Standardizing risk: Development of disease and regimen-specific side effect language to enhance consent and chemotherapy treatment plan.

162 Background: The American Society of Clinical Oncology recommends the use of a synoptic Chemotherapy Treatment Plan (CTP) to define care including outlining anticipated side effects of chemotherapy. Dana-Farber Cancer Institute (DFCI) sought to improve their existing CTP template in the Electronic Medical Record (EMR) by standardizing side effect language. While DFCI’s existing CTP template contained a side effect section, it was burdensome, requiring clinicians to develop and list the risks for individual treatments. Side effect language varied in content and length, often inaccurately depicting the risks of treatment. DFCI created standardized, disease and regimen specific side effect templates, accessible within the EMR, in order to populate the side effects section of the CTP and consent. Methods: A multi-disciplinary team comprised of physicians, pharmacists, and administrators developed side effect language for chemotherapy regimens. Through research of published materials, a pharmacist wrote unique side effect language for each regimen, translated into a 6th grade reading level. The physicians reviewed the templates for accuracy and completeness making clinical edits to doses, schedules, and risks. Administrators assessed the language for readability using DFCI’s approved Risk Lay Language and built the side effect templates into the EMR. Clinicians access the templates in the CTP section of the EMR and populate the CTP with the appropriate disease and regimen-specific language. Results: There are 36 adult solid tumor disease categories at DFCI. Side effect profiles were developed for 27 (75%) of these categories. By fall 2014, 100% of the side effect profiles will be completed and available in the EMR. In total, 612 regimens will have specific side effect language written and built into the EMR as custom paragraphs. To date, 500 (82%) of the side effect profiles are in development. Conclusions: Building standardized disease and regimen specific side effect language provides patients and clinicians with an accurate depiction of the risks of treatment; subsequently ensuring proper patient education and elimination of provider documentation burden.

Download Full-text

Subjective experience of electroconvulsive therapy

Psychiatric Bulletin ◽

10.1192/pb.28.8.289 ◽

2004 ◽

Vol 28 (8) ◽

pp. 289-291 ◽

Cited By ~ 11

Author(s):

Susan M. Benbow ◽

Joe Crentsil

Keyword(s):

Side Effects ◽

Electroconvulsive Therapy ◽

Side Effect ◽

Subjective Experience ◽

Treatment Plan ◽

Clinical Implications ◽

Policies And Procedures ◽

Routine Monitoring

Aims and MethodPeople receiving electroconvulsive therapy (ECT) in one clinic completed side-effect rating questionnaires during treatment, and a questionnaire rating their experience of different aspects of treatment on completion of the treatment course.ResultsSide-effects were commonly reported, but predominantly rated as mild or moderate. Most people reported that ECT had made them a little or a lot better, and that the treatment had been fairly or very well explained. Fewer than a fifth of respondents rated ECT as slightly or much worse than going to the dentist.Clinical ImplicationsWe recommend routine monitoring of the subjective experience of ECT, during treatment and on completion of the course. Ratings should inform the treatment plan, the policies and procedures of the ECT clinic.

Download Full-text

Assessing the Understanding of Pediatric-Oriented Medication Education Materials Versus Standard Available Education Materials

The Journal of Pediatric Pharmacology and Therapeutics ◽

10.5863/1551-6776-23.5.362 ◽

2018 ◽

Vol 23 (5) ◽

pp. 362-366

Author(s):

Jessica M. Biggs ◽

Nicole E. Glasgow ◽

Francoise Pradel ◽

Jill A. Morgan

Keyword(s):

Side Effects ◽

First Grade ◽

Reading Level ◽

Cross Sectional ◽

Education Material ◽

School Study ◽

The Us ◽

Dosing Frequency ◽

Grade Reading Level ◽

Study Participants

OBJECTIVES The objective of this study was to determine if education material targeting children would improve understanding of medication indication, administration, and common side effects in pediatric subjects. METHODS This cross-sectional pilot study included students 7 to 11 years old from a suburban elementary school. Study participants were read either the US Food and Drug Administration–approved adult medication leaflet or a pediatric medication leaflet created at a first-grade reading level for levetiracetam (Keppra, UCB, Inc, Atlanta, GA). Students were asked a set of standardized survey questions to evaluate comprehension of side effects, medication indication, dosing frequency, administration, and overall impression of the leaflet. RESULTS Fifty-eight children were included. Fifty percent of the children were male, 79% were Caucasian, and the average age was 9 years. There was no statistical difference for demographics in the adult leaflet versus the pediatric leaflet group. Children correctly stated the indication for the medication in 30% of participants (9/30) in the adult leaflet group and 79% of participants (22/28) in the pediatric leaflet group, p = 0.002. The administration frequency question was answered correctly in 93% of the pediatric leaflet group (26/28) as compared to 73% in the adult leaflet group (22/30), p = 0.05. For questions about side effects and how to administer the medication, there was no difference between the groups. The responses regarding readability and understanding of the leaflets were significantly different in the pediatric leaflet group compared to the adult leaflet group, p = 0.001 and p = 0.001, respectively. CONCLUSIONS Leaflets designed for pediatric patients resulted in an improvement in the understanding of the indication for levetiracetam.

