Patient Information Brochures Research Articles

Assessing Readability of FDA-Required Labeling for Breast Implants

Abstract Goals/Purpose In 2021, the United States (US) Food and Drug Administration (FDA) introduced regulations to improve the delivery of breast implant patient education, including new labeling requirements. The new regulations called for a patient decision checklist to be reviewed with a physician ahead of surgery. To ensure educational materials are accessible to most patients, the National Institutes of Health recommend they be written at a sixth to seventh grade level. This study aims to assess the readability of patient-facing FDA labeling for breast implants. Methods/Technique Eleven patient information brochures and seven patient decision checklists were obtained from four breast implant company websites. An example checklist was also obtained from the FDA website. Plain text was extracted from each of the documents. Figures, tables, references, and indices were omitted. The text files were analyzed using four measures of readability validated in clinical materials: Flesch-Kincaid Grade Level, Coleman-Liau Index, Simplified Measure of Gobbledygook (SMOG), and Automated Readability Index (ARI). Results/Complications On average, patient information brochures were 73 pages long (range: 48-92) and included 8 figures or graphics, while patient decision checklists were 5.7 pages long (range: 4-7) and included 0 figures or graphics. Mean readability scores of brochures were a Flesch-Kincaid of 12.7, Coleman-Liau Index of 13.0, SMOG of 14.0, and ARI of 12.7, with an overall mean grade level of 13.1 (13th grade). For decision checklists, results showed a Flesch-Kincaid of 14.2, Coleman-Liau Index of 13.3, SMOG of 15.6, and ARI of 14.8, with an overall grade level of 14.5 (14-15th grade). Comparatively, the sample decision checklist published by the FDA had a Flesch-Kincaid of 13.9, Coleman-Liau Index of 13.0, SMOG of 15.5, and ARI of 14.4, with an overall grade level of 14.2 (14th grade). Conclusion Although patient decision checklists were introduced to improve accessibility of breast implant educational materials, the level at which they are written exceeds the recommendation for the average US adult by several grade levels, suggesting that patients may not fully understand current materials. While shorter than the comprehensive information brochures available, decision checklists were more difficult to read across all readability scales assessed in this study, and neither brochures nor checklists met recommended reading levels on any of the assessed scales. In order to encourage patient understanding of surgical and implant risks and promote the positive health outcomes, the FDA and breast implant companies may consider revising labeling materials.

Evidence-based health information about pulmonary embolism: Assessing the quality, usability and readability of online and offline patient information.

Pulmonary embolism (PE) is the third most common cardiovascular disease worldwide. However, public awareness is considerably lower than for myocardial infarction or stroke. Patients suffering from PE complain about the lack of (understandable) information and express high informational needs. To uncover if reliable information is indeed scarce, this study evaluates the quantity and quality of existing patient information for tertiary prevention using an evidence-based health information paradigm. We conducted a quantitative content analysis (n = 21 patient information brochures; n = 67 websites) evaluating content categories addressed, methodical quality, usability, and readability. Results show that there is not enough patient information material focusing on PE as a main topic. Existing patient information material is mostly incomplete, difficult to understand, and low in actionability as well as readability. Our systematic analysis reveals the need for more high-quality patient information on PE as part of effective tertiary prevention. This is the first review analyzing content, methodical quality, readability, and usability of patient information on PE. The findings of this analysis are guiding the development of an innovative, evidence-based patient information on PE aiming to support patients' informational needs and their self-care behavior.

