Formal Guidance Research Articles

Stakeholder Groups' Unique Perspectives About the Attending Physician Preceptor Role: A Qualitative Study.

Attending physician preceptors are accountable to many stakeholder groups, yet stakeholders' views about what the preceptor role entails have not been sufficiently considered. To explore stakeholder groups' unique perspectives of the preceptor role. Qualitative study with a constructivist orientation. Semi-structured interviews were conducted with 73 participants from two university teaching hospitals between October 2012 and March 2014. Participants included representatives from seven stakeholder groups: patients and their families, allied healthcare providers, bedside nurses, nurse managers, medical students, internal medicine residents, and preceptors. An inductive thematic analysis was conducted where researchers coded transcripts, abstracted codes into themes, and then mapped themes onto six focus areas: role dimensions, role performance, stressors and rewards, mastery, fulfillment, and impact on others. Two authors then identified "recurrent themes" (emerging in two or more focus areas) and compared them across groups to identify "unique themes" (emerging from a maximum of two stakeholder groups). "Unique thematic emphases" (unique themes that would not have emerged if a stakeholder group was not interviewed) are described. Patients and their families emphasized preceptors' ultimate authority. Allied healthcare providers described preceptors as engaged collaborators involved in discharge planning and requiring a sense of humor. Bedside nurses highlighted the need for role standardization. Nurse managers stressed preceptors' need for humanism. Medical students highlighted preceptors' emotional labor and their influence on learners' emotional well-being. Residents emphasized preceptors' responsibilities to multiple stakeholders. Preceptors described lifelong learning and exercising control over one's environment. Various stakeholder groups hold unique and nuanced views of the attending physician preceptor role. These views could broaden formal role guidance for medical education and patient care. This study generated real-world, practical examples of what stakeholders feel are important preceptor skills. These skills should be practiced, taught, and role modeled in this clinical setting.

Attachment as a Tool in the Treatment of Children Within Foster Care

Despite nearly 20% of marriage and family therapists graduated from COAMFTE accredited programs work within adoption and foster care agencies, less than 5% of COAMFTE accredited programs offer formal education and guidance focusing on working with foster care children. Some estimates suggest over 500,000 children in the United States enter the foster care system every year with many of them encountering mild to severe emotional, mental, and physical health concerns. Focusing on strengthening attachment between the foster child and parent could assist in alleviating many of these concerns. In an effort to begin addressing this notable gap in training paired with a demand for competent therapists who can serve children within the foster care system, this article has a twofold purpose. First, through synthesizing existing literature this article offers context and education about adverse experiences and concerns of children in foster care. Second, through an attachment lens clinical suggestions and interventions are discussed to assist MFTs in improving many of the emotional, mental, and physical health concerns found in this population.

Ethics to Intersect Civic Participation and Formal Guidance

Sound governance arrangement in socio-ecological systems (human niche) combines different means of sense-making. The sustainability of human niche-building depends on the governability of the social-ecological systems (SES) forming the niche. Experiences from small-scale marine fisheries and seabed mining illustrate how ethical frameworks, civic participation and formalised guidance combine in the context of a “blue economy”. Three lines of inquiries contextualise these experiences driving research questions, such as “what is the function of ethics for governability?” First, complex-adaptive SES are featured to emphasise the sense-making feedback loop in SES. Actors are part of this feedback loop and can use different means of sense-making to guide their actions. Second, the “Voluntary Guidelines for Sustainable Small-Scale Fisheries” and geoethical thinking are featured to highlight the relevance of actor-centric concepts. Third, Kohlberg’s model of “stages of moral adequacy” and the United Nations Convention on the Law of the Sea (UNCLOS) are used to show how to strengthen actor-centric virtue-ethics. Combining these lines of inquiry leads to the conclusion that ethical frameworks, civic participation and formalised guidance, when put in a mutual context, support governability and multi-actor/level policy-making. Further research could explore how creativity can strengthen civic participation, a feature only sketched here.

