Transient elastography in patients at risk of liver fibrosis in primary care: a follow-up study over 54 months.

BACKGROUND: Liver fibrosis assessment services using transient elastography are growing in primary care. These services identify patients requiring specialist referral for liver fibrosis, and provide an opportunity for recommending lifestyle change. However, there are uncertainties regarding service design, effectiveness of advice given, and frequency of follow-up. AIM: To assess the following: (a) effectiveness of standard care lifestyle advice for weight management and alcohol consumption; (b) uptake for liver rescan; and (c) usefulness of a 4.5-year time interval of rescanning in monitoring progression of liver fibrosis. DESIGN & SETTING: Analysis of patient outcomes 4.5 years after the first 'liver service' attendance that included transient elastography in five GP practices in Southampton, UK. METHOD: Outcomes included weight, alcohol consumption, rescan uptake, time interval between scans, and change in liver fibrosis stage. RESULTS: A total of 401 participants were recontacted. Mean standard deviation (± SD) weight loss was 1.2 kg±8.4 kg (P = 0.005); Alcohol Use Disorders Identification Test (AUDIT) grade increased by 7.8% (P ≤0.001). A total of n = 116/401 participants were eligible for liver rescanning and n = 59/116 (50.9%) agreed to undergo rescanning. Mean ± SD time interval between scans was 53.6±3.4 months. Liver fibrosis progressed from mild (≥6.0 kPa-8.1 kPa) to significant fibrosis (8.2 kPa-9.6 kPa) in 3.4% of patients; from mild to advanced fibrosis (9.7 kPa-13.5 kPa) and cirrhosis (≥13.6 kPa) in 15.3% of patients, and did not progress in 81.3%. No baseline factors were independently associated with liver fibrosis progression at follow-up. CONCLUSION: Rescan recall attendance and adherence to lifestyle changes needs improving. Optimum time interval between scans remains uncertain. After a mean interval of 53.6 months between scans, and with no specific predictors indicated, a substantial minority (18.7%) experienced a deterioration in fibrosis grade.

Economic evaluation of the OSAC randomised controlled trial: oral corticosteroids for non-asthmatic adults with acute lower respiratory tract infection in primary care.

OBJECTIVE: To estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo. DESIGN: Cost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work. SETTING: Fifty-four National Health Service (NHS) general practices in England. PARTICIPANTS: 398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days. INTERVENTIONS: 2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets. OUTCOME MEASURES: Quality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up. RESULTS: 198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean 'profit' to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms. CONCLUSIONS: The use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms. TRIAL REGISTRATION NUMBERS: EudraCT 2012-000851-15 and ISRCTN57309858; Pre-results.

Patients' understanding of cellulitis and their information needs: a mixed-methods study in primary and secondary care.

BACKGROUND: Cellulitis is a painful infection of the skin and underlying tissues, commonly affecting the lower leg. Approximately one-third of people experience recurrence. Patients' ability to recover from cellulitis or prevent recurrence is likely to be influenced by their understanding of the condition. AIM: To explore patients' perceptions of cellulitis, and their information needs. DESIGN AND SETTING: Mixed-methods study comprising semi-structured, face-to-face interviews and a cross-sectional survey, recruiting through primary and secondary care, and advertising. METHOD: Adults aged ≥18 years with a history of cellulitis were invited to take part in a survey, qualitative interview, or both. RESULTS: In all, 30 interviews were conducted between August 2016 and July 2017. Qualitative data highlighted a low awareness of cellulitis before the first episode, uncertainty about when it had been diagnosed, concern/surprise at the severity of cellulitis, and a perceived insufficient information provision. People were surprised that they had never heard of cellulitis and that they had not received advice or leaflets giving self-care information. Some sought information from the internet and found this confusing.A total of 240 surveys were completed (response rate 17%). These showed that, although many participants had received information on the treatment of cellulitis (60.0%, n = 144), they often reported receiving no information about causes (60.8%, n = 146) or prevention of recurrence (73.3%, n = 176). CONCLUSION: There is a need to provide information for people with cellulitis, particularly in regard to naming their condition, the management of acute episodes, and how to reduce the risk of recurrences.

Local care and treatment of liver disease (LOCATE) - A cluster-randomized feasibility study to discover, assess and manage early liver disease in primary care.

