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Robert S Epstein,1 Upal K Basu Roy,2 Matti Aapro,3 Tehseen Salimi,4 Donald Moran,4 JoAnn Krenitsky,1 Megan L Leone-Perkins,5 Cynthia Girman,6 Courtney Schlusser,7 Jeffrey Crawford8 1Epstein Health, LLC., Woodcliff Lake, NJ, USA; 2LUNGevity Foundation, Bethesda, MD, USA; 3Clinique De Genolier, Genolier, Switzerland; 4G1 Therapeutics Ltd., Research Triangle Park, NC, USA; 5HealthiVibe, a Division of Corrona, LLC., Arlington, VA, USA; 6Chapel Hill Consulting, LLC., Chapel Hill, NC, USA; 7UNC Gillings School of Global Public Health, Chapel Hill, NC, USA; 8Duke University Medical Center, Durham, NC, USACorrespondence: Robert S EpsteinEpstein Health, LLC., Woodcliff Lake, NJ, 07677, USATel +1 201-285-5800Email repstein@epsteinhealth.comPurpose: To evaluate which side effects of chemotherapy are considered most burdensome by patients with cancer, identify which health care professionals pay most attention to symptoms associated with chemotherapy-induced myelosuppression (CIM) from the patient perspective, and capture the “patient voice” describing how CIM impacts their daily lives.Participants and Methods: Online survey of participants with breast, lung, or colorectal cancer who had received chemotherapy within the past 12 months and experienced ≥ 1 episode of CIM in the past year. Participants were asked to answer close-ended questions and provide qualitative responses to: “In your own words, please describe how side effects from myelosuppression have impacted your life.”Results: Among 301 survey participants, fatigue was the most frequently reported side effect of chemotherapy; 55% of participants rated fatigue as highly bothersome (9 or 10 on a 1– 10 scale of “bothersomeness”). Participants rated symptoms associated with CIM, including fatigue, weakened immune system (infections), bleeding and/or bruising, and shortness of breath, as being as bothersome as other side effects of chemotherapy, including alopecia, neuropathy, and nausea/vomiting. Overall, 24– 43% of participants thought that CIM and its symptoms had a negative impact on their daily lives, including their ability to complete tasks at home and work, and to socialize. Qualitative responses supported these findings; participants highlighted that CIM-related symptoms, particularly fatigue and fear of infections, affected their ability to be physically active, complete work, or continue meaningful relationships with friends and family.Conclusion: Participants described a real-world impact of CIM that often isolates them from family and friends, and means that they are unable to work or perform tasks of daily living. Using measures that help patients to recognize and communicate the signs and symptoms of CIM might increase the likelihood of maintaining daily lives as close to normal as possible, during and after chemotherapy treatment.Keywords: cancer, chemotherapy, myelosuppression, real world, quality of life, patient burden

Background and Objective: Spiritual self-care is defined as a set of exercises based on spirituality to promote healing in times of sickness and health. Patients' perception of the role of spiritual self-care can lead to chronic disease management. Life expectancy is an important criterion to reflect the mortality impact on longevity and disease in a population. Studies have shown that patients' need to spirituality is important in the presence of lifethreatening diseases; accordingly, the present study aimed to investigate the effect of spiritual self-care group therapy on life expectancy in patients with coronary artery disease (CAD). Materials and Methods: This study is an educational trial which was conducted on 111 patients with CAD, discharged from the intensive care unit of Ali-Ibn-Abitalib hospital in Rafsanjan in 2015. Samples were randomly allocated to two groups including an intervention and a control group. Spirituality workshop sessions (three sessions of one and a half hours one day per week) were administered for intervention group. Miller's life expectancy questionnaire was completed by both groups before and after study. Data were analyzed using independent t test, paired t test, and chi-square test. Results: The results showed that the mean life expectancy a week after the intervention was significantly higher in the intervention group compared to the control group (176.76 +43.38 vs. 159.50+41.87, p=0.035). Moreover, mean score of life expectancy (after intervention) had significantly increased in the intervention group compared to before intervention (the mean and standard deviationof changes were 13.35±14.07, p<0.001). Conclusion: Given the positive effect of spiritual self-care on patients life expectancy in the present study, nurses are recommended to pay attention to spiritual dimensions of patients and include it in their routine care. [ABSTRACT FROM AUTHOR]

Introduction: The gap between what is taught in the classroom and at the bedside to provide services is a major problem in training of nursing and midwifery students. This study aims to investigate the views of nursing and midwifery personnel in relation to the clinical application of nursing and midwifery courses. Methods: This cross-sectional study investigated all nursing and midwifery staff employed by the government hospital in Yazd city with work experience of 6 months to 5 years. The data collection tools was a questionnaire consisted of two parts; demographics data and viewpoints of clinical application of training courses. Results: Principles and skills of nursing (97.0 ± 95.3), intensive care nursing (1.05 ± 3.80), medical and surgical nursing 3 and 4 gained the highest score and community health gained the lowest score. The highest mean scores in midwifery were related to obstetrics and maternal and child nutrition and Anesthetics gained the lowest score Conclusions: Coordination between theoretical learning and clinical nursing and midwifery services should be improved. Decision makers should consider these findings to improve the quality of low score courses. [ABSTRACT FROM AUTHOR]

