Healthcare Professional Communication Research Articles

Implications of Direct Healthcare Professional Communication in Egypt: barriers and preferences of Health Care Professionals

Direct Healthcare Professional Communication (DHPC) is essentially distributed for fast communication of new serious drug safety information to healthcare professionals (HCPs). However, the use of this tool concerning the knowledge and preferences of HCPs has never been evaluated in Egypt. This study aimed to evaluate the HCPs' knowledge, preferences, and barriers to the use of DHPC in Egypt. A cross-sectional study of a random sample of 254 HCPs surveyed via face-to-face interviews to assess the Egyptian HCPs' awareness of DHPC, the preferences, and barriers that affect its use. Among the 297 approached HCPs, only 254 accepted to participate with a response rate of 85.5%, including (50% internists, 22.83% cardiologists, 11.02% neurologists, 11.02% pediatricians, and 5.12% from other specialties). Most HCPs were not familiar with DHPC (N= 254, 61.8%). One-third of the visited HCPs who were aware of concerned drugs' risk(s) got their information from DHPC (N= 149, 36.9%). HCPs preference for communication channel was highest for meetings (N= 254, 65.7%) and least for newsletters (N= 254, 28%). HCPs reported barriers to reading DHPC included; busy schedule (N= 254, 47.6%), mistrusted source (N= 254, 24.4%), view as a marketing tool (N= 254, 21.7%), invaluable information (N= 254, 9.8%) and disbelief (N= 254, 7.5%). The DHPC did not reach the target HCPs most of the time, but when received, it was successful in conveying the required message to the target HCPs. Multiple barriers were identified that negatively impacted the success of DHPC. It is recommended to use other electronic communication methods to enhance the reachability of the current method (DHPC).

End-of-Life Nursing and Education Consortium Communication Curriculum for Interdisciplinary Palliative Care Teams.

Background: Expert communication skills are essential for the delivery of effective palliative care across the domains of care. However, few health care providers receive formal communication training. To promote communication education for interdisciplinary palliative care teams, a train-the-trainer course for interdisciplinary hospital-based palliative care teams was developed to prepare them to teach other health care professionals communication skills. Course Design: The curriculum was organized by the eight domains of the National Consensus Project Guidelines for Quality Palliative Care and provided communication skills training for California-based teams. The two-day train-the-trainer course included skill-building exercises and interactive discussions to assist participants in integrating communication skills building into their clinical settings. Using a goal-directed method of teaching, faculty assisted teams in developing three institutional goals for providing palliative care communication training to other health care professionals. Evaluation of the course included immediate postcourse evaluation and follow-up evaluation at six and nine months. Results: The first statewide interdisciplinary communication training took place in January 2018 with 26 palliative care teams consisting of primarily nurses, followed by social workers, chaplains, and physicians. The 46 course participants' postcourse evaluations demonstrated high satisfaction with the course. On a scale of 1 to 5 (1 = lowest), the course met participants' expectations and objectives (4.8). The teams' precourse goals focused on (1) staff education, training, and mentorship, and (2) institution-wide system changes. Conclusion: Palliative care interdisciplinary teams can incorporate communication skills into their practice and provide communication skills training to their institutions.

Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron.

