Parents' preferences for nursery care when children are unwell: a discrete choice experiment.

BACKGROUND: Pre-school children's daycare is associated with increased incidence of respiratory and diarrhoeal illnesses. While the incidence might be reduced if all unwell children were kept at home, parental employment pressures make this difficult when children are marginally unwell. METHODS: A discrete choice experiment (DCE) was conducted to identify what aspects of daycare policy and provision would affect parents' decisions to keep marginally unwell children home. Prior qualitative research informed parameter choice. The DCE was accompanied by a best-worst scaling task examining preferences for four modifiable aspects of care: swapping unused daycare sessions, reimbursing unused sessions, daycare paracetamol policy and presence of a 'quiet room'. RESULTS: Paracetamol guidelines and the presence of a quiet room had the strongest predicted influence on parents' decision-making. Conditional on assumptions about the set-up of the daycare, introducing a 'no paracetamol' policy would result in a fall from 62 to 25% in mean predicted probabilities of a parent sending a marginally unwell child to nursery, while introducing a quiet room would increase the mean probability from 34 to 53%. CONCLUSIONS: Daycare policy, particularly the use of paracetamol prior to attendance, could impact parents' decisions to send unwell children to daycare, potentially influencing the transmission of children's infectious illness.

Management of multimorbidity using a patient-centred care model: a pragmatic cluster-randomised trial of the 3D approach.

BACKGROUND: The management of people with multiple chronic conditions challenges health-care systems designed around single conditions. There is international consensus that care for multimorbidity should be patient-centred, focus on quality of life, and promote self-management towards agreed goals. However, there is little evidence about the effectiveness of this approach. Our hypothesis was that the patient-centred, so-called 3D approach (based on dimensions of health, depression, and drugs) for patients with multimorbidity would improve their health-related quality of life, which is the ultimate aim of the 3D intervention. METHODS: We did this pragmatic cluster-randomised trial in general practices in England and Scotland. Practices were randomly allocated to continue usual care (17 practices) or to provide 6-monthly comprehensive 3D reviews, incorporating patient-centred strategies that reflected international consensus on best care (16 practices). Randomisation was computer-generated, stratified by area, and minimised by practice deprivation and list size. Adults with three or more chronic conditions were recruited. The primary outcome was quality of life (assessed with EQ-5D-5L) after 15 months' follow-up. Participants were not masked to group assignment, but analysis of outcomes was blinded. We analysed the primary outcome in the intention-to-treat population, with missing data being multiply imputed. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN06180958. FINDINGS: Between May 20, 2015, and Dec 31, 2015, we recruited 1546 patients from 33 practices and randomly assigned them to receive the intervention (n=797) or usual care (n=749). In our intention-to-treat analysis, there was no difference between trial groups in the primary outcome of quality of life (adjusted difference in mean EQ-5D-5L 0·00, 95% CI -0·02 to 0·02; p=0·93). 78 patients died, and the deaths were not considered as related to the intervention. INTERPRETATION: To our knowledge, this trial is the largest investigation of the international consensus about optimal management of multimorbidity. The 3D intervention did not improve patients' quality of life. FUNDING: National Institute for Health Research.

Qualitative assessment of the primary care outcomes questionnaire: a cognitive interview study.

BACKGROUND: The Primary Care Outcomes Questionnaire (PCOQ) is a new patient-reported outcome measure designed specifically for primary care. This paper describes the developmental process of improving the item quality and testing the face validity of the PCOQ through cognitive interviews with primary care patients. METHODS: Two formats of the PCOQ were developed and assessed: the PCOQ-Status (which has an adjectival scale) and the PCOQ-Change (which has the same items as the PCOQ-Status, but a transitional scale). Three rounds of cognitive interviews were held with twenty patients from four health centres in Bristol. Patients seeking healthcare were recruited directly by their GP or practice nurse, and others not currently seeking healthcare were recruited from patient participation groups. An adjusted form of Tourangeau's model of cognitive processing was used to identify problems. This contained four categories: general comprehension, temporal comprehension, decision process, and response process. The resultant pattern of problems was used to assess whether the items and scales were working as intended, and to make improvements to the questionnaires. RESULTS: The problems identified in the PCOQ-Status reduced from 41 in round one to seven in round three. It was noted that the PCOQ-Status seemed to be capturing a subjective view of health which might not vary with age or long-term conditions. However, as it is designed to be evaluative (measuring change over time) as opposed to discriminative (measuring change between different groups of people), this does not present a problem for validity. The PCOQ-Status was both understood by patients and was face valid. The PCOQ-Change had less face validity, and was misunderstood by three out of six patients in round 1. It was not taken forward after this round. CONCLUSIONS: The cognitive interviews successfully contributed to the development of the PCOQ. Through this study, the PCOQ-Status was found to be well understood by patients, and it was possible to improve comprehension through each round of interviews. The PCOQ-Change was poorly understood and, given that this corroborates existing research, this may call into question the use of transitional questionnaires generally.