Background: Hypomethylating agents (HMAs) are guideline-recommended treatment for higher-risk myelodysplastic syndromes/neoplasms (MDS). However, a prior survey of patients with MDS reported challenges with intravenous (IV) and subcutaneous (SC) HMA therapies, including pain related to treatment administration and interference with daily activities; most patients also indicated a preference to switch to an oral therapy if one were available., Objectives: This study evaluated the perspectives of US patients with MDS receiving oral decitabine/cedazuridine (DEC-C), an alternative to IV/SC HMAs., Methods: An online survey was conducted among adult patients with MDS in the United States (10 November 2022 to 5 December 2022) who had filled a prescription for oral DEC-C between 2021 and 2022., Results: A total of 150 patients completed the survey; 61% were aged ⩾60 years and 63% were male. Of these, 123 (82%) were still receiving oral DEC-C, and 27 (18%) had stopped oral DEC-C treatment. Half (50%) of patients had received oral DEC-C for ⩾6 months. The majority reported that treatment was convenient (83%) and that they were satisfied with treatment (86%). Most patients also reported very little/no interference with regular daily activities (82%), social activities (78%), and productivity (78%). When queried about negative impacts on quality of life (QOL), treatment side effects were the most commonly reported (30% of respondents). Among patients who had previously received IV/SC HMAs ( n  = 91), most agreed that oral DEC-C interfered less with daily life (91%) and had experienced improvement in QOL (85%) compared with previous treatment; 91% reported that oral DEC-C reduced the number of times they needed to travel to a healthcare facility., Conclusion: Survey results suggest very little/no impact on regular daily activities and improved QOL with oral DEC-C relative to IV/SC HMAs, highlighting the potential for oral DEC-C to reduce the treatment burden associated with parenteral HMA therapy., Competing Interests: AMZ is a Leukemia and Lymphoma Society scholar in clinical research. AMZ has received research funding (institutional) from Celgene/BMS, Abbvie, Astex, Pfizer, Kura, Medimmune/AstraZeneca, Boehringer-Ingelheim, Incyte, Takeda, Novartis, Shattuck Labs, Geron, Foran, and Aprea; has participated in advisory boards, and/or had a consultancy with and received honoraria from AbbVie, Pfizer, Celgene/BMS, Jazz, Incyte, Agios, Servier, Boehringer-Ingelheim, Novartis, Astellas, Daiichi Sankyo, Geron, Taiho, Seattle Genetics, Otsuka, BeyondSpring, Takeda, Ionis, Amgen, Janssen, Genentech, Epizyme, Syndax, Gilead, Kura, Chiesi, ALX Oncology, BioCryst, Notable, Orum, Mendus, Zentalis, Schrodinger, Regeneron, Syros, and Tyme; and has served on clinical trial committees for Novartis, Gilead, Syros, BioCryst, Abbvie, ALX Oncology, Kura, Geron, and Celgene/BMS. KP is an employee of CorEvitas LLC, paid consultants to Taiho Oncology, Inc. TS and TW are employees of Taiho Oncology, Inc. RSE is an employee of Epstein Health; holds leadership positions in Illumina, Veracyte, Fate Therapeutics, Tasso, and Diadem; and has received consulting fees and/or equity from TriAxia Health, Health Rhythms, Tasso, Avalon Healthcare, Halozyme, Merck, Janssen, Radius Health, G1 Therapeutics, and Taiho Oncology, Inc., (© The Author(s), 2024.)

During the cryopreservation of sperm, the production of highly reactive oxygen species (ROS) can reduce their viability and fertility. However, the addition of antioxidants can help reduce the harmful effects of ROS. One such antioxidant is selenium, which is a co-factor of the glutathione peroxidase enzyme that is effective in scavenging ROS. Cysteamine can also take part in the structure of this enzyme. The use of nanoparticles can be less toxic to cells than their salt form. To this end, researchers synthesized Se-NPs using the streptococcus bacteria and loaded cysteamine onto the synthesized Se-NPs. The biosynthesis of Se-NPs and cysteamine loaded on Se-NPs was confirmed by UV-visible spectroscopy, X-ray diffraction (EDX), Fourier transforms infrared (FTIR) spectroscopy, and Field Emission Scanning Electron Microscope (FE-SEM). For cryopreservation, ram semen samples were diluted, and different concentrations (0, 1, 5, 25, and 125 µg/mL) of cysteamine, Se-NPs, cysteamine loaded on Se-NPs, and sodium selenite were added. An extender containing no supplement was considered as control group. After cooling the semen samples, they were frozen and stored in liquid nitrogen for evaluation. The samples were thawed and analyzed for mobility, viability, membrane and DNA integrity, and sperm abnormalities, as well as malondialdehyde level (MDA) and superoxide dismutase (SOD). The data was processed using SPSS, and a significance level of p < 0.05 was considered. The results of this experiment showed that adding 1 μg/mL of cysteamine loaded on Se-NPs to the diluent significantly increased the motility, viability, and membrane integrity and SOD of spermatozoa compared to the other treatment groups and control group, and reduced the abnormality, apoptosis, and MDA level of spermatozoa in comparison with the other treatment groups and control group (p < 0.05). In conclusion, the addition of cysteamine loaded on Se-NPs was found to improve the quality of ram sperm after cryopreservation., (© 2024. The Author(s).)