Introduction: Pharmacovigilance may detect safety issues after marketing of medications, and this can result in regulatory action such as direct healthcare professional communications (DHPC). DHPC can be effective in changing prescribing behaviour, however the extent to which prescribers vary in their response to DHPC is unknown. This study aims to explore changes in prescribing and prescribing variation among general practitioner (GP) practices following a DHPC on the safety of mirabegron, a medication to treat overactive bladder (OAB). Methods: This is an interrupted time series study of English GP practices from 2014–2017. National Health Service (NHS) Digital provided monthly statistics on aggregate practice-level prescribing and practice characteristics (practice staff and registered patient profiles, Quality and Outcomes Framework indicators, and deprivation of the practice area). The primary outcome was monthly mirabegron prescriptions as a percentage of all OAB drug prescriptions and we assessed the change following a DHPC issued by the European Medicines Agency in September 2015. The DHPC stated mirabegron use was contraindicated with severe uncontrolled hypertension and cautioned with hypertension. Variation between practices in mirabegron prescribing before and after the DHPC was assessed using the systematic component of variation (SCV). Multilevel segmented regression with random effects quantified the change in level and trend of prescribing after the DHPC. Practice characteristics were assessed for their association with a reduction in prescribing following the DHPC. Results: This study included 7408 practices. During September 2015, 88.9% of practices prescribed mirabegron and mirabegron comprised a mean of 8.2% (SD 6.8) of OAB prescriptions. Variation between practices was classified as very high and the median SCV did not change significantly (p = 0.11) in the six months after the September 2015 DHPC (12.4) compared to before (11.6). Before the DHPC, the share of mirabegron over all OAB drug prescriptions increased by 0.294 (95% confidence interval (CI), 0.287, 0.301) percentage points per month. There was no significant change in the month immediately after the DHPC (−0.023, 95% CI −0.105 to 0.058), however there was a significant reduction in trend (−0.036, 95% CI −0.049 to −0.023). Higher numbers of registered patients, patients aged ≥65 years, and practice area deprivation were associated with having a significant decrease in level and slope of mirabegron prescribing post-DHPC. Conclusion: Variation in mirabegron prescribing was high over the study period and did not change substantively following the DHPC. There was no immediate prescribing change post-DHPC, although the monthly growth did slow. Knowledge of the degree of variation in and determinants of response to safety communications may allow those that do not change prescribing habits to be provided with additional support.

New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014–2017

ABSTRACTBackground: Safety monitoring of all drugs throughout their entire life cycle is mandatory in order to protect the public health. Our objective was to describe all new safety signals assessed at EU level by the Pharmacovigilance Risk Assessment Committee (PRAC).Methods: Publicly available data on signals assessment from PRAC meeting minutes for the period January 2014–November 2017 were analyzed and classified.Results: A total of 239 new signals for 194 drugs/drug combinations/therapeutic classes were evaluated by PRAC. A total of 154 signals were triggered by spontaneous reporting, 31 by literature case reports, and 26 by observational studies. In 188 signals, the drugs involved were authorized for more than 5 years. The drug classes for which most signals were detected were antineoplastic/immunomodulators (n = 75), anti-infectives (n = 34), and drugs acting on the nervous system (n = 27). Signals were triggered for drug interactions (n = 15), in utero exposure (n = 7), medication errors (n = 6), and for different disorders, among which the skin/subcutaneous tissue disorders were more common. PRAC recommendations consisted in label updates (n = 86), in Direct Healthcare Professional Communications (n = 17), and in eight recommendations for a more complex evaluation through referral procedures.Conclusions: Most new signals assessed were triggered by spontaneous reporting and led to routine risk minimization measures, such as updating the product information.

Building the patient–clinician relationship through conversation based on narrative approaches

Building the patient–clinician relationship through conversation based on narrative approaches

Communication skills training for healthcare professionals working with people who have cancer.

