Alice Tompson

Lack of evidence for interventions offered in UK fertility centres

Carl Heneghan and colleagues call for better quality evidence to help people seeking assisted reproduction make informed choices

Cohort study of Anticoagulation Self-Monitoring (CASM): a prospective study of its effectiveness in the community

Background Trials show that oral anticoagulation therapy (OAT) substantially reduces thromboembolic events without an increase in major haemorrhagic events, but it is not known whether these results translate into routine practice. Aim To estimate the current levels of control and adverse events in patients self-monitoring OAT, explore the factors that predict success, and determine whether the level of side effects reported from randomised controlled trials are translated to a non-selected population. Design and setting Prospective cohort study in the UK. Method Participants were aged ≥18 years and registered with a GP. Main outcomes were the proportion of participants, over 12 months, who were still self-monitoring, had not experienced adverse events, and had achieved >80% of time in therapeutic range (TTR). Results In total, 296 participants were recruited; their median age was 61 years and 55.1% were male. Participants were predominately professional or held a university qualification (82.7%). At 12 months, 267 (90.2%) were still self-monitoring. Mean TTR was 75.3% (standard deviation 16.9).Six serious and two minor adverse events were reported by GPs. Only 45.9% of participants received any in-person training at the outset. Increased age (P = 0.027), general wellbeing (EQ-5D visual score, P = 0.020), and lower target international normalised range (INR, P = 0.032) were all associated with high (>80% TTR) levels of control. Conclusion The findings show that, even with little training, people on OAT can successfully self-monitor, and even self-manage, their INR. TTR was shown to improve with age. However, widespread use of self-monitoring of INR may be limited by the initial costs, as well as a lack of training and support at the outset.

Global cardiovascular risk assessment in the primary prevention of cardiovascular disease in adults: systematic review of systematic reviews

Objective To identify, critically appraise and summarise existing systematic reviews on the impact of global cardiovascular risk assessment in the primary prevention of cardiovascular disease (CVD) in adults. Design Systematic review of systematic reviews published between January 2005 and October 2016 in The Cochrane Library, EMBASE, MEDLINE or CINAHL databases, and post hoc analysis of primary trials. Participants, interventions, outcomes Systematic reviews of interventions involving global cardiovascular risk assessment relative to no formal risk assessment in adults with no history of CVD. The primary outcomes of interest were CVD-related morbidity and mortality and all-cause mortality; secondary outcomes were systolic blood pressure (SBP), cholesterol and smoking. Results We identified six systematic reviews of variable but generally of low quality (mean Assessing the Methodological Quality of Systematic Reviews 4.2/11, range 0/11 to 7/11). No studies identified by the systematic reviews reported CVD-related morbidity or mortality or all-cause mortality. Meta-analysis of reported randomised controlled trials (RCTs) showed small reductions in SBP (mean difference (MD) −2.22 mm Hg (95% CI −3.49 to −0.95); I2=66%; n=9; GRADE: very low), total cholesterol (MD −0.11 mmol/L (95% CI −0.20 to −0.02); I2=72%; n=5; GRADE: very low), low-density lipoprotein cholesterol (MD −0.15 mmol/L (95% CI −0.26 to −0.05), I2=47%; n=4; GRADE: very low) and smoking cessation (RR 1.62 (95% CI 1.08 to 2.43); I2=17%; n=7; GRADE: low). The median follow-up time of reported RCTs was 12 months (range 2–36 months). Conclusions The quality of existing systematic reviews was generally poor and there is currently no evidence reported in these reviews that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality. There are reductions in SBP, cholesterol and smoking but they may not be clinically significant given their small effect size and short duration. Resources need to be directed to conduct high-quality systematic reviews focusing on hard patient outcomes, and likely further primary RCTs. Trial registration number CRD42015019821.

Getting our house in order: an audit of the registration and publication of clinical trials supported by the National Institute for Health Research Oxford Biomedical Research Centre and the Musculoskeletal Biomedical Research Unit

Objectives To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published. Setting 2 major research institutions supported by the National Institute of Health Research (NIHR). Primary and secondary outcome measures The proportion of trials reporting results within 12 months, 24 months and ‘ever’. Factors associated with non-publication were analysed using logistic regression. Inclusion criteria Phases 2–4 clinical trials identified from internal documents and publication lists. Results In total, 286 trials were identified. We could not find registration for 4 (1.4%) of these, all of which were completed and published. Of the trials with a registered completion date pre-January 2015, just over half (56%) were published, and half of these were published within 12 months (36/147, 25%). For some trials, information on the public registers was found to be out-of-date and/or inaccurate. No clinical trial characteristics were found to be significantly associated with non-publication. We have produced resources to facilitate similar audits elsewhere. Conclusions It was feasible to conduct an internal audit of registration and publication in 2 major research institutions. Performance was similar to, or better than, comparable cohorts of trials sampled from registries. The major resource input required was manually seeking information: if all registry entries were maintained, then almost the entire process of audit could be automated—and routinely updated—for all research centres and funders.

