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1.  Patient and practitioners’ views on the most important outcomes arising from primary care consultations: a qualitative study 
BMC Family Practice  2015;16:108.
Primary care clinicians often address multiple patient problems, with a range of possible outcomes. There is currently no patient-reported outcome measure (PROM) which covers this range of outcomes. Consequently, many researchers use PROMs that do not capture the full impact of primary care services. In order to identify what outcomes a PROM for primary care would need to include, we conducted interviews with patients and practitioners. This paper reports these patient and practitioners’ views on the outcomes arising from primary care consultations.
Semi-structured interviews were held with 30 patients and eight clinicians across five sites in Bristol. Interviews were audio-recorded, transcribed and analysed thematically. We used a broad definition of health outcome as ‘the impacts of healthcare on health, or a patient’s ability to impact health’ to identify outcomes through this process.
10 outcome groups were identified. These occupied 3 domains:
Health Empowerment: These are the internal and external resources which enable patients to improve their health. This involves 1) patients’ understanding of their illnesses, 2) ability to self-care and stay healthy, 3) agreeing and adhering to a patient-clinician shared plan, 4) confidence in seeking healthcare and 5) access to support.
Health Status: This involves 6) reduction of symptoms and 7) reducing the impact of symptoms on patients’ lives.
Health Perceptions: This involves 8) patients’ satisfaction with their health, 9) health concerns, and 10) confidence in their future health.
The structure, organisation and nature of primary care means it can affect all 3 domains.
No existing PROM captures all these outcomes. For example, many health empowerment PROMs do not consider patient preference on empowerment. Many health status tools are not responsive to changes resulting from primary care. Health perceptions PROMs have generally been designed for measuring personality traits rather than outcomes.
This study provides a platform for designing a new PROM containing outcomes that matter to patients and can be influenced by primary care. Such a PROM would greatly enhance the value of primary care research.
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-015-0323-9) contains supplementary material, which is available to authorized users.
PMCID: PMC4546201  PMID: 26297232
2.  Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial 
Trials  2015;16:304.
Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for ‘flares’, such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time?
This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants.
Recruitment is on-going. At the end of the study, as well as being able to answer the question, ‘Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?’, we will also have collected important data on the acceptability and effectiveness of four commonly used emollients.
Trial registration
Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0830-y) contains supplementary material, which is available to authorized users.
PMCID: PMC4501045  PMID: 26170126
children; eczema; emollients; feasibility; primary care; RCT
3.  Can oral corticosteroids reduce the severity or duration of an acute cough, and the associated National Health Service and societal costs, in adults presenting to primary care? Study protocol for a randomised controlled trial 
Trials  2015;16:78.
Acute lower respiratory tract infection (LRTI) is one of the most common conditions managed internationally and is costly to health services and patients. Despite good evidence that antibiotics are not effective for improving the symptoms of uncomplicated LRTI, they are widely prescribed, contributing to antimicrobial resistance. Many of the symptoms observed in LRTI are mediated by inflammatory processes also observed in exacerbations of asthma, for which there is strong evidence of corticosteroid effectiveness. The primary aim of the OSAC (Oral Steroids for Acute Cough) Trial is to determine whether oral prednisolone (40 mg daily for 5 days) can reduce the duration of moderately bad (or worse) cough and the severity of all its associated symptoms on days 2 to 4 post-randomisation (day 1 is trial entry) by at least 20% in adults ≥18 years with acute LRTI presenting to primary care.
OSAC is a two-arm, multi-centre, placebo-controlled, randomised superiority trial. The target sample size is 436 patients, which allows for a 20% dropout rate. Patients will be recruited from primary care sites (General Practitioner surgeries) across England and followed up until symptom resolution. The two primary clinical outcomes are the duration of moderately bad (or worse) cough, and the severity of all its associated symptoms on days 2 to 4 post-randomisation. Secondary outcomes include: antibiotic consumption; symptom burden; adverse events; participant satisfaction with treatment and intention to consult for future similar illnesses. A parallel economic evaluation will investigate the cost-effectiveness of the intervention.
