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1.  Developing a theory-based instrument to assess the impact of continuing professional development activities on clinical practice: a study protocol 
Background
Continuing professional development (CPD) is one of the principal means by which health professionals (i.e. primary care physicians and specialists) maintain, improve, and broaden the knowledge and skills required for optimal patient care and safety. However, the lack of a widely accepted instrument to assess the impact of CPD activities on clinical practice thwarts researchers' comparisons of the effectiveness of CPD activities. Using an integrated model for the study of healthcare professionals' behaviour, our objective is to develop a theory-based, valid, reliable global instrument to assess the impact of accredited CPD activities on clinical practice.
Methods
Phase 1: We will analyze the instruments identified in a systematic review of factors influencing health professionals' behaviours using criteria that reflect the literature on measurement development and CPD decision makers' priorities. The outcome of this phase will be an inventory of instruments based on social cognitive theories. Phase 2: Working from this inventory, the most relevant instruments and their related items for assessing the concepts listed in the integrated model will be selected. Through an e-Delphi process, we will verify whether these instruments are acceptable, what aspects need revision, and whether important items are missing and should be added. The outcome of this phase will be a new global instrument integrating the most relevant tools to fit our integrated model of healthcare professionals' behaviour. Phase 3: Two data collections are planned: (1) a test-retest of the new instrument, including item analysis, to assess its reliability and (2) a study using the instrument before and after CPD activities with a randomly selected control group to explore the instrument's mere-measurement effect. Phase 4: We will conduct individual interviews and focus groups with key stakeholders to identify anticipated barriers and enablers for implementing the new instrument in CPD practice. Phase 5: Drawing on the results from the previous phases, we will use consensus-building methods to develop with the decision makers a plan to implement the new instrument.
Discussion
This project proposes to give stakeholders a theory-based global instrument to validly and reliably measure the impacts of CPD activities on clinical practice, thus laying the groundwork for more targeted and effective knowledge-translation interventions in the future.
doi:10.1186/1748-5908-6-17
PMCID: PMC3063813  PMID: 21385369
2.  Perceptions of general practitioners towards the use of a new system for treating back pain: a qualitative interview study 
BMC Medicine  2011;9:49.
Background
Changing clinicians' behaviour is recognised as a major challenge. It is clear that behaviour change not only depends on demonstrating the proven effectiveness of clinical interventions; contextual and occupational factors, such as 'change readiness', may be central to their implementation. This paper highlights the context of behaviour change in relation to a healthcare innovation introduced within primary care, highlighting the importance of organisational and interpersonal factors that may help explain the dynamics of implementation.
Methods
Qualitative interviews were conducted with general practitioners (GPs) before (n = 32) and after (n = 9) the introduction of a subgrouping for targeted treatment system. GPs were offered an electronic six-item subgrouping tool, to identify patients according to their risk of poor outcome ('high', 'low') in order to help inform their decision making about treatment approaches. Recruitment was based on a 'maximum diversification sample', to obtain a wide representation of views across all five practices. A coding scheme was developed based on the emergent findings, and the data were analysed using 'constant comparison', drawing upon insights and developing connections between themes. We adopted the normalisation process theory (NPT) to explain the uptake of the new system and to examine the relevance of coherence for the implementation of innovations in organisations.
Results
GPs perceived back pain as a low clinical priority, and highlighted the importance of 'practical' and 'relational' coherence in decisions to adopt and engage with the new subgrouping for targeted treatment system. Health professionals often engage in 'sense making' about new innovations to 'road test' their applicability or relevance to daily clinical routines. Low back pain was generally perceived as an 'uninteresting' and clinically unchallenging health problem by GPs, which may partly explain their lack of engagement with the new subgrouping for targeted treatment system. The adoption of this new way of working by GPs was determined by the meaning that they ascribed to it in the context of their daily clinical routines.
Conclusions
We conclude that the key obstacle to implementation of the new subgrouping for targeted treatment system for low back pain in primary care was an initial failure to achieve 'coherence' of the desired practice change with GPs. Despite this, GPs used the tool to different degrees, though this signified a general commitment to participating in the study rather than a deeper attitude change towards the new system.
doi:10.1186/1741-7015-9-49
PMCID: PMC3098180  PMID: 21554696
3.  A qualitative systematic review of studies using the normalization process theory to research implementation processes 
Background
There is a well-recognized need for greater use of theory to address research translational gaps. Normalization Process Theory (NPT) provides a set of sociological tools to understand and explain the social processes through which new or modified practices of thinking, enacting, and organizing work are implemented, embedded, and integrated in healthcare and other organizational settings. This review of NPT offers readers the opportunity to observe how, and in what areas, a particular theoretical approach to implementation is being used. In this article we review the literature on NPT in order to understand what interventions NPT is being used to analyze, how NPT is being operationalized, and the reported benefits, if any, of using NPT.
Methods
Using a framework analysis approach, we conducted a qualitative systematic review of peer-reviewed literature using NPT. We searched 12 electronic databases and all citations linked to six key NPT development papers. Grey literature/unpublished studies were not sought. Limitations of English language, healthcare setting and year of publication 2006 to June 2012 were set.
Results
Twenty-nine articles met the inclusion criteria; in the main, NPT is being applied to qualitatively analyze a diverse range of complex interventions, many beyond its original field of e-health and telehealth. The NPT constructs have high stability across settings and, notwithstanding challenges in applying NPT in terms of managing overlaps between constructs, there is evidence that it is a beneficial heuristic device to explain and guide implementation processes.
Conclusions
NPT offers a generalizable framework that can be applied across contexts with opportunities for incremental knowledge gain over time and an explicit framework for analysis, which can explain and potentially shape implementation processes. This is the first review of NPT in use and it generates an impetus for further and extended use of NPT. We recommend that in future NPT research, authors should explicate their rationale for choosing NPT as their theoretical framework and, where possible, involve multiple stakeholders including service users to enable analysis of implementation from a range of perspectives.
doi:10.1186/1748-5908-9-2
PMCID: PMC3905960  PMID: 24383661
Implementation; Policy; Normalization process theory; Theory; Translational gaps
4.  Embedding effective depression care: using theory for primary care organisational and systems change 
Background
Depression and related disorders represent a significant part of general practitioners (GPs) daily work. Implementing the evidence about what works for depression care into routine practice presents a challenge for researchers and service designers. The emerging consensus is that the transfer of efficacious interventions into routine practice is strongly linked to how well the interventions are based upon theory and take into account the contextual factors of the setting into which they are to be transferred. We set out to develop a conceptual framework to guide change and the implementation of best practice depression care in the primary care setting.
Methods
We used a mixed method, observational approach to gather data about routine depression care in a range of primary care settings via: audit of electronic health records; observation of routine clinical care; and structured, facilitated whole of organisation meetings. Audit data were summarised using simple descriptive statistics. Observational data were collected using field notes. Organisational meetings were audio taped and transcribed. All the data sets were grouped, by organisation, and considered as a whole case. Normalisation Process Theory (NPT) was identified as an analytical theory to guide the conceptual framework development.
Results
Five privately owned primary care organisations (general practices) and one community health centre took part over the course of 18 months. We successfully developed a conceptual framework for implementing an effective model of depression care based on the four constructs of NPT: coherence, which proposes that depression work requires the conceptualisation of boundaries of who is depressed and who is not depressed and techniques for dealing with diffuseness; cognitive participation, which proposes that depression work requires engagement with a shared set of techniques that deal with depression as a health problem; collective action, which proposes that agreement is reached about how care is organised; and reflexive monitoring, which proposes that depression work requires agreement about how depression work will be monitored at the patient and practice level. We describe how these constructs can be used to guide the design and implementation of effective depression care in a way that can take account of contextual differences.
