Patient Brochures Research Articles

Business Competition Related to The Rapid Test Service For Diagnosis of Covid-19 in Hospitals in Surabaya, Indonesia

The cost of rapid tests in several hospitals in Surabaya, Indonesia, turns out to be a burden to patients. These hospitals were suspected of a tying-in agreement which prohibited. This study aims to determine the impact of implementing the tying-in agreement and to deal with violations related to the COVID-19 rapid test's prices. The tying-in agreement on the rapid test facilities procurement is a violation of the law, and the perpetrators can go to prison. This research method is qualitative through a statutory and conceptual approach, equipped with virtual search techniques on several online media news. The study did not find evidence in the form of a written document regarding the hospitals' tying-in agreement but obtained patient admissions and brochures on the price of rapid tests, which had a detrimental effect on patients. The results show the existence of the rapid test's prices impacted the emergence of market access restrictions, creating monopoly markets, disguising price-fixing practices, and harming consumers of price variations. The study considered Government for providing COVID-19 rapid test health facilities at the same price in all hospitals.

Regulatory restrictions on the use of valproate in girls and women of childbearing potential: status update

In 2019, some restrictions for use of valproic acid in women with reproductive potential by regulatory authorities and the original drug manufacturer based on the results of studies in real clinical practice were introduced. During 2019–2021, there were a further clinical data accumulation and labeling changes. The review presents a critical analysis of the changes in prescribing information and product label. There is a long lead time from the moment when safety data become known to the moment when changes are made to the medicinal product label and patient brochures. Some of the changes, including the need for high doses of folic acid to prevent neural tube defects, are debatable. Repealing the provision for mandatory archiving of informed consent forms for valproic acid use in girls and women raises legal risks. Improvements in pregnancy prevention programs and further research on the safety of valproic acid in real-world clinical settings are needed.

Patient Preferences for Rituximab Additional Risk Minimization Measures: Results From an International Online Survey.

ObjectivePatients’ opinions are essential in optimizing risk minimization measures (RMMs) because they bring their real-life experience of disease management and medicines’ use into the regulatory assessments. The aim of the survey launched in 2018 by the European Medicines Agency, in collaboration with the Pharmacovigilance Risk Assessment Committee, was to consult targeted patient groups treated with rituximab for nononcology indications to evaluate their preferences on how to receive information on progressive multifocal leukoencephalopathy and (serious) infections. Additional RMMs such as educational materials for physicians and patients including a patient alert card (PAC) and a patient brochure (PB) are in place to minimize these risks.MethodsA question-based online survey in English created on the EU-Survey platform and disseminated primarily via relevant European patient organizations.ResultsMost patients (47 of 61) had knowledge of these potential adverse effects. Mostly, they were informed by a healthcare professional. Both a PAC and a PB were supported as useful tools to raise awareness of these adverse effects and thus minimize the potential risks among patients. Where the participants had to choose only 1 of these educational materials, 43 of them preferred a PAC, a shorted description that is always held by the patient and reaches the relevant healthcare professional when needed.ConclusionsCollecting patients’ preferences supports periodic assessment of additional RMMs and increase transparency of regulatory processes. Considering the limitations of this initial survey, further investigation is needed to generalize the results into patients’ safety outcomes.

Development of Patient Education Material for Proton Pump Inhibitor Deprescribing: A Mixed-Methods Study.

Proton pump inhibitor (PPI) deprescribing is recommended in case of inappropriate use. Patient education materials are key elements in the deprescribing process. The study objective was to develop patient education material for PPI deprescribing in primary care in France. This was a mixed-methods study involving (1) a literature review of the existing patient education materials on PPI deprescribing to identify key points to optimize the layout and content of the document; (2) development of a first version of the brochure by a pluri-professional steering group, following the national reference methodology of the French National Authority for Health (Haute Autorité de Santé) and iterative modifications of the patient brochure; (3) assessment of the content and understandability of the brochure by questionnaires followed by semistructured interviews with target patients; and (4) iterative brochure readability assessment with the Flesch reading ease tool. The final patient education material is a double-sided A3 brochure-that is, 4 A4 pages. The first round of user testing by questionnaire (n = 14 patients) led to modifications to improve the document understandability, validated in the second round of user testing by questionnaire (n = 10 patients). The semistructured interviews (n = 10 patients) highlighted an adequate comprehension, whereas actionability required some minor modifications. The readability test score of the final education brochure was 59.4. This patient education brochure for PPI deprescribing is targeted to patients in primary care. Its impact on PPI deprescribing will be assessed in a population-based pragmatic trial in primary care.

Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial

BackgroundColorectal cancer (CRC) is a leading cause of cancer burden worldwide. In France, it is the second most common cause of cancer death after lung cancer. Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. Our aim is to assess the impact of an intervention combining HL and CRC screening training for general practitioners (GPs) with a pictorial brochure and video targeting eligible patients, to increase CRC screening and other secondary outcomes, after 1 year, in several underserved geographic areas in France.MethodsWe will use a two-arm multicentric randomized controlled cluster trial with 32 GPs primarily serving underserved populations across four regions in France with 1024 patients recruited. GPs practicing in underserved areas (identified using the European Deprivation Index) will be block-randomized to: 1) a combined intervention (HL and CRC training + brochure and video for eligible patients), or 2) usual care. Patients will be included if they are between 50 and 74 years old, eligible for CRC screening, and present to recruited GPs. The primary outcome is CRC screening uptake after 1 year. Secondary outcomes include increasing knowledge and patient activation. After trial recruitment, we will conduct semi-structured interviews with up to 24 GPs (up to 8 in each region) and up to 48 patients (6 to 12 per region) based on data saturation. We will explore strategies that promote the intervention’s sustained use and rapid implementation using Normalization Process Theory. We will follow a community-based participatory research approach throughout the trial. For the analyses, we will adopt a regression framework for all quantitative data. We will also use exploratory mediation analyses. We will analyze all qualitative data using a framework analysis guided by Normalization Process Theory.DiscussionLimited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among the most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeated screening).Trial registrationRegistry: ClinicalTrials.gov.Trial registration number: 2020-A01687-32.Date of registration: 17th November 2020.

Switching COPD patients from the disposable to the new reusable Respimat soft mist inhaler: a real-world study from Switzerland

Objective The aims of the survey were to assess first experiences of Swiss COPD patients switching from the disposable to the new reusable Respimat inhaler, and to evaluate physicians´ and patients´ views of the new training material. Methods Patients with a confirmed diagnosis of COPD using a disposable Respimat inhaler for at least three months were included. Patients´ demographics, COPD stage, current treatment, and comorbidities relevant for the handling of the device were assessed. Further, patients were trained on the reusable Respimat by placebo inhaler, patient brochure, video cards/demo films and SMS reminder service. After at least one cartridge change, patients gave comprehensive feedback on their satisfaction with the reusable Respimat and physicians evaluated the need for re-training. Results 235 patients participated in the survey. Of these, 37% suffered from comorbidities restricting the handling of the Respimat. 216 (92%) patients had a better overall satisfaction with the reusable than with the disposable Respimat. Dose counter (86%), monthly preparation (81%) and daily handling (77%) were also assessed as better by most of the patients. In 80% of cases, the user ability was stated as better than for the disposable Respimat. Less than 15% of the patients required further training. Placebo inhaler was the mostly preferred training material by both, physicians (in 86% of the patients) and patients (75%). In patients with comorbidities affecting inhaler handling, overall satisfaction was also better in 86% of the patients. Conclusion The majority of patients were satisfied with the new reusable Respimat device and proper handling could be attained using the provided training material, even in patients with restricting comorbidities.