Evaluation of enhanced recovery after surgery program components implemented in laparoscopic appendectomy: prospective randomized clinical study

BackgroundLaparoscopic appendectomy (LA) is a widely used surgical procedure. Patients often suffer from considerable postoperative pain and indigestion, which prolongs their in-hospital stay. Almost 10% of patients develop postoperative complications. The enhanced recovery after surgery (ERAS) program has proven its efficacy in elective surgery and could hypothetically improve LA outcomes. Currently, there is no ERAS program for LA.MethodsA modified ERAS (mERAS) protocol was studied in a prospective, randomized nonblinded clinical trial. The mERAS group consisted of 50 patients; the control group, of 54 patients. The mERAS protocol included a patient information brochure; minimizing drain use; local anesthesia; low-pressure pneumoperitoneum; early mobilization and oral diet. The primary outcome was postoperative length of stay (pLOS).ResultsModified protocol reduced median pLOS to 1.25 days vs 2 days in the controls (p < 0.0001). Twenty-one (42%) mERAS patients and 4 (7.4%) controls were discharged within 24 h (p < 0.001) after surgery; 0 readmissions were reported. Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 h, 2 h, 6 h, 12 h and 24 h after surgery: 2.33 ± 2.12 vs 4.19 ± 2.08 (p < 0.0001), 2.27 ± 1.91 vs 4.02 ± 1.89 (p < 0.0001), 2.28 ± 1.98 vs 3.70 ± 1.57 (p = 0.0001), 1.98 ± 1.72 vs 3.43 ± 1.54 (p < 0.0001) and 1.80 ± 1.74 vs 3.00 ± 1.27 (p = 0.032), respectively)]. The severity of shoulder and neck pain was lower but its incidence was similar. Peristalsis recovery was achieved earlier in the study group (median (min–max))—mERAS 7 (2–34) h vs control 11 (3–43) h; p = 0.009) but did not affect the time of the first flatus 23 (2–72) h vs 29 (6–70) h, respectively; p = 0.499).ConclusionsThe modified ERAS program for LA has advantages over the traditional approach.RegistrationThis trial was registered at ClinicalTrials.gov as NCT03754777 (27/11/2018).

Effect of the patient information brochure in communicating the risks associated with crizotinib treatment to patients with non-small cell lung cancer (NSCLC) in Europe.

Crizotinib (XALKORI®) is indicated for anaplastic lymphoma kinase‐positive and ROS1‐positive advanced non‐small cell lung cancer. This study evaluated the distribution of the crizotinib patient information brochure (PIB) in Europe and patient knowledge of the key messages in the PIB. A cross‐sectional survey was conducted in 10 European countries among patients who received crizotinib to ascertain whether each patient received and read the PIB, and his/her knowledge of its key messages on hepatotoxicity, interstitial lung disease/pneumonitis, QTc prolongation, bradycardia, and vision disorders. Of the 341 patients contacted, 40 responded (11.7%), and 39 patients were eligible. A total of 77% of respondents acknowledged receiving the PIB, of which, 93% reported reading it. Knowledge of the individual side effects ranged from 36% to 85%, and precautions for use ranged from 56% to 67%. Understanding the reasons for calling a physician ranged from 54% to 85%. Knowledge of each of the 6 key side effects was greater among readers of the PIB compared to non‐readers or respondents who did not recall receiving the PIB. Approximately three‐quarters of survey respondents recalled receiving the crizotinib PIB and respondents who read the PIB were more knowledgeable of the key side effects of crizotinib than those who did not read or receive. Caution should be taken in generalizing these results because of the potential for selection bias and small sample size. These survey results suggest that the crizotinib PIB may be an effective risk communication tool for crizotinib‐treated patients in Europe.

Clinical decision-making for complex feeding decisions: A national survey of current approaches and perspectives.

Decision-making around dysphagia management is becoming increasingly challenging due to the complexity of contexts associated with an ageing population. The current study explores current decision-making practices used by speech language therapists (SLTs) surrounding contexts related to palliative care, dementia, neuro-degenerative diseases, guardianship/family decisions, and other issues relevant to ongoing care of individuals with dysphagia. An exploratory prospective electronic survey of SLTs was conducted. A total of 202 respondents were eligible for inclusion. Only 55% of respondents reported their workplace had a standard approach to documentation. Only 19% reported their service had a defined policy to support decision-making, with only 28% reporting the existence of patient information brochures. Limited formal guidance or practice standards exist in the setting of complex dysphagia management, which limits the consistency of practice and clinical efficiency. This insight into current practices and perspectives supports the development of clinical guidelines.