BACKGROUND: Chronic liver disease is an escalating problem both in the United Kingdom and worldwide. In the UK mortality rates have risen sharply over the previous 50 years predominantly due to alcohol, however the increasing prevalence of non-alcohol related fatty liver disease both in the UK and elsewhere is also of concern. Liver disease develops silently hence early detection of fibrosis is essential to prevent progression. Primary care presents an opportunity to identify at risk populations, however assessment largely comprises of indirect markers of fibrosis which have little prognostic value. We hypothesised that setting up nurse-led primary care based liver clinics using additional non-invasive testing would increase the number of new diagnoses of liver disease compared to usual care. METHODS: This was a prospective, cluster randomised feasibility trial based in urban primary care in Southampton, United Kingdom. 10 GP practices were randomised to either intervention (liver health nurse) or control (care as usual). Pre recruitment audits were carried out in each practice to ascertain baseline prevalence of liver disease. Participants were subsequently recruited in intervention practices from July 2014-March 2016 via one of 3 pathways: GP referral, nurse led case finding based on risk factors or random AUDIT questionnaire mailouts. Liver assessment included the Southampton Traffic Light test (serum fibrosis markers HA and P3NP) and transient elastography (FibroScan). Cases were ascribed as 'no fibrosis', 'liver warning', 'progressive fibrosis' or 'probable cirrhosis'. Post recruitment audits were repeated and incident liver diagnoses captured from July 2014-September 2016. Each new diagnosis was reviewed in a virtual clinic by a consultant hepatologist. FINDINGS: 910 participants were seen in the nurse led clinic-44 (4.8%) probable cirrhosis, 141 (15.5%) progressive fibrosis, 220 (24.2%) liver warning and 505 (55.5%) no evidence of liver fibrosis. 450 (49.5%) cases were due to NAFLD with 356 (39.1%) from alcohol. In the 405 with a liver disease diagnosis, 136 (33.6%) were referred by GP, 218 (53.8%) from nurse led case finding and 51 (12.6%) from the AUDIT mailout. 544 incident cases were identified in the intervention arm compared to 221 in the control arm in the period July 2014-September 2016 (adjusted odds ratio 2.4, 95% CI 2.1 to 2.8). CONCLUSIONS: The incorporation of a liver health nurse into GP practices was simple to arrange and yielded a much higher number of new diagnoses of liver disease compared to usual care. Nearly half of all participants recruited had a degree of liver disease. Nurse led case finding and GP referrals were most effective compared to AUDIT questionnaire mailouts in an urban population in identifying unknown disease. Utilising study and previous data allowed quick and effective virtual review by a hepatologist. Identifying those who are at risk of liver disease from harmful alcohol use remains a challenge and needs to be addressed in future work.

Effect of Oral Prednisolone on Symptom Duration and Severity in Nonasthmatic Adults With Acute Lower Respiratory Tract Infection: A Randomized Clinical Trial.

Importance: Acute lower respiratory tract infection is common and often treated inappropriately in primary care with antibiotics. Corticosteroids are increasingly used but without sufficient evidence. Objective: To assess the effects of oral corticosteroids for acute lower respiratory tract infection in adults without asthma. Design, Setting, and Participants: Multicenter, placebo-controlled, randomized trial (July 2013 to final follow-up October 2014) conducted in 54 family practices in England among 401 adults with acute cough and at least 1 lower respiratory tract symptom not requiring immediate antibiotic treatment and with no history of chronic pulmonary disease or use of asthma medication in the past 5 years. Interventions: Two 20-mg prednisolone tablets (n = 199) or matched placebo (n = 202) once daily for 5 days. Main Outcomes and Measures: The primary outcomes were duration of moderately bad or worse cough (0 to 28 days; minimal clinically important difference, 3.79 days) and mean severity of symptoms on days 2 to 4 (scored from 0 [not affected] to 6 [as bad as it could be]; minimal clinically important difference, 1.66 units). Secondary outcomes were duration and severity of acute lower respiratory tract infection symptoms, duration of abnormal peak flow, antibiotic use, and adverse events. Results: Among 401 randomized patients, 2 withdrew immediately after randomization, and 1 duplicate patient was identified. Among the 398 patients with baseline data (mean age, 47 [SD, 16.0] years; 63% women; 17% smokers; 77% phlegm; 70% shortness of breath; 47% wheezing; 46% chest pain; 42% abnormal peak flow), 334 (84%) provided cough duration and 369 (93%) symptom severity data. Median cough duration was 5 days (interquartile range [IQR], 3-8 days) in the prednisolone group and 5 days (IQR, 3-10 days) in the placebo group (adjusted hazard ratio, 1.11; 95% CI, 0.89-1.39; P = .36 at an α = .05). Mean symptom severity was 1.99 points in the prednisolone group and 2.16 points in the placebo group (adjusted difference, -0.20; 95% CI, -0.40 to 0.00; P = .05 at an α = .001). No significant treatment effects were observed for duration or severity of other acute lower respiratory tract infection symptoms, duration of abnormal peak flow, antibiotic use, or nonserious adverse events. There were no serious adverse events. Conclusions and Relevance: Oral corticosteroids should not be used for acute lower respiratory tract infection symptoms in adults without asthma because they do not reduce symptom duration or severity. Trial Registration: ISRCTN.com Identifier: ISRCTN57309858.