Understanding the healthcare journey from a patient's perspective

According to Australian Institute of Health and Welfare (2014) chronic conditions are the leading cause of illness, disability and death in Australia. Tackling chronic conditions and their causes is the biggest challenge facing Australia’s health system. Through interaction with patients and their families it has revealed that they often experience:• a fragmented system, with providers and services working in isolation from each other rather than as a team; service duplication or absent / delayed services;• difficulty in accessing services due to lack of mobility, transport, language, financial barriers and remoteness; and feelings of disempowerment, frustration and disengagement.Our service intend to focus on developing our Integrated Care program to be patient centered, to work with patients, families and carers to deliver individualized care that is led by the patient for the patient. Consumer engagement has shaped and driven the planning and delivery of this project.The project aims to work in partnership with patients, families and carers to capture their perception and their healthcare experience. This involved collecting responses through a validated questionnaire known as Patient Reported Experience Measures (PREMs) provided by the Agency of Clinical Innovation (ACI).The PREMs questionnaire captured most accurately patient's healthcare perspective and generated valuable data on intervention effectiveness and service delivery.We have worked on interventions based on the identified barriers and challenges from the PREMs data results.Patients and especially families and carers identified that they were often at a loss with “Is there any support from community if I have chronic condition or terminal illness?"Part of the many outcomes from this project is the development of 3 information brochures for clinicians, general practitioners and patients outlining essential information. These brochures aims to provide streamlined processes which would hopefully improve access to appropriate interventions and support services in the community.Of the 31 patients from the survey, 75% have identified that, by NOT being able to get access to community health care services is the main reason they experience difficulty in managing their chronic conditions and this is often accompanied by a feeling of despair. Key to our project is the patient’s voice. We engaged consumer representation and learnt how treating families with dignity, compassion and respect promotes autonomy and health-seeking behavior.Feedback in particular from patients has been positive and particularly valuing the holistic and integrated approach to their care:“ Great resource, in easy to read format, basic information to help us navigate the services available in the community”“Don’t like hospitals, I’d rather be in the comfort of my home, pleased to know that help is available”Integrated care has wide reaching impacts, our project has improved connections between patients and community services. This is as much a preventive health initiative that seeks to reduce hospital admissions and negative engagement for patients with chronic conditions.We believe that this project will continue to keep patients with chronic conditions out of hospital, by engaging their families in support and early intervention, thus improving their health and wellbeing.

CN62 Heading home! A guidance brochure for hemato-oncological patients being discharged after a long-term stay at an isolation ward

As a consequence of a haematologic malignancy or high-dose chemotherapy, patients often have a reduced immune system. At the isolation ward the nursing team supports the patient to keep track of hygenic regulations and nutrition restrictions. When heading home after several weeks as an in-patient, the patient is confronted with the

An information leaflet for patients receiving treatment by intravitreal drug injections. Recommendations of the Expert Council on retinal and optic nerve diseases of the Association of Ophthalmologists, an All-Russian public organization

The widespread introduction of intravitreal drug injections into clinical practice has highlighted a number of issues to be solved, including the risk of serious complications, the treatment burden on patients and the patient’s insufficient adherence to treatment, as well as a significant effect on the healthcare cost and effort. One of the ways to resolve the issues is to increase the patients’ awareness concerning the therapy they are about to receive, which contributes to the patients’ understanding of the details of treatment and enables them to make correct decisions. The best option of presenting such information to the patient is to provide them with a written document. The Expert Council on Retinal and Optic Nerve Diseases of the All-Russian Association of Ophthalmologists has developed, approved and tested an information brochure for patients who receive intravitreal injections. It offers brief information on what the procedure is, contraindications, details of preparation, and symptoms, both common ones and those requiring emergency assistance. The paper outlines the results of the study and presents a layout of an information leaflet for patients recommended for use in the Russian Federation.