Results from the OSAC trial will increase knowledge regarding the clinical and cost-effectiveness of corticosteroids for LRTI, and will establish the potential of a new treatment option that could substantially improve patient health. We have chosen a relatively high ‘efficacy dose’ as this will enable us to decide on the potential for further research into lower dose oral and/or inhaled corticosteroids. This trial will also contribute to a growing body of research investigating the natural course of this very common illness, as well as the effects of steroids on the undesirable inflammatory symptoms associated with infection.
Trial registration
Current Controlled Trials ISRCTN57309858 (31 January 2013).
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0569-5) contains supplementary material, which is available to authorized users.
PMCID: PMC4358709  PMID: 25885677
Acute cough; Lower respiratory tract infection; Oral steroids; Corticosteroids; Prednisolone; Randomised controlled trial; Efficacy; Cost-effectiveness
4.  TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation 
BMJ Open  2015;5(2):e006448.
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.
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.
Primary care.
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.
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.
PMCID: PMC4322202  PMID: 25659890
5.  Keep it simple? Predicting primary health care costs with clinical morbidity measures 
Journal of Health Economics  2014;35(100):109-122.
•Clinical measures greatly increase the predictive power of primary care cost models.•Counts of diseases perform better than complex multimorbidity measures.•Capitation for given patient types varies strongly with the morbidity measure.•Gains from patient selection are substantial with all morbidity measures.•Pro poor horizontal inequity is smaller the better fitting the cost model.
Models of the determinants of individuals’ primary care costs can be used to set capitation payments to providers and to test for horizontal equity. We compare the ability of eight measures of patient morbidity and multimorbidity to predict future primary care costs and examine capitation payments based on them. The measures were derived from four morbidity descriptive systems: 17 chronic diseases in the Quality and Outcomes Framework (QOF); 17 chronic diseases in the Charlson scheme; 114 Expanded Diagnosis Clusters (EDCs); and 68 Adjusted Clinical Groups (ACGs). These were applied to patient records of 86,100 individuals in 174 English practices. For a given disease description system, counts of diseases and sets of disease dummy variables had similar explanatory power. The EDC measures performed best followed by the QOF and ACG measures. The Charlson measures had the worst performance but still improved markedly on models containing only age, gender, deprivation and practice effects. Comparisons of predictive power for different morbidity measures were similar for linear and exponential models, but the relative predictive power of the models varied with the morbidity measure. Capitation payments for an individual patient vary considerably with the different morbidity measures included in the cost model. Even for the best fitting model large differences between expected cost and capitation for some types of patient suggest incentives for patient selection. Models with any of the morbidity measures show higher cost for more deprived patients but the positive effect of deprivation on cost was smaller in better fitting models.
PMCID: PMC4051993  PMID: 24657375
Primary care; Costs; Horizontal equity; Capitation; Risk rating
6.  Implications of comorbidity for primary care costs in the UK: a retrospective observational study 
The British Journal of General Practice  2013;63(609):e274-e282.
Comorbidity is increasingly common in primary care. The cost implications for patient care and budgetary management are unclear.
To investigate whether caring for patients with specific disease combinations increases or decreases primary care costs compared with treating separate patients with one condition each.
Retrospective observational study using data on 86 100 patients in the General Practice Research Database.
Annual primary care cost was estimated for each patient including consultations, medication, and investigations. Patients with comorbidity were defined as those with a current diagnosis of more than one chronic condition in the Quality and Outcomes Framework. Multiple regression modelling was used to identify, for three age groups, disease combinations that increase (cost-increasing) or decrease (cost-limiting) cost compared with treating each condition separately.
Twenty per cent of patients had at least two chronic conditions. All conditions were found to be both cost-increasing and cost-limiting when co-occurring with other conditions except dementia, which is only cost-limiting. Depression is the most important cost-increasing condition when co-occurring with a range of conditions. Hypertension is cost-limiting, particularly when co-occurring with other cardiovascular conditions.
Three categories of comorbidity emerge, those that are: cost-increasing, mainly due to a combination of depression with physical comorbidity; cost-limiting because treatment for the conditions overlap; and cost-limiting for no apparent reason but possibly because of inadequate care. These results can contribute to efficient and effective management of chronic conditions in primary care.