Conclusions
Ideas about what is required for an effective model and system of depression care in primary care need to be accompanied by theoretically informed frameworks that consider how these can be implemented. The conceptual framework we have presented can be used to guide organisational and system change to develop common language around each construct between policy makers, service users, professionals, and researchers. This shared understanding across groups is fundamental to the effective implementation of change in primary care for depression.
doi:10.1186/1748-5908-5-62
PMCID: PMC2925331  PMID: 20687962
5.  Implementation of a self-management support approach (WISE) across a health system: a process evaluation explaining what did and did not work for organisations, clinicians and patients 
Background
Implementation of long-term condition management interventions rests on the notion of whole systems re-design, where incorporating wider elements of health care systems are integral to embedding effective and integrated solutions. However, most self-management support (SMS) evaluations still focus on particular elements or outcomes of a sub-system. A randomised controlled trial of a SMS intervention (WISE—Whole System Informing Self-management Engagement) implemented in primary care showed no effect on patient-level outcomes. This paper reports on a parallel process evaluation to ascertain influences affecting WISE implementation at patient, clinical and organisational levels. Normalisation Process Theory (NPT) provided a sensitising background and analytical framework.
Methods
A multi-method approach using surveys and interviews with organisational stakeholders, practice staff and trial participants about impact of training and use of tools developed for WISE. Analysis was sensitised by NPT (coherence, cognitive participation, collective action and reflective monitoring). The aim was to identify what worked and what did not work for who and in what context.
Results
Interviews with organisation stakeholders emphasised top-down initiation of WISE by managers who supported innovation in self-management. Staff from 31 practices indicated engagement with training but patchy adoption of WISE tools; SMS was neither prioritised by practices nor fitted with a biomedically focussed ethos, so little effort was invested in WISE techniques. Interviews with 24 patients indicated no awareness of any changes following the training of practice staff; furthermore, they did not view primary care as an appropriate place for SMS.
Conclusion
The results contribute to understanding why SMS is not routinely adopted and implemented in primary care. WISE was not embedded because of the perceived lack of relevance and fit to the ethos and existing work. Enacting SMS within primary care practice was not viewed as a legitimate activity or a professional priority. There was failure to, in principle, engage with and identify patients’ support needs. Policy presumptions concerning SMS appear to be misplaced. Implementation of SMS within the health service does not currently account for patient circumstances. Primary care priorities and support for SMS could be enhanced if they link to patients’ broader systems of implementation networks and resources.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0129-5) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0129-5
PMCID: PMC4210530  PMID: 25331942
Process evaluation; Normalisation Process Theory; Self-management support; Long-term conditions; Primary care
6.  Normalisation process theory: a framework for developing, evaluating and implementing complex interventions 
BMC Medicine  2010;8:63.
Background
The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation).
Discussion
In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential.
Summary
The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.
doi:10.1186/1741-7015-8-63
PMCID: PMC2978112  PMID: 20961442
7.  Development and Evaluation of a Pedagogical Tool to Improve Understanding of a Quality Checklist: A Randomised Controlled Trial 
PLoS Clinical Trials  2007;2(5):e22.
Objective:
The aim of this study was to develop and evaluate a pedagogical tool to enhance the understanding of a checklist that evaluates reports of nonpharmacological trials (CLEAR NPT).
Design:
Paired randomised controlled trial.
Participants:
Clinicians and systematic reviewers.
Interventions:
We developed an Internet-based computer learning system (ICLS). This pedagogical tool used many examples from published randomised controlled trials to demonstrate the main coding difficulties encountered when using this checklist.
Randomised participants received either a specific Web-based training with the ICLS (intervention group) or no specific training.
Outcome measures:
The primary outcome was the rate of correct answers compared to a criterion standard for coding a report of randomised controlled trials with the CLEAR NPT.
Results:
Between April and June 2006, 78 participants were randomly assigned to receive training with the ICLS (39) or no training (39). Participants trained by the ICLS did not differ from the control group in performance on the CLEAR NPT. The mean paired difference and corresponding 95% confidence interval was 0.5 (−5.1 to 6.1). The rate of correct answers did not differ between the two groups regardless of the CLEAR NPT item. Combining both groups, the rate of correct answers was high or items related to allocation sequence (79.5%), description of the intervention (82.0%), blinding of patients (79.5%), and follow-up schedule (83.3%). The rate of correct answers was low for items related to allocation concealment (46.1%), co-interventions (30.3%), blinding of outcome assessors (53.8%), specific measures to avoid ascertainment bias (28.6%), and intention-to-treat analysis (60.2%).
Conclusions:
Although we showed no difference in effect between the intervention and control groups, our results highlight the gap in knowledge and urgency for education on important aspects of trial conduct.
Editorial Commentary
Background: A key part of the practice of evidence-based medicine (essentially, the appropriate use of current best evidence in determining care of individual patients) involves appraising the quality of individual research papers. This process helps an individual to understand what has been done in a clinical research study, and to decipher the strengths, limitations, and importance of the work. Several tools already exist to help clinicians and researchers to assess the quality of particular types of study, including randomised controlled trials. One of these tools is called CLEAR NPT, which consists of a checklist that helps individuals to evaluate reports of nonpharmacological trials (i.e., trials not evaluating drugs but other types of intervention, such as surgery). The researchers who developed CLEAR NPT also produced an Internet-based computer learning system to help researchers use CLEAR NPT correctly. They wanted to evaluate to what extent this learning system helped people use CLEAR NPT and, therefore, carried out a randomised trial comparing the learning system to no specific training. A total of 78 health researchers were recruited as the “participants” in the trial, and 39 were randomised to each trial arm. Once the participants had received either the Internet training or no specific training, they used CLEAR NPT to evaluate reports of nonpharmacological trials. The primary outcome was the rate of “correct” answers that study participants gave using CLEAR NPT.
What the trial shows: The researchers found that the results on the primary outcome (rate of correct answers given by study participants) did not differ between the study arms. The rate of correct answers for individual items on the checklist also did not seem to differ between individuals receiving Internet training and those receiving no specific training. When looking at the scores for individual items, combined between the two study arms, participants scored highly on their appraisal of some aspects of trial design (such as generation of randomisation sequences and descriptions of blinding and the intervention) but poorly on other items (such as concealment of the randomisation sequence).
Strengths and limitations: Key strengths of this study include the randomised design and that the trial recruited enough participants to test the primary hypothesis. The failure to find a significant difference between study arms in this trial was likely not due to a lack of statistical power. One limitation of the study is that the group of researchers who participated were already fairly experienced in assessing trial quality at the start, and this may explain why no additional effect of the computer-based learning system was seen. It is possible that the training system may have some benefit for individuals who are less experienced in evaluating trials. A further possible limitation may be that there was a small imbalance at randomisation, with slightly more experienced researchers being recruited into the arm receiving no specific training. This imbalance might have underestimated the effect of the training system.
Contribution to the evidence: The researchers here report that this study is the first they are aware of that evaluates a computer-based learning system for improving assessment of the quality of reporting of randomised trials. The results here find that this particular tool did not improve assessment. However, the results emphasise that training should be considered an important part of the development of any critical appraisal tools.
doi:10.1371/journal.pctr.0020022
PMCID: PMC1865084  PMID: 17479163
8.  Enhanced maternal and child health nurse care for women experiencing intimate partner/family violence: protocol for MOVE, a cluster randomised trial of screening and referral in primary health care 
BMC Public Health  2012;12:811.
