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Background: Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence., Objective: This study aims to explore the mechanisms of action underpinning the intervention., Methods: A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis., Results: The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients' busy lives when delivered through a desktop computer., Conclusions: The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers., Trial Registration: International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797., (©Sarah J Drabble, Alicia O'Cathain, Alexander J Scott, Madelynne A Arden, Samuel Keating, Marlene Hutchings, Chin Maguire, Martin Wildman. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.10.2020.)

Background: Evidence of benefit for telehealth for chronic conditions is mixed. Two linked randomized controlled trials tested the Healthlines Service for 2 chronic conditions: depression and high risk of cardiovascular disease (CVD). This new telehealth service consisted of regular telephone calls from nonclinical, trained health advisers who followed standardized scripts generated by interactive software. Advisors facilitated self-management by supporting participants to use Web-based resources and helped to optimize medication, improve treatment adherence, and encourage healthier lifestyles. Participants were recruited from primary care. The trials identified moderate (for depression) or partial (for CVD risk) effectiveness of the Healthlines Service., Objective: An embedded qualitative study was undertaken to help explain the results of the 2 trials by exploring mechanisms of action, context, and implementation of the intervention., Methods: Qualitative interview study of 21 staff providing usual health care or involved in the intervention and 24 patients receiving the intervention., Results: Interviewees described improved outcomes in some patients, which they attributed to the intervention, describing how components of the model on which the intervention was based helped to achieve benefits. Implementation of the intervention occurred largely as planned. However, contextual issues in patients' lives and some problems with implementation may have reduced the size of effect of the intervention. For depression, patients' lives and preferences affected engagement with the intervention: these largely working-age patients had busy and complex lives, which affected their ability to engage, and some patients preferred a therapist-based approach to the cognitive behavioral therapy on offer. For CVD risk, patients' motivations adversely affected the intervention whereby some patients joined the trial for general health improvement or from altruism, rather than motivation to make lifestyle changes to address their specific risk factors. Implementation was not optimal in the early part of the CVD risk trial owing to technical difficulties and the need to adapt the intervention for use in practice. For both conditions, enthusiastic and motivated staff offering continuity of intervention delivery tailored to individual patients' needs were identified as important for patient engagement with telehealth; this was not delivered consistently, particularly in the early stages of the trials. Finally, there was a lack of active engagement from primary care., Conclusions: The conceptual model was supported and could be used to develop further telehealth interventions for chronic conditions. It may be possible to increase the effectiveness of this, and similar interventions, by attending to the human as well as the technical aspects of telehealth: offering it to patients actively wanting the intervention, ensuring continuity of delivery by enthusiastic and motivated staff, and encouraging active engagement from primary care staff.