Routine use of patient reported outcome measures (PROMs) for improving treatment of common mental health disorders in adults.

BACKGROUND: Routine outcome monitoring of common mental health disorders (CMHDs), using patient reported outcome measures (PROMs), has been promoted across primary care, psychological therapy and multidisciplinary mental health care settings, but is likely to be costly, given the high prevalence of CMHDs. There has been no systematic review of the use of PROMs in routine outcome monitoring of CMHDs across these three settings. OBJECTIVES: To assess the effects of routine measurement and feedback of the results of PROMs during the management of CMHDs in 1) improving the outcome of CMHDs; and 2) in changing the management of CMHDs. SEARCH METHODS: We searched the Cochrane Depression Anxiety and Neurosis group specialised controlled trials register (CCDANCTR-Studies and CCDANCTR-References), the Oxford University PROMS Bibliography (2002-5), Ovid PsycINFO, Web of Science, The Cochrane Library, and International trial registries, initially to 30 May 2014, and updated to 18 May 2015. SELECTION CRITERIA: We selected cluster and individually randomised controlled trials (RCTs) including participants with CMHDs aged 18 years and over, in which the results of PROMs were fed back to treating clinicians, or both clinicians and patients. We excluded RCTs in child and adolescent treatment settings, and those in which more than 10% of participants had diagnoses of eating disorders, psychoses, substance use disorders, learning disorders or dementia. DATA COLLECTION AND ANALYSIS: At least two authors independently identified eligible trials, assessed trial quality, and extracted data. We conducted meta-analysis across studies, pooling outcome measures which were sufficiently similar to each other to justify pooling. MAIN RESULTS: We included 17 studies involving 8787 participants: nine in multidisciplinary mental health care, six in psychological therapy settings, and two in primary care. Pooling of outcome data to provide a summary estimate of effect across studies was possible only for those studies using the compound Outcome Questionnaire (OQ-45) or Outcome Rating System (ORS) PROMs, which were all conducted in multidisciplinary mental health care or psychological therapy settings, because both primary care studies identified used single symptom outcome measures, which were not directly comparable to the OQ-45 or ORS.Meta-analysis of 12 studies including 3696 participants using these PROMs found no evidence of a difference in outcome in terms of symptoms, between feedback and no-feedback groups (standardised mean difference (SMD) -0.07, 95% confidence interval (CI) -0.16 to 0.01; P value = 0.10). The evidence for this comparison was graded as low quality however, as all included studies were considered at high risk of bias, in most cases due to inadequate blinding of assessors and significant attrition at follow-up.Quality of life was reported in only two studies, social functioning in one, and costs in none. Information on adverse events (thoughts of self-harm or suicide) was collected in one study, but differences between arms were not reported.It was not possible to pool data on changes in drug treatment or referrals as only two studies reported these. Meta-analysis of seven studies including 2608 participants found no evidence of a difference in management of CMHDs between feedback and no-feedback groups, in terms of the number of treatment sessions received (mean difference (MD) -0.02 sessions, 95% CI -0.42 to 0.39; P value = 0.93). However, the evidence for this comparison was also graded as low quality. AUTHORS' CONCLUSIONS: We found insufficient evidence to support the use of routine outcome monitoring using PROMs in the treatment of CMHDs, in terms of improving patient outcomes or in improving management. The findings are subject to considerable uncertainty however, due to the high risk of bias in the large majority of trials meeting the inclusion criteria, which means further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate. More research of better quality is therefore required, particularly in primary care where most CMHDs are treated.Future research should address issues of blinding of assessors and attrition, and measure a range of relevant symptom outcomes, as well as possible harmful effects of monitoring, health-related quality of life, social functioning, and costs. Studies should include people treated with drugs as well as psychological therapies, and should follow them up for longer than six months.

