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  • 1
    Online Resource
    Online Resource
    First International Congress of the Cell Transplant Society
    SAGE Publications ; 1992
    In:  Cell Transplantation Vol. 1, No. 1 ( 1992-01), p. 1-2
    Details
    In: Cell Transplantation, SAGE Publications, Vol. 1, No. 1 ( 1992-01), p. 1-2
    Type of Medium: Online Resource
    ISSN: 0963-6897 , 1555-3892
    URL: Article
    DOI: 10.1177/096368979200100101
    Language: English
    Publisher: SAGE Publications
    Publication Date: 1992
    detail.hit.zdb_id: 2020466-8
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  • 2
    Online Resource
    Online Resource
    Many Labs 2: Investigating Variation in Replicability Across Samples and Settings
    SAGE Publications ; 2018
    In:  Advances in Methods and Practices in Psychological Science Vol. 1, No. 4 ( 2018-12), p. 443-490
    Details
    In: Advances in Methods and Practices in Psychological Science, SAGE Publications, Vol. 1, No. 4 ( 2018-12), p. 443-490
    Abstract: We conducted preregistered replications of 28 classic and contemporary published findings, with protocols that were peer reviewed in advance, to examine variation in effect magnitudes across samples and settings. Each protocol was administered to approximately half of 125 samples that comprised 15,305 participants from 36 countries and territories. Using the conventional criterion of statistical significance ( p 〈 .05), we found that 15 (54%) of the replications provided evidence of a statistically significant effect in the same direction as the original finding. With a strict significance criterion ( p 〈 .0001), 14 (50%) of the replications still provided such evidence, a reflection of the extremely high-powered design. Seven (25%) of the replications yielded effect sizes larger than the original ones, and 21 (75%) yielded effect sizes smaller than the original ones. The median comparable Cohen’s ds were 0.60 for the original findings and 0.15 for the replications. The effect sizes were small ( 〈 0.20) in 16 of the replications (57%), and 9 effects (32%) were in the direction opposite the direction of the original effect. Across settings, the Q statistic indicated significant heterogeneity in 11 (39%) of the replication effects, and most of those were among the findings with the largest overall effect sizes; only 1 effect that was near zero in the aggregate showed significant heterogeneity according to this measure. Only 1 effect had a tau value greater than .20, an indication of moderate heterogeneity. Eight others had tau values near or slightly above .10, an indication of slight heterogeneity. Moderation tests indicated that very little heterogeneity was attributable to the order in which the tasks were performed or whether the tasks were administered in lab versus online. Exploratory comparisons revealed little heterogeneity between Western, educated, industrialized, rich, and democratic (WEIRD) cultures and less WEIRD cultures (i.e., cultures with relatively high and low WEIRDness scores, respectively). Cumulatively, variability in the observed effect sizes was attributable more to the effect being studied than to the sample or setting in which it was studied.
    Type of Medium: Online Resource
    ISSN: 2515-2459 , 2515-2467
    URL: Article
    DOI: 10.1177/2515245918810225
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 2904847-3
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  • 3
    Online Resource
    Online Resource
    Many Labs 5: Testing Pre-Data-Collection Peer Review as an Intervention to Increase Replicability
    SAGE Publications ; 2020
    In:  Advances in Methods and Practices in Psychological Science Vol. 3, No. 3 ( 2020-09), p. 309-331
    Details
    In: Advances in Methods and Practices in Psychological Science, SAGE Publications, Vol. 3, No. 3 ( 2020-09), p. 309-331
    Abstract: Replication studies in psychological science sometimes fail to reproduce prior findings. If these studies use methods that are unfaithful to the original study or ineffective in eliciting the phenomenon of interest, then a failure to replicate may be a failure of the protocol rather than a challenge to the original finding. Formal pre-data-collection peer review by experts may address shortcomings and increase replicability rates. We selected 10 replication studies from the Reproducibility Project: Psychology (RP:P; Open Science Collaboration, 2015) for which the original authors had expressed concerns about the replication designs before data collection; only one of these studies had yielded a statistically significant effect ( p 〈 .05). Commenters suggested that lack of adherence to expert review and low-powered tests were the reasons that most of these RP:P studies failed to replicate the original effects. We revised the replication protocols and received formal peer review prior to conducting new replication studies. We administered the RP:P and revised protocols in multiple laboratories (median number of laboratories per original study = 6.5, range = 3–9; median total sample = 1,279.5, range = 276–3,512) for high-powered tests of each original finding with both protocols. Overall, following the preregistered analysis plan, we found that the revised protocols produced effect sizes similar to those of the RP:P protocols (Δ r = .002 or .014, depending on analytic approach). The median effect size for the revised protocols ( r = .05) was similar to that of the RP:P protocols ( r = .04) and the original RP:P replications ( r = .11), and smaller than that of the original studies ( r = .37). Analysis of the cumulative evidence across the original studies and the corresponding three replication attempts provided very precise estimates of the 10 tested effects and indicated that their effect sizes (median r = .07, range = .00–.15) were 78% smaller, on average, than the original effect sizes (median r = .37, range = .19–.50).