Readability Analysis of the American Society of Ophthalmic Plastic & Reconstructive Surgery Patient Educational Brochures

ABSTRACT Introduction: Previous studies have shown patient education material (PEM) in ophthalmology has been written at levels exceeding appropriate reading levels. However, information for readability in the field of oculoplastics remains limited. The aim of this study was to evaluate the readability of patient educational brochures from the American Society of Ophthalmic Plastic & Reconstructive Surgery (ASOPRS). Methods: Patient educational brochures from ASOPRS were analyzed for readability. The body of text from all 18 ASOPRS patient brochures was analyzed by ten validated tests for English readability assessment: Flesch Reading Ease Test (FRE), Flesch-Kincaid Grade Level (FKGL), Simple Measure of Gobbledygook (SMOG), Coleman-Liau Index (CLI), Gunning Fog Index (GFI), New Dale-Chall Readability (NDC), FORCAST, Fry Graph Readability (FG), Raygor Readability Estimate (RRE), and New Fog Count (NFC). Results: The mean (± SD) readability scores from the 18 ASOPRS patient brochures were 48 (4.3), 11.0 (0.8), 13.0 (0.7), 11.7 (0.8), 13.6 (0.9), 11.3 (0.8), 11.1 (0.5), 12.1 (1.5), 12.2 (1.0), and 10.6 (1.3) for FRE, FKGL, SMOG, CLI, GFI, NDC, FORCAST, FG, RRE, and NFC, respectively. All ten of the mean readability scores were above the recommended reading levels. Conclusions: These findings show that the average patient may have difficulty understanding educational information provided by ASOPRS patient brochures, thereby hindering their ability to make informed decisions on their healthcare. Revision with readability as a primary goal, with input from patients and caregivers, may be necessary to improve health literacy among patients who seek oculoplastic care.

What Is Known about Community Pharmacy-Based Take-Home Naloxone Programs and Program Interventions? A Scoping Review.

A variety of new sources describing community pharmacy-based take-home naloxone (THN) programs have emerged recently in the literature. There is a need to define the types of take-home naloxone programs being offered to support future research designs in implementing and evaluating standardized programs that fill pharmacist and patient knowledge gaps and lift current barriers for optimal community pharmacy naloxone provision. The objective of this paper is to summarize the literature on community pharmacy-based THN programs, including specific program interventions used to increase naloxone dispensing, naloxone availability and dispensing patterns, facilitators and barriers for the THN programs, and knowledge gaps. Online databases such as PubMed, EMBASE, Scopus, and International Pharmaceutical s (IPA) and a search of the grey literature were used to identify eligible sources. Sources were screened by two reviewers for eligibility in COVIDENCE software. Both reviewers compared screening results and resolved conflicts through discussion. A data extraction form for all identified full texts was completed by both reviewers and results were compiled through reviewer discussion. Fifty-two sources met the eligibility criteria. The top three barriers identified were: cost/coverage of naloxone, stigma, and education/training for pharmacists. THN program interventions included screening tools, checklists, pocket cards, patient brochures, and utilizing the pharmacy management system to flag eligible patients. Patient knowledge gaps included naloxone misinformation and lack of awareness, while pharmacists demonstrated administrative, clinical, and counselling knowledge gaps. Naloxone availability was found to be highly variable, where independent and rural pharmacies were less likely to stock or dispense naloxone. Further, pharmacies located in districts with higher rates of opioid overdose deaths and lower household income were also less likely to have naloxone available. This review identified multiple new programs, showcasing that the implementation and evaluation of THN programs are an expanding area of research. Future research should focus on implementing and evaluating a THN program through a randomized controlled trial design that incorporates solutions for the barriers and knowledge gaps identified in this study.

Acceptance and self-reported use of a dementia care toolbox by general practice personal: results from an intervention study in German practices

BackgroundDementia is an age-related syndrome that is estimated to affect 46.8 million people worldwide (2015). In ageing populations, the prevalence of dementia is expected to increase. General practitioners (GPs) are often the first to be contacted when signs of dementia appear. This cluster-randomised trial (CRT) investigates the effects of a dementia care toolbox mailed to GP practices to facilitate dementia care. It contained patient brochures and posters for the waiting room in three languages, information cards for professionals and practical tools in three languages. The GPs’ and practice assistants’ (PrAs) use of and opinion about the toolbox is reported here.MethodsThree months after receiving the toolbox, participating GPs and PrAs were sent a standardised, self-administered questionnaire asking about the use and helpfulness of the various toolbox items by mail.ResultsA total of 50 GPs and PrAs (14 GPs and 36 PrAs) from 15 practices completed the questionnaire. Of the participants, 82.0% reported using at least one of the tools, while 18.0% had used none. In descending order, the patient brochures (70.0%), the information card (58.0%) and the poster (40.0%) were used. In general, the brochures (52.1%), the information card (44.9%) as well as the poster (28.6%) were perceived as helpful.ConclusionOverall, the dementia toolbox was widely accepted by both professional groups. Future research should investigate long-term effects of information strategies for GP practice settings.Trial registrationGerman Clinical Trials Register, DRKS00014632. Registered 02 August 2018. Clinical register of the study coordination office of the University hospital of Bonn. Registered 05 September 2017.

