What Does It Really Look Like to Properly Address a "Human Error Problem" in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance.

A clear picture of what Human Performance success looks like is now available from BioPhorum, where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool, which includes warning flags that help to identify significant obstacles in the way of effective human performance integration with operations that must be addressed. The effort to improve reliable operations within biopharma using elements of human performance borrowed from other industries have experienced uneven results and slow progress across the last seven years and has been bogged down for multiple significant reasons. These include a mental model that persists within the industry where workers are assumed to be the problem that needs fixing, the mistaken belief that Lean/Operational Excellence is a cure-all and nearly equivalent to human performance, neglecting the need to fundamentally rethink why and how investigations are performed, and truly underestimating the time, effort, strength of sponsor support, and strategy needed to change how work is designed, executed, and then later learned from.LAY ABSTRACT: Human Performance is an integrated risk management approach to improving systems, that includes human factors and systems safety, that leads to higher reliability and enhanced operational resilience. A clear picture of what Human Performance looks like in biopharma is available from the BioPhorum, where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool that will help to identify the steps to effective human performance integration with operations. The effort to improve reliable operations within biopharma using elements of human performance borrowed from other industries has experienced uneven results and slow progress across the last seven years and has been bogged down for multiple significant reasons. These include a mental model that persists within the industry where workers are assumed to be the problem that needs fixing, the mistaken belief that Lean practices (intended to improve productivity & efficiency) is a cure-all and nearly equivalent to human performance, neglecting the need to fundamentally rethink why and how investigations are performed, and truly underestimating the time, effort, strength of sponsor support needed to change how work is designed, executed, and then later learned from.

Nonpharmacological Interventions Addressing Pain, Sleep, and Quality of Life in Children and Adolescents with Primary Headache: A Systematic Review.

PURPOSE: Children and adolescents with primary headache are at risk of persistent somatic symptoms and reduced quality of life (Qol) due to pain and pain-related behaviors, such as avoiding school and activities. Sleep is essential to health, and children and adolescents with primary headaches have more sleep complaints than do healthy controls. A treatment approach that addresses multifactorial causes is likely important. Nonpharmacological interventions seem promising. However, knowledge about effective strategies is limited. The objective of this review is to assess the effect of nonpharmacological interventions in randomized controlled trials (RCTs) among children and adolescents with primary headache in order to identify useful strategies. PATIENTS AND METHODS: Outcome measures are pain, sleep, Qol, and coping versus no intervention or control intervention. Medline, CINAHL, EMBASE, and PsycINFO were searched for eligible trials. ClinicalTrials.gov. was searched for ongoing trials. Initial searches yielded 2588 publications. After initial screening and subsequent full-text review and quality assessment, 13 RCTs reported in 15 articles were selected for review. All reviewers independently assessed study quality using the CONSORT criteria for nonpharmacological interventions. RESULTS: Cognitive behavioral therapy (CBT), including education on pain-related topics, sleep, coping, and stress management, is an effective strategy for reducing headache and pain within groups over time. Fifteen studies assessed pain, 3 studies assessed sleep, 6 studies assessed Qol, and 11 studies assessed coping. CONCLUSION: Strategies identified as useful were parts of CBT interventions. However, it was not possible to identify a single effective intervention addressing pain, sleep, Qol, and coping in children and adolescents with headache, primarily because sleep was infrequently addressed. Various aspects of Qol and coping strategies were assessed, rendering comparison difficult. Strategies for future interventions should include descriptions of theory-driven CBT interventions, depending on clinical setting and based on local resources, to promote a solid evidence base for nonpharmacological interventions.

Biomarkers for the Detection of Prenatal Alcohol Exposure: A Review.

Alcohol exposure during pregnancy can cause adverse effects to the fetus, because it interferes with fetal development, leading to later physical and mental impairment. The most common clinical tool to determine fetal alcohol exposure is maternal self-reporting. However, a more objective and useful method is based on the use of biomarkers in biological specimens alone or in combination with maternal self-reporting. This review reports on clinically relevant biomarkers for detection of prenatal alcohol exposure (PAE). A systematic search was performed to ensure a proper overview in existing literature. Studies were selected to give an overview on clinically relevant neonatal and maternal biomarkers. The direct biomarkers fatty acid ethyl esters (FAEEs), ethyl glucuronide (EtG), ethyl sulfate, and phosphatidylethanol (PEth) were found to be the most appropriate biomarkers in relation to detection of PAE. To review each biomarker in a clinical context, we have compared the advantages and disadvantages of each biomarker, in relation to its window of detectability, ease of collection, and the ease and cost of analysis of each biomarker. The biomarkers PEth, FAEEs, and EtG were found to be applicable for detection of even low levels of alcohol exposure. Meconium is an accessible matrix for determination of FAEEs and EtG, and blood an accessible matrix for determination of PEth.

