Psychological impact of lung cancer screening using a novel antibody blood test followed by imaging: the ECLS randomized controlled trial.

BACKGROUND: The Early CDT®-Lung antibody blood test plus serial computed tomography scans for test-positives (TPGs) reduces late-stage lung cancer presentation. This study assessed the psychological outcomes of this approach. METHODS: Randomized controlled trial (n = 12 208) comparing psychological outcomes 1-12 months post-recruitment in a subsample (n = 1032) of TPG, test-negative (TNG) and control groups (CG). RESULTS: Compared to TNG, TPG had lower positive affect (difference between means (DBM), 3 months (3m: -1.49 (-2.65, - 0.33)), greater impact of worries (DBM 1m: 0.26 (0.05, 0.47); 3m: 0.28 (0.07, 0.50)), screening distress (DBM 1m: 3.59 (2.28, 4.90); 3m: 2.29 (0.97, 3.61); 6m: 1.94 (0.61, 3.27)), worry about tests (odds ratio (OR) 1m: 5.79 (2.66, 12.63) and more frequent lung cancer worry (OR 1m: 2.52 (1.31, 4.83); 3m: 2.43 (1.26, 4.68); 6m: 2.87 (1.48, 5.60)). Compared to CG, TPG had greater worry about tests (OR 1m: 3.40 (1.69, 6.84)). TNG had lower negative affect (log-transformed DBM 3m: -0.08 (-0.13, -0.02)), higher positive affect (DBM 1m: 1.52 (0.43, 2.61); 3m: 1.43 (0.33, 2.53); 6m: 1.27 (0.17, 2.37)), less impact of worries (DBM 3m: -0.27 (-0.48, -0.07)) and less-frequent lung cancer worry (OR 3m: 0.49 (0.26, 0.92)). CONCLUSIONS: Negative psychological effects in TPG and positive effects in TNG were short-lived and most differences were small.

Using Participatory Learning & Action (PLA) research techniques for inter-stakeholder dialogue in primary healthcare: an analysis of stakeholders' experiences.

PLAIN ENGLISH SUMMARY: It is important for health care workers to know the needs and expectations of their patients. Therefore, service users have to be involved in research. To achieve a meaningful dialogue between service users, healthcare workers and researchers, participatory methods are needed. This paper describes how the application of a specific participatory methodology, Participatory Learning and Action (PLA) can lead to such a meaningful dialogue. In PLA all stakeholders are regarded as equal partners and collaborators in research.During 2011-2015, a European project called RESTORE used PLA in Austria, Greece, Ireland, The Netherlands and the UK to investigate how communication between primary health care workers and their migrant patients could be improved.Seventy eight migrants, interpreters, doctors, nurses and other key stakeholders (see Table 2) participated in 62 PLA sessions. These dialogues (involving discussions, activities, PLA techniques and evaluations) were generally 2-3 h long and were recorded and analysed by the researchers.Participants reported many positive experiences about their dialogues with other stakeholders. There was a positive, trusting atmosphere in which all stakeholders could express their views despite differences in social power. This made for better understanding within and across stakeholder groups. For instance a doctor changed her view on the use of interpreters after a migrant explained why this was important. Negative experiences were rare: some doctors and healthcare workers thought the PLA sessions took a lot of time; and despite the good dialogue, there was disappointment that very few migrants used the new interpreting service. ABSTRACT: Background In order to be effective, primary healthcare must understand the health needs, values and expectations of the population it serves. Recent research has shown that the involvement of service users and other stakeholders and gathering information on their perspectives can contribute positively to many aspects of primary healthcare. Participatory methodologies have the potential to support engagement and dialogue between stakeholders from academic, migrant community and health service settings. This paper focuses on a specific participatory research methodology, Participatory Learning and Action (PLA) in which all stakeholders are regarded as equal partners and collaborators in research.Our research question for this paper was: "Does the application of PLA lead to meaningful engagement of all stakeholders, and if so, what elements contribute to a positive and productive inter-stakeholder dialogue?". Methods We explored the use of PLA in RESTORE, a European FP7-funded project, during 2011-2015 in 5 countries: Austria, Greece, Ireland, the Netherlands and the UK. The objective of RESTORE was to investigate and support the implementation of guidelines and training initiatives (G/TIs) to enhance communication in cross-cultural primary care consultations with migrants.Seventy eight stakeholders (migrants, interpreters, doctors, nurses and others - see Table 2) participated in a total of 62 PLA sessions (discussions, activities, evaluations) of approximately 2-3 h' duration across the five sites. During the fieldwork, qualitative data were generated about stakeholders' experiences of engagement in this dialogue, by means of various methods including participatory evaluations, researchers' fieldwork reports and researcher interviews. These were analysed following the principles of thematic analysis. Results Stakeholders involved in PLA inter-stakeholder dialogues reported a wide range of positive experiences of engagement, and very few negative experiences. A positive atmosphere during early research sessions helped to create a sense of safety and trust. This enabled stakeholders from very different backgrounds, with different social status and power, to offer their perspectives in a way that led to enhanced learning in the group - they learned with and from each other. This fostered shifts in understanding - for example, a doctor changed her view on interpreted consultations because of the input of the migrant service-users. Conclusion PLA successfully promoted stakeholder involvement in meaningful and productive inter-stakeholder dialogues. This makes it an attractive approach to enhance the further development of health research partnerships to advance primary healthcare.