Infection control perception and behavior: a question of sex and gender? Results of the AHOI feasibility study.

PurposeInfections, in particular with multidrug-resistant organisms, are a burden for inpatient and outpatient care and the whole community. The pathogens “roam” with patients and their relatives, forming an epidemiological bridge between different care facilities. Patients could play an important role in infection control, given that they are properly involved. The AHOI project stands for the Activation of patients, people in need of care, and care-providers for a Hygiene-conscious participatiOn in Infection prevention. To this end, a multimodal intervention bundle was developed and subjected to a feasibility study at a university hospital. Our goal was to clarify whether sex- and gender-specific characteristics are relevant in the field of infection prevention.Materials and methodsAHOI was tested with a cross-sectional design and a cross-media communication strategy at two surgical wards of a university hospital. Interventions included patient information brochures and motivational materials, reminders, and two video presentations. A welcome box with information material and two questionnaires was given to every inpatient. The patients were instructed to complete the questionnaires at the beginning and at the end of their stay.ResultsA sample size of 133 inpatients who completed questionnaires at the beginning and end of hospitalization was analyzable. The analysis produced a differentiated picture of the perception and reaction behavior of the sexes. Women had a more negative expectation of the response of doctors. In addition, there were differences in the perception of the positioning of disinfectant dispensers and cleaning processes as well as in satisfaction with the general cleanliness. For all subjects mentioned above, the differences were significant at least at the P-value 0.05.ConclusionThe AHOI study shows sex differences in hygiene perception and behavior. Measures to improve patient safety by involving patients in infection control must take these differences into account.

Effectiveness of the Crizotinib Therapeutic Management Guide in Communicating Risks, and Recommended Actions to Minimize Risks, Among Physicians Prescribing Crizotinib in Europe

To support a positive benefit/risk profile for crizotinib, additional risk minimization measures (RMMs) included a patient information brochure (PIB) and a therapeutic management guide (TMG) to inform patients and physicians in Europe about the risks associated with crizotinib. This study evaluated the effectiveness of the TMG in communicating risks associated with crizotinib. A cross-sectional survey was conducted among crizotinib-prescribing physicians in ten European countries. The survey included questions on awareness, receipt, and use of the crizotinib TMG and PIB, and on knowledge of crizotinib risks and actions to minimize risks. A total of 3978 invitations were sent to potential crizotinib-prescribing physicians, and 98 crizotinib prescribers completed the survey. Over three-quarters (78%) of responding physicians acknowledged awareness of the TMG or PIB. Among physicians who received the TMG and PIB, 78% acknowledged reading the TMG, and 86% acknowledged giving the PIB to their patients. Knowledge of risks listed in the TMG was 97% for vision disorders, 94% for hepatotoxicity, 89% for both interstitial lung disease (ILD)/pneumonitis and corrected QT (QTc) prolongation, 69% for neutropenia/leukopenia, and 68% for bradycardia. Knowledge of recommendations to minimize risks was 74% for ILD/pneumonitis, 64% for vision disorders, 42% for neutropenia and leukopenia, 41% for QTc prolongation, 35% for hepatotoxicity, and 23% for bradycardia. Most responding physicians were aware of, received, and read the crizotinib RMMs, and were aware of the crizotinib key risks. Knowledge of recommendations to minimize these risks revealed some gaps. The study results indicate the crizotinib RMMs were reasonably effective in communicating the crizotinib risks.

Patients' experience with intermittent catheterisation in everyday life.

