Publications by authors named "Farina Klocksieben"

11 Publications

  • Page 1 of 1

Association of pharmacist counseling with adherence, 30-day readmission, and mortality: A systematic review and meta-analysis of randomized trials.

J Am Pharm Assoc (2003) 2021 Mar 4. Epub 2021 Mar 4.

Objective(s): To determine the association of pharmacist medication counseling with medication adherence, 30-day hospital readmission, and mortality.

Methods: The initial search identified 21,590 citations. After applying the inclusion and exclusion criteria, 62 randomized controlled trials (RCTs) (49 for the meta-analysis) were included in the final analysis. Data were pooled using a random-effects model.

Results: The participants in most of the studies were older patients with chronic diseases who, therefore, were taking many drugs. The overall methodologic quality of evidence ranged from low to very low. Pharmacist medication counseling versus no such counseling was associated with a statistically significant 30% increase in relative risk (RR) for medication adherence, a 24% RR reduction in 30-day hospital readmission (number needed to treat = 4.2), and a 30% RR reduction in emergency department visits. RR reductions for primary care visits and mortality were not statistically significant.

Conclusion: The evidence supports pharmacist medication counseling to increase medication adherence and to reduce 30-day hospital readmissions and emergency department visits. However, higher-quality RCT studies are needed to confirm or refute these findings.
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March 2021

A prospective, head-to-head comparison of 2 EUS-guided liver biopsy needles in vivo.

Gastrointest Endosc 2021 May 9;93(5):1133-1138. Epub 2020 Oct 9.

Department of Gastroenterology, Lehigh Valley Health Network, Allentown, Pennsylvania, USA.

Background And Aims: Procedural standardization in endoscopic ultrasound-guided liver biopsy (EUS-LB) is necessary to obtain core biopsy specimens for accurate diagnosis. The objective of this study was to directly compare the diagnostic yield of 2 EUS-LB fine-needle biopsy (FNB) systems in vivo.

Methods: In this prospective, single-center study, 108 adult patients undergoing EUS-LB over a 1-year period were included. Each EUS-LB consisted of an EGD, followed by EUS-guided biopsy of the left lobe of the liver sequentially using 2 different 19-gauge needles: the fork-tip (SharkCore) and Franseen (Acquire) FNB systems. Specimens were then reviewed by a GI histopathologist to determine diagnostic adequacy as well as the number of complete portal tracts, specimen length, and degree of fragmentation.

Results: In 79.4% of cases, the fork-tip FNB system yielded a final diagnosis compared with 97.2% of the Franseen FNB specimens (P < .001). The mean number of complete portal tracts in the fork-tip FNB samples was 7.07 compared with 9.59 in the Franseen FNB samples (P < .001). The mean specimen length was 13.86 mm for the fork-tip FNB and 15.81 mm for the Franseen FNB (P = .004). Cores were intact in 47.6% of the fork-tip FNB samples and in 75.2% of the Franseen FNB samples (P = .004).

Conclusions: In EUS-LB, we found that the 19-gauge Franseen FNB system resulted in a statistically significant increase in diagnostic adequacy compared with biopsy using the fork-tip FNB system.
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May 2021

Unmet Rehabilitation Needs Indirectly Influence Life Satisfaction 5 Years After Traumatic Brain Injury: A Veterans Affairs TBI Model Systems Study.

Arch Phys Med Rehabil 2021 01 16;102(1):58-67. Epub 2020 Sep 16.

Mental Health & Behavioral Sciences Section (MHBSS), James A. Haley Veterans' Hospital, Tampa, Florida; Defense and Veterans Brain Injury Center (DVBIC), James A. Haley Veterans' Hospital, Tampa, Florida; Department of Internal Medicine, University of South Florida, Tampa, Florida.

Objective: To describe the association between unmet rehabilitation needs and life satisfaction 5 years after traumatic brain injury (TBI).

Design: Prospective observational cohort.

Setting: Five Veterans Affairs (VA) Polytrauma Rehabilitation Centers.

Participants: VA TBI Model Systems participants (N=301); 95% male; 77% white; average age, 39±14y).

Interventions: Not applicable.

Main Outcome Measures: Satisfaction With Life Scale (SWLS).