GP training in out-of-hours care: implications for the future workforce.

AIMS: To understand GP trainees' experience of out-of-hours (OOH) training in England; whether it is achieving educational aims, and to highlight potential improvements. Additionally to explore factors that influence the decision to work in OOH care. METHODS: An online survey was sent to 1091 GP trainees in England. Odds ratios were calculated for factors correlating with intention to work in OOH, or confidence and effectiveness in OOH work. Free text responses were coded and organised thematically. RESULTS: Trainees' experience of OOH care influences the decision to work there once qualified. Although this experience has positively influenced over three-quarters of trainees, it can be improved. Training is not achieving competencies in managing psychiatric emergencies and personal safety. Half of trainees received formal teaching in OOH skills; 3% receiving assessments in telephone triage. Only a quarter of trainees had worked with their usual GP trainer. Influential features of training included trainer enthusiasm and continuity, familiarity with the workplace, and confidence in OOH skills. Financial and lifestyle considerations were also important. CONCLUSION: OOH training in England has an impact on the future workforce and could be improved. The planned transition to a 4-year GP training structure offers an opportunity to address this.

Topical antifungal treatments for tinea cruris and tinea corporis.

BACKGROUND: Tinea infections are fungal infections of the skin caused by dermatophytes. It is estimated that 10% to 20% of the world population is affected by fungal skin infections. Sites of infection vary according to geographical location, the organism involved, and environmental and cultural differences. Both tinea corporis, also referred to as 'ringworm' and tinea cruris or 'jock itch' are conditions frequently seen by primary care doctors and dermatologists. The diagnosis can be made on clinical appearance and can be confirmed by microscopy or culture. A wide range of topical antifungal drugs are used to treat these superficial dermatomycoses, but it is unclear which are the most effective. OBJECTIVES: To assess the effects of topical antifungal treatments in tinea cruris and tinea corporis. SEARCH METHODS: We searched the following databases up to 13th August 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 7), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched five trials registers, and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials. We handsearched the journal Mycoses from 1957 to 1990. SELECTION CRITERIA: Randomised controlled trials in people with proven dermatophyte infection of the body (tinea corporis) or groin (tinea cruris). DATA COLLECTION AND ANALYSIS: Two review authors independently carried out study selection, data extraction, assessment of risk of bias, and analyses. MAIN RESULTS: Of the 364 records identified, 129 studies with 18,086 participants met the inclusion criteria. Half of the studies were judged at high risk of bias with the remainder judged at unclear risk. A wide range of different comparisons were evaluated across the 129 studies, 92 in total, with azoles accounting for the majority of the interventions. Treatment duration varied from one week to two months, but in most studies this was two to four weeks. The length of follow-up varied from one week to six months. Sixty-three studies contained no usable or retrievable data mainly due to the lack of separate data for different tinea infections. Mycological and clinical cure were assessed in the majority of studies, along with adverse effects. Less than half of the studies assessed disease relapse, and hardly any of them assessed duration until clinical cure, or participant-judged cure. The quality of the body of evidence was rated as low to very low for the different outcomes.Data for several outcomes for two individual treatments were pooled. Across five studies, significantly higher clinical cure rates were seen in participants treated with terbinafine compared to placebo (risk ratio (RR) 4.51, 95% confidence interval (CI) 3.10 to 6.56, number needed to treat (NNT) 3, 95% CI 2 to 4). The quality of evidence for this outcome was rated as low. Data for mycological cure for terbinafine could not be pooled due to substantial heterogeneity.Mycological cure rates favoured naftifine 1% compared to placebo across three studies (RR 2.38, 95% CI 1.80 to 3.14, NNT 3, 95% CI 2 to 4) with the quality of evidence rated as low. In one study, naftifine 1% was more effective than placebo in achieving clinical cure (RR 2.42, 95% CI 