Implementing Whole Person Primary Care: Results from a Year-Long Learning Collaborative.

PURPOSE: The National Academies of Medicine report on Implementing High-Quality Primary Care calls for a transformation of the primary care to a "whole person" model that is person-centered, relationship-based and takes into account the social, spiritual, emotional and behavioral aspects of health. However, our current delivery tools, such as the SOAP Note, do not sufficiently capture and organize the delivery of these elements in practice. To explore how to remedy this, an Integrative Health Learning Collaborative (IHLC) was established to implement and test new tools for changing primary care practices toward whole person care. METHODS: The IHLC comprised primary care practices committed to changing to a whole person care model of care along with a panel of experts in integrative health and change management. The IHLC met virtually monthly. Representatives from each practice and an assigned expert met to strategize and adapt the tools to their environment and practice. The practices used previously developed tools (the HOPE Note toolkit), change management tools, and quality improvement techniques to introduce, implement, and evaluate the changes. RESULTS: Sixteen clinics completed the process after 1 year. Overall, practices used the HOPE Note tools in 942 patients. Participants reported changes on the effectiveness of the collaborative (1) on clinical practice, (2) on the skills and attitudes of participants; and (3) the support in change management. CONCLUSIONS: This online learning collaborative supported practices implementing a whole person care model in primary care and improved the understanding, skills, and delivery ability of whole person care in all clinics completing the program.

Assessing mother-infant bonding: reliability of the recorded interaction task.

OBJECTIVE: This study examined the intra- and inter-rater reliability of the Recorded Interaction Task (RIT); a novel tool to assess mother-infant bonding via observational methods. BACKGROUND: Mother-infant bonding describes the reciprocal early emotional connection between mother and infant. Whilst various tools exist to assess mother-infant bonding, many incorrectly confuse this construct with mother-infant attachment. Further, available tools are limited to those that employ self-report methods, thus may reflect perceived behaviour, rather than actual behaviour. The RIT is a novel tool for observational assessment of mother-infant bonding. A standard interaction between mother and infant is recorded, and later assessed against specified bonding-related behaviours. Before its use in research, reliability testing must be undertaken to ensure the RIT may be used consistently. METHODS: The RIT was administered to 15 mother-infant dyads. Participant recordings were assessed by three trained raters at two time points, using the RIT observation scoring sheet. Intra-rater reliability was determined by comparing scores at each time point for each rater. Inter-rater reliability was determined by assessing reliability of scores at the first time point. RESULTS: Strong intra-rater reliability (ICC >0.86) and fair inter-rater reliability (ICC = 0.55) were observed. CONCLUSION: The current findings support the RIT's potential to reliably assess mother-infant bonding.

Introducing the Needs in Recovery Assessment (NiRA) into clinical practice: protocol for a pilot study investigating the formal and systematic assessment of clinical and social needs experienced by service users at a tertiary, metropolitan mental health service.

BACKGROUND: The Needs in Recovery Assessment (NiRA) is a newly developed needs assessment tool, designed to identify the needs of people recovering from mental illness. This tool has been evaluated outside of the clinical context for validity and reliability. The aim of this study is to introduce the NiRA into clinical practice and to evaluate the value of the NiRA as an adjunct to service delivery from the perspectives of stakeholders and to evaluate the barriers and facilitators of embedding the NiRA in a mental health service. METHODS: The establishment of the NiRA in a tertiary mental health unit over a 6-month period will be evaluated using a multi-methods approach. Quantitative data will be collected using the NiRA itself and the Recovery Self-Assessment (RSA). Face-to-face interviews with service users and clinicians will be conducted following the initial completion of the NiRA, with a follow-up interview for service users on discharge from the service. Regular informal follow-up with clinicians throughout the study will support the introduction of the NiRA. Descriptive statistics will be used to analyse quantitative data, and descriptive qualitative methods will be used to analyse data from interviews. DISCUSSION: Aligning mental health services with recovery-oriented frameworks of care is imperative. The NiRA is a tool that has been designed in accordance with recovery principles and may assist services to be more recovery-oriented. If the NiRA is able to achieve the aims and objectives of this project, a larger implementation study will be conducted. Trial registration Australian and New Zealand Clinical Trial Registry (ANZCTR), ACTRN12621000316808.

