Background: Home spirometry holds promise as a primary endpoint for clinical trials.Qualitative needs assessments describing the practices and perspectives of people with cystic fibrosis (PwCF), caregivers of PwCF, and research coordinators (RCs) regarding home spirometry can inform strategies for incorporating home spirometry into clinical trials.Methods: We conducted a series of focus groups that engaged PwCF, caregivers, or RCs (separately), led by an experienced facilitator and conducted via videoconference.PwCF aged 14 and older and caregivers with experience performing home spirometry were recruited through the Cystic Fibrosis Foundation (CFF) Community Voice.RCs with experience coaching home spirometry were recruited through the CFF Therapeutics Development Network from sites participating in the PROMISE study.Participants provided informed consent and completed an online survey before the focus group to describe their demographic characteristics and home spirometry devices.Focus groups elicited current experiences and barriers to and facilitators of home spirometry across six target areas, followed by discussion and prioritization.Target areas for PwCF and caregivers included research incentives, burden of procedures, reminders, remote coaching, training, and spirometry results.Target areas for RCs included participant and RC training, remote coaching, monitoring progress, participant engagement, and institution-specific issues.Qualitative analyses followed the deductive approach of template analysis [1].Common themes identified in each session were reviewed in all PwCF or RC sessions to identify areas of consensus, which were used to formulate recommendations for future clinical trials.Results: From September to November 2021, 27 PwCF and six caregivers stratified according to age and role (teens, adults aged 18-39, adults aged ≥40, caregivers) participated in seven sessions, and 24 RCs participated in five sessions.Groups identified barriers to and facilitators of use of home spirometry.Although most PwCF and caregivers found home spirometry convenient, many experienced technical barriers, reported a learning curve to home measurement, and expressed uncertainty about the quality and reliability of measurements.Major barriers that RCs identified involved tailoring participant training to individual needs, scheduling remote coaching, and performing effective coaching remotely.Participants offered age-specific recommendations in key domains: training materials and procedures (for PwCF and RCs), remote coaching, monitoring progress, maintaining engagement, and other areas, including differences in the conduct and interpretation of research versus clinical and home versus office spirometry.Conclusions: Recommendations from this qualitative needs assessment of PwCF, caregivers, and RCs regarding home spirometry in the research setting have been incorporated into the design of OUTREACH, a CFFfunded, multicenter, prospective study of the accuracy, variability, feasibility, and acceptability of home spirometry as a clinical trial endpoint.Our results can also help inform the design of future remote clinical trials.Acknowledgements: This work was supported by

Background: Randomized controlled trials (RCT) are an essential part of health care as we search for evidence-based outcomes to ensure best clinical practice.Research results are reported and evaluated; however, the process of research is seldom reviewed.Objective: To describe some of the difficulties and achievements in conducting a multi-centre research study over an extended period of time.Methods: The Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) Study ran over 10 yrs in 8 sites throughout Australia and New Zealand.Prospective data were collected for this RCT designed to examine BAL directed therapy in children diagnosed on newborn screening.168 infants were randomized at <6 months.Routine clinical management as well as exacerbations and hospitalizations were recorded for each patient.A standardized protocol was used across all sites.Results: Difficulties: Ethics approval across all sites took 4 yrs.The pharmaceutical company changed hands 3 times; there were 4 data managers and at least 2 coordinators at each of the 8 sites.Legal contracts replaced handshakes and quick emails.Achievements: An amazing 93% of patients completed their 5 yrs on the study.Over 1000 admissions, 2000 exacerbations, 2800 reviews, 2700 routine checks, 500 BALs, 1800 cough specimens, and 400 audiology tests were recorded.More than 350 blood and 1000 BAL specimens were moved to sites in Australia and overseas.None went astray or deteriorated in transit.