This is the third update of a review that was originally published in the Cochrane Library in 2002, Issue 2. People with cancer, their families and carers have a high prevalence of psychological stress, which may be minimised by effective communication and support from their attending healthcare professionals (HCPs). Research suggests communication skills do not reliably improve with experience, therefore, considerable effort is dedicated to courses that may improve communication skills for HCPs involved in cancer care. A variety of communication skills training (CST) courses are in practice. We conducted this review to determine whether CST works and which types of CST, if any, are the most effective. To assess whether communication skills training is effective in changing behaviour of HCPs working in cancer care and in improving HCP well-being, patient health status and satisfaction. For this update, we searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid, Embase via Ovid, PsycInfo and CINAHL up to May 2018. In addition, we searched the US National Library of Medicine Clinical Trial Registry and handsearched the reference lists of relevant articles and conference proceedings for additional studies. The original review was a narrative review that included randomised controlled trials (RCTs) and controlled before-and-after studies. In updated versions, we limited our criteria to RCTs evaluating CST compared with no CST or other CST in HCPs working in cancer care. Primary outcomes were changes in HCP communication skills measured in interactions with real or simulated people with cancer or both, using objective scales. We excluded studies whose focus was communication skills in encounters related to informed consent for research. Two review authors independently assessed trials and extracted data to a pre-designed data collection form. We pooled data using the random-effects method. For continuous data, we used standardised mean differences (SMDs). We included 17 RCTs conducted mainly in outpatient settings. Eleven trials compared CST with no CST intervention; three trials compared the effect of a follow-up CST intervention after initial CST training; two trials compared the effect of CST and patient coaching; and one trial compared two types of CST. The types of CST courses evaluated in these trials were diverse. Study participants included oncologists, residents, other doctors, nurses and a mixed team of HCPs. Overall, 1240 HCPs participated (612 doctors including 151 residents, 532 nurses, and 96 mixed HCPs).Ten trials contributed data to the meta-analyses. HCPs in the intervention groups were more likely to use open questions in the post-intervention interviews than the control group (SMD 0.25, 95% CI 0.02 to 0.48; P = 0.03, I² = 62%; 5 studies, 796 participant interviews; very low-certainty evidence); more likely to show empathy towards their patients (SMD 0.18, 95% CI 0.05 to 0.32; P = 0.008, I² = 0%; 6 studies, 844 participant interviews; moderate-certainty evidence), and less likely to give facts only (SMD -0.26, 95% CI -0.51 to -0.01; P = 0.05, I² = 68%; 5 studies, 780 participant interviews; low-certainty evidence). Evidence suggesting no difference between CST and no CST on eliciting patient concerns and providing appropriate information was of a moderate-certainty. There was no evidence of differences in the other HCP communication skills, including clarifying and/or summarising information, and negotiation. Doctors and nurses did not perform differently for any HCP outcomes.There were no differences between the groups with regard to HCP 'burnout' (low-certainty evidence) nor with regard to patient satisfaction or patient perception of the HCPs communication skills (very low-certainty evidence). Out of the 17 included RCTs 15 were considered to be at a low risk of overall bias. Various CST courses appear to be effective in improving HCP communication skills related to supportive skills and to help HCPs to be less likely to give facts only without individualising their responses to the patient's emotions or offering support. We were unable to determine whether the effects of CST are sustained over time, whether consolidation sessions are necessary, and which types of CST programs are most likely to work. We found no evidence to support a beneficial effect of CST on HCP 'burnout', the mental or physical health and satisfaction of people with cancer.

The attitude of healthcare professionals plays an important role in the uptake of diabetes self-management education: analysis of the Barriers to Uptake of Type 1 Diabetes Education (BUD1E) study survey.

To explore reasons for the poor uptake of accredited diabetes self-management education (DSME) in adults with Type 1 diabetes. The study was set in an urban population in South London, UK. A cross sectional survey gathered demographic, diabetes service-use data, psychological scores and reasons for non-attendance at locally-available DSME. In addition, 56 healthcare professionals were surveyed. Responses to surveys were returned by 496 adults with Type 1 diabetes (33% response rate), of whom 263 had attended DSME (53%). Multivariable analysis adjusted for significant variables identified four key variables influencing attendance. Non-attendance was associated with men (OR 0.55 CI 0.37-0.84, p = 0.005), lower educational attainment (OR 0.45 CI 0.28-0.73, p = 0.001), higher glycated haemoglobin (OR 1.74 CI 1.03-2.94, p = 0.04) and healthcare professional encouragement to attend (OR 1.7 CI 1.28-2.3, p = 0.001). The most frequently reported barriers to attendance were work (37%) and time (14%) commitments. Only 49% of healthcare professionals (HCPs) correctly identified the most likely barriers. Those HCPs who had observed courses believed more in their efficacy, with higher uptake within their clinic population. Social determinants of health, particularly educational attainment and gender, increase health inequalities by influencing decisions to attend evidence-based education courses. Healthcare professional communication is paramount to encourage attendance, and observation of a course may facilitate this.

New Immigrant Health Professional’s Individual, Societal and Economic Impact of Ryerson University’s Internationally Trained Medical Doctors (ITMDs) Bridging Program: Results from a Pilot Bridge Training Program at the Chang School of Continuing Education