This study reports about the experiences of 11 patients in the Netherlands who use intermittent self-catheterisation to manage their symptoms. The aim of the study was to get insight in underlying barriers and facilitators for patients dealing with intermittent catheterisation in everyday life. Studies show that intermittent catheterisation has an impact on everyday life. A positive effect does not guarantee that patients maintain catheterisation over a longer period of time. After the implementation of a guideline, a quantitative study was performed to determine successful intermittent catheterisation. The patients of this study had previously taken part in this quantitative study. This is a qualitative multicentre study using semistructured in-depth interviews with 11 patients between March-May 2013. Inclusion criteria included patients of a quantitative study (n = 124) with a variety of diagnoses referred to the outpatient clinic. Those who received instruction from the researcher and who at start of the study performed catheterisation ≤3 months were excluded. Of the total number that met the inclusion criteria, every fourth patient was invited to participate in an interview. Patients were asked about the introducing of intermittent catheterisation, the incorporation into everyday life, the progress after the instruction and guidance perceived, the cause of the bladder problem and the motivation to start intermittent catheterisation. Eleven interviews were performed (six males/five females). All patients described the instruction and follow-up care as positive. Barriers were the preparation before the handling, which is more difficult than the catheterisation itself, and the fact that patients felt constrained by the need to plan convenient times to catheterise themselves. This study shows that patients who perform catheterisation are satisfied about the instruction and follow-up care. Important barriers in everyday life are the preparation and the need to plan convenient times. Interviewing patients gave important additional information about dealing with intermittent catheterisation in everyday life. Prescribers and teachers of intermittent catheterisation must realise that they often have to high expectations of patients when it comes to being flexible in frequency of catheterisation. It is important to realise that patients experience barriers of which healthcare workers are not always aware of, such as the preparation before the handling and feeling constrained by the need to plan convenient times to catheterise. The outcome of this study can be used to improve the content of patient information brochures and guidelines for intermittent catheterisation.

"Chemo-Knights" and "Radio-Robby": Provision of Information in Pediatric Oncology.

Information provision is an important step in enabling pediatric patients to participate in healthcare. Storybooks and patient information brochures represent a channel through which children and adolescents with cancer are informed about their illness. However, the use of such written materials has received little academic attention. The aim of this article was to carry out an exploratory analysis of written information resources for pediatric cancer patients. The potential of these to enhance patient participation will be discussed. A convenience sample of 16 written resource materials in English and German were chosen for analysis. Thematic coding was carried out to identify major themes. Subthemes were summarized into 3 main categories: information on diagnosis, treatment, and illness experience. Information was provided on, for example, illness name and etiology, diagnostic and treatment procedures, emotions, and coping strategies. Storybooks and other written resources on cancer contain a broad array of information and describe illness-related issues to a varying extent. They represent an excellent possibility to ease patient participation in healthcare by providing them with necessary information while also inviting further discussion. Nurses and other healthcare professionals can use written resource materials to engage in discussions with pediatric patients concerning their illness. Nurses should be aware of the information children and adolescents receive in these materials in order to be able to adequately answer questions that may arise or identify misunderstandings as well as lack of information.

Knowledge, attitudes and referral patterns of lynch syndrome: a survey of clinicians in australia.

This study assessed Australian clinicians’ knowledge, attitudes and referral patterns of patients with suspected Lynch syndrome for genetic services. A total of 144 oncologists, surgeons, gynaecologists, general practitioners and gastroenterologists from the Australian Medical Association and Clinical Oncology Society responded to a web-based survey. Most respondents demonstrated suboptimal knowledge of Lynch syndrome. Male general practitioners who have been practicing for ≥10 years were less likely to offer genetic referral than specialists, and many clinicians did not recognize that immunohistochemistry testing is not a germline test. Half of all general practitioners did not actually refer patients in the past 12 months, and 30% of them did not feel that their role is to identify patients for genetic referral. The majority of clinicians considered everyone to be responsible for making the initial referral to genetic services, but a small preference was given to oncologists (15%) and general practitioners (13%). Patient information brochures, continuing genetic education programs and referral guidelines were favoured as support for practice. Targeted education interventions should be considered to improve referral. An online family history assessment tool with built-in decision support would be helpful in triaging high-risk individuals for pathology analysis and/or genetic assessment in general practice.