Download Full-text

Cancer Patients’ Perceived Value of a Smartphone App to Enhance the Safety of Home-Based Chemotherapy: Feasibility Study (Preprint)

10.2196/preprints.20636 ◽

2020 ◽

Author(s):

Nina Kongshaug ◽

John-Arne Skolbekken ◽

Arild Faxvaag ◽

Eva Hofsli

Keyword(s):

Side Effects ◽

Treatment Plan ◽

Hospital Setting ◽

Oral Chemotherapy ◽

Smartphone App ◽

Semistructured Interview ◽

Chemotherapy Treatment ◽

Modern Information Technology ◽

System Usability Scale

BACKGROUND Oral anticancer therapies can be self-administered by patients outside the hospital setting, which poses challenges of adherence to a drug plan and monitoring of side effects. Modern information technology may be developed and implemented to address these pertinent issues. OBJECTIVE The aim of this study was to explore how a smartphone app developed through a stepwise, iterative process can help patients using oral chemotherapy to take their drug, and to report adherence and side effects in a reliable and verifiable manner. METHODS Fourteen patients starting capecitabine treatment were included in this study and used the smartphone app in addition to regular follow up of capecitabine treatment. Nine of these patients fulfilled the treatment plan and were interviewed based on a semistructured interview guide and the System Usability Scale (SUS). In addition, two focus groups were completed with 7 oncologists and 7 oncology nurses, respectively. Interview data were analyzed in accordance with the principles of systematic text condensation. Features of the app were also assessed. RESULTS The smartphone app provided the patients with a feeling of reassurance regarding correct adherence of their oral chemotherapy treatment. They used the app as a memory tool about their treatment and possible serious side effects, as well as for treatment education. Patients expressed concerns about using the app to report side effects that were not considered to be obviously serious, fearing overreporting. The health personnel expressed an overall positive attitude to integrate this new tool in their everyday work. CONCLUSIONS Patients on oral chemotherapy treatment at home felt safe and found the app to be helpful. The app promoted learning about their treatment and made the patients more independent of the cancer clinic, reducing the need for the clinic’s limited resources for follow up of patients on oral anticancer medications.

Download Full-text

Cancer Patients’ Perceived Value of a Smartphone App to Enhance the Safety of Home-Based Chemotherapy: Feasibility Study

JMIR Formative Research ◽

10.2196/20636 ◽

2021 ◽

Vol 5 (1) ◽

pp. e20636

Author(s):

Nina Kongshaug ◽

John-Arne Skolbekken ◽

Arild Faxvaag ◽

Eva Hofsli

Keyword(s):

Side Effects ◽

Treatment Plan ◽

Hospital Setting ◽

Oral Chemotherapy ◽

Smartphone App ◽

Semistructured Interview ◽

Chemotherapy Treatment ◽

Modern Information Technology ◽

System Usability Scale

Background Oral anticancer therapies can be self-administered by patients outside the hospital setting, which poses challenges of adherence to a drug plan and monitoring of side effects. Modern information technology may be developed and implemented to address these pertinent issues. Objective The aim of this study was to explore how a smartphone app developed through a stepwise, iterative process can help patients using oral chemotherapy to take their drug, and to report adherence and side effects in a reliable and verifiable manner. Methods Fourteen patients starting capecitabine treatment were included in this study and used the smartphone app in addition to regular follow up of capecitabine treatment. Nine of these patients fulfilled the treatment plan and were interviewed based on a semistructured interview guide and the System Usability Scale (SUS). In addition, two focus groups were completed with 7 oncologists and 7 oncology nurses, respectively. Interview data were analyzed in accordance with the principles of systematic text condensation. Features of the app were also assessed. Results The smartphone app provided the patients with a feeling of reassurance regarding correct adherence of their oral chemotherapy treatment. They used the app as a memory tool about their treatment and possible serious side effects, as well as for treatment education. Patients expressed concerns about using the app to report side effects that were not considered to be obviously serious, fearing overreporting. The health personnel expressed an overall positive attitude to integrate this new tool in their everyday work. Conclusions Patients on oral chemotherapy treatment at home felt safe and found the app to be helpful. The app promoted learning about their treatment and made the patients more independent of the cancer clinic, reducing the need for the clinic’s limited resources for follow up of patients on oral anticancer medications.