Patient Perception of Mobile Phone Apps for the Care and Prevention of Sexually Transmitted Diseases: Cross-Sectional Study.

BackgroundIn the emerging era of digitalization and electronic health, various health-related apps have been launched, including apps for sexually transmitted diseases. Until now, little has been known about how patients perceive the value of such apps.ObjectiveTo investigate patient’s attitudes and awareness toward sexually transmitted disease–related apps in an outpatient sexually transmitted disease clinic setting.MethodsA cross-sectional study was conducted at a dermatovenereological outpatient unit between April and July 2019. Patients completed a self-administered questionnaire on their perceptions of the popularity and usefulness of sexually transmitted disease–related apps. Descriptive analysis was performed with expression of categorical variables as frequencies and percentages. For continuous variables, the median, range, and interquartile range were indicated. Contingency tables and chi-square tests were used to investigate associations between sociodemographic data and items of the questionnaire.ResultsA total of 226 patients were surveyed (heterosexual: 137/193, 71.0%; homosexual: 44/193, 22.8%; bisexual: 12/193, 6.2%); 11.9% (27/225) had previously used health-related apps. Nearly half of the patients (97/214, 45.3%) specifically considered sexually transmitted disease–related apps useful, 47.8% (100/209) voted that they could supplement or support the consultation of a physician. Interestingly, only 35.1% (74/211) preferred a printed patient brochure on sexually transmitted diseases over downloading and using an app, but 64.0% (134/209) would download a sexually transmitted disease–related app recommended by their physician. General information regarding sexually transmitted diseases (93/167, 55.7%), evaluation of skin diseases based on photos or videos (78/167, 53.3%), information on the prevention of sexually transmitted diseases (76/167, 45.5%), mediation of nearby contact points or test sites (74/167, 44.3%), anonymous medical advice (69/167, 41.3%), and calculation of the risk of having a sexually transmitted disease (63/167, 37.3%) were rated as the most important features. Men were more likely than women to find sexually transmitted disease–related apps useful in general (P=.04; χ2=6.28) and to pay for such apps (P=.01; χ2=9.19). Patients aged <40 years would rather download an app recommended by their physician (P=.03; χ2=7.23), whereas patients aged >40 years preferred reading a patient brochure on sexually transmitted diseases (P=.02; χ2=8.14).ConclusionsThis study demonstrated high general interest in the use of sexually transmitted disease–related apps in this sample of dermatovenereological outpatients. In particular, young age and male sex were significantly associated with a positive perception, underlining the high potential of apps in the prevention and early recognition of sexually transmitted diseases in this group. Future studies are warranted to validate these findings in other populations.

Evaluating Recruitment Strategies for a Randomized Clinical Trial with Heart Failure Patients.

Recruiting participants with chronic medical conditions is time-consuming and expensive. Electronic medical record databases and patient portals may enable outreach to larger numbers of patients in comparison to face-to-face methods. We aimed to describe the yields, benefits, and limitations of recruitment strategies used for a randomized clinical trial of cognitive behavioral therapy for insomnia among patients with chronic stable heart failure (NCT02660385). We used multiple recruitment strategies including clinic-based recruitment, letters to patients identified from electronic databases, the patient portal, brochures and posters placed in clinics, presentations to heart failure support groups, and online advertising. We screened 10,291 medical records, enrolled 231 participants, and 195 participants completed baseline data collection. We enrolled 92 (23%) participants using clinic-based recruitment, 24 and 29 (6% and 10%) using letters to patients from two electronic databases, and 42 (55%) via the patient portal. Multiple recruitment strategies and flexibility are needed to achieve recruitment goals.

