Deborah McCahon

A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome

BackgroundIrritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations.MethodsA multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS – Constipation or IBS – Mixed profile). Set in 13 general practices within central England. Individuals meeting the ROME III criteria for IBS, aged 18–65 completed a pre-study diary. Eligible individuals were randomized to consume dairy ‘yoghurt’ products which either did or did not contain active probiotics twice daily and to complete a daily diary. Primary outcome was subjective global assessment of symptom relief at week 4. Other outcomes comprised, IBS symptom scores, pain, bloating and flatulence levels, stool frequency, stool consistency, ease of bowel movement and quality of life.Results179 were randomized (91 active, 88 placebo). 76 (43 active, 33 placebo) completed the study. No significant between group differences existed at 4 weeks (57% active vs 53% placebo, reported adequate relief (p = 0.71)). By week 8, 46% active vs 68% placebo reported adequate relief (p = 0.03). This was sustained at week 12.ConclusionsSignificant improvements were reported for most outcomes in all trial participants but improvement did not differ by group. This trial does not provide evidence for effectiveness of a probiotic in IBS, in variance with a body of published literature and review conclusions. Differential drop out may however cloud interpretation of data.UK Trial registrationISRCTN78863629

Patient self-management of anticoagulation therapy: A trial-based cost-effectiveness analysis

Demand for anticoagulation management is increasing due to an expansion of clinical indications for therapy. One possible model of care to meet demand is patient self‐management (PSM), beneficial to patients who need control over their condition. This study aimed to determine the cost and cost‐effectiveness of PSM of anticoagulation compared with routine clinic‐based care for patients receiving long‐term anticoagulation. A cost–utility analysis was conducted alongside a randomised controlled trial; 617 patients were recruited and followed up for 12 months. There was no significant difference in mean quality‐adjusted life years (QALYs) between groups – after adjusting for baseline, the mean difference in QALYs was 0·009 (95% CI, −0·012 to 0·030). Overall mean healthcare costs in the PSM arm were significantly higher at £417 (CI £394–£442) compared with £122 (CI £103–£144) in the control arm. Therefore, using a formal cost‐effectiveness analysis, PSM of anticoagulation does not appear to be cost‐effective. However, PSM may have other benefits in relieving pressure on traditional clinic‐based care, and the cost‐effectiveness of this model of care for some subgroups of anticoagulation patients needs to be explored further.

Point of care testing for INR monitoring: where are we now?

Point of care (POC, or near patient) testing for measurement of the international normalized ratio (INR) has facilitated the devolution of service delivery from the traditional hospital outpatient setting. However it must be undertaken within the confines of safe practice involving quality control procedures. The evaluation of INR POC tests should be closely related to the clinical issues of management and, specifically, improving the quality of care. One benefit of POC testing is in the increased motivation that some practitioners feel, being able to perform diagnostic tests without sending samples to a laboratory. POC for INR testing within primary care eliminates the delay in waiting for the result to be processed by the hospital laboratory, and the subsequent delay in informing the patient of their dosing advice. This review describes the utilization of POC testing outside the laboratory setting to develop models of care for oral anticoagulation management.

The burden of common chronic disease on health-related quality of life in an elderly community-dwelling population in the UK

BACKGROUND Given the high prevalence of chronic conditions and multimorbidity in the elderly, there is a need to determine which chronic conditions have the greatest impact on health-related quality of life (HRQL) and identify where additional intervention may be required. OBJECTIVE To explore the impact of a range of common chronic conditions on HRQL in a community-based population aged 65 years or more in the UK. METHODS Secondary analysis of data derived from a large (n = 5849) cross-sectional study. HRQL was assessed using the EuroQoL EQ-5D. Multivariable models were used to estimate the relative effect of 15 individual common chronic conditions and combinations of these conditions on HRQL. RESULTS Mean age of participants was 74.6 years, 49.2% were male. The mean EQ-5D index score was 0.78 (standard deviation 0.2), range -0.43 to 1.00. Overall, 53% (n = 3078) of the cohort reported problems with pain, 39% (n = 2273) with mobility and 9% (n = 529) with self-care. Multivariate modelling demonstrated that impaired HRQL was significantly associated with 13 of the 15 common chronic conditions studied. Clinically meaningful reductions in EQ-5D index scores were observed for osteoarthritis (-0.081, P = 0.0006), neurological disease (-0.172, P < 0.0001) and depression (-0.269, P < 0.001). CONCLUSIONS This study quantifies the relative impact of 13 common chronic conditions on HRQL in a UK-based community-dwelling ageing population. Findings indicate that osteoarthritis, depression and neurological disease have a strong clinically important negative effect on HRQL. These findings may help clinical decision making and priority setting for management of individuals with multimorbidity.