Patient understanding of two commonly used patient reported outcome measures for primary care: a cognitive interview study.

BACKGROUND: Standardised generic patient-reported outcome measures (PROMs) which measure health status are often unresponsive to change in primary care. Alternative formats, which have been used to increase responsiveness, include individualised PROMs (in which respondents specify the outcomes of interest in their own words) and transitional PROMs (in which respondents directly rate change over a period). The objective of this study was to test qualitatively, through cognitive interviews, two PROMs, one using each respective format. METHODS: The individualised PROM selected was the Measure Yourself Medical Outcomes Profile (MYMOP). The transitional PROM was the Patient Enablement Instrument (PEI). Twenty patients who had recently attended the GP were interviewed while completing the questionnaires. Interview data was analysed using a modification of Tourangeau's model of cognitive processing: comprehension, response, recall and face validity. RESULTS: Patients found the PEI simple to complete, but for some it lacked face validity. The transitional scale was sometimes confused with a status scale and was problematic in situations when the relevant GP appointment was part of a longer episode of care. Some patients reported a high enablement score despite verbally reporting low enablement but high regard for their GP, which suggested hypothesis-guessing. The interpretation of the PEI items was inconsistent between patients. MYMOP was more difficult for patients to complete, but had greater face validity than the PEI. The scale used was open to response-shift: some patients suggested they would recalibrate their definition of the scale endpoints as their illness and expectations changed. CONCLUSIONS: The study provides information for both users of PEI/MYMOP and developers of individualised and transitional questionnaires. Users should heed the recommendation that MYMOP should be interview-administered, and this is likely to apply to other individualised scales. The PEI is open to hypothesis-guessing and may lack face-validity for a longer episode of care (e.g. in patients with chronic conditions). Developers should be cognisant that transitional scales can be inconsistently completed: some patients forget during completion that they are measuring change from baseline. Although generic questionnaires require the content to be more general than do disease-specific questionnaires, developers should avoid questions which allow broad and varied interpretations.

Identification, description and appraisal of generic PROMs for primary care: a systematic review.

BACKGROUND: Patients attend primary care with many types of problems and to achieve a range of possible outcomes. There is currently a lack of patient-reported outcome measures (PROMs) designed to capture these diverse outcomes. The objective of this systematic review was to identify, describe and appraise generic PROMs suitable for measuring outcomes from primary care. METHODS: We carried out a systematic Medline search, supplemented by other online and hand-searches. All potentially relevant PROMs were itemised in a long-list. Each PROM in the long-list which met inclusion criteria was included in a short-list. Short-listed PROMs were then described in terms of their measurement properties and construct, based on a previously published description of primary care outcome as three constructs: health status, health empowerment and health perceptions. PROMs were appraised in terms of extent of psychometric testing (extensive, moderate, low) and level of responsiveness (high, medium, low, unknown). RESULTS: More than 5000 abstracts were identified and screened to identify PROMs potentially suitable for measuring outcomes from primary care. 321 PROMs were long-listed, and twenty PROMs were catalogued in detail. There were five PROMs which measured change directly, without need for a baseline. Although these had less strong psychometric properties, they may be more responsive to change than PROMs which capture status at a point in time. No instruments provided coverage of all three constructs. Of the health status questionnaires, the most extensively tested was the SF-36. Of the health empowerment instruments, the PEI, PAM and heiQ provided the best combination of responsiveness and psychometric testing. The health perceptions instruments were all less responsive to change, and may measure a form of health perception which is difficult to shift in primary care. CONCLUSIONS: This systematic review is the first of its kind to identify papers describing the development and validation of generic PROMs suitable for measuring outcomes from primary care. It identified that: 1) to date, there is no instrument which comprehensively covers the outcomes commonly sought in primary care, and 2) there are different benefits both to PROMs which measure status at a point in time, and PROMs which measure change directly.

'Trying to put a square peg into a round hole': a qualitative study of healthcare professionals' views of integrating complementary medicine into primary care for musculoskeletal and mental health comorbidity.

