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  • Patient-Reported Outcome Alerts Ethical and Logistical Considerations in Clinical Trials

    The assessment of patient-reported outcomes (PROs) in clinical trials poses a number of potential problems. What happens when a patient reports a severe symptom and no one is monitoring that information; for example, when questionnaires are not reviewed until the end of a study? Do hospitals or researchers face liability if a patient reports suicidal thoughts on a questionnaire? http://jama.jamanetwork.com/article.aspx?articleid=1741830

  • Suicide-related events in young people following prescription of SSRIs and other antidepressants: a self-controlled case series analysis

    Objectives: We aimed to examine the temporal association between selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressant (TCA) prescriptions and suicide-related events in children and adolescents. Design: Self-controlled case series. Setting: Electronic health records were used from 479 general practices in The Health Improvement Network (THIN) UK primary care database from 1995 to 2009. Participants: 81 young people aged 10–18 years with a record of completed suicide, 1496 who attempted suicide, 1178 with suicidal ideation and 2361 with intentional self-harm. Main outcome measures Incidence Rate Ratios (IRRs) for completed and attempted suicide, suicidal ideation and intentional self-harm. Results: For non-fatal suicide-related behaviour, IRRs were similar for the time the person was prescribed either SSRIs or TCAs: IRRs increased during pre-exposure, peaked on prescription day, were stable up to the fourth prescription-week, and decreased after the prescriptions were stopped. For both types of antidepressants, IRRs were lower or similar to pre-exposure levels during the period of prescription. For SSRIs, there was an increase in the IRR for completed suicide on the day of prescription (N=5; IRR=42.5, 95% CI 4.5 to 403.4), and during the fourth week of SSRI prescription (N=2; IRR=11.3, 95% CI 1.1 to 115.6). Conclusions: We found that a very small number of young people were prescribed antidepressants and that there was an absence of a sustained increase in rates of suicide-related events in this group. There were no systematic differences between the association of TCAs and SSRIs and the incidence risk ratios for attempted suicide, suicidal ideation or intentional self-harm and, apart from the day of prescription, rates did not exceed pre-exposure levels. The pattern of IRR for suicide for SSRIs was similar to that found in non-fatal suicide-related events. Our results warrant a re-evaluation of the current prescription of SSRIs in young people. We recommend the creation of a pragmatic registry for active pharmacovigilance.

  • Implications of comorbidity for primary care costs in the UK: a retrospective observational study

    Background: Comorbidity is increasingly common in primary care. The cost implications for patient care and budgetary management are unclear. Aim: 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. Design: Retrospective observational study using data on 86 100 patients in the General Practice Research Database. Method: 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. Results: 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 costincreasing condition when co-occurring with a range of conditions. Hypertension is costlimiting, particularly when co-occurring with other cardiovascular conditions. Conclusion: 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. Keywords: comorbidity; costs and cost analysis; delivery of health care; depression; family practice; resource allocation.

  • A re-analysis of the Cochrane Library data: the dangers of unobserved heterogeneity in meta-analyses

    Heterogeneity has a key role in meta-analysis methods and can greatly affect conclusions. However, true levels of heterogeneity are unknown and often researchers assume homogeneity. We aim to: a) investigate the prevalence of unobserved heterogeneity and the validity of the assumption of homogeneity; b) assess the performance of various meta-analysis methods; c) apply the findings to published meta-analyses. Methods and findings We accessed 57,397 meta-analyses, available in the Cochrane Library in August 2012. Using simulated data we assessed the performance of various meta-analysis methods in different scenarios. The prevalence of a zero heterogeneity estimate in the simulated scenarios was compared with that in the Cochrane data, to estimate the degree of unobserved heterogeneity in the latter. We re-analysed all meta-analyses using all methods and assessed the sensitivity of the statistical conclusions. Levels of unobserved heterogeneity in the Cochrane data appeared to be high, especially for small meta-analyses. A bootstrapped version of the standard DerSimonian-Laird approach performed better both in detecting heterogeneity and providing more accurate overall effect estimates. Re-analysing all meta-analyses with this method we found that 17-20% of the statistical conclusions changed, when heterogeneity was detected with the standard model and ignored. The rates were much lower when the standard method did not detect heterogeneity or took it into account, between 1% and 3%. Conclusions: When evidence for heterogeneity is lacking, standard practice is to assume homogeneity and apply a simpler fixed-effect meta-analysis. We find that assuming homogeneity often results in a misleading analysis, since heterogeneity is very likely present but undetected. Our new method represents a small improvement but the problem largely remains, especially for very small meta-analyses. One solution is to test the sensitivity of the meta-analysis conclusions to assumed moderate and large degrees of heterogeneity. Equally, whenever heterogeneity is detected, it should not be ignored. Keywords: Meta-analysis; heterogeneity; homogeneity; DerSimonian-Laird; bootstrap; Cochrane library; Cochrane Database of Systematic Reviews; sensitivity analysis.

  • Are treatments more effective than placebos? A systematic review and meta-analysis

    Background Placebos are widely used in clinical practice in spite of ethical restrictions. Whether such use is justified depends in part on the relative benefit of placebos compared to ‘active’ treatments. A direct test for differences between placebo and ‘active’ treatment effects has not been conducted. Objectives We aimed to test for differences between treatment and placebo effects within similar trial populations. Data Sources A Cochrane Review compared placebos with no treatment in three-armed trials (no treatment, placebo, and treatment). We added an analysis of treatment and placebo differences within the same trials. Synthesis Methods For continuous outcomes we compared mean differences between placebo and no treatment with mean differences between treatment and placebo. For binary outcomes we compared the risk ratio for treatment benefit (versus placebo) with the risk ratio for placebo benefit (versus no treatment). We conducted several preplanned subgroup analyses: objective versus subjective outcomes, conditions tested in three or more trials, and trials with varying degrees of bias. Results In trials with continuous outcomes (n = 115) we found no difference between treatment and placebo effects (MD = −0.29, 95% CI −0.62 to 0.05, P = 0.10). In trials with binary outcomes (n = 37) treatments were significantly more effective than placebos (RRR = 0.72, 95%CI = 0.61 to 0.86, P = 0.0003). Treatment and placebo effects were not different in 22 out of 28 predefined subgroup analyses. Of the six subgroups with differences treatments were more effective than placebos in five. However when all criteria for reducing bias were ruled out (continuous outcomes) placebos were more effective than treatments (MD = 1.59, 95% CI = 0.40 to 2.77, P = 0.009).

  • Patient priorities in osteoarthritis and co-morbid conditions: a secondary analysis of qualitative data

    Objective. A lack of agreement between clinician and patient priorities can impact the clinician–patient relationship, treatment concordance, and potential health outcomes. Studies have suggested that patients with osteoarthritis (OA) may prioritize comorbidities over their OA, but as yet no explicit systematic exploration of OA patients’ priorities in relation to comorbidities exists. This study aims to explore how patients prioritize their OA among their conditions, which factors underlie this prioritization, and whether and why these priorities change over time. Methods. A secondary analysis of qualitative data was conducted utilizing 4 existing data sets collated from the 3 research centers involved. Purposive sampling provided a sample of 30 participants who all had OA and comorbidities. The research team collectively coded and analyzed the data thematically. Results. Three groups of patients emerged from the analysis. The 2 smaller groups had stable priorities (where OA was or was not prioritized) and illustrated the importance of factors, such as personal social context and the specific nature of the comorbid conditions. The third and largest group reported priorities that shifted over time. Shifting appeared to be influenced by the participants’ perceptions of control and/or interactions with clinical professionals, and could have important consequences for self-management behavior. Conclusion. The various factors underlying patients’ priorities among their conditions, and the fluctuating nature of these priorities, highlight the importance of regular assessments during clinician–patient consultations to allow better communication and treatment planning, and ultimately optimize patient outcomes.

  • Do depressed and anxious men do groups? What works and what are the barriers to help seeking?

    Aim: To map the availability and types of depression and anxiety groups, to examine men’s experiences and perception of this support as well as the role of health professionals in accessing support. Background: The best ways to support men with depression and anxiety in primary care are not well understood. Group-based interventions are sometimes offered but it is unknown whether this type of support is acceptable to men. Methods: Interviews with 17 men experiencing depression or anxiety. A further 12 interviews were conducted with staff who worked with depressed men (half of whom also experienced depression or anxiety themselves). There were detailed observations of four mental health groups and a mapping exercise of groups in a single English city (Bristol). Findings: Some men attend groups for support with depression and anxiety. There was a strong theme of isolated men, some reluctant to discuss problems with their close family and friends but attending groups. Peer support, reduced stigma and opportunities for leadership were some of the identified benefits of groups. The different types of groups may relate to different potential member audiences. For example, unemployed men with greater mental health and support needs attended a professionally led group whereas men with milder mental health problems attended peer-led groups. Barriers to help seeking were commonly reported, many of which related to cultural norms about how men should behave. General practitioners played a key role in helping men to acknowledge their experiences of depression and anxiety, listening and providing information on the range of support options, including groups. Men with depression and anxiety do go to groups and appear to be well supported by them. Groups may potentially be low cost and offer additional advantages for some men. Health professionals could do more to identify and promote local groups.

  • The content of general practice consultations: cross-sectional study based on video-recordings

    Objectives: To describe the number and types of problems discussed in general practice (GP) consultations, differences between problems raised by patients or doctors, and between problems discussed and recorded in medical records. Design: Cross-sectional study based on video-recordings of consultations. Setting: 30 representative GPs from 22 general practices in Bristol and North Somerset Participants: Adults making a pre-booked day-time appointment. Main outcome measures: Number and types of problems and issues discussed; who raised each problem/ issue; consultation duration; whether problems were recorded and coded. Results: Of 318 eligible patients, 229 (72.0%) participated. On average, 2.5 (95%CI 2.3 to 2.6) problems were discussed per consultation, with 41% (55/229) of consultations involving at least 3 problems. 72% (165/229) of consultations involved problems in multiple disease areas. Mean consultation duration was 11.9 minutes (95% CI 11.2 to 12.6). Consultation duration increased by 2 minutes per additional problem. Most problems discussed were raised by patients, but 43% (99/229) of consultations involved problem(s) raised by doctors. Patients and doctors raised different types of problems and issues. Of 562 problems discussed, 81% (n=455) were recorded in notes, but only 37% (n=206) were Read-coded, with differences between types of problems which were coded or not. Conclusions: Consultations in general practice are complex encounters addressing multiple problems across a wide range of disease areas in a short time. Additional problems are dealt with very briefly. GPs, like patients, bring an agenda to consultations. There is systematic bias in the types of problems coded in electronic medical records databases.

  • Opioid use among low back pain patients in primary care: Is opioid prescription associated with disability at 6-month follow-up?

    Opioid prescribing for chronic noncancer pain is increasing, but there is limited knowledge about longerterm outcomes of people receiving opioids for conditions such as back pain. This study aimed to explore the relationship between prescribed opioids and disability among patients consulting in primary care with back pain. A total of 715 participants from a prospective cohort study, who gave consent for review of medical and prescribing records and completed baseline and 6 month follow-up questionnaires, were included. Opioid prescription data were obtained from electronic prescribing records, and morphine equivalent doses were calculated. The primary outcome was disability (Roland-Morris Disability Questionnaire [RMDQ]) at 6 months. Multivariable linear regression was used to examine the association between opioid prescription at baseline and RMDQ score at 6 months. Analyses were adjusted for potential confounders using propensity scores reflecting the probability of opioid prescription given baseline characteristics. In the baseline period, 234 participants (32.7%) were prescribed opioids. In the final multivariable analysis, opioid prescription at baseline was significantly associated with higher disability at 6- month follow-up (P < .022), but the magnitude of this effect was small, with a mean RMDQ score of 1.18 (95% confidence interval: 0.17 to 2.19) points higher among those prescribed opioids compared to those who were not. Our findings indicate that even after adjusting for a substantial number of potential confounders, opioids were associated with slightly worse functioning in back pain patients at 6-month follow-up. Further research may help us to understand the mechanisms underlying these findings and inform clinical decisions regarding the usefulness of opioids for back pain.

  • Low muscle mass in older men: the role of lifestyle, diet and cardiovascular risk factors

    Abstract: Objective: To explore associations between low muscle mass and a wide range of lifestyle, dietary and cardiovascular risk factors in older men including metabolic risk factors, markers of inflammation, endothelial dysfunction and coagulation. Design: Cross-sectional study. Setting: British Regional Heart Study. Participants: 4252 men aged 60-79 years. Measurements: Participants attended a physical examination in 1998-2000, and completed a general questionnaire and a food frequency questionnaire. Low muscle mass was assessed by two measures: midarm muscle circumference (MAMC) and fat-free mass index (FFMI). Associations between risk factors and low muscle mass were analysed using logistic regression. Results: Physical inactivity, insulin resistance, C-reactive protein, von Willebrand factor and fibrinogen were associated with significantly increased odds of low MAMC and FFMI after adjustment for body mass index, lifestyle characteristics and morbidity. Those with higher percent energy intake from carbohydrates showed decreased odds of low MAMC (OR: 0.73, 95% CI: 0.55-0.96) and FFMI (OR: 0.76, 95% CI: 0.58-0.99). Other dietary variables, smoking, alcohol intake, D-dimer, interleukin 6 and homocysteine showed no important associations with MAMC and FFMI. Conclusion: Increasing physical activity, consuming a diet with a high proportion of energy from carbohydrates, and taking steps to prevent insulin resistance and reduce inflammation and endothelial dysfunction may help to reduce the risk of low muscle mass in older men.

