External quality assessment (EQA) and alternative assessment procedures (AAPs) in molecular diagnostics: findings of an international survey.

Objectives: Quality management for clinical laboratories requires the establishment of internal procedures including standard operating procedures (SOPs), internal quality control (QC), validation of test results and quality assessment. External quality assessment (EQA) and alternativeassessment procedures (AAPs) are part of the quality hierarchy required for diagnostic testing. The International Organization for Standardization (ISO) document with requirements for conformance ISO 15189 and the Clinical and Laboratory Standards Institute document (CLSI) QMS24 require participation in EQA schemes and AAPs where applicable. The purpose of this study was to perform a global survey of EQA and AAPs for key procedures in molecular diagnostic laboratories. Methods: The Committee for Molecular Diagnostics of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC C-MD) conducted a survey of international molecular laboratories that covered specific topics of molecular diagnostic services as well as methods for EQA and AAPs. The survey addressed the following aspects: (1) usage of laboratory-developed test (LDT), (2) participation in EQA schemes and (3) performance of AAPs. Results: A total of 93 responses from laboratories located in Asia, Europe, the Middle East, North America and South America were received. The majority of the participating laboratories (65.9%) use LDTs and 81.3% stated that it is mandatory for them to participate in EQA programs, while 22% of the laboratories reported not performing AAPs. Thirty-one percent of the laboratories use EQAs for fewer than 50.0% of their reported parameters/analytes. Conclusions: While the majority of laboratories perform EQA and AAPs to improve their quality in molecular diagnostics, the amount of AAPs as quality procedures differs within the laboratories. Further surveys are necessary to clarify the existing needs in additional EQAs and standardized AAPs. The survey will also guide future efforts of the IFCC C-MD for identifying quality practices in need to improve harmonization and standardization within molecular diagnostics.

Pilot trial of The Living Well Toolkit: qualitative analysis and implications for refinement and future implementation.

BACKGROUND: Following a neurological event, people's long-term health and well-being is hampered by a system that struggles to deliver person-centred communication and coordinated care and fails to harness individual and family capability to live well with the condition. We aimed to implement and evaluate a toolkit package to support these processes for people with long-term neurological conditions. METHODS: This is a multi-phased study drawing on the principles of participatory research. In this pilot phase, the toolkit package was introduced to clinicians, who introduced it to clients in four neurorehabilitation settings (inpatient and community-based). Individual and focus group interviews were carried out with clients (n = 10) and clinicians (n = 9). Data were categorised by the four components of Normalisation Process Theory (NPT), and data within each component was then coded inductively. This analysis was used to inform revisions to the toolkit package and wider implementation processes. RESULTS: There was widespread support for the principles underpinning the toolkit package from clients and clinicians. However, it was less clear how the client toolkit could support these principles in clinical practice which impacted buy-in. The flexibility of use of the client toolkit, which we encouraged, made it difficult for clinicians and clients to be clear about its purpose and for clinicians to operationalise in practice. Clinicians and clients identified a number of barriers that limited the time, energy and work users were able or prepared to invest, to the extent that uptake of the toolkit package was modest. Use of the toolkit package appeared more likely when clinicians perceived it to augment existing processes (e.g. goal setting) rather than detract from 'doing' therapy. This analysis was used to inform revisions to the toolkit package, including simplification of the client toolkit, development of videos with examples of use and a modular and reflective training package for clinical services. The refinements were intended to improve sense-making and minimise the cognitive barriers associated with implementation of a new intervention. CONCLUSION: Understanding how supporting the client toolkit could add value to the therapeutic encounter was necessary for clinicians to invest time and perceive the worth of the toolkit package. TRIAL REGISTRATION: ANZCTR: ACTRN12614000537651. Registered 21 May, 2014.

Accessibility and acceptability of health promotion services in New Zealand for minority refugee women.