Background: Pseudotumor cerebri is a serious obesity-related disorder that can result in severe complications. The aim of this study was to compare metabolic surgery with medical management of pseudotumor cerebri at a single bariatric center., Methods: After institutional review board approval, a retrospective review was conducted of individuals with severe obesity and pseudotumor cerebri (nonbariatric group) and patients with preoperative pseudotumor cerebri (bariatric group). The variables included demographic characteristics, comorbidities, and pseudotumor cerebri-related risk factors. Symptoms, medication use, and body mass index were analyzed during a 4-year follow-up., Results: A total of 86 patients with pseudotumor cerebri were included in the analysis. In the nonbariatric group (n = 77), the mean age was 34.1 ± 10.5 years and initial body mass index 37.2 ± 6.5 kg/m 2 . Initially, the most common symptom was headache (90.9%; n = 70), with a mean lumbar opening pressure of 341.94 ± 104.50 mm H 2 O. In the bariatric group (n = 9), the mean age was 36.1 ± 8.9 years and preoperative body mass index 46.1 ± 5.5 kg/m 2 . The most common preoperative symptom was headache (100%; n = 9), with a lumbar opening pressure of 320 ± 44.27 mm H 2 O. During the 4-year follow-up, both groups presented with a significant decrease in pseudotumor cerebri-related symptoms at 3 months (P < .0001). Additionally, pseudotumor cerebri medication use significantly decreased after 3 months in the bariatric group (P = .0406), whereas in the nonbariatric group decreased at 18 months (P = .023). Bariatric patients presented with a significant decrease in body mass index in ≤3 months of surgery (P = .0380), which was not observed in nonbariatric patients (P = .6644)., Conclusion: Metabolic surgery seems to provide a greater decrease in pseudotumor cerebri symptoms and medication use in a shorter period of time compared with medical management alone., (Copyright © 2022. Published by Elsevier Inc.)

Background: Alterations in fibroblast growth factor receptor 2 ( FGFR2 ) have emerged as promising drug targets for intrahepatic cholangiocarcinoma, a rare cancer with a poor prognosis. Futibatinib, a next-generation, covalently binding FGFR1-4 inhibitor, has been shown to have both antitumor activity in patients with FGFR -altered tumors and strong preclinical activity against acquired resistance mutations associated with ATP-competitive FGFR inhibitors., Methods: In this multinational, open-label, single-group, phase 2 study, we enrolled patients with unresectable or metastatic FGFR2 fusion-positive or FGFR2 rearrangement-positive intrahepatic cholangiocarcinoma and disease progression after one or more previous lines of systemic therapy (excluding FGFR inhibitors). The patients received oral futibatinib at a dose of 20 mg once daily in a continuous regimen. The primary end point was objective response (partial or complete response), as assessed by independent central review. Secondary end points included the response duration, progression-free and overall survival, safety, and patient-reported outcomes., Results: Between April 16, 2018, and November 29, 2019, a total of 103 patients were enrolled and received futibatinib. A total of 43 of 103 patients (42%; 95% confidence interval, 32 to 52) had a response, and the median duration of response was 9.7 months. Responses were consistent across patient subgroups, including patients with heavily pretreated disease, older adults, and patients who had co-occurring TP53 mutations. At a median follow-up of 17.1 months, the median progression-free survival was 9.0 months and overall survival was 21.7 months. Common treatment-related grade 3 adverse events were hyperphosphatemia (in 30% of the patients), an increased aspartate aminotransferase level (in 7%), stomatitis (in 6%), and fatigue (in 6%). Treatment-related adverse events led to permanent discontinuation of futibatinib in 2% of the patients. No treatment-related deaths occurred. Quality of life was maintained throughout treatment., Conclusions: In previously treated patients with FGFR2 fusion or rearrangement-positive intrahepatic cholangiocarcinoma, the use of futibatinib, a covalent FGFR inhibitor, led to measurable clinical benefit. (Funded by Taiho Oncology and Taiho Pharmaceutical; FOENIX-CCA2 ClinicalTrials.gov number, NCT02052778.)., (Copyright © 2023 Massachusetts Medical Society.)