BACKGROUND: Comorbidity of musculoskeletal (MSK) and mental health (MH) problems is common but challenging to treat using conventional approaches. Integration of conventional with complementary approaches (CAM) might help address this challenge. Integration can aim to transform biomedicine into a new health paradigm or to selectively incorporate CAM in addition to conventional care. This study explored professionals' experiences and views of CAM for comorbid patients and the potential for integration into UK primary care. METHODS: We ran focus groups with GPs and CAM practitioners at three sites across England and focus groups and interviews with healthcare commissioners. Topics included experience of co-morbid MSK-MH and CAM/integration, evidence, knowledge and barriers to integration. Sampling was purposive. A framework analysis used frequency, specificity, intensity of data, and disconfirming evidence. RESULTS: We recruited 36 CAM practitioners (4 focus groups), 20 GPs (3 focus groups) and 8 commissioners (1 focus group, 5 interviews). GPs described challenges treating MSK-MH comorbidity and agreed CAM might have a role. Exercise- or self-care-based CAMs were most acceptable to GPs. CAM practitioners were generally pro-integration. A prominent theme was different understandings of health between CAM and general practitioners, which was likely to impede integration. Another concern was that integration might fundamentally change the care provided by both professional groups. For CAM practitioners, NHS structural barriers were a major issue. For GPs, their lack of CAM knowledge and the pressures on general practice were barriers to integration, and some felt integrating CAM was beyond their capabilities. Facilitators of integration were evidence of effectiveness and cost effectiveness (particularly for CAM practitioners). Governance was the least important barrier for all groups. There was little consensus on the ideal integration model, particularly in terms of financing. Commissioners suggested CAM could be part of social prescribing. CONCLUSIONS: CAM has the potential to help the NHS in treating the burden of MSK-MH comorbidity. Given the challenges of integration, selective incorporation using traditional referral from primary care to CAM may be the most feasible model. However, cost implications would need to be addressed, possibly through models such as social prescribing or an extension of integrated personal commissioning.

Agreeing the content of a patient-reported outcome measure for primary care: a Delphi consensus study.

BACKGROUND: As the first contact for any health-related need, 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. Therefore, many research studies into primary care services use PROMs that do not capture the full impact of these services. OBJECTIVE: The study aim was to identify outcomes sought by primary care patients which clinicians can influence, thus providing the basis for a new primary care PROM. METHODS: We used a Delphi process starting with an outcomes list inductively derived in a prior qualitative study. Thirty-five experts were recruited into patient, clinician and academic panels. Participants rated each outcome on whether it was (i) relevant to health, (ii) influenced by primary care and (iii) detectable by patients. In each round, outcomes which passed/failed preset levels of agreement were accepted/rejected. Remaining outcomes continued to the next round. RESULTS: The process resulted in a set of outcomes occupying the domains of health status, health empowerment (internal and external), and health perceptions. Twenty-six of 36 outcomes were accepted for inclusion in a PROM. Primary care having insufficient influence was the main reason for exclusion. CONCLUSIONS: To our knowledge, this is the first time PROM outcomes have been agreed through criteria which explicitly exclude outcomes less relevant to health, uninfluenced by primary care or undetected by patients. The PROM in development covers a unique set of outcomes and offers an opportunity for enhanced research into primary care.

"What matters to someone who matters to me": using media campaigns with young people to prevent interpersonal violence and abuse.

BACKGROUND: While media campaigns are increasingly advocated as a strategy for preventing interpersonal violence and abuse, there is little evidence available regarding their effectiveness. SETTING AND DESIGN: Consultation with experts and young people was used as part of a UK scoping review to capture current thinking and practice on the use of media campaigns to address interpersonal violence and abuse among young people. Three focus groups and 16 interviews were undertaken with UK and international experts, and three focus groups were held with young people. MAIN RESULTS: Participants argued that, although campaigns initially needed to target whole populations of young people, subsequently, messages should be "granulated" for subgroups including young people already exposed to interpersonal violence and lesbian, gay, bisexual and transgender young people. It was suggested that boys, as the most likely perpetrators of interpersonal violence and abuse, should be the primary target for campaigns. Young people and experts emphasized that drama and narrative could be used to evoke an emotional response that assisted learning. Authenticity emerged as important for young people and could be achieved by delivering messages through familiar characters and relevant stories. Involving young people themselves in creating and delivering campaigns strengthened authenticity. CONCLUSIONS: Practice is developing rapidly, and robust research is required to identify the key conditions for effective campaigns in this field. The emotional impact of campaigns in this field appears to be as important as the transmission of learning.

