Barriers to and motives for engagement in an exercise-based cardiac rehabilitation programme in Ireland: a qualitative study.

BACKGROUND: Insufficient physical activity (PA) is a leading risk factor for premature death worldwide. Ireland's public healthcare system, the Health Service Executive (HSE), has supported the development of the National Exercise Referral Framework (NERF) to tackle low levels of PA amongst those with non-communicable diseases (NCDs). 'NERF centres' are medically supervised PA programmes across Ireland that have established referral pathways with local hospitals and general practitioners. ULMedX is one such NERF centre offering exercise-based cardiac rehabilitation (EBCR) with the aim of intervention development to reduce early drop-out and maximise adherence for optimal health benefits. AIM: The purpose of this research was to identify the major factors influencing participants' adherence and early drop-out at ULMedX. Exploring areas for future development were also prioritised. DESIGN & SETTING: Qualitative interviews were conducted with long-term attenders and people who have dropped out (PWDO) from ULMedX. METHODS: Guided by the Theory of Planned Behaviour the 1-1 semi-structured interviews were performed, transcribed, and evaluated through thematic analysis. RESULTS: Analysis was performed on 14 participants (50% female; mean age 67.3 years), comprising long-term attenders (n = 7; 13-month duration, 64% of classes) and PWDO (n = 7; 2.8-month duration, 22% of classes). Three major factors affecting adherence and drop-out were identified: social support, perceived outcomes from participation and practical barriers to attendance. Areas for future development included the provision of evening and advanced classes, psychological support, more exercise variety, more educational seminars and new members start as their own group. CONCLUSION: The findings suggest participants at ULMedX are more likely to have had a better experience and commit to the programme if they believed involvement would benefit their physical and mental health, increase their exercise motivation by engendering a positive attitude to exercise, and that the ability to attend was within their control. Future interventions at ULMedX should have their structures centred around these motives for engagement. ULMedX should also test the participant recommendations to overcome the common barriers to adherence.

Incorporating patient generated health data into pharmacoepidemiological research.

Epidemiology and pharmacoepidemiology frequently employ Real-World Data (RWD) from healthcare teams to inform research. These data sources usually include signs, symptoms, tests, and treatments, but may lack important information such as the patient's diet or adherence or quality of life. By harnessing digital tools a new fount of evidence, Patient (or Citizen/Person) Generated Health Data (PGHD), is becoming more readily available. This review focusses on the advantages and considerations in using PGHD for pharmacoepidemiological research. New and corroborative types of data can be collected directly from patients using digital devices, both passively and actively. Practical issues such as patient engagement, data linking, validation, and analysis are among important considerations in the use of PGHD. In our ever increasingly patient-centric world, PGHD incorporated into more traditional Real-Word data sources offers innovative opportunities to expand our understanding of the complex factors involved in health and the safety and effectiveness of disease treatments. Pharmacoepidemiologists have a unique role in realizing the potential of PGHD by ensuring that robust methodology, governance, and analytical techniques underpin its use to generate meaningful research results.

Situation awareness and the decision-making processes of final-year nursing students.

AIMS AND OBJECTIVES: To investigate final-year nursing students' use of situation awareness when making clinical decisions about patients' progress postsurgery. BACKGROUND: Making clinical decisions about patient care is a generic nursing competence, developed in preregistration nursing programmes and critical to providing safe patient care. Situation awareness is an important precursor to making decisions and is linked to improved clinical outcomes. However, there is evidence to suggest that nursing students feel inadequately prepared to make clinical decisions. DESIGN: Endsley's (Situation awareness analysis and measurement. Hillsdale, NJ: Lawrence Erlbaum Associates, 2000) 3-level situation awareness framework was used to guide the study. Level 1 situation awareness is perception of information required to make a decision. Level 2 relates to comprehending the information. Level 3 situation awareness is projecting how this information will inform the future. Twelve final-year nursing students were recruited to participate. Think-aloud research method was used to capture students' decision-making, followed by semi-structured interviews. Data were analysed using an adapted protocol analysis and were encoded inductively. The COREQ checklist has been used in reporting the study. RESULTS: Students demonstrated level 1, 2 and 3 situation awareness when making clinical decisions. However, it was not demonstrated consistently and at times subsequent decision-making was inappropriate. Three themes emerged: "systems approach to assessment of postoperative patients"; "policy drives practice"; and "deferring decisions to registered nurses". Within the themes, students demonstrated differing levels of situation awareness. CONCLUSION: Making safe clinical decisions is a paramount skill for nurses; however, student nurses are ill-equipped to undertake this skill. Situation awareness is important in informing safe decision-making, but students' use of situation awareness is variable. Cognitive apprenticeship, applied to supporting development of situation awareness, affords the opportunity to develop students' decision-making. RELEVANCE TO CLINICAL PRACTICE: Clinical decision-making is a generic competence for all registered nurses and imperative for safe practice. However, student nurses are unprepared to undertake this skill once registered.

