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A rational model for assessing and evaluating complex interventions in health care
Carl May
BMC Health Services Research , 2006, DOI: 10.1186/1472-6963-6-86
Abstract: Between 1995 and 2005 multiple qualitative studies were undertaken. These examined: professional-patient relationships; changing patterns of care; the development, evaluation and implementation of telemedicine and related informatics systems; and the production and utilization of evidence for practice. Data from these studies were subjected to (i) formative re-analysis, leading to sets of analytic propositions; and to (ii) a summative analysis that aimed to build a robust conceptual model of the normalization of complex interventions in health care.A normalization process model that enables analysis of the conditions necessary to support the introduction of complex interventions is presented. The model is defined by four constructs: interactional workability; relational integration; skill set workability and contextual integration. This model can be used to understand the normalization potential of new techniques and technologies in healthcare settingsThe normalization process model has face validity in (i) assessing the potential for complex interventions to become routinely embedded in everyday clinical work, and (ii) evaluating the factors that promote or inhibit their success and failure in practice.Health care providers increasingly seek new technological and organizational means of improving the efficiency and clinical and cost effectiveness of clinical care and health service delivery [1]. The assessment and evaluation of these solutions has become a major focus of investigation in health services research and health technology assessment. For both decision-makers and evaluation researchers, conceptualizing the practical workability of new treatment modalities or information systems, and assessing their potential for integration in healthcare settings, are key problems. The purpose of this article is therefore to present a rational conceptual model – the normalization process model – that can assist both service provider and research constituencies in underst
Development and formative evaluation of the e-Health Implementation Toolkit (e-HIT)
Elizabeth Murray, Carl May, Frances Mair
BMC Medical Informatics and Decision Making , 2010, DOI: 10.1186/1472-6947-10-61
Abstract: The content of the e-HIT was derived by combining data from a systematic review of reviews of barriers and facilitators to implementation of e-Health initiatives with qualitative data derived from interviews of "implementers", that is people who had been charged with implementing an e-Health initiative. These data were summarised, synthesised and combined with the constructs from the Normalisation Process Model. The software for the toolkit was developed by a commercial company (RocketScience). Formative evaluation was undertaken by obtaining user feedback.There are three components to the toolkit - a section on background and instructions for use aimed at novice users; the toolkit itself; and the report generated by completing the toolkit. It is available to download from http://www.ucl.ac.uk/pcph/research/ehealth/documents/e-HIT.xls webciteThe e-HIT shows potential as a tool for enhancing future e-Health implementations. Further work is needed to make it fully web-enabled, and to determine its predictive potential for future implementations.E-health, or the use of information and communication technology in health care, is seen as essential for a modern, cost-effective health service which is capable of addressing challenges such as improving equity of access and quality of care in a world facing an increasing burden of chronic disease [1]. There is an international commitment to e-Health, reflected in very considerable expenditure. The UK government has invested £12.4 bn over 10 years [2] and this is less than the US or many European countries [3]. However, despite the overwhelming political commitment and substantial investment, there has been significant variability in the success of different e-health implementations [4,5]. Many projects have been subject to delay [6], increasing budget overspends, and in some cases, severely negative impacts on the quality and effectiveness of care [7-9]. Although there is a considerable body of research on implementation of
Podocyte Dedifferentiation: A Specialized Process for a Specialized Cell
Carl J. May,Gavin I. Welsh
Frontiers in Endocrinology , 2014, DOI: 10.3389/fendo.2014.00148
Abstract: The podocyte is one of two cell types that contribute to the formation of the glomerular filtration barrier (GFB). It is a highly specialized cell with a unique structure. The key feature of the podocyte is its foot processes that regularly interdigitate. A structure known as the slit diaphragm can be found bridging the interdigitations. This molecular sieve comprises the final layer of the GFB. It is well accepted that the podocyte is the target cell in the pathogenesis of nephrotic syndrome. In nephrotic syndrome the glomerular filtration barrier no longer restricts the passage of macromolecules and protein is lost into the urine. A number of phenotypic and morphological changes are seen in the diseased podocyte and in the literature these have been described as an Epithelial-Mesenchymal Transition (EMT). However, there is a growing appreciation that this term does not accurately describe the changes that are seen. Definitions of type 2 EMT are based on typical epithelial cells. Whilst the podocyte is known as a visceral epithelial cell, it is not a typical epithelial cell. Moreover, podocytes have several features that are more consistent with mesenchymal cells. Therefore we suggest that the term Podocyte Disease Transformation (PDT) is more appropriate.
