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BACKGROUND: Deprescribing of antihypertensive medications for older patients with normal blood pressure is recommended by some clinical guidelines, where the potential harms of treatment may outweigh the benefits. This study aimed to assess the cost-effectiveness of this approach. METHODS: A Markov patient-level simulation was undertaken to model the effect of withdrawing one antihypertensive compared with usual care, over a life-time horizon. Model population characteristics were estimated using data from the OPTiMISE antihypertensive deprescribing trial, and the effects of blood pressure changes on outcomes were derived from the literature. Health-related quality of life was modeled in Quality-Adjusted Life Years (QALYs) and presented as costs per QALY gained. RESULTS: In the base-case analysis, medication reduction resulted in lower costs than usual care (mean difference £185), but also lower QALYs (mean difference 0.062) per patient over a life-time horizon. Usual care was cost-effective at £2975 per QALY gained (more costly, but more effective). Medication reduction resulted more heart failure and stroke/TIA events but fewer adverse events. Medication reduction may be the preferred strategy at a willingness-to-pay of £20 000/QALY, where the baseline absolute risk of serious drug-related adverse events was ≥7.7% a year (compared with 1.7% in the base-case). CONCLUSIONS: Although there was uncertainty around many of the assumptions underpinning this model, these findings suggest that antihypertensive medication reduction should not be attempted in many older patients with controlled systolic blood pressure. For populations at high risk of adverse effects, deprescribing may be beneficial, but a targeted approach would be required in routine practice.

Patient and Public Involvement and Engagement (PPIE) - sometimes called Community Engagement and Involvement (CEI) - comes as a big challenge but one that can be very helpful for health care professionals and stakeholders in planning better health policies for attending to the main needs of the community. PPIE involves three pillars: public involvement, public engagement, and participation. Public involvement occurs when members of the general population are actively involved in developing the research question, designing, and conducting the research. Public engagement tells people about new studies, why they are important, the impact of results, the possible implication of the main findings for the community, and the possible impact of these new findings in society, as well as, in the dissemination of knowledge to the general population. Participation is being a volunteer in the study. Our experience with PPIE, to the best of our knowledge the first initiative in Brazil, is a partnership with the University of Birmingham, the University of Liverpool, and the NIHR Global Health Group on Atrial Fibrillation (AF) Management focusing on the AF care pathway exploring the important aspects of diagnosis and treatment in the primary care system from a low-middle income area in São Paulo. The involvement of patients/public in the research represents a new step in the process of inclusion of all segments of our society based on patient illness and the gaps in knowledge aiming to open new horizons for continuous improvement and better acceptance of research projects.

Additional file 1: Table S1. Speech and language therapy (SLT) set-up costs. Table S2. Derivation of unit costs: sources and assumptions. Table S3. Resource use per patient over 12 months (NHS and social care funded). Table S4. Mean medication costs by drug type over 12 months, per patient (2014/15 costs). Table S5. Resource use per patient over 12 months (privately funded). Table S6. Patient funded care costs and out of pocket expenses over 12 months, per patient. Table S7. Convergence between index scores of EQ-5D-3L and ICECAP-O dimensions (Spearman’s rank correlation). Table S8. Convergence between index scores of PDQ39 dimensions and ICECAP-O responses (Spearman’s rank correlation). Table S9. Convergence between index scores of PDQ39 dimensions and EQ-5D-3L responses (Spearman’s rank correlation)

Objective: \ud To investigate the cost‐effectiveness (cost‐utility) of introducing general practitioner screening for anxiety and depression in patients consulting with osteoarthritis (OA).\ud \ud Methods: \ud A cluster‐randomised trial‐based economic evaluation to assess general practitioners screening for anxiety and depression symptoms in patients consulting with OA compared to usual care (screening for pain intensity) was undertaken over a 12‐month period from a UK National Health Service and Societal perspective. Patient‐level mean costs and mean quality‐adjusted life years (QALYs) were estimated and cost‐effectiveness acceptability curves controlling for cluster‐level data were constructed. The base‐case analysis used the net‐benefit regressions approach. The two‐stage non‐parametric sampling technique was explored in a sensitivity analysis.\ud \ud Results: \ud The base‐case analysis demonstrated that the intervention was as costly as, and less effective than, the control (QALY diff, 95% CI: ‐ 0.029 (95% CI ‐0.062 to 0.003)). In the base‐case analyses, GP screening for anxiety and depression was unlikely to be a cost‐effective option (probability < 5% at £20,000/QALY). Similar results were observed in all sensitivity analyses.\ud \ud Conclusions: \ud Prompting GP's to routinely screen and manage comorbid anxiety and depression in patients presenting with OA is unlikely to be cost‐effective. Further research is needed to explore clinically‐effective and cost‐effective models of managing anxiety and depression in patients presenting with clinical OA.

