Experience In Treating Patients Research Articles

Quality of Inpatient Tuberculosis Health Care in High-Burden Resource-Limited Settings: Protocol for a Comprehensive Mixed Methods Assessment Study

BackgroundThe quality of care for tuberculosis (TB) is deficient in high-burden countries and urgently needs improvement. However, comprehensively identifying the required improvements is challenging. Providing high-quality TB care is an important step toward improving patients’ quality of life and decreasing TB morbidity and mortality. Effective tools for assessing the quality of TB services using international standards and guidelines can identify existing gaps in services and inform improvements to ensure high-quality inpatient TB services.ObjectiveThis study aimed to develop evaluation instruments for defining the quality of provision of TB services.MethodsTo assess quality of services in the largest TB hospital in Armenia, we developed instruments based on the Joint Commission International Accreditation Standards for Hospitals, International Standards for TB Care, TB Laboratories Bio-Safety Standards, and the World Health Organization framework for conducting TB program reviews. A mixed methods approach was utilized, triangulating quantitative (checklists) and qualitative (in-depth interviews) results. A scoring system and strengths, weaknesses, opportunities, and treats analysis was applied to detail results for each of the 122 standards assessed. A scaling approach was used to present overall performances of inpatient services for eight patient-centered functions and five organization management functions.ResultsOverall, 40 in-depth interviews and 91 checklists (21 observations, 16 policy papers, 20 staff qualification documents, and 34 medical records) were developed, utilized, and analyzed to explore practices of health care professionals, assess inpatient treatment experience of patients and their family members, evaluate facility environmental conditions, and define the degree of compliance to standards.ConclusionsThe effective comprehensive evaluation instruments and methods developed in this study for quality of inpatient TB services support the implementation of similar effective assessments in other countries. It may also become a platform to develop similar approaches for assessing ambulatory TB services in resource-limited countries.International Registered Report Identifier (IRRID)DERR1-10.2196/13903

Protokol mehaničke ventilacije i prevencije komplikacija za kritično obolele bolesnike COVID-19 - prva verzija protokola za Srbiju

In December 2019, a new Corona virus (SARS-CoV-2) was identified as responsible for outbreak of viral pneumonia in Wuhan, Hubei Province, China. The World Health Organization has announced a pandemic of COVID-19 (Coronavirus disease 2019) on March 2nd 2020. COVID-19 is a respiratory infection where majority of patients have mild clinical symptoms. About 14% of patients require hospitalization and oxygen therapy and 5% of patients require admission to the intensive care unit. The most severe clinical cases include ARDS, sepsis and septic shock, acute renal failure, multiorgan dysfunction, and myocardial damage. Spread of the infection so far indicates that the number of patients requiring hospital admition and intensive care treatment will significantly burden the health care system in all countries. Several intensive and critical care protocols, based on the first experiences in treatment of viral pneumonia and severe COVID-19 illness, have already been published. Here we present the first version of a suggested protocol in our country, with an attached flowchart for the initial management of the COVID-19 patients in need for mechanical ventilation. The protocol is based on the worldwide existing experience in treatment of COVID-19 patients. The intention is not to replace the clinical experience and critical judgment of the attending doctors, but to strengthen their decisions and tailor treatment according to the recourses existing in our country.

Treatment Experiences of Traumatic Brain Injury Patients using Doctor-Helicopter Emergency Medical Service: Early Data in a Regional Trauma Center.

ObjectiveThe purpose of this study is to analyze the results of doctor helicopter emergency medical service (HEMS) in traumatic brain injury (TBI) patients and to understand the effect and improvement of doctor HEMS.MethodsWe included TBI patients transferred by doctor HEMS of our hospital between February 2016 and December 2017. Basic characteristics, HEMS data, treatment and results data were analyzed retrospectively. We divided the patients into 3 groups as regarding severity of patient, relevance of treatment and transfer. We investigated the preventable trauma death rate (PTDR) of these groups to increase the reliability of the treatment outcome.ResultsTBI patients using doctor HEMS were indicated in 98 patients (18.7%) among 522 overall HEMS patients. The overall mortality was consisted in 21.4% and 43.2% was resulted in Glasgow outcome scale 4 or 5. The group of proper transport and treatment for severe TBI was consisted in 62.2% including 13 mortality cases and no preventable death. The group of delayed transport or treatment for severe TBI was 18.3% including 8 mortality cases and 1 preventable death. The PTDR of TBI after doctor HEMS was significantly lower than that of overall TBI (4.8% vs. 11.6%, p=0.045).ConclusionIn patients with severe TBI, doctor HEMS can improve treatment outcomes by reducing treatment delay and unnecessary examinations and this result was evidenced that the PTDR were decreased significantly after doctor HEMS transport. The appropriate treatment is mandatory for real-time communication with the emergency doctor and treatment preparation of the trauma team during the HEMS transport.