Evaluating the Reliability of the Needs in Recovery Assessment (NiRA) with Simulated Patients.

INTRODUCTION: The Needs in Recovery Assessment (NiRA) is a tool designed to support recovery-oriented and person-centred approaches in mental health services through facilitating the identification and prioritisation of needs. The aim of this study was to evaluate the interrater reliability of the NiRA. Method: Ten mental health clinicians from various professional backgrounds used the NiRA to facilitate assessment interviews with Simulated Patients. Completed and semi-completed NiRA forms, questionnaires, and audio-visual recordings of assessment interviews were collected for analysis. The interrater reliability of the NiRA was calculated using percent agreement and Gwet's Agreement Coefficient (AC)1. Results: Percent agreement across all items of the finalised tool was 0.84 (item range: 0.55 to 1.0). Overall interrater reliability (Gwet's AC1) was 0.70 (95% CI 0.64-0.76) with items ranging from -0.08 to 1.0. Conclusion: The NiRA is a reliable tool and is ready to be trialled in a feasibility study in clinical settings. It is anticipated that the NiRA will facilitate a deeper understanding of service users' needs and a more targeted approach to meeting unmet needs.

The Recorded Interaction Task: A Validation Study of a New Observational Tool to Assess Mother-Infant Bonding.

INTRODUCTION: Mother-infant bonding describes the early emotional connectedness between a mother and her infant. The quality of the mother-infant bond early in life is related to the subsequent quality of the child's attachment, the quality of further mother-infant interactions, and various other social outcomes across the child's life span. The Recorded Interaction Task (RIT) was developed to assess mother-infant bonding using observational methods in a naturalistic but standardized setting, thus addressing shortcomings of previous self-report tools. The RIT focusses on the common interaction between mother and infant (aged 2 to 5 months old), during a diaper (nappy) change. The interaction is video recorded and later assessed. The RIT must be validated before it can be used to assess mother-infant bonding in future research or in clinical practice. METHODS: Face and content validity of the RIT were assessed by a panel of 6 experts in bonding and assessment of maternal and infant behavior. The RIT and self-reported Postpartum Bonding Questionnaire (PBQ) were administered to 15 mother-infant dyads with the correlation between their scores used to assess convergent validity. RESULTS: Acceptable face and content validity of the RIT was demonstrated. A weak correlation between the RIT and PBQ (r = -0.13) and their subscales (r = -0.22) were observed. A strong correlation between the RIT maternal behavior and infant behavior subscales was recorded (r = 0.69). DISCUSSION: The RIT appears to be a viable tool for the observational assessment of mother-infant bonding. Reliability testing and piloting will be required before the RIT can be used in future research or clinical practice.

"Who Am I and Why Am I Here?" A Scoping Review Exploring the Templates and Protocols That Direct Actors in Their Roles as Simulated (Standardized) Patients.

SUMMARY STATEMENT: Simulated patients (SPs) are increasingly used in health education and research. The aim of this article was to investigate templates and protocols that enable SPs to accurately and consistently adopt these roles. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews guided the search strategy for articles that detailed such templates or protocols. Embase Classic + Embase, ProQuest ERIC, Ovid MEDLINE, Ovid EMCare, psycINFO, and Scopus were searched, and 17 articles were included in the review. The templates and protocols that were located differed in structure, length, and depth and were developed or used in medical, nursing, allied health, and veterinary medicine disciplines. The validity, reliability, and replicability of studies are explored, and the quality of reporting is evaluated using the Simulation Research Rubric. Recommendations for increasing the rigor of programs and the reporting of research where SPs are adopted are considered.

A qualitative examination of the cognitive and behavioural challenges experienced by children with fetal alcohol spectrum disorder.

