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1.  Issues arising following a referral and subsequent wait for extraction under general anaesthetic: impact on children 
BMC Oral Health  2015;15:3.
Background
Untreated caries in young children can result in a referral for extraction in hospital under general anaesthetic (GA). This study aims to explore the impact of caries during the ensuing wait for GA on children resident in the North West of England.
Methods
The study involved 456 respondents referred to six hospitals in the Northwest of England. Over a two-month period each of these children/ families completed a questionnaire and gave permission to access their referral and consultation notes.
Results
Children (6.78 years old: 1.50 to 16.42) had on average five teeth extracted (ranging from one to a full clearance, with all teeth removed). Sixty seven per cent of parents reported their child had been in pain, 26% reported schools days being missed and 38% having sleepless nights. The average time from referral to operation was 137 days. Results indicated that children could be in discomfort during their wait, as pain was experienced, on average, 14 days before the operation. Wait time significantly predicated the number of sleepless nights b = .004, t(340) = 2.276, p = .023.
Conclusions
It is clear that pain, sleepless nights and missed school are a feature during a wait for dental GA and can be exacerbated by an extended wait. These data support the need for not only effective prevention of caries within primary care to reduce wait times and experience of GA but also effective management of pain and infection during a prolonged wait for treatment.
doi:10.1186/1472-6831-15-3
PMCID: PMC4324052  PMID: 25595299
Caries; Children; Pain; Impact; General anaesthetic
2.  Dynamic Consent: A Possible Solution to Improve Patient Confidence and Trust in How Electronic Patient Records Are Used in Medical Research 
JMIR Medical Informatics  2015;3(1):e3.
With one million people treated every 36 hours, routinely collected UK National Health Service (NHS) health data has huge potential for medical research. Advances in data acquisition from electronic patient records (EPRs) means such data are increasingly digital and can be anonymised for research purposes. NHS England’s care.data initiative recently sought to increase the amount and availability of such data. However, controversy and uncertainty following the care.data public awareness campaign led to a delay in rollout, indicating that the success of EPR data for medical research may be threatened by a loss of patient and public trust. The sharing of sensitive health care data can only be done through maintaining such trust in a constantly evolving ethicolegal and political landscape. We propose that a dynamic consent model, whereby patients can electronically control consent through time and receive information about the uses of their data, provides a transparent, flexible, and user-friendly means to maintain public trust. This could leverage the huge potential of the EPR for medical research and, ultimately, patient and societal benefit.
doi:10.2196/medinform.3525
PMCID: PMC4319083  PMID: 25586934
dynamic consent; electronic patient record (EPR); medical research; confidentiality; privacy; governance; NHS; data linkage; care.data
3.  The mediation of social influences on smoking cessation and awareness of the early signs of lung cancer 
BMC Public Health  2014;14(1):1043.
Background
Whilst there has been no clear consensus on the potential for earlier diagnosis of lung cancer, recent research has suggested that the time between symptom onset and consultation can be long enough to plausibly affect prognosis. In this article, we present findings from a qualitative study involving in-depth interviews with patients who had been diagnosed with lung cancer (n = 11), and people who were at heightened risk of developing the disease (n = 14).
Methods
A grounded theory methodology was drawn upon to conduct thematic and narrative based approaches to analysis.
Results
The paper focuses on three main themes which emerged from the study: i) fatalism and resignation in pathways to help-seeking and the process of diagnosis; ii) Awareness of smoking risk and response to cessation information and advice. iii) The role of social and other networks on help-seeking. Key findings included: poor awareness among participants of the symptoms of lung cancer; ambivalence about the dangers of smoking; the perception of lung cancer as part of a homogenisation of multiple illnesses; close social networks as a key trigger in help-seeking.
Conclusions
We suggest that future smoking cessation and lung cancer awareness campaigns could usefully capitalise on the influence of close social networks, and would benefit from taking a ‘softer’ approach.
doi:10.1186/1471-2458-14-1043
PMCID: PMC4209024  PMID: 25293382
4.  Qualitative Meta-Synthesis of User Experience of Computerised Therapy for Depression and Anxiety 
PLoS ONE  2014;9(1):e84323.