Implementing guidelines and training initiatives to improve cross-cultural communication in primary care consultations: a qualitative participatory European study.

BACKGROUND: Cross-cultural communication in primary care is often difficult, leading to unsatisfactory, substandard care. Supportive evidence-based guidelines and training initiatives (G/TIs) exist to enhance cross cultural communication but their use in practice is sporadic. The objective of this paper is to elucidate how migrants and other stakeholders can adapt, introduce and evaluate such G/TIs in daily clinical practice. METHODS: We undertook linked qualitative case studies to implement G/TIs focused on enhancing cross cultural communication in primary care, in five European countries. We combined Normalisation Process Theory (NPT) as an analytical framework, with Participatory Learning and Action (PLA) as the research method to engage migrants, primary healthcare providers and other stakeholders. Across all five sites, 66 stakeholders participated in 62 PLA-style focus groups over a 19 month period, and took part in activities to adapt, introduce, and evaluate the G/TIs. Data, including transcripts of group meetings and researchers' fieldwork reports, were coded and thematically analysed by each team using NPT. RESULTS: In all settings, engaging migrants and other stakeholders was challenging but feasible. Stakeholders made significant adaptations to the G/TIs to fit their local context, for example, changing the focus of a G/TI from palliative care to mental health; or altering the target audience from General Practitioners (GPs) to the wider multidisciplinary team. They also progressed plans to deliver them in routine practice, for example liaising with GP practices regarding timing and location of training sessions and to evaluate their impact. All stakeholders reported benefits of the implemented G/TIs in daily practice. Training primary care teams (clinicians and administrators) resulted in a more tolerant attitude and more effective communication, with better focus on migrants' needs. Implementation of interpreter services was difficult mainly because of financial and other resource constraints. However, when used, migrants were more likely to trust the GP's diagnoses and GPs reported a clearer understanding of migrants' symptoms. CONCLUSIONS: Migrants, primary care providers and other key stakeholders can work effectively together to adapt and implement G/TIs to improve communication in cross-cultural consultations, and enhance understanding and trust between GPs and migrant patients.

Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN).