Background: Previous analyses using the SEER-Medicare database have reported substantial underutilization of hypomethylating agents (HMAs) among patients with higher-risk myelodysplastic syndromes (MDS), and an association between poor HMA persistence and high economic burden. We aimed to compare rates of hospitalizations and emergency room (ER) visits among patients with higher-risk MDS according to use or non-use of HMA therapy, and to explore factors associated with early discontinuation of HMA therapy., Patients and Methods: We used the 2010-2016 SEER-Medicare database to identify patients aged ≥66 years with a new diagnosis of refractory anemia with excess blasts (RAEB; a surrogate for higher-risk MDS) between 2011 and 2015. New hospitalizations and ER visits during the 12 months following MDS diagnosis were determined. Treatment discontinuation was defined as stopping HMA therapy before 4 cycles., Results: Overall, 664 (55.8%) patients were HMA users and 526 (44.2%) non-users. Non-users had more hospitalizations (mean 0.47 vs. 0.30, P < .001) and ER visits (mean 0.69 vs. 0.41, P = .005) per month than HMA users. Among HMA users, 193 (29.1%) discontinued HMA therapy before 4 cycles, and 91 (47.2%) of these after 1 cycle. Older age and poor performance status were associated with higher risk of HMA discontinuation., Conclusion: An increased rate of hospitalizations and ER visits occurred in HMA non-users vs. HMA users. Approximately one-third of patients discontinued HMA therapy early. Predictors of discontinuation included older age and poor performance status. Novel approaches are needed to improve utilization and persistence with HMA therapy and associated outcomes, particularly among these higher-risk groups., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Chemotherapy-induced myelosuppression, which commonly exhibits as neutropenia, anemia, or thrombocytopenia, represents a substantial burden for patients with cancer that affects health-related quality of life and increases healthcare resource utilization (HCRU). We evaluated the burden of myelosuppression among chemotherapy-treated patients with small cell lung cancer (SCLC) using real-world data from community cancer care providers in the Western United States., Materials and Methods: This was a retrospective, observational analysis of electronic medical records (EMRs) from Providence St. Joseph Health hospital-associated oncology clinics between January 2016 and December 2019. Patient demographics were assessed from the date of first SCLC diagnosis in adult patients with chemotherapy-induced grade ≥3 myelosuppression in first-line (1L) or second-line-and-beyond (2L+) treatment settings. Myelosuppressive adverse events (AEs), treatment patterns, and HCRU were assessed from the date of chemotherapy initiation (index date) until 12 months, date of the last visit, date of death, or study end, whichever occurred earliest., Results: Of 347 eligible patients with SCLC who had received chemotherapy (mean age 66; 49% female), all had received at least 1L treatment, and 103 (29.7%) had a 2L + treatment recorded within the EMR during the study period. Of 338 evaluable patients with longitudinal laboratory data, 206 (60.9%) experienced grade ≥3 myelosuppressive AEs, most commonly neutropenia, anemia, and thrombocytopenia (44.9, 41.1, and 25.4 per 100 patients, respectively). Rates of granulocyte colony-stimulating factor use and red blood cell transfusions were 47.0 and 41.7 per 100 patients, respectively. There was a trend toward increasing the use of supportive care interventions and visits to inpatient and outpatient facilities in patients with myelosuppressive AEs in more than one cell lineage., Conclusions: Chemotherapy-induced myelosuppression places a substantial real-world burden on patients with SCLC in the community cancer care setting. Innovations to protect bone marrow from chemotherapy-induced damage have the potential to reduce this burden.

Background: Prophylaxis the current standard care for patients with severe hemophilia should be planned to optimize the replacement therapy and minimize bleeding. We report our single-center experience of tailored prophylaxis in children affected by hemophilia A (HA) and hemophilia B (HB)., Methods: This study was conducted on 55 patients, under 15 years, with HA (PWHA, n: 46) and HB (PWHB, n: 9) between 2015 and 2019. According to the phenotype, three prophylaxis regimens: 25-50 unit/kg once, twice, or three-times a week for PWHA, and two: 30-50 unit/kg once or twice a week for PWHB were administered. Following the occurrence of > 3 joint bleeding, or > 4 soft tissue bleeding, or one spontaneous major bleeding in the last 3 months, the prophylaxis regimen is changed. Annualized bleeding rate (ABR), annualized joint bleeding rate (AJBR), target joints development, inhibitor development, and hemophilia joint health score (HJHS) also were assessed., Results: A mean ± SD of 2520 ± 1045 IU/kg/yr coagulation factor (F) VIII was used to reduce ABR and AJBR from 1.02 ± 1.11 and 0.8 ± 1.3 (in the first year of the study) to 0.27 ± 0.44 (P < 0.001) and 0.19 ± 0.38 (P = 0.004) (at the end of the study) in PWHA, respectively. Furthermore, in PWHB, in the first year of the study, with using 2168 ± 1216 IU/kg coagulation FIX, ABR and AJBR were 0.19 ± 0.39 and 0.06 ± 0.1. At the end of the study, ABR and AJBR were 0.02 ± 0.05 (p = 0.156) and 0.01 ± 0.03 (p = 0.361), respectively. During the study period, the mean number of the target joints and mean HJHS were 0.25 ± 0.57 and 7.6 ± 2.1 for PWHA and 0 and 6.3 ± 1.8 for PWHB, respectively. Finally, 5 PWHA (11 %) did not need dose-escalation in their prophylaxis regimen, whereas 31 (67 %) and 10 (21 %) PWHA needed two and three infusions a week, respectively. In PWHB, 7 (78 %) and 2 (22 %) were adjusted to receive a once and twice weekly regimen, respectively., Conclusion: Our results suggest that tailored prophylaxis is an effective strategy to reduce the rate of bleeding and optimize the replacement therapy in children with hemophilia., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Myelodysplastic syndromes are hematological malignancies characterized by ineffective hematopoiesis and a high risk of progression to acute myeloid leukemia. Hypomethylating agents (HMAs), azacitidine and decitabine, are standard of care therapy for higher-risk myelodysplastic syndromes. However, outcomes reported for real-world studies fall short of those achieved in clinical trials. We conducted a targeted literature review exploring real-world utilization, persistence and outcomes with intravenous and subcutaneous HMA therapies to better understand barriers to achieving optimal outcomes in clinical practice. The potential benefits of oral HMA therapy were also explored. Underutilization and poor persistence with HMA therapy are associated with suboptimal outcomes, highlighting the need for approaches to improve utilization and persistence, so that patients achieve the optimum benefit from HMA therapy.