Objective
Computerised therapies play an integral role in efforts to improve access to psychological treatment for patients with depression and anxiety. However, despite recognised problems with uptake, there has been a lack of investigation into the barriers and facilitators of engagement. We aimed to systematically review and synthesise findings from qualitative studies of computerised therapies, in order to identify factors impacting on engagement.
Method
Systematic review and meta-synthesis of qualitative studies of user experiences of computer delivered therapy for depression and/or anxiety.
Results
8 studies were included in the review. All except one were of desktop based cognitive behavioural treatments. Black and minority ethnic and older participants were underrepresented, and only one study addressed users with a co-morbid physical health problem. Through synthesis, we identified two key overarching concepts, regarding the need for treatments to be sensitive to the individual, and the dialectal nature of user experience, with different degrees of support and anonymity experienced as both positive and negative. We propose that these factors can be conceptually understood as the ‘non-specific’ or ‘common’ factors of computerised therapy, analogous to but distinct from the common factors of traditional face-to-face therapies.
Conclusion
Experience of computerised therapy could be improved through personalisation and sensitisation of content to individual users, recognising the need for users to experience a sense of ‘self’ in the treatment which is currently absent. Exploiting the common factors of computerised therapy, through enhancing perceived connection and collaboration, could offer a way of reconciling tensions due to the dialectal nature of user experience. Future research should explore whether the findings are generalisable to other patient groups, to other delivery formats (such as mobile technology) and other treatment modalities beyond cognitive behaviour therapy. The proposed model could aid the development of enhancements to current packages to improve uptake and support engagement.
doi:10.1371/journal.pone.0084323
PMCID: PMC3894944  PMID: 24465404
5.  Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial 
Objective To determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care.
Design Pragmatic, two arm, cluster randomised controlled trial.
Setting General practices, serving a population in northwest England with high levels of deprivation.
Participants 5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices).
Intervention Practice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation.
Main outcome measures Primary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement.
Results We randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference.
Conclusions An intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients’ everyday lives.
Trial registration Current Controlled Trials ISRCTN90940049.
doi:10.1136/bmj.f2882
PMCID: PMC3652644  PMID: 23670660
6.  Social Networks, the ‘Work’ and Work Force of Chronic Illness Self-Management: A Survey Analysis of Personal Communities 
PLoS ONE  2013;8(4):e59723.
Self-management support forms a central aspect of chronic Illness management nationally and globally. Evidence for the success of self-management support has mainly focussed on individually-centred outcomes of behavioural change. While it is recognised that social network members play an important role there is currently a gap in knowledge regarding who provides what type of support and under what circumstances. This is relevant for understanding the division of labour and the meeting of needs for those living with a long-term condition. We therefore took a network approach to explore self-management support conceptualising it as types of illness ‘work’ undertaken within peoples’ social networks. 300 people from deprived areas and with chronic illnesses took part in a survey conducted in 2010 in the North West of England. A concentric circles diagram was used as a research tool with which participants identified 2,544 network members who contributed to illness management. The results provide an articulation of how social network members are substantially involved in illness management. Whilst partners and close family make the highest contributions there is evidence of inputs from a wide range of relationships. Network member characteristics (type of relationship, proximity, frequency of contact) impact on the amount of illness work undertaken in peoples’ networks. In networks with ‘no partner’ other people tend to contribute more in the way of illness related work than in networks with a partner. This indicates a degree of substitutability between differently constituted networks, and that the level and type of input by different members of a network might change according to circumstances. A network perspective offers an opportunity to redress the balance of an exclusively individual focus on self-management because it addresses the broader set of contributions and resources available to people in need of chronic illness management and support.
doi:10.1371/journal.pone.0059723
PMCID: PMC3615067  PMID: 23565162
7.  Experience of contractual change in UK general practice: a qualitative study of salaried GPs 
The British Journal of General Practice  2012;62(597):e282-e287.
Background
General practice in the UK underwent major change in 2004, with the introduction of new contracts and a significant element of pay for performance. Although salaried GPs form an increasing proportion of the general practice workforce, little is known of their experiences.
Aim
To explore the views and experiences of salaried GPs working in English general practice.
Design and setting
Qualitative study using semi-structured interviews in 17 practices across England, between July 2007 and September 2009.