Background: Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates by conducting a pragmatic ‘study within a trial’ (SWAT) embedding a trial of a multimedia resource within an existing trial. Methods: The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by patient and public involvement (PPI) contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised. Results: Nine point six percent of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (odds ratio (OR) = 0.844, 95% confidence interval (CI) 0.58 to 1.22). We also found no effects on the proportion of people responding to the invitation (OR = 1.02, 95% CI 0.79 to 1.33) or retention in the trial at 6 (ORs 0.84, 95% CI 0.57 to 1.22) and 12 months after randomisation (ORs 0.80, 95% CI 0.54 to 1.18), respectively. Conclusions: The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population. Trial registration: Current controlled trials ISRCTN 06710391. Registered on 21 November 2013. SWAT registration: SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START). Registered on 11 January 2012. Keywords: Recruitment, Patient information, Research methodology, Randomised controlled trial

Objectives Overprescribing of antibiotics by general practitioners (GPs) is seen as a major driver of antibiotic resistance. Training in communication skills and C-reactive protein (CRP) testing both appear effective in reducing such prescribing. This study assesses the cost-effectiveness (compared with usual care) of: (i) training GPs in the use of CRP testing; (ii) training GPs in communication skills; and (iii) training GPs in both CRP testing and communication skills. Methods Economic analyses [cost–utility analysis (CUA) accounting for the cost of antibiotic resistance and cost-effectiveness analysis (CEA)] were both conducted from a healthcare perspective with a time horizon of 28 days alongside a multinational, cluster, randomized, factorial controlled trial in patients with respiratory tract infections in five European countries. The primary outcome measures were QALYs and percentage reduction in antibiotic prescribing. Hierarchical modelling was used to estimate an incremental cost per QALY gained and an incremental cost per percentage reduction in antibiotic prescribing. Results Overall, the results of both the CUA and CEA showed that training in communication skills is the most cost-effective option. However, excluding the cost of antibiotic resistance in the CUA resulted in usual care being the most cost-effective option. Country-specific results from the CUA showed that training in communication skills was cost-effective in Belgium, UK and Netherlands whilst training in CRP was cost-effective in Poland. Conclusions Internet-based training in communication skills is a cost-effective intervention to reduce antibiotic prescribing for respiratory tract infections in primary care if the cost of antibiotic resistance is accounted for.

OBJECTIVES: The aim of this study was to examine the impact of transient ischaemic attack (TIA) service modification in two hospitals on costs and clinical outcomes. DESIGN: Discrete event simulation model using data from routine electronic health records from 2011. PARTICIPANTS: Patients with suspected TIA were followed from symptom onset to presentation, referral to specialist clinics, treatment and subsequent stroke. INTERVENTIONS: Included existing versus previous (less same day clinics) and hypothetical service reconfiguration (7-day service with less availability of clinics per day). OUTCOME MEASURES: The primary outcome of the model was the prevalence of major stroke after TIA. Secondary outcomes included service costs (including those of treating subsequent stroke) and time to treatment and attainment of national targets for service provision (proportion of high-risk patients (according to ABCD2 score) seen within 24 hours). RESULTS: The estimated costs of previous service provision for 490 patients (aged 74±12 years, 48.9% female and 23.6% high risk) per year at each site were £340 000 and £368 000, respectively. This resulted in 31% of high-risk patients seen within 24 hours of referral (47/150) with a median time from referral to clinic attendance/treatment of 1.15 days (IQR 0.93-2.88). The costs associated with the existing and hypothetical services decreased by £5000 at one site and increased £21 000 at the other site. Target attainment was improved to 79% (118/150). However, the median time to clinic attendance was only reduced to 0.85 days (IQR 0.17-0.99) and thus no appreciable impact on the modelled incidence of major stroke was observed (10.7 per year, 99% CI 10.5 to 10.9 (previous service) vs 10.6 per year, 99% CI 10.4 to 10.8 (existing service)). CONCLUSIONS: Reconfiguration of services for TIA is effective at increasing target attainment, but in services which are already working efficiently (treating patients within 1-2 days), it has little estimated impact on clinical outcomes and increased investment may not be worthwhile.