Background: Feeding jejunostomy is an alternative route of enteral nutrition in patients undergoing major gastrointestinal operations when a feeding gastrostomy is not suitable., Methods: A single institution review of patients who underwent open or laparoscopic jejunostomy tube (JT) placement between 2009 and 2019 was performed. Data collected included demographics, preoperative serum albumin, surgery indication, concomitancy of procedure, size of JT tube and time to its removal. JT complications were analyzed in the early postoperative period (< 30 days) and in a long-term follow-up (> 30 days). The Chi-square test was used to compare rates of complications according to tube size., Results: Seventy-three patients underwent JT placement, and gastroesophageal cancer (n = 48, 65.7%) was the most common indication. The JT was most frequently placed concomitantly (n = 56, 76.7%) to the primary operation and through a laparoscopic approach (n = 66, 90.4%). A total of 14 patients (19.1%) had early complications and 15 had late complications (20.5%). The reasons for early complications were clogged JT (n = 8, 10.9%), JT dislodgement (n = 3, 4.1%), leakage (n = 2, 2.7%), small bowel obstruction adjacent to the site of the jejunostomy tube (n = 2, 2.7%), JT site infection (n = 1, 1.3%), and intraperitoneal JT displacement (n = 1, 1.3%). The reasons for late complications were clogged JT (n = 6, 8.2%), JT dislodgement (n = 6, 8.2%), JT site infection (n = 3, 4.1%), and JT leakage (n = 1, 1.3%). There was no procedure-related mortality in this series. However, 12 patients (16.4%) died due to their baseline disease. The mean time to tube removal was 83.4 ± 93.6 days. The most frequently used JT size was 14 French (n = 39, 53.4%) but in nine patients the tube size was not reported. No statistical significance (p = 0.75) was found when comparing the two most commonly used sizes to rates of complications., Conclusion: The rate of JT complications in our study is comparable to other published reports in literature. As an alternative route for nutritional status optimization, the procedure appears to be safe despite the number of complications.

Introduction: Chemotherapy-induced myelosuppression (CIM) is one of the most common dose-limiting complications of cancer treatment, and is associated with a range of debilitating symptoms that can significantly impact patients' quality of life. The purpose of this study was to understand patients' perspectives on how the side effects of CIM are managed in routine clinical practice., Methods: An online survey was conducted of participants with breast, lung, or colorectal cancer who had received chemotherapy treatment within the past 12 months, and had experienced at least one episode of myelosuppression in the past year. The survey was administered with predominantly close-ended questions, and lay definitions of key terms were provided to aid response selection., Results: Of 301 participants who completed the online survey, 153 (51%) had breast cancer, 100 (33%) had lung cancer, and 48 (16%) had colorectal cancer. Anemia, neutropenia, lymphopenia, and thrombocytopenia were reported by 61%, 59%, 37%, and 34% of participants, respectively. Most participants (79%) reported having received treatment for CIM, and 64% of participants recalled chemotherapy dose modifications as a result of CIM. Although most participants believed their oncologist was aware of the side effects of CIM, and treated them quickly, 30% of participants felt their oncologists did not understand how uncomfortable they were due to the side effects of CIM. Overall, 88% of participants considered CIM to have a moderate or major impact on their lives., Conclusion: The data highlight that despite the various methods used to address CIM, and the patient-focused approach of oncologists, the real-world impact of CIM on patients is substantial. Improving communication between patients and health care providers may help improve patients' understanding of CIM, and foster shared decision-making in terms of treatment. Additional insights from patients should be obtained to further elucidate the totality of life burden associated with CIM.

Introduction: The management of acute postoperative pain remains a significant challenge for physicians. Poorly controlled postoperative pain is associated with poorer overall outcomes., Methods: Between April and May 2017, physicians from an online database who regularly prescribe intravenous (IV) medications for acute postoperative pain completed a 47-question survey on topics such as patient demographics, IV analgesia preferences, factors that influence prescribing decisions, and the challenges and unmet needs for the treatment of acute postoperative pain., Results: Of 501 surveyed physicians, 55% practiced in community hospitals, 60% had been in practice for > 10 years, and 60% were surgeons. The three categories of IV pain medications most likely to be prescribed to patients with moderate-to-severe pain immediately after surgery were morphine, hydromorphone, or fentanyl (95.8% of respondents); COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (73.7%); and acetaminophen (60.5%). Past clinical experience (81.6%), surgery type (78.2%), and onset of analgesia (67.1%) were practice-related factors that most determined their medication choice. Key patient-related risk factors, such as avoidance of medication-related adverse events (AEs), each influenced prescription decisions in > 75.0% of physicians. Nausea and vomiting were among the most common challenges associated with postoperative pain management (76.2 and 60.3%, respectively), and avoidance of analgesic medication-related AEs was among the three most influential patient-related factors that determined prescribing decision (75%). Physicians reported the top unmet need for acute pain management in patients experiencing moderate-to-severe postoperative pain was more medications with fewer side effects (i.e., nausea, vomiting, and respiratory depression; 80.7%)., Conclusions: Opioids remain an integral component of multimodal acute analgesic therapy for acute postoperative pain in hospitalized patients. The use of all IV analgesic medications is limited by concerns over AEs, particularly with opioids and in high-risk patients. There remains a key unmet need for effective analgesic medications that are associated with a lower risk of AEs., Funding: Trevena, Inc.