Method
Interviews were conducted with 23 salaried GPs. A topic guide included questions on motivations for a career in general practice, descriptions of their daily working environment and duties, practice relationships, and future aspirations.
Results
The new ability to opt out of out-of-hours responsibilities was deemed positive for the profession but not a major driver for choosing medical speciality. Views regarding the impact of the Quality and Outcomes Framework were ambivalent. Differences in pay were regarded as largely reflective of differences in responsibility between salaried GPs and principals. Most participants reported conducting varied work in collaborative practices. Participants held varying career aspirations.
Conclusion
Salaried GPs' working experiences were dependent upon personal aspirations and local context. Most salaried GPs were reportedly content with their current position but many also had aspirations of eventually attaining GP principal status. The current lack of available partnerships threatens to undo recent positive workforce progress and may lead to deep dissatisfaction within the profession and a future workforce crisis. Further large-scale quantitative work is required to assess the satisfaction and future expectations of those in salaried posts.
doi:10.3399/bjgp12X636128
PMCID: PMC3310035  PMID: 22520916
general practice; primary care; workforce
8.  An organisational analysis of the implementation of telecare and telehealth: the whole systems demonstrator 
Background
To investigate organisational factors influencing the implementation challenges of redesigning services for people with long term conditions in three locations in England, using remote care (telehealth and telecare).
Methods
Case-studies of three sites forming the UK Department of Health’s Whole Systems Demonstrator (WSD) Programme. Qualitative research techniques were used to obtain data from various sources, including semi-structured interviews, observation of meetings over the course programme and prior to its launch, and document review. Participants were managers and practitioners involved in the implementation of remote care services.
Results
The implementation of remote care was nested within a large pragmatic cluster randomised controlled trial (RCT), which formed a core element of the WSD programme. To produce robust benefits evidence, many aspect of the trial design could not be easily adapted to local circumstances. While remote care was successfully rolled-out, wider implementation lessons and levels of organisational learning across the sites were hindered by the requirements of the RCT.
Conclusions
The implementation of a complex innovation such as remote care requires it to organically evolve, be responsive and adaptable to the local health and social care system, driven by support from front-line staff and management. This need for evolution was not always aligned with the imperative to gather robust benefits evidence. This tension needs to be resolved if government ambitions for the evidence-based scaling-up of remote care are to be realised.
doi:10.1186/1472-6963-12-403
PMCID: PMC3532839  PMID: 23153014
Telecare; Telehealth; Whole system redesign; Organisational change; Adoption; Implementation; Ethnographic methods
9.  Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: a qualitative study 
Background
Telehealth (TH) and telecare (TC) interventions are increasingly valued for supporting self-care in ageing populations; however, evaluation studies often report high rates of non-participation that are not well understood. This paper reports from a qualitative study nested within a large randomised controlled trial in the UK: the Whole System Demonstrator (WSD) project. It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial.
Methods
Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention (n = 19), or who withdrew from the intervention arm (n = 3). Participants were recruited from the four trial groups (with diabetes, chronic obstructive pulmonary disease, heart failure, or social care needs); and all came from the three trial areas (Cornwall, Kent, east London). Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home. Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes.
Results
Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes: requirements for technical competence and operation of equipment; threats to identity, independence and self-care; expectations and experiences of disruption to services. Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderstandings. Respondents’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance, and views that interventions could undermine self-care and coping. Finally, participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued.
Conclusions
These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake. These insights have implications for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction. It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation.
doi:10.1186/1472-6963-12-220
PMCID: PMC3413558  PMID: 22834978
Telehealth; Telecare; Patients’ perspectives; Non-adoption; Non-participation; Barriers; Qualitative research; Whole System Demonstrator
10.  A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol 
Background
Patients with long-term conditions are increasingly the focus of quality improvement activities in health services to reduce the impact of these conditions on quality of life and to reduce the burden on care utilisation. There is significant interest in the potential for self-management support to improve health and reduce utilisation in these patient populations, but little consensus concerning the optimal model that would best provide such support. We describe the implementation and evaluation of self-management support through an evidence-based 'whole systems' model involving patient support, training for primary care teams, and service re-organisation, all integrated into routine delivery within primary care.
