Publications
43 results found
Posadzki P, Mastellos N, Ryan R, et al., 2016, Automated telephone communication systems for preventive healthcare and management of long-term conditions., Cochrane Database Syst Rev, Vol: 12
BACKGROUND: Automated telephone communication systems (ATCS) can deliver voice messages and collect health-related information from patients using either their telephone's touch-tone keypad or voice recognition software. ATCS can supplement or replace telephone contact between health professionals and patients. There are four different types of ATCS: unidirectional (one-way, non-interactive voice communication), interactive voice response (IVR) systems, ATCS with additional functions such as access to an expert to request advice (ATCS Plus) and multimodal ATCS, where the calls are delivered as part of a multicomponent intervention. OBJECTIVES: To assess the effects of ATCS for preventing disease and managing long-term conditions on behavioural change, clinical, process, cognitive, patient-centred and adverse outcomes. SEARCH METHODS: We searched 10 electronic databases (the Cochrane Central Register of Controlled Trials; MEDLINE; Embase; PsycINFO; CINAHL; Global Health; WHOLIS; LILACS; Web of Science; and ASSIA); three grey literature sources (Dissertation Abstracts, Index to Theses, Australasian Digital Theses); and two trial registries (www.controlled-trials.com; www.clinicaltrials.gov) for papers published between 1980 and June 2015. SELECTION CRITERIA: Randomised, cluster- and quasi-randomised trials, interrupted time series and controlled before-and-after studies comparing ATCS interventions, with any control or another ATCS type were eligible for inclusion. Studies in all settings, for all consumers/carers, in any preventive healthcare or long term condition management role were eligible. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods to select and extract data and to appraise eligible studies. MAIN RESULTS: We included 132 trials (N = 4,669,689). Studies spanned across several clinical areas, assessing many comparisons based on evaluation of different ATCS types and variable comparison groups. Forty-one studies evaluated ATCS for delivering p
van Velthoven MH, Mastellos N, Majeed A, et al., 2016, Feasibility of extracting data from electronic medical records for research: an international comparative study., BMC Med Inform Decis Mak, Vol: 16
BACKGROUND: Electronic medical records (EMR) offer a major potential for secondary use of data for research which can improve the safety, quality and efficiency of healthcare. They also enable the measurement of disease burden at the population level. However, the extent to which this is feasible in different countries is not well known. This study aimed to: 1) assess information governance procedures for extracting data from EMR in 16 countries; and 2) explore the extent of EMR adoption and the quality and consistency of EMR data in 7 countries, using management of diabetes type 2 patients as an exemplar. METHODS: We included 16 countries from Australia, Asia, the Middle East, and Europe to the Americas. We undertook a multi-method approach including both an online literature review and structured interviews with 59 stakeholders, including 25 physicians, 23 academics, 7 EMR providers, and 4 information commissioners. Data were analysed and synthesised thematically considering the most relevant issues. RESULTS: We found that procedures for information governance, levels of adoption and data quality varied across the countries studied. The required time and ease of obtaining approval also varies widely. While some countries seem ready for secondary uses of data from EMR, in other countries several barriers were found, including limited experience with using EMR data for research, lack of standard policies and procedures, bureaucracy, confidentiality, data security concerns, technical issues and costs. CONCLUSIONS: This is the first international comparative study to shed light on the feasibility of extracting EMR data across a number of countries. The study will inform future discussions and development of policies that aim to accelerate the adoption of EMR systems in high and middle income countries and seize the rich potential for secondary use of data arising from the use of EMR solutions.
O'Connor Y, Hardy V, Thompson M, et al., 2016, The Importance of form field validation: lessons learnt from a feasibility study of an mHealth application in Malawi, Africa., 20th Pacific Asia Conference on Information Systems (PACIS) 2016
Measuring adherence to clinical guidelines using mobile health (mHealth) technologies when form field validation is enforced or turned on could potentially be viewed as skewing the dataset, leading to 100% adherence to the clinical rule base. In theory, healthcare providers should fully abide by clinical guidelines, whether in paper or digital format, to ensure that the patient receives appropriate care. However, what happens when mHealth form field validation is turned off? As part of a feasibility study in Malawi, Africa, we explored this phenomenon. Switching off validation on the mHealth artefact served its purpose within the context of a feasibility study where a parallel paper-based clinical assessment process remained in place. The design of this technical artefact with the turnkey validation feature afforded us the opportunity to turn validation on and off seamlessly. Ultimately, from an ethical, clinical and technical perspective the optimum approach is to ensure that form field validation is switched on. With form field validation on adherence to the clinical guidelines is enforced which minimises incomplete assessment and the potential for suboptimal clinical decisions that could adversely affect patient care.