Isotretinoin and Pregnancy Prevention

It’snonews that isotretinoin,themosteffectivetreatmentforsevere or recalcitrant acne, is a potent teratogen. From its release asAccutanebyHoffman-LaRoche in1982, isotretinoinhadbeen classified as a pregnancy categoryXdrug,definedasadrug with positive evidence of humanfetal risk,where the risks involved inuseof thedrug inpregnantwomenclearlyoutweigh potentialbenefits.Riskmanagementatthetimeofinitialapproval was limited to labeling,whichdescribed the riskof teratogenicity in the package insert and the patient information brochure. In relatively short order, it was clear that such labelingwas not enough to reduce the risk of fetal exposure to isotretinoin. Ifonecombinestheteratogenicpotentialof isotretinoinand the fact that 50% of pregnancies in the United States are unplanned,1 preventing fetal exposure to isotretinoin becomes crucial.AccordingtotheUSFoodandDrugAdministration(FDA) DrugUseData,Accutaneuseinwomenincreasedmorethan200% from1992to1999.2Asof1998,therewereover1.4millionisotretinoin prescriptionswritten in the United States.3 Half of the patients taking isotretinoinwerewomen,and85%to90%of these womenwere of childbearing potential, ages 15 to 44 years. The first reports of birthdefects secondary to isotretinoin appeared in 1983.By the2000, therewere 1995 fetal exposures to isotretinoin,whichresultedin1446electiveorspontaneousterminations and383livebirths,ofwhichtherewere162infantswithcongenital anomalies.The futureofourbestweaponagainst adisease that hassuchphysicalandpsychologicalrepercussionswasprecarious. In 1988, a short article titled “The Needless Tragedies of Accutane” appeared in the New York Times Health Section.4 In it, the unnamed author claimed that 97% of those prescribedAccutane canbe treatedwith other drugs and that the FDA failed tomake sure that physicians do not overprescribe the drug. The authorwent on to say, “But the company (Hoffman-LaRoche), theFDA,andcarelessdermatologists share the blame for failing tominimize its side effects. FrankYoung, the FDA’s commissioner, now has a clear remedial task: Regulate Accutane so that allwhoneed it get it,withnobirth defects.”4 TheFDAregulationscame.Thefirst risk reductionprogram was theAccutanePregnancyPreventionProgram(PPP) in 1988, which proved to be unsuccessful in reducing pregnancy risk in patients prescribed Accutane, followed by the FDA’s System to ManageAccutane-RelatedTeratogenicity(SMART) in2002.Both the PPP and SMARTwere initiated byRoche, themanufacturer ofAccutane.Because theSMARTprogramdidnot substantially changepregnancyrates inpatientsprescribedAccutane,theFDA institutediPledge, itsmostrestrictiveriskreductionprogram,on March1, 2006.5OnJuly30,2007, theAssociatedPress6 reported that the number of pregnancies in the first year of iPledge was about the same as the numbers reported annually prior to FDA regulations. Unfortunately,what did decreasewas the number ofpatientstreatedwithisotretinoin.Astudyconductedtoevaluate the impactof iPledgeon isotretinoin fetalexposure ina large Californiamultispecialtymedical group showed that therewas anoverall29%decreaseintreatmentcoursesandpatientstreated with isotretinoin after the implementation of iPledge.7 It seems that more and more stringent regulations, which weregoingtosolvetheproblemoffetalexposureto isotretinoin, didnotwork.Where is thedisconnect?TheDrugSafetyandRisk ManagementAdvisoryCommittee’s iPledgeyear1updatestated that themostcommonreasons forpregnancyduring iPledge includecontraceptivefailureandnoncompliancewithbirthcontrol methods.8Similarly,underSMART,themostcommonlyreported reasons for pregnancyduring isotretinoin therapywere unsuccessfulattemptsatabstinence,useof ineffectivecontraception, inconsistentuseofcontraception,unexpectedsexualactivity,and contraceptive failure.9 Let’s look at these factorsmore closely. In 2003, Isaacs and Creinin10 examined the impact of prior healthcareprovidercounselingonprevioususeofcontraception inwomen seeking surgical abortion. The study concluded that miscommunicationbetweenpatientsandtheirhealthcareprovider negatively affected the use of a primary contraceptive methodin14%ofthepatients.AstudypublishedintheCanadian FamilyPhysician11 in2006lookedat theself-reportedreasonsfor women’snoncompliancewithpregnancypreventionrecommendationswhilereceivingisotretinointreatment.Thestudywasdesignedtoassesswhetherprescribingphysiciansadvised female patients receiving isotretinoin according to pregnancy prevention recommendations,whetherwomenunderstoodthose recommendations,andwhetherwomencompliedwithrecommendationstopreventpregnancy.Astandardizedquestionnairewas administeredbytelephoneto47eligiblefemalepatientswhowere 14yearsorolder,werefertileasfarastheyknew,andweretreated with isotretinoinat the timeof the interviewor in thepreceding 6months.Theauthorsfoundthattheassociationofwomen’suse of double contraceptionwith their recollection that physicians discussedpregnancypreventionduringtheinterviewwasstatistically significant. They concluded that women’s retention of knowledgeandtheirperceptionoftheprecautionstakenbyphysiciansareessential for their compliance.Oneadditionalpatient in3will complywithdoublecontraceptionwhenphysiciansdiscuss that issue. The absolute risk reductionwas 37%. Another study,12published in2010,examinedadherence to oralcontraceptionbywomentakingcategoryXmedications.The Related article page 366 Opinion