This study set out to evaluate influenza- and respiratory-related illnesses recorded during primary care physician consultations in England following the H1N1 pandemic in 2009 and to enable the development of a dynamic disease model. Data were obtained from the Clinical Practice Research Datalink of primary care records over four influenza seasons (2010-2014). The primary outcome of the study was incidence of influenza- and respiratory-related diagnoses, calculated per practice and by season and age group. Upper respiratory tract infection diagnoses were most frequently recorded (mean seasonal practice level incidence; 3,762 consultations per 100,000 [SD = 1,989]), and influenza-related diagnoses were least frequently recorded across all seasons, except one. Incidence rates for the under 18 population were higher than those for the general population, in particular for upper respiratory tract infection (range of 8,024-9,950 versus 3,228-4,120, respectively) and otitis media diagnoses (2,668-3,652 versus 782-1,057, respectively). For influenza-related diagnoses, the 65+ age group, the 0 to <2 and 2 to <4 groups had a higher risk (risk ratio = 1.33, 1.12 and 1.16, respectively) than other age groups. This study provides valuable insight into the incidence of influenza- and respiratory-related diagnoses in the primary care setting in England, and suggests a higher burden of disease in young children and the elderly. The study also indicates that some influenza illness is likely to be reported under respiratory-related diagnoses, given the low incidence of influenza-related diagnoses in the study.

Objectives: The rapid spread of infections due to antibiotic-resistant, Gram-negative bacteria in Europe and surrounding regions requires a heightened level of awareness among physicians within their practice settings., Methods: We surveyed 800 physicians who treat these infections across France, Germany, Spain, Italy, and Russia to assess their awareness of best management approaches., Results: We found that more than two-thirds do not consider themselves highly aware of best management practices. The respondents are facing these resistant infections as evidenced by the antibiotics they report using and their stated interest in newer agents. Respondents indicated that precious time is lost waiting for culture results, but also said they will need more information about accuracy, use, and costs for adopting rapid molecular testing., Conclusions: The survey further identified the need for treatment guidelines and clinical decision support tools that can be applied at the bedside.

Background: Medication errors which can cause several medical malfunctions, have been in the spotlight recently. Job satisfaction and fatigue seems to be related to the increase of medication errors in nursing., Objective: This study aimed to determine the correlation between the amount and type of medication errors with job satisfaction and fatigue of nurses working in Shahid Sadoughi hospital in Yazd-Iran., Methods: This is a descriptive study by a cross-sectional and correlational approach conducted on all the nurses working in an educational hospital who have characteristics of samples. Participants were 170 nurses working in Shahid Sadooghi hospital in Yazd, Iran in 2012. The questionnaires of demographic characteristics, medication administration error and nurses' job satisfaction and fatigue by purposive sampling were used for gathering data. Validity and reliability were checked for internal consistency and stability. Data were analysed by SPSS version 17 using Pearson correlation coefficient and Independent-samples t-test., Results: The findings did not illustrate a significant relationship between job satisfaction and fatigue with medication errors. Among the demographic characteristics, age of nurses was significantly associated with the frequency of medication errors (p=0.037). However, others were not significantly correlated (p>0.05)., Conclusion: In spite of the findings, based on no significant statistical relationship between job satisfaction and fatigue with the type and amount of medication errors in nursing, the effect of these variables on medication errors cannot be disregarded; thus further studies in this area are suggested., Competing Interests: Conflict of Interest: There is no conflict of interest to be declared.

Introduction: Opioid-induced constipation (OIC) is a common consequence of opioid use for chronic pain. OIC creates problems for patients independent of their pain syndromes, in addition to threatening pain treatment effectiveness. Healthcare practitioners need to be alert to how patients talk about OIC so that it is not missed. Using a survey mechanism, we sought patient expressions of the personal impact OIC imposes on how they are able to live their lives and on meanings that symptom relief would produce., Methods: We used an online survey asking adults with OIC about quality of life implications of OIC and focused on open-ended text responses to questions about personal impacts of straining and meanings attached to OIC symptom relief. Participants were from the US, Canada, UK, Germany, Sweden, and Norway., Results: A survey of 513 people with OIC produced 280 text responses concerning the impacts of straining on quality of life and 469 text responses on the meaning OIC symptom relief would confer. Text responses about the quality of life impacts of straining often included explicit descriptions conveying physical, psychological, or practical problems. Text responses about the meaning conferred from OIC symptom relief primarily concentrated around freedom from the constraints that OIC can impose., Conclusions: Patients are willing and able to comment on the problems OIC cause them, using a variety of terms and phrases. Their comments concerning impacts on their lives will often refer to physical consequences, psychological effects, or practical implications. These insights provide healthcare practitioners guidance on how to engage patients about OIC.