Background:The benefit of mentoring in chronic disease management is increasingly recognised.Aim: To evaluate preparatory training, delivery and impact on work practices of telephone-delivered self-management support augmented by information technology (IT) tools for people with cystic fibrosis (CF).Method: Volunteer health professionals undertook 12 hours of training covering CF, health-mentoring, and IT tools: a database and a mobile phone programme with symptom-monitoring through daily text messages.Health-mentoring was incorporated into daily workloads over six months.Understanding of mentoring, self-management, self-efficacy, goal setting, action planning and mentoring selfefficacy were measured pre/post training on a five-point Likert scale by selfadministered questionnaires.Qualitative data were collected by self-report, focus groups and interviews.Results: 29 of 34 mentors completed the training, which met the needs of 78.6% (22/29).Pre and post there were significant improvements in understanding of mentoring (p < 0.001), self-management (p = 0.002), self-efficacy (p < 0.001), action planning (p = 0.001) and mentoring self-efficacy (p = 0.006).Via in-depth qualitative interviews, mentors reported translating acquired skills to other work areas.Challenges included communication by phone, and closure of the mentoring relationship.

The Work Breakdown Structure (WBS) defines the work scope of a project. The way a WBS is defined depends on the person and his/her viewpoint. The aircraft modification business carries out a great variety of projects. Although the core skills and tasks are similar, there are very few projects that are exact repetition of previous work. The reuse of information is difficult without a good structure to archive and manage project information. This paper presents an integrated WBS approach for managing the work scope in aircraft modification projects. The model is the result of an in-depth study and analysis of the working methods in an aircraft modification industrial company. This WBS is designed to incorporate the information needs and the views of the different functions involved in aircraft modification. It provides the structure for the reuse of information, such as cost and schedules, in the diverse range of aircraft modification projects. In this model, the top tiers of the WBS are configured from a pre-defined industry specific template. The lower tiers are defined with a flexible structure to support the different views of the knowledge users and providers in the project. The information need for all the life stages of the project is fully covered. The integrated WBS is being implemented in an enterprise wide computing solution that is used for cost estimating in the collaborating company. The same approach could be used to enhance knowledge reuse where there is a great diversity in project contracts.

A series of niobium-hydrogen alloys with compositions in the two-phase and single-phase hydride fields has been examined at room temperature by X-ray diffractometer techniques. The closeness of the hydride structure to the cubic body-centred form allows simple formulae to be used to represent each complex diffraction profile in terms of a group of elementary components. The results are explained if the unit cells are slightly tetragonal and if there is a small departure from 90° of the angle opposite the c axis; thus the characteristics are comparable with those of the related tantalum hydride, though the ca ratios are much closer to unity. The symmetry of this arrangement is orthorhombic, the corresponding face-centred cell having sides a0, b0, C0 (= c) where a0 and b0 approximate to √2C0, and a volume twice that of the bodycentred cell. The edge parameters and the angular distortion vary across the single-phase field, and the latter also varies to a smaller extent across the two-phase field. It is suggested that this abnormal behaviour may be the result of lack of equilibrium or of an exceptional sensitivity of the niobium-hydrogen system to the presence of small amounts of impurity.

The design and construction of a Geiger-Müller counter spectrometer circle suitable for a wide variety of applications and of mechanical accuracy comparable with that of a precision power camera is described herein. Ancillary equipment for the study of integrated intensities from flat powder specimens has been constructed, utilizing monitored monochromatic radiation and making provision for automatic operation. Discussion of Geiger-Müller counter performance necessary to achieve a standard deviation of intensity measurements of about 0.5% is included with some results demonstrating the attainment of this accuracy.

The advantages and limitations of Geiger counter techniques in a laboratory applying X-ray methods to a variety of problems are discussed and some simple examples are described. These illustrate the convenience of its use in obtaining semi-quantitative results very rapidly and in following the effects of various treatments. The accuracy of the method is considered in relation to the statistical effects associated with the operation of the Geiger counter and the influence of damping in the recording system.

A specimen table having a geometrical mounting may be transferred from the microscope to the back-reflexion camera, so that the same area of the specimen viewed through the microscope is covered by the X-ray beam. A description is given of the general principles of construction, and of a subsidiary arrangement allowing more bulky specimens to be alined on the X-ray camera by viewing through the collimating tube.

A translatory movement is added to the oscillation normally given to materials of large grain size. By this means a more representative examination of the surface of a specimen may be made. A description is given of a simple form of film holder.