Evidence generation from healthcare databases: recommendations for managing change.

There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in communication and management, and provide a checklist of issues to consider for both database providers and users. The scope of the paper is database research, and changes are considered in relation to the three main components of database research: the data content itself, how it is accessed, and the support and tools needed to use the database. Copyright © 2016 John Wiley & Sons, Ltd.

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy.

BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. OBJECTIVE: To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a study of self-reported gestational exposures and pregnancy outcomes. METHODS: The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms. RESULTS: Over a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (P<.001). However, we identified international variations in both the cost-effectiveness of the various advertisement methods used and in their ability to recruit participants in early pregnancy. CONCLUSIONS: Recruitment of a pregnant cohort using direct-to-participant advertisement methods is feasible, but the total costs incurred are not insubstantial. Future research is needed to identify advertising strategies capable of recruiting large numbers of demographically representative pregnant women, preferentially in early pregnancy.

Balancing the interests of patient data protection and medication safety monitoring in a public-private partnership.

Obtaining data without the intervention of a health care provider represents an opportunity to expand understanding of the safety of medications used in difficult-to-study situations, like the first trimester of pregnancy when women may not present for medical care. While it is widely agreed that personal data, and in particular medical data, needs to be protected from unauthorized use, data protection requirements for population-based studies vary substantially by country. For public-private partnerships, the complexities are enhanced. The objective of this viewpoint paper is to illustrate the challenges related to data protection based on our experiences when performing relatively straightforward direct-to-patient noninterventional research via the Internet or telephone in four European countries. Pregnant women were invited to participate via the Internet or using an automated telephone response system in Denmark, the Netherlands, Poland, and the United Kingdom. Information was sought on medications, other factors that may cause birth defects, and pregnancy outcome. Issues relating to legal controllership of data were most problematic; assuring compliance with data protection requirements took about two years. There were also inconsistencies in the willingness to accept nonwritten informed consent. Nonetheless, enrollment and data collection have been completed, and analysis is in progress. Using direct reporting from consumers to study the safety of medicinal products allows researchers to address a myriad of research questions relating to everyday clinical practice, including treatment heterogeneity in population subgroups not traditionally included in clinical trials, like pregnant women, children, and the elderly. Nonetheless, there are a variety of administrative barriers relating to data protection and informed consent, particularly within the structure of a public-private partnership.

Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy.

BACKGROUND: Little is known about the effects of human fetal exposure when a new drug is authorized unless it was specifically developed for use in pregnancy. Since many factors may contribute to adverse fetal effects, having comprehensive information about in utero exposures will enhance our ability to make correct determinations about causality. OBJECTIVE: The objective of the study was to assess the extent to which women, recruited without the intervention of health care professionals (HCPs), will provide information, suitable for research purposes, via the Internet or by phone on some potential risk factors in pregnancy. METHODS: To pilot direct-to-patient research for pharmacovigilance, we conducted a prospective, noninterventional study of medication use and lifestyle factors as part of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) Consortium. Consenting women who self-identified as pregnant and residing in the United Kingdom (UK), Denmark (DK), The Netherlands, or Poland were recruited and could then choose to provide data every 2 or 4 weeks via the Internet or a telephonic interactive voice response system (IVRS). Self-reported drug use was compared with pharmacy register data in DK and with electronic health records in the UK. RESULTS: Recruited women were on average older and more highly educated than the general population. Most respondents chose a frequency of every 4 weeks (56.99%, 1177/2065). Only 29.83% (464/1555) of women with due dates occurring during the study provided information on pregnancy outcome. For those responding by Internet, over 90.00% (1915/2065) reported using >1 pregnancy-related medication, 83.34% (1721/2065) reported using >1 other medicine, and 23.53% (486/2065) reported only over-the-counter medications, not counting herbals and dietary supplements. Some respondents (7.16%, 148/2065) reported that they chose not to take a prescribed medication (mostly medicines for pain or inflammation, and for depression) and 1.30% (27/2065) reported using medicines that had been prescribed to a friend or family member (oxycodone, paracetamol, and medications for acid-related problems). Relatively few respondents reported using fish oil (4.60%, 95/2065), other dietary supplements (1.88%, 39/2065), herbal products (7.07%, 146/2065), or homeopathic products (1.16%, 24/2065). Most medications for chronic conditions that were listed in the Danish prescription registry were also self-reported (83.3%, 145/174 agreement), with larger discrepancies for medications indicated for short-term use (54.0%, 153/283 agreement) and pregnancy-related medications (66.1%, 78/118). CONCLUSIONS: Self-reported information on medication use as well as other potential teratogenic factors can be collected via the Internet, although recruitment costs are not insubstantial and maintaining follow-up is challenging. Direct data collection from consumers adds detail, but clinical input may be needed to fully understand patients' medical histories and capture birth outcomes.