First 500 Fractions Delivered with a Magnetic Resonance-guided Radiotherapy System: Initial Experience.

ObjectivesImproved soft-tissue visualization, afforded by magnetic resonance imaging integrated into a radiation therapy linear accelerator-based radiation delivery system (MR-linac) promises improved image-guidance. The availability of MR-imaging can facilitate on-table adaptive radiation planning and enable real-time intra-fraction imaging with beam gating without additional exposure to radiation. However, the novel use of magnetic resonance-guided radiation therapy (MRgRT) in the field of radiation oncology also potentially poses challenges for routine clinical implementation. Herein the early experience of a single institution, implementing the first MRgRT system in the country is reported. We aim to describe the workflow and to characterize the clinical utility and feasibility of routine use of an MR-linac system.MethodsThe ViewRay MRIdian MR-linac system consists of a split-magnet 0.35 T MR-imaging scanner with a double focused multi-leaf collimator (MLC) equipped 6MV linear accelerator. Unique to the system are the control console integrated on-table adaptive radiation therapy (oART) planning capabilities as well as automated beam gating based on real-time intra-fraction MR imaging. From the first day of clinical implementation, oART was performed according to physicians’ discretion when medically indicated. All fractions were delivered under real-time imaging with soft tissue-based automated beam gating with individualized gating boundary settings. Patients actively assisted in breath-hold beam gating with the help of custom designed prismatic glasses allowing sight of a computer monitor mounted on the back wall just behind the MRI system bore. Patient demographics and treatment experience, indications for MRgRT including diagnosis and disease site, radiation dose prescribed and fractionation scheme, utilization of oART, respiratory gating settings, as well as duration of each treatment phase were analyzed.ResultsBetween September 2018 and May 2019, 72 patients with 84 tumor sites were treated with MRgRT in 500 total fractions. Median patient age was 66 years (range: 28-83 years). Among 84 tumor sites, the most frequently treated regions were upper abdominal and pelvic (n = 36, 43% and n = 29, 34%, respectively). The most common diagnosis was prostate cancer, with 14 patients treated. In 69 patients (93.2%) oART was used at least once during a treatment course. Twenty-nine targets (43.1%) with significant breathing-related motion were treated in breath-hold with patient visual feedback. Median prescribed dose was 36.25 Gy (range: 24-70 Gy) in median five fractions (range: 3-28 fractions). A gating boundary of 3 mm around a gating region of interest (gROI) was most commonly used (range: 3-5 mm) with 95% of the gROI (range: 93-97%) required to be within the gating boundary for the beam to automatically engage. Mean total treatment time was 47 min (range: 21-125 min) and mean beam-on time was 16.7 min (range: 6-62 min).ConclusionsMRgRT afforded by an MR-linac system has been successfully implemented into routine clinical use at our institution as the first system of its kind in Turkey. While the overall number of patients treated and fractions delivered is still limited, we have demonstrated the feasibility of both on-table adaptive radiation therapy as well as automated real-time beam gating on a daily basis in acceptable time schedules.

Preliminary Exploration of Patient Perspectives on Tyrosine Kinase Inhibitors for the Treatment of Chronic-Phase Chronic Myeloid Leukemia