  • Influence of initial severity of depression on effectiveness of low intensity interventions: meta-analysis of individual patient data

    Objective: To assess how initial severity of depression affects the benefit derived from low intensity interventions for depression. Design: Meta-analysis of individual patient data from 16 datasets comparing low intensity interventions with usual care. Setting: Primary care and community settings. Participants: 2470 patients with depression. Interventions: Low intensity interventions for depression (such as guided self help by means of written materials and limited professional support, and internet delivered interventions). Main outcome measures: Depression outcomes (measured with the Beck Depression Inventory or Center for Epidemiologic Studies Depression Scale), and the effect of initial depression severity on the effects of low intensity interventions. Results: Although patients were referred for low intensity interventions, many had moderate to severe depression at baseline. We found a significant interaction between baseline severity and treatment effect (coefficient −0.1 (95% CI −0.19 to −0.002)), suggesting that patients who are more severely depressed at baseline demonstrate larger treatment effects than those who are less severely depressed. However, the magnitude of the interaction (equivalent to an additional drop of around one point on the Beck Depression Inventory for a one standard deviation increase in initial severity) was small and may not be clinically significant. Conclusions: The data suggest that patients with more severe depression at baseline show at least as much clinical benefit from low intensity interventions as less severely depressed patients and could usefully be offered these interventions as part of a stepped care model.

  • A short guide and a forest pilot command (ipdforest) for one-stage meta-analysis

    This article describes a new individual patient data (IPD) meta-analysis post-estimation command, ipdforest. The command produces a forest plot, following an one-stage meta-analysis with xtmixed or xtmelogit. The over-all effect is obtained from the preceding mixed-effects regression and the study effects from linear or logistic regressions on each study which are executed within ipdforest. IPD meta-analysis models with Stata are discussed.

  • Osteoarthritis and the Rule of Halves

    Background: Symptomatic osteoarthritis poses a major challenge to primary health care but no studies have related accessing primary care (‘detection’), receiving recommended treatments (‘treatment’), and achieving adequate control (‘control’). Objective: To provide estimates of detection, treatment, and control within a single population adapting the approach used to determine a Rule of Halves for other long-term conditions. Setting: General population Participants: 400 adults aged 50+ years with prevalent symptomatic knee osteoarthritis. Design: Prospective cohort with baseline questionnaire, clinical assessment, and plain radiographs, and questionnaire follow-up at 18 and 36 months and linkage to primary care medical records. Outcome measures: ‘Detection’ was defined as at least one musculoskeletal knee-related GP consultation between baseline and 36 months. ‘Treatment’ was self-reported use of at least one recommended treatment or physiotherapy/hospital specialist referral for their knee problem at all three measurement points. Pain was ‘controlled’ if characteristic pain intensity <5 out of 10 on at least two occasions. Results: In 221 cases (55.3%; 95%CI: 50.4, 60.1) there was evidence that the current problem had been detected in general practice. Of those detected, 164 (74.2% (68.4, 80.0)) were receiving one or more of the recommended treatments at all three measurement points. Of those detected and treated, 45 (27.4% (20.5, 34.3)) had symptoms under control on at least two occasions. Using narrower definitions resulted in substantially lower estimates. Conclusion: Osteoarthritis care does not conform to a Rule of Halves. Symptom control is low among those accessing healthcare and receiving treatment.

  • A Greedy Algorithm for Representative Sampling: repsample in Stata

    Quantitative empirical analyses of a population of interest usually aim to estimate the causal eect of one or more independent variables on a dependent variable. How- ever, only in rare instances is the whole population available for analysis. Researchers tend to estimate causal eects on a selected sample and generalize their conclusions to the whole population. The validity of this approach rests on the assumption that the sample is representative of the population on certain key characteristics. A study using a non-representative sample is lacking in external validity by failing to minimize population choice bias. When the sample is large and non-response bias is not an issue, a random selection process is adequate to ensure external validity. If that is not the case, however, researchers could follow a more deterministic approach to ensure representativeness on the selected characteristics, provided these are known, or can be estimated, in the parent population. Although such approaches exist for matched sampling designs, research on representative sampling and the similarity between the sample and the parent popula- tion seems to be lacking. In this article we propose a greedy algorithm for obtaining a representative sample and quantifying representativeness in Stata.

  • The Relationship Between Quality of Care and Choice of Clinical Computing System: Retrospective Analysis of Family Practice Performance Under the UK’s Quality and Outcomes Framework

    Objectives: To investigate the relationship between performance on the UK Quality and Outcomes Framework pay-for-performance scheme and choice of clinical computer system. Design: Retrospective longitudinal study. Setting: Data for 2007-8 to 2010-11, extracted from the clinical computer systems of general practices in England. Participants: All English practices participating in the pay-for-performance scheme: average 8257 each year, covering over 99% of the English population registered with a general practice. Main outcome measures: Levels of achievement on 62 quality of care indicators, measured as: reported achievement (levels of care after excluding inappropriate patients); population achievement (levels of care for all patients with the relevant condition); and percentage of available quality points attained. Multilevel mixed effects multiple linear regression models were used to identify population, practice, and clinical computing system predictors of achievement. Results: Seven clinical computer systems were consistently active in the study period, collectively holding approximately 99% of the market share. Of all population and practice characteristics assessed, choice of clinical computing system was the strongest predictor of performance across all three outcome measures. Differences between systems were greatest for intermediate outcomes indicators (for example, control of cholesterol levels). Conclusions: Under the UK’s pay-for-performance scheme, differences in practice performance were associated with choice of clinical computing system. This raises the question of whether particular system characteristics facilitate higher quality of care, better data recording, or both. Inconsistencies across systems need to be understood and addressed, and researchers need to be cautious when generalising findings from samples of providers using a single computing system.

  • Track and Trigger in an Emergency Department: an observational evaluation study

    Objective To evaluate the utilisation of paper-based track and trigger (T&T) charts in a UK emergency department (ED). Methods A single-centre prospective observational cohort study was conducted in the ED of a medium-sized teaching hospital. Charted vital-sign data were collected from adults attending the resuscitation room, majors or observation ward. These data were examined in parallel with clinical notes to identify ‘escalation’ events. For each set of vital signs, the authors calculated the T&T score retrospectively. Results Data from 472 patient episodes (2965 sets of vital signs) were examined. 85.8% of patients had at least one full set of observations (CEM standard) and 60.6% had at least one T&T score documented. However, only 34.5% of observation sets had a corresponding T&T score. 20.6% of T&T score totals (1024) were incorrect, potentially preventing a ‘trigger’ from being recognised. 204 patient episodes had at least one recorded escalation. Physiological escalations were associated with vital-sign scores that met the triggering thresholds (98/104), while patients who had non-physiological escalations or no escalations were more likely to have scores below the triggering thresholds (88/100). Only 26.9% of physiological escalations were associated with a documented T&T score above the triggering threshold. Retrospective completion of the charts increased that figure to 94.2%. Conclusion T&T in the ED is challenged by poor completion rates and numerical errors made during score calculation. However the potential for recognition of a deteriorating patient should not be ignored. The future work of the authors intends to evaluate an electronic system for automatically calculating T&T scores within the ED environment.

  • Data fusion for estimating respiratory rate from a single-channel ECG

    Respiratory rate, an important antecedent of patient deterioration, is inadequately recorded by hospital staff, partially due to the absence of a reliable automated technique for measuring it. The ECG has been proposed by several authors in recent years as a source of reliable respiratory information. Most algorithms proposed use either respiratory sinus arrhythmia (RSA) or the R-peak amplitude (RPA) modulation of the ECG. In this paper, we propose a novel method for estimating respiratory rate from the ECG which fuses frequency information from the two methods. The method was evaluated on data from 40 young and elderly subjects and validated against a “gold standard” respiratory rate obtained from simultaneously recorded respiration data. The fusion method outperformed the RSA and RPA methods, giving a mean absolute error of 0.81 bpm for the young subject population and 0.84 bpm for the elderly, using 1-min windows of data. Unlike other algorithms, the technique does not underperform at the lower or higher respiratory rates.

  • Alcohol consumption screening of newly-registered patients in primary care: a cross sectional analysis

    Although screening and brief intervention is effective at reducing alcohol consumption in primary care and is recommended by guidelines, there are numerous barriers to its delivery. Screening newly-registered patients for alcohol-use disorders provides an opportunity for systematic collection of alcohol consumption data.

  • Montelukast for post-infectious cough in adults: a double-blind randomised placebo-controlled trial

    Background Post-infectious cough is common in primary care, but has no proven effective treatments. Cysteinyl leukotrienes are involved in the pathogenesis of post-infectious cough and whooping cough (pertussis). We determined the effectiveness of montelukast, a cysteinyl leukotriene receptor antagonist, in the treatment of post-infectious cough. Methods Non-smoking adults aged 16 to 49 years with post-infectious cough of two to eight weeks’ duration were recruited from 25 general practices in England. Patients were tested for pertussis (oral fluid anti-pertussis toxin IgG) and randomly assigned to montelukast 10 mg daily or image-matched placebo for two weeks. Patients chose whether to continue study medication for another two weeks. The randomisation sequence was computer-generated and stratified by general practice. Patients, healthcare professionals and researchers were blinded to treatment allocation. Effectiveness was assessed using the Leicester Cough Questionnaire to measure changes in cough-specific quality of life between baseline and two follow-up stages (two weeks and four weeks). The primary analysis was by intention to treat with imputation by last observation carried forward. Recruitment closed on 21st September 2012 and follow-up has been completed. Findings We randomly assigned 276 patients to montelukast (n=137) or placebo (n=139). Seventy patients had laboratory-confirmed pertussis (25%). Improvements in cough-specific quality of life occurred in both groups after two weeks (montelukast: mean 2•7, [95% confidence interval 2•2 to 3•3]; placebo: 3•6 [2•9 to 4•3], p=0•04) but the difference between groups was not clinically significant (mean difference -0•9 [-1•7 to -0•04]). This difference was not statistically significant in any sensitivity analyses. After two weeks, 74•1% of patients elected to continue study medication (montelukast 76•7%; placebo 71•5%). After four weeks, there were no significant between-group differences in cough-specific quality of life improvement (montelukast: 5•2 [4•5 to 5•9]; placebo: 5•9 [5•1 to 6•7]; mean difference -0•5 [-1•5 to 0•6], p=0•38) or adverse event rates (montelukast 15•3%; placebo 22•3%, p=0•14). The most common adverse events reported were increased mucus production (montelukast, n=6; placebo, n=2) and headache (montelukast, n=2; placebo, n=6). One serious adverse event was reported (placebo, n=1), which was unrelated to study medication (shortness of breath and throat tightness after severe coughing bouts). This trial is registered with EudraCT (2010-019647-19), UKCRN Portfolio (ID 8360), and ClinicalTrials.gov (NCT01279668). Interpretation Montelukast is not an effective treatment for post-infectious cough. However, the burden of post-infectious cough in primary care is high, making it an ideal setting for future anti-tussive treatment trials.

  • Brief interventions for weight loss in primary care

    Overweight and obesity are common and important causes of chronic disease. This should mean that primary care physicians feel tackling obesity is important, but it is uncommon for them to do so. Physicians perceive that this is not their job; they fear offending their patients and are unclear what may be effective. In this review we found two systematic reviews showing that motivational interviewing can lead to effective weight loss but it may not be practicable in this setting. Two trials show referral to specially trained nurses in primary care appears ineffective. Several randomized trials show referral to commercial weight management companies is effective. Observational data but no trials suggest that screening for and opportunistic brief interventions may motivate attempts to lose weight and lead to some weight loss. We conclude there is insufficient evidence to promote treatment opportunistically but sufficient evidence to refer patients wanting to lose weight to commercial weight management services. http://link.springer.com/article/10.1007/s13679-013-0073-8

  • A systematic review investigating fatigue, psychological and cognitive impairment following TIA and minor stroke: protocol paper

    Heterogeneity has a key role in meta-analysis methods and can greatly affect conclusions. However, true levels of heterogeneity are unknown and often researchers assume homogeneity. We aim to: a) investigate the prevalence of unobserved heterogeneity and the validity of the assumption of homogeneity; b) assess the performance of various meta-analysis methods; c) apply the findings to published meta-analyses.

  • The Sexunzipped trial: Young People’s Views of Participating in an Online Randomized Controlled Trial

    Background Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants’ experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Objective Our goal was to determine participants’ views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. Methods We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Results Interview participants found the trial design, including online recruitment via Facebook, online registration, email communication with the researchers, and online completion of sexual health questionnaires to be highly acceptable and preferable to traditional methods. Incentives might assist in recruiting those who would not otherwise participate. Participants generally enjoyed taking part in sexual health research online and found the questionnaire itself thought-provoking. Completing the sexual health questionnaires online encouraged honesty in responding that might not be achieved with other methods. The majority of interview participants also thought that receiving and returning a urine sample for chlamydia testing via post was acceptable. Conclusions These findings provide strong support for the use of online research methods for sexual health research, emphasizing the importance of careful planning and execution of all trial procedures including recruitment, respondent validation, trial related communication, and methods to maximize follow-up. Our findings suggest that sexual health outcome measurement might encourage reflection on current behavior, sometimes leading to behavior change.

  • Experiences of predictive testing in young people at risk of Huntington’s disease, familial cardiomyopathy or hereditary breast and ovarian cancer.

    While debate has focused on whether testing of minors for late onset genetic disorders should be carried out if there is no medical benefit, less is known about the impact on young people (<25 years) who have had predictive testing often many years before the likely onset of symptoms. We looked at the experiences of young people who had had predictive testing for a range of conditions with variable ages at onset and options for screening and treatment. A consecutive series of 61 young people who had a predictive test aged 15-25 years at the Clinical Genetic Service, Manchester, for HD, HBOC (BrCa 1 or 2) or FCM (Hypertrophic Cardiomyopathy or Dilated Cardiomyopathy), were invited to participate. Thirty-six (36/61; 59%) agreed to participate (10 HD, 16 HBOC and 10 FCM) and telephone interviews were audiotaped, transcribed and analysed using Interpretative Phenomenological Analysis. None of the participants expressed regret at having the test at a young age. Participants saw the value of pretest counselling not in facilitating a decision, but rather as a source of information and support. Differences emerged among the three groups in parent/family involvement in the decision to be tested. Parents in FCM families were a strong influence in favour of testing, in HBOC the decision was autonomous but usually congruent with the views of parents, whereas in HD the decision was autonomous and sometimes went against the opinions of parents/grandparents. Participants from all three groups proposed more tailoring of predictive test counselling to the needs of young people.European Journal of Human Genetics advance online publication, 17 July 2013; doi:10.1038/ejhg.2013.143.