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost-utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability.

Background:\ud \ud Speech-related problems are common in Parkinson’s disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®).\ud Methods:\ud \ud The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6–8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings.\ud Results:\ud \ud Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: − 12.5 points; 95% CI − 26.2, 1.2) and SLT (difference at 3 months compared with control: − 9.8 points; 95% CI − 23.2, 3.7) which needs to be confirmed in an adequately powered trial.\ud Conclusion:\ud \ud Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient-reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial.\ud Trial registration:\ud \ud International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. registered 22 March 2012.

Principal Investigator questionnaire:Â Patient and Public Involvement in your research project. (DOCX 114Â kb)

Costs and Consequences Framework for the Costs and Consequences project. (DOCX 18Â kb)

Public Contributor questionnaire:Â the Costs and Effects of Patient and Public Involvement (PPI) in Primary Care Research. (DOCX 110Â kb)

Self-assessment of the Cost and Consequences studyâ s performance against the Boote et al.â s PPI Quality Indicators [25]. (DOCX 16Â kb)

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost–utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability.

Objectives: The aim of this study was to examine the impact of transient ischaemic attack service modification in two hospitals on costs and clinical outcomes. Design: Discrete event simulation model using data from routine electronic health records from 2011. Participants: Patients with suspected TIA were followed from symptom onset to presentation, referral to specialist clinics, treatment and subsequent stroke. Interventions: Included existing versus previous (less same day clinics) and hypothetical service reconfiguration (7-day service with less availability of clinics per day). Outcome measures: The primary outcome of the model was the prevalence of major stroke after TIA. Secondary outcomes included service costs (including those of treating subsequent stroke) and time to treatment and attainment of national targets for service provision (proportion of high risk patients [according to ABCD2 score] seen within 24 hours). Results: The estimated costs of previous service provision for 490 patients (aged 74±12 years, 48.9% female and 23.6% high risk) per year at each site were £340,000 and £368,000 respectively. This resulted in 31% of high risk patients seen within 24 hours of referral (47/150) with a median time from referral to clinic attendance/treatment of 1.15 days (IQR 0.93-2.88). The costs associated with the existing and hypothetical services decreased by £5,000 at one site and increased £21,000 at the other site. Target attainment was improved to 79% (118/150). However, the median time to clinic attendance was only reduced to 0.85 days (IQR 0.17-0.99) and thus no appreciable impact on the modelled incidence of major stroke was observed (10.7 per year, 99%CI 10.5-10.9 [previous service] vs. 10.6 per year, 99%CI 10.4-10.8 [existing service]). Conclusions: Reconfiguration of services for TIA is effective at increasing target attainment, but in services which are already working efficiently (treating patients within 1-2 days), it has little estimated impact on clinical outcomes and increased investment may not be worthwhile.