PMCID: PMC3609475  PMID: 23540484
comorbidity; costs and cost analysis; delivery of health care; depression; family practice; resource allocation
7.  Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials 
Trials  2014;15:36.
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.
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.
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.
PMCID: PMC3906859  PMID: 24460845
Cardiovascular disease risk; Depression; Randomized controlled trial; Telehealth
9.  A pragmatic randomised controlled trial of ‘PhysioDirect’ telephone assessment and advice services for patients with musculoskeletal problems: economic evaluation 
BMJ Open  2013;3(10):e003406.
To compare the cost-effectiveness of PhysioDirect with usual physiotherapy care for patients with musculoskeletal problems.
(1) Cost-consequences comparing cost to the National Health Service (NHS), to patients, and the value of lost productivity with a range of outcomes. (2) Cost-utility analysis comparing cost to the NHS with Quality-Adjusted Life Years (QALYs).
Four physiotherapy services in England.
Adults (18+) referred by their general practitioner or self-referred for physiotherapy.
PhysioDirect involved telephone assessment and advice followed by face-to-face care if needed. Usual care patients were placed on a waiting list for face-to-face care.
Primary and secondary outcomes
Primary clinical outcome: physical component summary from the SF-36v2 at 6 months. Also included in the cost-consequences: Measure Yourself Medical Outcomes Profile; a Global Improvement Score; response to treatment; patient satisfaction; waiting time. Outcome for the cost-utility analysis: QALYs.
2249 patients took part (1506 PhysioDirect; 743 usual care). (1) Cost-consequences: there was no evidence of a difference between the two groups in the cost of physiotherapy, other NHS services, personal costs or value of time off work. Outcomes were also similar. (2) Cost-utility analysis based on complete cases (n=1272). Total NHS costs, including the cost of physiotherapy were higher in the PhysioDirect group by £19.30 (95% CI −£37.60 to £76.19) and there was a QALY gain of 0.007 (95% CI −0.003 to 0.016). The incremental cost-effectiveness ratio was £2889 and the net monetary benefit at λ=£20 000 was £117 (95% CI −£86 to £310).
PhysioDirect may be a cost-effective alternative to usual physiotherapy care, though only with careful management of staff time. Physiotherapists providing the service must be more fully occupied than was possible under trial conditions: consideration should be given to the scale of operation, opening times of the service and flexibility in the methods used to contact patients.
PMCID: PMC3796275  PMID: 24091423
economic evaluation; physiotherapy; telehealth; PRIMARY CARE; costs & cost analysis
10.  Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial 
Trials  2013;14:221.
Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations.
Methods and study design
This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up.
This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group.
Trial registration
PMCID: PMC3718639  PMID: 23866771
11.  A comparison of four different approaches to measuring health utility in depressed patients 
A variety of instruments are used to measure health related quality of life. Few data exist on the performance and agreement of different instruments in a depressed population. The aim of this study was to investigate agreement between, and suitability of, the EQ-5D-3L, EQ-5D Visual Analogue Scale (EQ-5D VAS), SF-6D and SF-12 new algorithm for measuring health utility in depressed patients.
The intraclass correlation coefficient (ICC) and Bland and Altman approaches were used to assess agreement. Instrument sensitivity was analysed by: (1) plotting utility scores for the instruments against one another; (2) correlating utility scores and depressive symptoms (Beck Depression Inventory (BDI)); and (3) using Tukey’s procedure. Receiver Operating Characteristic (ROC) analysis assessed instrument responsiveness to change. Acceptability was assessed by comparing instrument completion rates.
The overall ICC was 0.57. Bland and Altman plots showed wide limits of agreement for each pair wise comparison, except between the SF-6D and SF-12 new algorithm. Plots of utility scores displayed ’ceiling effects’ in the EQ-5D-3L index and ’floor effects’ in the SF-6D and SF-12 new algorithm. All instruments showed a negative monotonic relationship with BDI, but the EQ-5D-3L index and EQ-5D VAS could not differentiate between depression severity sub-groups. The SF-based instruments were better able to detect changes in health state over time. There was no difference in completion rates of the four instruments.