INTRODUCTION: At present it is unclear whether there is a consistent behavioural phenotype for children with Fetal Alcohol Spectrum Disorder (FASD) that can support screening efforts. There has been a dearth of qualitative studies exploring the behavioural phenotype from the perspective of caregivers raising children with FASD. The current study explores the cognitive and behavioural difficulties and impairments experienced by children with FASD aged between four and 12 years from the perspective of caregivers. METHODS: Fourteen caregivers of children with FASD participated in telephone interviews. Caregivers were recruited until data saturation occurred. Thematic analysis was undertaken on the transcribed interviews, using NVivo 12. RESULTS: Three over-arching themes were identified that consisted of subthemes 1) Self-regulation; behavioural, emotional, and attention; 2) Cognitive abilities; academic abilities and learning and memory; and 3) Adaptive functioning; social skills, communication and language skills, motor skills, and sleep concerns. Multiple subthemes were consistently identified across participants. A further two cross-cutting themes were identified; children behaving young for their age, and inconsistency in behaviour and strategies. DISCUSSION: Despite the lack of a consistent behavioural phenotype for FASD, the findings suggest consistency between caregivers in their reports of the difficulties experienced by children with FASD. The implications for early identification and screening tool development are discussed.

Development and validation of the Needs in Recovery Assessment (NiRA): A clinical tool for assessing the needs of individuals recovering from a first episode of mental illness.

Recovering from a first episode of mental illness entails unique challenges and often includes experiencing unmet needs. The availability of a formal, structured and valid means of assessing the needs of individuals recovering from a first episode of mental illness may improve mental health service delivery. This article describes the development of a new needs assessment tool, the Needs in Recovery Assessment (NiRA), and presents the results of processes used to validate the tool. The NiRA was developed using data collected in a previous literature review and focus groups with mental health service users. It contains three sections for the identification, prioritization, planning and re-evaluation of a broad array of needs. It was presented in two workshops, where mental health service users and clinicians evaluated its validity, acceptability and usability. Items of need and the format of the NiRA were evaluated using Likert-scale questions, open-ended short answer and closed questions. Each item of need was evaluated for its validity by a panel of experts via an online survey. Descriptive statistics were used to analyse data, including means, percentages and the Content Validity Index (CVI).Streiner and Kottner's scale development and testing guidelines were used in the reporting of this study. 48 items of need were evaluated as valid by mental health service users, clinicians and academics. Most items received an I-CVI of greater than .93. The scale CVI/Avg was .96. The NiRA is perceived as a valid and acceptable tool for assessing the needs of people recovering from a first episode of mental illness.

Needs of Individuals Recovering from a First-Episode of Mental Illness: A Qualitative Descriptive Analysis of Focus Group Discussions.

A broad array of needs often arise for individuals when significant physical or mental illness occurs. The aim of this study was to investigate the needs experienced by individuals recovering from a first-episode of mental illness, to explore how these needs have been assessed and to gauge the acceptability of participating in formal, systematic needs assessments in the future. Fifteen individuals who had presented to a tertiary mental health service within the previous 3 years, and who were considered to be recovering from a first-episode of mental illness discussed their current and previous needs in small focus groups. A qualitative descriptive methodology was adopted to analyse data. Three themes incorporating the broad range of inter-related and often complex needs were identified as being: the need for safety, stability and security; the need to be understood and to understand and; the need for support networks and services. Participants reported a lack of involvement in discussions with mental health clinicians regarding their needs, and were in favour of participating in formal, systematic needs assessments in the future.

Adjuvant therapy with antidepressants for the management of inflammatory bowel disease.