OBJECTIVE: To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management. DESIGN AND SETTING: Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care. PARTICIPANTS: Adults (age≥16 years) with physician diagnosed, symptomatic asthma (Asthma Control Questionnaire (ACQ) score ≥1). People with unstable asthma or other lung disease were excluded. INTERVENTION: 'Living Well with Asthma' is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma. It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity. OUTCOME MEASURES: Primary outcomes were recruitment/retention, website use, ACQ and mini-Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation and health service contacts after 12 weeks. Blinding postrandomisation was not possible. RESULTS: Recruitment target met. 51 participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%; 20 intervention group) followed up. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 0.89; p=0.136). No adverse events. CONCLUSIONS: Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial. TRIAL REGISTRATION NUMBER: ISRCTN78556552; Results.

Minimally disruptive medicine: the evidence and conceptual progress supporting a new era of healthcare.

Patients with chronic conditions or multimorbidity, and often their caregivers, have to adjust their lives and mobilise their capacity (ability) to respond to the workload (demands) imposed by treatments and the care of their conditions. There is a continuous and complex interaction between workload and capacity. When capacity proves insufficient to address the treatment workload, creating a burden, patients may place a lower priority on other aspects of their lives, or reduce engagement with healthcare. Guidelines usually focus on disease-centred outcomes without consideration of limited capacity or demanding workload (burden) from treatment regimens. It seems reasonable to consider that healthcare needs reshaping so that care that pursues goals important to patients as well as those suggested by evidence-based medicine. This can be achieved by using shared decision approaches guided by the expertise of clinicians to deliver optimal care while minimising the burden of treatment on patients, their caregivers, and the healthcare system. What we need is minimally disruptive medicine.

Teledermatology in the UK: lessons in service innovation.

BACKGROUND: Teledermatology has the potential to revolutionize the delivery of dermatology services by facilitating access to specialist services at a distance. In the U.K. over the previous decade there have been numerous attempts at introducing and using teledermatology; however, the development of teledermatology as routine service provision remains limited. OBJECTIVES: To identify factors that promote successful use of teledermatology as a part of routine service provision. METHODS: A longitudinal qualitative study of teledermatology, drawing on data from in-depth semistructured interviews; observations of systems in practice; and public meetings. Data were analysed collectively by the research team using established qualitative analytical techniques to identify key thematic categories. The sample consisted of teledermatology services within the U.K. (n = 12) studied over 8 years (1997-2005). Individual participants (n = 68 interviews) were consultant dermatologists, researchers, teledermatology nurses, administrators, patient advocates, general practitioners and technologists. RESULTS: The analysis compared services that did or did not become part of routine healthcare practice to identify features that supported the normalization of teledermatology. Requirements for using and integrating teledermatology into practice included: political support; perceived benefit and relative commitment that outweighs effort; pragmatic approaches to proving efficacy and safety; perception of risk as being 'manageable' on the basis of professional judgement; high levels of flexibility in practice (in terms of individuals, technology and organization); and reconceptualizing professional roles. CONCLUSIONS: Successful implementation of teledermatology as a routine service requires greater understanding of and attention to the interplay between social and technical aspects of teledermatology, and how this is accommodated both by healthcare professionals and the organizations in which they work.

Recruitment difficulties in a home telecare trial.

We analysed the difficulties encountered in recruiting predominantly older patients, suffering from an acute exacerbation of a chronic illness, to a randomized controlled trial of home telecare. Of 653 patients approached for study participation, after full assessment, 80% (519) met the trial eligibility criteria. Of these, 104 (20%) consented to study participation and 415 (80%) refused. A logistic regression model was constructed to examine independent effects of patient factors on probability of trial participation. Only two independent variables were associated with decreased likelihood of consent: increasing age (1 year older: odds ratio [OR] = 0.96); and being on inhaled steroid medication (OR = 0.60). The most common reason for refusal to participate, accounting for almost one-third of respondents, was a stated preference for a face-to-face nurse visiting service rather than a telecare service. Perhaps home telecare services should continue to be targeted at the more stable chronically ill population and not at those suffering from acute illness.

Patient and provider perspectives on home telecare: preliminary results from a randomized controlled trial.