  • A systematic review of predictors and moderators of response to psychological therapies in OCD: Do we have enough empirical evidence to target treatment?

    Obsessive–compulsive disorder (OCD) is a disabling mental health condition. Despite effective psychological treatments for OCD, a significant percentage of patients fail to experience lasting benefit. Factors underlying variable treatment response are poorly understood. Moderators of outcome can help understand “for whom” and “under what circumstances” an intervention works best and thus improve service effectiveness. This paper synthesizes the evidence on predictors and moderators and assesses the quality of reporting of related analyses in psychological therapies for adults with OCD. Trialswere identified through electronic searches (CENTRAL, MEDLINE, PsycINFO, EMBASE), key author, and reference list searches of relevant systematic reviews. Fifty five percent (38/69) of relevant trials reported baseline factors associated with outcome; these encompassed clinical, demographic, interpersonal, OCD symptom-specific, psychological/psychosocial, and treatment-specific variables. Predictors were commonly assessed via a validated pre-randomization measure, though fewtrials adopted best practice by stating a priori hypotheses or conducting a test of interaction. Potential associations emerged betweenworse OCD treatment outcome and the following factors: hoarding pathology, increased anxiety and OCD symptom severity, certain OCD symptom subtypes, unemployment, and being single/not married. However, the applied utility of these analyses is currently limited by methodological weaknesses.

  • The Effect of Complex Interventions on Depression and Anxiety in Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-Analysis

    Background: Depression and anxiety are very common in people with chronic obstructive pulmonary disease (COPD) and are associated with excess morbidity and mortality. Patients prefer non-drug treatments and clinical guidelines promote non-pharmacological interventions as first line therapy for depression and anxiety in people with long term conditions. However the comparative effectiveness of psychological and lifestyle interventions among COPD patients is not known. We assessed whether complex psychological and/or lifestyle interventions are effective in reducing symptoms of anxiety and depression in patients with COPD. We then determined what types of psychological and lifestyle interventions are most effective. Methods and Findings: Systematic review of randomised controlled trials of psychological and/or lifestyle interventions for adults with COPD that measured symptoms of depression and/or anxiety. CENTRAL, Medline, Embase, PsychINFO, CINAHL, ISI Web of Science and Scopus were searched up to April 2012. Meta-analyses using random effects models were undertaken to estimate the average effect of interventions on depression and anxiety. Thirty independent comparisons from 29 randomised controlled trials (n = 2063) were included in the meta-analysis. Overall, psychological and/or lifestyle interventions were associated with small reductions in symptoms of depression (standardised mean difference 20.28, 95% confidence interval 20.41 to 20.14) and anxiety (standardised mean difference 20.23, 95% confidence interval 20.38 to 20.09). Multi-component exercise training was the only intervention subgroup associated with significant treatment effects for depression (standardised mean difference 20.47, 95% confidence interval 20.66 to 20.28), and for anxiety (standardised mean difference 20.45, 95% confidence interval 20.71 to 20.18). Conclusions: Complex psychological and/or lifestyle interventions that include an exercise component significantly improve symptoms of depression and anxiety in people with COPD. Furthermore, multi-component exercise training effectively reduces symptoms of anxiety and depression in all people with COPD regardless of severity of depression or anxiety, highlighting the importance of promoting physical activity in this population.

  • English to Arabic Translation of the Composite Abuse Scale (CAS): A Multi-Method Approach

    The composite abuse scale (CAS) is a comprehensive tool used to measure intimate partner violence (IPV). The aim of the present study is to translate the CAS from English to Arabic. Methods The translation of the CAS was conducted in four stages using a multi-method approach: 1) preliminary forward translation, 2) discussion with a panel of bilingual experts, 3) focus groups discussion, and 4) back-translation of the CAS. The discussion included a linguistic validation by a comparison of the Arabic translation with the original English by assessing conceptual and content equivalence. Findings In all the stages of translation, there was an agreement to remove the question from the CAS that asked women about the use of objects in the vagina. Wording, format and order of the items were refined according to comments and suggestions made by the experts’ panel and focus groups’ members. The back-translated CAS showed similar wording and language of the original English version. Conclusions The Arabic version of the CAS will help to measure the problem of IPV among Saudi women and possibly other Arabic-speaking women in future studies. This is important, particularly, in longitudinal studies or intervention studies among abused women and it allows a comparison of the results of studies from different cultures. However, further validations studies are needed to ensure accurate and equivalent Arabic translation of the CAS. Citation: Alhabib S, Feder G, Horwood J (2013) English to Arabic Translation of the Composite Abuse Scale (CAS): A Multi-Method Approach. PLoS ONE 8(9): e75244. doi:10.1371/journal.pone.0075244

  • Why are GPs treating subclinical hypothyroidism? Case note review and GP survey

    Background Subclinical hypothyroidism (SCHo) is a common biochemical diagnosis in older age. Evidence of impact is inconclusive and guidelines are inconsistent. With increasing numbers of thyroid function tests (TFTs) performed, GPs frequently have to make management decisions regarding this diagnosis. However, little is known about how SCHo is currently being managed in primary care. Aim To explore management of SCHo in primary care and GP reported rationale for treatment of SCHo in older individuals. Design Descriptive study using retrospective case note review and GP survey. Setting Nineteen General Practices, Central England, UK. Methods Follow-up of a large cohort with subsequent detailed review of individuals for whom therapy had been initiated following diagnosis of SCHo. Data on practice policies, and rationale behind treatment were collected via GP questionnaire. Results Forty-two individuals were treated following identification of SCHo. Factors regarded as supporting instigation of therapy recorded by practitioners included symptoms, a positive antithyroid antibody test and history of radioiodine therapy. In all, 55% were registered at 3/19 practices suggesting significant between practice variation. Reasons for testing included chronic disease check-up (n = 14), presenting ‘thyroid symptoms’ (n = 5) and presenting other symptoms (n = 9). Reasons for therapy initiation were only recorded in 26 cases and included presence of symptoms, persistently high or increasing serum thyroid stimulating hormone concentration and patient request. Only 2/15 GPs reported having practice guidelines on management. Conclusion Results suggest that GPs are uncertain how to interpret symptoms and TFT results in older individuals. There is considerable variation in management of SCHo between GPs with some GPs treating patients outside of all guideline recommendations.

  • Development and feasibility testing of a smartphone based attentive eating intervention

    Background Attentive eating means eating devoid of distraction and increasing awareness and memory for food being consumed. Encouraging individuals to eat more attentively could help reduce calorie intake, as a strong evidence base suggests that memory and awareness of food being consumed substantially influence energy intake. Methods The development and feasibility testing of a smartphone based attentive eating intervention is reported. Informed by models of behavioral change, a smartphone application was developed. Feasibility was tested in twelve overweight and obese volunteers, sampled from university staff. Participants used the application during a four week trial and semi-structured interviews were conducted to assess acceptability and to identify barriers to usage. We also recorded adherence by downloading application usage data from participants’ phones at the end of the trial. Results Adherence data indicated that participants used the application regularly. Participants also felt the application was easy to use and lost weight during the trial. Thematic analysis indicated that participants felt that the application raised their awareness of what they were eating. Analysis also indicated barriers to using a smartphone application to change dietary behavior. Conclusions An attentive eating based intervention using smartphone technology is feasible and testing of its effectiveness for dietary change and weight loss is warranted. Keywords: Attentive eating; Memory; Attention; Awareness; Food intake; Mobile phone

  • Slimming World in Stop smoking Services (SWISSS): study protocol for a randomized controlled trial

    Quitting smokers gain weight. This deters some from trying to stop smoking and may explain the increased incidence of type 2 diabetes after cessation. Dieting when stopping smoking may be counterproductive. Hunger increases cravings for smoking and tackling two behaviours together may undermine quitting success. A meta-analysis of randomized controlled trials (RCTs) showed individualized dietary support may prevent weight gain, although there is insufficient evidence whether it undermines smoking cessation. Commercial weight management providers (CWMPs), such as Slimming World, provide individualized dietary support for National Health Service (NHS) patients; however, there is no evidence that they can prevent cessation-related weight gain. Our objective is to determine whether attending Slimming World from quit date, through referral from NHS Stop Smoking Services, is more effective than usual care at preventing cessation-related weight gain. Methods This RCT will examine the effectiveness of usual cessation support plus referral to Slimming World compared to usual cessation support alone. Healthy weight, overweight and obese adult smokers attending Stop Smoking Services will be included. The primary outcome is weight change in quitters 12 weeks post-randomization. Multivariable linear regression analysis will compare weight change between trial arms and adjust for known predictors of cessation-related weight gain. We will recruit 320 participants, with 160 participants in each arm. An alpha error rate of 5% and 90% power will detect a 2 kg (SD = 2.5) difference in weight gain at 12 weeks, assuming 20% remain abstinent by then. Discussion This trial will establish whether referral to the 12-week Slimming World programme plus usual care is an effective intervention to prevent cessation-related weight gain. If so, we will seek to establish whether weight control comes at the expense of a successful quit attempt in a further non-inferiority trial. Positive results from both these trials would provide a potential solution to cessation-related weight gain, which could be rolled out across England within Stop Smoking Services to better meet the needs of 0.75 million smokers stopping with NHS support every year.

  • Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists.

    BACKGROUND: Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. METHODS AND FINDINGS: We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. CONCLUSIONS: Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.

  • Experiences of using email for general practice consultations: a qualitative study

    Reports suggest approximately 21–23% of GPs in the UK have consulted with patients using email, but little is known about the nature of this use and what it means for clinicians and patients in general practice. Aim To understand the use of email consultation in general practice by investigating the experiences of existing users and views of experts. Design and setting A qualitative study conducted in 2010 using purposive sampling and semi-structured interviews in general practice and community settings in some London boroughs. Method A maximum variation sample of GPs and patients who had used email for consultation in general practice were recruited, as were policy and/or implementation experts. Interviews continued until saturation was achieved. Results In total 10 GPs, 14 patients, and six experts were interviewed. Consultation by email was often triggered by logistic or practical issues; motivators for ongoing use were the benefits, such as convenience, for GPs and patients. Both GPs and patients reported concerns about safety and lack of guidance about the ‘rules of engagement’ in email consultations, with GPs also concerned about workload. In response, both groups attempted to introduce their own rules, although this only went some way to addressing uncertainty. Long term, participants felt there was a need for regulation and guidance. Conclusion Consultations by email in general practice occur in an unregulated and unstructured way. Current UK policy is to promote consultations by email, making it crucial to consider the responsibility and workload faced by clinicians, and the changes required to ensure safe use; not doing so may risk safety breaches and result in suboptimal care for patients.

  • Evidence of Effectiveness of Health Care Professionals Using Handheld Computers: A Scoping Review of Systematic Reviews

    Background: Handheld computers and mobile devices provide instant access to vast amounts and types of useful information for health care professionals. Their reduced size and increased processing speed has led to rapid adoption in health care. Thus, it is important to identify whether handheld computers are actually effective in clinical practice. Objective: A scoping review of systematic reviews was designed to provide a quick overview of the documented evidence of effectiveness for health care professionals using handheld computers in their clinical work. Methods: A detailed search, sensitive for systematic reviews was applied for Cochrane, Medline, EMBASE, PsycINFO, Allied and Complementary Medicine Database (AMED), Global Health, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. All outcomes that demonstrated effectiveness in clinical practice were included. Classroom learning and patient use of handheld computers were excluded. Quality was assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. A previously published conceptual framework was used as the basis for dual data extraction. Reported outcomes were summarized according to the primary function of the handheld computer. Results: Five systematic reviews met the inclusion and quality criteria. Together, they reviewed 138 unique primary studies. Most reviewed descriptive intervention studies, where physicians, pharmacists, or medical students used personal digital assistants. Effectiveness was demonstrated across four distinct functions of handheld computers: patient documentation, patient care, information seeking, and professional work patterns. Within each of these functions, a range of positive outcomes were reported using both objective and self-report measures. The use of handheld computers improved patient documentation through more complete recording, fewer documentation errors, and increased efficiency. Handheld computers provided easy access to clinical decision support systems and patient management systems, which improved decision making for patient care. Handheld computers saved time and gave earlier access to new information. There were also reports that handheld computers enhanced work patterns and efficiency. Conclusions: This scoping review summarizes the secondary evidence for effectiveness of handheld computers and mhealth. It provides a snapshot of effective use by health care professionals across four key functions. We identified evidence to suggest that handheld computers provide easy and timely access to information and enable accurate and complete documentation. Further, they can give health care professionals instant access to evidence-based decision support and patient management systems to improve clinical decision making. Finally, there is evidence that handheld computers allow health professionals to be more efficient in their work practices. It is anticipated that this evidence will guide clinicians and managers in implementing handheld computers in clinical practice and in designing future research.

