Research output on primary care in Australia, Canada, Germany, the Netherlands, the United Kingdom, and the United States: bibliometric analysis

Objective To compare the volume and quality of original research in primary care published by researchers from primary care in the United Kingdom against five countries with well established academic primary care

Is statin-modified reduction in lipids the most important preventive therapy for cardiovascular disease? A pro/con debate.

The most prescribed medications in the world are statins, lipid modifiers that have been available for over 25 years and amongst the most investigated of all drug classes. With over a million patient years of trial data and publications in the most prestigious medical journals, it is remarkable that quite so much debate remains as to their place in healthcare. They have had a bittersweet passage, with vocal concerns over their possible risks, from suicide to cancer, and allegations that they do not work in women or the elderly, to statements that the whole published dataset, on over 200,000 patients consenting to enter trials, was fatally compromised by being industry-funded by and large. On the other side, there have been billions of dollars spent on generating their evidence base followed by promotion which has returned that investment many times over in profits, and a powerful scientific lobby that argue they are wonder drugs and that continued nihilism on their value risks patient lives. So who is right

Accuracy of monitors used for blood pressure checks in English retail pharmacies::a cross-sectional observational study

BACKGROUND: Free blood pressure (BP) checks offered by community pharmacies provide a potentially useful opportunity to diagnose and/or manage hypertension, but the accuracy of the sphygmomanometers in use is currently unknown. AIM: To assess the accuracy of validated automatic BP monitors used for BP checks in a UK retail pharmacy chain. DESIGN AND SETTING: Cross-sectional, observational study in 52 pharmacies from one chain in a range of locations (inner city, suburban, and rural) in central England. METHOD: Monitor accuracy was compared with a calibrated reference device (Omron PA-350), at 50 mmHg intervals across the range 0–300 mmHg (static pressure test), with a difference from the reference monitor of +/− 3 mmHg at any interval considered a failure. The results were analysed by usage rates and length of time in service. RESULTS: Of 61 BP monitors tested, eight (13%) monitors failed (that is, were >3 mmHg from reference), all of which underestimated BP. Monitor failure rate from the reference monitor of +/− 3 mmHg at any testing interval varied by length of time in use (2/38, 5% <18 months; 4/14, 29% >18 months, P = 0.038) and to some extent, but non-significantly, by usage rates (4/22, 18% in monitors used more than once daily; 2/33, 6% in those used less frequently, P = 0.204). CONCLUSION: BP monitors within a pharmacy setting fail at similar rates to those in general practice. Annual calibration checks for blood pressure monitors are needed, even for new monitors, as these data indicate declining performance from 18 months onwards

Evaluation of the accuracy of serum MMP-9 as a test for colorectal cancer in a primary care population

Background Bowel cancer is common and is a major cause of death. Meta-analysis of randomised controlled trials estimates that screening for colorectal cancer using faecal occult blood (FOB) test reduces mortality from colorectal cancer by 16%. However, FOB testing has a low positive predictive value, with associated unnecessary cost, risk and anxiety from subsequent investigation, and is unacceptable to a proportion of the target population. Increased levels of an enzyme called matrix metalloproteinase 9 (MMP-9) have been found to be associated with colorectal cancer, and this can be measured from a blood sample. Serum MMP-9 is potentially an accurate, low risk and cost-effective population screening tool. This study aims to evaluate the accuracy of serum MMP-9 as a test for colorectal cancer in a primary care population. Methods/Design People aged 50 to 69 years, who registered in participating general practices in the West Midlands Region, will be asked to complete a questionnaire that asks about symptoms. Respondents who describe any colorectal symptoms (except only abdominal bloating and/or anal symptoms) and are prepared to provide a blood sample for MMP9 estimation and undergo a colonoscopy (current gold standard investigation) will be recruited at GP based clinics by a research nurse. Those unfit for colonoscopy will be excluded. Colonoscopies will be undertaken in dedicated research clinics. The accuracy of MMP-9 will be assessed by comparing the MMP-9 level with the colonoscopy findings, and the combination of factors (e.g. symptoms and MMP-9 level) that best predict a diagnosis of malignancy (invasive disease or polyps) will be determined. Discussion Colorectal cancer is a major cause of morbidity and mortality. Most colorectal cancers arise from adenomas and there is a period for early detection by screening, but available tests have risks, are unacceptable to many, have high false positive rates or are expensive. This study will establish the potential of serum MMP-9 as a screening test for colorectal cancer. If it is confirmed as accurate and acceptable, this serum marker has the potential to assist with reducing the morbidity and mortality from colorectal cancer

Different systolic blood pressure targets for people with history of stroke or transient ischaemic attack: PAST-BP (Prevention After Stroke--Blood Pressure) randomised controlled trial.