The energy based devices for vaginal "rejuvenation," urinary incontinence, vaginal cosmetic procedures, and other vulvo-vaginal disorders: An international multidisciplinary expert panel opinion.

Energy-based devices using radiofrequency and laser technologies have gained popularity as therapies for vaginal atrophy, urinary incontinence, and vaginal prolapse. They have been promoted by cosmetic and aesthetic industries for vaginal "laxity" and vaginal "rejuvenation," both of which are undefined conditions and terms. This article aims to review the current available literature and its quality on this emerging technology. An international panel of gynaecologists, urogynaecologists, and urologists undertook a review of the available published literature, identifying articles, guidance, and society statements on the use vaginal energy-based devices. There is currently no formal guidance for the use of vaginal energy based therapies. No randomized controlled trials have been published. No comparative studies to existing treatment has been carried out. Studies suggest that vaginal laser can be used in the treatment of vaginal prolapse or "vaginal laxity" and stress urinary incontinence with no quality evidence supporting the use of the therapy for vaginal atrophy or lichen sclerosis. This international group propose that whilst there remains a paucity of good quality data describing the safety, benefits, and appropriate use of vaginal radiofrequency or laser treatments in gynaecology and urogynaecology, a consensus best practice document by an established scientific community needs to be developed.

Dietary Supplement Use Among Chinese Primary School Students: A Cross-Sectional Study in Hunan Province

Dietary supplement use is increasing globally, especially among children. However, few studies have been conducted to examine dietary supplement use among Chinese children. The aim of this study was to examine the prevalence of dietary supplement use and the associated factors in primary school students. A cross-sectional study was conducted in four primary schools in Hunan province, China. A total of 706 Chinese parents/caregivers of school children aged 6–12 years old were enrolled. Self-administrated questionnaires were used to collect information about the children’s dietary supplement use, and their socio-demographic characteristics. The prevalence of dietary supplement use in primary school students was 20.4%. Calcium (16.7%), vitamin C (9.2%), and vitamin D (8.5%) were the most commonly used types of dietary supplement. The main reasons for parents/caregivers to purchase dietary supplements for their children were immunity improvement (43.6%), and for growth promotion (36.5%). Some caregivers (26.4%) purchased dietary supplements online, including from dubious or unknown sellers. However, 37.5% of caregivers did not receive formal guidance on supplementation even if they purchased their supplements through formal channels. Parents/caregivers were unclear about the appropriate choices for children’s dietary supplement use. Guidelines and counseling regarding dietary supplements for children may be helpful in public health work.

Methods of sample size calculation in descriptive retrospective burden of illness studies

BackgroundObservational burden of illness studies are used in pharmacoepidemiology to address a variety of objectives, including contextualizing the current treatment setting, identifying important treatment gaps, and providing estimates to parameterize economic models. Methodologies such as retrospective chart review may be utilized in settings for which existing datasets are not available or do not include sufficient clinical detail. While specifying the number of charts to be extracted and/or determining whether the number that can feasibly extracted will be clinically meaningful is an important study design consideration, there is a lack of rigorous methods available for sample size calculation in this setting. The objective of this study was to develop recommended sample size calculations for use in such studies.MethodsCalculations for identifying the optimal feasible sample size calculations were derived, for studies characterizing treatment patterns and medical costs, based on the ability to comprehensively observe treatments and maximize precision of resulting 95% confidence intervals. For cost outcomes, if the standard deviation is not known, the coefficient of variation cv can be used as an alternative. A case study of a chart review of advanced melanoma (MELODY) was used to characterize plausible values for cv in a real-world example.ResultsAcross sample sizes, any treatment given with greater than 1% frequency has a high likelihood of being observed. For a sample of size 200, and a treatment given to 5% of the population, the precision of a 95% confidence interval (CI) is expected to be ±0.03. For cost outcomes, for the median cv value observed in the MELODY study (0.72), a sample size of approximately 200 would be required to generate a 95% CI precise to within ±10% of the mean.ConclusionThis study presents a formal guidance on sample size calculations for retrospective burden of illness studies. The approach presented here is methodologically rigorous and designed for practical application in real-world retrospective chart review studies.

Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology.

In economic evaluations in oncology, adjusted survival should be generated if imbalances in prognostic/predictive factors across treatment arms are present. To date, no formal guidance has been developed regarding how such adjustments should be made. We compared various covariate-adjusted survival modeling approaches, as applied to the ENDEAVOR trial in multiple myeloma that assessed carfilzomib plus dexamethasone (Cd) versus bortezomib plus dexamethasone (Vd). Overall survival (OS) data and baseline characteristics were used for a subgroup (bortezomib-naïve/one prior therapy). Four adjusted survival modeling approaches were compared: propensity score weighting followed by fitting a Weibull model to the two arms of the balanced data (weighted data approach); fitting a multiple Weibull regression model including prognostic/predictive covariates to the two arms to predict survival using the mean value of each covariate and using the average of patient-specific survival predictions; and applying an adjusted hazard ratio (HR) derived from a Cox proportional hazard model to the baseline risk estimated for Vd. The mean OS estimated by the weighted data approach was 6.85years (95% confidence interval [CI] 4.62-10.70) for Cd, 4.68years (95% CI 3.46-6.74) for Vd, and 2.17years (95% CI 0.18-5.06) for the difference. Although other approaches estimated similar differences, using the mean value of covariates appeared to yield skewed survival estimates (mean OS was 7.65years for Cd and 5.40years for Vd), using the average of individual predictions had limited external validity (implausible long-term OS predictions with > 10% of the Vd population alive after 30years), and using the adjusted HR approach overestimated uncertainty (difference in mean OS was 2.03, 95% CI - 0.17 to 6.19). Adjusted survival modeling based on weighted or matched data approaches provides a flexible and robust method to correct for covariate imbalances in economic evaluations. The conclusions of our study may be generalizable to other settings. ClinicalTrials.gov identifier NCT01568866 (ENDEAVOR trial).

'It's too late'. Is it really? Considerations for amblyopia treatment in older children.

In recent years, media coverage has demonstrated instances in which families of children aged 7 and older, newly diagnosed with strabismic and/or anisometropic amblyopia through community eyecare services, were told it was ‘too late’ for their child to effectively respond to conventional amblyopia treatment (occlusion or atropine penalisation). Formal guidance pertaining to binocular vision anomalies from eyecare professional bodies does not specifically make reference to a child’s age, beyond stating the importance of early diagnosis and treatment of strabismus/amblyopia. However, there have been many changes in the way we view the recovery period for amblyopia, and it is well demonstrated both within literature and clinical practice that conventional treatment can improve amblyopic eye visual acuity in children beyond the age of 7 years. The occurrence of these media described cases within the community eyecare sphere would suggest it is worthwhile revisiting the literature on the subject of amblyopia treatment in older children (aged 7+ years), to address misconceptions and place in the spotlight current considerations facing clinicians when treating newly diagnosed amblyopia within this age group. This perspective review provides an evidence-based update covering the various considerations associated with treatment of amblyopia in older children, along with recent amblyopia treatment advances that could have an impact on treatment prospects for this patient group. Considerations include the risks, benefits and efficacy of treating newly diagnosed amblyopia in older children, monitoring density of suppression to mitigate intractable diplopia risk, and recent findings regarding binocular treatments for amblyopia.

National survey of UK endoscopists showing variation in diathermy practice for colonic polypectomy

IntroductionDiathermy practice in colonic polypectomy has a poor evidence base. We surveyed endoscopists across the UK to gain an insight in current diathermy practice.MethodsAn eight-question survey was designed to be...