Approach to sexuality and sexual dysfunction by reproductive doctors in France

Summary Numerous studies have examined the negative impact of medically assisted reproduction (MAR) on patients’ sex lives. It appears necessary to question patients and sometimes to counsel them about management for their sexual and reproductive health. In this study prospective, quantitative, multicenter trial conducted from December 2018 through February 2019, we contacted the offices of all clinical MAR centers registered with the Agence de la Biomedecine (Biomedical Agency) to obtain a list of email addresses of the doctors working there and sent them questionnaires. We received 171 responses. The respondents were very predominantly women (89%), and their median age was 34 years (range: 28–64). Overall, 56% always discussed sexual function during their first consultation, 30% often, and 14% sometimes. We compared two groups: the “regular discussion” (RD) group, which included the doctors (n = 147) who responded “always” and “often”. The “occasional discussion” (OD) group included those (n = 24) who responded “sometimes”. The RD group discussed scheduling sexual relations less often than the OD group (P = 0.029). The RD and OD groups differed significantly in their rates of questions about the frequency of sexual relations (P = 0.04) and about problems of penetration (P = 0.025) and desire (P = 0.041); the RD group asked more often about all of these topics. In the RD group, 37% of the respondents had a sex therapist working at their center, and in the OD group, 21%, while respectively 9% and 17% did not know to whom or where to refer these patients, and 93% and 75% thought a sex therapist with expertise in MAR would be useful at their center. This study shows deficiencies in the management of sexual dysfunctions in MAR patients. Some actions that might improve the situation include: the creation of a directory of sex therapists, the creation of job lines at MAR centers for sex therapists specialized in this field, and the development of patient brochures and questionnaires.

Survey of Third-Party Parenting Options Associated With Fertility Preservation Available to Patients With Cancer Around the Globe.

PurposeIn the accompanying article, “Survey of Fertility Preservation Options Available to Patients With Cancer Around the Globe,” we showed that specific fertility preservation services may not be offered at various sites around the world because of cultural and legal barriers. We assessed global and regional experiences as well as the legal status of third-party reproduction and adoption to serve as a comprehensive international data set and resource for groups that wish to begin oncofertility interventions.MethodsWe provide data on the legalities of third-party assisted reproductive technologies and other family-building options in the 28 oncofertility-practicing countries surveyed.ResultsWe found regional and country differences that will be important in the development of tailored resources for physicians and for patient brochures that are sensitive to these local restrictions and cultural norms.ConclusionBecause many patients first consult Web-based materials, the formal assessment of the availability of these options provides members of the global oncofertility community with data to which they might otherwise not have ready access to better serve their patients.

The Difficulty of German Information Booklets on Psoriasis and Psoriatic Arthritis: Automated Readability and Vocabulary Analysis