Methods
The evaluation involves a large-scale, multi-site study of the implementation, effectiveness, and cost-effectiveness of this model of self-management support using a cluster randomised controlled trial in patients with three long-term conditions of diabetes, chronic obstructive pulmonary disease (COPD), and irritable bowel syndrome (IBS). The outcome measures include healthcare utilisation and quality of life. We describe the methods of the cluster randomised trial.
Discussion
If the 'whole systems' model proves effective and cost-effective, it will provide decision-makers with a model for the delivery of self-management support for populations with long-term conditions that can be implemented widely to maximise 'reach' across the wider patient population.
Trial registration number
ISRCTN: ISRCTN90940049
doi:10.1186/1748-5908-7-7
PMCID: PMC3274470  PMID: 22280501
11.  A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial 
Background
It is expected that increased demands on services will result from expanding numbers of older people with long-term conditions and social care needs. There is significant interest in the potential for technology to reduce utilisation of health services in these patient populations, including telecare (the remote, automatic and passive monitoring of changes in an individual's condition or lifestyle) and telehealth (the remote exchange of data between a patient and health care professional). The potential of telehealth and telecare technology to improve care and reduce costs is limited by a lack of rigorous evidence of actual impact.
Methods/Design
We are conducting a large scale, multi-site study of the implementation, impact and acceptability of these new technologies. A major part of the evaluation is a cluster-randomised controlled trial of telehealth and telecare versus usual care in patients with long-term conditions or social care needs. The trial involves a number of outcomes, including health care utilisation and quality of life. We describe the broad evaluation and the methods of the cluster randomised trial
Discussion
If telehealth and telecare technology proves effective, it will provide additional options for health services worldwide to deliver care for populations with high levels of need.
Trial Registration
Current Controlled Trials ISRCTN43002091
doi:10.1186/1472-6963-11-184
PMCID: PMC3169462  PMID: 21819569
12.  Social networks, work and network-based resources for the management of long-term conditions: a framework and study protocol for developing self-care support 
Background
Increasing the effective targeting and promotion of self-care support for long-term conditions requires more of a focus on patient contexts and networks. The aim of this paper is to describe how within a programme of research and implementation, social networks are viewed as being centrally involved in the mobilisation and deployment of resources in the management of a chronic condition. This forms the basis of a novel approach to understanding, designing, and implementing new forms of self-management support.
Methods
Drawing on evidence syntheses about social networks and capital and the role of information in self-management, we build on four conceptual approaches to inform the design of our research on the implementation of self-care support for people with long-term conditions. Our approach takes into consideration the form and content of social networks, notions of chronic illness work, normalisation process theory (NPT), and the whole systems informing self-management engagement (WISE) approach to self-care support.
Discussion
The translation and implementation of a self-care agenda in contemporary health and social context needs to acknowledge and incorporate the resources and networks operating in patients' domestic and social environments and everyday lives. The latter compliments the focus on healthcare settings for developing and delivering self-care support by viewing communities and networks, as well as people suffering from long-term conditions, as a key means of support for managing long-term conditions. By focusing on patient work and social-network provision, our aim is to open up a second frontier in implementation research, to translate knowledge into better chronic illness management, and to shift the emphasis towards support that takes place outside formal health services.
doi:10.1186/1748-5908-6-56
PMCID: PMC3120720  PMID: 21619695
13.  Unstated factors in orthopaedic decision-making: a qualitative study 
Background
Total joint replacement (TJR) of the hip or knee for osteoarthritis is among the most common elective surgical procedures. There is some inequity in provision of TJR. How decisions are made about who will have surgery may contribute to disparities in provision. The model of shared decision-making between patients and clinicians is advocated as an ideal by national bodies and guidelines. However, we do not know what happens within orthopaedic practice and whether this reflects the shared model. Our study examined how decisions are made about TJR in orthopaedic consultations.
Methods
The study used a qualitative research design comprising semi-structured interviews and observations. Participants were recruited from three hospital sites and provided their time free of charge. Seven clinicians involved in decision-making about TJR were approached to take part in the study, and six agreed to do so. Seventy-seven patients due to see these clinicians about TJR were approached to take part and 26 agreed to do so. The patients' outpatient appointments ('consultations') were observed and audio-recorded. Subsequent interviews with patients and clinicians examined decisions that were made at the appointments. Data were analysed using thematic analysis.