  • Suitability of emergency department attenders to be assessed in primary care: survey of general practitioner agreement in a random sample of triage records analysed in a service evaluation project

    Objectives: To assess the proportion of ED attendances that would be suitable for primary care and the inter-rater reliability of GP assessment of primary care suitability. Design of Study: Survey of general practitioners’ agreement of suitability for primary care on a random anonymised sample of all ED patients attending over a one month period. Setting: Emergency Department of a UK Hospital serving a population of 600,000 Method: Four GPs independently used data extracted from clinical notes to rate appropriateness for management in primary care as well as need for investigations, specialist review or admission. Agreement was assessed using Cohen’s Kappa Results: The mean percentage of patients that GPs considered suitable for primary care management was 43% (range 38% to 47%). Kappa for agreement was 0.54 (95% CI 0.44 to 0.64) and 0.47(95% CI 0.38-0.59). In patients deemed not suitable for primary care, GPs were more likely to determine the need for specialist review (RR = 3.5, 95% CI 3.0 to 4.2, p<0.001) and admission (RR = 3.9, 95% CI 3.2 to 4.7, p<0.001). In patients assessed as suitable for primary care, GPs would initiate investigations in 51% of cases. Consensus over primary care appropriateness was higher for paediatric than adult attenders. Conclusion: A significant number of patients attending ED could be managed by GPs, including those requiring investigations at triage. Stronger agreement among GPs over place of care may be seen for paediatric than for adult attenders. More effective signposting of patients presenting with acute or urgent problems, and supporting a greater role for primary care in relieving the severe workflow pressures in ED in the UK are potential solutions.

  • Health on the web: randomised trial of work-based online screening and brief intervention for hazardous and harmful drinking

    Alcohol misuse is a significant international public health problem. Screening and brief intervention (SBI) in primary care reduces alcohol consumption by about 15 – 30%, sustained over 12 months in hazardous or harmful drinkers but implementation has proved difficult leading to growing interest in exploring the effectiveness of SBI in other settings, including the workplace. Computerised interventions for alcohol misuse can be as effective as traditional face-to-face interventions and may have advantages, including anonymity, convenience and availability.

  • Longitudinal measurement of cortisol in association with mental health and experience of domestic violence and abuse: study protocol.

    Domestic violence and abuse is threatening behavior, violence/abuse used by one person to control the other within an intimate or family-type relationship. Women experience more severe physical and sexual domestic violence and abuse and more mental health consequences than men. The current study aims at exploring of the role of hypothalamic-pituitary-adrenocortical axis activity in abuse impact on women's mental health. Study objectives: 1) To evaluate diurnal cortisol slope, cortisol awakening response, and the mean cortisol concentration in women with a current or recent experience of abuse; 2) To estimate whether cortisol secretion is associated with type, severity, duration and cessation of abuse; 3) To investigate whether cortisol acts as mediator between abuse and mental health condition; 4) To examine whether there is any distinction in cortisol levels between those women exposed to both childhood abuse and domestic violence and abuse and those experienced only the latter. 4) To explore whether cortisol secretion differs between women living in refuge and those still living in the community.

  • Evidence for non-communicable diseases: analysis of Cochrane reviews and randomised trials by World Bank classification

    Introduction Prevalence of non-communicable diseases (NCDs) is increasing globally, with the greatest projected increases in low-income and middle-income countries. We sought to quantify the proportion of Cochrane evidence relating to NCDs derived from such countries. Methods We searched the Cochrane database of systematic reviews for reviews relating to NCDs highlighted in the WHO NCD action plan (cardiovascular, cancers, diabetes and chronic respiratory diseases). We excluded reviews at the protocol stage and those that were repeated or had been withdrawn. For each review, two independent researchers extracted data relating to the country of the corresponding author and the number of trials and participants from countries, using the World Bank classification of gross national income per capita. Results 797 reviews were analysed, with a reported total number of 12 340 trials and 10 937 306 participants. Of the corresponding authors 90% were from high-income countries (41% from the UK). Of the 746 reviews in which at least one trial had met the inclusion criteria, only 55% provided a summary of the country of included trials. Analysis of the 633 reviews in which country of trials could be established revealed that almost 90% of trials and over 80% of participants were from high-income countries. 438 (5%) trials including 1 145 013 (11.7%) participants were undertaken in low-middle income countries. We found that only 13 (0.15%) trials with 982 (0.01%) participants were undertaken in low-income countries. Other than the five Cochrane NCD corresponding authors from South Africa, only one other corresponding author was from Africa (Gambia). Discussion The overwhelming body of evidence for NCDs pertains to high-income countries, with only a small number of review authors based in low-income settings. As a consequence, there is an urgent need for research infrastructure and funding for the undertaking of high-quality trials in this area.

  • Comparative Effectiveness of Placebos and Treatments: a Systematic Review and Meta-Analysis.

    Objectives Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown. Methods We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. Results We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances. Conclusion and implications Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions.

  • Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners.

    Objectives Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown. Methods We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. Results We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances. Conclusion and implications Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions.

  • Primary care clinicians’ attitudes towards point-of-care blood testing: a systematic review of qualitative studies.

    Background Point-of-care blood tests are becoming increasingly available and could replace current venipuncture and laboratory testing for many commonly used tests. However, at present very few have been implemented in most primary care settings. Understanding the attitudes of primary care clinicians towards these tests may help to identify the barriers and facilitators to their wider adoption. We aimed to systematically review qualitative studies of primary care clinicians’ attitudes to point-of-care blood tests. Methods We systematically searched Medline, Embase, ISI Web of Knowledge, PsycINFO and CINAHL for qualitative studies of primary care clinicians’ attitudes towards point-of-care blood tests in high income countries. We conducted a thematic synthesis of included studies. Results Our search identified seven studies, including around two hundred participants from Europe and Australia. The synthesis generated three main themes: the impact of point-of-care testing on decision-making, diagnosis and treatment; impact on clinical practice more broadly; and impact on patient-clinician relationships and perceived patient experience. Primary care clinicians believed point-of-care testing improved diagnostic certainty, targeting of treatment, self-management of chronic conditions, and clinician-patient communication and relationships. There were concerns about test accuracy, over-reliance on tests, undermining of clinical skills, cost, and limited usefulness. Conclusions We identified several perceived benefits and barriers regarding point-of-care tests in primary care. These imply that if point-of-care tests are to become more widely adopted, primary care clinicians require evidence of their accuracy, rigorous testing of the impact of introduction on patient pathways and clinical practice, and consideration of test funding.

  • A mixed methods pilot study of the acceptability and effectiveness of a brief mindfulness intervention for people with diabetes and coronary heart disease.

    Mindfulness based interventions can successfully target negative perseverative cognitions such as worry and thought suppression, but their acceptability and effectiveness in people with long term conditions is uncertain. We therefore pilot tested a 6-week meditation and mindfulness intervention in people (n = 40) with diabetes and coronary heart disease. We used a sequential mixed-methods approach that measured change in worry and thought suppression and qualitatively explored acceptability, feasibility and user experience with a focus group (n = 11), and in-depth interviews (n = 16). The intervention was highly acceptable, with 90% completing ≥5 sessions. Meditation and mindfulness skills led to improved sleep, greater relaxation and more accepting approaches to illness and illness experience. At the end of the 6-week meditation course worry (mean difference = 5.71, SD = 14.45, p = .000) and thought suppression (mean difference = 3.19, SD = 13.1, p = .015) were significantly reduced. Positive impacts on psychological health may relate to acquisition and development of meta-cognitive skills but this needs experimental confirmation.

  • Same difference? Complementary therapy consultations delivered in NHS and private settings - A qualitative study.

    Objective The aim of this study was to explore similarities and differences in complementary therapy consultations offered in NHS primary care and private settings to contribute empirical evidence to the debate about integrative healthcare. Methods Seventeen interviews were conducted with therapists and clients with experience of NHS and private complementary therapy consultations. In addition, a homoeopath and an acupuncturist were observed delivering 22 consultations in private and NHS primary care premises. Interview data were analysed thematically, drawing on observational data to confirm or dispute identified themes. In a second order analysis, the content and timing of two pairs of matched consultations were analysed in-depth. Results Negligible differences were found between NHS and private consultations in interview or observation data. Where minimal variation was noted, in the NHS therapists experienced slightly more complex cases, some restrictions to equipment, noisier premises, slightly tighter boundaries with clients and some time restrictions. Therapists were aware of more differences than clients, who did not report variation in the quality of consultations due to consultation setting. Clients tended to prefer the clinic with the most accessible location, regardless of its NHS or private setting. Conclusion For those who experienced both types of settings little difference appeared to exist between complementary therapy consultations delivered in NHS primary care or private sectors. Future research exploring the complex relationships between practitioners and clients and the impact of shortened consultations on client satisfaction and perceptions of effectiveness would be valuable.

  • Brief interventions for weight loss in primary care

    Overwieght and obesity are common and important causes of chronic disease. This should mean that primary care physicians feel tackling obesity is important, but it is uncommon for them to do so. Physicians perceive that this is not their job; they fear offending their patients and are unclear what may be effective. In this review we found two systematic reviews showing that motivational interviewing can lead to effective weight loss but it may not be practicable in this setting. Two trials show referral to specially trained nurses in primary care appears effective.

  • Regular self-weighing to promote weight maintenance after intentional weight loss: a quasi randomised controlled trial.

    BACKGROUND: Many overweight people take action to lose weight but most regain this weight.PurposeTo examine the effectiveness of a weight maintenance intervention focused on regular self-weighing after receiving a 12-week weight loss programme. METHODS: Quasi-randomized controlled trial of 3768 obese or overweight men and women. The intervention group (n = 3290) received two telephone calls, the offer of free weighing scales, encouragement to weigh themselves weekly and record this on a card. The main outcome was change in weight between 3 and 12 months. RESULTS: Using intention to treat analysis both groups regained weight; however, the intervention group on average regained 1.23 kg, whereas the control group regained 1.83 kg. Adjusting for covariates resulted in a mean difference of 0.68 kg (95% CI 0.12, 1.24) at 12-month follow-up. CONCLUSIONS: Encouraging people who have recently lost weight to weigh themselves regularly prevents some weight regain.

  • Development of a risk prediction model for chemotherapy-related nausea and vomiting

    BACKGROUND: A number of risk factors have been implicated in the development of chemotherapy-induced nausea/vomiting (CINV). Our aim was to develop a risk prediction model and identify patients at high risk for developing CINV before their chemotherapy treatment. PATIENTS AND METHODS: A multisite, observational, prospective longitudinal design was used. Participants were 336 chemotherapy-naïve cancer patients providing 791 assessments. They completed measures to assess potential risk factors for CINV, including socio-demographic and clinical/treatment-related characteristics, symptom distress, expectations for CINV and state-trait anxiety. CINV was measured with the MASCC Antiemesis Tool. Participants were divided randomly to a training set (=286) and a test set (=50). Random-effects models were run to ascertain the contribution of risk factors in the development of CINV using the training sample. Specificity and sensitivity of the model were assessed in both sets of samples. RESULTS: Younger age, history of nausea/vomiting, trait anxiety and fatigue were linked with higher levels of CINV, and use of moderately and low emetogenic chemotherapy were linked with lower CINV. The model's specificity were 55.4 and 50.0 % and sensitivity were 80.3 and 79.0 % in the training and test sample, respectively. A dynamic web-based tool is freely available for use by clinicians. CONCLUSION: This model of risk prediction for CINV can be an aid to clinical decision-making and assist clinicians to rationalise antiemetic use with their patients.

  • Prospective evaluation of cisplatin- and carboplatin‑mediated ototoxicity in paediatric and adult soft tissue and osteosarcoma patients

    Platinum-compound chemotherapy is known to have ototoxic side-effects. However, there is a paucity of literature examining hearing function prospectively and longitudinally in cohorts containing paediatric and adult patients treated within the same cisplatin- or carboplatincontaining treatment trial protocols. In Germany, Austria and Switzerland, late effects of treatment for osteosarcoma and soft tissue sarcoma have been prospectively and longitudinally registered by the Late Effects Surveillance System since 1998. The aim of this study was to analyse cisplatin- and carboplatin-induced ototoxity in a group of 129 osteosarcoma and soft tissue sarcoma patients treated within the COSS-96, CWS-96 and CWS-2002P treatment trials. The cohort consisted of 112 children and 17 adults. The median age at diagnosis was 13.56 (IQR, 10.2616.27) years. Follow-up was 6.97 (IQR, 0.8715.63) months. Hearing function was examined by audiometry before and after platinum treatment. A total of 108 patients were treated with cisplatin with a median cumulative dose of 360 mg/m2. Thirteen patients received carboplatin with a median cumulative dose of 1500 mg/m2 and 8 patients were treated with both platinum compounds (median cisplatin dose, 240 mg/m2; IQR, 240-360 mg/m2 and median carboplatin dose: 1200 mg/m2; IQR, 600-3000 mg/m2). Following cessation of therapy, 47.3% of the patients demonstrated a hearing impairment, namely 55 children (49.1%) and 6 adults (42.1%). Out of thirteen children treated with carboplatin with a cumulative dose of 1500 mg/m2, six revealed a significant hearing impairment. Although ototoxicity caused by platinum compounds is considered irreversible, we identified hearing improvements over time in 11 children (9.8%) and 3 adults (17.6%). None of these patients received irradiation to the head. We conclude that hearing loss is frequent in children treated with protocols containing platinum compounds and recommend prospective testing via audiometry.

  • Eating Attentively: A systematic review and meta-analysis of the effect of food intake memory and awareness on eating.

    Background: Cognitive processes such as attention and memory may influence food intake, but the degree to which they do is unclear. Objective: The objective was to examine whether such cognitive processes influence the amount of food eaten either immediately or in subsequent meals. Design: We systematically reviewed studies that examined experimentally the effect that manipulating memory, distraction, awareness, or attention has on food intake. We combined studies by using inverse variance meta-analysis, calculating the standardized mean difference (SMD) in food intake between experimental and control groups and assessing heterogeneity with the I2 statistic. Results: Twenty-four studies were reviewed. Evidence indicated that eating when distracted produced a moderate increase in immediate intake (SMD: 0.39; 95% CI: 0.25, 0.53) but increased later intake to a greater extent (SMD: 0.76; 95% CI: 0.45, 1.07). The effect of distraction on immediate intake appeared to be independent of dietary restraint. Enhancing memory of food consumed reduced later intake (SMD: 0.40; 95% CI: 0.12, 0.68), but this effect may depend on the degree of the participants’ tendencies toward disinhibited eating. Removing visual information about the amount of food eaten during a meal increased immediate intake (SMD: 0.48; 95% CI: 0.27, 0.68). Enhancing awareness of food being eaten may not affect immediate intake (SMD: 0.09; 95% CI: −0.42, 0.35). Conclusions: Evidence indicates that attentive eating is likely to influence food intake, and incorporation of attentive-eating principles into interventions provides a novel approach to aid weight loss and maintenance without the need for conscious calorie counting.