Mastellos N, Bliźniuk G, Czopnik D, et al., 2016, Feasibility and acceptability of TRANSFoRm to improve clinical trial recruitment in primary care., Fam Pract, Vol: 33, Pages: 186-191
BACKGROUND: Recruitment of study participants is a challenging process for health professionals and patients. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) clinical trial tools enable automated identification, recruitment and follow-up in clinical trials, potentially saving time, effort and costs for all parties involved. OBJECTIVES: This study evaluates the acceptability and feasibility of TRANSFoRm to improve clinical trial recruitment in primary care. METHODS: A feasibility study was conducted in three general practices in Poland. Participants were physicians and patients with gastro-oesophageal reflux disease. Semi-structured interviews were held to obtain feedback about the usefulness, ease of use and overall experience with the TRANSFoRm tools and to identify potential usability issues. Data were analysed thematically. RESULTS: A total of 5 physicians and 10 patients participated in the study. Physicians were satisfied with the usefulness of the system, as it enabled easier and faster identification, recruitment and follow-up of patients compared with existing methods. Patients found the TRANSFoRm apps easy to use to report patient outcomes. However, they also felt that the apps may not be useful for patients with limited exposure to smartphone and web technologies. Two main usability issues were identified: physicians could not access the result of the randomization at the end of each visit, and participants could not locate the follow-up reminder email. CONCLUSIONS: This study provides new evidence on the acceptability and feasibility of TRANSFoRm to enable automated identification, recruitment and follow-up of study participants in primary care trials. It also helps to better understand and address users' requirements in eHealth-supported clinical research.
Tran T, Akram A, Mastellos N, et al., 2015, Engaging older individuals with CHARIOT, Cognitive Health in Ageing Register, 1st International Conference of Primary Care & Public Health Medicine
Dementia affects over 850,000 people in the UK (one in three people over the age of 65). Dementia is not an inevitable part of ageing, and the CHARIOT Register aims to facilitate the involvement of elderly people in dementia prevention research. The CHARIOT Register is a research register of cognitively healthy individuals between the ages of 60 and 85 who are interested and willing to participate in future studies in relation to dementia prevention. Recruitment to the CHARIOT Register is primarily conducted through primary care facilities. The CHARIOT register team approaches General Practices (GPs) throughout greater London to seek their cooperation in identifying eligible individuals. Eligible individuals are sent an invitation letter with an information sheet and consent form via post. Upon consenting to join the Register, their details are collected and securely stored in the CHARIOT Register. Participants are then invited to join studies focusing on the prevention of cognitive decline and dementia. The Register currently consists of 25,000+ individuals from 130 GPs. At present, three studies are being conducted with over 1,000 Register participants. In addition to being at the forefront of dementia prevention research, participants also benefit from regular newsletters with up-to-date information on current studies and new research.
Mastellos N, Andreasson A, Huckvale K, et al., 2015, A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol., Implement Sci, Vol: 10
BACKGROUND: Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. METHODS/DESIGN: This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. DISCUSSION: The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. TRIAL REGISTRATION: EudraCT: 2014-001314-25.