There was a lack of agreement between utility scores generated by the different instruments. According to the criteria of sensitivity, responsiveness and acceptability that we applied, the SF-6D and SF-12 may be more suitable for the measurement of health related utility in a depressed population than the EQ-5D-3L, which is the instrument currently recommended by NICE.
PMCID: PMC3663709  PMID: 23659557
Depression; EQ-5D; SF-6D; Health related utility; QALYs
12.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation 
Objective An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain.
Design Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial.
Participants 579 patients with chronic or recurrent low back pain recruited from primary care.
Interventions Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse.
Main outcome measures Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves.
Results Intervention costs ranged from £30 for exercise prescription to £596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from £50 for 24 lessons in Alexander technique to £124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value (£61 per point on disability score, £9 per additional pain-free day, £2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional £64 per point on disability score, £43 per additional pain-free day, £5332 per QALY gain).
Conclusions An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above £20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.
PMCID: PMC3272680  PMID: 19074232
13.  The impact of co‐located NHS walk‐in centres on emergency departments 
Emergency Medicine Journal : EMJ  2007;24(4):265-269.
To determine the impact of establishing walk‐in centres alongside emergency departments (EDs) on attendance rates, visit duration, process, costs and outcome of care.
Eight hospitals with co‐located EDs and walk‐in centres were compared with eight matched EDs without walk‐in centres. Site visits were conducted. Routine data about attendance numbers and use of resources were analysed. A random sample of records of patients attending before and after the opening of walk‐in centres was also assessed. Patients who had not been admitted to hospital were sent a postal questionnaire.
At most sites, the walk‐in centres did not have a distinct identity and there were few differences in the way services were provided compared with control sites. Overall, there was no evidence of an increase in attendance at sites with walk‐in centres, but considerable variability across sites was found. The proportion of patients managed within the 4 h National Health Service target improved at sites both with and without walk‐in centres. There was no evidence of any difference in reconsultation rates, costs of care or patient outcomes at sites with or without walk‐in centres.
Most hospitals in this study implemented the walk‐in centre concept to a very limited extent. Consequently, there was no evidence of any effect on attendance rates, process, costs or outcome of care.
PMCID: PMC2658232  PMID: 17384380
14.  Comparing care at walk‐in centres and at accident and emergency departments: an exploration of patient choice, preference and satisfaction 
Emergency Medicine Journal : EMJ  2007;24(4):260-264.
To explore the impact of establishing walk‐in centres alongside emergency departments on patient choice, preference and satisfaction.
A controlled, mixed‐method study comparing 8 emergency departments with co‐located walk‐in centres with the same number of “traditional” emergency departments. This paper focuses on the results of a cross‐sectional questionnaire survey of users.
Survey data demonstrated that patients were frequently unable to distinguish between being treated at a walk‐in centre or at an accident and emergency (A&E) department and, even where this was the case, opportunities to exercise choice about their preferred care provider were often limited. Few made an active choice to attend a co‐located walk‐in centre. Patients attending walk‐in centres were just as likely to be satisfied overall with the care they received as their counterparts who were treated in the co‐located A&E facility, although walk‐in centre users reported greater satisfaction with some specific aspects of their care and consultation.
Whereas one of the key policy goals underpinning the co‐location of walk‐in centres next to an A&E department was to provide patients with more options for accessing healthcare and greater choice, leading in turn to increased satisfaction, this evaluation was able to provide little evidence to support this. The high percentage of patients expressing a preference for care in an established emergency department compared with that in a new walk‐in centre facility raises questions for future policy development. Further consideration should therefore be given to the role that A&E‐focused walk‐in centres play in the Department of Health's current policy agenda, as far as patient choice is concerned.
PMCID: PMC2658231  PMID: 17384379
15.  'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial 
Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect.
This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined.
Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost.
Qualitative methods will be used to explore factors associated with the success or failure of the service, the acceptability of PhysioDirect to patients and staff, and ways in which the service could be improved.
It is still relatively unusual to evaluate new forms of service delivery using randomised controlled trials. By combining rigorous trial methods with economic analysis of cost-effectiveness and qualitative research this study will provide robust evidence to inform decisions about the widespread introduction of PhysioDirect services.