Background: Many countries are exploring the potential of telehealth interventions to manage the rising number of people with chronic disorders. However, evidence of the effectiveness of telehealth is ambiguous. Based on an evidence-based conceptual framework, we developed an integrated telehealth service (the Healthlines Service) for chronic disorders and assessed its effectiveness in patients with depression. We aimed to compare the Healthlines Depression Service plus usual care with usual care alone., Methods: This study was a pragmatic, multicentre, randomised controlled trial with participants recruited from 43 general practices in three areas of England. To be eligible, participants needed to have access to the internet and email, a Patient Health Questionnaire 9 (PHQ-9) score of at least 10, and a confirmed diagnosis of depression. Participants were individually assigned (1:1) to either the Healthlines Depression Service plus usual care or usual care alone. Random assignment was done by use of a web-based automated randomisation system, stratified by site and minimised by practice and PHQ-9 score. Participants were aware of their allocation, but outcomes were analysed masked. The Healthlines Service consisted of regular telephone calls from non-clinical, trained health advisers who followed standardised scripts generated by interactive software. After an initial assessment and goal-setting telephone call, the advisers called each participant on six occasions over 4 months, and then made up to three more calls at intervals of roughly 2 months to provide reinforcement and to detect relapse. Advisers supported participants in the use of online resources (including computerised cognitive behavioural therapy) and sought to encourage healthier lifestyles, optimise medication, and improve treatment adherence. The primary outcome was the proportion of participants responding to the intervention (defined as PHQ-9 <10 and reduction in PHQ-9 of ≥5 points) at 4 months after randomisation. The primary analysis was based on the intention-to-treat principle without imputation and all serious adverse events were investigated. This trial is registered with Current Controlled Trials, number ISRCTN 14172341., Findings: Between July 24, 2012, and July 31, 2013, we recruited 609 participants, randomly assigning 307 to the Healthlines Service plus usual care and 302 to usual care. Primary outcome data were available for 525 (86%) participants. At 4 months, 68 (27%) of 255 individuals in the intervention group had a treatment response compared with 50 (19%) of 270 individuals in the usual care group (adjusted odds ratio 1·7, 95% CI 1·1-2·5, p=0·019). Compared with usual care alone, intervention participants reported improvements in anxiety, better access to support and advice, greater satisfaction with the support they received, and improvements in self-management and health literacy. During the trial, 70 adverse events were reported by participants, one of which was related to the intervention (increased anxiety from discussing depression) and was not serious., Interpretation: This telehealth service based on non-clinically trained health advisers supporting patients in use of internet resources was both acceptable and effective compared with usual care. Our results provide support for the development and assessment of similar interventions in other chronic disorders to expand care provision., Funding: National Institute for Health Research (NIHR)., (Copyright © 2016 Salisbury et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.)

Objective:  To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies., Design:  Pragmatic, multicentre, randomised controlled trial., Setting:  42 general practices in three areas of England., Participants:  Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score., Interventions:  Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone., Main Outcome Measures:  The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked., Results:  50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic -2.7 mm Hg (95% confidence interval -4.7 to -0.6 mm Hg), mean diastolic -2.8 (-4.0 to -1.6 mm Hg); weight -1.0 kg (-1.8 to -0.3 kg), and body mass index -0.4 ( -0.6 to -0.1) but not cholesterol -0.1 (-0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (-0.4, -1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure., Conclusions:  This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care.Trial registration Current Controlled Trials ISRCTN 27508731., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Telehealth interventions use information and communication technology to provide clinical support. Some randomised controlled trials of telehealth report high patient decline rates. A large study was undertaken to determine which patients decline to participate in telehealth trials and their reasons for doing so., Methods: Two linked randomised controlled trials were undertaken, one for patients with depression and one for patients with raised cardiovascular disease risk (the Healthlines Study). The trials compared usual care with additional support delivered by the telephone and internet. Patients were recruited via their general practice and could return a form about why they were not participating., Results: Of the patients invited, 82.9% (20,021/24,152) did not accept the study invite, either by returning a decline form (n = 7134) or by not responding (n = 12,887). In both trials patients registered at deprived general practices were less likely to accept the study invite. Decline forms were received from 29.5% (7134/24,152) of patients invited. There were four frequently reported types of reasons for declining. The most common was telehealth-related: 54.7% (3889/,7115) of decliners said they did not have access or the skills to use the internet and/or computers. This was more prevalent amongst older patients and patients registered at deprived general practices. The second was health need-related: 40.1% (n = 2852) of decliners reported that they did not need additional support for their health condition. The third was related to life circumstances: 27.2% (n = 1932) of decliners reported being too busy. The fourth was research-related: 15.3% (n = 1092) of decliners were not interested in the research., Conclusions: A large proportion of patients declining participation in these telehealth trials did so because they were unable to engage with telehealth or did not perceive a need for it. This has implications for engagement with telehealth in routine practice, as well as for trials, with a need to offer technological support to increase patients' engagement with telehealth. More generally, triallists should assess why people decline to participate in their studies., Trial Registration: The Healthlines Study has the following trial registrations: depression trial: ISRCTN14172341 (registered 26 June 2012) and CVD risk trial: ISRCTN27508731 (registered 05 July 2012).