OBJECTIVE: To assess whether using intensive blood pressure targets leads to lower blood pressure in a community population of people with prevalent cerebrovascular disease. DESIGN: Open label randomised controlled trial. SETTING: 99 general practices in England, with participants recruited in 2009-11. PARTICIPANTS: People with a history of stroke or transient ischaemic attack whose systolic blood pressure was 125 mm Hg or above. INTERVENTIONS: Intensive systolic blood pressure target (<130 mm Hg or 10 mm Hg reduction from baseline if this was <140 mm Hg) or standard target (<140 mm Hg). Apart from the different target, patients in both arms were actively managed in the same way with regular reviews by the primary care team. MAIN OUTCOME MEASURE: Change in systolic blood pressure between baseline and 12 months. RESULTS: 529 patients (mean age 72) were enrolled, 266 to the intensive target arm and 263 to the standard target arm, of whom 379 were included in the primary analysis (182 (68%) intensive arm; 197 (75%) standard arm). 84 patients withdrew from the study during the follow-up period (52 intensive arm; 32 standard arm). Mean systolic blood pressure dropped by 16.1 mm Hg to 127.4 mm Hg in the intensive target arm and by 12.8 mm Hg to 129.4 mm Hg in the standard arm (difference between groups 2.9 (95% confidence interval 0.2 to 5.7) mm Hg; P=0.03). CONCLUSIONS: Aiming for target below 130 mm Hg rather than 140 mm Hg for systolic blood pressure in people with cerebrovascular disease in primary care led to a small additional reduction in blood pressure. Active management of systolic blood pressure in this population using a <140 mm Hg target led to a clinically important reduction in blood pressure.Trial registration Current Controlled Trials ISRCTN29062286.This report is independent research funded by the National Institute for Health Research (Stroke Prevention in Primary Care, Programme Grant for Applied Research, RP-PG-0606-1153), and by an NIHR Professorship (Prof McManus). FDRH is part funded as Director of the National Institute for Health Research (NIHR) School for Primary Care Research (SPCR), Theme Leader of the NIHR Oxford Biomedical Research Centre (BRC), and Director of the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Oxford. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS. The study sponsor was the University of Birmingham. The study funder and sponsor had no role in the study design, collection, analysis or interpretation of data, in the writing of the report, or in the decision to submit to publication. The researchers are independent of the funders.This is the final version of the article. It first appeared from the BMJ Publishing Group via http://dx.doi.org/10.1136/bmj.i70

Self-monitoring blood pressure in patients with hypertension: an internet-based survey of UK GPs.

BACKGROUND: Previous research suggests that most GPs in the UK use self-monitoring of blood pressure (SMBP) to monitor the control of hypertension rather than for diagnosis. This study sought to assess current practice in the use of self-monitoring and any changes in practice following more recent guideline recommendations. AIM: To survey the views and practice of UK GPs in 2015 with regard to SMBP and compare them with a previous survey carried out in 2011. DESIGN AND SETTING: Web-based survey of a regionally representative sample of 300 UK GPs. METHOD: GPs completed an online questionnaire concerning the use of SMBP in the management of hypertension. Analyses comprised descriptive statistics, tests for between-group differences (z, Wilcoxon signed-rank, and χ2 tests), and multivariate logistic regression. RESULTS: Results were available for 300 GPs (94% of those who started the survey). GPs reported using self-monitoring to diagnose hypertension (169/291; 58%; 95% confidence interval (CI) = 52 to 64) and to monitor control (245/291; 84%; 95% CI = 80 to 88), the former having significantly increased since 2011 (from 37%; 95% CI = 33 to 41; P<0.001) with no change in monitoring for control. More than half of GPs used higher systolic thresholds for diagnosis (118/169; 70%; 95% CI = 63 to 77) and treatment (168/225; 75%; 95% CI = 69 to 80) than recommended in guidelines, and under half (120/289; 42%; 95% CI = 36 to 47) adjusted the SMBP results to guide treatment decisions. CONCLUSION: Since new UK national guidance in 2011, GPs are more likely to use SMBP to diagnose hypertension. However, significant proportions of GPs continue to use non-standard diagnostic and monitoring thresholds. The use of out-of-office methods to improve the accuracy of diagnosis is unlikely to be beneficial if suboptimal thresholds are used.This study was funded by the British Hypertension Society and the NIHR. Ben Fletcher receives funding from the National Institute for Health Research (NIHR) School for Primary Care Research (SPCR) Doctoral Studentship. Richard McManus holds an NIHR Professorship (RP-02-12-015)) and receives funding from the NIHR Oxford CLAHRC. This article presents independent research funded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.This is the author accepted manuscript. The final version is available from Royal College of General Practitioners via https://doi.org/10.3399/bjgp16X68703