Experiences of abortion: A narrative review of qualitative studies
Mabel LS Lie, Stephen C Robson, Carl R May
BMC Health Services Research , 2008, DOI: 10.1186/1472-6963-8-150
Abstract: To undertake a narrative review of qualitative studies of women's experiences of TOP and their perspectives on surgical or medical methods.Keyword searches of Medline, CINAHL, ISI, and IBSS databases. Manual searches of other relevant journals and reference lists of primary articles.Qualitative studies (n = 18) on women's experiences of abortion were identified. Analysis of the results of studies reviewed revealed three main themes: experiential factors that promote or inhibit the choice to seek TOP; experiences of TOP; and experiential aspects of the environment in which TOP takes place.Women's choices about TOP are mainly pragmatic ones that are related to negotiating finite personal and family and emotional resources. Women who are well informed and supported in their choices experience good psychosocial outcomes from TOP. Home TOP using mifepristone appears attractive to women who are concerned about professionals' negative attitudes and lack of privacy in formal healthcare settings but also leads to concerns about management and safety.Although abortion or termination of pregnancy (TOP) by clinical means is politically contentious in some countries (notably the US), in most developed countries it has become a normalized [1] component of women's health care [2] over the past forty years. For most of this period, TOP was a surgical procedure but since the mid-1990s, pharmaceutical developments (i.e. RU-486 also known as mifepristone, and methotrexate [3]), have made medical TOP possible. Clinical trials have established that medical TOP provides a clinical and cost effective alternative to vacuum aspiration for the early termination of pregnancy [4-8]. While a Cochrane systematic review highlighted inadequate evidence [9], a more recent systematic review concluded that the incidence of side effects in medical abortion was low [10]. Even so, mifepristone has only been approved in the US since September 2000, whereas the UK and Sweden have had more than a decade of
Which quality of life score is best for glaucoma patients and why?
Philip Severn, Scott Fraser, Tracy Finch, Carl May
BMC Ophthalmology , 2008, DOI: 10.1186/1471-2415-8-2
Abstract: Medline, Embase and Google Scholar were searched for relevant articles. No time period was defined and all types of article were included.11 Quality of Life scores were identified that have been used with glaucoma patients.There is no generally accepted 'best' Quality of Life instrument for use in glaucoma. Many of the scales are biased towards physical symptoms and do little to address the personal or social factors of the disease. Further work is needed to produce scales that address all these areas as well as being simple to administer in a clinical setting.Glaucoma is the term given to the chronic, debilitating, progressive group of eye disorders that can lead to visual field loss and blindness. Glaucoma usually produces certain characteristic visual field defects in the individual's peripheral, as well as central vision. Due to the intractable nature of the disease the patient usually spends, following diagnosis, the rest of their life attending an eye hospital and taking frequent (daily) ocular anti-hypertensive medication. The treatment has associated side effects, it is expensive and often inconvenient to instill. It has been reported that approximately 67 million patients suffer from glaucoma and roughly 10% of these are blind. It is therefore not surprising that glaucoma frequently has a large impact on a patient's quality of life [1].The diagnosis of glaucoma affects people in different ways. Some readily accept the diagnosis and are keen to seek out information [2]. Others are more ignorant and disappear into the community, only to return years later with a marked deterioration in their visual function. Most patients fall in between the two extremes and adhere to their treatment in the main with little or no understanding of the disease process.Physicians have long strived to quantify quality of life (QoL) in patients with glaucoma. The reasons for this range from understanding of the patients experience of the disease to the measurement of outcomes in t
Implementing nutrition guidelines for older people in residential care homes: a qualitative study using Normalization Process Theory
Bamford Claire,Heaven Ben,May Carl,Moynihan Paula
Implementation Science , 2012, DOI: 10.1186/1748-5908-7-106