Background
Intimate partner violence (IPV) can result in significant harm to women and families and is especially prevalent when women are pregnant or recent mothers. Maternal and child health nurses (MCHN) in Victoria, Australia are community-based nurse/midwives who see over 95% of all mothers with newborns. MCHN are in an ideal position to identify and support women experiencing IPV, or refer them to specialist family violence services. Evidence for IPV screening in primary health care is inconclusive to date. The Victorian government recently required nurses to screen all mothers when babies are four weeks old, offering an opportunity to examine the effectiveness of MCHN IPV screening practices. This protocol describes the development and design of MOVE, a study to examine IPV screening effectiveness and the sustainability of screening practice.
Methods/design
MOVE is a cluster randomised trial of a good practice model of MCHN IPV screening involving eight maternal and child health nurse teams in Melbourne, Victoria. Normalisation Process Theory (NPT) was incorporated into the design, implementation and evaluation of the MOVE trial to enhance and evaluate sustainability. Using NPT, the development stage combined participatory action research with intervention nurse teams and a systematic review of nurse IPV studies to develop an intervention model incorporating consensus guidelines, clinical pathway and strategies for individual nurses, their teams and family violence services. Following twelve months’ implementation, primary outcomes assessed include IPV inquiry, IPV disclosure by women and referral using data from MCHN routine data collection and a survey to all women giving birth in the previous eight months. IPV will be measured using the Composite Abuse Scale. Process and impact evaluation data (online surveys and key stakeholders interviews) will highlight NPT concepts to enhance sustainability of IPV identification and referral. Data will be collected again in two years.
Discussion
MOVE will be the first randomised trial to determine IPV screening effectiveness in a community based nurse setting and the first to examine sustainability of an IPV screening intervention. It will further inform the debate about the effectiveness of IPV screening and describe IPV prevalence in a community based post-partum and early infant population.
Trial registration
ACTRN12609000424202
doi:10.1186/1471-2458-12-811
PMCID: PMC3564741  PMID: 22994910
Intimate partner violence; Screening; Cluster randomised controlled trial; Maternal and child health nurse
9.  Exploring implementation and sustainability of models of care: can theory help? 
BMC Public Health  2011;11(Suppl 5):S8.
Objective
Research on new models of care in health service provision is complex, as is the introduction and embedding of such models, and positive research findings are only one factor in whether a new model of care will be implemented. In order to understand why this is the case, research design must not only take account of proposed changes in the clinical encounter, but the organisational context that must sustain and normalise any changed practices. We use two case studies where new models of maternity care were implemented and evaluated via randomised controlled trials (RCTs) to discuss how (or whether) the use of theory might inform implementation and sustainability strategies. The Normalisation Process Model is proposed as a suitable theoretical framework, and a comparison made using the two case studies – one where a theoretical framework was used, the other where it was not.
Context and approach
In the maternity sector there is considerable debate about which model of care provides the best outcomes for women, while being sustainable in the organisational setting. We explore why a model of maternity care – team midwifery (where women have a small group of midwives providing their care) – that was implemented and tested in an RCT was not continued after the RCT’s conclusion, despite showing the same or better outcomes for women in the intervention group compared with women allocated to usual care. We then discuss the conceptualisation and rationale leading to the use of the ‘Normalisation Process Model' as an aid to exploring aspects of implementation of a caseload midwifery model (where women are allocated a primary midwife for their care) that has recently been evaluated by RCT.
Discussion
We demonstrate how the Normalisation Process Model was applied in planning of the evaluation phases of the RCT as a means of exploring the implementation of the caseload model of care. We argue that a theoretical understanding of issues related to implementation and sustainability can make a valuable contribution when researching complex interventions in complex settings such as hospitals.
Conclusion and implications
Application of a theoretical model in the research of a complex intervention enables a greater understanding of the organisational context into which new models of care are introduced and identification of factors that promote or challenge implementation of these models of care.
doi:10.1186/1471-2458-11-S5-S8
PMCID: PMC3247031  PMID: 22168585
10.  Implementing a stepped-care approach in primary care: results of a qualitative study 
Background
Since 2004, 'stepped-care models' have been adopted in several international evidence-based clinical guidelines to guide clinicians in the organisation of depression care. To enhance the adoption of this new treatment approach, a Quality Improvement Collaborative (QIC) was initiated in the Netherlands.
Methods
Alongside the QIC, an intervention study using a controlled before-and-after design was performed. Part of the study was a process evaluation, utilizing semi-structured group interviews, to provide insight into the perceptions of the participating clinicians on the implementation of stepped care for depression into their daily routines. Participants were primary care clinicians, specialist clinicians, and other healthcare staff from eight regions in the Netherlands. Analysis was supported by the Normalisation Process Theory (NPT).
Results
The introduction of a stepped-care model for depression to primary care teams within the context of a depression QIC was generally well received by participating clinicians. All three elements of the proposed stepped-care model (patient differentiation, stepped-care treatment, and outcome monitoring), were translated and introduced locally. Clinicians reported changes in terms of learning how to differentiate between patient groups and different levels of care, changing antidepressant prescribing routines as a consequence of having a broader treatment package to offer to their patients, and better working relationships with patients and colleagues. A complex range of factors influenced the implementation process. Facilitating factors were the stepped-care model itself, the structured team meetings (part of the QIC method), and the positive reaction from patients to stepped care. The differing views of depression and depression care within multidisciplinary health teams, lack of resources, and poor information systems hindered the rapid introduction of the stepped-care model. The NPT constructs 'coherence' and 'cognitive participation' appeared to be crucial drivers in the initial stage of the process.
Conclusions
Stepped care for depression is received positively in primary care. While it is difficult for the implementation of a full stepped-care approach to occur within a short time frame, clinicians can make progress towards achieving a stepped-care approach, particularly within the context of a QIC. Creating a shared understanding within multidisciplinary teams of what constitutes depression, reaching a consensus about the content of depression care, and the division of tasks are important when addressing the implementation process.
doi:10.1186/1748-5908-7-8
PMCID: PMC3292960  PMID: 22293362
11.  German translation of the Alberta context tool and two measures of research use: methods, challenges and lessons learned 
Background
Understanding the relationship between organizational context and research utilization is key to reducing the research-practice gap in health care. This is particularly true in the residential long term care (LTC) setting where relatively little work has examined the influence of context on research implementation. Reliable, valid measures and tools are a prerequisite for studying organizational context and research utilization. Few such tools exist in German. We thus translated three such tools (the Alberta Context Tool and two measures of research use) into German for use in German residential LTC. We point out challenges and strategies for their solution unique to German residential LTC, and demonstrate how resolving specific challenges in the translation of the health care aide instrument version streamlined the translation process of versions for registered nurses, allied health providers, practice specialists, and managers.
Methods
Our translation methods were based on best practices and included two independent forward translations, reconciliation of the forward translations, expert panel discussions, two independent back translations, reconciliation of the back translations, back translation review, and cognitive debriefing.
Results
We categorized the challenges in this translation process into seven categories: (1) differing professional education of Canadian and German care providers, (2) risk that German translations would become grammatically complex, (3) wordings at risk of being misunderstood, (4) phrases/idioms non-existent in German, (5) lack of corresponding German words, (6) limited comprehensibility of corresponding German words, and (7) target persons’ unfamiliarity with activities detailed in survey items. Examples of each challenge are described with strategies that we used to manage the challenge.