Effect of Oral Prednisolone on Symptom Duration and Severity in Nonasthmatic Adults With Acute Lower Respiratory Tract Infection: A Randomized Clinical Trial.

Importance: Acute lower respiratory tract infection is common and often treated inappropriately in primary care with antibiotics. Corticosteroids are increasingly used but without sufficient evidence. Objective: To assess the effects of oral corticosteroids for acute lower respiratory tract infection in adults without asthma. Design, Setting, and Participants: Multicenter, placebo-controlled, randomized trial (July 2013 to final follow-up October 2014) conducted in 54 family practices in England among 401 adults with acute cough and at least 1 lower respiratory tract symptom not requiring immediate antibiotic treatment and with no history of chronic pulmonary disease or use of asthma medication in the past 5 years. Interventions: Two 20-mg prednisolone tablets (n = 199) or matched placebo (n = 202) once daily for 5 days. Main Outcomes and Measures: The primary outcomes were duration of moderately bad or worse cough (0 to 28 days; minimal clinically important difference, 3.79 days) and mean severity of symptoms on days 2 to 4 (scored from 0 [not affected] to 6 [as bad as it could be]; minimal clinically important difference, 1.66 units). Secondary outcomes were duration and severity of acute lower respiratory tract infection symptoms, duration of abnormal peak flow, antibiotic use, and adverse events. Results: Among 401 randomized patients, 2 withdrew immediately after randomization, and 1 duplicate patient was identified. Among the 398 patients with baseline data (mean age, 47 [SD, 16.0] years; 63% women; 17% smokers; 77% phlegm; 70% shortness of breath; 47% wheezing; 46% chest pain; 42% abnormal peak flow), 334 (84%) provided cough duration and 369 (93%) symptom severity data. Median cough duration was 5 days (interquartile range [IQR], 3-8 days) in the prednisolone group and 5 days (IQR, 3-10 days) in the placebo group (adjusted hazard ratio, 1.11; 95% CI, 0.89-1.39; P = .36 at an α = .05). Mean symptom severity was 1.99 points in the prednisolone group and 2.16 points in the placebo group (adjusted difference, -0.20; 95% CI, -0.40 to 0.00; P = .05 at an α = .001). No significant treatment effects were observed for duration or severity of other acute lower respiratory tract infection symptoms, duration of abnormal peak flow, antibiotic use, or nonserious adverse events. There were no serious adverse events. Conclusions and Relevance: Oral corticosteroids should not be used for acute lower respiratory tract infection symptoms in adults without asthma because they do not reduce symptom duration or severity. Trial Registration: ISRCTN.com Identifier: ISRCTN57309858.

Factors influencing parents' decision-making when sending children with respiratory tract infections to nursery.

BACKGROUND: Many families rely on formal day care provision, which can be problematic when children are unwell. Attendance in these circumstances may impact on the transmission of infections in both day care and the wider community. METHODS: Thirty-one semi-structured interviews were conducted to investigate how parents make decisions about nursery care when children are unwell. Topics for discussion included: illness attitudes, current practice during childhood illness and potential nursery policy changes that could affect decision-making. RESULTS: A combination of illness perceptions and external factors affected decision-making. Parents: (i) considered the severity of respiratory and non-respiratory symptoms differently, and stated that while most other contagious illnesses required nursery exclusion, coughs/colds did not; (ii) said decisions were not solely based on nursery policy, but on practical challenges such as work absences, financial penalties and alternative care availability; (iii) identified modifiable nursery policy factors that could potentially help parents keep unwell children at home, potentially reducing transmission of infectious illness. CONCLUSIONS: Decision-making is a complex interaction between the child's illness, personal circumstance and nursery policy. Improving our understanding of the modifiable aspects of nursery policies and the extent to which these factors affect decision-making could inform the design and implementation of interventions to reduce the transmission of infectious illness and the associated burden on NHS services.

Using willingness-to-pay to establish patient preferences for cancer testing in primary care.