Results
Clinical and lifestyle factors were central components of the decision-making process. In addition, the roles that patients assigned to clinicians were key, as were communication styles. Patients saw clinicians as occupying expert roles and they deferred to clinicians' expertise. There was evidence that patients modified their behaviour within consultations to complement that of clinicians. Clinicians acknowledged the complexity of decision-making and provided descriptions of their own decision-making and communication styles. Patients and clinicians were aware of the use of clinical and lifestyle factors in decision-making and agreed in their description of clinicians' styles. Decisions were usually reached during consultations, but patients and clinicians sometimes said that treatment decisions had been made beforehand. Some patients expressed surprise about the decisions made in their consultations, but this did not necessarily imply dissatisfaction.
Conclusions
The way in which roles and communication are played out in decision-making for TJR may affect the opportunity for shared decisions. This may contribute to variation in the provision of TJR. Making the importance of these factors explicit and highlighting the existence of patients' 'surprise' about consultation outcomes could empower patients within the decision-making process and enhance communication in orthopaedic consultations.
doi:10.1186/1471-2474-11-213
PMCID: PMC2954986  PMID: 20849636
14.  Creating 'good' self-managers?: Facilitating and governing an online self care skills training course 
Background
In chronic disease management, patients are increasingly called upon to undertake a new role as lay tutors within self-management training programmes. The internet constitutes an increasingly significant healthcare setting and a key arena for self-management support and communication. This study evaluates how a new quasi-professional health workforce – volunteer tutors – engage, guide and attempt to manage people with long-term conditions in the ways of 'good' self-management within the context of an online self-management course.
Methods
A qualitative analysis of postings to the discussion centre of 11 online classes (purposively selected from 27) run as part of the Expert Patients Programme. Facilitators (term for tutors online) and participants posted questions, comments and solutions related to self-management of long-term conditions; these were subjected to a textual and discursive analysis to explore:
a) how facilitators, through the internet, engaged participants in issues related to self-management;
b) how participants responded to and interacted with facilitators.
Results
Emergent themes included: techniques and mechanisms used to engage people with self-management; the process facilitators followed – 'sharing', 'modelling' and 'confirming'; and the emergence of a policing role regarding online disclosure. Whilst exchanging medical advice was discouraged, facilitators often professed to understand and give advice on psychological aspects of behaviour.
Conclusion
The study gave an insight into the roles tutors adopt – one being their ability to 'police' subjective management of long-term conditions and another being to attempt to enhance the psychological capabilities of participants.
doi:10.1186/1472-6963-9-93
PMCID: PMC2699343  PMID: 19505302
15.  Factors associated with change in pain and disability over time: a community-based prospective observational study of hip and knee osteoarthritis 
Background
Hip and knee osteoarthritis are frequent causes of primary care consultations. They are considered slowly progressive disorders, often resulting in severe pain or disability and the need for joint replacements. There have been few longitudinal studies of progression to inform individual prognoses in primary care.
Aim
To describe the degree of progression and investigate predictors of change in hip or knee pain and disability.
Design of study
Prospective community-based cohort.
Setting
An age–sex stratified survey of 27 000 people registered with 40 general practices in Avon and Somerset yielded 2437 reporting hip and/or knee symptoms at baseline (1992–1994). A 25% random sample of 587 individuals was followed up between 1998 and 1999.
Method
Pain or disability was measured at baseline and follow-up using the New Zealand score. For the worst joint according to the New Zealand score at baseline, hip and knee problems were analysed separately. Regression models ascertained characteristics of non-responders and factors associated with change in scores. Seven sociodemographic, seven comorbidity, and two healthcare utilisation variables were considered.
Results
Generally pain and disability worsened over the 7 years, but 35% and 29% of those initially reporting hip and knee pain respectively had improved. Reporting ‘other health problems’ was associated with greater deterioration for both hip and knee disease, as was cardiovascular morbidity for hip disease and lower social class, being retired, hypertension, and higher body mass index for knee disease. Deteriorations in scores were strongly associated with individuals consulting their GP about joint problems.