Conclusion
Translating an existing instrument is complex and time-consuming, but a rigorous approach is necessary to obtain instrument equivalence. Essential components were (1) involvement of and co-operation with the instrument developers and (2) expert panel discussions, including both target group and content experts. Equivalent translated instruments help researchers from different cultures to find a common language and undertake comparative research. As acceptable psychometric properties are a prerequisite for that, we are currently carrying out a study with that focus.
doi:10.1186/1472-6963-13-478
PMCID: PMC3893410  PMID: 24238613
Translation; Cultural adaptation; Alberta Context Tool; Estabrooks’ Kind of Research Utilization; Conceptual Research Use scale; Organizational context; Research utilization; Residential long term care
12.  Assessing the quality of healthcare provided to children. 
Health Services Research  1998;33(4 Pt 2):1059-1090.
OBJECTIVE: To present a conceptual framework for evaluating quality of care for children and adolescents, summarize the key issues related to developing measures to assess pediatric quality of care, examine some existing measures, and present evidence about their current level of performance. PRINCIPAL FINDINGS: Assessing the quality of care for children poses many challenges not encountered when making these measurements in the adult population. Children and adolescents (from this point forward referred to collectively as children unless differentiation is necessary) differ from adults in two clinically important ways (Jameson and Wehr 1993): (1) their normal developmental trajectory is characterized by change, and (2) they have differential morbidity. These factors contribute to the limitations encountered when developing measures to assess the quality of care for children. The movement of a child through the various stages of development makes it difficult to establish what constitutes a "normal" outcome and by extension what constitutes a poor outcome. Additionally, salient developmental outcomes that result from poor quality of care may not be observed for several years. This implies that poor outcomes may be observed when the child is receiving care from a delivery system other than the one that provided the low-quality care. Attributing the suboptimal outcome to the new delivery system would be inappropriate. Differential morbidity refers to the fact that the type, prevalence, and severity of illness experienced by children is measurably different from that observed in adults. Most children experience numerous self-limited illness of mild severity. A minority of children suffer from markedly more severe diseases. Thus, condition-specific measures in children are problematic to implement for routine assessments because of the extremely low incidence and prevalence of most severe pediatric diseases (Halfon 1996). However, children with these conditions are potentially the segment of the pediatric population that can be most affected by variations in the quality of care. Improving the care provided to these children is likely to have the largest impact on quality of life and longevity. The low prevalence of most severe pediatric diseases also makes it difficult to evaluate the effectiveness of new treatment modalities; multi-center trials or long enrollment periods are usually required to obtain a large enough patient sample to conduct the necessary randomized controlled trials or cohort studies. Another challenge encountered when measuring quality of care for children is that, in most cases, they depend on adults to both obtain care and to report on the outcomes of that care. Parents and their children may have different perceptions of what defines health or have different levels of satisfaction with the care they receive. Children, particularly those with special needs, also depend on a broad range of services including the medical system, community intervention programs, social programs, and school-based services. Dependency on these various services adds to the difficulty of measuring and appropriately attributing health outcomes observed in children to a particular service delivery entity. Adolescents also depend on adults for access to some of their care; however, they have special needs related to confidentiality and parent-child information sharing. Adolescents commonly seek care at facilities, such as school-based clinics, that allow them to obtain confidential care. These facilities usually provide out-of-health plan care for these children, which raises special issues related to information availability for quality assessments and for assessing utilization patterns in this population. If the source of poor health outcomes is not known, quality improvement is not possible. The many challenges faced when constructing pediatric (this term will be used to refer to both children and adolescents) quality of care measures have resulted in few of these instruments being developed specifically for children. Most of the measures developed to date have either a very limited pediatric component or still require the process or outcome validation step. Although several practice guidelines and indicators of quality have been constructed, a conceptual framework to guide the development of such tools for quality assessment in the pediatric population is lacking. CONCLUSIONS. Pediatric health services researchers and the organizations that fund this work need to focus on developing a set of quality assessment tools that will address several challenging issues. Working within the context of the conceptual framework presented, we draw several conclusions related to issues that should be considered in developing quality of care measures for children.
PMCID: PMC1070304  PMID: 9776949
13.  Aligning everyday life priorities with people’s self-management support networks: an exploration of the work and implementation of a needs-led telephone support system 
Background
Recent initiatives to target the personal, social and clinical needs of people with long-term health conditions have had limited impact within primary care. Evidence of the importance of social networks to support people with long-term conditions points to the need for self-management approaches which align personal circumstances with valued activities. The Patient-Led Assessment for Network Support (PLANS) intervention is a needs-led assessment for patients to prioritise their health and social needs and provide access to local community services and activities. Exploring the work and practices of patients and telephone workers are important for understanding and evaluating the workability and implementation of new interventions.
Methods
Qualitative methods (interviews, focus group, observations) were used to explore the experience of PLANS from the perspectives of participants and the telephone support workers who delivered it (as part of an RCT) and the reasons why the intervention worked or not. Normalisation Process Theory (NPT) was used as a sensitising tool to evaluate: the relevance of PLANS to patients (coherence); the processes of engagement (cognitive participation); the work done for PLANS to happen (collective action); the perceived benefits and costs of PLANS (reflexive monitoring). 20 patients in the intervention arm of a clinical trial were interviewed and their telephone support calls were recorded and a focus group with 3 telephone support workers was conducted.
Results
Analysis of the interviews, support calls and focus group identified three themes in relation to the delivery and experience of PLANS. These are: formulation of ‘health’ in the context of everyday life; trajectories and tipping points: disrupting everyday routines; precarious trust in networks. The relevance of these themes are considered using NPT constructs in terms of the work that is entailed in engaging with PLANS, taking action, and who is implicated this process.
Conclusions
PLANS gives scope to align long-term condition management to everyday life priorities and valued aspects of life. This approach can improve engagement with health-relevant practices by situating them within everyday contexts. This has potential to increase utilisation of local resources with potential cost-saving benefits for the NHS.
Trial registration
ISRCTN45433299.
doi:10.1186/1472-6963-14-262
PMCID: PMC4071856  PMID: 24938492
Vascular disease; Self-management; Long-term conditions; Normalization process theory; Randomized controlled trial; Inequalities; Social networks; Social prescribing; Chronic kidney disease; Asset-based community development
14.  Translating and testing the Alberta context tool for use among nurses in Swedish elder care 
Background
There is emerging evidence that context is important for successful transfer of research knowledge into health care practice. The Alberta Context Tool (ACT) is a Canadian developed research-based instrument that assesses 10 modifiable concepts of organizational context considered important for health care professionals’ use of evidence. Swedish and Canadian health care have similarities in terms of organisational and professional aspects, suggesting that the ACT could be used for measuring context in Sweden. This paper reports on the translation of the ACT to Swedish and a testing of preliminary aspects of its validity, acceptability and reliability in Swedish elder care.
Methods
The ACT was translated into Swedish and back-translated into English before being pilot tested in ten elder care facilities for response processes validity, acceptability and reliability (Cronbach’s alpha). Subsequently, further modification was performed.
Results
In the pilot test, the nurses found the questions easy to respond to (52%) and relevant (65%), yet the questions’ clarity were mainly considered ‘neither clear nor unclear’ (52%). Missing data varied between 0 (0%) and 19 (12%) per item, the most common being 1 missing case per item (15 items). Internal consistency (Cronbach’s Alpha > .70) was reached for 5 out of 8 contextual concepts. Translation and back translation identified 21 linguistic- and semantic related issues and 3 context related deviations, resolved by developers and translators.