Download Full-text

Cutaneous ulcers following hydroxyurea therapy

Phlebologie ◽

10.1055/s-0037-1621559 ◽

2004 ◽

Vol 33 (06) ◽

pp. 202-205 ◽

Cited By ~ 2

Author(s):

K. Hartmann ◽

S. Nagel ◽

T. Erichsen ◽

E. Rabe ◽

K. H. Grips ◽

...

Keyword(s):

Side Effects ◽

Side Effect ◽

Antineoplastic Agent ◽

Limited Time ◽

Myeloproliferative Diseases ◽

Dermatological Side Effects ◽

Chronic Myeloproliferative Diseases ◽

Hydroxyurea Therapy

SummaryHydroxyurea (HU) is usually a well tolerated antineoplastic agent and is commonly used in the treatment of chronic myeloproliferative diseases. Dermatological side effects are frequently seen in patients receiving longterm HU therapy. Cutaneous ulcers have been reported occasionally.We report on four patients with cutaneous ulcers whilst on long-term hydroxyurea therapy for myeloproliferative diseases. In all patients we were able to reduce the dose, or stop HU altogether and their ulcers markedly improved. Our observations suggest that cutaneous ulcers should be considered as possible side effect of long-term HU therapy and healing of the ulcers can be achieved not only by cessation of the HU treatment, but also by reducing the dose of hydroxyurea for a limited time.

Download Full-text

Bladder Cancer Health Literacy: Assessing Readability of Online Patient Education Materials

Bladder Cancer ◽

10.3233/blc-200387 ◽

2020 ◽

pp. 1-8

Author(s):

Lauren E. Powell ◽

Theodore I. Cisu ◽

Adam P. Klausner

Keyword(s):

Bladder Cancer ◽

Health Literacy ◽

Patient Education ◽

Search Engine ◽

Reading Ability ◽

Health Care Expenditure ◽

Reading Level ◽

T Test ◽

Grade Levels ◽

Grade Reading Level

BACKGROUND: Understanding of health-related materials, termed health literacy, affects decision makings and outcomes in the treatment of bladder cancer. The National Institutes of Health recommend writing education materials at a sixth-seventh grade reading level [6]. The goal of this study is to assess readability of bladder cancer materials available online. OBJECTIVE: The goal of this study is to characterize available information about bladder cancer online and evaluate readability. METHODS: Materials on bladder cancer were collected from the American Urological Association’s Urology Care Foundation (AUA-UCF) and compared to top 50 websites by search engine results. Resources were analyzed using four different validated readability assessment scales. The mean and standard deviation of the materials was calculated, and a two-tailed t test for used to assess for significance between the two sets of patient education materials. RESULTS: The average readability of AUA materials was 8.5 (8th–9th grade reading level). For the top 50 websites, average readability was 11.7 (11–12th grade reading level). A two-tailed t test between the AUA and top 50 websites demonstrated statistical significance between the readability of the two sets of resources (P = 0.0001), with the top search engine results being several grade levels higher than the recommended 6–7th grade reading level. CONCLUSIONS: Most health information provided by the AUA on bladder cancer is written at a reading ability that aligns with most US adults, with top websites for search engine results exceeding the average reading level by several grade levels. By focusing on health literacy, urologists may contribute lowering barriers to health literacy, improving health care expenditure and perioperative complications.

Download Full-text

Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

Scientific Reports ◽

10.1038/s41598-021-87198-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Mona Dietrichkeit ◽

Marion Hagemann-Goebel ◽

Yvonne Nestoriuc ◽

Steffen Moritz ◽

Lena Jelinek

Keyword(s):

Side Effects ◽

Side Effect ◽

Statistical Power ◽

Controlled Trial ◽

Treatment Options ◽

Cognitive Remediation ◽

Negative Effects ◽

Metacognitive Training ◽

To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

Download Full-text

Readability of Online Patient Information Relating to Cleft Palate Surgery

The Cleft Palate-Craniofacial Journal ◽

10.1177/10556656211013177 ◽

2021 ◽

pp. 105566562110131

Author(s):

Christopher V. Lavin ◽

Evan J. Fahy ◽

Darren B. Abbas ◽

Michelle Griffin ◽

Nestor M. Diaz Deleon ◽

...