Conclusion
Osteoarthritis does not invariably deteriorate, but when it does social as well as biological factors appear to be important. These findings may aid outcome prediction. Future research on osteoarthritis should be conducted within a biopsychosocial rather than a purely biological paradigm.
PMCID: PMC1463091  PMID: 15808036
disability evaluation; disease progression; New Zealand score; osteoarthritis; pain; projections and predictions
16.  Reporting on quality of life in randomised controlled trials: bibliographic study 
BMJ : British Medical Journal  1998;317(7167):1191-1194.
Objectives
To examine the frequency and quality of reporting on quality of life in randomised controlled trials.
Design
Search of the Cochrane Controlled Trials Register 1980 to 1997 to identify trials from all disciplines, from oncology, and from cardiovascular medicine that reported on quality of life. Assessment of abstracts from articles published from 1993 to 1996. Assessment of a sample of full reports with a standardised instrument.
Main outcome measures
Prevalence of reporting on quality of life. Conditions and interventions studied in trials reporting on quality of life. Quality of reporting on quality of life.
Results
During 1980-97 reporting on quality of life increased from 0.63% to 4.2% for trials from all disciplines, from 1.5% to 8.2% for cancer trials, and from 0.34% to 3.6% for cardiovascular trials. Of 364 abstracts, 65% reported on drug interventions. Of a sample of 67 full reports, authors of 48 (72%) used 62 established quality of life instruments. In 15 reports (22%) authors developed their own measures, and in 2 (3%) methods were unclear. Response rates were given in 38 (57%), and complete reporting on all items and scales occurred in 31 (46%).
Conclusions
Less than 5% of all randomised controlled trials reported on quality of life, and this proportion was below 10% even for cancer trials. A plethora of instruments was used in different studies, and the reporting of methods and results was often inadequate. Standards for the measurement and reporting of quality of life in clinical trials research need to be developed.
Key messagesWe examined the reporting on quality of life in randomised controlled trials listed in the Cochrane Controlled Trials RegisterAlthough reporting on quality of life increased over time, fewer than 5% of trials overall and fewer than 10% of cancer trials included quality of life in 1997Among 67 articles selected at random for detailed examination, a wide range of established and self developed measures of quality of life were usedOnly about half of trials gave response rates, and less than half reported on all items and scales usedStandards for assessing and reporting quality of life in clinical research trials need to be developed
PMCID: PMC28701  PMID: 9794853
17.  UK guidance on the initial evaluation of an infant or an adolescent with a suspected disorder of sex development 
Clinical Endocrinology  2011;75(1):12-26.
It is paramount that any child or adolescent with a suspected disorder of sex development (DSD) is assessed by an experienced clinician with adequate knowledge about the range of conditions associated with DSD. If there is any doubt, the case should be discussed with the regional team. In most cases, particularly in the case of the newborn, the paediatric endocrinologist within the regional DSD team acts as the first point of contact. The underlying pathophysiology of DSD and the strengths and weaknesses of the tests that can be performed should be discussed with the parents and affected young person and tests undertaken in a timely fashion. This clinician should be part of a multidisciplinary team experienced in management of DSD and should ensure that the affected person and parents are as fully informed as possible and have access to specialist psychological support. Finally, in the field of rare conditions, it is imperative that the clinician shares the experience with others through national and international clinical and research collaboration.
doi:10.1111/j.1365-2265.2011.04076.x
PMCID: PMC3132446  PMID: 21521344
18.  Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial  
Objective To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions.
Design A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively.
Setting Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems.
Participants Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009.
Main outcome measures Generic, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale).
Results In the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480≤P≤0.904) or available case (0.181≤P≤0.905) cohorts. The magnitude of differences between trial arms did not reach the trial defined, minimal clinically important difference (0.3 standardised mean difference) for any outcome in either cohort at four or 12 months. Per protocol analyses replicated the primary analyses; the main effect of trial arm (telehealth v usual care) was non-significant for any outcome (complete case cohort 0.273≤P≤0.761; available case cohort 0.145≤P≤0.696).
Conclusions Second generation, home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not effective or efficacious compared with usual care only. Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease, diabetes, or heart failure over 12 months. The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients.
Trial Registration ISRCTN43002091.
doi:10.1136/bmj.f653
PMCID: PMC3582704  PMID: 23444424

Results 1-18 (18)