Patient use of blood pressure self-screening facilities in general practice waiting rooms: a qualitative study in the UK

Background Blood pressure (BP) self-screening, whereby members of the public have access to BP monitoring equipment outside of healthcare consultations, may increase the detection and treatment of hypertension. Currently in the UK such opportunities are largely confined to GP waiting rooms. Aim To investigate the reasons why people do or do not use BP self-screening facilities. Design and setting A cross-sectional, qualitative study in Oxfordshire, UK. Method Semi-structured interviews with members of the general public recruited using posters in GP surgeries and community locations were recorded, transcribed, and coded thematically. Results Of the 30 interviewees, 20% were hypertensive and almost half had self-screened. Those with no history of elevated readings had limited concern over their BP: self-screening filled the time waiting for their appointment or was done to help their doctor. Patients with hypertension self-screened to avoid the feelings they associated with ‘white coat syndrome’ and to introduce more control into the measurement process. Barriers to self-screening included a lack of awareness, uncertainty about technique, and worries over measuring BP in a public place. An unanticipated finding was that several interviewees preferred monitoring their BP in the waiting room than at home. Conclusion BP self-screening appeared acceptable to service users. Further promotion and education could increase awareness among non-users of the need for BP screening, the existence of self-screening facilities, and its ease of use. Waiting room monitors could provide an alternative for patients with hypertension who are unwilling or unable to monitor at home.

Current and potential providers of blood pressure self-screening: a mixed methods study in Oxfordshire

Objectives To (1) establish the extent of opportunities for members of the public to check their own blood pressure (BP) outside of healthcare consultations (BP self-screening), (2) investigate the reasons for and against hosting such a service and (3) ascertain how BP self-screening data are used in primary care. Design A mixed methods, cross-sectional study. Setting Primary care and community locations in Oxfordshire, UK. Participants 325 sites were surveyed to identify where and in what form BP self-screening services were available. 23 semistructured interviews were then completed with current and potential hosts of BP self-screening services. Results 18/82 (22%) general practices offered BP self-screening and 68/110 (62%) pharmacies offered professional-led BP screening. There was no evidence of permanent BP self-screening activities in other community settings. Healthcare professionals, managers, community workers and leaders were interviewed. Those in primary care generally felt that practice-based BP self-screening was a beneficial activity that increased the attainment of performance targets although there was variation in its perceived usefulness for patient care. The pharmacists interviewed provided BP checking as a service to the community but were unable to develop self-screening services without a clear business plan. Among potential hosts, barriers to providing a BP self-screening service included a perceived lack of healthcare commissioner and public demand, and a weak—if any—link to their core objectives as an organisation. Conclusions BP self-screening currently occurs in a minority of general practices. Any future development of community BP self-screening programmes will require (1) public promotion and (2) careful consideration of how best to support—and reward—the community hosts who currently perceive little if any benefit.

Supporting patients to self-monitor their oral anticoagulation therapy: Recommendations based on a qualitative study of patients' experiences

Background Clinical trials suggest that oral anticoagulation therapy (OAT) self-monitoring is safe and effective, however little is known about the patient experience of this process. There is a lack of understanding about how best to train and support patients embarking on OAT self-monitoring. Aim To collect in-depth information about patients’ experiences of OAT self-monitoring outside of clinical trial conditions and to produce a set of recommendations on how best to support such patients. Design and setting Semi-structured qualitative interviews with patients who self-monitor and live in England. Method In total, 26 of the 267 (9.7%) who participated in the Cohort study of Anticoagulation Self-Monitoring (CASM) and were still self-monitoring after 12 months’ follow-up were interviewed. Topics discussed included experiences of OAT self-monitoring, healthcare support, training, and decision making. Framework analysis was used. Results Following initial problems using the monitoring device, interviewees described a mostly positive experience. Although less effort was expended attending monitoring appointments with health professionals, effort was required to conduct self-monitoring tests and to interpret and act on the results. Desire to self-manage was variable, especially when dosing advice systems worked promptly and reliably. Interviewees overcame patchy healthcare system knowledge and support of self-monitoring by educating themselves. Family and friends provided support with learning to use the monitor and managing OAT dosage adjustments. Conclusion Better, more-consistent training and health-service support would have alleviated a number of problems encountered by these patients who were self-monitoring. This training and support will become even more important if self-monitoring becomes more accessible to the general population of people on OAT.

General practitioner referrals to one-stop clinics for symptoms that could be indicative of cancer: a systematic review of use and clinical outcomes.