Keyword(s):

Health Care ◽

Cleft Palate ◽

Grade Level ◽

Reading Level ◽

Online Information ◽

Health Care Education ◽

Search Results ◽

Cleft Palate Repair ◽

Grade Reading Level ◽

Google Search

Objective: It is important for health care education materials to be easily understood by caretakers of children requiring craniofacial surgery. This study aimed to analyze the readability of Google search results as they pertain to “Cleft Palate Surgery” and “Palatoplasty.” Additionally, the study included a search from several locations globally to identify possible geographic differences. Design: Google searches of the terms “Cleft Palate Surgery” and “Palatoplasty” were performed. Additionally, searches of only “Cleft Palate Surgery” were run from several internet protocol addresses globally. Main Outcome Measures: Flesch-Kincaid Grade Level and Readability Ease, Gunning Fog Index, Simple Measure of Gobbledygook (SMOG) index, and Coleman-Liau Index. Results: Search results for “Cleft Palate Surgery” were easier to read and comprehend compared to search results for “Palatoplasty.” Mean Flesch-Kincaid Grade Level scores were 7.0 and 10.11, respectively ( P = .0018). Mean Flesch-Kincaid Reading Ease scores were 61.29 and 40.71, respectively ( P = .0003). Mean Gunning Fog Index scores were 8.370 and 10.34, respectively ( P = .0458). Mean SMOG Index scores were 6.84 and 8.47, respectively ( P = .0260). Mean Coleman-Liau Index scores were 12.95 and 15.33, respectively ( P = .0281). No significant differences were found in any of the readability measures based on global location. Conclusions: Although some improvement can be made, craniofacial surgeons can be confident in the online information pertaining to cleft palate repair, regardless of where the search is performed from. The average readability of the top search results for “Cleft Palate Surgery” is around the seventh-grade reading level (US educational system) and compares favorably to other health care readability analyses.

Download Full-text

Short-term adverse effects of testosterone used for priming in prepubertal boys before growth hormone stimulation test

Journal of Pediatric Endocrinology and Metabolism ◽

10.1515/jpem-2017-0280 ◽

2018 ◽

Vol 31 (1) ◽

pp. 21-24 ◽

Cited By ~ 8

Author(s):

Andrea Albrecht ◽

Theresa Penger ◽

Michaela Marx ◽

Karin Hirsch ◽

Helmuth G. Dörr

Keyword(s):

Growth Hormone ◽

Side Effects ◽

Adverse Effects ◽

Side Effect ◽

Serum Testosterone ◽

Low Flow ◽

Effect Rate ◽

Testosterone Levels ◽

Testicular Pain ◽

Prepubertal Boys

AbstractBackground:Despite the fact that priming with sex steroids in prepubertal children before growth hormone (GH) provocative tests is recommended, there is an ongoing controversial discussion about the appropriate age of the children, the drug used for priming, the dose and the period between priming and the GH test. Interestingly, there is no discussion on the safety of this procedure. To date, only little data have been available on the possible side effects of priming with testosterone.Methods:We analyzed the outcome in 188 short-statured prepubertal boys who had been primed with testosterone enanthate (n=136: 50 mg; n=51: 125 mg, and accidentally one boy with 250 mg) 7 days prior to the GH test. Serum testosterone levels were measured on the day of the GH test in 99 boys.Results:Overall, only five boys developed adverse side effects. Two boys (dose 125 mg) showed severe low-flow priapism and had to undergo decompression of the corpora cavernosa. One boy suffered from self-limiting priapism and testicular pain (dose 50 mg). Two patients reported testicular pain (each dose 50 mg). The single patient with 250 mg testosterone did not show any adverse effects. The total side effect rate was 2.7%. The serum testosterone levels of the boys with side effects were not different from the testosterone levels of the boys without any side effects.Conclusions:Parents and patients should be informed about the possible side effects of priming with testosterone such as priapism and testicular pain. However, the overall side effect rate is low. We found no correlation between the outcome and the testosterone dose used and/or the level of serum testosterone.

Download Full-text

¿Comprenderán Mis Amigos y La Familia? Analyzing Spanish Translations of Admission Materials for Latina/o Students Applying to 4-Year Institutions in the United States

Journal of Hispanic Higher Education ◽

10.1177/1538192718775478 ◽

2018 ◽

Vol 19 (2) ◽

pp. 195-209 ◽

Cited By ~ 4

Author(s):

Zachary W. Taylor

Keyword(s):

English Language ◽

The United States ◽

Reading Level ◽

Spanish Language ◽

First Year ◽

Linguistic Capital ◽

Undergraduate Admissions ◽

Research And Practice ◽

Grade Reading Level ◽

Language Content

This study examines first-year undergraduate admissions materials from 325 bachelor-degree granting U.S. institutions, closely analyzing the English-language readability and Spanish-language readability and translation of these materials. Via Yosso’s linguistic capital, the results reveal 4.9% of first-year undergraduate admissions materials had been translated into Spanish, 4% of institutional admissions websites embed translation widgets, and the average readability of English-language content is above the 13th-grade reading level. Implications for research and practice are discussed.

Download Full-text