BACKGROUND: Shared decision making is a stated aim of several healthcare systems. In the area of cancer, patients' views have informed policy on screening and treatment but there is little information about their views on diagnostic testing in relation to symptom severity. METHODS: We used the technique of willingness-to-pay to determine public preferences around diagnostic testing for colorectal, lung, and pancreatic cancer in primary care in the UK. Participants were approached in general practice waiting rooms and asked to complete a two-stage electronic survey that described symptoms of cancer, the likelihood that the symptoms indicate cancer, and information about the appropriate diagnostic test. Part 1 asked for a binary response (yes/no) as to whether they would choose to have a test if it were offered. Part 2 elicited willingness-to-pay values of the tests using a payment scale followed by a bidding exercise, with the aim that these values would provide a strength of preference not detectable using the binary approach. RESULTS: A large majority of participants chose to be tested for all cancers, with only colonoscopy (colorectal cancer) demonstrating a risk gradient. In the willingness-to-pay exercise participants placed a lower value on an X-ray (lung cancer) than the tests for colorectal or pancreatic cancer and X-ray was the only test where risk was clearly related to the willingness-to-pay value. CONCLUSION: Willingness-to-pay values did not enhance the binary responses in the way intended; participants appeared to be motivated differently when responding to the two parts of the questionnaire. More work is needed to understand how participants perceive risk in this context and how they respond to questions about willingness-to-pay. Qualitative methods could provide useful insights.

Patient and practitioners' views on the most important outcomes arising from primary care consultations: a qualitative study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Preventing domestic abuse for children and young people: A review of school-based interventions.

Schools provide the setting in which interventions aimed at preventing intimate partner violence and abuse (IPVA) are delivered to young people in the general population and a range of programmes have been designed and evaluated. To date, most rigorous studies have been undertaken in North America and the extent to which programmes are transferable to other settings and cultures is uncertain. This paper reports on a mixed methods review, aimed at informing UK practise and policy, which included a systematic review of the international literature, a review of the UK grey literature and consultation with young people as well as experts to address the question of what works for whom in what circumstances. The context in which an intervention was delivered was found to be crucial. Context included: the wider policy setting; the national or regional level, where the local culture shaped understandings of IPVA, and the readiness of an individual school. The programmes included in the systematic review provided stronger evidence for changing knowledge and attitudes than for behavioural change and those young people who were at higher risk at baseline may have exerted a strong influence on study outcomes. Shifting social norms in the peer group emerged as a key mechanism of change and the young people consulted emphasised the importance of authenticity which could be achieved through the use of drama and which required those delivering programmes to have relevant expertise. While the consultation identified increasing interest in targeting interventions on boys, there was an identified lack of materials designed for minority groups of young people, especially Lesbian, Gay, Bisexual and Transgender young people. Increased responsivity to the local context can be achieved by involving those who will deliver and receive these preventive programmes in their development. Schools need to be better prepared and supported in the task of delivering these interventions and this is particularly relevant for the management of disclosures of IPVA. Outcomes measured by evaluations should include those relevant to education.

Preferences for cancer investigation: a vignette-based study of primary-care attendees.

BACKGROUND: The UK lags behind many European countries in terms of cancer survival. Initiatives to address this disparity have focused on barriers to presentation, symptom recognition, and referral for specialist investigation. Selection of patients for further investigation has come under particular scrutiny, although preferences for referral thresholds in the UK population have not been studied. We investigated preferences for diagnostic testing for colorectal, lung, and pancreatic cancers in primary-care attendees. METHODS: In a vignette-based study, researchers recruited individuals aged at least 40 years attending 26 general practices in three areas of England between Dec 6, 2011, and Aug 1, 2012. Participants completed up to three of 12 vignettes (four for each of lung, pancreatic, and colorectal cancers), which were randomly assigned. The vignettes outlined a set of symptoms, the risk that these symptoms might indicate cancer (1%, 2%, 5%, or 10%), the relevant testing process, probable treatment, possible alternative diagnoses, and prognosis if cancer were identified. Participants were asked whether they would opt for diagnostic testing on the basis of the information in the vignette. FINDINGS: 3469 participants completed 6930 vignettes. 3052 individuals (88%) opted for investigation in their first vignette. We recorded no strong evidence that participants were more likely to opt for investigation with a 1% increase in risk of cancer (odds ratio [OR] 1·02, 95% CI 0·99-1·06; p=0·189), although the association between risk and opting for investigation was strong when colorectal cancer was analysed alone (1·08, 1·03-1·13; p=0·0001). In multivariable analysis, age had an effect in all three cancer models: participants aged 60-69 years were significantly more likely to opt for investigation than were those aged 40-59 years, and those aged 70 years or older were less likely. Other variables associated with increased likelihood of opting for investigation were shorter travel times to testing centre (colorectal and lung cancers), a family history of cancer (colorectal and lung cancers), and higher household income (colorectal and pancreatic cancers). INTERPRETATION: Participants in our sample expressed a clear preference for diagnostic testing at all risk levels, and individuals want to be tested at risk levels well below those stipulated by UK guidelines. This willingness should be considered during design of cancer pathways, particularly in primary care. The public engagement with our study should encourage general practitioners to involve patients in referral decision making. FUNDING: The National Institute for Health Research Programme Grants for Applied Research programme.