Conclusion
Modifying an instrument is a detailed process, requiring time and consideration of the linguistic and semantic aspects of the instrument, and understanding of the context where the instrument was developed and where it is to be applied. A team, including the instrument’s developers, translators, and researchers is necessary to ensure a valid translation. This study suggests preliminary validity, reliability and acceptability evidence for the ACT when used with nurses in Swedish elder care.
doi:10.1186/1472-6963-13-68
PMCID: PMC3599200  PMID: 23421736
Questionnaire; Translation; Validity; Health care context; Research utilization; Nursing
15.  Measuring organizational and individual factors thought to influence the success of quality improvement in primary care: a systematic review of instruments 
Background
Continuous quality improvement (CQI) methods are widely used in healthcare; however, the effectiveness of the methods is variable, and evidence about the extent to which contextual and other factors modify effects is limited. Investigating the relationship between these factors and CQI outcomes poses challenges for those evaluating CQI, among the most complex of which relate to the measurement of modifying factors. We aimed to provide guidance to support the selection of measurement instruments by systematically collating, categorising, and reviewing quantitative self-report instruments.
Methods
Data sources: We searched MEDLINE, PsycINFO, and Health and Psychosocial Instruments, reference lists of systematic reviews, and citations and references of the main report of instruments. Study selection: The scope of the review was determined by a conceptual framework developed to capture factors relevant to evaluating CQI in primary care (the InQuIRe framework). Papers reporting development or use of an instrument measuring a construct encompassed by the framework were included. Data extracted included instrument purpose; theoretical basis, constructs measured and definitions; development methods and assessment of measurement properties. Analysis and synthesis: We used qualitative analysis of instrument content and our initial framework to develop a taxonomy for summarising and comparing instruments. Instrument content was categorised using the taxonomy, illustrating coverage of the InQuIRe framework. Methods of development and evidence of measurement properties were reviewed for instruments with potential for use in primary care.
Results
We identified 186 potentially relevant instruments, 152 of which were analysed to develop the taxonomy. Eighty-four instruments measured constructs relevant to primary care, with content measuring CQI implementation and use (19 instruments), organizational context (51 instruments), and individual factors (21 instruments). Forty-one instruments were included for full review. Development methods were often pragmatic, rather than systematic and theory-based, and evidence supporting measurement properties was limited.
Conclusions
Many instruments are available for evaluating CQI, but most require further use and testing to establish their measurement properties. Further development and use of these measures in evaluations should increase the contribution made by individual studies to our understanding of CQI and enhance our ability to synthesise evidence for informing policy and practice.
doi:10.1186/1748-5908-7-121
PMCID: PMC3573896  PMID: 23241168
Continuous quality improvement; Primary care; Evaluation; Systematic review; Measurement; Instrument; Conceptual framework; Theoretical model; Intervention fidelity; Organizational context
16.  The Role of Health Systems Factors in Facilitating Access to Psychotropic Medicines: A Cross-Sectional Analysis of the WHO-AIMS in 63 Low- and Middle-Income Countries 
PLoS Medicine  2012;9(1):e1001166.
In a cross-sectional analysis of WHO-AIMS data, Ryan McBain and colleagues investigate the associations between health system components and access to psychotropic drugs in 63 low and middle income countries.
Background
Neuropsychiatric conditions comprise 14% of the global burden of disease and 30% of all noncommunicable disease. Despite the existence of cost-effective interventions, including administration of psychotropic medicines, the number of persons who remain untreated is as high as 85% in low- and middle-income countries (LAMICs). While access to psychotropic medicines varies substantially across countries, no studies to date have empirically investigated potential health systems factors underlying this issue.
Methods and Findings
This study uses a cross-sectional sample of 63 LAMICs and country regions to identify key health systems components associated with access to psychotropic medicines. Data from countries that completed the World Health Organization Assessment Instrument for Mental Health Systems (WHO-AIMS) were included in multiple regression analyses to investigate the role of five major mental health systems domains in shaping medicine availability and affordability. These domains are: mental health legislation, human rights implementations, mental health care financing, human resources, and the role of advocacy groups. Availability of psychotropic medicines was associated with features of all five mental health systems domains. Most notably, within the domain of mental health legislation, a comprehensive national mental health plan was associated with 15% greater availability; and in terms of advocacy groups, the participation of family-based organizations in the development of mental health legislation was associated with 17% greater availability. Only three measures were related with affordability of medicines to consumers: level of human resources, percentage of countries' health budget dedicated to mental health, and availability of mental health care in prisons. Controlling for country development, as measured by the Human Development Index, health systems features were associated with medicine availability but not affordability.
Conclusions
Results suggest that strengthening particular facets of mental health systems might improve availability of psychotropic medicines and that overall country development is associated with affordability.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Mental disorders—conditions that involve impairment of thinking, emotions, and behavior—are extremely common. Worldwide, mental illness affects about 450 million people and accounts for 13.5% of the global burden of disease. About one in four people will have a mental health problem at some time in their life. For some people, this will be a short period of mild depression, anxiety, or stress. For others, it will be a serious, long-lasting condition such as schizophrenia, bipolar disorder, or major depression. People with mental health problems need help and support from professionals and from their friends and families to help them cope with their illness but are often discriminated against, which can make their illness worse. Treatments include counseling and psychotherapy (talking therapies), and psychotropic medicines—drugs that act mainly on the brain. Left untreated, many people with serious mental illnesses commit suicide.
Why Was This Study Done?
About 80% of people with mental illnesses live in low- and middle-income countries (LAMICs) where up to 85% of patients remain untreated. Access to psychotropic medicines, which constitute an essential and cost-effective component in the treatment of mental illnesses, is particularly poor in many LAMICs. To improve this situation, it is necessary to understand what health systems factors limit the availability and affordability of psychotropic drugs; a health system is the sum of all the organizations, institutions, and resources that act together to improve health. In this cross-sectional study, the researchers look for associations between specific health system components and access to psychotropic medicines by analyzing data collected from LAMICs using the World Health Organization's Assessment Instrument for Mental Health Systems (WHO-AIMS). A cross-sectional study analyzes data collected at a single time. WHO-AIMS, which was created to evaluate mental health systems primarily in LAMICs, is a 155-item survey that Ministries of Health and other country-based agencies can use to collect information on mental health indicators.
What Did the Researchers Do and Find?
The researchers used WHO-AIMS data from 63 countries/country regions and multiple regression analysis to evaluate the role of mental health legislation, human rights implementation, mental health care financing, human resources, and advocacy in shaping medicine availability and affordability. For each of these health systems domains, the researchers developed one or more summary measurements. For example, they measured financing as the percentage of government health expenditure directed toward mental health. Availability of psychotropic medicines was defined as the percentage of mental health facilities in which at least one psychotropic medication for each therapeutic category was always available. Affordability was measured by calculating the percentage of daily minimum wage needed to purchase medicine by the average consumer. The availability of psychotropic medicines was related to features of all five mental health systems domains, report the researchers. Notably, having a national mental health plan (part of the legislation domain) and the participation (advocacy) of family-based organizations in mental health legislation formulation were associated with 15% and 17% greater availability of medicines, respectively. By contrast, only the levels of human resources and financing, and the availability of mental health care in prisons (part of the human rights domain) were associated with the affordability of psychotropic medicines. Once overall country development was taken into account, most of the associations between health systems factors and medicine availability remained significant, while the associations between health systems factors and medicine affordability were no longer significant. In part, this was because country development was more strongly associated with affordability and explained most of the relationships: for example, countries with greater overall development have higher expenditures on mental health and greater medicine affordability compared to availability.
What Do These Findings Mean?