The risk of offspring developing substance use disorders when exposed to one versus two parent(s) with alcohol use disorder: A nationwide, register-based cohort study.

AIM: Few population-based, family studies have examined associations between exposure to one vs. two parent(s) with alcohol use disorder (AUD) and the risk of offspring developing substance use disorder (SUD). Moreover, these studies have focused solely on the development of AUD, and not SUD, in offspring. The purpose of this study was to investigate whether exposure to one vs. two parent(s) with AUD increases the risk of offspring developing SUD. METHODS: A population-based, cohort study was conducted in which offspring born in Denmark between 1983 and 1989 were followed through national registries until 2011. Register-based data were obtained from the: Psychiatric Central Research Register, National Patient Registry, Civil Registration System, Fertility Database, and Cause of Death Register. Adjusted hazard ratios were calculated using multivariate Cox-regression models. FINDINGS: A total of 398,881 offspring were included in this study. Of these, 3.9% had at least one parent with AUD. Parental AUD was significantly associated with the development of SUD in offspring. Having one parent with AUD was linked to a 1.44-fold increased risk (95% CL, 1.29-1.61), while having two parents with AUD was linked to a 2.29-fold increased risk (95% CI, 1.64-3.20). No significant differences were found in relation to either parental or offspring gender. CONCLUSIONS: Exposure to parental AUD is linked to an increased risk of offspring developing SUD. This risk is additive for offspring exposed to double parental AUD. The findings have important implications for clinical assessment and intervention strategies, as well as the management of offspring exposed to parental AUD.

Relay model for recruiting alcohol dependent patients in general hospitals--a single-blind pragmatic randomized trial.

BACKGROUND: A large proportion of the Danish population consumes more than the officially recommended weekly amount of alcohol. Untreated alcohol use disorders lead to frequent contacts with the health care system and can be associated with considerable human and societal costs. However, only a small share of those with alcohol use disorders receives treatment. A referral model to ensure treatment for alcohol dependent patients after discharge is needed. This study evaluates the i) cost-effectiveness ii) efficacy and iii) overall impact on societal costs of the proposed referral model - The Relay Model. METHOD/DESIGN: The study is a single-blind pragmatic randomized controlled trial including patients admitted to the hospital. The study group (n = 500) will receive an intervention, and the control group (n = 500) will be referred to treatment by usual procedures. All patients complete a lifestyle questionnaire with the Alcohol Use Disorders Identification Test embedded as a case identification strategy. The primary outcome of the study will be health care expenditures 12 months after discharge. The secondary outcome will be the percentage of the target group, who 30 days after discharge, reports at the alcohol treatment clinics. In order to analyse both outcomes, difference-in-difference models will be used. DISCUSSION: We expect to establish evidence as to whether The Relay Model is either cost-neutral or cost-effective, compared to referral by usual procedures. TRIAL REGISTRATION: https://register.clinicaltrials.gov/by identifier: RESCueH_Relay NCT02188043 Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals (TRN Registration: 07/09/2014).

Identifying parents with risky alcohol consumption habits in a paediatric unit--are screening and brief intervention appropriate methods?

BACKGROUND: There is no systematic identification of parents with excessive alcohol use who have a child admitted to hospital. Children in families with excessive alcohol issues form a high risk group as substantial alcohol consumption has a damaging influence on a child emotionally, cognitively, socially and physically. Alcohol consumption is a sensitive issue, and health staff needs knowledge, qualifications and adequate training in communicating with parents about this taboo. AIM: • To identify specific patterns in subgroups of parents by comparing results from screening and demographic variables • To identify systematic patterns in staff members by demographic variables to decide whether these factors influence the screening results. METHODS: During 1 year, screening and brief intervention (SBI) was accomplished, including health staff conducting dialogues with parents of a hospitalized child using motivational interviewing (MI) and screening for risky alcohol behaviour by Cut down, Annoyance from others, feel Guilty, Early-morning Craving (CAGE)-C. Data were analysed by descriptive statistics, and relationships were tested with a statistical significance level of 0.05, using SPSS (version 16.0). RESULTS: Motivational dialogues with 779 parents were conducted by 43 staff members, and 11% of the parents were screened positive for risky alcohol behaviour. Drinking alcohol 4 days a week or more and drinking alcohol outside mealtimes were main risk factors. Parents' gender was the strongest predictor of screening positive and OR was 6.8 for men (CI 4.03-11.74) compared to women, p<0.0001. An OR of 1.2 for parents' age (CI 1.02-1.42) indicates the risk of screening positive increases with age, p=0.027. CONCLUSIONS: Brief intervention using CAGE-C and MI has proven successful in mapping parents' alcohol consumption patterns and in identifying parents with risky alcohol consumption habits. Health staff is able to manage health promotion and prevention when having the right competences and when being supervised.