  • Email for clinical communication between patients/caregivers and healthcare professionals

    Email is a popular and commonly-used method of communication, but its use in health care is not routine. Where email communication has been demonstrated in health care this has included its use for communication between patients/caregivers and healthcare professionals for clinical purposes, but the effects of using email in this way is not known.This review addresses the use of email for two-way clinical communication between patients/caregivers and healthcare professionals.

  • Use of email for consulting with patients in general practice

    Email is ubiquitous. Estimates in 2009 were that 97% of UK adult internet users across all generations and demographic groups had used email. While professionals and the majority of industry would struggle without email, health care has not embraced this type of interaction and there is no accepted way for patients to email their doctor, with health care utilising more traditional methods of communication like post and telephone.

  • Managing smoking cessation related weight gain

    About 80% of smokers who stop smoking gain weight after they stop; on average 5 kg in the first year and about 6 to 7 kg overall. However, weight gain varies a lot between individuals, with some putting on 10 kg or more in a year. Although some factors predict who will gain excessive weight, they are not clinically useful for targeting individuals at high risk. Instead, it may be prudent to monitor weight gain after cessation and intervene with people gaining more than 1 kg/month. There is some evidence that weight gain after cessation can be prevented by dietary intervention that includes setting an energy intake goal and regular monitoring of weight and adjustment of energy intake. However, there are fears that such an approach may harm the success of a quit attempt because it may worsen craving for cigarettes. There is no evidence that this is the case, but the data are too imprecise to be completely reassuring. Exercise programs may reduce cravings for tobacco and increase the likelihood of achieving smoking abstinence, and there is some evidence that they reduce weight gain in the longer term. Consequently, they may be safely recommended but the effect on weight gain is modest. Long‑term nicotine replacement therapy prevents several kilograms of weight gain but it may produce harmful metabolic changes that increase cardiovascular risk. Randomized trials are needed to assess efficacy. Thus, weight gain after cessation remains problematic with few interventions to prevent it that have only modest effectiveness.

  • The under-representation of ethnic minority groups in research studies.

    THE IMPLICATIONS OF SUPER-DIVERSITY FOR HEALTH AND RESEARCH People have been coming to the UK since the beginning of recorded time.1 The latest Census shows that England and Wales have become more ethnically diverse with the majority of individuals still identifying themselves as white British (80.6%).2 Over the past two decades, as a result of economic and political changes, migration patterns into the UK have shifted from postcolonial migration particularly referring to relatively discreet communities from the Indian sub-continent and West Indies settling in the UK, to a new type of migration with many different people arriving from many different places. This shift in pattern has resulted in a new kind of diversity which Vertovec3 has coined ‘super-diversity’ characterised by overlapping variables including country of origin (ethnicity, language, religious tradition, regional and/ or local identities), migration experience (influenced by sex, age, education, specific social networks, economic factors), and legal status (encompassing a variety of entitlements and restrictions). Thus ethnic and cultural diversity is becoming more complex. While diversity has many benefits for the economy, science, and culture, it also presents health services and research with the challenges of meeting the needs of a population that is super-diverse in terms of their health profiles and behaviour.4

  • Why are GPs treating subclinical hypothyroidism? Case note review and GP survey.

    Background Subclinical hypothyroidism (SCHo) is a common biochemical diagnosis in older age. Evidence of impact is inconclusive and guidelines are inconsistent. With increasing numbers of thyroid function tests (TFTs) performed, GPs frequently have to make management decisions regarding this diagnosis. However, little is known about how SCHo is currently being managed in primary care. Aim To explore management of SCHo in primary care and GP reported rationale for treatment of SCHo in older individuals. Design Descriptive study using retrospective case note review and GP survey. Setting Nineteen General Practices, Central England, UK. Methods Follow-up of a large cohort with subsequent detailed review of individuals for whom therapy had been initiated following diagnosis of SCHo. Data on practice policies, and rationale behind treatment were collected via GP questionnaire. Results Forty-two individuals were treated following identification of SCHo. Factors regarded as supporting instigation of therapy recorded by practitioners included symptoms, a positive antithyroid antibody test and history of radioiodine therapy. In all, 55% were registered at 3/19 practices suggesting significant between practice variation. Reasons for testing included chronic disease check-up (n = 14), presenting ‘thyroid symptoms’ (n = 5) and presenting other symptoms (n = 9). Reasons for therapy initiation were only recorded in 26 cases and included presence of symptoms, persistently high or increasing serum thyroid stimulating hormone concentration and patient request. Only 2/15 GPs reported having practice guidelines on management. Conclusion Results suggest that GPs are uncertain how to interpret symptoms and TFT results in older individuals. There is considerable variation in management of SCHo between GPs with some GPs treating patients outside of all guideline recommendations.

  • Low muscle mass in older men: the role of lifestyle, diet and cardiovascular risk factors

    Objective: To explore associations between low muscle mass and a wide range of lifestyle, dietary and cardiovascular risk factors in older men including metabolic risk factors, markers of inflammation, endothelial dysfunction and coagulation. Design: Cross-sectional study. Setting: British Regional Heart Study. Participants: 4252 men aged 60-79 years. Measurements: Participants attended a physical examination in 1998-2000, and completed a general questionnaire and a food frequency questionnaire. Low muscle mass was assessed by two measures: midarm muscle circumference (MAMC) and fat-free mass index (FFMI). Associations between risk factors and low muscle mass were analysed using logistic regression. Results: Physical inactivity, insulin resistance, C-reactive protein, von Willebrand factor and fibrinogen were associated with significantly increased odds of low MAMC and FFMI after adjustment for body mass index, lifestyle characteristics and morbidity. Those with higher percent energy intake from carbohydrates showed decreased odds of low MAMC (OR: 0.73, 95% CI: 0.55-0.96) and FFMI (OR: 0.76, 95% CI: 0.58-0.99). Other dietary variables, smoking, alcohol intake, D-dimer, interleukin 6 and homocysteine showed no important associations with MAMC and FFMI. Conclusion: Increasing physical activity, consuming a diet with a high proportion of energy from carbohydrates, and taking steps to prevent insulin resistance and reduce inflammation and endothelial dysfunction may help to reduce the risk of low muscle mass in older men.

  • Identifying families’ reasons for engaging or not engaging with childhood obesity services: a qualitative study.

    The rise in childhood obesity in recent years has been accompanied by a number of initiatives to treat the condition. However, such interventions have often been characterised by poor levels of adherence to treatment and corresponding high attrition rates. This article presents data drawn from qualitative interviews to examine families' reasons for engaging or not engaging with child obesity services. Interviews took place with 15 families whose children attended a UK-based childhood obesity service and 17 families whose children withdrew from treatment. Our data suggested that involvement of children in the decision to attend a clinic was important in building engagement. Specialist diet and exercise advice tailored to individual family circumstance encouraged clinic engagement, but failed to engage some families who felt their personal circumstances had not been considered sufficiently. The clinic environment was viewed as not age appropriate for some children and did not match the expectations of some families. Our findings highlight the value of involving children in the decision to attend an obesity service and practitioners should, as much as possible, tailor advice to the circumstances of each family. Providing clinics for particular age groups in terms of environment and timing may enhance engagement with services.

  • Commentary on Jung et al., Attitudes of Physicians Towards Automated Alerting in Computerized Physician Order Entry Systems. A Comparative International Survey.

    OBJECTIVES: To analyze the attitude of physicians towards alerting in CPOE systems in different hospitals in different countries, addressing various organizational and technical settings and the view of physicians not currently using a CPOE. METHODS: A cross-sectional quantitative and qualitative questionnaire survey. We invited 2,600 physicians in eleven hospitals from nine countries to participate. Eight of the hospitals had different CPOE systems in use, and three of the participating hospitals were not using a CPOE system. RESULTS: 1,018 physicians participated. The general attitude of the physicians towards CPOE alerting is positive and is found to be mostly independent of the country, the specific organizational settings in the hospitals and their personal experience with CPOE systems. Both quantitative and qualitative results show that the majority of the physicians, both CPOE-users and non-users, appreciate the benefits of alerting in CPOE systems on medication safety. However, alerting should be better adapted to the clinical context and make use of more sophisticated ways to present alert information. The vast majority of physicians agree that additional information regarding interactions is useful on demand. Around half of the respondents see possible alert overload as a major problem; in this regard, physicians in hospitals with sophisticated alerting strategies show partly better attitude scores. CONCLUSIONS: Our results indicate that the way alerting information is presented to the physicians may play a role in their general attitude towards alerting, and that hospitals with a sophisticated alerting strategy with less interruptive alerts tend towards more positive attitudes. This aspect needs to be further investigated in future studies.

  • A randomised controlled trial of the clinical and cost-effectiveness of the BRIGHT (BRinging Information & Guided Help Together) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: trial protocol.

    Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease.

  • Who should get low-intensity treatments for depression? An individual patient data meta-analysis.

    Objective To assess how initial severity of depression affects the benefit derived from low intensity interventions for depression. Design Meta-analysis of individual patient data from 16 datasets comparing low intensity interventions with usual care. Setting Primary care and community settings. Participants 2470 patients with depression. Interventions Low intensity interventions for depression (such as guided self help by means of written materials and limited professional support, and internet delivered interventions). Main outcome measures Depression outcomes (measured with the Beck Depression Inventory or Center for Epidemiologic Studies Depression Scale), and the effect of initial depression severity on the effects of low intensity interventions. Results Although patients were referred for low intensity interventions, many had moderate to severe depression at baseline. We found a significant interaction between baseline severity and treatment effect (coefficient −0.1 (95% CI −0.19 to −0.002)), suggesting that patients who are more severely depressed at baseline demonstrate larger treatment effects than those who are less severely depressed. However, the magnitude of the interaction (equivalent to an additional drop of around one point on the Beck Depression Inventory for a one standard deviation increase in initial severity) was small and may not be clinically significant. Conclusions The data suggest that patients with more severe depression at baseline show at least as much clinical benefit from low intensity interventions as less severely depressed patients and could usefully be offered these interventions as part of a stepped care model.

  • Prospective observational cohort study of Health Related Quality of Life (HRQOL), chronic foot problems and their determinants in gout: a research protocol.

    Background Gout is the commonest inflammatory arthritis affecting around 1.4% of adults in Europe. It is predominantly managed in primary care and classically affects the joints of the foot, particularly the first metatarsophalangeal joint. Gout related factors (including disease characteristics and treatment) as well as comorbid chronic disease are associated with poor Health Related Quality of Life (HRQOL) yet to date there is limited evidence concerning gout in a community setting. Existing epidemiological studies are limited by their cross-sectional design, selection of secondary care patients with atypical disease and the use of generic tools to measure HRQOL. This 3 year primary care-based prospective observational cohort study will describe the spectrum of HRQOL in community dwelling patients with gout, associated factors, predictors of poor outcome, and prevalence and incidence of foot problems in gout patients. Methods Adults aged ≥ 18 years diagnosed with gout or prescribed colchicine or allopurinol in the preceding 2 years will be identified through Read codes and mailed a series of self-completion postal questionnaires over a 3-year period. Consenting participants will have their general practice medical records reviewed. Discussion This is the first prospective cohort study of HRQOL in patients with gout in primary care in the UK. The combination of survey data and medical record review will allow an in-depth understanding of factors that are associated with and lead to poor HRQOL and foot problems in gout. Identification of these factors will improve the management of this prevalent, yet under-treated, condition in primary care.

  • Health related quality of life in gout: a systematic review.

    OBJECTIVES: To identify the instruments that have been used to measure health-related quality of life (HRQOL) in gout and assess their clinimetric properties, determine the distribution of HRQOL in gout and identify factors associated with poor HRQOL. METHODS: Medline, CINAHL, EMBASE and PsycINFO were searched from inception to October 2012. Search terms pertained to gout, health or functional status, clinimetric properties and HRQOL. Study data extraction and quality assessment were performed by two independent reviewers. RESULTS: From 474 identified studies, 22 met the inclusion criteria. Health Assessment Questionnaire Disability Index (HAQ-DI) and Short Form 36 (SF-36) were most frequently used and highest rated due to robust construct and concurrent validity, despite high floor and ceiling effects. The Gout Impact Scale had good content validity. Gout had a greater impact on physical HRQOL compared to other domains. Both gout-specific features (attack frequency and intensity, intercritical pain and number of joints involved) and comorbid disease were associated with poor HRQOL. Evidence for objective features such as tophi and serum uric acid was less robust. Limitations of existing studies include cross-sectional design, recruitment from specialist clinic settings and frequent use of generic instruments. CONCLUSION: Most studies have used the generic HAQ-DI and SF-36. Gout-specific characteristics and comorbidities contribute to poor HRQOL. There is a need for a cohort study in primary care (where most patients with gout are treated) to determine which factors predict changes in HRQOL over time. This will enable those at risk of deterioration to be identified and better targeted for treatment.

  • Understanding Responses to a Renal Dosing Decision Support System in Primary Care.

    Renal dosing clinical decision support (CDS) systems have demonstrated clinical effectiveness and potential benefits for patient outcomes. However, the high override rates consistently reported are problematic and undesirable. To understand providers' use patterns of renal dosing CDS, we investigated the override reasons obtained from primary care practices affiliated with two teaching hospitals. We selected a stratified random sample of 300 alerts and reviewed electronic medical records. Appropriateness criteria and an inter-rater reliability process were used. We found that two thirds of alerts were overridden inappropriately, and this proportion was similar for frequent over-riders as compared to the remainder of physicians. These findings imply that strategies are needed to convince providers to accept more clinically appropriate suggestions, though they need to be broadly targeted.