BackgroundInformation-seeking Psoriasis or Psoriatic Arthritis patients are confronted with numerous educational materials when looking through the internet. Literature suggests that only 17.0-21.4% (Psoriasis, Psoriatic Arthritis) of patients have a good level of knowledge about psoriasis treatment and self-management. A study from 1994 found that English Psoriasis/Psoriatic Arthritis brochures required a reading level between grades 8-12 to be understandable, which was confirmed in a follow-up study 20 years later. As readability of written health-related text material should not exceed the sixth-grade level, Psoriasis/Psoriatic Arthritis material seems to be ill-suited to its target audience. However, no data is available on the readability levels of Psoriasis/Psoriatic Arthritis brochures for German-speaking patients, and both the volume and their scope are unclear.ObjectiveThis study aimed to analyze freely available educational materials for Psoriasis/Psoriatic Arthritis patients written in German, quantifying their difficulty by assessing both the readability and the vocabulary used in the collected brochures.MethodsData collection was conducted manually via an internet search engine for Psoriasis/Psoriatic Arthritis–specific material, published as PDF documents. Next, raw text was extracted, and a computer-based readability and vocabulary analysis was performed on each brochure. For the readability analysis, we applied the Flesch Reading Ease (FRE) metric adapted for the German language, and the fourth Vienna formula (WSTF). To assess the laymen-friendliness of the vocabulary, the computation of an expert level was conducted using a specifically trained Support Vector Machine classifier. A two-sided, two-sample Wilcoxon test was applied to test whether the difficulty of brochures of pair-wise topic groups was different from each other.ResultsIn total, n=68 brochures were included for readability assessment, of which 71% (48/68) were published by pharmaceutical companies, 22% (15/68) by nonprofit organizations, and 7% (5/68) by public institutions. The collection was separated into four topic groups: basic information on Psoriasis/Psoriatic Arthritis (G1/G2), lifestyle, and behavior with Psoriasis/Psoriatic Arthritis (G3/G4), medication and therapy guidance (G5), and other topics (G6). On average, readability levels were comparatively low, with FRE=31.58 and WSTF=11.84. However, two-thirds of the educational materials (69%; 47/68) achieved a vocabulary score ≦4 (ie, easy, very easy) and were, therefore, suitable for a lay audience. Statistically significant differences between brochure groups G1 and G3 for FRE (P=.001), WSTF (P=.003), and vocabulary measure (L) (P=.01) exist, as do statistically significant differences for G2 and G4 in terms of FRE (P=.03), WSTF (P=.03) and L (P=.03).ConclusionsOnline Psoriasis/Psoriatic Arthritis patient education materials in German require, on average, a college or university education level. As a result, patients face barriers to understanding the available material, even though the vocabulary used seems appropriate. For this reason, publishers of Psoriasis/Psoriatic Arthritis brochures should carefully revise their educational materials to provide easier and more comprehensible information for patients with lower health literacy levels.

Enrollment Obstacles in a Randomized Controlled Trial: A Performance Survey of Enrollment in BEST-CLI Sites

Although randomized controlled trials (RCTs) provide the most reliable form of scientific evidence, they are challenging to complete because of a variety of enrollment obstacles. We evaluated obstacles in a large RCT by comparing survey results at high-performing sites (HPS) and low-performing sites (LPS). The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is a prospective, pragmatic, multicenter, and multispecialty RCT that will compare clinical outcomes, quality of life, and cost in patients with CLI randomized to surgical bypass or endovascular therapy. BEST-CLI aims to enroll 2100 patients at 160 sites in North America, Europe, and New Zealand. We surveyed the 30 HPS and 30 LPS to assess perceptions of enrollment obstacles. HPS were defined by enrollment of 0.5 subjects or more per month or more than 8 total subjects enrolled. LPS were defined by enrollment of 0.1 subjects per month or only 1 subject total. Responses were compared by site performance status. There were 22 of 30 (73%) HPS and 14 of 30 (47%) LPS that answered the survey (P=0.06), including 17 investigators and 31 coordinators. The mean total enrollment and rate of enrollment at HPS and LPS were 12.5 subjects at 1.5 subjects/month and 1.0 subject at 0.1 subjects/month, respectively. The most common barrier to enrollment at HPS was difficulty convincing patients and their families to participate (36%), whereas at LPS both difficulty convincing patients and difficulty motivating investigators to enroll (29% each) were most frequently cited. At HPS, the most common obstacle to consenting patients for the trial was patient/family having strong preference toward revascularization strategy (32%) and at LPS it was patient/family not wanting to have treatment chosen at random (36%). At 55% of HPS and 43% of LPS, the trial team was reported as extremely collaborative (P=0.73), whereas 68% of HPS and 64% of LPS reported having identified a trial champion on their team (P=1). The most restrictive perceived enrollment criterion at HPS was prior index limb stenting with significant restenosis (32%), whereas at LPS it was excessive risk for surgical bypass (43%). Materials to aid enrollment were used equally at HPS and LPS: patient brochures at 59% HPS and 64% LPS (P=1); investigator talking points at 45% of HPS and 36% of LPS (P=0.73). Patient perceptions and investigator biases are significant challenges to enrollment in large RCTs. In the BEST-CLI trial, difficulty convincing patients and families to allow treatment randomization and difficulty in motivating investigators were major enrollment obstacles.