    Type of Medium: Online Resource
    ISSN: 2515-2459 , 2515-2467
    URL: Article
    DOI: 10.1177/2515245920958687
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2904847-3
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  • 4
    Online Resource
    Online Resource
    Surgery for Pediatric Subglottic Stenosis: Disease-Specific Outcomes
    SAGE Publications ; 2001
    In:  Annals of Otology, Rhinology & Laryngology Vol. 110, No. 12 ( 2001-12), p. 1109-1113
    Details
    In: Annals of Otology, Rhinology & Laryngology, SAGE Publications, Vol. 110, No. 12 ( 2001-12), p. 1109-1113
    Abstract: To set the foundation to develop a disease-based, operation-specific model to predict the outcome of pediatric airway reconstruction surgery, we performed a retrospective database review of children operated on at a single, tertiary-care children's hospital. Over the 12-year period 1988 to 2000, a total of 1,296 airway reconstruction procedures were performed. Out of these, charts were identified for 199 children who underwent laryngotracheal reconstruction for a sole diagnosis of subglottic stenosis. Children were excluded from the study if their disorder included supraglottic, glottic, or upper tracheal disease. The main outcome measures were Myer-Cotton grade-specific decannulation and extubation rates, including both operation-specific and overall results. There were 101 children who underwent double-stage laryngotracheal reconstruction. The operation-specific decannulation rates for Myer-Cotton grades 2, 3, and 4 were 85% (18/21), 37% (23/61), and 50% (7/14) (χ 2 analysis, p =.0007). The overall decannulation rates were 95% (20/21), 74% (45/61), and 86% (12/14) (χ 2 analysis, p =.04). There were 98 children who underwent single-stage laryngotracheal reconstruction. The operation-specific extubation rates for Myer-Cotton grades 2, 3, and 4 were 82% (37/45), 79% (34/43), and 67% (2/3) (χ 2 analysis, p =.63). The overall extubation rates were 100% (45/45), 86% (37/43), and 100% (3/3) (χ 2 analysis, p =.03). Logistic regression analysis showed no effect of age (less than or greater than 2 years of age) on operation-specific or overall outcome parameters. We conclude that laryngotracheal reconstruction for pediatric subglottic stenosis remains a challenging set of procedures in which multiple operations may be required to achieve eventual extubation or decannulation. Children with Myer-Cotton grade 3 or 4 disease continue to represent a significant challenge, and refinements of techniques are being examined to address this subset of children. Disease-based, operation-specific outcome statistics are the first step in the development of a meaningful predictive model.