Guidelines for good database selection and use in pharmacoepidemiology research.

The use of healthcare databases in research provides advantages such as increased speed, lower costs and limitation of some biases. However, database research has its own challenges as studies must be performed within the limitations of resources, which often are the product of complex healthcare systems. The primary purpose of this document is to assist in the selection and use of data resources in pharmacoepidemiology, highlighting potential limitations and recommending tested procedures. This guidance is presented as a detailed text with a checklist for quick reference and covers six areas: selection of a database, use of multiple data resources, extraction and analysis of the study population, privacy and security, quality and validation procedures and documentation.

The distribution of lung cancer across sectors of society in the United Kingdom: a study using national primary care data.

BACKGROUND: There is pressing need to diagnose lung cancer earlier in the United Kingdom (UK) and it is likely that research using computerised general practice records will help this process. Linkage of these records to area-level geo-demographic classifications may also facilitate case ascertainment for public health programmes, however, there have as yet been no extensive studies of data validity for such purposes. METHODS: To first address the need for validation, we assessed the completeness and representativeness of lung cancer data from The Health Improvement Network (THIN) national primary care database by comparing incidence and survival between 2000 and 2009 with the UK National Cancer Registry and the National Lung Cancer Audit Database. Secondly, we explored the potential of a geo-demographic social marketing tool to facilitate disease ascertainment by using Experian's Mosaic Public Sector ™ classification, to identify detailed profiles of the sectors of society where lung cancer incidence was highest. RESULTS: Overall incidence of lung cancer (41.4/100, 000 person-years, 95% confidence interval 40.6-42.1) and median survival (232 days) were similar to other national data; The incidence rate in THIN from 2003-2006 was found to be just over 93% of the national cancer registry rate. Incidence increased considerably with area-level deprivation measured by the Townsend Index and was highest in the North-West of England (65.1/100, 000 person-years). Wider variations in incidence were however identified using Mosaic classifications with the highest incidence in Mosaic Public Sector ™types 'Cared-for pensioners, ' 'Old people in flats' and 'Dignified dependency' (191.7, 174.2 and 117.1 per 100, 000 person-years respectively). CONCLUSIONS: Routine electronic data in THIN are a valid source of lung cancer information. Mosaic ™ identified greater incidence differentials than standard area-level measures and as such could be used as a tool for public health programmes to ascertain future cases more effectively.

Generalisability of The Health Improvement Network (THIN) database: demographics, chronic disease prevalence and mortality rates.

INTRODUCTION: The degree of generalisability of patient databases to the general population is important for interpreting database research. This report describes the representativeness of The Health Improvement Network (THIN), a UK primary care database, of the UK population. METHODS: Demographics, deprivation (Townsend), Quality and Outcomes Framework (QOF) condition prevalence and deaths from THIN were compared with national statistical and QOF 2006/2007 data. RESULTS: Demographics were similar although THIN contained fewer people aged under 25 years. Condition prevalence was comparable, e.g. 3.5% diabetes prevalence in THIN, 3.7% nationally. More THIN patients lived in the most affluent areas (23.5% in THIN, 20% nationally). Between 1990 and 2009, standardised mortality ratio ranged from 0.81 (95% CI: 0.39-1.49; 1990) to 0.93 (95% CI: 0.48-1.64; 1995). Adjusting for demographics/deprivation, the 2006 THIN death rate was 9.08/1000 population close to the national death rate of 9.4/1000 population. CONCLUSION: THIN is generalisable to the UK for demographics, major condition prevalence and death rates adjusted for demographics and deprivation.

Feasibility study and methodology to create a quality-evaluated database of primary care data.

OBJECTIVES: To build and test a model for the collection of computerised retrospective primary care data from the UK, and to assess its quality for use in medical and pharmaceutical research. DESIGN: Collection and evaluation of sampled retrospective general practice data recording. SETTING: General practices, using the Vision practice management software in the UK. MAIN OUTCOME MEASURES: Quality indicators of completeness of data recording. RESULTS: Initial audit of 236 practices indicated good recording of prescribing in all practices and a high level of completeness of recording of clinical information in many of the practices. CONCLUSIONS: In the group of practices studied, levels of recording were generally assessed to be of sufficient quality to enable a database of quality-evaluated, anonymised primary care records to be created.