Introduction: Tyrosine kinase inhibitors (TKIs) represent the standard of care for patients with chronic-phase chronic myeloid leukemia (CP-CML). The emergence and availability of second-generation TKIs (dasatinib, nilotinib and bosutinib) has led to increased choice for patients and physicians, with data from randomized clinical trials indicating improved efficacy of such therapies compared to the first-generation TKI (imatinib). Differences in the efficacy of second-generation TKIs are negligible; however, all have distinct dosing instructions and safety profiles. Understanding the patient perspective is invaluable for optimizing healthcare decisions, with interest in information regarding patient preferences growing among a wide variety of stakeholders, including regulatory agencies, reimbursement bodies and prescribers. However, evidence is lacking regarding treatment preferences and priorities for patients with CP-CML. The aim of this study was to explore attributes of currently-licensed TKI therapies that are relevant and important to patients with CP-CML. This research represents the first step in the conduct of a discrete choice experiment (DCE), or conjoint analysis, to explore treatment preferences more broadly among CP-CML patients. Patient-guided design is crucial to ensuring attributes of investigation are meaningful. Hence the qualitative insights will advise and validate attribute and level selection for inclusion in the forthcoming DCE. Methods: In-depth qualitative interviews were conducted with 12 US-based patients with a clinician-confirmed diagnosis of CP-CML. The sample included 10 females and 2 males (median age 46 years) who were diagnosed 2 years (n=3), 4-7 years (n=5), 10-12 years (n=3) and 16.5 years (n=1) prior to interview. Ten patients had received a second-generation TKI. Current treatments were dasatinib (n=8), bosutinib (n=1) and imatinib (n=3). Previous treatments included imatinib (n=6), nilotinib (n=3) and dasatinib (n=1). The interviews utilized concept elicitation techniques to capture attributes of importance in both TKI treatment experience and TKI treatment selection. Transcripts were thematically analyzed using Atlas.ti. Results: Open-ended questioning elicited an array of attributes related to TKI treatments. It was important to all patients to ensure that a CP-CML treatment was effective. Treatment efficacy was conveyed with multiple descriptors; most commonly "BCR-ABL" (n=7) or major molecular response "MMR", polymerase chain reaction "PCR" and "remission" (each n=3). Eight patients discussed the importance of dose frequency, specifically the burden of scheduling self-administration of oral tablets (n=5). Seven patients conveyed the difficulty of taking a TKI with specific meal requirements, most notably when fasting is required prior to and post-administration (n=4). A multitude of important treatment side effects were elicited at investigation into the patient TKI treatment experience. Fatigue was reported by 11 patients (n=10 spontaneous) and considered by most patients (n=8/11) to be directly attributable to treatment versus the CML itself. Four patients considered fatigue an inevitable component of TKI treatment. Nausea was elicited by 7 patients (n=5 spontaneous) and some patients (n=5/9) considered it to be influential in treatment selection. Muscle pain was reported by 6 patients (n=4 spontaneous), while skin rash was reported by 5 patients and bone pain by 4 patients (all spontaneous). Diarrhea was reported by 4 patients (n=3 spontaneous). Additional symptoms reported by ≤2 patients are presented in Figure 1. Spontaneously elicited concepts were ranked by importance. All patients considered efficacy within the top three most important attributes. Six patients considered fatigue to be either of second or third most-importance. The rankings in Figure 2 serve to portray the varied perspectives and experiences of patients on TKI treatments. Conclusions: The TKI treatment experience for CP-CML patients is multifaceted. This type of study - the first that we know of - supplies valuable insight into the patient perspectives of TKI treatment to establish a foundation to better inform relevant decisions in the field. The qualitative findings will provide the input necessary to inform attribute and level selection to characterize treatment profiles ahead of an upcoming patient-preference DCE. Disclosures Mason: Adelphi Values: Employment; Pfizer: Consultancy. Mamolo:Pfizer: Employment, Equity Ownership. Johnson:Pfizer Inc: Consultancy; Adelphi Values Ltd: Employment. Viqueira:Pfizer Inc: Employment, Equity Ownership. Gater:Pfizer Inc: Consultancy; Adelphi Values Ltd: Employment. Russell-Smith:Pfizer: Employment, Equity Ownership. Tatlock:Adelphi Values: Employment. Shah:Pfizer: Employment, Equity Ownership. Cappelleri:Pfizer: Employment, Equity Ownership.

Patient and provider differences in the treatment of opioid-induced constipation: a qualitative study

BackgroundPatients using opioids to treat chronic non-cancer pain often experience side effects that may affect health-related quality of life (HRQOL). These side effects include opioid-induced constipation (OIC), sedation, dizziness, and nausea. OIC can significantly affect HRQOL for patients on a daily basis. However, it is not well understood whether patients and clinicians view OIC management similarly.AimsIn this study, we sought to elucidate the decision-making process around managing OIC by assessing patient and provider treatment preferences, experiences, and communication regarding this condition.MethodsWe conducted semi-structured interviews with 33 clinicians, and held three focus groups with patients who were currently using or had used opioids for chronic non-cancer pain. We then analyzed transcribed interviews using descriptive qualitative methods based on grounded theory methodology.ResultsClinicians recognized OIC as a concern but prioritized pain management over constipation. They focused on medication-based treatments for OIC, but also recommended lifestyle changes (e.g., diet) and reducing opioids to relieve symptoms. Patients reported using over-the-counter treatments, but the majority focused on diet-related constipation management. Patients reported not receiving adequate information from clinicians about OIC and relevant treatments. Cost of treatment was a major concern for both patients and clinicians.ConclusionsAssessing experiences with and preferences for OIC treatment, including cost, ease of access, and side effects, could improve patient-provider communication and HRQOL. Quality improvement efforts can target uncovered misalignments between patients and clinicians to improve communication about opioid medication adverse effects and relevant treatment options, which may help improve quality of life for patients with chronic pain.