Larsen ME, Curry L, Mastellos N, et al., 2015, Development of the CHARIOT Research Register for the Prevention of Alzheimer's Dementia and Other Late Onset Neurodegenerative Diseases., PLoS One, Vol: 10
BACKGROUND: Identifying cognitively healthy people at high risk of developing dementia is an ever-increasing focus. These individuals are essential for inclusion in observational studies into the natural history of the prodromal and early disease stages and for interventional studies aimed at prevention or disease modification. The success of this research is dependent on having access to a well characterised, representative and sufficiently large population of individuals. Access to such a population remains challenging as clinical research has, historically, focussed on patients with dementia referred to secondary and tertiary services. The primary care system in the United Kingdom allows access to a true prodromal population prior to symptoms emerging and specialist referral. We report the development and recruitment rates of the CHARIOT register, a primary care-based recruitment register for research into the prevention of dementia. The CHARIOT register was designed specifically to support recruitment into observational natural history studies of pre-symptomatic or prodromal dementia stages, and primary or secondary prevention pharmaceutical trials or other prevention strategies for dementia and other cognitive problems associated with ageing. METHODS: Participants were recruited through searches of general practice lists across the west and central London regions. Invitations were posted to individuals aged between 60 and 85 years, without a diagnosis of dementia. Upon consent, a minimum data set of demographic and contact details was extracted from the patient's electronic health record. RESULTS: To date, 123 surgeries participated in the register, recruiting a total of 24,509 participants-a response rate of 22.3%. The age, gender and ethnicity profiles of participants closely match that of the overall eligible population. Higher response rates tended to be associated with larger practices (r = 0.34), practices with a larger older population (r = 0.27), less s
Mastellos N, Car J, Majeed A, et al., 2014, Using information to deliver safer care: a mixed-methods study exploring general practitioners' information needs in North West London primary care., J Innov Health Inform, Vol: 22, Pages: 207-213
BACKGROUND: The National Health Service in England has given increasing priority to improving inter-professional communication, enabling better management of patients with chronic conditions and reducing medical errors through effective use of information. Despite considerable efforts to reduce patient harm through better information usage, medical errors continue to occur, posing a serious threat to patient safety. OBJECTIVES: This study explores the range, quality and sophistication of existing information systems in primary care with the aim to capture what information practitioners need to provide a safe service and identify barriers to its effective use in care pathways. METHOD: Data were collected through semi-structured interviews with general practitioners from surgeries in North West London and a survey evaluating their experience with information systems in care pathways. RESULTS: Important information is still missing, specifically discharge summaries detailing medication changes and changes in the diagnosis and management of patients, blood results ordered by hospital specialists and findings from clinical investigations. Participants identified numerous barriers, including the communication gap between primary and secondary care, the variable quality and consistency of clinical correspondence and the inadequate technological integration. CONCLUSION: Despite attempts to improve integration and information flow in care pathways, existing systems provide practitioners with only partial access to information, hindering their ability to take informed decisions. This study offers a framework for understanding what tools should be in place to enable effective use of information in primary care.
Mastellos N, Andreasson A, Curcin V, et al., 2014, TRANSFoRm: Assessing the potential of eHealth to transform patient recruitment and follow-up in primary care studies, 19th WONCA Europe Conference: New Routes for General Practice and Family Medicine
Background: Opportunistic recruitment to clinical studies is a particularly demanding process for GPs, patients and researchers. To date, this is performed manually using paper-based administration methods. The EU FP7-funded TRANSFoRm project team is currently finalising the tools to enable automated identification, randomisation and follow-up of eligible patients in primary care studies, potentially saving time and costs for all parties involved. This will be achieved using electronic case report forms (eCRFs) completed by general practitioners and patient mobile/web applications collecting patient-reported outcomes (PRO). Like any new intervention, TRANSFoRm will undergo rigorous testing and evaluation. In this conference, we aim to present the methods and early results from a study assessing the feasibility of TRANSFoRm to carry out patient recruitment and follow-up data collection. Following successful testing, the effectiveness of the tools will be evaluated in a cluster RCT investigating the question “what gives most symptom relief and improvement in quality of life in patients with Gastro-Oesophageal Reflux Disease (GORD), on demand or continuous use of proton pump inhibitors?”. Methods: The feasibility study is a mixed-methods study conducted in two general practices in the Netherlands. Participants will include six GPs, twenty GORD patients and a researcher. Data collection and analysis will take place April-June 2014. This will involve comparison of the results generated by TRANSFoRm against those identified through manual audit to assess the sensitivity and specificity of the TRANSFoRm case finding algorithms. The accuracy of data captured into the eCRFs and patient-facing tools will be also assessed by comparing the data extracted from the eHR and the mobile/web tools to prospectively defined eHR and PRO data. Usability will be tested through observation of users performing recruitment and follow-up data collection and any issues will be expl
Mastellos N, Gunn L, Harris M, et al., 2014, Assessing patients' experience of integrated care: a survey of patient views in the North West London Integrated Care Pilot., Int J Integr Care, Vol: 14, ISSN: 1568-4156
INTRODUCTION: Despite the importance of continuity of care and patient engagement, few studies have captured patients' views on integrated care. This study assesses patient experience in the Integrated Care Pilot in North West London with the aim to help clinicians and policymakers understand patients' acceptability of integrated care and design future initiatives. METHODS: A survey was developed, validated and distributed to 2029 randomly selected practice patients identified as having a care plan. RESULTS: A total of 405 questionnaires were included for analysis. Respondents identified a number of benefits associated with the pilot, including increased patient involvement in decision-making, improved patient-provider relationship, better organisation and access to care, and enhanced inter-professional communication. However, only 22.4% were aware of having a care plan, and of these only 37.9% had a copy of the care plan. Knowledge of care plans was significantly associated with a more positive experience. CONCLUSIONS: This study reinforces the view that integrated care can improve quality of care and patient experience. However, care planning was a complex and technically challenging process that occurred more slowly than planned with wide variation in quality and time of recruitment to the pilot, making it difficult to assess the sustainability of benefits.