Accuracy of blood pressure monitors owned by patients with hypertension (ACCU-RATE study)

Background Home blood pressure (BP) monitoring is recommended in guidelines and increasingly popular with patients and health care professionals, but the accuracy of patients’ own monitors in real world use is not known. Aim To assess the accuracy of home BP monitors used by people with hypertension, and investigate factors affecting accuracy. Design and Setting Patients on the hypertension register at seven practices in central England were surveyed to ascertain if they owned a monitor and wanted it tested. Method Monitor accuracy was compared to a calibrated reference device, at 50 mmHg intervals between 0-280/300 mmHg (static pressure test), with a difference from the reference monitor of +/-3 mmHg at any interval considered a failure. Cuff performance was also assessed. Results were analysed by usage rates, length of time in service, make and model, monitor validation status, cost, and any previous testing. Results 251 (76%, 95% CI 71-80%) of 331 tested devices passed all tests (monitors and cuffs) and 86% passed the static pressure test, deficiencies primarily due to overestimation. 40% of testable monitors were unvalidated. Pass rate on the static pressure test was greater in validated monitors (96% [95% CI 94-98%] vs 64% [95% CI 58-69%]), those retailing for over £10, and those in use for less than four years.12% of cuffs failed. Conclusion Patients’ own BP monitor failure rate was similar to that in studies performed in professional settings, though cuff failure was more frequent. Clinicians can be confident of the accuracy of patients’ own BP monitors, if validated and less than five years old.This work represents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-1209-10051). The views expressed in this study are those of the authors and not necessarily of the NHS, the NIHR or the Department of Health. RJM was supported by an NIHR Professorship (NIHR-RP-02-12-015) and by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Oxford at Oxford Health NHS Foundation Trust. FDRH is part funded as Director of the National Institute for Health Research (NIHR) School for Primary Care Research (SPCR), Theme Leader of the NIHR Oxford Biomedical Research Centre (BRC), and Director of the NIHR CLAHRC Oxford. JM is an NIHR Senior Investigator. No funding for this study was received from any monitor manufacturer

Impact of Changes to National Hypertension Guidelines on Hypertension Management and Outcomes in the United Kingdom.

In recent years, national and international guidelines have recommended the use of out-of-office blood pressure monitoring for diagnosing hypertension. Despite evidence of cost-effectiveness, critics expressed concerns this would increase cardiovascular morbidity. We assessed the impact of these changes on the incidence of hypertension, out-of-office monitoring and cardiovascular morbidity using routine clinical data from English general practices, linked to inpatient hospital, mortality, and socio-economic status data. We studied 3 937 191 adults with median follow-up of 4.2 years (49% men, mean age=39.7 years) between April 1, 2006 and March 31, 2017. Interrupted time series analysis was used to examine the impact of changes to English hypertension guidelines in 2011 on incidence of hypertension (primary outcome). Secondary outcomes included rate of out-of-office monitoring and cardiovascular events. Across the study period, incidence of hypertension fell from 2.1 to 1.4 per 100 person-years. The change in guidance in 2011 was not associated with an immediate change in incidence (change in rate=0.01 [95% CI, -0.18-0.20]) but did result in a leveling out of the downward trend (change in yearly trend =0.09 [95% CI, 0.04-0.15]). Ambulatory monitoring increased significantly in 2011/2012 (change in rate =0.52 [95% CI, 0.43-0.60]). The rate of cardiovascular events remained unchanged (change in rate =-0.02 [95% CI, -0.05-0.02]). In summary, changes to hypertension guidelines in 2011 were associated with a stabilisation in incidence and no increase in cardiovascular events. Guidelines should continue to recommend out-of-office monitoring for diagnosis of hypertension

Accuracy of blood-pressure monitors owned by patients with hypertension (ACCU-RATE study): a cross-sectional, observational study in central England.