Effective stakeholder engagement: design and implementation of a clinical trial (SWOG S1415CD) to improve cancer care

BackgroundThe Fred Hutchinson Cancer Research Center has engaged an External Stakeholder Advisory Group (ESAG) in the planning and implementation of the TrACER Study (S1415CD), a five-year pragmatic clinical trial assessing the effectiveness of a guideline-based colony stimulating factor standing order intervention. The trial is being conducted by SWOG through the National Cancer Institute Community Oncology Research Program in 45 clinics. The ESAG includes ten patient partners, two payers, two pharmacists, two guideline experts, four providers and one medical ethicist. This manuscript describes the ESAG’s role and impact on the trial.MethodsDuring early trial development, the research team assembled the ESAG to inform plans for each phase of the trial. ESAG members provide feedback and engage in problem solving to improve trial implementation. Each year, members participate in one in-person meeting, web conferences and targeted email discussion. Additionally, they complete a survey that assesses their satisfaction with communication and collaboration. The research team collected and reviewed stakeholder input from 2014 to 2018 for impact on the trial.ResultsThe ESAG has informed trial design, implementation and dissemination planning. The group advised the trial’s endpoints, regimen list and development of cohort and usual care arms. Based on ESAG input, the research team enhanced patient surveys and added pharmacy-related questions to the component application to assess order entry systems. ESAG patient partners collaborated with the research team to develop a patient brochure and study summary for clinic staff. In addition to identifying recruitment strategies and patient-oriented platforms for publicly sharing results, ESAG members participated as co-authors on this manuscript and a conference poster presentation highlighting stakeholder influence on the trial. The annual satisfaction survey results suggest that ESAG members were satisfied with the methods, frequency and target areas of their engagement in the trial during project years 1–3.ConclusionsDiverse stakeholder engagement has been essential in optimizing the design, implementation and planned dissemination of the TrACER Study. The lessons described in the manuscript may assist others to effectively partner with stakeholders on clinical research.

2260-PUB: Inpatient Diabetes Patient Brochure: What You Need to Know while You Are in the Hospital

Hospitalized patients with diabetes, whether previously on insulin or not, are generally treated with insulin. This change from outpatient medication, the type of insulin, and insulin regimen may be significantly different from what the patient is familiar with and may result in confusion, discomfort or even confrontation about the treatment plan. To ease the transition from outpatient to inpatient, we developed a “Brochure for Patients with Diabetes: What you need to know while you are in the hospital” to help make the patient feel more comfortable about the glycemic care they receive and improve patient satisfaction. The specific items covered in the brochure are: 1) Why the management of your diabetes may be quite different from what you usually do at home; 2) Goals for blood sugars (why different from home: fighting infections, avoiding hypoglycemia); 3) How we manage your blood sugar levels; 4) Blood sugar checks (how often); 5) Diet (restrictions, meals on demand); 6) Discharge planning; 7) Common questions such as use of own meter, reasons for different insulins, pumps, and CGM. The brochure is printed for the patient with the first time any insulin order set is ordered. The brochure is available in Spanish, Chinese and Russian. Evaluation: We audited brochure distribution to determine percentage of patients who received the brochure and developed a survey to determine the patient’s understanding of the brochure. Results: Audit results: After upgrades to the order sets so brochure would be printed, 100% of 50 charts had printed brochures. The survey: was hand delivered to 40 consecutive patients on insulin. 32 of the patients had ≧90% correct responses. The remaining 8 averaged 60% correct response. Conclusion: We successfully produced a brochure that explains inpatient diabetes management to newly admitted patients. Whether the patients who had decreased understanding may have been too ill to completely understand the brochure and possible changes in patient satisfaction remain to be explored. Disclosure R.J. Rushakoff: None. H.W. MacMaster: None.