Background This study aimed to evaluate whether prompting general practitioners (GPs) to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA) improves pain outcomes. Methods and findings We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire–2 for depression, a two-item Generalized Anxiety Disorder–2 questionnaire for anxiety, and a question about current pain intensity [0–10 numerical rating scale]). The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm). Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices). Follow-up rates were similar in both arms, totalling 1,093 (77.4%) at 3 mo, 1,064 (75.4%) at 6 mo, and 1,017 (72.0%) at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59). Secondary outcomes were consistent with the primary outcome measure in reflecting better outcomes as a whole for the control group than the intervention group. Anxiety and depression scores did not reduce following the intervention. The main limitations of this study are two potential sources of bias: an imbalance in cluster size (mean practice size 7,397 [intervention] versus 5,850 [control]) and a difference in the proportion of patients for whom the GP deactivated the template (33.6% [intervention] versus 27.8% [control]). Conclusions In this study, we observed no beneficial effect on pain outcomes of prompting GPs to routinely screen for and manage comorbid anxiety and depression in patients presenting with symptoms due to OA, with those in the intervention group reporting statistically significantly higher average pain scores over the four follow-up time points than those in the control group. Trial registration ISRCTN registry ISRCTN40721988, Christian Mallen and colleagues report on a cluster-randomized trial investigating screening for anxiety and depression in patients presenting with osteoarthritis., Author summary Why was this study done? Patients with painful conditions, such as osteoarthritis, are at higher risk of experiencing depression and anxiety. People with pain and coexisting mood problems are more likely to have a poorer long-term outcome. Routine screening for anxiety and depression in higher risk patients is controversial, with conflicting evidence. What did the researchers do and find? We conducted a large cluster randomised trial to investigate the impact on pain of screening and treating people with osteoarthritis for depression and anxiety in the general practice consultation. General practices were randomised either to routinely screen patients consulting with osteoarthritis for depression and anxiety or to not screen. We found that those screened for depression and anxiety had worse pain outcomes over the following 12 months than those not screened. What do these findings mean? Our findings do not support the implementation of routine screening of patients with osteoarthritis for depression and anxiety in primary care. Further work is needed to determine the potential benefit of screening patients with different musculoskeletal disorders.

Background: A previous economic analysis of self-management, that is, self-monitoring with self-titration of antihypertensive mediation evaluated cost-effectiveness among patients with uncomplicated hypertension. This study considered cost-effectiveness of self-management in those with raised blood pressure plus diabetes, chronic kidney disease (CKD) and/or previous cardiovascular disease.\ud \ud Design and methods: A Markov model-based economic evaluation was undertaken to estimate the long-term cost-effectiveness of self-management of blood pressure in a cohort of 70-year old ‘high risk’ patients, compared with usual care. The model used the results of the TASMIN-SR trial. A cost-utility analysis was undertaken from a UK health and social care perspective, taking into account lifetime costs of treatment, cardiovascular events and quality adjusted life years (QALYs). A sub-group analysis ran the model separately for men and women. Deterministic sensitivity analyses examined the effect of different time horizons and reduced effectiveness of self-management.\ud \ud Results: Base-case results indicated that self-management was cost-effective compared with usual care, resulting in more QALYs (0.21) and cost savings (-£830) per patient. There was a 99% chance of the intervention being cost-effective at a willingness to pay threshold of £20,000 per QALY gained. Similar results were found for separate cohorts of men and women. The results were robust to sensitivity analyses, provided that the blood pressure lowering effect of self-management was maintained for more than a year.\ud \ud Conclusion: Self-management of blood pressure in ‘high risk’ people with poorly controlled hypertension not only reduces blood pressure, compared with usual care, but also represents a cost-effective use of health care resources.

BACKGROUND: A previous economic analysis of self-management, that is, self-monitoring with self-titration of antihypertensive medication evaluated cost-effectiveness among patients with uncomplicated hypertension. This study considered cost-effectiveness of self-management in those with raised blood pressure plus diabetes, chronic kidney disease and/or previous cardiovascular disease. DESIGN AND METHODS: A Markov model-based economic evaluation was undertaken to estimate the long-term cost-effectiveness of self-management of blood pressure in a cohort of 70-year-old 'high risk' patients, compared with usual care. The model used the results of the TASMIN-SR trial. A cost-utility analysis was undertaken from a UK health and social care perspective, taking into account lifetime costs of treatment, cardiovascular events and quality adjusted life years. A subgroup analysis ran the model separately for men and women. Deterministic sensitivity analyses examined the effect of different time horizons and reduced effectiveness of self-management. RESULTS: Base-case results indicated that self-management was cost-effective compared with usual care, resulting in more quality adjusted life years (0.21) and cost savings (-£830) per patient. There was a 99% chance of the intervention being cost-effective at a willingness to pay threshold of £20,000 per quality adjusted life year gained. Similar results were found for separate cohorts of men and women. The results were robust to sensitivity analyses, provided that the blood pressure lowering effect of self-management was maintained for more than a year. CONCLUSION: Self-management of blood pressure in high-risk people with poorly controlled hypertension not only reduces blood pressure, compared with usual care, but also represents a cost-effective use of healthcare resources.