Refugees are forced to flee their native country to escape war or oppression. They are resilient and generally have a high level of motivation to rebuild their lives, as well as to make a meaningful contribution to the host country. However, refugees in general have complex health needs and they often face significant barriers in accessing health services in their host countries. Health promotion has been identified as an effective approach for increasing service utilization by minority populations such as refugees, and contributing to their overall positive health outcomes. This qualitative study examined the accessibility and acceptability of health promotion services for Bhutanese refugee women who resettled in New Zealand. The study consisted of two phases: focus group discussions with 32 Bhutanese women and eight Bhutanese men, followed by individual interviews with 12 health professionals including five nurses, four doctors and three midwives. The data were collected in two regional towns of New Zealand in 2014. The study's conceptual framework utilized the strategies and actions underpinning the Ottawa Charter for Health Promotion. Findings of this study revealed that Bhutanese women were missing some essential health promotion services, such as antenatal education sessions mainly due to language and cultural barriers. This study recommends to develop health promotion resources in the Nepali language; and to deliver the health promotion sessions by culturally and linguistically competent providers. This study also uncovered resiliency and strengths of Bhutanese women that could be recognized, strengthened and utilized in promoting their health and well-being.

Availability, Accessibility, Acceptability, and Quality of Interpreting Services to Refugee Women in New Zealand.

A significant number of people have been displaced from their country of origin and become refugees. Good health is essential for refugees to actively engage and take up opportunities within the society in their host countries. However, negotiating a new and unfamiliar health system hinders refugees' ability to access and make use of the available health services. Communication difficulties due to language barriers are the most commonly cited challenges faced by refugees in accessing and utilizing health services post-resettlement. In this study, we aimed to examine effectiveness of interpreting services for refugee women in New Zealand. Data were collected through three sources: focus groups with Bhutanese women, focus group with Bhutanese men, and individual interviews with health professionals. The findings of this study reveal inadequacies and constraints in the provision of a socioculturally and linguistically effective interpreting service to Bhutanese women and provide evidence for recommendations to address these inadequacies.

Showers: from a violent treatment to an agent of cleansing.

In the early nineteenth century, physicians designed the first manufactured showers for the purpose of curing the insane. Sustained falls of cold water were prescribed to cool hot, inflamed brains, and to instil fear to tame impetuous wills. By the middle of the century showers had appeared in both asylums and prisons, but shower-related deaths led to their decline. Rather than being abandoned, however, the shower was transformed by the use of warm water to economically wash the skins of prison and asylum populations. In stark contrast to an involuntary, deliberately unpleasant treatment, by the end of the century the shower was a desirable product for the improvement of personal hygiene and population health.

Toward harmonization of clinical molecular diagnostic reports: findings of an international survey.

BACKGROUND: The International Organization for Standardization (ISO) 15189 standard provides recommendations for the postexamination reporting phase to enhance quality in clinical laboratories. The purpose of this study was to encourage a broad discussion on current reporting practices for molecular diagnostic tests by conducting a global survey of such practices. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine's Committee for Molecular Diagnostics (IFCC C-MD) surveyed laboratories on selected ISO 15189 recommendations and topics. The survey addressed the following aspects: (1) laboratory demographics, (2) report format, (3) result reporting/layout, (4) comments in report and (5) interpretation and clinical decision-making information. Additionally, participants indicated categories needing standardization. RESULTS: Sixteen responses from laboratories located in Asia, Europe, the Middle East, North America and South America were received. Several categories yielded 100% agreement between laboratories, whereas other categories had less than or equal to 50% concordance. Participants scored "nomenclature" and "description of methodologies" as the two most frequently cited aspects needing standardization. CONCLUSIONS: The postexamination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. Surveyed laboratories were most likely to follow explicit ISO 15189 recommendations vs. recommendations when the term(s) "where appropriate or where applicable" was used. Interpretation and reporting of critical values varied among participants. Although the outcome of this study may not fully represent the practices of all molecular testing laboratories in countries around the world, the survey identified and specified several recommendations that are requirements for harmonized reporting in molecular diagnostics.

Preference for cesarean section in young nulligravid women in eight OECD countries and implications for reproductive health education.