Abstract: Background Optimizing the dietary intake of older people can prevent nutritional deficiencies and diet-related diseases, thereby improving quality of life. However, there is evidence that the nutritional intake of older people living in care homes is suboptimal, with high levels of saturated fat, salt, and added sugars. The UK Food Standards Agency therefore developed nutrient- and food-based guidance for residential care homes. The acceptability of these guidelines and their feasibility in practice is unknown. This study used the Normalization Process Theory (NPT) to understand the barriers and facilitators to implementing the guidelines and inform future implementation. Methods We conducted a process evaluation in five care homes in the north of England using qualitative methods (observation and interviews) to explore the views of managers, care staff, catering staff, and domestic staff. Data were analyzed thematically and discussed in data workshops; emerging themes were then mapped to the constructs of NPT. Results Many staff perceived the guidelines as unnecessarily restrictive and irrelevant to older people. In terms of NPT, the guidelines simply did not make sense (coherence), and as a result, relatively few staff invested in the guidelines (cognitive participation). Even where staff supported the guidelines, implementation was hampered by a lack of nutritional knowledge and institutional support (collective action). Finally, the absence of observable benefits to clients confirmed the negative preconceptions of many staff, with limited evidence of reappraisal following implementation (reflexive monitoring). Conclusions The successful implementation of the nutrition guidelines requires that the fundamental issues relating to their perceived value and fit with other priorities and goals be addressed. Specialist support is needed to equip staff with the technical knowledge and skills required for menu analysis and development and to devise ways of evaluating the outcomes of modified menus. NPT proved useful in conceptualizing barriers to implementation; robust links with behavior-change theories would further increase the practical utility of NPT.
Process evaluation for complex interventions in primary care: understanding trials using the normalization process model
Carl R May, Frances S Mair, Christopher F Dowrick, Tracy L Finch
BMC Family Practice , 2007, DOI: 10.1186/1471-2296-8-42
Abstract: In this paper the model is applied to two different complex trials: (i) the delivery of problem solving therapies for psychosocial distress, and (ii) the delivery of nurse-led clinics for heart failure treatment in primary care.Application of the model shows how process evaluations need to focus on more than the immediate contexts in which trial outcomes are generated. Problems relating to intervention workability and integration also need to be understood. The model may be used effectively to explain the implementation process in trials of complex interventions.The model invites evaluators to attend equally to considering how a complex intervention interacts with existing patterns of service organization, professional practice, and professional-patient interaction. The justification for this may be found in the abundance of reports of clinical effectiveness for interventions that have little hope of being implemented in real healthcare settings.Getting new ways of delivering and organizing healthcare into practice is a problem. In recent years governments and healthcare providers across the advanced economies have been concerned with improving the technological and organizational capabilities of health services. At the same time, they have sought to measure the outcomes and costs of these interventions, in the face of constant and increasing fiscal pressures and their political consequences [1]. One result of these political and economic pressures has been the emergence of new fields of health research, especially health technology assessment and health services research, that bring together clinical, social science and statistical researchers and ally them with policy interests that demand the clinical and economic evaluation of already discovered treatments, technologies and professional or organizational interventions [2,3] and which emphasize the importance of outcomes.But as outcomes research has become more important, its practitioners have also increasingly
Why is it difficult to implement e-health initiatives? A qualitative study
Elizabeth Murray, Joanne Burns, Carl May, Tracy Finch, Catherine O'Donnell, Paul Wallace, Frances Mair
Implementation Science , 2011, DOI: 10.1186/1748-5908-6-6