BACKGROUND: The PAST-BP trial found that using a lower systolic blood pressure target (

IMPORTANCE: Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups.\ud \ud OBJECTIVE: To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease.\ud \ud DESIGN, SETTING, AND PATIENTS: A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013.\ud \ud INTERVENTIONS: Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary.\ud \ud MAIN OUTCOMES AND MEASURES: The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit.\ud \ud RESULTS: Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events.\ud \ud CONCLUSIONS AND RELEVANCE: Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months.

BACKGROUND AND PURPOSE: Thrombolysis in acute stroke is effective up to 4.5 hours after symptom onset but relies on early recognition, prompt arrival in hospital, and timely brain scanning. This study aimed to establish the cost-effectiveness of increasing thrombolysis rates through a series of hypothetical change strategies designed to optimize the acute care pathway for stroke. METHODS: A decision-tree model was constructed, which relates the acute management of patients with suspected stroke from symptom onset to outcome. Current practice was modeled and compared with 7 change strategies designed to facilitate wider eligibility for thrombolysis. The model basecase consisted of data from consenting patients following the acute stroke pathway recruited in participating hospitals with data on effectiveness of treatment and costs from published sources. RESULTS: All change strategies were cost saving while increasing quality-adjusted life years gained. Using realistic estimates of effectiveness, the change strategy with the largest potential benefit was that of better recording of onset time, which resulted in 3.3 additional quality-adjusted life years and a cost saving of US $46,000 per 100,000 population. All strategies increased the number of thrombolysed patients and the number requiring urgent brain imaging (by 9% to 21% dependent on the scenario). Assuming a willingness-to-pay of US $30,000 per quality-adjusted life year gained, the potential budget available to deliver the interventions in each strategy ranged from US $50,000 to US $144,000. CONCLUSIONS: These results suggest that any strategy that increases thrombolysis rates will result in cost savings and improved patient quality of life. Healthcare commissioners could consider this model when planning improvements in stroke care.

Background Chronic obstructive pulmonary disease (COPD) remains a significant public health burden. Non-invasive ventilation (NIV) is a method of supported breathing used as standard care for acutely unwell patients in hospital with COPD, but there is uncertainty around the potential benefits of using NIV in the treatment of stable patients in a non-hospital setting. This is a protocol for systematic reviews of the clinical and cost-effectiveness of NIV in this context, being undertaken in support of a model based economic evaluation. Methods/Design Standard systematic review methods aimed at minimising bias will be employed for study identification, selection and data extraction for both the clinical and economic systematic reviews. Bibliographic databases (for example MEDLINE, EMBASE) and ongoing trials registers will be searched from 1980 onwards. The search strategy will combine terms for the population with those for the intervention. Studies will be selected for review if the population includes adult patients with COPD and hypercapnic respiratory failure, however defined. Systematic reviews, randomised controlled trials and observational studies (with n >1) will be included, and quality assessment will be tailored to the different study designs. The primary outcome measures of interest are survival, quality of life, and healthcare utilisations (hospitalisation and Accident and Emergency attendances). Meta-analyses will be undertaken where clinical and methodological homogeneity exists, supported by predefined subgroup analyses where appropriate. A systematic review of the evidence on the cost-effectiveness of non-hospital NIV will be completed, and a model-based cost-utility analysis undertaken to determine the cost-effectiveness of non-hospital-based NIV compared with standard care. Discussion These reviews will attempt to clarify the clinical effectiveness of non-hospital NIV in COPD patients as well as the cost-effectiveness. The findings may indicate whether NIV in a non-hospital setting should be considered more routinely in this patient group, and what the likely cost implications will be. PROSPERO registration 2012:CRD42012003286.

Background Many people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach. Methods/Design In this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations. All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants. The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure. A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach. Discussion This will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first. Trial registration Current controlled trials ISRCTN14930255 Electronic supplementary material The online version of this article (doi:10.1186/1471-2466-14-157) contains supplementary material, which is available to authorized users.