Predicting Pre-emptive Discussions of Biologic Treatment: Results from an Openness and Preference Survey of Inflammatory Bowel Disease Patients and Their Prescribers

Introduction

It is important to compare patient and provider discrepancies on stated openness to and preference for biologics as well as predictors associated with initial discussions on biologic use.

Methods

Patients (N = 263) and physicians (N = 100) completed a self-administered Web-based survey assessing demographics, health characteristics, and behaviors related to inflammatory bowel disease (IBD) treatment. Bootstrap methods were used to check discrepancies between providers’ and patients’ stated openness to and preference for biologics. Classification and regression tree (CART) analysis identified patient-specific predictors associated with initial biologics discussions.

Results

A total of 170 patients responded consistently to preference questions, and 169 patients responded consistently to openness questions. Physicians significantly overestimated patients’ openness to biologics in general (85.46% vs. 74.61%, p < 0.0001), but underestimated patients’ openness to the intravenous (IV) mode of administration (MOA; 55.97% vs. 63.96%, p < 0.0001). Overall, physicians significantly underestimated patient preference for IV MOA (22.07% vs. 42.35%, p < 0.0001) and, to a lesser extent, subcutaneous MOA (48.84% vs. 54.69%, p < 0.0001). Among Crohn’s disease (CD) patients (N = 123), CART threshold analysis identified an inpatient visit in the last 6 months, CD diagnosis for more than 3 years, and non-adherence to prior IBD treatment as most positively predictive of having an initial biologics discussion.

Conclusion

Physicians appear to underestimate patient preferences in favor of biologics, especially IV formulations. Since it is unclear if physicians were aware of the patients’ preferences beforehand, this study supports the need for validated, shared decision-making tools when initiating IBD treatment. Additional studies are necessary to measure physicians’ influences on patient preference/treatment-related decisions and the impact on patient outcomes.

     

The role of biologic in foot and ankle trauma—a review of the literature

Purpose of review

The use of biologics in orthopedics is becoming increasingly popular as an adjuvant in healing musculoskeletal injuries. Though many biologics involved in the management of foot and ankle injuries are used based on physician preference, reports of improved outcomes when combined with standard operative treatment has led to further clinical interest especially in foot and ankle trauma.

Recent findings

The most recent studies have shown benefits for biologic use in patients predisposed to poor bone and soft tissue healing. Biologics have shown benefit in treating soft tissue injuries such as Achilles ruptures as well as the complications of trauma such as non-unions and osteoarthritis.

Summary

Biologics have shown some benefit in improving functional and pain scores, as well as reducing time to heal in foot and ankle traumatic injuries, with particular success shown with patients that have risk factors for poor healing. As the use of biologics continues to increase, there is a need for high-level studies to confirm early findings of lower level reports.

     

Monitoring for and Characterizing Crizotinib Progression: A Chart Review of <Emphasis Type="Italic">ALK</Emphasis>-Positive Non-Small Cell Lung Cancer Patients

Introduction

Crizotinib is recommended as first-line therapy for ALK-positive non-small cell lung cancer (NSCLC), but within a year of treatment initiation many patients develop resistance. With the recent approval of second-generation ALK inhibitors, this study assessed how physicians monitor for and diagnose progression and how they alter treatment following progression on crizotinib.

Methods

A panel of oncologists from the United States were surveyed regarding their monitoring practices and criteria for diagnosing progression on crizotinib. The physicians also retrospectively provided data (March–June 2016) from the medical charts of their adult patients with locally advanced or metastatic ALK-positive NSCLC who progressed on crizotinib after the approval (April 2014) of the first second-generation ALK inhibitor, ceritinib.

Results

A total of 28 physicians responded to the survey. Data was abstracted on 74 patients. In the physician survey, most physicians (71%) reported monitoring for radiographic progression every 3–4 months. When new lesions were detected, physician response varied. Following a symptomatic isolated lesion, most physicians (75%) would add local therapy and resume crizotinib. Following multiple symptomatic lesions, 96% and 64% of physicians would switch to a new therapy depending on whether the lesions were extracranial or isolated to the brain, respectively. For the patient cohort, physician-defined progression on crizotinib was diagnosed after a median of 10 months, and within 30 days of diagnosis, 86% of patients discontinued crizotinib. Among all patients who discontinued crizotinib, 77% switched to ceritinib, 14% to chemotherapy, and 1% to alectinib. The remaining 7% did not receive additional systemic antineoplastic therapy.