Mastellos N, Gunn LH, Felix LM, et al., 2014, Transtheoretical model stages of change for dietary and physical exercise modification in weight loss management for overweight and obese adults., Cochrane Database Syst Rev, Vol: 2014
BACKGROUND: Obesity is a global public health threat. The transtheoretical stages of change (TTM SOC) model has long been considered a useful interventional approach in lifestyle modification programmes, but its effectiveness in producing sustainable weight loss in overweight and obese individuals has been found to vary considerably. OBJECTIVES: To assess the effectiveness of dietary intervention or physical activity interventions, or both, and other interventions based on the transtheoretical model (TTM) stages of change (SOC) to produce sustainable (one year and longer) weight loss in overweight and obese adults. SEARCH METHODS: Studies were obtained from searches of multiple electronic bibliographic databases. We searched The Cochrane Library, MEDLINE, EMBASE and PsycINFO. The date of the last search, for all databases, was 17 December 2013. SELECTION CRITERIA: Trials were included if they fulfilled the criteria of randomised controlled clinical trials (RCTs) using the TTM SOC as a model, that is a theoretical framework or guideline in designing lifestyle modification strategies, mainly dietary and physical activity interventions, versus a comparison intervention of usual care; one of the outcome measures of the study was weight loss, measured as change in weight or body mass index (BMI); participants were overweight or obese adults only; and the intervention was delivered by healthcare professionals or trained lay people at the hospital and community level, including at home. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data, assessed studies for risk of bias and evaluated overall study quality according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). We resolved disagreements by discussion or consultation with a third party. A narrative, descriptive analysis was conducted for the systematic review. MAIN RESULTS: A total of three studies met the inclusion criteria, allocating 2971 participants t
Curry N, Harris M, Gunn LH, et al., 2013, Integrated care pilot in north-west London: a mixed methods evaluation., Int J Integr Care, Vol: 13, ISSN: 1568-4156
INTRODUCTION: This paper provides the results of a year-long evaluation of a large-scale integrated care pilot in north-west London. The pilot aimed to integrate care across primary, acute, community, mental health and social care for people with diabetes and/or those aged 75+ through care planning, multidisciplinary case reviews, information sharing and project management support. METHODS: The evaluation team conducted qualitative studies of change at organisational, clinician and patient levels (using interviews, focus groups and a survey); and quantitative analysis of change in service use and patient-level clinical outcomes (using patient-level datasets and a matched control study). RESULTS: The pilot had successfully engaged provider organisations, created a shared strategic vision and established governance structures. However, the engagement of clinicians was variable and there was no evidence to date of significant reductions in emergency admissions. There was some evidence of changes in care processes. CONCLUSION: Although the pilot has demonstrated the beginnings of large-scale change, it remains in the early stages and faces significant challenges as it seeks to become sustainable for the longer term. It is critical that National Health Service managers and clinicians have realistic expectations of what can be achieved in a relatively short period of time.
Mastellos N, Aylin P, 2012, Quality and safety in primary care: an exploration of the factors hindering the effective use of information in care pathways, Publisher: Centre for Patient Safety and Service Quality (CPSSQ)
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