Flood risk to commercial property

PurposeImproved management of commercial property at risk from flooding may result from well-targeted advice from built environment (BE) professionals, such as surveyors, valuers and project managers. However, research indicates that the role of these professionals in providing such advice is currently limited for a variety of reasons. This paper aims to investigate the (perceived and real) barriers and opportunities for providing such advice in a number of international locations. In particular, the research sought greater understanding of the link between regulation and guidance; perceived roles and capacity; and training and education needs.Design/methodology/approachTo cover different international settings, an illustrative case study approach was adopted within the selected countries (Australia, UK, USA, China and Germany). This involved a qualitative approach using semi-structured interviews of BE professionals with experience of advising on commercial properties at risk of flooding. Due to the specific nature of these interviews, a purposive sampling approach was implemented, leading to a sample of 72 interviews across the five international locations.FindingsPerceived barriers were linked to regulatory issues, a shortage of suitably experienced professionals, a lack of formal guidance and insurance requirements. BE professionals defined their roles differently in each case study in relation to these factors and stressed the need for closer collaboration among the various disciplines and indeed the other key stakeholders (i.e. insurers, loss adjusters and contractors). A shortage of knowledgeable experts caused by a lack of formal training, and education was a common challenge highlighted in all locations.Originality/valueThe research is unique in providing an international perspective on issues affecting BE professionals in providing robust and impartial advice on commercial property at risk of flooding. While acknowledging the existence of local flood conditions, regulatory frameworks and insurance regimes, the results indicate some recurring themes, indicating a lack of general flood risk education and training across all five case study countries. Learning across case studies coupled with appropriate policy development could contribute toward improved skills development and more consistent integration of BE professionals within future flood risk management practice, policy and strategy.

PRM221 - NETWORK META-ANALYSIS IN THE PRESENCE OF NON-PROPORTIONALITY: A REVIEW OF NICE SUBMISSIONS

Survival network meta-analyses (NMAs) are a key component of many health technology assessment submissions in oncology when head-to-head evidence is not available for all comparators. Traditional NMA methods of survival outcomes using hazard ratios (HRs) assume proportional effects of treatment over time. More recent fractional polynomial (FP) techniques do not rely on this proportional hazards (PH) assumption. Currently, no formal Decision Support Unit guidance exists on performing survival NMA. The objectives of this work were to examine PH and NMA methods in National Institute for Health and Care Excellence (NICE) submissions and their associated acceptability, and to explore the comparability of results from FP and HR NMAs in the presence of non-PH. We comprehensively identified and extracted information relating to NICE appraisal consultations for oncology products since June 2016. Information extracted included testing of PH, NMA methods, and Evidence Review Group (ERG) and committee comments. A targeted literature review of studies comparing FP and HR NMAs also was conducted. Since June 2016, 60% (47/78) of oncology submissions included survival NMAs or indirect comparisons. Of those, 47% utilised only HR-based NMAs, one (2%) used only an FP-based NMA, 13% used FP and HR, 38% used other approaches. The remaining submissions included limited evidence on comparable populations or availability of head-to-head evidence for all comparators. Tests of PH were reported in 81%. Of those reporting non-PH, approximately half only performed HR based approaches. Where there was evidence of non-PH, and the initial submission reported only HR NMAs, the ERG requested FP analysis. When non-PH was identified, FP and HR analysis sometimes provided conflicting results. It is important for submissions considering time-to-event endpoints to assess and report whether non-proportionality exists using visual and formal tests. Where there is evidence of non-proportionality, both HR and FP techniques are recommended.