Results: Average SWLS score was 22±8. Univariable analyses demonstrated several statistically significant predictors of life satisfaction, including employment status, participation, psychiatric symptom severity, past year mental health treatment, and total number of unmet rehabilitation needs (all P<.05). Multivariable analyses revealed that depression and participation were each associated with life satisfaction. An ad hoc mediation model suggested that unmet rehabilitation needs total was indirectly related to life satisfaction. Total unmet rehabilitation needs ranged from 0-21 (mean, 2.0±3.4). Correlational analyses showed that 14 of the 21 unmet rehabilitation needs were associated with life satisfaction.

Conclusions: Findings support the need for rehabilitation engagement in later stages of TBI recovery. Ongoing assessment of and intervention for unmet rehabilitation needs in the chronic phase of recovery have the potential to mitigate decline in life satisfaction.
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January 2021

Clinical factors associated with the development of postoperative atrial fibrillation in esophageal cancer patients receiving multimodality therapy before surgery.

J Gastrointest Oncol 2020 Feb;11(1):68-75

Department of GI Oncology, Moffitt Cancer Center, Tampa, FL, USA.

Background: The incidence of esophageal cancer (EC) is increasing in the USA. Neoadjuvant therapy for locally advanced cancers followed by surgical resection is the standard of care. The most common post-esophagectomy cardiac complication is atrial fibrillation (AF). New-onset postoperative AF can require a prolonged hospital stay and may confer an overall poorer prognosis. In this study, we seek to identify clinical factors associated with postoperative AF.

Methods: Query of an IRB approved database of 1,039 esophagectomies at our institution revealed 677 patients with EC from 1999 to 2017 who underwent esophagectomy after neoadjuvant treatment. Age, treatment location (primary other), gender, neoadjuvant radiation type [2D 3D intensity modulated radiation therapy (IMRT)], radiation dose, surgery type (transthoracic transhiatal three field), smoking history, coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), operative time, blood transfusions, fluid management, and length of stay (LOS) were analyzed in relationship to the development of AF. Statistical analysis was performed with SPSS 24.

Results: The mean age of the entire cohort was 64.3 (range, 28-86 years), with a Caucasian and male preponderance (White: 94.5%; male: 83.6%). Of the 677 patients, 14.9% (n=101) developed postoperative AF. Increasing age (P<0.001), increased radiation dose (P=0.034), operative time (P=0.001), and blood transfusions (P=0.027) were associated with AF. LOS was longer in patients with AF than those without AF (10.5 10.0 days, P=0.001). On multivariate analysis, increasing age (95% CI: 1.023-1.080, P<0.001) and radiation dose (95% CI: 1.000-1.001, P=0.034) remained significant. None of the other parameters assessed were associated with the development of AF.

Conclusions: Increasing age and radiation dose were associated with the development of postoperative AF in this cohort. This study suggests that older patients or patients receiving higher radiation dose should be monitored more closely in the postoperative setting and potentially referred earlier preoperatively for cardio-oncology assessment. Future study is required to determine if modification of current radiation techniques and cardiac dose constraints in this patient population may be warranted.
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February 2020

Clinical Factors and Outcomes of Octogenarians Receiving Curative Surgery for Esophageal Cancer.

J Surg Res 2020 07 28;251:100-106. Epub 2020 Feb 28.

Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, Florida. Electronic address:

Background: The incidence of esophageal cancer is increasing in the United States. Although neoadjuvant therapy (NAT) for locally advanced cancers followed by surgical resection is the standard of care, there are no clearly defined guidelines for patients aged ≥79 y.

Methods: Query of an institutional review board-approved database of 1031 esophagectomies at our institution revealed 35 patients aged ≥79 y from 1999 to 2017 who underwent esophagectomy. Age, gender, tumor location, histology, clinical stage, Charlson Comorbidity Index (CCI), NAT administration, pathologic response rate to NAT, surgery type, negative margin resection status, postoperative complications, postoperative death, length of stay, 30- and 90-d mortality, and disease status parameters were analyzed in association with clinical outcome.

Results: The median age of the octogenarian cohort was 82.1 y with a male preponderance (91.4%). American Joint Committee on Cancer clinical staging was stage I for 20% of patients, stage II for 27% of patients, and stage III for 50% of patients, which was not statistically significant compared with the younger cohort (P = 0.576). Within the octogenarian group, 54% received NAT compared with 67% in the younger group (P = 0.098). There was no difference in postoperative complications (P = 0.424), postoperative death (P = 0.312), and recurrence rate (P = 0.434) between the groups. However, CCI was significantly different between the octogenarian and nonoctogenarian cohort (P = 0.008), and octogenarians had shorter overall survival (18 versus 62 mo, P<0.001). None of the other parameters assessed were associated with clinical outcomes.