Endovascular treatment of chronic lower limb ischemia - the first experience of consecutive patients in the Kyrgyz Republic

Objective: Pure atherosclerosis and diabetes mellitus are often responsible for the lesion of lower limb arteries. As a result, critical ischemia may develop. Endovascular treatment of lower extremities chronic ischemia in the modern world one of the most effective methods of limbs salvage. This report is an analysis of the first experience of endovascular treatment in consecutive patients with chronic lower limb ischemia in the Kyrgyz Republic. Methods: In 2016-2018, there were 31 patients with chronic lower limb ischemia in IIb-IV Fontaine's stages who underwent endovascular treatment. The primary endpoint was 6-month painlessness or reduction of the Fontaine stage; freedom from amputation up to six months; active regenerative process or full recovery of ulcers/wounds up to six months. The secondary endpoints included 6-month all-cause mortality and reintervention rate. Results: Overall, 27 (87.1%) patients reached painless form (stage I according to Fontaine (ABI ≥0.9)), with complete regeneration or active reparative process observed in 20 (64. 5%) patients. In general, major amputation was avoided in 29 (93.5%) patients (two patients underwent amputation by E. Burgess). Minor amputations were performed below the level of foot dorsum (Sharp) in 35.5% (11 patients). Simultaneous percutaneous coronary interventions and peripheral interventions were performed in 6 (19. 4%) cases. In total, within 6 months one death was registered (3.2%). Conclusion: The first endovascular treatment of consecutive patients showed encouraging 6-month results. Simultaneous («Ad-hoc») or stepwise (at the current hospitalization) procedures on coronary and peripheral arteries ensure safety and can provide more chances of patient`s survival.

The Conundrum of Dual Primary Malignancies: Four Years’ Experience of a Single Tertiary Care Institute in India

Abstract Background: Encountering more than one malignancy in a cancer patient is no longer uncommon; this increasing incidence is mostly attributable to the improvements in life expectancy, awareness, and diagnostic facilities. This article aims to highlight this institute’s experience in diagnosis and treatment of patients of multiple primary malignancies and a comprehensive review of literature. Materials and Methods: This is a descriptive study of retrospectively collected data of a single institution over 4 years from 2013 to 2016. Known cases of cancer who were diagnosed with a second primary malignancy were included in the study. Various details such as age, sex, site of disease, temporal relation of two cancers (synchronous or metachronous), family history, tobacco use, treatment given, and survival at 1 year were recorded, organized in a tabular form, analyzed, and described. Results: A total of 29 cases of dual malignancies comprising 0.74% of a total of 3879 patients of cancer were encountered. Seventy-two percent of the cases were metachronous and 5 years was the mean time interval between tumors. There was a female preponderance, and the average age was 56 years. Breast was the most common site of malignancy. At 1 year from diagnosis of second primary, 69% of the patients were alive and 27% were disease-free. Conclusion: Second primary in a patient of cancer is becoming increasingly common and the suspicion of the same should always be borne in mind during follow-up. Prognosis as well as intent of treatment depends on respective stages of the two malignancies.

Compounded Stigma in LGBTQ+ People: A Framework for Understanding the Relationship Between Substance Use Disorders, Mental Illness, Trauma, and Sexual Minority Status

Lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ+) people are sexual minorities and have higher rates of substance use disorders, mental illness, and trauma, which translates into compounded stigma for them. Compounded stigma is the additive and cumulative impact of belonging to one, or several, marginalized groups (eg, racial/ethnic minority, LGBTQ+) and also suffering from addiction, mental illness, and/or trauma. There are important interactions among these comorbidities, trauma, and sexual minority status that affect patient behavior, treatment planning, and treatment outcomes. This article presents a Venn diagram as a helpful clinical tool to visually illustrate the complex interactions of mental illness, addictions, trauma, and LGBTQ+ minority status for both health care providers and patients. Having an awareness and understanding of these important interactions can enhance patient rapport and treatment experience as well as treatment planning. [ Psychiatr Ann. 2019;49(10):446–452.]

Partnering with patients and caregivers to improve systemic treatment regimen information.