In a rapidly changing health care environment, it is more important than ever that pharmaceutical manufacturers improve the quality and efficiency of their research and development efforts in order to help ensure the right drug gets to the right patient at the right time. The evolving role of the Medical Affairs, Health Economics & Outcomes Research (HEOR) and other functions engaged in evidence generation within the pharmaceutical industry is leading to earlier involvement in the clinical development process so that the proof of concept for new therapies can be more strongly linked to the proof of medical value. In this article, the authors outline key components of an Early Engagement Model that connects the proof of concept to proof of medical value through a systematic approach linking molecular profile with early insights on disease, unmet needs, stakeholder requirements, and patient-centric differentiation.

Background: Supervisors should have certain characteristics and adequate preparation for their roles. Yet, there are no well-educated experts knowing about the supervisor's role and responsibilities and how to train them. So, this research was conducted with the purpose of finding the factors affecting nursing supervisor training., Materials and Methods: This research is an inductive content analysis. Participants were 25 in number, consisting of nurses and supervisors in Shahid Sadoughi University hospitals. The participants were chosen by a purposive sampling method. Data collection was done by semi-structured interviews and reviewing documents. Data were analyzed using conventional content analysis., Results: Findings included two main themes: Firstly, establishment of a supervisory infrastructure that includes "making the appointments and retention of supervisors, clarifying the duties and authority of supervisor, developing supervisory culture, specializing supervision, and conducting practice-based training" and secondly, comprehensive supervisory competencies that include "acquiring scientific, managing, communicative, professional, ethical, pedagogical, and supporting adequacy.", Conclusions: Clinical supervisor has a major role in ensuring the quality of nursing care. This leads to improvements in patient care and nurses' personal and professional development. So, it is necessary that for effective supervision in nursing, first an infrastructure is provided for supervision and then the comprehensive competency of a supervisor is enhanced to apply effective supervision.

Background: Coma is one of the most important complications of brain injury. Comatose patients in the intensive care units are exposed to sensory deprivation. This study aims to survey the effect of family members' voice on level of consciousness of comatose patients hospitalized in the intensive care units., Materials and Methods: In this single-blind randomized controlled trial, 40 comatose patients with brain injury with acute subdural hematoma in intensive care units were randomly assigned into two groups. The intervention group was stimulated twice a day each time 5-15 min with a recorded MP3 from family members' voice for 10 days. The patients' level of consciousness was measured with Glasgow Coma Scale before and after auditory stimulations. In the control group, GCS was measured without auditory stimulation with the same time duration like intervention group. Data analysis in software SPSS version 15 and using Chi-square test, independent t-test, paired t- test and analysis of variance with repeated measures was done., Results: On the first day before the intervention, there was no a statistically significant difference between the mean of GCS in both groups (P = 0.89), but on the tenth day after the intervention, there was a significant difference (P = 0.0001) between the mean GCS in both control and intervention groups. Also, there was a significant difference between the mean daily GCS scores in two groups (P = 0.003). The findings during ten days showed the changes in the level of consciousness in the intervention group from the 4(rd) day of the study were more in the mean daily GCS scores than control group., Conclusion: This study indicated that family members' voice can increase level of consciousness of comatose patients with acute subdural hematoma.

Introduction: While opioids have become a standard treatment option for those experiencing moderate to severe chronic pain, side effects of constipation and related symptoms have interfered with their usage in as many as 40-50% of treated patients. Prior research has elucidated the range of these symptoms, but no study has determined which of these symptoms patients most desire improving or whether improving constipation itself by as little as one more bowel movement per week is deemed an important change., Methods: We conducted an online patient survey of 513 participants residing in one of six countries who reported having chronic pain, were taking opioids, and experiencing opioid-induced constipation (OIC) to address these questions., Results: Respondents rank ordered their preferences and the following eight symptoms generated >80% endorsement as important to improve: improvement in having bowel movements without rectal pain, soft stools that are not loose or watery, regular bowel movements, a reduction in rectal straining, relief from feeling bloated, feeling less fear about having OIC when following their opioid medication regime, a desire to worry less overall about having a bowel movement, and with less 'stomach' area pain. When asked 'how important is it you to have 1 more bowel movement per week", over 90% endorsed it was 'somewhat', 'very', or 'extremely important' with nearly 70% (n = 354) endorsing the 'extremely' or 'very important' response options. In multivariate models, being in more overall pain or reporting fewer than 3 bowel movements per week were found to be independent predictors of the importance., Conclusions: These results highlight the notable range of OIC symptoms most desired by patients to improve and demonstrate that bowel movements of only one more per week were important to register a meaningful improvement. The latter is particularly helpful for those assessing the minimal clinically important difference in treating this condition.