Although Canada is home to a large number of internationally educated health professionals, their skills and experiences are grossly underutilized in the Canadian healthcare landscape. Barriers to medical practice are pervasive, and as a result the majority of internationally trained medical doctors (ITMDs) work in “survival” jobs significantly below their skill level. The pilot ITMD Bridging Program was developed to provide an alternative path for ITMDs by providing the skills and competencies required for non-licensed health sector employment, ultimately aiming to improve integration of ITMDs into the Canadian workforce. This secondary research evaluates the ITMD Bridging Program by assessing the impact of the program at both individual and societal levels.Qualitative and quantitative data were used to evaluate the individual and societal impact of the program. Secondary data from participants’ entry and exit surveys, as well as key informant interviews conducted with ITMDs upon program completion were used for the analysis. The economic impact of the program and its overall utility to the economy of Ontario were assessed through literature review and social rate of return analysis.ITMDs program participants reported substantial improvements in skills related each of the core courses including health research methods, health informatics and data management, fundamentals of project management, as well as healthcare professionals communication and leadership skills. ITMDs also perceived the program to be a viable option to address human potential waste, enhance the economy, develop individual capacity building, and alleviate frustrations associated with labour market exclusion. The program is also economically viable at the societal level, and represents a rate of return of 6.52%.The ITMD Bridging Program has demonstrated that providing non-licensed health sector employment is a viable option for policymakers to consider in their efforts to address the current brain waste in the Ontario healthcare sector. Bridging programs similar to the ITMD Bridging Program have the capacity to impact individual outcomes of ITMDs, the economic landscape in Ontario, and Canada at large.

Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination

The incidence of human papillomavirus (HPV)-related cancers is more than 35 000 cases in the United States each year. Effective HPV vaccines have been available in the United States for several years but are underused among adolescents, the target population for vaccination. Interventions to increase uptake are needed. To evaluate the effect of a 5-component health care professional HPV vaccine communication intervention on adolescent HPV vaccination. A cluster randomized clinical trial using covariate-constrained randomization to assign study arms and an intent-to-treat protocol was conducted in 16 primary care practices in the Denver, Colorado, metropolitan area. Participants included 188 medical professionals and 43 132 adolescents. The 5 components of the intervention were an HPV fact sheet library to create customized information sheets relevant to each practice's patient population, a tailored parent education website, a set of HPV-related disease images, an HPV vaccine decision aid, and 2½ hours of communication training on using a presumptive vaccine recommendation, followed by motivational interviewing if parents were resistant to vaccination. Each practice participated in a series of 2 intervention development meetings over a 6-month period (August 1, 2014, to January 31, 2015) before the intervention. Differences between control and intervention changes over time (ie, difference in differences between the baseline and intervention period cohorts of patients) in HPV vaccine series initiation (≥1 dose) and completion (≥3 doses) among patients aged 11 to 17 years seen at the practices between February 1, 2015, and January 31, 2016. Vaccination data were obtained from the practices' records and augmented with state immunization information system data. Sixteen practices and 43 132 patients (50.3% female; median age, 12.6 years [interquartile range, 10.8-14.7 years] at the beginning of the study period) participated in this trial. Adolescents in the intervention practices had significantly higher odds of HPV vaccine series initiation (adjusted odds ratio [aOR], 1.46; 95% CI, 1.31-1.62) and completion (aOR, 1.56; 95% CI, 1.27-1.92) than those in the control practices (a 9.5-absolute percentage point increase in HPV vaccine series initiation and a 4.4-absolute percentage point increase in HPV vaccine series completion in intervention practices). The intervention had a greater effect in pediatric practices compared with family medicine practices and in private practices compared with public ones. Health care professionals reported that communication training and the fact sheets were the most used and useful intervention components. A health care professional communication intervention significantly improved HPV vaccine series initiation and completion among adolescent patients. clinicaltrials.gov Identifier: NCT02456077.

Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study.

IntroductionNational competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs.ObjectiveThe objective was to assess and compare general practitioners’ (GPs’), cardiologists’, and pharmacists’ familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues.MethodsGPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their awareness of safety issues that had recently been communicated and involved the following drugs: combined hormonal contraceptives, diclofenac, valproate, and ivabradine. Those HCPs who were aware of the specific safety issues were subsequently asked to indicate the source through which they had become aware of them. Differences between professions in familiarity with DHPCs and awareness were tested using a Pearson χ2 test per country and post hoc Pearson χ2 tests in the case of statistically significant differences.ResultsOf the 3288 included respondents, 54% were GPs, 40% were pharmacists, and 7% were cardiologists. The number of respondents ranged from 67 in Denmark to 916 in Spain. Most respondents (92%) were familiar with DHPCs, with one significant difference between the professions: pharmacists were more familiar than GPs in Italy (99 vs 90%, P = 0.004). GPs’ awareness ranged from 96% for the diclofenac issue to 70% for the ivabradine issue. A similar pattern was shown for pharmacists (91% aware of the diclofenac issue to 66% of the ivabradine issue). Cardiologists’ awareness ranged from 91% for the ivabradine issue to 34% for the valproate issue. Overall, DHPCs were a common source through which GPs (range: 45% of those aware of the contraceptives issue to 60% of those aware of the valproate issue), cardiologists (range: 33% for the contraceptives issue to 61% for the valproate issue), and pharmacists (range: 41% for the contraceptives issue to 51% for the ivabradine issue) had become aware of the specific safety issues, followed by information on websites or in newsletters.ConclusionsGPs, cardiologists, and pharmacists were to a similar extent (highly) familiar with DHPCs, but they differed in awareness levels of specific safety issues. Cardiologists were less aware of safety issues associated with non-cardiology drugs even if these had cardiovascular safety concerns. This implies that additional strategies may be needed to reach specialists when communicating safety issues regarding drugs outside their therapeutic area but with risks related to their field of specialisation. DHPCs were an important source for the different professions to become aware of specific safety issues, but other sources were also often used. NCAs should consider the use of a range of sources when communicating important safety issues to HCPs.Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0643-5) contains supplementary material, which is available to authorized users.