185 Background: Cancer Care Ontario’s Drug Formulary is a web-based drug information resource. Patient information is currently provided as single-drug information sheets, with a limited number of multi-drug regimen information sheets (RIS) for breast and lung cancer treatments. Patients identified a need to create additional, high-quality, “user-friendly” RIS. Objectives of this project were to 1) engage patients and caregivers in RIS redesign; 2) evaluate the original vs a redesigned model RIS; and 3) use the model RIS template to create additional RIS across disease sites. Methods: The project team included a patient and family advisor (PFA) and clinical and research experts. This was a qualitative study between August 2017 to May 2019. A focus group (FG) was conducted with 5 PFAs to identify and prioritize drug information needs. A model RIS was designed, incorporating FG input and health literacy best practices. RIS were evaluated through blinded comparative cognitive interviews with 13 PFAs, to assess RIS for usability, understandability and content relevance. Evaluation informed iterative revisions. RIS were also evaluated by clinical and education experts using the Patient Education Materials Assessment Tool (PEMAT). An RIS style guide was developed to inform the creation of future RIS. Ethics approval was obtained from the University of Toronto. Results: The FG prioritized information on regimen details, Dos and Don’ts while on treatment, drug interactions, side effects and contact information. Guidance was provided on simplifying language, highlighting important information and aesthetics. Cognitive interviews consistently reported preference for model RIS over original RIS in most domains. PEMAT scores for original versus model RIS were 64% and 94% respectively (for understandability) and 60% and 82% respectively (for actionability). To date, the style guide has informed the creation of RIS for 10 high-use regimens. Conclusions: PFA and clinician co-design along with health literacy best practices informed measurable improvements in RIS. The style guide will enable the future creation and ongoing evaluation of high-quality RIS to enhance the cancer treatment experience for patients and caregivers.

Anastomotic Leak after Colorectal Surgery. Our Experience in three Years.

Background: One of the most severe complication after intestinal resection, often with catastrophic consequence for the patient is leakage from the anastomosis. The severity of complications after anastomotic leak may range from a small localized peritonitis or abscess formation without sepsis, to a development of a four quadrant peritonitis with septic shock. Until now despite the seriousness of this complications, the cause of anastomotic leakage are not yet definitively clear. Aim: The aim of this study is to submit our experience in treatment of patients with anastomotic leakage after intestinal resection and their outcome.
 Materials and Methods: The study included 63 patients with colorectal cancer operated in the Department of Surgery at the Clinical Hospital of Tetova. In all patients intestinal resection with end to end anastomosis was performed.
 Conclusions: Anastomotic leak after large bowel resection is a very serious complication with a great impact on patient’s morbidity and mortality. Multiple risk factors are associated with occurrence of this complication whereas the more suspected are: preoperative anaemia, hypoalbuminemia, emergent surgery without adequate preparation of patient, intraoperative blood loss and blood transfusion during surgery etc. Early detection of AL is very important and helpful to improve the outcome of patients and to minimize postoperative rate of morbidity and mortality.
 Keywords: anastomotic leaks, colorectal surgery, risk factors

Analysis of Clinical Trial Exit Interview Data in Patients with Treatment-Resistant Depression.

Clinical outcome assessments may not fully capture patients' perspectives of treatment benefit or tolerability. Incorporating individual exit interviews might enhance the description of the patient experience of drug effects. The objective of this study was to evaluate the patient treatment experience in a clinical trial of treatment-resistant depression utilizing exit interview methodology. Individual patient interviews were conducted with subjects exiting two phase II clinical trials involving investigational agents for treatment-resistant depression. Interviews included standardized questions about patients' perceptions of health changes and interest in continued use of the investigational agent. Constant comparative analysis of blinded data was used to identify, code, and categorize the data followed by a subsequent analysis of unblinded data to evaluate any potential treatment differences. Ninety subjects completed exit interviews across the two trials. Most subjects (90%, Trial 2001; 74%, Trial 2002) reported at least one health change. Most subjects rated these changes to be at least moderately important, with most being rated "very important" to "extremely important." After unblinding, participants receiving active therapy alone reported most of the positive health changes (80% of overall positive changes in Trial 2001, 89% in Trial 2002), whereas patients taking placebo alone reported the majority of negative health changes (57% in Trial 2002). Positive changes included not only anticipated changes in mood but also potential cognitive benefits such as mental alertness, improved sleep, and better concentration. Standardized interview data provided direct patient insight into the treatment experience from the patient perspective. Data from these interviews assisted in phase III endpoint selection by providing data on relevant concepts in the target treatment-resistant depression population receiving a new treatment, thus enabling the selection of tools to capture noted treatment effects and, by eliminating irrelevant constructs or measures, thereby reducing data "noise." ClinicalTrials.gov NCT01640080; NCT01627782.

Clinical characteristics and treatment of thallium poisoning in patients with delayed admission in China.