BACKGROUND: Symptoms of anxiety and depression are common in inflammatory bowel disease (IBD). Antidepressants are taken by approximately 30% of people with IBD. However, there are no current guidelines on treating co-morbid anxiety and depression in people with IBD with antidepressants, nor are there clear data on the role of antidepressants in managing physical symptoms of IBD. OBJECTIVES: The objectives were to assess the efficacy and safety of antidepressants for treating anxiety and depression in IBD, and to assess the effects of antidepressants on quality of life (QoL) and managing disease activity in IBD. SEARCH METHODS: We searched MEDLINE; Embase, CINAHL, PsycINFO, CENTRAL, and the Cochrane IBD Group Specialized Register from inception to 23 August 2018. Reference lists, trials registers, conference proceedings and grey literature were also searched. SELECTION CRITERIA: Randomised controlled trials (RCTs) and observational studies comparing any type of antidepressant to placebo, no treatment or an active therapy for IBD were included. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. We used the Newcastle-Ottawa Scale to assess quality of observational studies. GRADE was used to evaluate the certainty of the evidence supporting the outcomes. Primary outcomes included anxiety and depression. Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS) or the Hamilton Anxiety Rating Scale (HARS). Depression was assessed using HADS or the Beck Depression Inventory. Secondary outcomes included adverse events (AEs), serious AEs, withdrawal due to AEs, quality of life (QoL), clinical remission, relapse, pain, hospital admissions, surgery, and need for steroid treatment. QoL was assessed using the WHO-QOL-BREF questionnaire. We calculated the risk ratio (RR) and corresponding 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) with 95% CI. A fixed-effect model was used for analysis. MAIN RESULTS: We included four studies (188 participants). Two studies were double-blind RCTs, one was a non-randomised controlled trial, and one was an observational retrospective case-matched study. The age of participants ranged from 27 to 37.8 years. In three studies participants had quiescent IBD and in one study participants had active or quiescent IBD. Participants in one study had co-morbid anxiety or depression. One study used duloxetine (60 mg daily), one study used fluoxetine (20 mg daily), one study used tianeptine (36 mg daily), and one study used various antidepressants in clinical ranges. Three studies had placebo controls and one study had a no treatment control group. One RCT was rated as low risk of bias and the other was rated as high risk of bias (incomplete outcome data). The non-randomised controlled trial was rated as high risk of bias (random sequence generation, allocation concealment, blinding). The observational study was rated as high methodological quality, but is still considered to be at high risk of bias given its observational design.The effect of antidepressants on anxiety and depression is uncertain. At 12 weeks, the mean anxiety score in antidepressant participants was 6.11 + 3 compared to 8.5 + 3.45 in placebo participants (MD -2.39, 95% -4.30 to -0.48, 44 participants, low certainty evidence). At 12 months, the mean anxiety score in antidepressant participants was 3.8 + 2.5 compared to 4.2 + 4.9 in placebo participants (MD -0.40, 95% -3.47 to 2.67, 26 participants; low certainty evidence). At 12 weeks, the mean depression score in antidepressant participants was 7.47 + 2.42 compared to 10.5 + 3.57 in placebo participants (MD -3.03, 95% CI -4.83 to -1.23, 44 participants; low certainty evidence). At 12 months, the mean depression score in antidepressant participants was 2.9 + 2.8 compared to 3.1 + 3.4 in placebo participants (MD -0.20, 95% -2.62 to 2.22, 26 participants; low certainty evidence).The effect of antidepressants on AEs is uncertain. Fifty-seven per cent (8/14) of antidepressant participants group reported AEs versus 25% (3/12) of placebo participants (RR 2.29, 95% CI 0.78 to 6.73, low certainty evidence). Commonly reported AEs include nausea, headache, dizziness, drowsiness, sexual problems, insomnia, fatigue, low mood/anxiety, dry mouth, muscle spasms and hot flushes. None of the included studies reported any serious AEs. None of the included studies reported on pain.One study (44 participants) reported on QoL at 12 weeks and another study (26 participants) reported on QoL at 12 months. Physical, Psychological, Social and Environmental QoL were improved at 12 weeks compared to placebo (all low certainty evidence). There were no group differences in QoL at 12 months (all low certainty evidence). The effect of antidepressants on maintenance of clinical remission and endoscopic relapse is uncertain. At 12 months, 64% (9/14) of participants in the antidepressant group maintained clinical remission compared to 67% (8/12) of placebo participants (RR 0.96, 95% CI 0.55 to 1.69; low certainty evidence). At 12 months, none (0/30) of participants in the antidepressant group had endoscopic relapse compared to 10% (3/30) of placebo participants (RR 0.14, 95% CI 0.01 to 2.65; very low certainty evidence). AUTHORS' CONCLUSIONS: The results for the outcomes assessed in this review are uncertain and no firm conclusions regarding the efficacy and safety of antidepressants in IBD can be drawn. Future studies should employ RCT designs, with a longer follow-up and develop solutions to address attrition. Inclusion of objective markers of disease activity is strongly recommended as is testing antidepressants from different classes, as at present it is unclear if any antidepressant (or class thereof) has differential efficacy.

