Health data processes. A framework for analysing and discussing efficient use and reuse of health data with focus on Patient Reported Outcome (PRO) measures

This is is the final version. Available from Journal of Medical Internet Research via the DOI in this record.The collection and use of patient health data is central to any kind of activity in the healthcare system. This data may be produced during routine clinical processes or obtained directly from the patient using patient-reported outcome (PRO) measures. Although efficiency and other reasons justify data availability for a range of potential relevant uses, these data are nearly always collected for a single specific purpose. The healthcare data literature reflects this narrow scope, and there is limited literature on the joint use of health data for daily clinical use, clinical research, surveillance and administrative purposes. The aim of this paper is to provide a framework for a discussion of the efficient use of health data with specific focus on the role of PRO measures. PRO data may be used: i) at an individual patient level to inform patient care or shared-decision making and tailor care to individual needs or ii) at group level as a complement to health record data e.g. on mortality and readmission to inform service delivery and measure real-world effectiveness of treatment. PRO may be used either for their own sake, to provide valuable information from the patient perspective, or as proxy for clinical data that would be otherwise not feasible to collect. We introduce a framework to analyse any health care activity that involves health data. The framework consists of four data processes (patient identification, data collection, data aggregation and data use), further structured into two dichotomous dimensions in each data process (level: group vs patient; and timeframe: ad hoc vs systematic). This framework is used to analyse various health activities with respect to joint use of data considering the technical, legal, organisational and logistical challenges that characterize each data process. Finally, we propose a model for joint use of health data with data collected during follow-up as basis. Demands for health data will continue to increase which will further add to the need for the concerted use and reuse of PRO data for parallel purposes. Repeated and uncoordinated PRO data collection for the same patient for different purposes results in misuse of resources for the healthcare system as well as reduced response rates owing to questionnaire fatigue. PRO data can be routinely collected both at the hospital (in- as well as outpatients) and outside of hospital settings, in primary or social care settings, or in the patient’s home provided the health informatics infrastructure is in place. In the future, clinical settings are likely to be a prominent source of PRO data; however we are also likely to see increased remote collection of PRO data by patients in their own home (telePRO). Data collection for research and quality surveillance will have to adapt to this circumstance and adopt complementary data capture methods which take advantage of the utility of PRO data collected during daily clinical practice. The European Union’s regulation with respect to the protection of personal data, General Data Protection Regulation, imposes severe restrictions on use of health data for parallel purposes and steps should be taken to alleviate the consequences while still protecting personal data against misuse.National Institute for Health Research (NIHR

FULSOME: a fuzzy logic modeling tool for software metricians

There has been a growing body of literature suggesting that some of the problems faced by software development project managers can be at least partially overcome by using fuzzy logic techniques. However, one issue that has been generally overlooked in this recommendation is the means by which these “software metricians” can collect data for, develop, and interpret fuzzy logic models in practice. We describe a freely available system that has been built with this in mind called FULSOME (FUzzy Logic for SOftware MEtrics). While there are many tools available for developing fuzzy models, it is suggested that before there will be real adoption of such techniques by project managers there will need to be suitable tools that support their particular workflows and that use appropriate terminology. Another requirement will be the development of some standard procedures and definitions for such models. Issues involved with membership function elicitation and extraction are also discussed as a first step towards this second goal

FULSOME: fuzzy logic for software metric practitioners and researchers

There has been increasing interest in recent times for using fuzzy logic techniques to represent software metric models, especially those predicting the software development effort. The use of fuzzy logic for this application area offers several advantages when compared to other commonly-used techniques. These include the use of a single model with different levels of precision for the inputs and outputs used throughout the development life-cycle, the possibility of model development with little or no data, and its effectiveness when used as a communication tool. The use of fuzzy logic in any applied field, however, requires that suitable tools are available for both practitioners and researchers-satisfying both interface- and functionality-related requirements. After outlining some of the specific needs of the software metrics community, including results from a survey of software developers on this topic, this paper describes the use of a set of tools called FULSOME (FUzzy Logic for SOftware MEtrics). The development of a simple fuzzy logic system by a software metrician and its subsequent tuning are then discussed using a real-world set of software metric data. The automatically generated fuzzy model performs acceptably when compared to regression-based model

A comparison of the development of audiovisual integration in children with autism spectrum disorders and typically developing children

This study aimed to investigate the development of audiovisual integration in children with Autism Spectrum Disorder (ASD). Audiovisual integration was measured using the McGurk effect in children with ASD aged 7–16 years and typically developing children (control group) matched approximately for age, sex, nonverbal ability and verbal ability. Results showed that the children with ASD were delayed in visual accuracy and audiovisual integration compared to the control group. However, in the audiovisual integration measure, children with ASD appeared to ‘catch-up’ with their typically developing peers at the older age ranges. The suggestion that children with ASD show a deficit in audiovisual integration which diminishes with age has clinical implications for those assessing and treating these children

IgG4-related pulmonary disease: the protean impersonator?

IgG4-related disease is an immune-mediated fibro-inflammatory disease, characterised by distinct pathological features. An increasing number of clinical phenotypes are described, from single-organ disease to a multisystem disorder, which can present to a variety of different specialities. Recognition is key; its protean manifestations can mimic other inflammatory diseases, infection and malignancy. Here, we present three cases to highlight the importance of being familiar with this condition in its various forms

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol.

Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported.Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r)

International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study

Purpose: Evidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions. Methods: Semi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame. Results: Forty-four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists’ reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified. Conclusion: Misconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines

Simultaneous quantification of 12 different nucleotides and nucleosides released from renal epithelium and in human urine samples using ion-pair reversed-phase HPLC

Nucleotides and nucleosides are not only involved in cellular metabolism but also act extracellularly via P1 and P2 receptors, to elicit a wide variety of physiological and pathophysiological responses through paracrine and autocrine signalling pathways. For the first time, we have used an ion-pair reversed-phase high-performance liquid chromatography ultraviolet (UV)-coupled method to rapidly and simultaneously quantify 12 different nucleotides and nucleosides (adenosine triphosphate, adenosine diphosphate, adenosine monophosphate, adenosine, uridine triphosphate, uridine diphosphate, uridine monophosphate, uridine, guanosine triphosphate, guanosine diphosphate, guanosine monophosphate, guanosine): (1) released from a mouse renal cell line (M1 cortical collecting duct) and (2) in human biological samples (i.e., urine). To facilitate analysis of urine samples, a solid-phase extraction step was incorporated (overall recovery rate ? 98 %). All samples were analyzed following injection (100 ?l) into a Synergi Polar-RP 80 Å (250 × 4.6 mm) reversed-phase column with a particle size of 10 ?m, protected with a guard column. A gradient elution profile was run with a mobile phase (phosphate buffer plus ion-pairing agent tetrabutylammonium hydrogen sulfate; pH 6) in 2-30 % acetonitrile (v/v) for 35 min (including equilibration time) at 1 ml min(-1) flow rate. Eluted compounds were detected by UV absorbance at 254 nm and quantified using standard curves for nucleotide and nucleoside mixtures of known concentration. Following validation (specificity, linearity, limits of detection and quantitation, system precision, accuracy, and intermediate precision parameters), this protocol was successfully and reproducibly used to quantify picomolar to nanomolar concentrations of nucleosides and nucleotides in isotonic and hypotonic cell buffers that transiently bathed M1 cells, and urine samples from normal subjects and overactive bladder patients