Thallium is highly toxic and its effects are cumulative. The clinical symptoms of thallium poisoning are non-specific, thereby delaying admission and treatment. This study aimed to summarize the clinical features and treatment experience of patients with delayed admission who experience thallium poisoning.We conducted a retrospective descriptive analysis of patients in our hospital from 2008 to 2018 who had thallium poisoning and experienced a delay in hospital admission. The time from symptom onset to admission was assessed. The patients were divided into 3 groups and descriptive analyses of their clinical characteristics, including basic patient information, symptoms, laboratory test results, examination findings, treatment methods, outcomes, and follow-up information, were conducted.A total of 34 patients with thallium poisoning were included: 8 were admitted to the hospital early or with mild delay, 9 had a moderate delay, and 17 had a severely delayed admission. The time from illness onset to admission was 13 (interquartile range, 7.5-26) days. Some patients with delayed admission had significant symptoms associated with central nervous system damage, and changes in magnetic resonance images and electroencephalograms were also noted. After admission, all patients received Prussian blue treatment, and some patients with relatively high blood concentration received blood purification treatments. Following treatment, the blood and urine thallium concentrations of all patients decreased significantly, and their symptoms were alleviated.Our results show that delayed patient admission in cases of thallium poisoning is associated with greater risk of central nervous system damage. Use of Prussian blue combined with blood purification treatments might improve patients' conditions.

A Qualitative Research on the Treatment Experiences of Patients with Serious Injury in Traffic Accidents Treated with Traditional Korean Medicine

A Qualitative Research on the Treatment Experiences of Patients with Serious Injury in Traffic Accidents Treated with Traditional Korean Medicine

PS1029 CLINICAL BENEFIT OF GLASDEGIB PLUS LOW-DOSE CYTARABINE IN PATIENTS WITH DE NOVO AND SECONDARY ACUTE MYELOID LEUKEMIA: LONG-TERM ANALYSIS OF A PHASE 2 RANDOMIZED TRIAL

Background: The combination of all-trans retinoic acid (ATRA) and intravenous arsenic trioxide (IV ATO) cures most patients with acute promyelocytic leukemia (APL). However, daily 2-hour infusions of ATO over several months constitute a significant burden for hospitals and patients. A novel encapsulated formulation of oral ATO (Phebra Pty Ltd, Australia) has the potential to significantly simplify treatment delivery and improve the overall treatment experience of patients with APL. Aims: To characterize the bioavailability of encapsulated oral ATO in patients with APL by comparing the AUC0–24 and Cmax of total arsenic in whole blood (WB) and plasma (PL) after oral and IV ATO administration. Methods: ALLG APML5 (ACTRN12616001022459) is a bioavailability study embedded within a standard-of-care consolidation regimen. Eligibility required documented hematological complete remission following induction with ATRA + IV ATO (+ idarubicin for patients with initial WBC count > 10x109/l). Registered patients were consolidated with 7 cycles of ATRA 45 mg/m2/d (7d/week for 2 weeks, with 2 weeks between cycles), and 4 cycles of IV ATO 0.15 mg/kg/d (5d/week for 4 weeks, with 4 weeks between cycles). Pharmacokinetic (PK) sampling was performed on days 1 and 4 in week 1 of each ATO cycle. Oral ATO 0.15 mg/kg/d (administered 1 hour before food as 10 mg and/or 1 mg capsules rounded up to the nearest 1 mg) was substituted for IV ATO in week 1 of cycle 2, and again in week 1 of cycle 4 (with PK-directed dose modification if required). Total arsenic was quantitated by inductively coupled plasma mass spectrometry. Point estimates of mean oral/IV arsenic ratios ± 90% confidence intervals (CI) for AUC0–24 and Cmax in WB and PL were calculated by linear mixed model analysis incorporating fixed and random effects, and the results were compared with conventional bioequivalence limits (0.80, 1.25). Results: This preliminary analysis encompasses 53 evaluable PK profiles from 9 patients: 4 males, 5 females, median age 52 years (range 20–66). Both formulations were associated with significant increases in all PK parameters from day 1 to day 4 (p < 0.001 for WB AUC0–24, PL AUC0–24, WB Cmax and PL Cmax; Figure 1), indicative of short-term arsenic accumulation within each cycle. However there was no accumulation of arsenic between sequential cycles. No significant PK differences between the oral and IV formulations were identified (Figure 1). Estimates of the geometric mean of the oral/IV ratio for each PK parameter closely approximate unity (Table 1), and the 90% CIs fall within (or just upon) the bioequivalence limits (0.80, 1.25). Although exposure to encapsulated oral ATO was restricted to 10 days, its use was not associated with any increase in the frequencies of grade 3–4 adverse events, gastrointestinal toxicity or QTc prolongation. No patient required dose adjustment of oral ATO in cycle 4 based on PK or toxicity criteria.Summary/Conclusion: The data demonstrate promising evidence of average bioequivalence for the oral and IV arsenic formulations with low inter- and intra-patient variability, and indicate encapsulated oral ATO 0.15 mg/kg/d and IV ATO 0.15 mg/kg/d provide comparable arsenic exposure over repeated cycles of consolidation.