Conclusion

The findings from this physician survey and retrospective chart review study suggest that physician response to the development of new lesions in crizotinib-treated ALK-positive NSCLC patients varies with location and extent of the lesions. Once patients were considered to have progressed, most of them were immediately switched to ceritinib.

Funding

Novartis Pharmaceuticals Corporation.

     

Assessing utility and completeness of information transmission during emergency department transfers

Background

The transfer of patients from community emergency departments to tertiary care centers is a daily occurrence in the practice of emergency medicine, but the completeness of medical data in the transfer documentation is a relatively unstudied area. The goal of this study was to evaluate the completeness of information transmitted in the transfer documentation between transferring and accepting institutions and its perceived value at the receiving tertiary center on medical management.

Methods

Prospective, observational, and convenience sample survey study at a tertiary referral center in Boston, MA.

Results

A total of 100 surveys were completed during the 2-month study period. The presence of the radiology report and the provider note was most important in physician assessment of utility of the transfer packet for subsequent care of patients, yet these were the most commonly missing items (31.1% and 21% respectively). Other common missing data were medication administration records, nursing notes, and laboratory results.

Conclusions

Medical data is absent in 15–31% of patients transferred from a community ED to a tertiary center. Provider notes and radiology reports were assessed as having the most utility to the receiving physicians.

     

Olanzapine vs haloperidol: treating delirium in a critical care setting

Objective

To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.

Design

Prospective randomized trial

Setting

Tertiary care university affiliated critical care unit.

Patients

All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.

Interventions

Patients were randomized to receive either enteral olanzapine or haloperidol.

Measurements

Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.

Main results

Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.

Conclusions

Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.

     

Bedeutung präoperativer Angst für den postoperativen Verlauf bei urologischen Patienten

Background

Preoperative anxiety is not systematically assessed during premedication appointments, although it may influence the postoperative course and outcome.

Objectives

The aim of this study was to assess preoperative anxiety in a sample of patients before major urological surgery and to characterize the impact on postoperative pain. An additional aim was to analyze the agreement between patients’ self-ratings and physicians’ anxiety ratings.

Patients and methods

In all, 127 male and 27 female patients participated in a prospective observational study. Preoperative anxiety was assessed with two validated instruments – the APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the State Scale of the STOA questionnaire (State-Trait Operation Anxiety) – during the premedication appointment. Physicians provided their subjective ratings on patients’ anxiety and need for information using the APAIS. The predictive value of preoperative anxiety for postoperative pain was evaluated.

Results

Nearly four out of ten patients were identified as “anxiety cases”; thereof women were more afraid than men were. Preoperative anxiety was not correctly assessed by physicians, who overestimated patients’ anxiety. In female patients, preoperative anxiety was predictive of increased postoperative pain scores.

Conclusion

Preoperative anxiety is a frequent concern and often not correctly assessed by physicians. The use of scoring systems to detect preoperative anxiety is useful in clinical routine and helps to decide on therapeutic interventions.

     

Low dose quetiapine induced galactorrhoea: a case report

Background

Quetiapine causes less prolactin elevation and/or galactorrhoea than other atypical antipsychotics.

Case Presentation

Ms AB had galactorrhoea and raised prolactin levels at only 100 mg of quetiapine daily.

Conclusion

Low dose quetiapine can also cause galactorrhoea.

     

Exploding Head Syndrome: a Review

Purpose of Review

To explain our current understanding of exploding head syndrome (EHS), an unusual and underreported sensory parasomnia.

Recent Findings

Based on findings from recent studies of EHS, the prevalence is higher than previously suggested by the literature, which historically has consisted mostly of case reports. The typical presentation also has been better illustrated by recent case series, and diagnostic criteria have been defined. Its pathophysiology is still unclear.

Summary

EHS is underrecognized and its symptoms are alarming, but a review of our current state of knowledge will allow physicians to make a diagnosis of this benign condition with greater confidence.

     

Public perception of female paramedics at King Abdulaziz Medical City,Saudi Arabia

Background

Although emergency medical service (EMS) providers recognize that both male and female paramedics are necessary, Saudi EMSs are currently fully staffed by men. Cultural bias against care provision by male paramedics to female victims in the absence of male guardians underscores the need for female paramedics. Consequently, we explored public perception of female paramedics at King Abdulaziz Medical City (KAMC), Riyadh.