Background: There is a substantial and continually growing literature on the effectiveness and implementation of discrete telehealth interventions for health condition management. However, it is difficult to predict which technologies are likely to work and be used in practice. In this context, identifying the core mechanisms associated with successful telehealth implementation is relevant to consolidating the likely elements for ensuring a priori optimal design and deployment of telehealth interventions for supporting patients with long-term conditions (LTCs)., Methods: We adopted a two-stage realist synthesis approach to identify the core mechanisms underpinning telehealth interventions. In the second stage of the review, we tested inductively and refined our understanding of the mechanisms. We reviewed qualitative papers focused on COPD, heart failure, diabetes, and behaviours and complications associated with these conditions. The review included 15 papers published 2009 to 2014., Results: Three concepts were identified, which suggested how telehealth worked to engage and support health-related work. Whether or not and how a telehealth intervention enables or limits the possibility for relationships with professionals and/or peers. Telehealth has the potential to reshape and extend existing relationships, acting as a partial substitute for the role of health professionals. The second concept is fit: successful telehealth interventions are those that can be well integrated into everyday life and health care routines and the need to be easy to use, compatible with patients' existing environment, skills, and capacity, and that do not significantly disrupt patients' lives and routines. The third concept is visibility: visualisation of symptoms and feedback has the capacity to improve knowledge, motivation, and a sense of empowerment; engage network members; and reinforce positive behaviour change, prompts for action and surveillance., Conclusions: Upfront consideration should be given to the mechanisms that are most likely to ensure the successful development and implementation of telehealth interventions. These include considerations about whether and how the telehealth intervention enables or limits the possibility for relationships with professionals and peers, how it fits with existing environment and capacities to self-manage, and visibility-enabling-enhanced awareness to self and others.

Objective: To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression., Design: The model was based on several strands of evidence: a metareview and realist synthesis of quantitative and qualitative evidence on telehealth for chronic conditions; a qualitative study of patients' and health professionals' experience of telehealth; a quantitative survey of patients' interest in using telehealth; and review of existing models of chronic condition management and evidence-based treatment guidelines. Based on these evidence strands, a model was developed and then refined at a stakeholder workshop. Then a telehealth intervention ('Healthlines') was designed by incorporating strategies to address each of the model components. The model also provided a framework for evaluation of this intervention within parallel randomised controlled trials in the two exemplar conditions, and the accompanying process evaluations and economic evaluations., Setting: Primary care., Results: The TElehealth in CHronic Disease (TECH) model proposes that attention to four components will offer interventions the best chance of success: (1) engagement of patients and health professionals, (2) effective chronic disease management (including subcomponents of self-management, optimisation of treatment, care coordination), (3) partnership between providers and (4) patient, social and health system context. Key intended outcomes are improved health, access to care, patient experience and cost-effective care., Conclusions: A conceptual model has been developed based on multiple sources of evidence which articulates how telehealth may best provide benefits for patients with chronic health conditions. It can be used to structure the design and evaluation of telehealth programmes which aim to be acceptable to patients and providers, and cost-effective., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: There is growing interest in telehealth-the use of technology to support the remote delivery of health care and promote self-management-as a potential alternative to face-to-face care for patients with chronic diseases. However, little is known about what precipitates interest in the use of telehealth among these patients., Objective: This survey forms part of a research program to develop and evaluate a telehealth intervention for patients with two exemplar chronic diseases: depression and raised cardiovascular disease (CVD) risk. The survey was designed to explore the key factors that influence interest in using telehealth in these patient groups., Methods: Thirty-four general practices were recruited from two different regions within England. Practice records were searched for patients with (1) depression (aged 18+ years) or (2) 10-year risk of CVD ≥20% and at least one modifiable risk factor (aged 40-74 years). Within each general practice, 54 patients in each chronic disease group were randomly selected to receive a postal questionnaire. Questions assessed five key constructs: sociodemographics, health needs, difficulties accessing health care, technology-related factors (availability, confidence using technology, perceived benefits and drawbacks of telehealth), and satisfaction with prior use of telehealth. Respondents also rated their interest in using different technologies for telehealth (phone, email and Internet, or social media). Relationships between the key constructs and interest in using the three mediums of telehealth were examined using multivariable regression models., Results: Of the 3329 patients who were sent a study questionnaire, 44.40% completed it (872/1740, 50.11% CVD risk; 606/1589, 38.14% depression). Overall, there was moderate interest in using phone-based (854/1423, 60.01%) and email/Internet-based (816/1425, 57.26%) telehealth, but very little interest in social media (243/1430, 16.99%). After adjusting for health needs, access difficulties, technology-related factors, and prior use of telehealth, interest in telehealth had largely no association with sociodemographic variables. For both patient groups and for each of the three technology mediums, the most important constructs related to interest in telehealth were having the confidence to use the associated technology, as well as perceiving greater advantages and fewer disadvantages from using telehealth. To illustrate, greater confidence using phone technologies (b=.16, 95% CI 0.002-0.33), while also perceiving more benefits (b=.31, 95% CI 0.21-0.40) and fewer drawbacks (b=-.23, 95% CI -0.28 to -0.17) to using telehealth were associated with more interest in using phone-based telehealth technologies for patients with depression., Conclusions: There is widespread interest in using phone-based and email/Internet-based telehealth among patients with chronic diseases, regardless of their health status, access difficulties, age, or many other sociodemographic factors. This interest could be increased by helping patients gain confidence using technologies and through highlighting benefits and addressing concerns about telehealth. While the same pattern exists for social media telehealth, interest in using these technologies is minimal.