  • On the alert: future priorities for alerts in clinical decision support for computerized physician order entry identified from a European workshop.

    Clinical decision support (CDS) for electronic prescribing systems (computerized physician order entry) should help prescribers in the safe and rational use of medicines. However, the best ways to alert users to unsafe or irrational prescribing are uncertain. Specifically, CDS systems may generate too many alerts, producing unwelcome distractions for prescribers, or too few alerts running the risk of overlooking possible harms. Obtaining the right balance of alerting to adequately improve patient safety should be a priority. Methods A workshop funded through the European Regional Development Fund was convened by the University Hospitals Birmingham NHS Foundation Trust to assess current knowledge on alerts in CDS and to reach a consensus on a future research agenda on this topic. Leading European researchers in CDS and alerts in electronic prescribing systems were invited to the workshop. Results We identified important knowledge gaps and suggest research priorities including (1) the need to determine the optimal sensitivity and specificity of alerts; (2) whether adaptation to the environment or characteristics of the user may improve alerts; and (3) whether modifying the timing and number of alerts will lead to improvements. We have also discussed the challenges and benefits of using naturalistic or experimental studies in the evaluation of alerts and suggested appropriate outcome measures. Conclusions We have identified critical problems in CDS, which should help to guide priorities in research to evaluate alerts. It is hoped that this will spark the next generation of novel research from which practical steps can be taken to implement changes to CDS systems that will ultimately reduce alert fatigue and improve the design of future systems.

  • Personalised care planning for adults with chronic or long-term health conditions (Protocol)

    This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects of personalised care planning for patients with long-term health conditions, as compared to forms of care in which active involvement of patients in treatment and management decisions (at least in goal setting and action planning) is not explicitly attempted or achieved. We will address the following primary research questions: Is personalised care planning effective for improving physical health (e.g. lipid measurements)? Is personalised care planning effective for improving psychological health (e.g. anxiety and depression)? Is personalised care planning effective for improving psychosocial health (e.g. quality of life)? Is personalised care planning effective for improving patients' capabilities for self-managing their condition? We will also look for evidence to address the following secondary research questions: Is personalised care planning effective for improving patients' health-related behaviours? How does personalised care planning impact on rates of use and costs of formal health services? What is the relative effectiveness of different types of intervention used to promote personalised care planning?

  • Who is the expert? The ambiguity of expertise in over-the-counter CAM purchasing: an ethnographic study of UK community pharmacies and health shops.

    Chapter in In Adams J, Magin P, Broom A. (Eds) Primary Health Care and Complementary and Integrative Medicine Complementary and integrative medicine (CIM) has become big business. Alongside the increased consumption of complementary medicine and the swelling numbers of complementary health practitioners has emerged a growing interest in these medicines and therapies from within the ranks of conventional primary health care. At the level of practice and beyond, a culture of confrontation and antagonism has begun to be replaced by a focus upon potential integration, collaboration and common ground. With these significant developments in mind, this ground-breaking book is a valuable and timely addition to the CIM and primary health care research literature. The collection outlines the core issues, challenges and opportunities facing the CIM–primary health care interface and its study and will provide insight and inspiration for those practising, studying and researching the contemporary relations between CIM and primary health care. The book is the first to be authored by leading international CIM–primary health care researchers from diverse disciplines and backgrounds, including health social science, statistics, qualitative methodology, general practice, clinical trials design, clinical pharmacology, health services research and public health. All contributors are active CIM–primary health care researchers and their extensive research and practice experience helps lend a unique immediacy and richness to the contributions and collection.

  • Pay-for-performance: impact on diabetes.

    Pay-for-performance schemes explicitly link provider remuneration to the quality of care provided, with the aims of modifying provider behavior and improving patient outcomes. If successful, pay-for-performance schemes could drive improvements in quality and efficiency of care. However, financial incentives could also erode providers’ intrinsic motivation, narrow their focus, promote unethical behavior, and ultimately increase health care inequalities. Evidence from schemes implemented to date suggests that carefully designed pay-for-performance schemes that align sufficient rewards with clinical priorities can produce modest but significant improvements in processes of diabetic care and intermediate outcomes. There is limited evidence, however, on whether improvements in processes of care result in improved outcomes, in terms of patient satisfaction, reduced complications, and greater longevity. The lack of adequate control groups has limited research findings to date, and more robust studies are needed to explore both the potential long-term benefits of pay-for-performance schemes and their unintended consequences.

  • N-terminal pro brain natriuretic peptide but not copeptin improves prediction of heart failure over other routine clinical risk parameters in oldermen with and without cardiovascular disease: population-based study

    Measurement of NT-proBNPand copeptin may help identify those at high risk of heart failure (HF).However the value of NT-proBNP and copeptin has been little studied in the older population in primary care. This study aims to examine the use of NT-proBNP and copeptin in improving risk prediction and stratification of HF in older men with and without cardiovascular disease (CVD). Methods and results This was a prospective study of 3870 men aged 60–79 years with no diagnosed HF followed up for a mean period of 11 years, during which there were 254 incident HF cases. NT-proBNP was associated with HF in those with and without established CVD [diagnosed myocardial infarction (MI), angina, or stroke]. NT-proBNP improved prediction beyond routine conventional risk factors (age, obesity, diabetes, hypertension, history of MI, and history of angina) and the Health ABC Heart Failure Score in all men and in men with and without established CVD (P,0.0001 for improvement in c-statistics). The net reclassification index (NRI) beyond conventional risk factors was 18.8% overall (27.4% for men without CVD and 17.4% for men with CVD). In contrast, copeptin was associated with HF in men with CVD only and did not improve prediction of HF after inclusion of conventional risk factors (P ¼ 0.95 for improvement in c-statistics). Conclusion NT-proBNP, but not copeptin significantly improves prediction and risk stratification of HF beyond routine clinical parameters obtained in general practice settings in older men both with and without established CVD

  • Sarcopenic obesity and risk of cardiovascular disease and mortality: a population-based cohort study of older men.

    To examine associations between sarcopenia, obesity, and sarcopenic obesity and risk of cardiovascular disease (CVD) and all-cause mortality in older men.

  • The Sexunzipped trial: Young People’s Views of Participating in an Online Trial

    Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants' experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement.

  • Withdrawing performance indicators: retrospective analysis of general practice performance under UK Quality and Outcomes Framework

    To investigate the effect of withdrawing incentives on recorded quality of care, in the context of the UK Quality and Outcomes Framework pay for performance scheme.

  • Dealing with family history of breast cancer: something new, something old

    Breast cancer is a major burden to society and individuals with 49 564 new cases and 11 633 deaths in the UK in 2010. A woman in the UK has an up to 1 in 8 lifetime risk of developing breast cancer1 and 20% of women with breast cancer will have a positive family history.2 While the management of breast cancer is carried out largely in specialist care, the ability to potentially intervene in people at increased familial risk of breast cancer will enhance the role of primary care.

  • Effect of antibiotic prescribing in primary care on meticillin-resistant Staphylococcus aureus carriage in community-resident adults: a controlled observational study

    The objectives of this study were to investigate the relationship between primary care antibiotics prescribed within 2 months and 12 months and the carriage of meticillin-resistant Staphylococcus aureus (MRSA) in nasal flora from a large representative sample of community-resident adults. S. aureus isolates were obtained from nasal samples submitted by UK resident adults aged ≥16 years registered with 12 general practices in the former Avon and Gloucestershire health authority areas. Individual-level antibiotic exposure data during the 12 months prior to providing the samples were collected from the primary care electronic records. MRSA status was determined by measuring resistance to cefoxitin. In total, 6937 adults were invited to take part, of whom 5917 returned a nasal sample. S. aureus was identified in 946 samples and a total of 761 participants consented to primary care record review and had complete data for the analyses. There was no evidence of an association between any antibiotic in the previous 2 months and MRSA isolation, with an adjusted odds ratio (aOR) of 1.33 [95% confidence interval (CI) 0.12–15; P = 0.8]. There was a suggestion of an association between any antibiotic use in the previous 12 months and MRSA, with an aOR of 2.45 (95% CI 0.95–6.3; P = 0.06). In conclusion, there is a suggestion that antibiotics prescribed within 12 months is associated with the carriage of MRSA, but not within 2 months, although the 2-month analysis had fewer data subjects and was therefore underpowered to detect this association. A larger study would be able to clarify these associations further.

  • Antibiotic Prescribing in Primary Care and Antimicrobial Resistance in Patients Admitted to Hospital with Urinary Tract Infection: A Controlled Observational Pilot Study

    There is growing evidence that primary care prescribed antibiotics lead to antibiotic resistance in bacteria causing minor infections or being carried by asymptomatic adults, but little research to date has investigated links between primary care prescribed antibiotics and resistance among more serious infections requiring hospital care. Knowledge of these effects is likely to have a major influence on public expectations for, and primary care use of, antibiotics. This study aimed to assess the feasibility of recruiting symptomatic adult patients admitted to hospital with urinary infections and to link primary and secondary data information to investigate the relationship between primary care prescribed antibiotics and antimicrobial resistance in these patients. A microbiology database search of in patients who had submitted a urine sample identified 740 patientswho were potentially eligible to take part in the study. Of these, 262 patients did not meet the eligibility criteria, mainly due to use of a urinary catheter (40%). Two-hundred and forty three patients could not be recruited as the nurse was unable to visit the patients prior to discharge, as they were too unwell. Eighty patients provided complete information. Results indicate that there is evidence that prior antibiotic use is associated with resistant infections in hospital patients. A fully powered study, conducted using routinely collected data is proposed to fully clarify the precision of the association.

  • Evaluating the implementation of HeLP-Diabetes within NHS services: study protocol

    Self-management by people with type 2 diabetes is central to good health outcomes and the prevention of associated complications. Structured education to teach self-management is recommended by the National Institute for Heath and Clinical Excellence; however, only a small proportion of patients report being offered this education and even fewer attend. This study aims to evaluate the implementation of a new internet-based self-management intervention: HeLP-Diabetes (Healthy Living for People with type 2 Diabetes) within the National Health Service. Specific objectives are to a) determine the uptake and use of HeLPDiabetes by services and patients; b) identify the factors which inhibit or facilitate use; c) identify the resources needed for effective implementation; d) explore possible effects of HeLP-Diabetes use on self-reported patient outcome measures.

  • Quality of life among hazardous and harmful drinkers: EQ-5D over a 1-year follow-up period

    To investigate the ability of the EQ-5D to discriminate between levels of alcohol risk in a large sample of hazardous and harmful drinkers, and to explore the relationship between transitions between alcohol risk levels and changes in EQ-5D up to 12 months. METHODS: This is a web-based randomised controlled trial evaluating a novel intervention for hazardous and harmful alcohol consumption. EQ-5D scores were compared among groups of drinkers at baseline (low/medium/high risk according to self-reported past week alcohol consumption), and changes in EQ-5D scores were estimated as a function of changes in alcohol consumption level. RESULTS: Baseline EQ-5D scores were dominated by problems with anxiety/depression, which increased with alcohol risk level, whilst high-risk drinkers also experienced more problems with physical HRQoL dimensions. However, the tool demonstrated a considerable ceiling effect. At follow-up, despite considerable reductions in alcohol consumption across the sample, significant changes in aggregated EQ-5D index scores were only observed for high-risk drinkers at baseline who reduced their drinking, with small improvements (0.04-0.06) compared to those who did not reduce. CONCLUSIONS: Our results suggest that the three-option EQ-5D may not be an optimal primary end point for measuring clinical and cost-effectiveness in randomised controlled trials of interventions among hazardous and harmful alcohol users, although further testing of the sensitivity of the tool in these populations is needed.

  • Understanding GRADE: an Introduction

    Grading of recommendations, assessment, development, and evaluations (GRADE) is arguably the most widely used method for appraising studies to be included in systematic reviews and guidelines. In order to use the GRADE system or know how to interpret it when reading reviews, reading several articles and attending a workshop are required. Moreover, the GRADE system is not covered in standard medical textbooks. Here, we explain GRADE concisely with the use of examples so that students and other researchers can understand it.

  • Is cancer associated with polymyalgia rheumatica (PMR)? a cohort study in the Genernal Practice Research Database.

    Objective To investigate the incidence of new cancer diagnoses in a community sample of patients with polymyalgia rheumatica (PMR). Methods All incident cases of PMR in the UK General Practice Research Database (GPRD) (1987–99), without pre-existing cancer or vascular disease and treated with corticosteroids (n=2877) were matched with up to five age, sex and GP practice patients without PMR (n=9942). Participants were followed up until first cancer diagnosis, death, transfer out of the database or end of available records. Results The mean age of the sample was 71.6 years (SD 9.0), 73% were female. Median follow-up time was 7.8 years (IQR 3.4, 12.3). 667 (23.2%) people with a PMR diagnosis developed cancer compared with 1938 (19.5%) of those without PMR. There was an interaction between PMR status and time. In the first 6 months after diagnosis, those with a PMR diagnosis were significantly more likely to receive a cancer diagnosis (adjusted HR (95% CI): 1.69 (1.18 to 2.42)). The number of events was small, but occurrences of prostate, blood, lymph nodes, female reproductive and nervous system cancers may be more common in those with PMR in the first 6 months after PMR diagnosis. Conclusions An increase in the rate of cancer diagnoses was noted in the first 6 months of observation, but we were unable to determine whether the cancer incidence in PMR was different from controls, beyond this time point. Clinicians should ensure they fully exclude cancer as a cause of PMR-like symptoms and monitor patients for possible malignancies.