Method

This observational, cross-sectional study used convenience sampling to assess the perceptions of patients, visitors, and employees at the emergency rooms in KAMC and King Abdullah Specialized Children’s Hospital via self-administered English- and Arabic-language questionnaires. Questionnaire reliability and validity were assessed in a pilot study.

Results

Three hundred twelve respondents completed the survey (67.30% men). The sample included 43.27% medical (40% paramedics, 22% physicians, 12% nurses, and 23% other) and 56.73% nonmedical participants, of whom 53% and 63%, respectively, strongly agreed regarding the importance of female paramedics. Moreover, in the male participant group, 6% of medical and 8% of nonmedical participants strongly disagreed with treatment of their female relatives by male paramedics, and 20% of medical and 30% of nonmedical participants declined medical help because female paramedics were unavailable.

Conclusions

Respondents rated the importance of trained female paramedics in the EMS system. Most strongly agreed that female and male paramedics had equal patient-management capabilities and skills.

     

Role of Side Effects,Physician Involvement,and Patient Perception in Non-Adherence with Oral Bisphosphonates

Introduction

The benefits of osteoporosis therapy are compromised by low adherence, thus requiring a better understanding of its barriers and unmet needs. The objective of this study was to assess reasons for non-adherence with oral bisphosphonates among osteoporotic women.

Methods

A cross-sectional patient survey of women who initiated therapy with risedronate or alendronate between the years 2010 and 2012 were non-adherent [Medication Possession Ratio (MPR) <70%] or switched therapy within the first year. Survey participants were identified using Maccabi Health Services computerized database. Patients who gave informed consent completed a 20-min telephonic survey, assessing reasons for discontinuation or switching, including physician involvement, side effects, administration regimen, perceptions of bone health, and medications’ efficacy.

Results

The study population included 493 females (mean age = 66 ± 7) of whom 40% discontinued all anti-osteoporotic therapy (mean MPR = 19%), 9% remained on initial therapy (mean MPR = 47%), and 51% switched therapy (mean MPR = 62%). Family history, fracture history, socioeconomic status, and index drug class and frequency were similar in all groups. The most common reasons for switching or discontinuation of the first-line therapy were gastrointestinal side effects, such as heartburn, acid reflux or other (40.0%), and physician recommendation (26.7%). The major reasons for complete discontinuation of therapy were side effects (26.9%) and physician recommendation (20.0%). Perceived low importance was more commonly mentioned than high cost of medication (14% vs. 3%).

Conclusion

Our findings highlight the importance of low tolerability to non-adherence with osteoporosis therapy and underlines poor patients’ awareness and sub-optimal physicians’ involvement in conveying the importance of this therapy.

Funding

Merck & Co Inc.

     

Wissen,Haltung und Meinung von Patienten zum neuen Patientenverfügungsgesetz

Background

In September 2009 a new legislation for advance care planning was introduced in Germany with the important characteristics of bindingness and unlimited validity for individual directives. Knowledge regarding this act and the attitude towards its characteristics among patients is unclear.

Aim of this study

Analysis of knowledge, attitude and opinion of patients in a general internal medical department regarding advance care planning in general and the recent German legislation.

Methods

A total of 200 consecutive patients in an internal medicine ward were interviewed with the help of a questionnaire regarding their attitude to and knowledge on advance care planning in general and the current legislation.

Results

Approximately 40?% of the patients had issued some form of directive (either advance care directive or health care proxy) and only 7.5?% were advised by their physicians to make an advance directive. Patients with no directive were not willing to deal with dying and death, were not well-informed about directives or assumed that relatives or physicians would make an appropriate decision. Characteristics of the new legislation were controversially assessed; only 21?% of the patients wished to have a literal implementation of their directive. Regarding the content of an advance directive, more than 80?% of the patients voted for pain control in the palliative setting.

Conclusion

The proportion of patients with a directive regarding advance care planning is only slowly increasing. Many patients are not well-informed, do not want to deal with dying or would like to delegate decisions to relatives and physicians. The present characteristics of the German legislation are controversially assessed and often do not represent the wishes of the patients.

     

Anonymisieren oder personalisieren?