These findings indicate that access to psychotropic medicines in LAMICs is related to key components within the mental health systems of these countries but that availability and affordability are affected to different extents by these components. They also show that country development plays a strong role in determining affordability but has less effect on determining availability. Because cross-sectional data were used in this study, these findings only indicate associations; they do not imply causality. They are also limited by the relatively small number of observations included in this study, by the methods used to collect mental health systems data in many LAMICs, and by the possibility that some countries may have reported biased results. Despite these limitations, these findings suggest that strengthening specific mental health system features may be an important way to facilitate access to psychotropic medicines but also highlight the role that country wealth and development play in promoting the treatment of mental disorders.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/ 10.1371/journal.pmed.1001166.
The US National Institute of Mental Health provides information on all aspects of mental health (in English and Spanish)
The UK National Health Service Choices website provides information on mental health; its Live Well feature provides practical advice on dealing with mental health problems and personal stories
The UK charity Mind provides further information about mental illness, including personal stories
MedlinePlus provides links to many other sources of information on mental health (in English and Spanish)
Information on WHO-AIMS, including versions of the instrument in several languages, and WHO-AIMS country reports are available
doi:10.1371/journal.pmed.1001166
PMCID: PMC3269418  PMID: 22303288
17.  A formative evaluation of the implementation of an upper limb stroke rehabilitation intervention in clinical practice: a qualitative interview study 
Background
The Graded Repetitive Arm Supplementary Program (GRASP) is a hand and arm exercise programme designed to increase the intensity of exercise achieved in inpatient stroke rehabilitation. GRASP was shown to be effective in a randomised controlled trial in 2009 and has since experienced unusually rapid uptake into clinical practice. The aim of this study was to conduct a formative evaluation of the implementation of GRASP to inform the development and implementation of a similar intervention in the United Kingdom.
Methods
Semi-structured interviews were conducted with therapists who were involved in implementing GRASP at their work site, or who had experience of using GRASP. Normalisation Process Theory (NPT), a sociological theory used to explore the processes of embedding innovations in practice, was used to develop an interview guide. Intervention components outlined within the GRASP Guideline Manual were used to develop prompts to explore how therapists use GRASP in practice. Interview transcripts were analysed using a coding frame based on implementation theory.
Results
Twenty interviews were conducted across eight sites in British Columbia Canada. Therapists identified informal networks and the free online availability of GRASP as key factors in finding out about the intervention. All therapists reported positive opinions about the value of GRASP. At all sites, therapists identified individuals who advocated for the use of GRASP, and in six of the eight sites this was the practice leader or senior therapist. Rehabilitation assistants were identified as instrumental in delivering GRASP in almost all sites as they were responsible for organising the GRASP equipment and assisting patients using GRASP. Almost all intervention components were found to be adapted to some degree when used in clinical practice; coverage was wider, the content adapted, and the dose, when monitored, was less.
Conclusions
Although GRASP has translated into clinical practice, it is not always used in the way in which it was shown to be effective. This formative evaluation has informed the development of a novel intervention which aims to bridge this evidence-practice gap in upper limb rehabilitation after stroke.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0090-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0090-3
PMCID: PMC4156624  PMID: 25112430
18.  Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges 
Background
The PARiHS framework (Promoting Action on Research Implementation in Health Services) has proved to be a useful practical and conceptual heuristic for many researchers and practitioners in framing their research or knowledge translation endeavours. However, as a conceptual framework it still remains untested and therefore its contribution to the overall development and testing of theory in the field of implementation science is largely unquantified.
Discussion
This being the case, the paper provides an integrated summary of our conceptual and theoretical thinking so far and introduces a typology (derived from social policy analysis) used to distinguish between the terms conceptual framework, theory and model – important definitional and conceptual issues in trying to refine theoretical and methodological approaches to knowledge translation.
Secondly, the paper describes the next phase of our work, in particular concentrating on the conceptual thinking and mapping that has led to the generation of the hypothesis that the PARiHS framework is best utilised as a two-stage process: as a preliminary (diagnostic and evaluative) measure of the elements and sub-elements of evidence (E) and context (C), and then using the aggregated data from these measures to determine the most appropriate facilitation method. The exact nature of the intervention is thus determined by the specific actors in the specific context at a specific time and place.
In the process of refining this next phase of our work, we have had to consider the wider issues around the use of theories to inform and shape our research activity; the ongoing challenges of developing robust and sensitive measures; facilitation as an intervention for getting research into practice; and finally to note how the current debates around evidence into practice are adopting wider notions that fit innovations more generally.
Summary
The paper concludes by suggesting that the future direction of the work on the PARiHS framework is to develop a two-stage diagnostic and evaluative approach, where the intervention is shaped and moulded by the information gathered about the specific situation and from participating stakeholders. In order to expedite the generation of new evidence and testing of emerging theories, we suggest the formation of an international research implementation science collaborative that can systematically collect and analyse experiences of using and testing the PARiHS framework and similar conceptual and theoretical approaches.
We also recommend further refinement of the definitions around conceptual framework, theory, and model, suggesting a wider discussion that embraces multiple epistemological and ontological perspectives.
doi:10.1186/1748-5908-3-1
PMCID: PMC2235887  PMID: 18179688
19.  The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview 
PLoS Medicine  2011;8(1):e1000387.
Aziz Sheikh and colleagues report the findings of their systematic overview that assessed the impact of eHealth solutions on the quality and safety of health care.
Background
There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.
Methods and Findings
We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.
Conclusions
There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given. In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
There is considerable international interest in exploiting the potential of digital health care solutions, often referred to as eHealth—the use of information and communication technologies—to enhance the quality and safety of health care. Often accompanied by large costs, any large-scale expenditure on eHealth—such as electronic health records, picture archiving and communication systems, ePrescribing, associated computerized provider order entry systems, and computerized decision support systems—has tended to be justified on the grounds that these are efficient and cost-effective means for improving health care. In 2005, the World Health Assembly passed an eHealth resolution (WHA 58.28) that acknowledged, “eHealth is the cost-effective and secure use of information and communications technologies in support of health and health-related fields, including health-care services, health surveillance, health literature, and health education, knowledge and research,” and urged member states to develop and implement eHealth technologies. Since then, implementing eHealth technologies has become a main priority for many countries. For example, England has invested at least £12.8 billion in a National Programme for Information Technology for the National Health Service, and the Obama administration in the United States has committed to a US$38 billion eHealth investment in health care.
Why Was This Study Done?
Despite the wide endorsement of and support for eHealth, the scientific basis of its benefits—which are repeatedly made and often uncritically accepted—remains to be firmly established. A robust evidence-based perspective on the advantages on eHealth could help to suggest priority areas that have the greatest potential for benefit to patients and also to inform international eHealth deliberations on costs. Therefore, in order to better inform the international community, the authors systematically reviewed the published systematic review literature on eHealth technologies and evaluated the impact of these technologies on the quality and safety of health care delivery.
What Did the Researchers Do and Find?
The researchers divided eHealth technologies into three main categories: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. Then, implementing methods based on those developed by the Cochrane Collaboration and the NHS Service Delivery and Organisation Programme, the researchers used detailed search strategies and maps of health care quality, safety, and eHealth interventions to identify relevant systematic reviews (and related theoretical, methodological, and technical material) published between 1997 and 2010. Using these techniques, the researchers retrieved a total of 46,349 references from which they identified 108 reviews. The 53 reviews that the researchers finally selected (and critically reviewed) provided the main evidence base for assessing the impact of eHealth technologies in the three categories selected.
In their systematic review of systematic reviews, the researchers included electronic health records and picture archiving communications systems in their evaluation of category 1, computerized provider (or physician) order entry and e-prescribing in category 2, and all clinical information systems that, when used in the context of eHealth technologies, integrate clinical and demographic patient information to support clinician decision making in category 3.