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.

BACKGROUND: Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. METHODS: This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. FINDINGS: Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). INTERPRETATION: Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. FUNDING: National Institute for Health Research Health Technology Assessment.

Cost-effectiveness of cognitive-behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: economic evaluation of the CoBalT Trial.

BACKGROUND: Depression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication. AIMS: To assess the cost-effectiveness of cognitive-behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone. METHOD: Economic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs). RESULTS: The mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups. CONCLUSIONS: The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.

Effectiveness of PhysioDirect telephone assessment and advice services for patients with musculoskeletal problems.

STUDY QUESTION: Are PhysioDirect services, based on initial telephone assessment and advice from a physiotherapist, as effective as usual care involving patients waiting for a face-to-face appointment? SUMMARY ANSWER: Patients allocated to PhysioDirect received treatment more quickly than those allocated to usual care, and had equivalent clinical outcomes.

A comparison of four different approaches to measuring health utility in depressed patients.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

An evaluation of the impact and costs of three strategies used to recruit acutely unwell young children to a randomised controlled trial in primary care.

BACKGROUND: Recruitment to primary care trials, particularly those involving young children, is known to be difficult. There are limited data available to inform researchers about the effectiveness of different trial recruitment strategies and their associated costs. PURPOSE: To describe, evaluate, and investigate the costs of three strategies for recruiting febrile children to a community-based randomised trial of antipyretics. METHODS: The three recruitment strategies used in the trial were termed as follows: (1) 'local', where paediatric research nurses stationed in primary care sites invited parents of children to participate; (2) 'remote', where clinicians at primary care sites faxed details of potentially eligible children to the trial office; and (3) 'community', where parents, responding to trial publicity, directly contacted the trial office when their child was unwell. RESULTS: Recruitment rates increased in response to the sequential introduction of three recruitment strategies, which were supplemented by additional recruiting staff, flexible staff work patterns, and improved clinician reimbursement schemes. The three strategies yielded different randomisation rates. They also appeared to be interdependent and highly effective together. Strategy-specific costs varied from £297 to £857 per randomised participant and represented approximately 10% of the total trial budget. LIMITATIONS: Because the recruitment strategies were implemented sequentially, it was difficult to measure their independent effects. The cost analysis was performed retrospectively. CONCLUSIONS: Trial recruiter expertise and deployment of several interdependent, illness-specific strategies were key factors in achieving rapid recruitment of young children to a community-based randomised controlled trial (RCT). The 'remote' recruitment strategy was shown to be more cost-effective compared to 'community' and 'local' strategies in the context of this trial. Future trialists should report recruitment costs to facilitate a transparent evaluation of recruitment strategy cost-effectiveness.

Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial.

BACKGROUND: Despite strong evidence for its effectiveness, cognitive-behavioural therapy (CBT) remains difficult to access. Computerised programs have been developed to improve accessibility, but whether these interventions are responsive to individual needs is unknown. We investigated the effectiveness of CBT delivered online in real time by a therapist for patients with depression in primary care. METHODS: In this multicentre, randomised controlled trial, 297 individuals with a score of 14 or more on the Beck depression inventory (BDI) and a confirmed diagnosis of depression were recruited from 55 general practices in Bristol, London, and Warwickshire, UK. Participants were randomly assigned, by a computer-generated code, to online CBT in addition to usual care (intervention; n=149) or to usual care from their general practitioner while on an 8-month waiting list for online CBT (control; n=148). Participants, researchers involved in recruitment, and therapists were masked in advance to allocation. The primary outcome was recovery from depression (BDI score <10) at 4 months. Analysis was by intention to treat. This trial is registered, number ISRCTN 45444578. FINDINGS: 113 participants in the intervention group and 97 in the control group completed 4-month follow-up. 43 (38%) patients recovered from depression (BDI score <10) in the intervention group versus 23 (24%) in the control group at 4 months (odds ratio 2.39, 95% CI 1.23-4.67; p=0.011), and 46 (42%) versus 26 (26%) at 8 months (2.07, 1.11-3.87; p=0.023). INTERPRETATION: CBT seems to be effective when delivered online in real time by a therapist, with benefits maintained over 8 months. This method of delivery could broaden access to CBT. FUNDING: BUPA Foundation.