  • The association of polymyalgia rheumatica with socioeconomic status in primary care: a cross-sectional observational study.

    OBJECTIVES: Polymyalgia rheumatica (PMR) is an inflammatory musculoskeletal condition, predominantly diagnosed and managed in the community. Socioeconomic status (SES) is known to be associated with many inflammatory rheumatological conditions, but has not been investigated in relation to PMR. This study aims to investigate the association between PMR and SES at both the area and the individual level. METHODS: Patients over 50 years registered with eight general practices in North Staffordshire were sent a questionnaire requesting details of their general health, socioeconomic status (SES) and lifestyle. Individual SES was measured using occupation, educational level and perceived adequacy of income. Area level SES was measured using the Index of Multiple Deprivation (IMD), derived from respondents' postcodes. Electronic primary care medical records were searched for Read code diagnoses of PMR two years before and after the survey. RESULTS: Of the 13,831 respondents, 141 had a recorded PMR diagnosis in their electronic medical records, a prevalence of 10 per 1000 patients. No association between PMR and SES was seen at either the individual or area levels. CONCLUSIONS: No association was found between PMR and SES, at either the area or the individual level. Unlike several of the inflammatory arthritides which are commoner in the more deprived areas, PMR shows no such association. In part this may be due to PMR affecting an older population. Whilst socioeconomic factors are important for clinicians and researchers to consider, in patients with PMR further epidemiological work is needed to fully characterise this disabling disorder. © 2013 American College of Rheumatology

  • The association of gout with socioeconomic status in primary care: a cross-sectional observational study.

    OBJECTIVE: Little is known about the association between gout and socioeconomic status (SES). Inequalities in rheumatology provision associated with SES may need to be addressed by health care planners. The aim of this study is to investigate the association of gout and SES in the community at both the individual and area levels. METHODS: Questionnaires were sent to all patients older than age 50 years who were registered with eight general practices in North Staffordshire. Data on individual SES were collected by questionnaire while area SES was measured using the Index of Multiple Deprivation derived from respondents' postcodes. Responders reported their occupation, education and the adequacy of their income; their medical records were searched for consultations for gout. RESULTS: Of the 348 consultations for gout in this period, at the individual level there was a significant association between gout and income. An association of gout with education was seen only in the unadjusted analyses. No association was found between gout and area level deprivation. CONCLUSION: Gout is associated with some aspects of individual level but not area level deprivation. More extensive musculoskeletal services may need to be provided in low income areas, although further research is needed.

  • Predicting multiple sclerosis following isolated optic neuritis in children

    BACKGROUND AND PURPOSE: Isolated optic neuritis (ON) is frequently the initial symptom of multiple sclerosis (MS). The aim of our study was to investigate the risk of conversion to MS in children following isolated ON and to evaluate the performance of current diagnostic methods such as cranial magnetic resonance imaging (cMRI), visual evoked potentials (VEPs) and oligoclonal bands in spinal fluid (OCB) as predictive factors for MS development. METHODS: Medical records of 159 patients presenting with acute ON between 2000 and 2010 at the Department of Pediatrics, University of Erlangen, were screened; 34 patients with isolated ON were identified. Progression to MS was defined according to the revised McDonald criteria 2005. Age, sex, VEPs, ON type, cMRI, OCB and visual recovery were assessed as predictors of progression to MS using simple logistic regressions. A multiple logistic regression model included variables found to be significant in univariate analyses. RESULTS: Abnormal cMRI was associated with an increase in the odds of MS development (odds ratio 20.57; 95% CI 2.16-196.10, P < 0.001), as was positive OCB (odds ratio 12.0; 95% CI 1.29-111.32, P = 0.001). However, only cMRI remained statistically significant in multiple regressions. CONCLUSIONS: Multiple sclerosis-like cMRI lesions and OCB are suitable for assessing the risk of progression to MS following isolated ON, as children with both cMRI abnormalities and positive OCB at onset of ON are at high risk of developing MS.

  • Cardiovascular events as a function of serum bilirubin levels in a large, statin-treated cohort.

    BACKGROUND: Serum bilirubin is an endogenous antioxidant that is routinely measured before a statin is prescribed primarily to assess liver function, but the association with cardiovascular disease (CVD) in this population has not been explored. METHOD AND RESULTS: We identified patients from a United Kingdom primary care database (The Health Improvement Network) with measurements of serum total bilirubin levels recorded 3 months before the first statin treatment between January 1, 2000, and December 31, 2010, and no history of liver disease or CVD. In total, 130 052 patients met the inclusion criteria, and after a median follow-up of 43 months, there were 7850 CVD events. In men, the incidence of CVD in the lowest decile category of bilirubin (1-6 μmol/L [0.06-0.35 mg/dL]) was 215 per 10 000 person-years compared with 163 per 10 000 person-years in the highest decile (19-40 μmol/L [1.1-2.3 mg/dL]). Similar differences were seen for women. After conventional CVD risk factors were accounted for, the associations with bilirubin were nonlinear (L shaped), and the models predicted that, compared with patients with a bilirubin level of 10 μmol/L (0.6 mg/dL), those with a similar CVD risk profile but a bilirubin level of 5 μmol/L (0.3 mg/dL) had an 18% (95% confidence interval, 9-27) higher risk of any CVD event, a 34% (95% confidence interval, 13-56) higher risk of myocardial infarction, and a 33% (95% confidence interval, 21-46) higher risk of death resulting from any cause. CONCLUSIONS: Serum bilirubin level measured before a statin prescription to assess liver function is an independent risk factor for CVD and death in both men and women.

  • Gilbert's syndrome and the risk of death: a population-based cohort study.

    BACKGROUND AND AIMS: Gilbert's syndrome is a common familial hyperbilirubinemia that may reduce the risk of various age-related diseases because of the antioxidant properties of bilirubin. We conducted a large cohort study using The Health Improvement Network primary care database and compared all-cause mortality rates in those with and without Gilbert's syndrome. METHODS: Mortality rates in patients with a diagnosis of Gilbert's syndrome and raised bilirubin level (n = 4266) were compared with those of patients with similar characteristics but with normal bilirubin levels (n = 21 968). Multivariate Poisson regression was also used to estimate adjusted mortality rate ratios. RESULTS: During the 350 000 PYs of follow up across the Gilbert's and comparison cohorts, there were 1174 deaths. Mortality rates were 24/10 000 PYs in the Gilbert's cohort versus 50/10 000 PYs in the comparison cohort. Mortality rates were around half in patients with Gilbert's syndrome after accounting for sociodemographics and general health indicators (adjusted mortality rate ratio: 0.5 [95% confidence interval; 0.4-0.7; P < 0.001]). CONCLUSIONS: Mortality rates observed for people with Gilbert's syndrome in the general population are almost half those of people without evidence of Gilbert's syndrome.

  • Health services changes: is a run-in period necessary before evaluation in randomised clinical trials?

    Most randomised clinical trials (RCTs) testing a new health service do not allow a run-in period of consolidation before evaluating the new approach. Consequently, health professionals involved may feel insufficiently familiar or confident, or that new processes or systems that are integral to the service are insufficiently embedded in routine care prior to definitive evaluation in a RCT. This study aimed to determine the optimal run-in period for a new physiotherapy-led telephone assessment and treatment service known as PhysioDirect and whether a run-in was needed prior to evaluating outcomes in an RCT.

  • Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) Trial

    A multi-centre, prospective, randomized, open, blinded end-point, 36-month study of 2616 patients within primary care with Stage 3b Chronic Kidney Disease to compare the efficacy of spironolactone 25mg once daily in addition to routine care on mortality and cardiovascular outcomes verses routine care alone Background CKD is common and increasing in prevalence. Cardiovascular disease is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway. Methods The study is a Prospective Randomised Open Blinded Endpoint-PROBE trial. The study is set in primary care where patients will primarily be identified by their GPs. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30-44 ml/min/1.73m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25mg OD in addition to routine care or routine care alone. Patients will be followed up for 36 months Discussion BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of cardiovascular disease) in patients with stage 3b CKD.

  • A pragmatic randomised controlled trial to evaluate the effectiveness of a facilitated exercise intervention as a treatment for postnatal depression: the PAM-PeRS trial

    Objective: To investigate the effectiveness of exercise as a treatment for postnatal depression alongside any usual care. Design: Randomised controlled trial. Setting: Primary Care, West Midlands, UK. Participants: 94 women who fulfilled International Classification of Diseases-10 criteria for major depression in the first six postnatal months were recruited and randomised. Intervention: Both groups received usual care and the intervention group were offered two face to face consultations and two telephone support calls with a physical activity facilitator over six months to support participants to engage in regular exercise. Leaflets to further prompt exercise were mailed throughout the intervention. Main outcome measures: The primary outcome was symptoms of depression using the Edinburgh Postnatal Depression Scale (EPDS) at six month post-randomisation. Secondary outcomes included EPDS score as a binary variable (recovered and improved), social support and physical activity at six and 12 month post-randomisation. Results: 146 women were potentially eligible and 94 were randomised. 34% reported thoughts of self harm at baseline. After adjusting for baseline EPDS, analyses revealed a -2.04 mean difference in EPDS score, favouring the exercise group (95% CI: -4.11 to 0.03, p=0.05). When also adjusting for pre-specified demographics the effect was larger and statistically significant (mean difference=-2.26, 95% CI:-4.36 to -0.16, p=0.03). Based on EPDS score a larger proportion of the intervention group were recovered (46.5% versus 23.8%, p=0.03) compared with usual care at six months follow up. Conclusion: This trial indicates that a facilitated exercise intervention is likely to be an effective treatment for postnatal depression.

  • Keep it simple? Predicting primary health care costs with clinical morbidity measures

    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 formore deprived patients but the positive effect of deprivation on cost was smaller in better fitting Q3 models.

  • Changes in HbA1c level over a 12-week follow-up in patients with type 2 diabetes following a medication change

    Background: Current guidance about the interval needed before retesting HbA1c when monitoring for glycaemic control is based on expert opinion rather than well-powered studies. The aim of our work was to explore how fast HbA1c changes after a change in glucose-lowering medication. This has implications for whether routine HbA1c testing intervals before 12 weeks could inform diabetes medication adjustments. Methods: This 12-week cohort study recruited patients from 18 general practices in the United Kingdom with non-insulin treated diabetes who were initiating or changing dose of oral glucose-lowering medication. HbA1c was measured at baseline and 2, 4, 8 and 12 weeks after recruitment. HbA1c levels at earlier time intervals were correlated with 12-week HbA1c. A ROC curve analysis was used to identify the 8-week threshold above which medication adjustment may be clinically appropriate. Results: Ninety-three patients were recruited to the study. Seventy-nine patients with no change in medication and full 12-week follow-up had the following baseline characteristics: mean±standard deviation age of 61.3±10.8 years, 34% were female and diabetes duration of 6.0±4.3 years. Mean HbA1c at baseline, 2, 4, 8 and 12 weeks was 8.7±1.5%, (72.0±16.8mmol/mol) 8.6±1.6% (70.7±17.0mmol/mol), 8.4±1.5% (68.7±15.9mmol/mol), 8.2±1.4% (66.3±15.8mmol/mol) and 8.1±1.4% (64.8±15.7mmol/mol) respectively. At the end of the study 61% of patients had sub-optimal glycaemic control (HbA1c>7.5% or 59mmol/mol). The 8-week change correlated significantly with the 12-week change in HbA1c and an HbA1c above 8.2% (66mmol/mol) at 8 weeks correctly classified all 28 patients who had not achieved glycaemic control by 12 weeks. Conclusions/interpretation: This is the first study designed with sufficient power to examine short-term changes in HbA1c. The 12-week change in HbA1c can be predicted 8 weeks after a medication change. Many participants who had not achieved glycaemic control after 12 weeks may have benefitted from an earlier review of their HbA1c and medication.

  • The need for increased harmonisation of clinical trials and economic evaluations.

    Expert Review of Pharmacoeconomics & Outcomes Research. Despite the increasing number of protocol and reporting guidelines available to trialists, there is still little guidance for protocol writers on the incorporation of patient-reported outcomes and economic assessments alongside clinical trials. It is unsurprising, therefore, that trial protocols present disproportionately less information for the economic evaluation component than for clinical outcomes. Costing methodologies, generalisability considerations, methods to address sensitive patient-reported outcome information and missing data are often insufficiently described in the trial protocol. The paper illustrates these shortcomings with specific examples and makes a case for shifting researchers’ attention from the reporting to the design stage of trial-based economic evaluation to promote the validity, generalisability and accountability of trial-based economic evaluations.

  • An introduction to patient-reported outcome measures in ophthalmic research.

    Clinical outcomes, such as quantifying the extent of visual field loss by automated perimetry, are valued highly by health professionals, but such measures do not capture the impact of the condition on a patient’s life. Patient-reported outcomes describe any report or measure of health reported by the patient, without external interpretation by a clinician or researcher. In this review, we discuss the value of the measures that capture this information (patient-reported outcome measures; PROMs), and why they are important to both the clinician and the researcher. We also consider issues around developing or selecting a PROM for ophthalmic research, the emerging challenges around conducting and reporting PROMs in clinical trials and highlight best practice for their use. Search terms for this review comprised: (1) (patient-reported outcomes OR patient-reported outcome measures) AND (2) randomised controlled trials AND (3) limited to ophthalmic conditions. These terms were expanded as follows: (((‘patients’(MeSH Terms) OR ‘patients’(All Fields) OR ‘patient’(All Fields)) AND (‘research report’(MeSH Terms) OR (‘research’(All Fields) AND ‘report’(All Fields)) OR ‘research report’(All Fields) OR ‘reported’(All Fields)) AND outcomes(All Fields)) OR ((‘patients’(MeSH Terms) OR ‘patients’(All Fields) OR ‘patient’(All Fields)) AND (‘research report’(MeSH Terms) OR (‘research’(All Fields) AND ‘report’(All Fields)) OR ‘research report’(All Fields) OR ‘reported’(All Fields) AND (‘outcome assessment (health care)’(MeSH Terms) OR (‘outcome’(All Fields) AND ‘assessment’(All Fields) AND ‘(health’(All Fields) AND ‘care)’(All Fields)) OR ‘outcome assessment (health care)’(All Fields) OR (‘outcome’(All Fields) AND ‘measures’(All Fields)) OR ‘outcome measures’(All Fields)))) AND (‘randomized controlled trial’(Publication Type) OR ‘randomized controlled trials as topic’(MeSH Terms) OR ‘randomised controlled trials’(All Fields) OR ‘randomized controlled trials’(All Fields)) AND (ophth*(All Fields)). The authors also utilised the extensive non-ophthalmic literature and online resources relating to PROs and PROMs to inform this review.