How to achieve a collaborative approach in health promotion: preferences and ideas of users of mental health services.

Collaborative approaches to consensus building or decision-making are beneficial in health-promoting activities targeting users of mental health services (users). However, little is known about how to achieve a collaborative approach in practice. The purpose of this study was to explore: (1) users' preferences and ideas related to achieving a collaborative approach in health-related communication and (2) perspectives of healthcare and social work professionals and family members on users' ideas and preferences. Data were collected through interactive workshops with users (n=15), professionals (n=21) and users' family members (n=12). Data were analysed using systematic text condensation. Users provided three recommendations for establishing a collaborative approach in communication about health: (1) involving users in deciding the agenda and setting for health-promoting activities; (2) exchanging knowledge between users and professionals about health and values; and (3) exploring users' motivation for change. Users and professionals had diverging perceptions of the value of establishing a collaborative approach. Professionals regarded relationship building and health promotion as separate phenomena, whereas users perceived relationship building as inherently health promoting. Family members of users requested specific guidance and support with regard to clarifying and fulfilling the best possible support role as a family member. The findings suggest that a collaborative approach in health promotion may be difficult to achieve without a focus on professional development for healthcare and social work professionals.

Need for information, honesty and respect: patient perspectives on health care professionals communication about cancer and fertility

BackgroundIndividuals affected by cancer report a need for information about fertility from health care professionals (HCPs), in order to inform decision making and alleviate anxiety. However, there is evidence that many health professionals do not engage in such discussions.MethodA mixed method design was used to examine the construction and subjective experience of communication with health professionals about fertility in the context of cancer, from the perspective of patients. A survey was completed by 693 women and 185 men, across a range of cancer tumour types and age groups, and in-depth one-to-one interviews conducted with a purposively selected subsample of survey respondents, 61 women and 17 men. The chi square test for independence was used to test for group differences between women and men on closed survey items. Thematic analysis was used to examine the open ended survey responses and interviews.ResultsSignificantly more women (57%, n = 373) than men (46%, n = 80) (X2(2517) = 6.54, p = .011) reported that they had discussed fertility with a HCP since diagnosis of cancer. Satisfaction with the discussion was reported by 65% (n = 242) of women and 69% (n = 54) (ns) of men. This discussion was reported to have been initiated by the patient or their partner in 44% (n = 165) of women and 47% (n = 37) (ns) of men. In the interviews and open ended surveys three themes were identified: Feeling heard and informed about fertility after cancer: Positive experiences of HCP communication; “I was never given full disclosure”: HCP silence or reticence about discussing fertility after cancer, including the sub-theme “Their primary concern is getting me cancer free”: Constructions of absence of fertility communication by HCPs; and Confusion and lack of compassion: Unsatisfactory information provision about fertility and cancer.ConclusionDiscussion with a HCP about fertility concerns, and satisfaction with the discussion, was associated with reports of lower patient distress, greater knowledge and understanding of the consequences of cancer on fertility, involvement in the decision making process about fertility preservation, and satisfaction with health care.

Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.

AimsEvaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research.MethodsWe searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non‐European Union regulatory actions to safeguard public health published until March 2017. References from systematic reviews and articles from other known sources were added. Regulatory interventions, data sources, outcomes of interest, methodology and key findings were extracted.ResultsFrom 1246 screened articles, 229 were eligible for full‐text review and 153 articles in English language were included in the descriptive analysis. Over a third of articles studied analgesics and antidepressants. Interventions most frequently evaluated are regulatory safety communications (28.8%), black box warnings (23.5%) and direct healthcare professional communications (10.5%); 55% of studies measured changes in drug utilization patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour or changes in clinical practice. Unintended consequences like switching therapies or spill‐over effects were rarely evaluated. Two‐thirds used before–after time series and 15.7% before–after cross‐sectional study designs. Various analytical approaches were applied including interrupted time series regression (31.4%), simple descriptive analysis (28.8%) and descriptive analysis with significance tests (23.5%).ConclusionWhilst impact evaluation of pharmacovigilance and product‐specific regulatory interventions is increasing, the marked heterogeneity in study conduct and reporting highlights the need for scientific guidance to ensure robust methodologies are applied and systematic dissemination of results occurs.

Communication of healthcare professionals: Is there ageism?

Elderspeak is often used when talking to older individuals and is characterised by a slower and/or louder speech, a patronising tone, etc. A part of the reason of such communication can be found in the actual context of negative view of ageing. However, the link between view of ageing and elderspeak has never been objectively studied in oncology. Therefore, 40 healthcare professionals (physicians and medical students) record a podcast where they have to explain an endocrine therapy to two fictional patients (40- vs. 70-year old). Results show that when participants explained the treatment to the older patient, they used shorter utterances and made more repetitions. They also evoked fewer side effects such as sexual issues. Moreover, reduction in length of utterances and of word-per-minute rate was observed for older patient when participants have a positive view of ageing but for both patients when they have a negative view of ageing. In conclusion, physicians and medical students used elderspeak when they explained a treatment to older patients. Participants with a more negative view of ageing also unconsciously talked slower and made shorter utterances to a 40-year-old patient.

Evaluation of Risk-Minimization Activities for Cyproterone Acetate 2mg/Ethinylestradiol 35µg: A Cross-Sectional Physician Survey.

BackgroundCyproterone acetate 2 mg/ethinylestradiol 35 µg, an estrogen/progestogen treatment with anti-androgenic properties, shares a thromboembolism risk with combined hormonal contraceptives. Educational materials (i.e., direct healthcare professional communication, patient information card, prescriber checklist) were distributed to physicians to increase risk awareness.ObjectiveThe objective of this study was to measure physician knowledge of thromboembolism risk of cyproterone acetate 2 mg/ethinylestradiol 35 µg and ascertain whether physicians received the educational materials.MethodsA cross-sectional web-based physician survey of recent prescribers of cyproterone acetate 2 mg/ethinylestradiol 35 µg in Austria, the Czech Republic, France, the Netherlands, and Spain was conducted. Sampling targets for physician specialty were based on country-specific prescribing patterns. Frequency of correct responses was calculated for 14 knowledge questions.ResultsAmong 759 physician respondents (37% of obstetricians/gynecologists, 42% of general practitioners, 20% of dermatologists), 51% received one or more of three educational materials. Knowledge was highest (≥80%) for symptoms of possible deep vein thrombosis, pulmonary embolism, and cerebrovascular accident; most important risk factors for thrombosis; use in smokers; indication for moderate-to-severe acne; and understanding that cyproterone acetate 2 mg/ethinylestradiol 35 µg should not be used for contraception alone. Knowledge varied for contraindications, myocardial infarction symptoms, other risk factors for thrombosis, instructions regarding anticipated prolonged immobilization, and selected concomitant medical conditions. Knowledge was lower regarding prescribing cyproterone acetate 2 mg/ethinylestradiol 35 µg for acne only after failure of topical therapy or systemic antibiotics. Generally, knowledge did not vary by physician specialty, receipt of educational materials, number of patients prescribed cyproterone acetate 2 mg/ethinylestradiol 35 µg in the previous 3 months, and years in practice.ConclusionsKnowledge was generally high for thromboembolism risk and varied for more complex or infrequent topics.Electronic supplementary materialThe online version of this article (doi:10.1007/s40290-017-0203-9) contains supplementary material, which is available to authorized users.

Communication on Safety of Medicines in Europe: Current Practices and General Practitioners' Awareness and Preferences.