Background: As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring., Methods/design: This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs. Two randomized controlled trials will be conducted in parallel, recruiting patients with two exemplar LTCs: depression or raised cardiovascular disease (CVD) risk. A total of 1,200 patients will be recruited from approximately 42 general practices near Bristol, Sheffield and Southampton, UK. Participants will be randomly allocated to either usual care (control group) or usual care plus the NHS Direct Healthlines Service (intervention group). The intervention is based on a conceptual model incorporating promotion of self-management, optimisation of treatment, coordination of care and engagement of patients and general practitioners. Participants will be provided with tailored help, combining telephone advice from health information advisors with support to use a range of online resources. Participants will access the service for 12 months. Outcomes will be collected at baseline, four, eight and 12 months for the depression trial and baseline, six and 12 months for the CVD risk trial. The primary outcome will be the proportion of patients responding to treatment, defined in the depression trial as a PHQ-9 score <10 and an absolute reduction in PHQ-9 ≥5 after 4 months, and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months. The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services. An embedded qualitative interview study will explore healthcare professionals' and patients' views of the intervention., Discussion: This study evaluates a complex telehealth intervention which combines evidence-based components and is delivered by an established healthcare organisation. The study will also analyse health economic information. In doing so, the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention., Trial Registration: Current Controlled Trials: Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731.

Aim: This paper is a report of the synthesis of evidence on the appropriateness of, and compliance with, telephone triage decisions., Background: Telephone triage plays an important role in managing demand for health care. Important questions are whether triage decisions are appropriate and patients comply with them., Data Sources: CINAHL, Cochrane Clinical Trials Database, Medline, Embase, Web of Science, and Psyc Info were searched between 1980-June 2010., Literature Review: Rapid Evidence Synthesis., Review Methods: The principles of rapid evidence assessment were followed., Results: We identified 54 relevant papers: 26 papers reported appropriateness of triage decision, 26 papers reported compliance with triage decision, and 2 papers reported both. Nurses triaged calls in most of the studies (n=49). Triage decisions rated as appropriate varied between 44-98% and compliance ranged from 56-98%. Variation could not be explained by type of service or method of assessing appropriateness. However, inconsistent definitions of appropriateness may explain some variation. Triage decisions to contact primary care may have lower compliance than decisions to contact emergency services or self care., Conclusion: Telephone triage services can offer appropriate decisions and decisions that callers comply with. However, the association between the appropriateness of a decision and subsequent compliance requires further investigation and further consideration needs to be given to the minority of calls which are inappropriately managed. We suggest that a definition of appropriateness incorporating both accuracy and adequacy of triage decision should be encouraged., (© 2012 Blackwell Publishing Ltd.)