BACKGROUND: Efforts to reduce unnecessary Cesarean sections (CS) in high and middle income countries have focused on changing hospital cultures and policies, care provider attitudes and behaviors, and increasing women's knowledge about the benefits of vaginal birth. These strategies have been largely ineffective. Despite evidence that women have well-developed preferences for mode of delivery prior to conceiving their first child, few studies and no interventions have targeted the next generation of maternity care consumers. The objectives of the study were to identify how many women prefer Cesarean section in a hypothetical healthy pregnancy, why they prefer CS and whether women report knowledge gaps about pregnancy and childbirth that can inform educational interventions. METHODS: Data was collected via an online survey at colleges and universities in 8 OECD countries (Australia, Canada, Chile, England, Germany, Iceland, New Zealand, United States) in 2014/2015. Childless young men and women between 18 and 40 years of age who planned to have at least one child in the future were eligible to participate. The current analysis is focused on the attitudes of women (n = 3616); rates of CS preference across countries are compared, using a standardized cohort of women aged 18-25 years, who were born in the survey country and did not study health sciences (n = 1390). RESULTS: One in ten young women in our study preferred CS, ranging from 7.6% in Iceland to 18.4% in Australia. Fear of uncontrollable labor pain and fear of physical damage were primary reasons for preferring a CS. Both fear of childbirth and preferences for CS declined as the level of confidence in women's knowledge of pregnancy and birth increased. CONCLUSION: Education sessions delivered online, through social media, and face-to-face using drama and stories told by peers (young women who have recently had babies) or celebrities could be designed to maximize young women's capacity to understand the physiology of labor and birth, and the range of methods available to support them in coping with labor pain and to minimize invasive procedures, therefore reducing fear of pain, bodily damage, and loss of control. The most efficacious designs and content for such education for young women and girls remains to be tested in future studies.

Effectiveness of Primary Health Care Services in Addressing Mental Health Needs of Minority Refugee Population in New Zealand.

Many people are displaced from their country of origin and become refugees, mostly due to armed conflicts, political violence and human rights abuse. Refugees have complex mental, physical, and social health problems related to their traumatic background and the experiences they have endured during their refugee journey. The aim of this qualitative exploratory study was to examine the effectiveness of primary health care services in addressing mental health needs of Bhutanese refugee women resettled in New Zealand. This study included focus group discussion with Bhutanese women and men followed by interviews with health service providers. The findings of this study highlighted inadequacies and constraints in addressing Bhutanese refugee women's mental health needs in New Zealand and provided evidence for recommendations to address these inadequacies.

Incorporating Spirituality into Health Sciences Education.

Researchers are beginning to collect empiric data about coping mechanisms of health science students. Yet, there is an important aspect of coping with stress that is only partially addressed in health sciences curricula: students' spiritual well-being. In this essay, we describe a course in spirituality and health care that we offered to fourth-year medical students, as well as a small empirical study we conducted to assess students' spiritual needs and practices. We then offer reflections on the broad applicability of this work to students in the health sciences more generally, including suggestions for curriculum interventions that may ensure students' success.

Revealing tact within postnatal care.

In this article, we explore the nature of good postnatal care through a hermeneutic unpacking of the notion of tact, drawing on the philosophical writings of Heidegger, Gadamer, and van Manen. The tactful encounters considered were from a hermeneutic research study within a small, rural birthing center in New Zealand. Insights drawn from the analysis were as follows: the openness of listening, watching and being attuned that builds a positive mode of engagement, recognizing that the distance the woman needs from her nurse/midwife is a call of tact, that tact is underpinned by a spirit of care, within tact there are moods and tact might require firmness, and that all of these factors come together to build trust. We conclude that the attunement of tact requires that the staff member has time to spend with a woman, enough energy to engage, and a spirit of care. Women know that tactful practice builds their confidence and affects their mothering experience. Tact cannot be assumed; it needs to be nurtured and sheltered.

The IL1RN promoter rs4251961 correlates with IL-1 receptor antagonist concentrations in human infection and is differentially regulated by GATA-1.

IL-1R antagonist (IL-1Ra) is required for adequate host defense in invasive pneumococcal disease (IPD). The minor allele of an IL1RN gene (C/T) promoter polymorphism (rs4251961) has been shown to be associated with decreased IL-1Ra production in healthy adults. We genotyped 299 children with IPD, and examined 19 IL1RN haplotype-tagging single-nucleotide polymorphisms. Human embryonic kidney HEK293(T) cells were transfected with the promoter reporter plasmid pGL3p containing either allelic variant C (pGL3pCC) or T (pGL3pTT) with or without cotransfection with an expression construct overexpressing the globin transcription factor GATA-1. Plasma IL-1Ra concentrations were significantly higher in nonsurvivors compared with survivors (p < 0.0005), and the C allele of rs4251961 was associated with a significant increase in plasma IL-1Ra concentrations (p = 0.01) during the acute illness of IPD. These findings were validated in a cohort of 276 treatment-naive HIV-infected adults, with borderline significance (p = 0.058). Functional analyses demonstrated that the activity of the promoter constructs containing the T allele increased ~6-fold as compared with basal activity, and that containing the C allele by ~9-fold (p < 0.001) in the presence of GATA-1. Our findings suggest that the IL-1Ra single-nucleotide polymorphism rs4251961 plays a key role in the pathophysiology of IPD and in other human infections.