Patient self management of oral anticoagulation in routine care in the UK

Background: Self management of anticoagulation: a randomised trial (SMART) was the first large scale UK trial to assess clinical and cost effectiveness of patient self management (PSM) of oral anticoagulation therapy compared to routine care. SMART showed that while PSM was as clinically effective as routine care, it was not as cost effective. SMART adds to the growing body of trial data to support PSM; however there are no data on clinical effectiveness and cost of PSM in routine care. Aim: To evaluate clinical effectiveness of PSM compared to routine care outside trial conditions. Methods: A retrospective multicentre matched control study. 63 PSM patients from primary care in the West Midlands were matched by age and international normalised ratio (INR) target with controls. INR results were collected for the period 1 July 2003–30 June 2004. The primary outcome measure was INR control. Results: 38 PSM and 40 control patients were recruited. INR percentage time in range was 70% PSM vs 64% controls. 60% PSM were having a regular clinical review, 45% were performing an internal quality control (IQC) test and 82% were performing external quality assurance (EQA) on a regular basis. Conclusion: PSM outside trial conditions is as clinically effective as routine UK care.

Is screening for AF worthwhile? Stroke risk in a screened population from the SAFE study

INTRODUCTION Atrial fibrillation (AF) is an important independent risk factor for stroke and oral anticoagulation therapy provides a highly effective treatment to reduce this risk. Active screening strategies improve detection of AF in comparison with routine care; however, whether screen-detected patients have stroke risk profiles favouring anticoagulation is unclear. Using data derived from the screening for AF in the elderly (SAFE) study, the aim of this article was to determine if patients with AF detected via active screening have stroke risk profiles that warrant prophylactic anticoagulation. METHODS Secondary analysis of data derived from 25 general practices within which cohorts of 200 patients were randomly allocated to opportunistic [pulse and electrocardiogram (ECG)] or systematic screening (postal invitation for ECG). Stroke risk assessment was undertaken using baseline data extracted from medical records and CHADS2 criteria. CHADS2 scores were compared between the screening groups. RESULTS One hundred and forty-nine new cases of AF were detected, 75 via opportunistic screening and 74 via systematic screening. CHADS2 scores were ≥1 in 83% [95% confidence interval (CI) 72.6-89.6] of patients detected via opportunistic screening and 78% (95% CI 67.7-86.2) detected via systematic screening. There were no significant differences in stroke risk profiles of patients detected via opportunistic and systematic screenings. CONCLUSION Stroke risk profiles of patients detected via opportunistic and systematic screenings were similar. Data derived from the SAFE study suggest that active screening for AF in patients aged ≥65 years in primary care is a useful screening programme with 78-83% of patients identified eligible for anticoagulation treatment according to the CHADS2 criteria.

Primary care REFerral for EchocaRdiogram (REFER) in heart failure: a diagnostic accuracy study

Background Symptoms of breathlessness, fatigue, and ankle swelling are common in general practice but deciding which patients are likely to have heart failure is challenging. Aim To evaluate the performance of a clinical decision rule (CDR), with or without N-Terminal pro-B type natriuretic peptide (NT-proBNP) assay, for identifying heart failure. Design and setting Prospective, observational, diagnostic validation study of patients aged >55 years, presenting with shortness of breath, lethargy, or ankle oedema, from 28 general practices in England. Method The outcome was test performance of the CDR and natriuretic peptide test in determining a diagnosis of heart failure. The reference standard was an expert consensus panel of three cardiologists. Results Three hundred and four participants were recruited, with 104 (34.2%; 95% confidence interval [CI] = 28.9 to 39.8) having a confirmed diagnosis of heart failure. The CDR+NT-proBNP had a sensitivity of 90.4% (95% CI = 83.0 to 95.3) and specificity 45.5% (95% CI = 38.5 to 52.7). NT-proBNP level alone with a cut-off <400 pg/ml had sensitivity 76.9% (95% CI = 67.6 to 84.6) and specificity 91.5% (95% CI = 86.7 to 95.0). At the lower cut-off of NT-proBNP <125 pg/ml, sensitivity was 94.2% (95% CI = 87.9 to 97.9) and specificity 49.0% (95% CI = 41.9 to 56.1). Conclusion At the low threshold of NT-proBNP <125 pg/ml, natriuretic peptide testing alone was better than a validated CDR+NT-proBNP in determining which patients presenting with symptoms went on to have a diagnosis of heart failure. The higher NT-proBNP threshold of 400 pg/ml may mean more than one in five patients with heart failure are not appropriately referred. Guideline natriuretic peptide thresholds may need to be revised.