The article presents a study on the use of telephone-accessed health care in delivering health care. Topics discussed include the introduction of NHS 111 as a telephone service to access National Health Service health care in Great Britain within different sub-groups, evidence suggesting that older people are less likely to use telephone-accessed health care, and satisfaction levels with NHS 111 during the pilot phase of the study.

Background As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people withLTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring. Methods/Design This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs. Two randomized controlled trials will be conducted in parallel, recruiting patients with two exemplar LTCs: depression or raised cardiovascular disease (CVD) risk. A total of 1,200 patients will be recruited from approximately 42 general practices near Bristol, Sheffield and Southampton, UK. Participants will be randomly allocated to either usual care (control group) or usual care plus the NHS Direct Healthlines Service (intervention group). The intervention is based on a conceptual model incorporating promotion of self-management, optimisation of treatment, coordination of care and engagement of patients and general practitioners. Participants will be provided with tailored help, combining telephone advice from health information advisors with support to use a range of online resources. Participants will access the service for 12 months. Outcomes will be collected at baseline, four, eight and 12 months for the depression trial and baseline, six and 12 months for the CVD risk trial. The primary outcome will be the proportion of patients responding to treatment, defined in the depression trial as a PHQ-9 score <10 and an absolute reduction in PHQ-9 ⩾5 after 4 months, and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months. The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services. An embedded qualitative interview study will explore healthcare professionals' and patients' views of the intervention. Discussion This study evaluates a complex telehealth intervention which combines evidence-based components and is delivered by an established healthcare organisation. The study will also analyse health economic information. In doing so, the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention. Trial registration Current Controlled Trials: Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731. [ABSTRACT FROM AUTHOR]

In the UK National Health Service (NHS), NHS Direct, the national 24-h telephone helpline, has been available in England and Wales since 2000 and has been termed a 'single gateway' to health care. We conducted a population survey of 15,004 people in areas covered by the service, which included questions about NHS Direct use and socio-economic characteristics. After removing undeliverable questionnaires, the survey response rate was 60% (8750/14,516). In all, a quarter of respondents had ever used NHS Direct (26%, 95% confidence interval 25–27), ranging from 32% of the population in Preston/Chorley (888/2794) and Newcastle and North Tyneside (515/1621) to 17% (2215/8536) in Sheffield, which had introduced the service 20 months later. Logistic regression showed that those from poorer socioeconomic groups or with communication difficulties were less likely to have used the service than others. Overcoming this apparent bias against those likely to have the greatest need is an unsolved problem not confined to telemedicine. [ABSTRACT FROM AUTHOR]

o'cathain a., sampson f.c., munro j.f., thomas k.j. & nicholl j.p. (2004) Journal of Advanced Nursing 45(3), 280–286 Nurses’ views of using computerized decision support software in NHS Direct Nurses working in NHS Direct, the 24-hour telephone advice line in England, use computerized decision support software to recommend to callers the most appropriate service to contact, or to advise on self-care. To explore nurses’ views of their roles and the computerized decision support software in NHS Direct. Qualitative analysis of semi-structured interviews with 24 NHS Direct nurses in 12 sites. Nurses described both the software and themselves as essential to the clinical decision-making process. The software acted as safety net, provider of consistency, and provider of script, and was relied upon more when nurses did not have clinical knowledge relevant to the call. The nurse handled problems not covered by the software, probed patients for the appropriate information to enter into the software, and interpreted software recommendations in the light of contextual information which the software was unable to use. Nurses described a dual process of decision-making, with the nurse as active decision maker looking for consensus with the software recommendation and ready to override recommendations made by the software if necessary. However, nurses’ accounts of the software as a guide, prompt or support did not fully acknowledge the power of the software, which they are required to use, and the recommendation of which they are required to follow under some management policies. Over time, the influence of nurse and software merges as nurses internalize the software script as their own knowledge, and navigate the software to produce recommendations that they feel are most appropriate. The nurse and the software have distinct roles in NHS Direct, although the effect of each on the clinical decision-making process may be difficult to determine in practice. [ABSTRACT FROM AUTHOR]