PARPi after PARPi in epithelial ovarian cancer

The objective of this study was to describe the treatment experience of patients with recurrent epithelial ovarian cancer who are retreated with an inhibitor of poly(ADP-ribose)-polymerase (PARPi). We conducted a multi-institutional, retrospective review of ovarian cancer patients who received ≥2 lines of therapy containing a PARPi. Demographic, clinical, and pathological data were analyzed with descriptive statistics. Twenty-two patients were identified. For initial PARPi (PARPi1), 12 patients (54.5%) received veliparib, 7 (31.8%) olaparib and 3 (13.6%) rucaparib resulting in 10 patients who had no evidence of disease at the completion of therapy (NED), 3 partial responses (PR), 4 stable disease (SD), and 3 progressive disease (PD). (All 10 CRs involved veliparib given in conjunction with cytotoxic chemotherapy). PARPi1 was used as maintenance in 2 patients. PARPi1 was discontinued because planned number of cycles was reached (n = 10), progression (n = 8), toxicity (n = 2), other (n = 2). For second PARPi (PARPi2), 10 patients (45.4%) received niraparib, 6 (27.3%) olaparib, and 6 (27.3%) rucaparib resulting in 3 PR, 13 SD, and 3 PD. PARPi2 was used as maintenance in 3 patients. The 3 patients who experienced a PR to PARPi2 had a BRCA mutation and were NED following PARPi1. PARPi2 was discontinued because of progression (n = 13), toxicity (n = 6), other (n = 2). One patient currently remains on PARPi2. Toxicity after PARPi1 was not associated with toxicity from PARPi2 (p > 0.05). With 3 approved PARPi for different indications including frontline and recurrence, the opportunity to reuse PARPi has increased. Characterizing those who should be re-challenged is an important initiative moving forward.

Long-term symptom burden and quality of life in metastatic melanoma patients treated with checkpoint inhibitors.

e23090 Background: Patients with metastatic melanoma (MMel) who achieve durable long-term responses to checkpoint inhibitors (CI) represent a new type of cancer survivor, but their long-term quality of life (QOL) is poorly described. We measured symptom burden and long-term QOL in MMel patients treated with CIs at Memorial Sloan Kettering Cancer Center (MSK). Methods: Between February and August 2018 we performed a cross-sectional survey of adult patients with MMel treated with CI at MSK beginning at least 12 months prior to this study. Surveys were self-administered online using RedCap. We assessed patient treatment experience and QOL using the PRO-CTCAE bank, EORTC, EQ-5D, and Fatigue Severity Scale. We performed chart abstraction to assess extent of cancer burden, ECOG status, Charlson Comorbidity Index (CCI), concurrent medical conditions, and immune-related adverse events (irAEs) developing during or after treatment. For analysis, we dichotomized age (&lt; 65 vs ≥65) and months from CI initiation (&lt; 25 vs ≥25). Results: We enrolled 107 patients (39% survey response rate); 106 completed surveys. Participants were 57.0% male and 93.5% white, with median age 60.5 years (IQR: 51.1, 67.5 years). 79.4% had a CCI of 0 at start of CI; preexisting autoimmune disorders were rare. Median time since CI initiation was 36.4 months (range: 14.2, 133.9 months). Median length of CI treatment was 7.3 months (IQR: 2.1, 24.3 months); 15 patients were on treatment at the time of survey completion. Among those off treatment at the time of survey completion, median time off treatment was 27.1 months (IQR: 16.7, 40.4 months). The most common irAEs were rash (34.6%), colitis (24.3%), thyroiditis (19.6%), hepatitis (18.7%), and hypophysitis (13.1%). irAEs did not differ by age. Few patients reported symptoms at time of survey, most commonly aching joints (18%), fatigue (14%), aching muscles (13%), and difficulty sleeping (11%). Few (&lt; 12%) had difficulty with physical, role, emotional, cognitive, or social functioning and almost none (1%) reported anxiety, depression or pain on the EQ-5D. QOL was excellent, with a median of 83.3% on the EQ-5D global health score and no differences based on toxicities or time from treatment. Conclusions: Long-term survivors of MMel patients report few burdensome symptoms after CI therapy and have excellent QOL.