Background

The subjective state of health with respect to pain and psyche was surveyed utilizing validated pain questionnaires in patients undergoing special pain therapy and represents the basis for targeted treatment measures.

Objective

The purpose of this study was to investigate the possible distortion of answers due to social desirability of responses in chronic pain patients.

Material and methods

During two survey periods assessing patient satisfaction using both anonymized and personalized questionnaires, the effects arising from socially desirable response patterns were analyzed. The sample consisted of chronic pain patients being treated in an inpatient therapy setting.

Results

In both periods of observation no significant impact on the response behavior of chronic pain patients was found in personalized or anonymized questionnaires.

Conclusion

The results of the study suggest that the responses of chronic pain patients with respect to their subjective state of health are not influenced by social desirability. Thus, scoring systems such as the German pain questionnaire will not be influenced by social desirability in chronic pain patients and can therefore be used as a part of diagnostics and therapy planning.

     

Context region discovery for automatic motion compensation in fluoroscopy

Purpose

Image-based tracking for motion compensation is an important topic in image-guided interventions, as it enables physicians to operate in a less complex space. In this paper, we propose an automatic motion compensation scheme to boost image guidence power in transcatheter aortic valve implantation (TAVI).

Methods

The proposed tracking algorithm automatically discovers reliable regions that correlate strongly with the target. These discovered regions can assist to estimate target motion under severe occlusion, even if target tracker fails.

Results

We evaluate the proposed method for pigtail tracking during TAVI. We obtain significant improvement (12 %) over the baseline in a clinical dataset. Calcification regions are automatically discovered during tracking, which would aid TAVI processes.

Conclusion

In this work, we open a new paradigm to provide dynamic real-time guidance for TAVI without user interventions, specially in case of severe occlusion where conventional tracking methods are challenged.

     

Phytomedicines in Acute Rhinosinusitis: A Prospective,Non-interventional Parallel-Group Trial

Introduction

The objective of this prospective, multicenter, parallel-group, non-interventional clinical trial (NIT) was to characterize the effectiveness of a treatment with the phytomedicines ELOM-080 and BNO 1016 in patients with acute rhinosinusitis (ARS).

Methods

A total of 228 patients suffering from ARS took part in this NIT and were treated for a maximum of 14 days with either BNO 1016 or ELOM-080. Focus was on improvement of rhinosinusitis-associated pain/discomfort and nasal congestion in real-life conditions of primary care setting, as assessed by numeric and verbal rating scale, and five-point Likert scale.

Results

The course of the key ARS symptom facial pain demonstrated a faster recovery in patients with ELOM-080, when compared to BNO 1016. ELOM-080 tended to be superior for several ancillary criteria and induced significantly higher patient satisfaction with regard to the improvement of feeling of general illness. Physicians assessed both products to be very effective and well tolerated. Adverse drug reactions classified as gastrointestinal disorders occurred in both groups to a comparable extent.

Conclusion

This trial demonstrated comparable effectiveness of a therapy of ARS with the phytomedicines ELOM-080 and BNO 1016, although the treatment with ELOM-080 resulted in a more rapid and more complete recovery in ARS key symptoms and tended to be superior for several ancillary criteria. Both treatments were well tolerated.

Trial registration number

NIS-6471.

Funding

G. Pohl-Boskamp GmbH & Co. KG.

     

Spinal Cord Stimulation,MILD Procedure,and Regenerative Medicine,Novel Interventional Nonopioid Therapies in Chronic Pain

Purpose of Review

Chronic pain is a highly prevalent condition affecting millions of individuals.

Recent Findings

In recent years, newer treatments have emerged that are changing the way clinicians treat pain pathogenesis, including novel nonopioid strategies. In this regard, spinal cord stimulation, the MILD procedure, and regenerative medicine have shown promise. This review summarizes recent literature on these three emerging treatment strategies.

Summary

The results of this review suggest that under certain conditions, spinal cord stimulation, the MILD procedure, and regenerative medicine can be effective treatment modalities.

     

Création d’un programme d’éducation thérapeutique en douleur chronique (PETDC) — Expérience Canadienne

Aims

Create an educational program in chronic pain (EPCP).

Material and methods

We used a four-step process to create the EPCP tailored to patient’s needs.

Results

Five groups of patients can benefit from the program annually. Based on their own assessment, patients stated that their knowledge of chronic pain improved between 2.8 to 24%. The satisfaction with the EPCP was 8.67/10.