  • Polycystic ovary syndrome: A Randomised feasibility and pilot study using Chinese Herbal medicine to explore Impact on Dysfunction (ORCHID) – Study Protocol.

    We aim to evaluate the feasibility of, and pilot procedures for, a randomised study in the UK administering Chinese herbal medicine (CHM) to women with polycystic ovary syndrome (PCOS) related oligo- and/or amenorrhoea. Our primary aim of this feasibility study is to evaluate how appropriate oligo- and amenorrhoea is as the primary outcome of the main study.

  • Easily Missed? Bladder cancer in women

    A 76 year old woman reports recurrent urinary frequency, dysuria, and malodorous urine. No bacterial growth has been identified on two midstream urine samples, though empirical treatment with antibiotics has improved her symptoms. After three months, an episode of visible haematuria prompts referral and a transitional cell carcinoma of the bladder is diagnosed.

  • Electronic medical records: the way forward for primary care research?

    Electronic medical records (EMRs) are becoming the norm in many health systems internationally, especially in the primary care setting. Though designed to help family doctors and other clinicians to record and manage patient care more accurately and efficiently, they are often useful for research purposes too. Indeed recent years have seen huge advances in the quality, availability and use of EMR databases for research. This increased use of EMRs for research has led to work, such as a recent paper from The Netherlands, attempting to establish quality criteria for these EMRs to be used in research (1). In the UK, the General Practice Research Database has recently become the Clinical Practice Research Datalink (CPRD) and aims to substantially extend its coverage in terms of population size and also the sources of data available (2). As with several Scandinavian registries [e.g. (3)], CPRD data can be linked with national registers (e.g. mortality, cancer), as well as sociodemographic and hospital admissions data. Until recently, the majority of primary care EMRs suitable for use in research have been from Western European countries, possibly due to their health care systems readily facilitating this sort of data collation. This is now changing, with a notable example of an up-and-coming EMR for use in research being Canadian Primary Care Sentinel Surveillance Network.

  • The potential role of NT-proBNP in screening for and predicting prognosis in heart failure: a survival analysis

    Objective: To determine the potential role of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in screening for and predicting prognosis in heart failure by examining diagnosis and survival of patients with a raised NT-proBNP at screening. Design: Survival analysis. Setting Prospective: substudy of the Echocardiographic Heart of England Screening study (ECHOES) to investigate 10-year survival in participants with an NT-proBNP level at baseline. Participants 594 participants took part in the substudy. Records of all participants in the ECHOES cohort were flagged during the screening phase which ended on 25 February 1999. All deaths until 25 February 2009 were coded. Outcome measures: Logistic regression was used to examine whether NT-proBNP is useful in predicting heart failure at screening after adjustment for age, sex and cohort. Kaplan-Meier curves and log rank tests were used to compare survival times of participants according to NT-proBNP level. Cox regression was carried out to assess the prognostic effect of NT-proBNP after allowing for significant covariates and receiver operator curves were used to determine test reliability. Results: The risk of heart failure increased almost 18-fold when NT-proBNP was 150 pg/mL or above (adjusted OR=17.7, 95% CI 4.9 to 63.5). 10-year survival in the general population cohort was 61% (95% CI 48% to 71%) for those with NT-proBNP ≥150 pg/mL and 89% (95% CI 84% to 92%) for those below the cut-off at the time of the initial study. After adjustment for age, sex and risk factors for heart failure, NT-proBNP level ≥150 pg/mL was associated with a 58% increase in the risk of death within 10 years (adjusted HR=1.58, 95% CI 1.09 to 2.30). Conclusions: Raised NT-proBNP levels, when screening the general population, are predictive of a diagnosis of heart failure (at a lower threshold than guidelines for diagnosing symptomatic patients) and also predicted reduced survival at 10 years.

  • Depression and Anxiety in Prostate Cancer: A Systematic Review and Meta-Analysis of Prevalence Rates.

    OBJECTIVES: To systematically review the literature pertaining to the prevalence of depression and anxiety in patients with prostate cancer as a function of treatment stage. DESIGN: Systematic review and meta-analysis. PARTICIPANTS: 4494 patients with prostate cancer from primary research investigations. PRIMARY OUTCOME MEASURE: The prevalence of clinical depression and anxiety in patients with prostate cancer as a function of treatment stage. RESULTS: We identified 27 full journal articles that met the inclusion criteria for entry into the meta-analysis resulting in a pooled sample size of 4494 patients. The meta-analysis of prevalence rates identified pretreatment, on-treatment and post-treatment depression prevalences of 17.27% (95% CI 15.06% to 19.72%), 14.70% (95% CI 11.92% to 17.99%) and 18.44% (95% CI 15.18% to 22.22%), respectively. Pretreatment, on-treatment and post-treatment anxiety prevalences were 27.04% (95% CI 24.26% to 30.01%), 15.09% (95% CI 12.15% to 18.60%) and 18.49% (95% CI 13.81% to 24.31%), respectively. CONCLUSIONS: Our findings suggest that the prevalence of depression and anxiety in men with prostate cancer, across the treatment spectrum, is relatively high. In light of the growing emphasis placed on cancer survivorship, we consider that further research within this area is warranted to ensure that psychological distress in patients with prostate cancer is not underdiagnosed and undertreated.

  • Increased cardiovascular mortality associated with gout: a systematic review and meta-analysis

    Background Hyperuricaemia, the biochemical precursor to gout, has been shown to be an independent risk factor for mortality from cardiovascular disease (CVD), although studies examining the clinical phenomenon of gout and risk of CVD mortality report conflicting results. This study aimed to produce a pooled estimate of risk of mortality from cardiovascular disease in patients with gout. Design Systematic review and meta-analysis. Methods Electronic bibliographic databases were searched from inception to November 2012, with results reviewed by two independent reviewers. Studies were included if they reported data on CVD mortality in adults with gout who were free of CVD at time of entry into the study. Pooled hazard ratios (HRs) for this association were calculated both unadjusted and adjusted for traditional vascular risk factors. Results Six papers, including 223,448 patients, were eligible for inclusion (all (CVD) mortality n = 4, coronary heart disease (CHD) mortality n = 3, and myocardial infarction mortality n = 3). Gout was associated with an excess risk of CVD mortality (unadjusted HR 1.51 (95% confidence interval, CI, 1.17–1.84)) and CHD mortality (unadjusted HR 1.59, 95% CI 1.25–1.94)). After adjusting for traditional vascular risk factors, the pooled HR for both CVD mortality (HR 1.29, 95% CI 1.14–1.44) and CHD mortality (HR 1.42, 95% CI 1.22–1.63) remained statistically significant, but none of the studies reported a significant association with myocardial infarction. Conclusions Gout increases the risk of mortality from CVD and CHD, but not myocardial infarction, independently of vascular risk factors.

  • Exploring the role of social factors on help-seeking, symptom interpretation and diagnosis, in patients with lung cancer or at heightened risk of developing lung cancer

    People with Chronic Obstructive Pulmonary Disease (COPD) are at heightened risk of developing lung cancer. Recent research has suggested that in people who have the disease, the time between symptom onset and consultation can be long enough to significantly affect prognosis. The regular and routine clinical encounters that people with COPD engage in provide an opportunity for them to highlight new symptoms of concern, and for clinicians to be watchful for new symptomatic indicators. We present a micro-analysis of naturalistic data from a corpus of such encounters with the aim of exploring the interactional factors within these routine consultations which influence when and how new symptoms of concern are raised. Our hypothesis is that although the underlying aim of the review consultation is the same in both settings, the different consultation structures oriented to by nurses and GPs have a tangible effect on how new and concerning symptomatic information is introduced. Conversation analysis (CA) was used to examine 39 naturalistic review consultation recordings in two clinical settings; GP led (n=16), and practice nurse led (n=23). We describe three interactional formats by which patients chose to present new symptomatic concerns; ‘direct’, ‘embedded’, and ‘oblique’. Both settings provided interactional ‘slots’ for patients to offer new and concerning symptomatic information. However, the structure of nurse led encounters tended to limit opportunities for patients to develop extended symptom narratives which in turn facilitated ‘oblique’ formats. We suggest that the attenuation of the ‘oblique’ format in this particular clinical setting has implications relating to the psycho-social idiosyncrasies of lung cancer and the maintenance of interactional conditions that encourage patients to disclose new symptomatic concerns.

  • Which features of primary care affect unscheduled secondary care use? A systematic review

    Objectives To conduct a systematic review to identify studies that describe factors and interventions at primary care practice level that impact on levels of utilisation of unscheduled secondary care. Setting Observational studies at primary care practice level. Participants Studies included people of any age of either sex living in Organisation for Economic Co-operation and Development (OECD) countries with any health condition. Primary and secondary outcome measures The primary outcome measure was unscheduled secondary care as measured by emergency department attendance and emergency hospital admissions. Results 48 papers were identified describing potential influencing features on emergency department visits (n=24 studies) and emergency admissions (n=22 studies). Patient factors associated with both outcomes were increased age, reduced socioeconomic status, lower educational attainment, chronic disease and multimorbidity. Features of primary care affecting unscheduled secondary care were more complex. Being able to see the same healthcare professional reduced unscheduled secondary care. Generally, better access was associated with reduced unscheduled care in the USA. Proximity to healthcare provision influenced patterns of use. Evidence relating to quality of care was limited and mixed. Conclusions The majority of research was from different healthcare systems and limited in the extent to which it can inform policy. However, there is evidence that continuity of care is associated with reduced emergency department attendance and emergency hospital admissions.

  • Smoking cessation in adults with diabetes: a systematic review and meta-analysis of data from randomised controlled trials

    Objectives To evaluate the effects of more intensive smoking cessation interventions compared to less intensive interventions on smoking cessation in people with type 1 or type 2 diabetes. Design A systematic review and meta-analysis of randomised trials of smoking cessation interventions was conducted. Electronic searches were carried out on the following databases: MEDLINE, EMBASE, CINAHL and PsycINFO to September 2013. Searches were supplemented by review of trial registries and references from identified trials. Citations and full-text articles were screened by two reviewers. A random-effect Mantel-Haenszel model was used to pool data. Setting Primary, secondary and tertiary care. Participants Adults with type 1 or type 2 diabetes. Interventions Smoking cessation interventions or medication (more intensive interventions) compared to usual care, counselling or optional medication (less intensive interventions). Outcome measures Biochemically verified smoking cessation was the primary outcome. Secondary outcomes were adverse events and effects on glycaemic control. We also carried out a pooled analysis of self-reported smoking cessation outcomes. Results We screened 1783 citations and reviewed seven articles reporting eight trials in 872 participants. All trials were of 6 months duration. Three trials included pharmacotherapy for smoking cessation. The risk ratio of biochemically verified smoking cessation was 1.32 (95% CI 0.23 to 7.43) for the more intensive interventions compared to less intensive interventions with significant heterogeneity (I2=76%). Only one trial reported measures of glycaemic control. Conclusions There is an absence of evidence of efficacy for more intensive smoking cessation interventions in people with diabetes. The more intensive strategies tested in trials to date include interventions used in the general population, adding in diabetes-specific education about increased risk. Future research should focus on multicomponent smoking cessation interventions carried out over a period of at least 1 year, and also assess impact on glycaemic control.

  • Description and process evaluation of pharmacists' interventions in a pharmacist-led information technology-enabled multicentre cluster randomised controlled trial for reducing medication errors in general practice (PINCER trial).

    To undertake a process evaluation of pharmacists' recommendations arising in the context of a complex IT-enabled pharmacist-delivered randomised controlled trial (PINCER trial) to reduce the risk of hazardous medicines management in general practices. METHODS: PINCER pharmacists manually recorded patients' demographics, details of interventions recommended, actions undertaken by practice staff and time taken to manage individual cases of hazardous medicines management. Data were coded, double-entered into SPSS version 15 and then summarised using percentages for categorical data (with 95% confidence interval (CI)) and, as appropriate, means (± standard deviation) or medians (interquartile range) for continuous data. KEY FINDINGS: Pharmacists spent a median of 20 min (interquartile range 10, 30) reviewing medical records, recommending interventions and completing actions in each case of hazardous medicines management. Pharmacists judged 72% (95% CI 70, 74; 1463/2026) of cases of hazardous medicines management to be clinically relevant. Pharmacists recommended 2105 interventions in 74% (95% CI 73, 76; 1516/2038) of cases and 1685 actions were taken in 61% (95% CI 59, 63; 1246/2038) of cases; 66% (95% CI 64, 68; 1383/2105) of interventions recommended by pharmacists were completed and 5% (95% CI 4, 6; 104/2105) of recommendations were accepted by general practitioners (GPs), but not completed at the end of the pharmacists' placement; the remaining recommendations were rejected or considered not relevant by GPs. CONCLUSIONS: The outcome measures were used to target pharmacist activity in general practice towards patients at risk from hazardous medicines management. Recommendations from trained PINCER pharmacists were found to be broadly acceptable to GPs and led to ameliorative action in the majority of cases. It seems likely that the approach used by the PINCER pharmacists could be employed by other practice pharmacists following appropriate training.