The public knows little about urology: How important is this?

Until recently, my mother thought I was a neurologist. It must be because urology and neurology rhyme. Should this worry me? Should I be concerned that according to a recent paper by Gagnon and colleagues,1 many of our potential patients either do not understand or misunderstand urology? The authors conducted a study among the public to assess their knowledge of urology. The authors found that most respondents knew little about urology and were not sure which organs urologists deal with. In comparing Quebec and Vermont, there appeared to be no cultural or regional differences between knowledge. What are the negative implications of these findings? The authors conclude that we should spend time and money on a public relations campaign to educate the public about urology and about what urologists do. The authors believe that patients with more knowledge about urology would be urged to consult a urologist earlier rather than later, when it may be too late to intervene. While I agree with the spirit behind this idea, I do think that patients should be consulting with their primary care physicians earlier as opposed to going directly to urologists. In the Canadian health-care system, it is infinitely more important that our referring physicians understand our role in the assessment and treatment of urologic diseases. It would have been interesting to see what 150 primary care physicians knew about urologists. Where I practise, it is not unusual to have patients simultaneously referred to a nephrologist and a urologist for the assessment of microscopic hematuria. The difference in our workups is dramatic and a primary care physician would need to have a clear and thorough understanding of urology to better assess and refer these patients. In my opinion, contrary to the authors’, public knowledge of what we do is unlikely to improve the delivery of urologic care; it could hinder it. For example, publicity regarding our expertise on penile health might encourage patients to bypass their primary care physicians to see the “expert.” Most penile issues can be (and should be) dealt with outside of our packed offices. Providing succinct, accurate disease information and improving primary care access to our offices would have a positive impact. We should discourage self-referrals as should our “private” American colleagues. Urologists, through their professional associations and cooperation with industry, have done an excellent job in compiling useful information on most urologic conditions (one notable example of this is the CUA’s patient information brochures). Any money available for education should be spent on these endeavours, as opposed to advertisements in the lay press. Once diagnosed, patients with genitourinary issues have little difficulty finding an appropriate website or resources that will educate them on their particular problem. These ancillary resources streamline care and help all of us produce better outcomes.