Integrating genetic risk assessment for multi-factorial conditions into primary care

The genetic basis of many common, multi-factorial conditions is increasingly being understood but use of the knowledge created, raises major dilemmas for primary care. Identification of individuals that may be genetically predisposed to serious medical conditions provides the opportunity to offer screening or prophylactic treatment, for early detection or prevention and delay in disease onset in many complex conditions. We describe a new pilot service development to introduce genetic risk assessment for a wide range of conditions to primary care, and discuss the findings from its evaluation. The evaluation highlighted the issues about the incorporation of genetic risk assessment in primary care. The results of the evaluation along with findings from other studies, juxtaposed with the implications of developments in genetics suggest that changes are required to accommodate the integration of genetic risk assessment into primary care clinical practice. We discuss what these changes are, the benefits and drawbacks, and whether primary care can and is ready to make the changes required, further shifting the focus from disease treatment to disease prevention.

MICE or NICE? An economic evaluation of clinical decision rules in the diagnosis of heart failure in primary care ☆ ☆☆

Background Detection and treatment of heart failure (HF) can improve quality of life and reduce premature mortality. However, symptoms such as breathlessness are common in primary care, have a variety of causes and not all patients require cardiac imaging. In systems where healthcare resources are limited, ensuring those patients who are likely to have HF undergo appropriate and timely investigation is vital. Design A decision tree was developed to assess the cost-effectiveness of using the MICE (Male, Infarction, Crepitations, Edema) decision rule compared to other diagnostic strategies to identify HF patients presenting to primary care. Methods Data from REFER (REFer for EchocaRdiogram), a HF diagnostic accuracy study, was used to determine which patients received the correct diagnosis decision. The model adopted a UK National Health Service (NHS) perspective. Results The current recommended National Institute for Health and Care Excellence (NICE) guidelines for identifying patients with HF was the most cost-effective option with a cost of £4400 per quality adjusted life year (QALY) gained compared to a “do nothing” strategy. That is, patients presenting with symptoms suggestive of HF should be referred straight for echocardiography if they had a history of myocardial infarction or if their NT-proBNP level was ≥ 400 pg/ml. The MICE rule was more expensive and less effective than the other comparators. Base-case results were robust to sensitivity analyses. Conclusions This represents the first cost-utility analysis comparing HF diagnostic strategies for symptomatic patients. Current guidelines in England were the most cost-effective option for identifying patients for confirmatory HF diagnosis. The low number of HF with Reduced Ejection Fraction patients (12%) in the REFER patient population limited the benefits of early detection.

Assessing the utility of an online registry for patients monitoring their own warfarin therapy

Aims To evaluate the utility of an online self-report registry for patient self-monitoring and self-management (PSM) of warfarin therapy. Methods A prospective observational study of UK-based patients undertaking PSM and recording their international normalised ratio (INR) data via an online registry. Consenting participants recorded INR test dates, results and warfarin dosages using the online registry for a period of 12 months. Participants reported demographic data, disease characteristics and treatment-related adverse events and provided feedback via a survey. Data accuracy was assessed through comparison of INR results recorded online with results stored on 19 INR testing devices. Percentage time spent within therapeutic time in range (TTR) was also examined. Results Eighty-seven per cent (39/45) completed the study period. Age ranged from 26 to 83 years, 44% had undertaken PSM for >5 years. Sixty-six per cent (25/38) reported that the registry was easy to navigate and use. Forty-two participants contributed a total of 1669 INR results. Agreement between self-reported INR results and source INR data was high (99%). Mean TTR was 76% (SD 18.58) with 83% having >60% TTR. Conclusions Findings suggest that an online PSM registry is feasible, accurate and acceptable to patients. These findings require confirmation in a larger cohort of PSM patients. An online self-report registry could provide a valuable resource for gathering real world evidence of clinical effectiveness and safety of these developing models of care.