Abstract: We used a case study methodology, using semi-structured interviews with implementers for data collection. Case studies were selected to provide a range of healthcare contexts (primary, secondary, community care), e-health initiatives, and degrees of normalization. The initiatives studied were Picture Archiving and Communication System (PACS) in secondary care, a Community Nurse Information System (CNIS) in community care, and Choose and Book (C&B) across the primary-secondary care interface. Implementers were selected to provide a range of seniority, including chief executive officers, middle managers, and staff with 'on the ground' experience. Interview data were analyzed using a framework derived from Normalization Process Theory (NPT).Twenty-three interviews were completed across the three case studies. There were wide differences in experiences of implementation and embedding across these case studies; these differences were well explained by collective action components of NPT. New technology was most likely to 'normalize' where implementers perceived that it had a positive impact on interactions between professionals and patients and between different professional groups, and fit well with the organisational goals and skill sets of existing staff. However, where implementers perceived problems in one or more of these areas, they also perceived a lower level of normalization.Implementers had rich understandings of barriers and facilitators to successful implementation of e-health initiatives, and their views should continue to be sought in future research. NPT can be used to explain observed variations in implementation processes, and may be useful in drawing planners' attention to potential problems with a view to addressing them during implementation planning.The challenges facing healthcare systems in the twenty-first century have been well described: an aging population; increasing prevalence of long-term conditions; improving health technologies leading to
From theory to 'measurement' in complex interventions: Methodological lessons from the development of an e-health normalisation instrument
Tracy L Finch, Frances S Mair, Catherine O'Donnell, Elizabeth Murray, Carl R May
BMC Medical Research Methodology , 2012, DOI: 10.1186/1471-2288-12-69
Abstract: A 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals.The developed instrument was pre-tested in two professional samples (N?=?46; N?=?231). Ratings of items representing normalisation ‘processes’ were significantly related to staff members’ perceptions of whether or not e-health had become ‘routine’. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts.To develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.
Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations
Eileen Kaner, Ben Heaven, Tim Rapley, Madeleine Murtagh, Ruth Graham, Richard Thomson, Carl May
BMC Medical Informatics and Decision Making , 2007, DOI: 10.1186/1472-6947-7-2
Abstract: A video-based study set in an efficacy trial which compared the use of paper-based guidelines (control) with two forms of computer-based decision aids (implicit and explicit versions of DARTS II). Treatment decision concerned warfarin anti-coagulation to reduce the risk of stroke in older patients with atrial fibrillation. Twenty nine consultations were video-recorded. A ten-minute 'slice' of the consultation was sampled for detailed content analysis using existing interaction analysis protocols for verbal behaviour and ethological techniques for non-verbal behaviour.Median consultation times (quartiles) differed significantly depending on the technology used. Paper-based guidelines took 21 (19–26) minutes to work through compared to 31 (16–41) minutes for the implicit tool; and 44 (39–55) minutes for the explicit tool. In the ten minutes immediately preceding the decision point, GPs dominated the conversation, accounting for 64% (58–66%) of all utterances and this trend was similar across all three arms of the trial. Information-giving was the most frequent activity for both GPs and patients, although GPs did this at twice the rate compared to patients and at higher rates in consultations involving computerised decision aids. GPs' language was highly technically focused and just 7% of their conversation was socio-emotional in content; this was half the socio-emotional content shown by patients (15%). However, frequent head nodding and a close mirroring in the direction of eye-gaze suggested that both parties were active participants in the conversationIrrespective of the arm of the trial, both patients' and GPs' behaviour showed that they were reciprocally engaged in these consultations. However, even in consultations aimed at promoting shared decision-making, GPs' were verbally dominant, and they worked primarily as information providers for patients. In addition, computer-based decision aids significantly prolonged the consultations, particularly the later phases
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