Conclusion

Our EPCP helps patients gain and maintain the skills they need to best manage their lives with a chronic pain.

     

Current and Emerging Treatment Modalities for Leber’s Hereditary Optic Neuropathy: A Review of the Literature

Introduction

The purpose of this review is to present the current and emerging treatment alternatives for Leber’s hereditary optic neuropathy (LHON), emphasizing the most recent use of idebenone and stem cells or gene therapy.

Methods

A comprehensive literature review was performed at the PubMed database regarding the various treatment modalities for LHON.

Results

Treatment modalities for LHON include nutritional supplements, activators of mitochondrial biogenesis, brimonidine, and symptomatic and supportive treatment, but nowadays attention is being paid to idebenone and gene therapy or stem cells.

Conclusion

The treatment of LHON remains challenging, given the nature of the disease and its prognosis.

     

Promoting Patient and Family Partnerships in Ambulatory Care Improvement: A Narrative Review and Focus Group Findings

Introduction

Ambulatory practices that actively partner with patients and families in quality improvement (QI) report benefits such as better patient/family interactions with physicians and staff, and patient empowerment. However, creating effective patient/family partnerships for ambulatory care improvement is not yet routine. The objective of this paper is to provide practices with concrete evidence about meaningfully involving patients and families in QI activities.

Methods

Review of literature published from 2000–2015 and a focus group conducted in 2014 with practice advisors.

Results

Thirty articles discussed 26 studies or examples of patient/family partnerships in ambulatory care QI. Patient and family partnership mechanisms included QI committees and advisory councils. Facilitators included process transparency, mechanisms for acting on patient/family input, and compensation. Challenges for practices included uncertainty about how best to involve patients and families in QI. Several studies found that patient/family partnership was a catalyst for improvement and reported that partnerships resulted in process improvements. Focus group results were concordant.

Conclusion

This paper describes emergent mechanisms and processes that ambulatory care practices use to partner with patients and families in QI including outcomes, facilitators, and challenges.

Funding

Gordon and Betty Moore Foundation.

     

Fundamentals of Cardiovascular Molecular Imaging: a Review of Concepts and Strategies

Purpose of the Review

In this review, we will discuss the basic fundamentals of how to perform molecular imaging to better understand the underlying mechanisms contributing to cardiovascular disease.

Report Findings

Molecular imaging combines molecular biology with in vivo imaging. Molecular probes are used to target discrete biological processes such as cell death, inflammation, and angiogenesis. These probes emit signals that are detected by traditional imaging systems. Because the same disease processes can manifest in individuals in different ways, molecular imaging may emerge as an important strategy for delivering precision medicine.

Summary

Molecular imaging is a powerful tool that may help physicians provide more personalized care in the near future.

     

Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE,a Non-Interventional Study in the UK and Ireland

Introduction

The objective of this non-interventional study was to investigate the long-term safety and effectiveness of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) in the UK and Ireland.

Methods

Patients were prescribed CZP at their physicians’ discretion and followed during routine clinical practice for up to 88 weeks. DAS28(ESR) response (defined as at least a 1.2-point reduction from baseline) was measured in the full analysis set (FAS) at week 12, and patients were categorized by week 12 responder status in all subsequent analyses. The primary outcome was DAS28(ESR) response at week 78. Secondary outcomes included change from baseline in DAS28(ESR), HAQ-DI, and RADAI scores at week 78, and EULAR response at week 78. Adverse drug reactions (ADRs) were recorded for all patients who received at least one dose of CZP.

Results

A total of 149 patients were enrolled, of whom 111 (74.5%) formed the FAS. At week 12, 80 patients (72.1%) were DAS28(ESR) responders and 31 (27.9%) non-responders. Compared to non-responders, a greater proportion of week 12 responders had a DAS28(ESR) response at week 78 (43.8% versus 22.6%). Improvements in DAS28(ESR), HAQ-DI, and RADAI scores were also greater on average among week 12 responders, as was the proportion of patients meeting EULAR criteria. Overall, 9 patients (6.1%) experienced 13 ADRs during the study.

Conclusion

These data demonstrate the safety and effectiveness of CZP in adult patients with RA treated during routine clinical practice in the UK and Ireland.

Trial Registration

ClinicalTrials.gov identifier, NCT01288287.

Funding

UCB Pharma.