CUA as health advocate

As mentioned in past CUA News pieces, the CUA Executive has embarked on a 5-Year Strategic Plan. One of the objectives is to develop and implement an advocacy business plan. The realization of this objective would position CUA as the voice for all matters urological in Canada. What does this really mean? Where does the CUA fit in? A 2007 study1 showed that, among urology residents, 68% believe that the role of the health advocate is an important one in residency training and in urological practice. Knowing its importance, how can the CUA put this ideal into practice? According to the Royal College of Physicians and Surgeons of Canada, the role of health advocate includes identifying “the determinants of health that affect a patient, so as to be able to effectively contribute to improving individual and societal health in Canada.” In this area, CUA’s Patient Information Brochures meet this need. They are available to CUA members (as a benefit of membership) for distribution to patients. They are written in an informal and non-scientific tone to speak directly to the patient. The brochures range from disease descriptions to discharge instructions. According to a recent CUA survey, these brochures were cited as being an important part of patient care and education. Another recent CUA initiative contributing to improving societal health is the urologic information site—www.uroinfo.ca. This site is becoming the “go-to” place for patients. The information on it is written by CUA members. The goal of the site is to be the source of “honest and balanced” information about urology. Uroinfo.ca is open to the general public, patients and their family members. Another aspect of the health advocate’s role is recognizing and responding to “issues, settings, circumstances or situations in which advocacy on behalf of patients, professions or society is appropriate.” The CUA is working hard to respond to this role. The PSA-screening controversy last year illustrated how important it was to have the CUA respond to queries—from our patients and from the public. We will be embracing many tools to address the public when these health issues and questions arise. Advocacy is fundamental to the promotion of health. The CUA is taking its place as a health advocate in Canada. We look forward to sharing our initiatives with you.

GRP-103 Integration of Oral Anticancer Drugs into Standardised Computerised Physician Order Entry Systems

BackgroundOral anticancer drugs still contain some of the most critical issues in terms of right use and compliance. Patients need to be advised and guided concerning dosing schedules, risks and...

Welcome message from the new president

We have had an extremely eventful and successful past year at the CUA. An excellent annual meeting hosted by our past president Luc Valiquette and a tremendous social program with Bruno Laroche. With 5 years as secretary, Bruno Laroche has done a tremendous amount of work — thank you! He has passed the reigns on to the very capable Denis Lavoie who has proved himself by starting and following through on the successful patient information brochures. This past year will be remembered by 2 exciting developments. The first is the establishment of the first CUA owned journal — CUAJ. Already, the journal is a tremendous success. The second is the development of the Office of Education headed by Dr. Peter Anderson with the experienced full-time help of Dr. Harry Zwanenburg. We are working hard in Edmonton to get ready for the 2008 annual meeting and promise an excellent social program. The hard-working committee is led by Dr. Michael Chetner. The program promises to be exciting with an excellent array of international speakers as well as emphasis on live surgery and video surgery. There will be more audience participation through a wider use of the poster sessions. Lastly, our central office support has been tremendous and continues to enable and improve our important activities. We promise an excellent meeting in Edmonton, with registration available in early spring for both hotels and the meeting. We look forward to greeting you in Edmonton!