PNS231 THE VALUE OF EMBEDDED INTERVIEWS: CASE STUDY OF QUALITATIVE AND QUANTITATIVE ASSESSMENT OF THE PATIENT EXPERIENCE OF MEPOLIZUMAB SELF-ADMINISTRATION

To describe the value and operational learnings of embedded interviews using mepolizumab trials as a case study. Mepolizumab is licensed to treat severe eosinophilic asthma in the US. Development of a prefilled autoinjector (AI) and prefilled syringe (PFS) has been undertaken to allow self-administration, which may improve the patient treatment experience. Quantitative questionnaires [AI: n=153; PFS: n=56] and complementary qualitative exit interviews [AI: n=25; PFS: n=7] assessing the patient experience of self-injection were embedded in two real-world use studies of mepolizumab administered via an AI [N=159] and PFS [N=56]. • Capturing the patient experience through clinical endpoints alongside quantitative and qualitative patient reported outcomes provided a fuller picture of the value of the mepolizumab AI and PFS. • Qualitative interviews allowed improved interpretation of quantitative results. Example – mepolizumab AI/PFS self-administration studies Primary endpoint • > 99% of injections via both devices were successfully self-administered at week 8. Example of patient treatment experience results • Quantitative (satisfaction): >96% of respondents were “satisfied”/“very satisfied” with using the device (AI/PFS) at home. ○ AI qualitative response example: “… it’s comfortable. I have it at home, I’m independent from anyone else. I can do it any day of the week, any time of the day, and, you know, it’s easy to do. It’s not a big deal”. • Quantitative (convenience): >96% of respondents reported receiving mepolizumab using the device at home (AI/PFS) as “moderately”/”very”/”extremely” convenient. ○ AI qualitative response example: “It’s very convenient, because like I said, you don’t have to leave the house to go to some office in order to get it done”. Operationalisation learnings will allow for implementation improvements of future embedded interviews. Seeking the patient experience can provide valuable additional information. Including qualitative interviews alongside quantitative questionnaires increases response understanding. However, proactive consideration of the operationalisation of embedded interviews is necessary.

#ttc on Instagram: a multimodal discourse analysis of the treatment experience of patients pursuing in vitro fertilization

While searching the Internet for health information is now commonplace, giving and receiving medical expertise on social media platforms such as Instagram (IG) is underexplored. In order to investigate the ways in which social media platforms are a resource for seeking medical expertise, we employed a multimodal discourse analysis; specifically, we focused on the hashtag #ttc and the engagement of the IG community it comprised. We examined three main themes around medical expertise during treatment indexed by the hashtag: treatment protocol choices, treatment side effects and pregnancy diagnosis/confirmation. Our findings suggest that social media platforms provide a new arena in which patients can challenge medical expertise by circumventing it or adopting lay expertise instead of practitioner suggestions. We close with research implications and suggestions for further research.

\u201cI need somebody who knows about feet\u201d a qualitative study investigating the lived experiences of conservative treatment for patients with posterior tibial tendon dysfunction

BackgroundPosterior tibial tendon dysfunction is a disabling, chronic, progressive tendon condition that detrimentally affects foot, ankle and lower limb function. Research suggests that posterior tibial tendon dysfunction is poorly recognised and difficult to treat. When posterior tibial tendon dysfunction is diagnosed, the clinician is faced with a weak evidence base and guidelines for the common conservative treatments to guide their management. Moreover, there are no current evidence-based guidelines for the conservative management of posterior tibial tendon dysfunction. Emerging research suggests that posterior tibial tendon dysfunction not only has a physical impact on the patient, but it also has psychosocial impact on quality of life.Conservative treatments for posterior tibial tendon dysfunction are generally undertaken during early management. The most common are foot orthoses, exercises, bracing, lifestyle changes and injections. Quantitative evidence supporting conservative treatments for posterior tibial tendon dysfunction in relation to function, pain and patient reported outcome measures are reported in the literature.There is a paucity of qualitative research investigating the psychosocial impact of the common treatments for posterior tibial tendon dysfunction. Interpretative phenomenology is concerned with lived experience which is involves the detailed exploration of experience which is embedded within the social and temporal contexts of the lifeworld of the person. The aim of study research is to investigate the lived experience of conservative treatments for patients who have posterior tibial tendon dysfunction using Interpretative Phenomenological Analysis.MethodsFive participants with posterior tibial tendon dysfunction were purposively recruited from a private podiatry practice and semi-structured interviews were conducted to examine their lived experiences of treatment for posterior tibial tendon dysfunction. The data for this study was collected and analysed using Interpretative Phenomenological Analysis.ResultsThis research identified three superordinate themes which influenced the lived experience of treatment for these patients (i) adverse experience during the patient journey (ii) treatment burden, and (iii) negative self-concept.ConclusionThis study highlights some of what is anecdotally known about the lived experience of treatment for patients with posterior tibial tendon dysfunction, but has never been studied in a qualitative, methodological manner. This study addresses the gap in the qualitative literature. It reveals novel aspects of the lived experience throughout the patient journey, the detrimental impact of treatment burden, loss and negative self-concept. This evidence is important because it highlights the need for a greater understanding of the psychological and social factors that can influence the lived experience of treatment for this group of patients.