Trial registration
Current Controlled Trials ISRCTN55666618
PMCID: PMC2729308  PMID: 19650913
16.  Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial 
Objective To estimate the cost to the NHS and to parents and carers of treating febrile preschool children with paracetamol, ibuprofen, or both, and to compare these costs with the benefits of each treatment regimen.
Design Cost consequences analysis and cost effectiveness analysis conducted as part of a three arm, randomised controlled trial.
Participants Children between the ages of 6 months and 6 years recruited from primary care and the community with axillary temperatures ≥37.8°C and ≤41°C.
Interventions Paracetamol, ibuprofen, or both drugs.
Main outcome measures Costs to the NHS and to parents and carers. Cost consequences analysis at 48 hours and 5 days comparing cost with children’s temperature, discomfort, activity, appetite, and sleep; cost effectiveness analysis at 48 hours comparing cost with percentage of children “recovered.”
Results Difficulties in recruiting children to the trial lowered the precision of the estimates of cost and some outcomes. At 48 hours, cost to the NHS was £11.33 for paracetamol, £8.49 for ibuprofen, and £8.16 for both drugs. By day 5 these costs rose to £19.63, £18.36, and £13.92 respectively. For parents and carers, the 48 hour costs were £23.86 for paracetamol, £20.60 for ibuprofen, and £25.07 for both, and the day 5 costs were £26.35, £29.90, and £24.02 respectively. Outcomes measured at 48 hours and 5 days were inconclusive because of lack of power; the cost effectiveness analysis at 48 hours provided little evidence that one treatment choice was significantly more cost effective than another. At 4 hours ibuprofen and the combined treatment were superior to paracetamol in terms of the trial primary outcome of time without fever; at 24 hours the combined treatment performed best on this outcome.
Conclusions There is no strong evidence of a difference in cost between the treatments, but clinical and cost data together indicate that using both drugs together may be most cost effective over the course of the illness. This treatment option performs best and is no more expensive because of less use of healthcare resources, resulting in lower costs to the NHS and to parents.
PMCID: PMC2658467  PMID: 18782838
17.  Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial 
Objective To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home.
Design Individually randomised, blinded, three arm trial.
Setting Primary care and households in England.
Participants Children aged between 6 months and 6 years with axillary temperatures of at least 37.8°C and up to 41.0°C.
Intervention Advice on physical measures to reduce temperature and the provision of, and advice to give, paracetamol plus ibuprofen, paracetamol alone, or ibuprofen alone.
Main outcome measures Primary outcomes were the time without fever (<37.2°C) in the first four hours after the first dose was given and the proportion of children reported as being normal on the discomfort scale at 48 hours. Secondary outcomes were time to first occurrence of normal temperature (fever clearance), time without fever over 24 hours, fever associated symptoms, and adverse effects.
Results On an intention to treat basis, paracetamol plus ibuprofen were superior to paracetamol for less time with fever in the first four hours (adjusted difference 55 minutes, 95% confidence interval 33 to 77; P<0.001) and may have been as good as ibuprofen (16 minutes, −7 to 39; P=0.2). For less time with fever over 24 hours, paracetamol plus ibuprofen were superior to paracetamol (4.4 hours, 2.4 to 6.3; P<0.001) and to ibuprofen (2.5 hours, 0.6 to 4.4; P=0.008). Combined therapy cleared fever 23 minutes (2 to 45; P=0.025) faster than paracetamol alone but no faster than ibuprofen alone (−3 minutes, 18 to −24; P=0.8). No benefit was found for discomfort or other symptoms, although power was low for these outcomes. Adverse effects did not differ between groups.
Conclusion Parents, nurses, pharmacists, and doctors wanting to use medicines to supplement physical measures to maximise the time that children spend without fever should use ibuprofen first and consider the relative benefits and risks of using paracetamol plus ibuprofen over 24 hours.
Trial registration Current Controlled Trials ISRCTN26362730.
PMCID: PMC2528896  PMID: 18765450
18.  Measuring the financial burden of acute cough in pre-school children: a cost of illness study 
BMC Family Practice  2008;9:10.