Moving forward in a role as a researcher: the effect of a research method course on nurses' research activity.

The aim of this study was to investigate whether a 1-year research course in basic research methodology, designed for clinical nurses, had a positive effect on the nurses' own research activity and their commitment to research in general. The research method applied was use of semistructured interviews. Seventy-nine clinical nurses participated in the study. Students of the research course (n = 37), i.e. the study group, were compared with a group of clinical nurses who did not participate in the course (n = 42), i.e. the reference group. A statistically significant difference was found in several variables between the two groups. Eighty-nine per cent of the study group members were active in planning their own research projects compared with 35.7% in the reference group. The study group also showed a higher level of interest and commitment to research results of others and read English language articles. A total of 13.9% of the study group experienced being unable to find time during working hours to participate in research projects, while this was true for 50% of nurses in the reference group. Experiences from the research course in basic methodology show that educational programmes designed for clinical nurses may facilitate and support their own research efforts as well as enhance their commitment to research in general. The course reinforced nurses' self-confidence in research-based practice. Clinical nurses require personal initiative, perseverance and competence in research methodology as well as sensitization towards a research culture in order to move away from the salaried work of a practitioner and into the role of a researcher.

Danish research-active clinical nurses overcome barriers in research utilization.

AIM: The aim of this study was to examine whether there was a difference between clinical nurses who were research-active, and clinical nurses who were nonresearch-active in utilization of research. A further aim was to identify the most significant barriers faced by a group of Danish clinical nurses in their use of research. BACKGROUND: Discrepancy between the improved quality of research results and the lack of implementing them was the starting point for a series of studies which showed the types of barriers clinical nurses found especially cumbersome when applying the research results of other researchers. This study investigates whether the clinical nurses' own engagement in research had any impact on their perception of research utilization. METHODOLOGY: The study had an exploratory and descriptive design. Seventy-nine Danish clinical nurses participated and semi-structured interviewing was used as the research method. FINDINGS: There was a statistically significant difference between the research-active and nonresearch-active nurses on various variables. The study showed that, to a larger extent, research-active nurses used evidence-based knowledge and were generally more internationally orientated. Furthermore, two important barriers for research utilization were identified by all 79 clinical nurses included in the study, i.e. 90% of the nurses explained that the quantity of research results was overwhelming, and 75% of them found that they were unable to evaluate the quality of the research. CONCLUSIONS: Clinical nurses, who were research-active themselves, experienced more success in overcoming some of the barriers, which existed in applying research to practice. The research potential found amongst clinical nurses in Denmark needed to be further supported through training and guidance in research methodology, establishing introductory stipends and part-time research positions. By doing so, some of the barriers affecting research utilization and the so-called theory-practice gap might be reduced. Further empirical studies, based on Giddens theory of sociological reflectivity, might see clinical nurses in a more serious light and simultaneously perceive them as producers of knowledge.

There is no gap 'per se' between theory and practice: Research knowledge and clinical knowledge are developed in different contexts and follow their own logic.

The aim of this article is to highlight relations between theory and practice and the genesis of professional action in clinical nursing and among researchers. With use of a sociologically based empirical approach, focus is placed on the knowledge involved in the work of researchers and practitioners in terms of the source of their knowledge. Unlike a dominant barrier paradigm, theory and practice have different logics; they are not on a continuum nor are they hierarchically ordered. They exist in their own right as theoretical knowledge and practical knowledge. In daily practice, clinical nurses are inspired and learn from the context, including each other, and they are active producers of knowledge, not simply recipients of knowledge. This study, therefore, claims that there is no research-practice gap "in itself" (per se) as argued in the "barriers paradigm."