Aotearoa New Zealand Deaf women's perspectives on breast and cervical cancer screening.

AIMS: Since the introduction of both cervical and breast screening programmes in Aotearoa New Zealand, mortality rates have dropped. Both screening programmes track women's engagement, but neither capture the level of engagement of Deaf women who are New Zealand Sign Language users or their experiences in these screening programmes. Our paper addresses this knowledge deficit and provides insights that will benefit health practitioners when providing screening services to Deaf women. METHODS: We used qualitative interpretive descriptive methodology to investigate the experiences of Deaf women who are New Zealand Sign Language users. A total of 18 self-identified Deaf women were recruited to the study through advertisements in key Auckland Deaf organisations. The focus group interviews were audiotaped and transcribed. The data was then analysed using thematic analysis. RESULTS: Our analysis indicated that a woman's first screening experience may be made more comfortable when staff are Deaf aware and a New Zealand Sign Language interpreter is used. Our findings also showed that when an interpreter is present, extra time is required for effective communication, and that the woman's privacy needs to be ensured. CONCLUSION: This paper provides insights, as well as some communication guidelines and strategies, which may be useful to health providers when engaging with Deaf women who use New Zealand Sign Language to communicate. The use of New Zealand Sign Language interpreters in health settings is regarded as best practice, however their presence needs to be negotiated with each woman.

Results from an IFCC global survey on laboratory practices for the analysis of circulating tumor DNA.

BACKGROUND: The clinical validity of ctDNA analysis as a diagnostic, prognostic and predictive biomarker has been demonstrated in many studies. The rapid spread of tests for the analysis of ctDNA raises questions regarding their standardization and quality assurance. The aim of this study was to provide a global overview of the test methods, laboratory procedures and quality assessment practices using ctDNA diagnostics. METHODS: The Molecular Diagnostics Committee of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC C-MD) conducted a survey among international laboratories performing ctDNA analysis. Questions on analytical techniques, test parameters, quality assurance and the reporting of findings were included. RESULTS: A total of 58 laboratories participated in the survey. The majority of the participating laboratories (87.7 %) performed testing for patient care. Most laboratories conducted their assays for lung cancer (71.9 %), followed by colorectal (52.6 %) and breast (40.4 %) cancer, and 55.4 % of the labs used ctDNA analysis for follow-up/monitoring of treatment-resistant alterations. The most frequent gene analysed was EGFR (75.8 %), followed by KRAS (65.5 %) and BRAF (56.9 %). Participation in external quality assessment programs was reported by only 45.6 % of laboratories. CONCLUSIONS: The survey indicates that molecular diagnostic methods for the analysis of ctDNA are not standardized across countries and laboratories. Furthermore, it reveals a number of differences regarding sample preparation, processing and reporting test results. Our findings indicate that ctDNA testing is being conducted without sufficient attention to analytical performance between laboratories and highlights the need for standarisation of ctDNA analysis and reporting in patient care.

One percent tenofovir applied topically to humanized BLT mice and used according to the CAPRISA 004 experimental design demonstrates partial protection from vaginal HIV infection, validating the BLT model for evaluation of new microbicide candidates.

Recent iPrEx clinical trial results provided evidence that systemic preexposure prophylaxis (PrEP) with emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) can partially prevent rectal HIV transmission in humans. Similarly, we have previously demonstrated that systemic administration of the same FTC-TDF combination efficiently prevented rectal transmission in humanized bone marrow/liver/thymus (BLT) mice. The CAPRISA 004 trial recently demonstrated that topical application of the tenofovir could partially prevent vaginal HIV-1 transmission in humans. To further validate the usefulness of the BLT mouse model for testing HIV prevention strategies, we evaluated the topical administration of tenofovir as used in CAPRISA 004 to prevent vaginal HIV transmission in BLT mice. Our results demonstrate that vaginally administered 1% tenofovir significantly reduced HIV transmission in BLT mice (P = 0.002). Together with the results obtained after systemic antiretroviral PrEP, these topical inhibitor data serve to validate the use of humanized BLT mice to evaluate both systemic and topical inhibitors of HIV transmission. Based on these observations, we tested six additional microbicide candidates for their ability to prevent vaginal HIV transmission: a C-peptide fusion inhibitor (C52L), a membrane-disrupting amphipathic peptide inhibitor (C5A), a trimeric d-peptide fusion inhibitor (PIE12-Trimer), a combination of reverse transcriptase inhibitors (FTC-TDF), a thioester zinc finger inhibitor (TC247), and a small-molecule Rac inhibitor (NSC23766). No protection was seen with the Rac inhibitor NSC23766. The thioester compound TC247 offered partial protection. Significant protection was afforded by FTC-TDF, and complete protection was offered by three different peptide inhibitors tested. Our results demonstrate that these effective topical inhibitors have excellent potential to prevent vaginal HIV transmission in humans.