Context: Acute cough is a very common symptom presentation among children in primary care and is usually due to respiratory infection, yet its cost is unknown. An estimate of the cost to healthcare providers and parents would aid budgetary decision-making, and provide an insight into the need for interventions to reduce the burden. Purpose: To estimate the cost per child per episode, and the annual population cost in the UK, of acute cough in pre-school children presenting to primary care.
Design: Incidence and prevalence-based cost-of-illness study from the perspectives of the UK NHS and of parents and caregivers. Setting: 11 general practices in Bristol, UK. Subjects: 121 children without known asthma aged 3 to 59 months presenting for the first time with an acute (≤ 28 days) cough.
Mean cost per episode to the NHS: £27.43 (95% CI: £24.38 – £30.49). Mean cost per episode to parents and carers: £14.77 (£4.90 – £24.65). Annual cost to the NHS in the UK: at least £31.5 m (95% CI: £28.0 m – £35.0 m).
The cost burden on the healthcare provider of acute cough in pre-school children is substantial; the majority of this cost arises from consultations with general practitioners. Parents experience some personal cost through travel and expenditure on over-the-counter preparations, and may suffer significantly if loss of earnings is experienced. There is scope for evaluating interventions designed to reduce this burden.
PMCID: PMC2253540  PMID: 18237423
19.  Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial 
Trials  2008;9:6.
Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed.
The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease.
Patients with active thyroid eye disease will be randomised to receive (i) azathioprine or oral placebo and (ii) radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure) at 12 months and secondary end-points include quality of life scores and health economic measures.
The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a) robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b) constructing effective inclusion and exclusion criteria to select for active disease; and (c) selecting pragmatic outcome measures.
Trial registration
Current controlled trials ISRCTN22471573
PMCID: PMC2275219  PMID: 18237441
20.  Comparing the cost of nurse practitioners and GPs in primary care: modelling economic data from randomised trials 
The role of nurse practitioners in primary care has recently expanded. While there are some outcome data available for different types of consultations, little is known about the relative cost.
To compare the cost of primary care provided by nurse practitioners with that of salaried GPs.
Design of study
Synthesis, modelling, and analysis of published data from the perspective of general practices and the NHS.
Data sources
Two published randomised controlled trials.
A dataset of resource use for a simulated group of patients in a typical consultation was modelled. Current unit costs were used to obtain a consensus mean cost per consultation.
Mean cost of a nurse practitioner consultation was estimated at £9.46 (95% confidence interval [CI] = £9.16 to £9.75) and for a GP was £9.30 (95% CI = £9.04 to £9.56) according to salary and overheads, that is, from the perspective of general practices. From the NHS perspective, which included training costs, the estimated mean costs were £30.35 (95% CI = £27.10 to £33.59) and £28.14 (95% CI = £25.43 to £30.84) respectively. Sensitivity analysis suggested that the time spent by GPs contributing to nurse practitioners' consultations (including return visits) was an important factor in increasing costs associated with nurse practitioners.
Employing a nurse practitioner in primary care is likely to cost much the same as employing a salaried GP according to currently available data. There is considerable variability of qualifications and experience of nurse practitioners, which suggests that skill-mix decisions should depend on the full range of roles and responsibilities rather than cost.
PMCID: PMC1872064  PMID: 16834880
cost of care; family practice; nurse practitioner; primary health care; skill mix
21.  Targeted routine asthma care in general practice using telephone triage 
There is a high non-attendance rate for traditional clinic-based routine asthma care in general practice. Alternative methods of providing routine asthma care need to be examined.
To examine the cost and effectiveness of targeted routine asthma care in general practice using telephone triage, compared to usual clinic care.
Design of study
An open randomised controlled trial.
A single semi-rural practice in the southwest of England.
Adult patients with asthma were randomised to receive either their routine asthma care in the surgery or care by telephone triage. Asthma control parameters, health status and NHS resource utilisation were measured over the 12-month study period.
