Effect of smoking status on lung function, patient-reported outcomes, and safety among patients with COPD treated with indacaterol/glycopyrrolate: Pooled analysis of the FLIGHT1 and FLIGHT2 studies

Study Design: Longitudinal cohort. Objective: It is unclear if patients with a recurrent disc herniation benefit from a concurrent fusion compared with a repeat decompression alone. We compared outcomes of decompression alone (D0) versus decompression and fusion (DF) for recurrent disc herniation. Methods: Patients enrolled in the Quality and Outcomes Database from 3 sites with a first episode of recurrent disc herniation were identified. Demographic, surgical, and radiographic data including the presence of listhesis and extent of facet resection on computed tomography or magnetic resonance imaging prior to the index surgery were collected. Patient-reported outcomes were collected preoperatively and at 3 and 12 months postoperatively. Results: Of 94 cases identified, 55 had D0 and 39 had DF. Patients were similar in age, sex distribution, smoking status, body mass index, American Society of Anesthesiologists grade and surgical levels. Presence of listhesis (D0 = 7, DF = 5, P = .800) and extent of facet resection (D0 = 19%, DF = 16%, P = .309) prior to index surgery were similar between the 2 groups. Estimated blood loss (D0 = 26 cm3, DF = 329 cm3, P < .001), operating room time (D0 = 79 minutes, DF = 241 minutes, P < .001) and length of stay (D0 <1 day, DF = 4 days, P < .001) were significantly less in the D0 group. Preoperative and 1-year postoperative patient-reported outcomes were similar in both groups. Three patients in the D0 group and 2 patients in the DF group required revision. Regression analysis showed that presence of listhesis, extent of facet resection and fusion were not associated with the 12-month Oswestry Disability Index (ODI) score. Conclusion: For a first episode recurrent disc herniation, surgeons can expect similar outcomes whether patients are treated with decompression alone or decompression and fusion.

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Effect of Cigarette Smoking on Patient-Reported Outcomes in Hip Arthroscopic Surgery: A Matched-Pair Controlled Study With a Minimum 2-Year Follow-up

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967118822837 ◽

2019 ◽

Vol 7 (1) ◽

pp. 232596711882283 ◽

Cited By ~ 2

Author(s):

Ajay C. Lall ◽

Jon E. Hammarstedt ◽

Asheesh G. Gupta ◽

Joseph R. Laseter ◽

Mitchell R. Mohr ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Smoking Status ◽

Arthroscopic Surgery ◽

Matched Pair ◽

Harris Hip Score ◽

Controlled Study ◽

Control Group ◽

Patient Reported ◽

Smoking Group

Background: The rate of hip arthroscopic surgery has recently increased; however, there is limited literature examining patient-reported outcomes (PROs) in cigarette smokers. Purpose/Hypothesis: The purpose of this study was to evaluate whether smoking status for patients undergoing hip arthroscopic surgery affects clinical findings and PRO scores. We hypothesized that patients who smoke and undergo primary hip arthroscopic surgery will have similar clinical examination findings and preoperative and postoperative PRO scores compared with nonsmoking patients. Study Design: Cohort study; Level of evidence, 3. Methods: Data were collected on all patients who underwent primary hip arthroscopic surgery from February 2008 to July 2015. A retrospective analysis of the data was then conducted to identify patients who reported cigarette use at the time of the index procedure. Patients were matched 1:2 (smoking:nonsmoking) based on sex, age within 5 years, labral treatment (repair vs reconstruction vs debridement), workers’ compensation status, and body mass index within 5 kg/m2. All patients were assessed preoperatively and postoperatively using 4 PRO measures: the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score–Sport-Specific Subscale (HOS-SSS), and International Hip Outcome Tool–12 (iHOT-12). Pain was estimated using a visual analog scale. Satisfaction was measured on a scale from 0 to 10. Significance was set at P < .05. Results: A total of 75 hips were included in the smoking group, and 150 hips were included in the control group. Preoperatively, the smoking group had significantly lower PRO scores compared with the control group for the mHHS, NAHS, and HOS-SSS. Both groups demonstrated significant improvement from preoperative levels. A minimum 2-year follow-up was achieved, with a mean of 42.5 months for the smoking group and 47.6 months for the control group ( P = .07). At the latest follow-up, the smoking group reported inferior results for all outcome measures compared with controls. The improvement in PRO scores and rates of treatment failure, revision arthroscopic surgery, and complications was not statistically different between the groups. Conclusion: Patients who smoke had lower PRO scores preoperatively and at the latest follow-up compared with nonsmokers. Both groups demonstrated significant improvement in all PRO scores. These results show that while hip arthroscopic surgery may still yield clinical benefit in smokers, these patients may ultimately achieve an inferior functional status. To optimize results, physicians should advise patients to cease smoking before undergoing hip arthroscopic surgery.