The researchers found that many of the clinical claims made about the most commonly used eHealth technologies were not substantiated by empirical evidence. The evidence base in support of eHealth technologies was weak and inconsistent and importantly, there was insubstantial evidence to support the cost-effectiveness of these technologies. For example, the researchers only found limited evidence that some of the many presumed benefits could be realized; importantly, they also found some evidence that introducing these new technologies may on occasions also generate new risks such as prescribers becoming over-reliant on clinical decision support for e-prescribing, or overestimate its functionality, resulting in decreased practitioner performance.
What Do These Findings Mean?
The researchers found that despite the wide support for eHealth technologies and the frequently made claims by policy makers when constructing business cases to raise funds for large-scale eHealth projects, there is as yet relatively little empirical evidence to substantiate many of the claims made about eHealth technologies. In addition, even for the eHealth technology tools that have proven to be successful, there is little evidence to show that such tools would continue to be successful beyond the contexts in which they were originally developed. Therefore, in light of the lack of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, the authors say that future eHealth technologies should be evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle, and include socio-technical factors to maximize the likelihood of successful implementation and adoption in a given context. Furthermore, it is equally important that eHealth projects that have already been commissioned are subject to rigorous, multidisciplinary, and independent evaluation.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000387.
The authors' broader study is: Car J, Black A, Anandan C, Cresswell K, Pagliari C, McKinstry B, et al. (2008) The Impact of eHealth on the Quality and Safety of Healthcare. Available at: http://www.haps.bham.ac.uk/publichealth/cfhep/001.shtml
More information is available on the World Health Assembly eHealth resolution
The World Health Organization provides information at the Global Observatory on eHealth, as well as a global insight into eHealth developments
The European Commission provides Information on eHealth in Europe and some examples of good eHealth practice
More information is provided on NHS Connecting for Health
doi:10.1371/journal.pmed.1000387
PMCID: PMC3022523  PMID: 21267058
20.  A framework and a measurement instrument for sustainability of work practices in long-term care 
Background
In health care, many organizations are working on quality improvement and/or innovation of their care practices. Although the effectiveness of improvement processes has been studied extensively, little attention has been given to sustainability of the changed work practices after implementation. The objective of this study is to develop a theoretical framework and measurement instrument for sustainability. To this end sustainability is conceptualized with two dimensions: routinization and institutionalization.
Methods
The exploratory methodological design consisted of three phases: a) framework development; b) instrument development; and c) field testing in former improvement teams in a quality improvement program for health care (N teams = 63, N individual = 112). Data were collected not until at least one year had passed after implementation.
Underlying constructs and their interrelations were explored using Structural Equation Modeling and Principal Component Analyses. Internal consistency was computed with Cronbach's alpha coefficient. A long and a short version of the instrument are proposed.
Results
The χ2- difference test of the -2 Log Likelihood estimates demonstrated that the hierarchical two factor model with routinization and institutionalization as separate constructs showed a better fit than the one factor model (p < .01). Secondly, construct validity of the instrument was strong as indicated by the high factor loadings of the items. Finally, the internal consistency of the subscales was good.
Conclusions
The theoretical framework offers a valuable starting point for the analysis of sustainability on the level of actual changed work practices. Even though the two dimensions routinization and institutionalization are related, they are clearly distinguishable and each has distinct value in the discussion of sustainability. Finally, the subscales conformed to psychometric properties defined in literature. The instrument can be used in the evaluation of improvement projects.
doi:10.1186/1472-6963-11-314
PMCID: PMC3234291  PMID: 22087884
21.  The applicability of normalisation process theory to speech and language therapy: a review of qualitative research on a speech and language intervention 
Background
The Bercow review found a high level of public dissatisfaction with speech and language services for children. Children with speech, language, and communication needs (SLCN) often have chronic complex conditions that require provision from health, education, and community services. Speech and language therapists are a small group of Allied Health Professionals with a specialist skill-set that equips them to work with children with SLCN. They work within and across the diverse range of public service providers. The aim of this review was to explore the applicability of Normalisation Process Theory (NPT) to the case of speech and language therapy.
Methods
A review of qualitative research on a successfully embedded speech and language therapy intervention was undertaken to test the applicability of NPT. The review focused on two of the collective action elements of NPT (relational integration and interaction workability) using all previously published qualitative data from both parents and practitioners' perspectives on the intervention.
Results
The synthesis of the data based on the Normalisation Process Model (NPM) uncovered strengths in the interpersonal processes between the practitioners and parents, and weaknesses in how the accountability of the intervention is distributed in the health system.
Conclusions
The analysis based on the NPM uncovered interpersonal processes between the practitioners and parents that were likely to have given rise to successful implementation of the intervention. In previous qualitative research on this intervention where the Medical Research Council's guidance on developing a design for a complex intervention had been used as a framework, the interpersonal work within the intervention had emerged as a barrier to implementation of the intervention. It is suggested that the design of services for children and families needs to extend beyond the consideration of benefits and barriers to embrace the social processes that appear to afford success in embedding innovation in healthcare.
doi:10.1186/1748-5908-6-95
PMCID: PMC3169488  PMID: 21838911
22.  Collaborations for Leadership in Applied Health Research and Care: lessons from the theory of communities of practice 
Background
The paper combines the analytical and instrumental perspectives on communities of practice (CoPs) to reflect on potential challenges that may arise in the process of interprofessional and inter-organisational joint working within the Collaborations for Leaderships in Applied Health Research and Care (CLAHRCs)--partnerships between the universities and National Health Service (NHS) Trusts aimed at conducting applied health research and translating its findings into day-to-day clinical practice.
Discussion
The paper discusses seminal theoretical literature on CoPs as well as previous empirical research on the role of these communities in healthcare collaboration, which is organised around the following three themes: knowledge sharing within and across CoPs, CoP formation and manageability, and identity building in CoPs. It argues that the multiprofessional and multi-agency nature of the CLAHRCs operating in the traditionally demarcated organisational landscape of the NHS may present formidable obstacles to knowledge sharing between various professional groupings, formation of a shared 'collaborative' identity, and the development of new communities within the CLAHRCs. To cross multiple boundaries between various professional and organisational communities and hence enable the flow of knowledge, the CLAHRCs will have to create an effective system of 'bridges' involving knowledge brokers, boundary objects, and cross-disciplinary interactions as well as address a number of issues related to professional and organisational identification.
Summary
The CoP approach can complement traditional 'stage-of-change' theories used in the field of implementation research and provide a basis for designing theory-informed interventions and evaluations. It can help to illuminate multiple boundaries that exist between professional and organisational groups within the CLAHRCs and suggest ways of crossing those boundaries to enable knowledge transfer and organisational learning. Achieving the aims of the CLAHRCs and producing a sustainable change in the ways applied health research is conducted and implemented may be influenced by how effectively these organisations can navigate through the multiple CoPs involved and promote the development of new multiprofessional and multi-organisational communities united by shared practice and a shared sense of belonging--an assumption that needs to be explored by further empirical research.
doi:10.1186/1748-5908-6-64
PMCID: PMC3130688  PMID: 21699712
23.  Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science 
Background
Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts.
Methods
We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts.
Results
The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct.
Conclusion
The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.
doi:10.1186/1748-5908-4-50
PMCID: PMC2736161  PMID: 19664226
24.  Professional Uncertainty and Disempowerment Responding to Ethnic Diversity in Health Care: A Qualitative Study 
PLoS Medicine  2007;4(11):e323.
Background
While ethnic disparities in health and health care are increasing, evidence on how to enhance quality of care and reduce inequalities remains limited. Despite growth in the scope and application of guidelines on “cultural competence,” remarkably little is known about how practising health professionals experience and perceive their work with patients from diverse ethnic communities. Using cancer care as a clinical context, we aimed to explore this with a range of health professionals to inform interventions to enhance quality of care.