PHP365 - TRENDS AND CHARACTERISTICS OF MANAGED ACCESS AGREEMENTS APPROVED BY NICE

Managed access agreements (MAAs) allow patients access to new treatments while long term data are collected and before final reimbursement decisions are made. The National Institute for Health and Care Excellence (NICE) first approved a MAA for a Highly Specialised Technology (HST) appraisal in November 2015, and in July 2016 the Cancer Drugs Fund (CDF) MAA process started. An analysis of MAAs' characteristics can provide information that aid future MAA development, but has yet to be reported. The objective therefore was to determine the number and characteristics of NICE approved MAAs. The NICE website was searched using the terms "managed access agreement“, “managed entry agreement” and “commercial access agreement”. Information on the process, timelines and content for completed appraisals up to December 2017 were extracted from the retrieved documents. Fifteen MAAs have been approved by NICE: one in 2015, two in 2016 and twelve in 2017. Eleven were within the CDF process, three within the HST programme and one for a single technology appraisal. Guidance on processes and timelines were available from the NICE website for CDF appraisals, but no formal MAA guidance were retrieved for other appraisal routes. Key appraisal uncertainties in clinical outcomes drove the MAA duration, data sources and data collection elements. Long term survival (n=11), treatment duration (n=10) and health-related quality of life (n=7) were the most requested outcomes, collected from disease registries (n=14), ongoing clinical trials (n=10) or both (n=10). Data collection periods ranged from <5 months to 4 years. All MAAs offered a simple discount patient access scheme and/or a reduced drug cost commercial access agreement. New NICE approved MAAs increased each year since 2015, were characterised by a standard format structured around the data required to answer key uncertainties and always included financial agreements to minimise NHS treatment costs during the MAA period.

Promotion and views on tinnitus self-help within United Kingdom national health service audiology departments

Self-help has the potential to provide low-cost and effective ways of improving access to psychological support for people with tinnitus. When developing and evaluating resources it is important to consider issues that may influence successful implementation. This Survey explored clinicians’ use and views on self-help, and barriers to implementation. An online survey was distributed to 220 UK audiology departments. One-hundred and twenty-four clinicians responded to the survey (91 audiologists, 32 hearing therapists, 1 clinical psychologist), each representing a different tinnitus department. Two-thirds of respondents reported providing or recommending self-help resources. Potential benefits were patient empowerment and providing a means of engaging patients in their care. Almost half of respondents felt that there is insufficient training or guidance for clinicians on using or promoting self-help. Clinicians felt that for patients with low-level tinnitus severity, self-help may reduce the number of audiology appointments required. For patients with more complex needs self-help may be useful to engage with between clinical appointments. Further research is needed to determine effectiveness, who benefits, and by what mechanism, before clinicians can confidently recommend or implement self-help. Clinicians will benefit from formal guidance on promoting and supporting use of self-help for tinnitus.

Mat nýliða á gagnsemi leiðsagnar í starfi kennara

Í greininni er fjallað um íslenskan hluta norrænnar rannsóknar á nýliðum í grunn- og framhaldsskólum – Nordment1 . Rannsóknin var unnin í samstarfi fræðimanna frá háskólunum í Osló, Gautaborg, Árósum, Turku og Akureyri. Markmið rannsóknarinnar var að kanna hvernig stuðningur í skólum, skólastjórnun og skipulag innan skóla hefur áhrif á það hvernig nýir kennarar aðlagast kennarastarfinu og hvernig þeir meta eigin færni og þær aðstæður sem skólarnir bjóða þeim. Þýði rannsóknarinnar var kennarar á 1.–3. starfsári eða sem höfðu nýlokið þremur starfsárum. Rannsóknin var megindleg og var sami spurningalisti notaður, þýddur og staðfærður, í öllum þátttökulöndunum. Hér á landi var spurningalistinn sendur til 280 kennara, um þriðjungur starfaði í framhaldsskóla og tveir þriðju í grunnskóla. Niðurstöður eru byggðar á svörum 239 kennara, svarhlutfall var rúm 85%.Meginmarkmið þessarar greinar er að gefa innsýn í þann hluta niðurstaðnanna sem lýtur að leiðsögn nýliða í grunn- og framhaldsskólum á Íslandi. Skoðað er hvernig henni er háttað á fyrsta starfsári og hvort tengsl eru milli formlegrar leiðsagnar, tíðni funda með leiðsagnarkennara og mats nýliða á gagnsemi leiðsagnarinnar.Helstu niðurstöður eru þær að leiðsögn hefur áhrif á starfshætti og líðan nýliða ef hún er veitt af kennara sem hefur svipaðan faglegan grunn og nýliðinn og ef þeir funda reglulega saman á leiðsagnartíma. Um þriðjungur þátttakenda hafði hugleitt að hætta í starfi en aðeins tíundi hluti þeirra hafði þó leitað sér að öðru starfi. Ekki voru tengsl milli hugleiðinga þeirra um brotthvarf og þess stuðnings sem þeir fengu í starfi.