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Clinically meaningful improvements with reslizumab in patient-reported outcomes and lung function in a sub-population defined by the EU indication with ≥3 exacerbations

10.1183/1393003.congress-2017.pa4687 ◽

2017 ◽

Author(s):

Leif Bjermer ◽

Margaret Garin ◽

Shawn X. Sun

Keyword(s):

Lung Function ◽

Patient Reported Outcomes ◽

Patient Reported ◽

The Eu

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Stratification of eosinophilic asthma patients treated with reslizumab and GINA Step 4 or 5 therapy

ERJ Open Research ◽

10.1183/23120541.00004-2017 ◽

2017 ◽

Vol 3 (3) ◽

pp. 00004-2017 ◽

Cited By ~ 11

Author(s):

Guy Brusselle ◽

Janice Canvin ◽

Sivan Weiss ◽

Shawn X. Sun ◽

Roland Buhl

Keyword(s):

Lung Function ◽

Patient Reported Outcomes ◽

Secondary Analysis ◽

Forced Expiratory Volume ◽

Phase Iii ◽

Eosinophilic Asthma ◽

Interleukin 5 ◽

Severe Eosinophilic Asthma ◽

Patient Reported ◽

Asthma Patients

Reslizumab, an anti-interleukin-5 monoclonal antibody, significantly reduces exacerbation frequency and improves lung function, asthma control and quality of life in adults with severe eosinophilic asthma, as demonstrated in Phase III studies.This secondary analysis assessed reslizumab's efficacy in patients receiving baseline treatment per Global Initiative for Asthma (GINA) Step 4 and Step 5 guidelines.Pooled data from duplicate, Phase III, reslizumab versus placebo studies in patients with severe eosinophilic asthma (blood eosinophils ≥400 cells·µL−1) were stratified by baseline therapy. Efficacy assessments were exacerbation rates and changes from baseline forced expiratory volume in 1 s (FEV1) and patient-reported outcomes.Of 953 patients, 69% (n=657) and 11% (n=106) were receiving Step 4 and Step 5 therapy, respectively. Compared with placebo, reslizumab reduced exacerbation rates by 53% (95% CI 0.36–0.62) and 72% (95% CI 0.15–0.52), in Step 4 and Step 5 groups respectively. By study end, reslizumab increased FEV1 in Step 4 and Step 5 groups by 103 mL (95% CI 52–154 mL) and 237 mL (95% CI 68–407 mL), respectively. Reslizumab also improved patient-reported outcomes compared with placebo in both groups.Reslizumab reduces exacerbation rates and improves lung function and patient-reported outcomes in patients with eosinophilic asthma receiving therapy per Steps 4 and 5 of the GINA guidelines.

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Toward Improving Patients’ Experiences of Acute Toxicity From Breast Radiotherapy: Insights From the Analysis of Patient-Reported Outcomes in a Large Multicenter Cohort

Journal of Clinical Oncology ◽

10.1200/jco.20.01703 ◽

2020 ◽

Vol 38 (34) ◽

pp. 4019-4029

Author(s):

Reshma Jagsi ◽

Kent A. Griffith ◽

Frank Vicini ◽

Thomas Boike ◽

Jacob Burmeister ◽

...

Keyword(s):

Supportive Care ◽

Patient Reported Outcomes ◽

Smoking Status ◽

Breast Volume ◽

Breast Pain ◽

Breast Radiotherapy ◽

Conventional Fractionation ◽

Younger Age ◽

Whole Breast Radiotherapy ◽

Patient Reported

PURPOSE Understanding acute toxicities after whole-breast radiotherapy is important to inform patients, guide treatment decisions, and target supportive care. We evaluated patient-reported outcomes prospectively collected from a cohort of patients with breast cancer. METHODS We describe the maximal toxicity reported by 8,711 patients treated between 2012 and 2019 at 27 practices. Multivariable models identified characteristics associated with (1) breast pain, (2) bother from itching, stinging/burning, swelling, or hurting of the treated breast, and (3) fatigue within 7 days of completing whole-breast radiotherapy. RESULTS Moderate or severe breast pain was reported by 3,233 (37.1%): 1,282 (28.9%) of those receiving hypofractionation and 1,951 (45.7%) of those receiving conventional fractionation. Frequent bother from at least one breast symptom was reported by 4,424 (50.8%): 1,833 (41.3%) after hypofractionation and 2,591 (60.7%) after conventional fractionation. Severe fatigue was reported by 2,008 (23.1%): 843 (19.0%) after hypofractionation and 1,165 (27.3%) after conventional fractionation. Among patients receiving hypofractionated radiotherapy, younger age ( P < .001), higher body mass index (BMI; P < .001), Black ( P < .001) or other race ( P = .002), smoking status ( P < .001), larger breast volume ( P = .002), lack of chemotherapy receipt ( P = .004), receipt of boost treatment ( P < .001), and treatment at a nonteaching center predicted breast pain. Among patients receiving conventionally fractionated radiotherapy, younger age ( P < .001), higher BMI ( P = .003), Black ( P < .001) or other race ( P = .002), diabetes ( P = .001), smoking status ( P < .001), and larger breast volume ( P < .001) predicted breast pain. CONCLUSION In this large observational data set, substantial differences existed according to radiotherapy dose fractionation. Race-related differences in pain existed despite controlling for multiple other factors; additional research is needed to understand what drives these differences to target potentially modifiable factors. Intensifying supportive care may be appropriate for subgroups identified as being vulnerable to greater toxicity.

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