Conclusions: Curative surgery is viable and safe for octogenarians with esophageal cancer. Long-term survival was significantly shorter in the octogenarian group, suggesting the need for better clinical selection criteria for esophagectomy after chemoradiation and that identification of complete responders for nonoperative management is warranted.
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July 2020

Corrigendum to 'Efficacy of allogeneic HCT in HTLV-1 associated adult T-cell leukemia/lymphoma: results of a systematic review/meta-analysis' [Biology of Blood and Marrow Transplantation 25/8 (2019) 1695-1700].

Biol Blood Marrow Transplant 2020 Jan 11;26(1):209-212. Epub 2019 Oct 11.

Division of Hematology-Oncology and Blood and Marrow Transplantation Program, Mayo Clinic, Jacksonville, Florida. Electronic address:

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January 2020

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.

JAMA Netw Open 2019 09 4;2(9):e1911111. Epub 2019 Sep 4.

Department of Supportive Care Medicine, City of Hope, Duarte, California.

Importance: The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.

Objectives: To determine how often the FDA has authorized novel interventions based on non-RCTs and to assess whether there is an association of the magnitude of treatment effects with FDA requirements for additional testing in randomized clinical trials (RCTs).

Data Sources: Overall, 606 drug applications for the Breakthrough Therapy designation from its inception in January 2012 were downloaded from the FDA website in January 2017 and August 2018, and 71 medical device applications for the Humanitarian Device Exemption from its inception in June 1996 were downloaded in August 2017.

Study Selection: Approved applications based on non-RCTs were included; RCTs, studies with insufficient information, duplicates, and safety data were excluded.

Data Extraction And Synthesis: Data were extracted by 2 independent investigators. A statistical association of the magnitude of estimated effect (expressed as an odds ratio) with FDA requests for RCTs was assessed. The data were also meta-analyzed to evaluate the differences in odds ratios between applications that required further testing and those that did not. The results are reported according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.

Main Outcomes And Measures: Disease, laboratory, and patient-related outcomes, including disease response or patient survival, were considered.

Results: Among 677 drug and medical device applications, 68 (10.0%) were approved by the FDA based on non-RCTs. Estimates of effects were larger when no further RCTs were required (mean natural logarithm of the odds ratios, 2.18 vs 1.12; odds ratios, 8.85 vs 3.06; P = .03). The meta-analysis results confirmed these findings: estimated effects were approximately 2.5-fold higher for treatments or devices that were approved based on non-RCTs than for treatments or devices for which further testing in RCTs was required (6.30 [95% CI, 4.38-9.06] vs 2.46 [95% CI, 1.70-3.56]; P < .001). Overall, 9 of 677 total applications (1.3%) that were approved on the basis of non-RCTs had relative risks of 10 or greater and 12 (1.7%) had relative risks of 5 or greater. No clear threshold above which the FDA approved interventions based on the magnitude of estimated effect alone was detected.

Conclusions And Relevance: In this study, estimated magnitudes of effect were larger among studies for which the FDA did not require RCTs compared with studies for which it did. There was no clear threshold of treatment effect above which no RCTs were requested.
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September 2019

Efficacy of Allogeneic Hematopoietic Cell Transplantation in Human T Cell Lymphotropic Virus Type 1-Associated Adult T Cell Leukemia/Lymphoma: Results of a Systematic Review/Meta-Analysis.

Biol Blood Marrow Transplant 2019 08 25;25(8):1695-1700. Epub 2019 May 25.