BACKGROUND One-stop clinics provide comprehensive diagnostic testing in one outpatient appointment. They could benefit patients with conditions, such as cancer, whose outcomes are improved by early diagnosis, and bring efficiency savings for health systems. OBJECTIVE To assess the use and outcomes of one-stop clinics for symptoms where cancer is a possible diagnosis. DESIGN AND SETTING Systematic review of studies reporting use and outcomes of one-stop clinics in primary care patients. METHOD We searched MEDLINE, Embase, and Cochrane Library for studies assessing one-stop clinics for adults referred after presenting to primary care with any symptom that could be indicative of cancer. Study selection was carried out independently in duplicate with disagreements resolved through discussion. RESULTS Twenty-nine studies were identified, most were conducted in the UK and observational in design. Few included a comparison arm. A pooled comparison of the cancer conversion rate of one-stop and multi-stop clinics was only possible for breast symptoms, and we found no significant difference. One-stop clinics were associated with significant reductions in the interval from referral to testing (15 versus 75 days) and more patients diagnosed on the same day (79% versus 25%) compared to multi-stop pathways. The majority of patients and GPs found one-stop clinics to be acceptable. CONCLUSION This review found one-stop clinics were associated with reduced time from referral to testing, increased same day diagnoses, and were acceptable to patients and GPs. Our conclusions are limited by high levels of heterogeneity, scarcity of comparator groups, and the overwhelmingly observational nature of included studies.

Direct access cancer testing in primary care: a systematic review of use and clinical outcomes

BACKGROUND Direct access (DA) testing allows GPs to refer patients for investigation without consulting a specialist. The aim is to reduce waiting time for investigations and unnecessary appointments, enabling treatment to begin without delay. AIM To establish the proportion of patients diagnosed with cancer and other diseases through DA testing, time to diagnosis, and suitability of DA investigations. DESIGN AND SETTING Systematic review assessing the effectiveness of GP DA testing in adults. METHOD MEDLINE, Embase, and the Cochrane Library were searched. Where possible, study data were pooled and analysed quantitatively. Where this was not possible, the data are presented narratively. RESULTS The authors identified 60 papers that met pre-specified inclusion criteria. Most studies were carried out in the UK and were judged to be of poor quality. The authors found no significant difference in the pooled cancer conversion rate between GP DA referrals and patients who first consulted a specialist for any test, except gastroscopy. There were also no significant differences in the proportions of patients receiving any non-cancer diagnosis. Referrals for testing were deemed appropriate in 66.4% of those coming from GPs, and in 80.9% of those from consultants; this difference was not significant. The time from referral to testing was significantly shorter for patients referred for DA tests. Patient and GP satisfaction with DA testing was consistently high. CONCLUSION GP DA testing performs as well as, and on some measures better than, consultant triaged testing on measures of disease detection, appropriateness of referrals, interval from referral to testing, and patient and GP satisfaction.

Medications that reduce emergency hospital admissions: an overview of systematic reviews and prioritisation of treatments.

BackgroundRates of emergency hospitalisations are increasing in many countries, leading to disruption in the quality of care and increases in cost. Therefore, identifying strategies to reduce emergency admission rates is a key priority. There have been large-scale evidence reviews to address this issue; however, there have been no reviews of medication therapies, which have the potential to reduce the use of emergency health-care services. The objectives of this study were to review systematically the evidence to identify medications that affect emergency hospital admissions and prioritise therapies for quality measurement and improvement.MethodsThis was a systematic review of systematic reviews. We searched MEDLINE, PubMed, the Cochrane Database of Systematic Reviews & Database of Abstracts of Reviews of Effects, Google Scholar and the websites of ten major funding agencies and health charities, using broad search criteria. We included systematic reviews of randomised controlled trials that examined the effect of any medication on emergency hospital admissions among adults. We assessed the quality of reviews using AMSTAR. To prioritise therapies, we assessed the quality of trial evidence underpinning meta-analysed effect estimates and cross-referenced the evidence with clinical guidelines.ResultsWe identified 140 systematic reviews, which included 1968 unique randomised controlled trials and 925,364 patients. Reviews contained 100 medications tested in 47 populations. We identified high-to moderate-quality evidence for 28 medications that reduced admissions. Of these medications, 11 were supported by clinical guidelines in the United States, the United Kingdom and Europe. These 11 therapies were for patients with heart failure (angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, aldosterone receptor antagonists and digoxin), stable coronary artery disease (intensive statin therapy), asthma exacerbations (early inhaled corticosteroids in the emergency department and anticholinergics), chronic obstructive pulmonary disease (long-acting muscarinic antagonists and long-acting beta-2 adrenoceptor agonists) and schizophrenia (second-generation antipsychotics and depot/maintenance antipsychotics).ConclusionsWe identified 11 medications supported by strong evidence and clinical guidelines that could be considered in quality monitoring and improvement strategies to help reduce emergency hospital admission rates. The findings are relevant to health systems with a large burden of chronic disease and those managing increasing pressures on acute health-care services.