Perspectives of mild cycle IVF: a qualitative study.

BACKGROUND: The introduction of mild cycle IVF adds to the repertoire of fertility treatments. However, its place is still novel and is contested within the literature. Women's experiences of mild cycle IVF have received minimal attention. The aim of the study was to explore women's perspectives regarding mild cycle IVF. METHODS: In this qualitative thematic analysis study, 17 women, and 2 partners were interviewed regarding their perceptions of 'mild' cycle IVF. Data were thematically analysed to identify the key aspects of participants' perceptions. RESULTS: Participants reported that 'mild' cycle IVF offered a number of positive aspects, including the reduction in the intrusion of IVF procedures in women's lives, the short timeframe spent in awaiting the results and the way mild cycle worked with women's natural hormonal cycles. CONCLUSIONS: 'Mild' cycle IVF was perceived positively by the participants particularly in terms of timeframes and the impact on their physical and emotional wellbeing.

Embedding the living well toolkit into service delivery - A complex process.

Objective: To embed the Living Well Toolkit package and to understand how it was implemented at each site and to explore the experiences of users. Methods: The toolkit package was introduced in four rehabilitation settings using a tailored implementation process negotiated with each site. The varied data sources were analysed drawing on directed content analysis. Results: Clients with neurological conditions and clinicians initially weighed the merits of the toolkit package. A positive weighing up was prerequisite for deciding to use. Clinicians described considerable thought and planning to make the toolkit package fit and flow in clinical practice. Users of the toolkit package described ways in which it shaped their thinking. Conclusion: Implementation of the toolkit package was a complex process for clinicians and services, involving ongoing work to optimise its impact relative to the client and context. Clinicians and clients who used the toolkit package described positive changes, congruent with person-centred communication. Innovation: The Living Well Toolkit is freely available for all to use. Clinicians who used reflective and responsive thinking to make the toolkit package work found it provided them with a broader perspective of the client.

Access to and engagement with cervical and breast screening services for women with disabilities in Aotearoa New Zealand.

PURPOSE: To describe access to and engagement with cervical and breast screening services for women who are Deaf or live with a physical or sensory disability in Aotearoa New Zealand (NZ). METHOD: We carried out an online survey on a convenience sample of 84 women. Tests of association were undertaken between socio-demographics and cervical and breast screening; and between disability type, and health outcomes and barriers to screening respectively. Participants also reported specific barriers to screening. RESULTS: Living without family/partner and unemployment were associated with never having a cervical smear. Non-English preferred language, and urban residence were related to lower levels of breast self-examination; having insufficient income was related to never having a mammogram. Disability type was not related to either smear or mammogram on eligibility, uptake ever, or uptake timeframe. A higher proportion of those with multiple disability types experienced service environment barriers to having a cervical smear. Specific barriers to screening covered accessibility, service environment, and information. CONCLUSIONS: This study, unique in Aotearoa, provides insights into disabled women's access to and engagement with screening services and suggests factors that may inhibit or facilitate participation. Women with multiple disabilities may be disadvantaged in the seeking and delivery of screening.Implications for rehabilitationRehabilitation and other practitioners need to be attuned to how women living with multiple disabilities may be disadvantaged in the seeking of, and, more importantly, the delivery of breast or cancer screening.Practitioners need to discuss with disabled women what supports or resources they need to have screening procedures, and to advocate for these supports for their clients.Practitioners need to ensure accessibility that encompasses the whole screening journey from the initial invitation to the obtaining of results.For practitioners to be able to provide equitable service delivery, the government and institutional policies and procedures that are developed must take into consideration the multiple needs of women living with disabilities.