Practice nursed-based, individual and video-assisted patient education in oral anticoagulation - Protocol of a cluster-randomized controlled trial

BackgroundManaging oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only.Methods and designThis trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range.DiscussionThis trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to observe differences in adverse effects, we expect to discover differences in secondary outcomes, such as the time spent in the therapeutic range.Trial registrationDeutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586Universal Trial Number (UTN U1111-1118-3464)

Testicular biopsy before ART: the patients’ perspective on the quality of care

So far, research on the patients' perspective on fertility care has mainly focused on women. Our primary aim was to explore what is important to men with respect to care related to testicular sperm extraction (TESE) and to identify strengths and weaknesses of that care. This was a mixed-method study including phenomenology on interviews with 17 'interview participants' (a purposive sample with diversification for the TESE result) who received a TESE treatment at a tertiary university clinic. Strengths and weaknesses of our TESE-related quality of care were identified. Additionally, a telephone questionnaire was answered by 15 'rating participants' not willing to be interviewed and the questionnaire was analyzed quantitatively. Interview participants wanted more than effective treatment and attached importance to the attitude of fertility clinic staff, information, time flow, personalized care, 'all that is necessary', coaching, a homely atmosphere, continuity, privacy and separate accommodation. The satisfaction of rating participants (independent of the TESE result) was problematic for 'overall experience', 'physician at the day clinic' and 'gynecologist at discussion of the result'. The attitude of fertility clinic staff and information were the most obvious strengths of our TESE-related care. Weaknesses were lack of practical information on post-surgical recovery and waiting times in the waiting room. TESE patients focus not only on clinical effectiveness but also on patient-centeredness of care, and this has led to organizational changes and a new patient information brochure in our center. Qualitative research is useful to examine, understand and improve the patient-centeredness of care.

Non-Hospital Owned Medical Equipment Poses Challenge

Non-Hospital Owned Medical Equipment Poses Challenge

Meeting your high expectations

These are exciting times for our association, as it consolidates the transition from a simpler volunteer organization to a more complex one with a professional workforce. The CUA has gone from an entity whose main role was organizing the Annual Meeting, to one with many year-round initiatives. These include the Office of Education (OE), CUAJ, the patient brochure initiative and our guidelines. The complexity and cost of the organization has increased substantially. This reflects the increasing maturity of the CUA and the higher expectations of its members. Growth creates opportunities and challenges. The opportunities are obvious. The OE resoundingly establishes the CUA as an organizer of continuing medical education activities year-round. CUAJ is a wonderful initiative, of which we should all be proud, and has tremendous upside potential. The patient information brochures have had a huge and positive impact on patient education. The challenges relate primarily to the future. Where are we going, and what kind of organization do we want to become? What services should we focus on? What kind of annual meeting serves our members the best? Should we increase our political activities (as the AUA has done) at the federal level? What direction should the OE take? What can we do to make us more attractive to Canadian urologists (there are about 150 nonmembers in Canada)? How can we increase our visibility to the medical profession and the public? What about our financial stability? Remarkably, there is no record of the CUA ever going through a formal strategic planning process to address these questions in a systematic way. To that end, we are planning to do this with the CUA executive this year. We have engaged a strategic planning consultant to assist in this process. Over the next few months a series of interviews will be carried out with the current, past and future CUA leadership, as well as with many members of the executive. Questionnaires will be sent out to many members. This process will aim to gather diverse perspectives. The process will culminate in a full-day retreat just before the CUA executive meeting in January, followed by a formal report. We hope that this document will serve as a road map for the next 5 years, and will contribute to the development of a mature and healthy CUA that meets its members’ needs in many domains, including education, practice support, manpower planning and publication. Some members have expressed justifiable concern about the growth of the central office and the increased costs involved. Members are likely aware that the CUA shares offices and personnel with the Societe Internationale d’Urologie (SIU). Your executive has exercised a great deal of due diligence in evaluating the performance of the central office and establishing a sound cost-shared arrangement for the future. We are very satisfied that the current arrangement is reasonable and fair. We benefit tremendously from the experience and diverse talents of the CUA staff and have been able to leverage the lessons they learned from managing the SIU.

‘No one likes to wait’—Development of a patient information brochure to provide written information to patients at triage

‘No one likes to wait’—Development of a patient information brochure to provide written information to patients at triage