Finding synergies for 3Rs – Toxicokinetics and read-across: Report from an EPAA partners' Forum

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a Partners' Forum Toxicokinetics and Read-Across to provide an overview on research activities to develop in vitro toxicokinetics methods and physiologically-based kinetic (PBK) models and to find synergies to enhance use of toxicokinetic data to strengthen read-across. Currently, lacking toxicokinetic data often prevent the application of read-across. Preferably, toxicokinetic data should be generated using in vitro and in silico tools and anchored towards human relevance. In certain sectors, PBK modelling is being used for risk assessment, but less so in others. Specific activities were identified to facilitate the use of in vitro and in silico toxicokinetic data to support read-across: The collation of available tools indicating the parameters and applicability domains covered; endpoint-specific guidance on toxicokinetics parameters required for read-across; case studies exemplifying how toxicokinetic data help support read-across. Activities to enhance the scientific robustness of read-across include the further user-friendly combination of read-across tools and formal guidance by the authorities specifying the minimum information requirements to justify read-across for a given toxicity endpoint. The EPAA was invited to continue dissemination activities and to explore possibilities to collate a contemporaneous list of open toxicokinetics tools that assist risk assessment.

IRS Guidance – Rulemaking and Deference to IRS Statutory Interpretation

This article deals with one of the key intersections of federal tax law and administrative law: IRS rulemaking. The IRS makes rules that affect the public through regulations and subregulatory guidance. I first discuss the IRS process for issuing such guidance and the principal forms the IRS uses. I then discuss the administrative law concept of deference to agency statutory interpretations. In administrative law, the two key regimes for deference are Chevron deference and Skidmore deference. Chevron deference requires the court to defer to an agency interpretation in formal guidance when the statutory text being interpreted is ambiguous and the agency interpretation is a reasonable interpretation even though the court believes there is a more reasonable interpretation. In the IRS context, Chevron deference applies to Treasury Regulations. Skidmore deference requires the court to defer to an agency interpretation in subregulatory guidance to the extent that the interpretation is persuasive. (That Skidmore formulation may sound a bit odd, but I get into that in the article.) The nonmainstream discussion in the article has two interrelated components: First, Chevron does not apply to legislative regulations. Legislative regulations are regulations, exemplified in the tax area by the consolidated return regulations under § 1502, where Congress delegated to the IRS the power to make the law. Second, Chevron does apply to interpretive regulations--regulations which interpret the statutory text. Some authors assert that, if Chevron deference applies to give the interpretation the force of law, then the regulation is a legislative regulation with the APA requirements for legislative regulations--promulgation in the Federal Register and prospective application only. The same argument, presumably, would apply if Skidmore or any other deference is given to an IRS interpretation in subregulatory guidance, because by conferring deference the interpretation has the force of law. I disagree with those authors. I assert that a court adopting--deferring to, if you will--an agency interpretation of ambiguous statutory text does not transform interpretation into legislative rulemaking under the APA. Hence, for such agency interpretations promulgation in the Federal Register is not required and the interpretations can apply retroactively. The IRS usually does issue its formal interpretations in regulations subject to notice and comment, so that is not a key difference. But, IRS interpretive regulations can and often do have retroactive effect.

A survey to explore health care staff perceptions of spirituality and spiritual care working in a single district health area in New Zealand