BACKGROUND: Home blood-pressure (BP) monitoring is recommended in guidelines and is increasingly popular with patients and health professionals, but the accuracy of patients' own monitors in real-world use is not known. AIM: To assess the accuracy of home BP monitors used by people with hypertension, and to investigate factors affecting accuracy. DESIGN AND SETTING: Cross-sectional, observational study in urban and suburban settings in central England. METHOD: Patients (n = 6891) on the hypertension register at seven practices in the West Midlands, England, were surveyed to ascertain whether they owned a BP monitor and wanted it tested. Monitor accuracy was compared with a calibrated reference device at 50 mmHg intervals between 0-280/300 mmHg (static pressure test); a difference from the reference monitor of +/-3 mmHg at any interval was considered a failure. Cuff performance was also assessed. Results were analysed by frequency of use, length of time in service, make and model, monitor validation status, purchase price, and any previous testing. RESULTS: In total, 251 (76%, 95% confidence interval [95% CI] = 71 to 80%) of 331 tested devices passed all tests (monitors and cuffs), and 86% (CI] = 82 to 90%) passed the static pressure test; deficiencies were, primarily, because of monitors overestimating BP. A total of 40% of testable monitors were not validated. The pass rate on the static pressure test was greater in validated monitors (96%, 95% CI = 94 to 98%) versus unvalidated monitors (64%, 95% CI = 58 to 69%), those retailing for >£10 (90%, 95% CI = 86 to 94%), those retailing for ≤£10 (66%, 95% CI = 51 to 80%), those in use for ≤4 years (95%, 95% CI = 91 to 98%), and those in use for >4 years (74%, 95% CI = 67 to 82%). All in all, 12% of cuffs failed. CONCLUSION: Patients' own BP monitor failure rate was similar to that demonstrated in studies performed in professional settings, although cuff failure was more frequent. Clinicians can be confident of the accuracy of patients' own BP monitors if the devices are validated and ≤4 years old

Predicting out-of-office blood pressure level using repeated measurements in the clinic: an observational cohort study.

OBJECTIVES: Identification of people with lower (white-coat effect) or higher (masked effect) blood pressure at home compared to the clinic usually requires ambulatory or home monitoring. This study assessed whether changes in SBP with repeated measurement at a single clinic predict subsequent differences between clinic and home measurements. METHODS: This study used an observational cohort design and included 220 individuals aged 35-84 years, receiving treatment for hypertension, but whose SBP was not controlled. The characteristics of change in SBP over six clinic readings were defined as the SBP drop, the slope and the quadratic coefficient using polynomial regression modelling. The predictive abilities of these characteristics for lower or higher home SBP readings were investigated with logistic regression and repeated operating characteristic analysis. RESULTS: The single clinic SBP drop was predictive of the white-coat effect with a sensitivity of 90%, specificity of 50%, positive predictive value of 56% and negative predictive value of 88%. Predictive values for the masked effect and those of the slope and quadratic coefficient were slightly lower, but when the slope and quadratic variables were combined, the sensitivity, specificity, positive and negative predictive values for the masked effect were improved to 91, 48, 24 and 97%, respectively. CONCLUSION: Characteristics obtainable from multiple SBP measurements in a single clinic in patients with treated hypertension appear to reasonably predict those unlikely to have a large white-coat or masked effect, potentially allowing better targeting of out-of-office monitoring in routine clinical practice.This study presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-1209–10051). R.J.Mc.M. holds an NIHR Professorship. J.S. was funded by the NIHR Birmingham and Black Country Collaboration for Leadership in Applied Health Research and Care during part of this work, but now holds a Medical Research Council Strategic Skills Postdoctoral Fellowship. B.W. is a NIHR Senior Investigator and is supported by the NIHR UCL Hospitals Biomedical Research Centre. The TASMINH2 trial was funded by the UK Department of Health Policy Research Programme and the National Coordinating Centre for Research Capacity Development. The views and opinions expressed are those of the authors and do not necessarily reflect those of the NHS, NIHR, or the Department of Health. All equipment used in the study was purchased commercially