A randomized controlled trial of home telecare for the management of acute exacerbations of chronic obstructive pulmonary disease has been undertaken in the north-west of England. A videophone was used that communicates via the ordinary telephone network. The intervention period for each participant was two weeks. Participants in the telecare arm of the trial were asked to complete logbooks to record their experiences of each telecare encounter. A simple, self-completed, 10-item questionnaire was used that consisted of a Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). Fourteen nurses completed 150 logbooks and 22 patients completed 145 logbooks. These results demonstrate significant differences in perception between patients and their health-care providers with regard to telecare encounters across all the domains addressed. Participating patients consistently demonstrated more positive views of the telecare encounters than their healthcare providers.

Lessons from the implementation of a home telecare service.

We conducted a qualitative evaluation of the introduction of a telenursing service. The service used an analogue videophone linked with a physiological monitoring device, which allowed the transmission of data between the patient's home and the hospital. A researcher kept a detailed diary of day-to-day activity for the first year of the project. Computer software for qualitative data analysis was used to code the text and the analysis followed the principles of constant comparison. The diary entries documented how the commercially available equipment was adapted to suit the organization and content of the nurses' work. The nurses made a number of suggestions to improve the user-friendliness of the equipment. The technology, the existing home care service (the comparison arm of the study) and the randomized controlled trial itself all underwent continuous change. The traditional randomized control design of trial has limitations in this situation, and there is a need for more realistic trial designs.

Factors influencing the evaluation of telehealth interventions: preliminary results from a qualitative study of evaluation projects in the UK.

We have carried out a qualitative study of factors that influence the evaluation of telehealth. The study concerned six telehealth projects that are being tracked over two years. In the first 12 months of the study we carried out semistructured interviews and made observations of the participants in the projects. Each case study involved 5-15 subjects, many of whom were interviewed several times. The results indicate that important issues affecting telehealth evaluation include developing and maintaining the technology, reorganization of clinical and administrative duties, professional dynamics, and the difficulty of integrating service provision and evaluation. The findings suggest that the evaluation of telehealth interventions is highly complex, and that this complexity is often underestimated in the design and conduct of evaluation studies.

A review of telemedicine cost-effectiveness studies.

As interest in telemedicine grows, many of its proponents and vendors increasingly suggest that it is now time to move to full-scale implementation of telemedicine services in a variety of contexts throughout the world, and question the need for further evidence of its utility and cost-effectiveness. We have reviewed the published literature relating to cost-effectiveness studies in telemedicine and have identified some important weaknesses. Ten recommendations regarding the design of economic evaluations of telemedicine are suggested.

The role of telecare in the management of exacerbations of chronic obstructive pulmonary disease in the home.

We examined home care as an alternative to hospital admission in exacerbations of chronic obstructive pulmonary disease (COPD). We performed a pilot study to investigate the feasibility of using telecommunications technology to assist in the support of acutely ill patients with exacerbations of COPD at home. Realtime, interactive video, via an analogue video-phone, was used to allow patients in their own homes to obtain nursing support from a nurse located at a distant base station. Six individuals, four male and two female, had video-phones installed in their homes by members of the nursing intervention team. The age range was 52-72 years, mean 61.5. These patients used the system on 18 occasions. Experience in home telecare, via interactive video, has been limited to provision of ongoing support for relatively stable individuals with chronic illness. This pilot project represents the first attempt at providing home telecare in the UK to those experiencing an acute exacerbation of their chronic illness, who would otherwise have merited acute hospital admission.

Clinical applications of thrombolytic therapy.

Although thrombolytic therapy is used in a variety of settings, it has gained the most prominence in the treatment of myocardial infarction. The effectiveness of thrombolytic agents in reducing mortality in patients who present with myocardial infarction has been clearly demonstrated by large-scale studies. Unfortunately, only a minority of patients who present with myocardial infarction are currently receiving thrombolytic therapy. Many patients who could benefit from thrombolysis are unnecessarily excluded from treatment. It is now recommended that all patients who have appropriate electrocardiographic changes and present within 12 hours of the onset of acute myocardial infarction be considered for thrombolytic therapy. Factors such as age and history of previous myocardial infarction are no longer viewed as barriers to treatment.