Background and Aim: Human Papilomavirus (HPV) is one of the most widespread sexually transmitted diseases is highly related to cervical cancer in women. Cervical cancer's crude incidence rate in Iran is 6-8 per 100,000. The HPV vaccine provides a chance to considerably decrease the transmission of most types of HPV. The aim of this study was to evaluate awareness and knowledge of HPV infection and vaccines and to assess the attitude and approach toward these vaccines among female nurses at Shahid Sadoughi University of Medical Sciences, Yazd, Iran., Materials and Methods: This cross-sectional, descriptive study was performed among 380 female nurses. Data were collected using a questionnaire was consisted in demographic variables and questions on knowledge of participants about HPV infection, HPV vaccine and cervical cancer and also questions on attitude of ourses towards HPV vaccination. The validity and internal consistency of questionnaire was confirmed during experts consents and pilot testing (alpha = 0.79). Data analysis was performed using SPSS15 using chi2-test or Fisher's exact test., Results: Three hundred and eighty questionnaires were distributed and 357 female nurses completed and returned their questionnaires: Only one hundred and thirty-one of the nurses (36.7%) knew about HPV infection and how it can cause abnormal pap Smear results. about 147 (41.2%) of the nurses stated they would want to be vaccinated. About 146 (40.9%) of respondents supported vaccination of preadolescent girls., Conclusion: The results of this study confirm the lack of knowledge about HPV vaccine and its relation to cervical cancer and also the ways of this cancer prevention. Our study shows an urgent need to design similar studies in other regions of Iran and draw a broad estimation on knowledge of different target groups to make a national program to increase the knowledge of women on this matter and help to decrease the rate of cervical cancer in Iranian population.

Newly developed healthcare treatments face a complex environment with many stakeholders who can accelerate or decelerate adoption, most notably the healthcare system payers. Understanding and integrating their needs earlier in clinical development will ensure a smoother transition from bench to bedside. This paper describes a new approach to shaping a more effective complementary process of 'value' evidence generation both in and outside the clinical drug development process. We propose that biopharmaceutical companies consider bringing new solutions to market by marshaling cross-functional approaches to what we term an evidence-definition phase, evidence-generation phase and evidence-translation phase to drug and technology research and development. The organization of ongoing discovery, evaluation and translation with a 'real- world' perspective should provide a more streamlined approach to ensure both regulatory and eventual marketplace success.

Translational research and relative effectiveness are being incorporated into drug development programs to meet the demands for more robust evidence generation to support the value of new therapies. Translational research includes translating basic research into clinical practice, controlled clinical trials into potential clinical implications, evidence-based guidelines into routine clinical practice and standard practices into population health. These research concepts link with real-world outcomes, and feed into each other to improve the efficiency of research. Translational research can run into road blocks in terms of conveying the added or comparative value of research or during adoption into clinical practice. Understanding these roadblocks and developing solutions are important for success. Comparative effectiveness research can be a useful research technique to accomplish many translational medicine goals. These studies generally include heterogeneous patient populations and evaluate outcomes of relevance to payers and health technology assessors. Comparative effectiveness research can be used in drug development; different methodologies may be useful in different phases. In this article, suggestions and examples of successful use of comparative effectiveness studies are provided. Translational research and comparative effectiveness research, although clearly independent concepts, can provide a focused approach to drug development, resulting in products entering the market that bring added benefit to patients and the healthcare system overall.

The rapidity of change and increasing complexity of today's healthcare environment dictates that pharmaceutical companies refine their drug development process to ensure that products provide maximal value to consumers. Innovation should receive the support and encouragement it deserves but the balance between cost of therapy and enhanced benefits to the end users, the patients, must not be compromised. The health or quality-of-life outcomes that therapies are likely to achieve need to be clearly stated for patients so they know what to expect before beginning treatment. A drug development program that incorporates principles of 'patient-centered medicine' early on can help define the true value of a health technology. This demands not only demonstrating value as measured by actual patient experience and patient-reported outcomes, but understanding the unmet needs of multiple stakeholders: what is their perception of what represents value? What factors impact healthcare coverage decisions? In this paper, we describe an illustrative framework designed to weave 'patient-centric' medical and real-world evidence into the phases of research and development. This evidence and value development framework works iteratively, providing useful insights parallel to product development from early phase to life-cycle management while forming a progressive evidence chain throughout the phases of research and development. This in turn leads to the creation of value-based innovation with robust foundational evidence for clinical decisions, postlaunch coverage and reimbursement evaluations.

Purpose: The impact of preoperative saphenous vein mapping and intraoperative angioscopy on the results of in situ saphenous vein bypass is analyzed in this study., Methods: A new technique developed for in situ saphenous vein bypass (ISVB) was used in 26 patients (group I) and consisted of (1) preoperative duplex scanning and mapping of the saphenous vein and its tributaries, (2) small incisions for dissecting the proximal and distal arteries and veins, (3) ligation of marked tributaries through small incisions, (4) angioscopically directed incision of venous valves with a flexible-tipped valvulotome, and (5) femoral and distal anastomoses. The results were compared with those of 14 patients (group II) in whom the technique was similar except that venous tributaries were identified angioscopically and then ligated and 24 patients (group III) who underwent standard "open" ISVB through one long incision without angioscopy or vein mapping and in whom valvulotomy was carried out with a rigid valvulotome passed through tributaries., Results: In comparing the results of groups I and III, significant reductions in operative intravenous fluid requirements (1930 ml vs 2675 ml; p = 0.04), postoperative length of stay (4.4 days vs 9.1 days; p < 0.001), and wound complications (1 vs 9; p = 0.01) were observed. Angioscopic irrigation fluid volume in group I was less than that in group II (360 ml vs 1014 ml; p < 0.001). At 12 months, the primary graft patency rate in all 64 patients was 91% for femoropopliteal and 89% for femoral-infrapopliteal ISBV and 84% for the 40 patients in groups I and II., Conclusions: This report demonstrates the effectiveness of our modified technique for ISVB, which helped reduce wound complications and length of stay while satisfactory early graft patency was also maintained.