Methods and Findings
We conducted a qualitative study involving 18 focus groups with a purposeful sample of 106 health professionals of differing disciplines, in primary and secondary care settings, working with patient populations of varying ethnic diversity in the Midlands of the UK. Data were analysed by constant comparison and we undertook processes for validation of analysis. We found that, as they sought to offer appropriate care, health professionals wrestled with considerable uncertainty and apprehension in responding to the needs of patients of ethnicities different from their own. They emphasised their perceived ignorance about cultural difference and were anxious about being culturally inappropriate, causing affront, or appearing discriminatory or racist. Professionals' ability to think and act flexibly or creatively faltered. Although trying to do their best, professionals' uncertainty was disempowering, creating a disabling hesitancy and inertia in their practice. Most professionals sought and applied a knowledge-based cultural expertise approach to patients, though some identified the risk of engendering stereotypical expectations of patients. Professionals' uncertainty and disempowerment had the potential to perpetuate each other, to the detriment of patient care.
Conclusions
This study suggests potential mechanisms by which health professionals may inadvertently contribute to ethnic disparities in health care. It identifies critical opportunities to empower health professionals to respond more effectively. Interventions should help professionals acknowledge their uncertainty and its potential to create inertia in their practice. A shift away from a cultural expertise model toward a greater focus on each patient as an individual may help.
From a qualitative study, Joe Kai and colleagues have identified opportunities to empower health professionals to respond more effectively to challenges in their work with patients from diverse ethnic communities.
Editors' Summary
Background.
Communities are increasingly diverse in terms of ethnicity (belonging to a group of people defined by social characteristics such as cultural tradition or national origin) and race (belonging to a group identified by inherited physical characteristics). Although health professionals and governments are striving to ensure that everybody has the same access to health care, there is increasing evidence of ethnic inequalities in health-care outcomes. Some of these inequalities reflect intrinsic differences between groups of people—Ashkenazi Jews, for example, often carry an altered gene that increases their chance of developing aggressive breast cancer. Often, however, these differences reflect inequalities in the health care received by different ethnic groups. To improve this situation, “cultural competence” has been promoted over recent years. Cultural competence is the development of skills by individuals and organizations that allow them to work effectively with people from different cultures. Health professionals are now taught about ethnic differences in health beliefs and practices, religion, and communication styles to help them provide the best service to all their patients.
Why Was This Study Done?
Numerous guidelines aim to improve cultural competency but little is known about how health professionals experience and perceive their work with patients from diverse ethnic groups. Is their behavior influenced by ethnicity in ways that might contribute to health care disparities? For example, do doctors sometimes avoid medical examinations for fear of causing offence because of cultural differences? If more were known about how health professionals handle ethnic diversity (a term used here to include both ethnicity and race) it might be possible to reduce ethnic inequalities in health care. In this qualitative study, the researchers have explored how health professionals involved in cancer care are affected by working with ethnically diverse patients. A qualitative study is one that collects nonquantitative data such as how doctors “feel” about treating people of different ethnic backgrounds; a quantitative study might compare clinical outcomes in different ethnic groups.
What Did the Researchers Do and Find?
The researchers enrolled 106 doctors, nurses, and other health-related professionals from different health-service settings in the Midlands, an ethnically diverse region of the UK. They organized 18 focus groups in which the health professionals described their experiences of caring for people from ethnic minority backgrounds. The participants were encouraged to recall actual cases and to identify what they saw as problems and strengths in their interactions with these patients. The researchers found that the health professionals wrestled with many challenges when providing health care for patients from diverse ethnic backgrounds. These challenges included problems with language and with general communication (for example, deciding when it was acceptable to touch a patient to show empathy). Health professionals also worried they did not know enough about cultural differences. As a result, they said they often felt uncertain of their ability to avoid causing affront or appearing racist. This uncertainty, the researchers report, disempowered the health professionals, sometimes making them hesitate or fail to do what was best for their patient.
What Do These Findings Mean?
These findings reveal that health professionals often experience considerable uncertainty when caring for ethnically diverse patients, even after training in cultural competency. They also show that this uncertainty can lead to hesitancy and inertia, which might contribute to ethnic health care inequalities. Because the study participants were probably already interested in ethnic diversity and health care, interviews with other health professionals (and investigations of patient experiences) are needed to confirm these findings. Nevertheless, the researchers suggest several interventions that might reduce health care inequalities caused by ethnic diversity. For example, health professionals should be encouraged to recognize their uncertainty and should have access to more information and training about ethnic differences. In addition, there should be a shift in emphasis away from relying on knowledge-based cultural information towards taking an “ethnographic” approach. In other words, health professionals should be helped to feel able to ask their patients about what matters most to them as individuals about their illness and treatment.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040323.
Information on cultural competence and health care is available from the US National Center for Cultural Competence (in English and Spanish) and DiversityRx
PROCEED (Professionals Responding to Cancer in Ethnic Diversity) is a multimedia training tool for educators within the health and allied professions developed from the results of this study; a press release on PROCEED is available from the University of Nottingham
Transcultural Health Care Practice: An educational resource for nurses and health care practitioners is available on the web site of the UK Royal College of Nursing
doi:10.1371/journal.pmed.0040323
PMCID: PMC2071935  PMID: 18001148
25.  Explaining clinical behaviors using multiple theoretical models 
Background
In the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of the methods, the performance of the theories, and consider where these methods sit alongside the range of methods for studying healthcare professional behavior change.
Methods
These were five studies of the theory-based cognitions and clinical behaviors (taking dental radiographs, performing dental restorations, placing fissure sealants, managing upper respiratory tract infections without prescribing antibiotics, managing low back pain without ordering lumbar spine x-rays) of random samples of primary care dentists and physicians. Measures were derived for the explanatory theoretical constructs in the Theory of Planned Behavior (TPB), Social Cognitive Theory (SCT), and Illness Representations specified by the Common Sense Self Regulation Model (CSSRM). We constructed self-report measures of two constructs from Learning Theory (LT), a measure of Implementation Intentions (II), and the Precaution Adoption Process. We collected data on theory-based cognitions (explanatory measures) and two interim outcome measures (stated behavioral intention and simulated behavior) by postal questionnaire survey during the 12-month period to which objective measures of behavior (collected from routine administrative sources) were related. Planned analyses explored the predictive value of theories in explaining variance in intention, behavioral simulation and behavior.
Results
Response rates across the five surveys ranged from 21% to 48%; we achieved the target sample size for three of the five surveys. For the predictor variables, the mean construct scores were above the mid-point on the scale with median values across the five behaviors generally being above four out of seven and the range being from 1.53 to 6.01. Across all of the theories, the highest proportion of the variance explained was always for intention and the lowest was for behavior. The Knowledge-Attitudes-Behavior Model performed poorly across all behaviors and dependent variables; CSSRM also performed poorly. For TPB, SCT, II, and LT across the five behaviors, we predicted median R2 of 25% to 42.6% for intention, 6.2% to 16% for behavioral simulation, and 2.4% to 6.3% for behavior.
Conclusions
We operationalized multiple theories measuring across five behaviors. Continuing challenges that emerge from our work are: better specification of behaviors, better operationalization of theories; how best to appropriately extend the range of theories; further assessment of the value of theories in different settings and groups; exploring the implications of these methods for the management of chronic diseases; and moving to experimental designs to allow an understanding of behavior change.
doi:10.1186/1748-5908-7-99
PMCID: PMC3500222  PMID: 23075284

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