Division of Hematology-Oncology and Blood and Marrow Transplantation Program, Mayo Clinic, Jacksonville, Florida. Electronic address:

Human T cell lymphotropic virus type 1 (HTLV1)-associated adult T cell leukemia/lymphoma (ATLL) is an aggressive malignant disorder. Intensive conventional chemotherapy regimens and autologous hematopoietic cell transplantation (HCT) have failed to improve outcomes in ATLL. Allogeneic HCT (allo-HCT) is commonly offered as front-line consolidation despite lack of randomized controlled trials. We performed a comprehensive search of the medical literature using PubMed/Medline, EMBASE, and Cochrane reviews on September 10, 2018. We extracted data on clinical outcomes related to benefits (complete response [CR], overall survival [OS], and progression-free survival [PFS]) and harms (relapse and nonrelapse mortality [NRM]), independently by 2 authors. Our search strategy identified a total of 801 references. Nineteen studies (n = 2446 patients) were included in the systematic review; however, only 18 studies (n = 1767 patients) were included in the meta-analysis. Reduced intensity conditioning regimens were more commonly prescribed (52%). Bone marrow (50%) and peripheral blood (40%) were more frequently used as stem cell source. The pooled post-allografting CR, OS, and PFS rates were 73% (95% confidence interval [CI], 57% to 87%), 40% (95% CI, 33% to 46%), and 37% (95% CI, 27% to 48%), respectively. Pooled relapse and NRM rates were 36% (95% CI, 28% to 43%) and 29% (95% CI, 21% to 37%), respectively. The heterogeneity among the included studies was generally high. These results support the use of allo-HCT as an effective treatment for patients with ATLL, yielding pooled OS rates of 40%, but relapse still occurs in over one-third of cases. Future studies should evaluate strategies to help reduce relapse in patients with ATLL undergoing allo-HCT.
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August 2019

Larger effect sizes in nonrandomized studies are associated with higher rates of EMA licensing approval.

J Clin Epidemiol 2018 06 10;98:24-32. Epub 2018 Feb 10.

James Lind Initiative, Summertown Pavilion, Middle Way, Oxford OX2 7LG, UK.

Objectives: The aim of this study was to evaluate how often the European Medicines Agency (EMA) has authorized drugs based on nonrandomized studies and whether there is an association between treatment effects and EMA preference for further testing in randomized clinical trials (RCTs).

Study Design And Setting: We reviewed all initial marketing authorizations in the EMA database on human medicines between 1995 and 2015 and included authorizations granted without randomized data. We extracted data on treatment effects and EMA preference for further testing in RCTs.

Results: Of 723 drugs, 51 were authorized based on nonrandomized data. These 51 drugs were licensed for 71 indications. In the 51 drug-indication pairs with no preference for further RCT testing, effect estimates were large [odds ratio (OR): 12.0 (95% confidence interval {CI}: 8.1-17.9)] compared to effect estimates in the 20 drug-indication pairs for which future RCTs were preferred [OR: 4.3 (95% CI 2.8-6.6)], with a significant difference between effects (P = 0.0005).

Conclusion: Nonrandomized data were used for 7% of EMA drug approvals. Larger effect sizes were associated with greater likelihood of approval based on nonrandomized data alone. We did not find a clear treatment effect threshold for drug approval without RCT evidence.
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June 2018

Treatment targeted at underlying disease versus palliative care in terminally ill patients: a systematic review.

BMJ Open 2017 01 6;7(1):e014661. Epub 2017 Jan 6.

Comparative Effectiveness Research, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.

Objective: To assess the efficacy of active treatment targeted at underlying disease (TTD)/potentially curative treatments versus palliative care (PC) in improving overall survival (OS) in terminally ill patients.

Design: We performed a systematic review and meta-analysis of randomised controlled trials (RCT). Methodological quality of included RCTs was assessed using the Cochrane risk of bias tool.

Data Sources: Medline and Cochrane databases were searched, with no language restriction, from inception to 19 October 2016.

Eligibility Criteria For Selecting Studies: Any RCT assessing the efficacy of any active TTD versus PC in adult patients with terminal illness with a prognosis of <6-month survival were eligible for inclusion.

Results: Initial search identified 8252 citations of which 10 RCTs (15 comparisons, 1549 patients) met inclusion criteria. All RCTs included patients with cancer. OS was reported in 7 RCTs (8 comparisons, 1158 patients). The pooled results showed no statistically significant difference in OS between TTD and PC (HR (95% CI) 0.85 (0.71 to 1.02)). The heterogeneity between pooled studies was high (I=62.1%). Overall rates of adverse events were higher in the TTD arm.

Conclusions: Our systematic review of available RCTs in patients with terminal illness due to cancer shows that TTD compared with PC did not demonstrably impact OS and is associated with increased toxicity. The results provide assurance to physicians, patients and family that the patients' survival will not be compromised by referral to hospice with focus on PC.
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January 2017