Management of heart failure.

Heart failure is associated with high rates of morbidity and mortality. Because heart failure is difficult to diagnose accurately on the basis of the history and physical examination alone, It is vital that clinical evaluation such as echocardiography be used to confirm the diagnosis. In addition, it is important to identify etiologic or predisposing factors that may be reversible. Angiotensin-converting enzyme inhibitors should be considered in all patients with a diagnosis of left ventricular systolic dysfunction, unless contraindications exist. Diuretics and digoxin are helpful in specific circumstances. Comorbid factors such as excessive alcohol intake and coronary artery insufficiency should be addressed. Patient and family education and cooperation with medical regimens can reduce morbidity and mortality.

Prevalence, aetiology and management of heart failure in general practice.

BACKGROUND: There is a high level of morbidity and mortality among patients with heart failure. Management of the condition has changed substantially in recent years. However, there is little information on the management of heart failure in general practice. AIM: A study was carried out in 1994 to assess the prevalence, aetiology and management of heart failure in a general practice setting. METHOD: A retrospective review was undertaken of the manual and computerized medical records of patients in two group practices in Liverpool (combined patient population of 17 400). RESULTS: A total of 266 patients with heart failure were identified (a prevalence of 15 per 1000). The two practices had 2747 patients who were aged 65 years and over and 221 of these had heart failure (prevalence of 80 per 1000). The principal aetiological factor considered responsible for heart failure was: coronary heart disease in 45% of patients, hypertension 18%, valve disease 9%, cor pulmonale 7%, cardiomyopathy 2% and a metabolic problem 2% (aetiology unknown in 17% of cases). Urea and electrolytes had been checked in the last year in 59% of patients. Chest x-ray and electrocardiography had been performed in 89% and 80% of patients, respectively, and echocardiography in 30%. Angiotensin converting enzyme (ACE) inhibitors were being prescribed to 33% of patients. CONCLUSION: The study found a high prevalence of heart failure among patients aged 65 years and over. Coronary heart disease was considered to be the main aetiological factor. Patients were being investigated mainly by means of chest x-ray and electrocardiography. Most patients with heart failure were not receiving treatment with ACE inhibitors. Evaluation of heart failure by clinical criteria alone is now deemed insufficient. Echocardiography should be used routinely to assess cardiac dysfunction. Patients with confirmed left ventricular dysfunction will benefit from treatment with ACE inhibitors unless contraindications exist. The study suggests that there is a need to explore ways of optimizing the management of patients with heart failure.

Pharmacokinetics of human insulin zinc suspension (recombinant DNA) in normal man: a comparison with porcine insulin zinc suspension.

A single dose crossover study in 10 fasting, non-diabetic men compared the 24-hour profiles of blood glucose, plasma insulin, and C-peptide following a single subcutaneous injection of either human insulin zinc suspension crystalline (recombinant DNA), or highly purified porcine insulin zinc suspension (mixed), in a standard dose of 0.2 U/kg. Both insulins produced moderate hypoglycaemia within 3 hours which persisted for 24 hours after administration. The rate of fall of blood glucose was similar from 0-3 hours but was significantly lower after the porcine insulin at 4 and 7 hours (p less than 0.05). Mean plasma insulin values were higher after porcine insulin between 2 and 6 hours (p less than 0.05) and a biphasic pattern was observed following injection of both insulins. Plasma C-peptide declined after each insulin was administered, and was significantly lower between 2 and 7 hours after porcine insulin. The duration of the hypoglycaemic action of human crystalline insulin (recombinant DNA), assessed by blood glucose measurements and C-peptide suppression, was equivalent to porcine insulin zinc suspension (mixed) (Monotard MC, Novo) over 24 hours.