IntroductionNational competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs).ObjectiveThe aim of this study was to assess current European NCA safety communication practices and to investigate European GPs’ awareness of and preferences for safety communications on medicines.MethodsWeb-based surveys were distributed among European NCAs and healthcare professionals (HCPs). The survey among regulators was emailed to a representative of each of the 27 European countries participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. HCPs from nine European countries (Denmark, Spain, Croatia, Ireland, Italy, The Netherlands, Norway, Sweden, and the UK) were asked about their preferences through a link to the survey on websites, in newsletters, and/or in a direct email. From this survey, data from GPs were used and descriptive analyses were conducted.ResultsCurrent NCA practices were reported for 26 countries. In 23 countries (88%), NCAs published direct healthcare professional communications (DHPCs, i.e. urgent communication letters for serious safety issues) on their website in addition to distribution to individual HCPs. Educational materials were available on the NCA’s website in 10 countries (40%), and 21 NCAs (81%) indicated they had their own bulletin/newsletter, which is often presented on the NCA’s website (15 countries; 60%). More than 90% of the 1766 GPs who completed the survey were aware of DHPCs. The most preferred senders of safety information were NCAs and professional bodies, while the preferred channels for keeping up to date with safety information were medicines reference books and clinical guidelines. GPs found the repetition of safety issues useful (range of 80% in the UK to 97% in Italy). Preference for an electronic copy rather than a hardcopy varied per country (36% in Sweden to 72% in Spain).ConclusionsNCAs use similar methods for safety communications on medicines. Most GPs were aware of urgent communications and preferred similar senders of safety communications; however, their preferences towards the format differed per country.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-017-0535-0) contains supplementary material, which is available to authorized users.

Post-marketing drug withdrawals: Pharmacovigilance success, regulatory problems

Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence. Conflicts of interest may inhibit decision-making. Recommendations that arise from these observations are that: health professionals and patients should be more vigorously encouraged to report suspected adverse drug reactions; regulatory authorities and drug manufacturers should take quicker confirmatory action when serious suspected adverse drug reactions are reported, even anecdotally, with formal studies to test for causality conducted sooner rather than later, applying lower than usual thresholds for suspicion; temporary suspensions or restrictions could be considered during such assessments; universal guidelines are needed for determining when a drug should be withdrawn if serious adverse drug reactions are suspected; there should be more rigorous monitoring and verification of deaths and reporting of reasons for drop-outs during clinical trials, with more transparency in reporting adverse events and ready access to premarketing clinical study reports; post-marketing drug monitoring systems and medicines regulation in low-to-middle income economies, especially in Africa, where withdrawals are fewer than elsewhere, should be strengthened.

Communication of Healthcare Professionals with Geriatric Patients

Background: In their daily professional activity, the nurses constantly communicate with the patients, their relatives and with the members of the medical team. The ability to communicate is fundamental in medical specialist’s work. For the development of individual, effective plan for medical care and education, the nurse can rely entirely on her communication skills. Caring for geriatric patients also require professional competence and specific communication skills. Purpose: To investigate and analyze the level of communication between the nurse and the patient, as well as his relatives, during the hospitalization. Respondents through an anonymous survey of 392 patients aged over 65 received treatment in surgery, internal and emergency department of the Hospital “St. Panteleimon”, Hospital “Plovdiv”-Plovdiv, University Hospital “Caspela”-Plovdiv, University Hospital “Trimontsium”-Plovdiv, University Hospital “Eurohospital”-Plovdiv, University Hospital “Pulmed”-Plovdiv. Results and conclusion: Analysis of the results shows that nurses are able to communicate with patients and no problems during the communication occurred. Disturbing is the fact that not a small percentage of the health professionals do not communicate with the relatives of patients. The respondents placed first as the main reason for disturbances in the relationship between them and the medical staff-the specific age of the patients (51.8%).

Clinical Supervision of Interns: Understanding the View of Interns and the Potential of ICT to Deliver Supervision for Safer Patient Care.

Clinical communication and clinical supervision of junior healthcare professionals are identified as the two most common preventable factors to reduce medical errors. While multiple strategies have been implemented to improve clinical communication, clinical supervision has not attracted as much attention. This is in part due to the lack of understanding of clinical supervision. Furthermore, there is a lack of exploration of information communication technology (ICT) in assisting the delivery of clinical supervision from the perspective of users (i.e. junior clinicians). This paper presents a study to understand clinical supervision from the perspective of medical and pharmacy interns. The important elements of good clinical supervisors and good clinical supervision have been presented in this paper based on our study. More importantly, our results suggest a distinction between good supervisors and good supervisions. Both these factors impact on patient safety. Through discussion of user requirements of good supervision by users (interns), this paper then explores and presents a conceptual framework to assist in the discussion and design of ICT by healthcare organisations to improve clinical supervision of interns and therefore improve patient safety.