IntroductionThere is increasing literature suggestive of the positive benefits of 'spirituality' and their links to health and wellbeing. We wished to explore staff’s perceptions of spirituality and spiritual care working in a single district health area in New Zealand. MethodA staff survey was undertaken using a questionnaire incorporating the validated 17-item Spirituality and Spiritual Care Rating Scale (SSCRS) and a new 4-item Spiritual Care Confidence Scale (SCCS). Results635 participants completed the survey (48.4% nurses, 10.7% physicians, 36.6% allied health professionals and administration staff). Participants identifying a religious belief had a higher mean score for spiritual care confidence than staff reporting no religion, t(608) = −3.69, p = .000. Nurses recorded a statistically significant higher SSCRS mean score (x¯ = 66.36, 95% CI [65.68, 67.05]) compared to allied health professionals (x¯ = 64.44, 95% CI [63.58, 65.69]) p = .012. Nurses, midwives or physicians had a significantly higher mean score for spiritual care confidence (x¯ = 15.4.7, SD = 2.2) than allied health professionals (x¯ = 14.3, SD = 3.1), t(307) = −4.42, p = .000. Formal training (62.7%) and guidance on spirituality and spiritual care (60.5%), communication skills (56.3%) and inclusion on staff induction programs (51.1%) was requested to help staff meet patients’ spiritual care needs. ConclusionThis multi-professional survey suggests differences in perceptions of spirituality and confidence in providing spiritual care dependent on religious beliefs and professional role. Results should be used to shape design and delivery of spiritual care education across clinical settings.

Security and Privacy Issues with IoT in Healthcare

In healthcare, the Internet of Things (IoT) offers many benefits, including being able to monitor patients more closely and using data for analytics. When it comes to IoT for medical device integration, the focus is shifted towards the consumer end, such as glucose meters, blood pressure cuffs, and other devices designed to record data on patient vital signs. This enables healthcare providers to automatically collect information and apply decision support rules to allow for earlier intervention in the treatment process. Unfortunately, medical companies often do not consider the security risks of connecting these devices to the internet. There is a possibility that a zero-day exploit in a medical device can be used to injure or even kill someone without being detected. The rise in hackable medical devices has forced the FDA to issue formal guidance on how medical device makers should handle reports about cyber vulnerabilities. This paper aims to explore the role of IoT in healthcare, vulnerabilities, attacks, and security issues and solutions.

Interview-based research in accounting 2000–2014: Informal norms, translation and vibrancy

This paper brings to light informal norms that surround the production of interview-based research in the accounting domain – specifically regarding the number of interviews, the notion of saturation, length of articles, length of dedicated method section, reference to data coding, and number of block quotations per article. Our premise is that while the formal methodological literature in qualitative research provides guiding principles, the guidance tends to be general, and at times contradictory and ambiguous, thereby rendering its implementation a thorny exercise. This formal guidance thus needs significant translation in the context of specific research projects. We conceive of methodological translation as a socially constituted endeavour, which is influenced (not deterministically however) by social norms that informally surround the undertaking of research projects. To carry out the investigation we tabulate 639 interview-based research articles in major accounting journals published in the 15-year period 2000–2014 and examine patterns in the way that interview data is drawn upon to support research claims. Across this period, we find that the median number of interviews in published articles in leading accounting journals is 26, with variation across journal outlet and time period. We note that only a minority of papers mention the notion of saturation. Further, when being mentioned, saturation is often articulated in a hazy way. We also find several other trends across the period including a decrease in the number of interviews in published articles, an escalation in article length, a marked increase in the length of method sections, a significant augmentation in reference to data coding procedures, and an increase in the number of block quotations.

Cross-border healthcare for all EU residents? Linguistic access in the European Union

In 2011, the European Union introduced a Directive to facilitate cross-border healthcare, thus enhancing options for EU citizens and residents who are able to travel. However, if healthcare services are provided in a language patients cannot fully understand, equal access to safe and high-quality healthcare cannot be guaranteed. This exploratory study examines provisions for linguistically diverse patients seeking cross-border healthcare in areas of Germany, Greece, Italy, Spain and the UK. To address the language needs of these patients, healthcare organisations resort to a number of strategies, ranging from monolingual communication matching the language of the patient, to professional translation, interpreting and cultural mediation, or to informal and non-professional ad hoc solutions. In the absence of formal language guidance in EU legislation, in most observed cases appropriate language services are not provided for patients who are not proficient in the language of the Member State in which they seek healthcare. This study raises ethical questions regarding access and communication and has implications for policy makers, healthcare providers, educators, translators, interpreters and cultural mediators serving the needs of linguistically and culturally diverse patients.