The private journey: An interpretative phenomenological analysis of exclusive breastfeeding.

BACKGROUND: Exclusive breast milk provides complete nutrition for a baby's first six months of life. In Australia, breastfeeding initiation rates are high, however duration rates are low. Although numerous studies have explored the reasons behind low levels of breastfeeding, few have examined the experiences of women who maintain exclusive breastfeeding for the recommended six-month duration. AIM: This paper will present an in-depth, idiographic interpretation of first-time mothers' experience of exclusive breastfeeding for six months in Australia. METHOD: Interpretative phenomenological analysis was used to explore how five new mothers understood their six-month exclusive breastfeeding journey. Face-to-face, semi-structured interviews were conducted retrospectively, transcribed in full, and analysed using the flexible seven-step approach of interpretative phenomenological analysis. FINDINGS: Three higher-order themes were identified: (1) exclusive breastfeeding is a personal choice, (2) exclusive breastfeeding is harder than expected, and (3) everyone has something to say about breastfeeding. CONCLUSION: The mothers were not prepared for public debates around infant feeding methods, where mothers judge each other and give advice that supports their own goals, both of which create an unnecessary divide between mothers. Despite these issues, the findings highlight the personal and social meanings aligned with exclusive breastfeeding and point to the significance in fostering determination as a means to achieve exclusive breastfeeding goals. This qualitative reflection contributes a nuanced understanding of mothers' lived experience of exclusive breastfeeding, deepening our understanding and enabling appropriate strategies and support for the longevity of exclusive breastfeeding, as well as direction for continued research.

The supportive care needs of individuals recovering from first episode psychosis: A scoping review.

BACKGROUND: First episode psychosis (FEP) can be a traumatic experience that may alter an individual's ability to meet their own needs. The Supportive Care Needs Framework (SCNF) could complement the recovery-oriented, person-centred approach that is the current foundation of mental health care. AIM: To identify the supportive care needs (SCNs) of individuals recovering from a FEP. METHODS: A scoping review of the literature was undertaken. Review questions were developed, and relevant studies were identified through database and hand searches of peer-reviewed journal articles. Data from selected articles were tabulated, and contextual meaning was given to the data through a process of collating, summarizing, and reporting. RESULTS: A total of 14 peer-reviewed journal articles met inclusion criteria. SCNs were identified at different stages of recovery, ranging from initial treatment to 7 years postdiagnosis. Emotional, informational, practical, psychological, and social needs were identified in over half of the included articles, while needs in the physical and spiritual domains were identified in less than five. CONCLUSIONS: Unmet needs in each of the seven domains of need of the SCNF were identified in this population. There are a number of gaps in the literature relating to the specific needs of this population and the timing for which individuals may require more supportive care in their recovery journey.

Needs of individuals recovering from a first episode of mental illness: A scoping review.