Up-scaling of an integrated care model for frail elderly patients

Introduction : Population aging and the increased number of chronic diseases push the healthcare systems to design and implement new strategies to improve the quality of services. These strategies require investment in ICT tools, promotion of patient empowerment in the management of their disease and a better integration of health and social care services. CareWell project focuses on the delivery of integrated healthcare to frail elderly patients who have complex health and social care needs, are at high risk of hospital or care home admission and require a range of high-level interventions due to their frailty and multiple chronic diseases. Carewell aims at deploying services supported by ICT which enhance the coordination and communication of healthcare professionals, improves patient´s remote follow up and boosts patient (and caregiver) empowerment. The aim of the project is the identification of the impact of implementing an integrated care model for frail elderly patients, according to quality of care, efficiency and both patients´ and professionals´ satisfaction. Short description of the intervention : Following the inclusion criteria and based on the population stratification dataset, the GP identifies potential candidates. Then, the GP proceeds to schedule a consultation with the patient to perform a comprehensive assessment, define the therapeutic plan and provide patient with educational material in order increase his/her self-management capability. Then, the GP nurse schedules a face-to-face follow-up plan depending on the patient's needs. During this face-to-face consultation, the GP nurse analyses patient's therapeutic plan and his/her adherence to treatment, reinforces patient's self-management capacity through an educational plan, revises lab tests and performs medical examinations. If no worsening symptoms are detected, the patient is reviewed approximately every three months. However, if any instability sign is identified, the patient is referred to the GP in order to reassess his/her clinical situation. If the patient can benefit from home care, a variety of resources can be activated. If the patient cannot be treated at home, or his/her health status continues to worsen, the patient will be admitted to hospital. During the hospitalisation, the reference internist is in charge of assessing the patient's clinical situation, defining corresponding treatment, managing medical interventions and coordinating specialists. Once the patient is stable, the reference internist will consider if the patient requires additional interventions such as home-hospitalisation, admission to a sub-acute hospital, social care, or special coordination with primary care. At hospital discharge, the reference internist writes the discharge letter and contacts the GP to ensure continuity of care. In addition, the hospital nurse draws up the patient's follow-up plan, and schedules a face-to-face appointment between the patient and the GP nurse. The visit with the GP nurse is the starting point of the integrated care pathway, from where the patient can be referred to periodic follow-up consultations or to hospital, depending on his/her health status. Key findings: The definition of the care pathway supported by ICTs has been deeply discussed in an inter-organizational and multidisciplinary work group (managers, clinicians nursing of primary care and hospitals, eHealth Centre, Department of Information Systems, Department of Healthcare and Kronikgune), ensuring that all stakeholders´ opinions and needs are considered. 200 patients (100 intervention group and 100 control group) have been recruited and the services aforementioned are fully operational. At this moment the enrolment data is being collected and the baseline analysis (quantitative and qualitative indicators) will be performed during December. In addition, predictive modeling approach will be carried out to estimate the use of resources in mid- and long-term after the new service deployment. Highlights and conclusions : Intervention perspective: - Need of a clear methodology to design the intervention (analysis of current model, detection of improvement areas, prioritize actions and define the new care pathway) - Need of resource re-organization and definition of new roles to improve coordination between different healthcare levels (primary and secondary care). - Primary Care is responsible for proactive control of the patients. - Patient and informal caregiver empowerment leaded by nursing is essential. - Technology is crucial to facilitate coordination between healthcare professionals. Implementation perspective: - Need to align the objectives of the project with the strategic plan of the central organization so the deployment of the service becomes a priority. - Importance of reach consensus among all stakeholders in the definition of the care pathways in order to consider different perspectives (managerial, technical and methodological competences). - Ensure the service is adaptable and flexible enough to be adopted in new contexts. - Distributed leadership is crucial from the implementation process perspective (clinical, managerial and methodological) - Need to share midterm results and collect feedback from front-line professionals to detect improvement areas