1.41 to 4.16, NNT 3, 95% CI 2 to 5) with the quality of evidence rated as low.Across two studies, mycological cure rates favoured clotrimazole 1% compared to placebo (RR 2.87, 95% CI 2.28 to 3.62, NNT 2, 95% CI 2 to 3).Data for several outcomes were pooled for three comparisons between different classes of treatment. There was no difference in mycological cure between azoles and benzylamines (RR 1.01, 95% CI 0.94 to 1.07). The quality of the evidence was rated as low for this comparison. Substantial heterogeneity precluded the pooling of data for mycological and clinical cure when comparing azoles and allylamines. Azoles were slightly less effective in achieving clinical cure compared to azole and steroid combination creams immediately at the end of treatment (RR 0.67, 95% CI 0.53 to 0.84, NNT 6, 95% CI 5 to 13), but there was no difference in mycological cure rate (RR 0.99, 95% CI 0.93 to 1.05). The quality of evidence for these two outcomes was rated as low for mycological cure and very low for clinical cure.All of the treatments that were examined appeared to be effective, but most comparisons were evaluated in single studies. There was no evidence for a difference in cure rates between tinea cruris and tinea corporis. Adverse effects were minimal - mainly irritation and burning; results were generally imprecise between active interventions and placebo, and between different classes of treatment. AUTHORS' CONCLUSIONS: The pooled data suggest that the individual treatments terbinafine and naftifine are effective. Adverse effects were generally mild and reported infrequently. A substantial number of the studies were more than 20 years old and of unclear or high risk of bias; there is however, some evidence that other topical antifungal treatments also provide similar clinical and mycological cure rates, particularly azoles although most were evaluated in single studies.There is insufficient evidence to determine if Whitfield's ointment, a widely used agent is effective.Although combinations of topical steroids and antifungals are not currently recommended in any clinical guidelines, relevant studies included in this review reported higher clinical cure rates with similar mycological cure rates at the end of treatment, but the quality of evidence for these outcomes was rated very low due to imprecision, indirectness and risk of bias. There was insufficient evidence to confidently assess relapse rates in the individual or combination treatments.Although there was little difference between different classes of treatment in achieving cure, some interventions may be more appealing as they require fewer applications and a shorter duration of treatment. Further, high quality, adequately powered trials focusing on patient-centred outcomes, such as patient satisfaction with treatment should be considered.

Corticosteroids for acute and subacute cough following respiratory tract infection: a systematic review.

BACKGROUND: Cough associated with acute respiratory tract infection (RTI) is one of the most common problems managed in primary care. Despite minimal evidence for the use of antibiotics, they continue to be prescribed at great cost and are a significant cause of emerging bacterial resistance. OBJECTIVES: To carry out a systematic review of randomized controlled trials to evaluate the effect of corticosteroid therapy in otherwise-healthy adults with acute RTI. METHODS: Seven electronic databases and five ongoing trial registers were searched. Studies were eligible if they compared the use of any corticosteroid treatment against a control group in adults with an acute (<3 weeks) or subacute (<8 weeks) cough associated with an RTI but no asthma. Primary outcomes were differences in mean cough and other symptom scores. Secondary outcomes included adverse effects, subsequent diagnosis of asthma and patient satisfaction. RESULTS: Four trials (335 participants) investigating the effects of inhaled corticosteroids were identified. None investigated the use of oral corticosteroids. Results were mixed, with two reporting equivalence and two reporting benefits for mean cough score (P = 0.012) and cough frequency (P = 0.047). One reported additional benefits in non-smokers. Adverse events were rare and there were no data on patient satisfaction or the subsequent diagnosis of asthma. Most trials were of unclear risk of bias. Study outcomes were too heterogeneous to meta-analyse. CONCLUSIONS: There is insufficient evidence to recommend the routine use of inhaled corticosteroids for acute RTI in adults. However, some trials have shown benefits, suggesting the need for further high-quality, adequately powered trials.