Central to the role of mental health clinicians is the assessment of needs. A number of assessment tools have been used to evaluate the needs of individuals diagnosed with a mental illness. These tools have largely been developed for people with a severe and persistent mental illness and may not be suitable for individuals who are recovering from a first episode of mental illness. The aims of this review were therefore to identify the needs experienced by individuals recovering from a first episode of mental illness; determine what tools have been used to evaluate these needs; and explore whether existing tools adequately reflect the needs described in the literature. Twenty-one articles were included, comprising articles which identified needs (n = 10), needs assessment tools (n = 1), or articles which identified both needs and a needs assessment tool (n = 10). Results indicate that individuals who have been admitted to a specialized mental health unit and are recovering from a first episode of mental illness may experience an extensive range of needs, spanning emotional, psychological, social, informational, functional, practical, and relationship needs. Four established needs assessment tools were found to have been used to evaluate these needs; however, these do not appear to represent all needs discovered in this review, were mostly developed for populations with a long-term mental illness, and may not be suitable for assessing the needs of individuals recovering from a first episode of mental illness following a presentation to a specialized mental health unit.

Validation of a risk prediction model for Barrett's esophagus in an Australian population.

BACKGROUND: Esophageal adenocarcinoma is a disease that has a high mortality rate, the only known precursor being Barrett's esophagus (BE). While screening for BE is not cost-effective at the population level, targeted screening might be beneficial. We have developed a risk prediction model to identify people with BE, and here we present the external validation of this model. MATERIALS AND METHODS: A cohort study was undertaken to validate a risk prediction model for BE. Individuals with endoscopy and histopathology proven BE completed a questionnaire containing variables previously identified as risk factors for this condition. Their responses were combined with data from a population sample for analysis. Risk scores were derived for each participant. Overall performance of the risk prediction model in terms of calibration and discrimination was assessed. RESULTS: Scores from 95 individuals with BE and 636 individuals from the general population were analyzed. The Brier score was 0.118, suggesting reasonable overall performance. The area under the receiver operating characteristic was 0.83 (95% CI 0.78-0.87). The Hosmer-Lemeshow statistic was p=0.14. Minimizing false positives and false negatives, the model achieved a sensitivity of 74% and a specificity of 73%. CONCLUSION: This study has validated a risk prediction model for BE that has a higher sensitivity than previous models.

Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.

BACKGROUND AND AIMS: Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo. METHODS: A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups. RESULTS: Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05]. CONCLUSIONS: In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.].

People with schizophrenia and depression have a low omega-3 index.

Cardiovascular disease (CVD) is higher in people with mental illness and is associated with a 30 year higher mortality rate in this population. Erythrocyte docosahexaenoic acid (DHA) plus eicosapentaenoic acid (EPA) (omega-3 index)≤4% is a marker for increased mortality risk from CVD while >8% is protective. Omega-3 polyunsaturated fatty acids are also important for brain function and may ameliorate symptoms of mental illness. We investigated the erythrocyte omega-3 index in people with mental illness. One hundred and thirty adults aged 18-65 years (32.6% male) with schizophrenia (n=14) and depression (n=116) provided blood samples and completed physiological assessments and questionnaires. Both populations had risk factors for metabolic syndrome and CVD. The average omega-3 index was 3.95% (SD=1.06), compared to an estimated 5% in the Australian population. These data indicate an unfavourable omega-3 profile in people with mental illness that could contribute to higher CVD risk.

A cognitive behavioural therapy booklet for anxiety in functional gastrointestinal disorders: Patient and health practitioner perspectives.

OBJECTIVE: Psychotherapy is commonly used to treat functional gastrointestinal disorders (FGiDs), yet face-to-face psychotherapy is 15 labour intensive, less convenient for patients as it involves travel to the practice, costly and not always easily available. Self-administered psychotherapies have not been extensively investigated in this population. This study aimed to examine the feasibility and acceptability of a self-administered cognitive behavioural therapy booklet to reduce anxiety in patients with FGiD. METHOD: A mixed-methods study underpinned by the Health Belief Model was conducted. RESULTS: The booklet has been well received by patients (n = 26) and doctors (n = 8) and its acceptability and feasibility confirmed. CONCLUSIONS: The results of the study suggest that this self-help tool is acceptable by patients and doctors as part of treatment for anxiety in FGiDs and its effectiveness should be further tested in adequately powered studies.