    Type of Medium: Online Resource
    ISSN: 0003-4894 , 1943-572X
    URL: Article
    DOI: 10.1177/000348940111001204
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2001
    detail.hit.zdb_id: 2033055-8
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  • 5
    Online Resource
    Online Resource
    Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint
    SAGE Publications ; 2018
    In:  Therapeutic Advances in Gastroenterology Vol. 11 ( 2018-01-01), p. 175628481877167-
    Details
    In: Therapeutic Advances in Gastroenterology, SAGE Publications, Vol. 11 ( 2018-01-01), p. 175628481877167-
    Abstract: Alosetron is approved to treat women with severe IBS and diarrhea (IBS-D) who have failed standard therapy. In our study, we aimed to evaluate alosetron efficacy using new US Food and Drug Administration (FDA) endpoints and utilization in clinical practice. Methods: This prospective, open-label, multicenter, observational 12-week study evaluated women with severe IBS-D enrolled in the alosetron prescribing program. The coprimary FDA endpoints were changes from baseline in stool consistency and abdominal pain severity. Responders achieved a 30% decrease compared with baseline in weekly average of the worst abdominal pain in the past 24 h, and a 50% or greater reduction from baseline in the number of days/week with at least one stool of type 6 (mushy) or type 7 (watery) consistency. Secondary endpoints included changes from baseline in stool frequency, fecal urgency and fecal incontinence. Results: Enrolled patients ( n = 192) were primarily White (90.6%), with a mean age of 44.5 years. Patient and physician rating of IBS severity was between moderate and severe (85.9% concordance, Spearman coefficient 0.429, p 〈 0.0001). Alosetron 0.5 mg twice daily (82.8%) was the most common dosing regimen. A total of 152 alosetron-treated patients completed the study. Of 105 fully evaluable patients, 45% met the FDA composite endpoint responder criteria for ⩾50% of the study period. Improvements in all individual symptoms were statistically significant compared with baseline. There were no serious adverse events, cases of colonic ischemia, or complications of constipation. Conclusion: In a clinical practice setting study, alosetron demonstrated treatment success using a rigorous FDA composite endpoint and also improved multiple other IBS symptoms, including fecal urgency and incontinence in women with severe IBS-D [ ClinicalTrials.gov identifier: NCT01257477].
    Type of Medium: Online Resource
    ISSN: 1756-2848 , 1756-2848
    URL: Article
    DOI: 10.1177/1756284818771674
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 2440710-0
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  • 6
    Online Resource
    Online Resource
    Impact of patient and disease characteristics on the efficacy and safety of eluxadoline for IBS-D: a subgroup analysis of phase III trials
    SAGE Publications ; 2019
    In:  Therapeutic Advances in Gastroenterology Vol. 12 ( 2019-01), p. 175628481984129-
    Details
    In: Therapeutic Advances in Gastroenterology, SAGE Publications, Vol. 12 ( 2019-01), p. 175628481984129-
    Abstract: Irritable bowel syndrome with diarrhea (IBS-D) is a prevalent gastrointestinal (GI) disorder with a varied presentation, often overlapping with other GI and non-GI disorders. Eluxadoline is a locally active mixed µ- and κ-opioid receptor agonist and δ-opioid receptor antagonist approved for the treatment of IBS-D in adults. As IBS-D is a heterogeneous disease, factors such as patient demographics, symptom severity, and symptom pattern history can potentially inform treatment selection. Methods: Here, we report additional prospectively planned analyses of two large double-blind, placebo-controlled studies (IBS-3001 and IBS-3002) enrolling patients meeting Rome III criteria for IBS-D. Patients were randomized 1:1:1 to receive placebo or eluxadoline 75 mg or 100 mg twice daily. Efficacy (abdominal pain, stool consistency, and composite, simultaneous improvement in both) and safety were assessed for prospectively defined patient subgroups stratified by age, sex, race, presence of comorbidities, and baseline disease characteristics. Results: Across all age, sex, race, comorbidity, and disease characteristic subgroups, a greater proportion of patients were composite responders with both eluxadoline doses as compared with placebo, including patients with a history of depression or a history of gastroesophageal reflux disease. Among patients aged ⩾65 years, a greater proportion of patients receiving eluxadoline 75 mg were composite, abdominal pain, and stool consistency responders compared with those receiving 100 mg. The proportion of patients with at least one adverse event was slightly higher in patients aged ⩾65 years and also in female patients. Conclusions: This analysis suggests that eluxadoline is effective in treating IBS-D across a range of commonly encountered patient types. In contrast to the overall population, patients aged ⩾65 years demonstrated a greater proportion of responders at the lower approved 75 mg eluxadoline dose.
    Type of Medium: Online Resource
    ISSN: 1756-2848 , 1756-2848
    URL: Article
    DOI: 10.1177/1756284819841290
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2440710-0
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