One hundred and ninety-four patients were randomised and 35% per cent more patients (n = 84 versus n = 62) received more than one consultation in the telephone group. Asthma control as measured by the asthma control questionnaire (ACQ) was similar in the clinic and telephone groups: mean change in ACQ = −0.11 (95% CI = −0.32 to 0.11) versus −0.18 (95% CI = −0.38 to 0.02). Mean NHS costs were £210 per patient per year in the telephone group compared to £334 in the clinic group (P-value of bootstrapped difference = 0.071).
Targeted routine asthma care by telephone triage of adult asthmatics can lead to more asthma patients being reviewed, at less cost per patient and without loss of asthma control compared to usual routine care in the surgery.
PMCID: PMC1570530  PMID: 16378560
asthma; costs and cost analysis; delivery of health care; primary health care; telephone; triage
23.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain 
Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain.
Design Factorial randomised trial.
Setting 64 general practices in England.
Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription.
Interventions Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling.
Main outcome measures Roland Morris disability score (number of activities impaired by pain) and number of days in pain.
Results Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported.
Conclusions One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.
Trial registration National Research Register N0028108728.
PMCID: PMC3272681  PMID: 18713809
24.  Facilitated physical activity as a treatment for depressed adults: randomised controlled trial 
Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care.
Design Pragmatic, multicentre, two arm parallel randomised controlled trial.
Setting General practices in Bristol and Exeter.
Participants 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more.
Interventions In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity.
Main outcome measures The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up.
Results There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score −0.54 (95% confidence interval −3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003).
Conclusions The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone.
Trial registration Current Controlled Trials ISRCTN16900744.
PMCID: PMC3368484  PMID: 22674921
25.  Effectiveness of PhysioDirect telephone assessment and advice services for patients with musculoskeletal problems: pragmatic randomised controlled trial 
Objectives To assess the clinical effectiveness, effect on waiting times, and patient acceptability of PhysioDirect services in patients with musculoskeletal problems, compared with usual care.
Design Pragmatic randomised controlled trial to assess equivalence in clinical effectiveness. Patients were individually randomised in a 2:1 ratio to PhysioDirect or usual care.
Setting Four physiotherapy services in England.
Participants Adults (aged ≥18 years) referred by general practitioners or self referred for musculoskeletal physiotherapy.
Interventions PhysioDirect services invited patients to telephone a physiotherapist for initial assessment and advice, followed by face-to-face physiotherapy if necessary. Usual care involved patients joining a waiting list for face-to-face treatment.
Main outcome measures Numbers of appointments, waiting time for treatment, and non-attendance rates. Primary outcome was physical health (SF-36v2 physical component score) at six months. Secondary outcomes included four other measures of health outcome, mental component score and scales from the SF-36v2, time lost from work, and patient satisfaction and preference. Participants were not blind to allocation, but outcome data were collected blind to allocation.
Results Of 1506 patients allocated to PhysioDirect and 743 to usual care, 85% provided primary outcome data at six months (1283 and 629 patients, respectively). PhysioDirect patients had fewer face-to-face appointments than usual care patients (mean 1.91 v 3.11; incidence rate ratio 0.59 (95% confidence interval 0.53 to 0.65)), a shorter waiting time (median 7 days v 34 days; arm time ratio 0.32 (0.29 to 0.35)), and lower rates of non-attendance (incidence rate ratio 0.55 (0.41 to 0.73)). After six months’ follow-up, the SF-36v2 physical component score was equivalent between groups (adjusted difference in means −0.01 (−0.80 to 0.79)). Health outcome measures suggested a trend towards slightly greater improvement in the PhysioDirect arm at six week follow-up and no difference at six months. There was no difference in time lost from work. PhysioDirect patients were no more satisfied with access to physiotherapy than usual care patients, but had slightly lower satisfaction overall at six months (difference in satisfaction −3.8% (−7.3% to −0.3%); P=0.031). PhysioDirect patients were more likely than usual care patients to prefer PhysioDirect in future. No adverse events were detected.
Conclusions PhysioDirect is equally clinically effective compared with usual care, provides faster access to physiotherapy, and seems to be safe. However, it could be associated with slightly lower patient satisfaction.
Trial registration Current Controlled Trials ISRCTN55666618.
PMCID: PMC3558547  PMID: 23360891

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