drivers of long-term declines in lung function, quality of life, and life expectancy. Surveillance for development of PEx and their treatment is a fundamental component of chronic CF management, and the merits of novel CF therapies are often judged based on their ability to reduce the frequency of PEx. Given the central role that they play, it is surprising how poorly PEx are understood, how thin is the evidence base for their treatment and how often they are left unrecognized and untreated in clinical practice. This paper reviews what is known and what is unknown regarding the nature of PEx, and discusses the impact of missed recognition and treatment of these episodes as well as the apparent variation in practice across CF care centers. The arguments supporting a liberal, highly sensitive approach to the diagnosis of PEx are presented, as well as recommendation for how care programs can achieve consistency in their early recognition and treatment. A stepwise approach to personalized treatment supported by close follow-up to ensure the successful resolution of all signs and symptoms will lead to the stabilization of patients' lung function and quality of life. Recommendations are made regarding important priorities for research into evidence-based approaches to improving the care of PEx.

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Standardized Treatment of Pulmonary Exacerbations (STOP) study: Physician treatment practices and outcomes for individuals with cystic fibrosis with pulmonary Exacerbations

Abstract: In this prospective observational study of PEx, treatment regimens and durations showed substantial variation. A significant proportion of patients did not reach physician's treatment goals, yet treatment was deemed successful.

Cited by 80 publications

References 23 publications

Standardized Treatment of Pulmonary Exacerbations (STOP) study: Observations at the initiation of intravenous antibiotics for cystic fibrosis pulmonary exacerbations

Standardized Treatment of Pulmonary Exacerbations (STOP) study: Observations at the initiation of intravenous antibiotics for cystic fibrosis pulmonary exacerbations

Poor recovery from cystic fibrosis pulmonary exacerbations is associated with poor long‐term outcomes

Reevaluating approaches to cystic fibrosis pulmonary exacerbations

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