Could habits hold the key to weight loss maintenance? A narrative review.

Despite the significance placed on lifestyle interventions for obesity management, most weight loss is followed by weight regain. Psychological concepts of habitual behaviour and automaticity have been suggested as plausible explanations for this overwhelming lack of long-term weight loss success. Interventions that focus on changing an individual's behaviour are not usually successful at changing an individual's habits because they do not incorporate the strategies required to break unhealthy habits and/or form new healthy habits. A narrative review was conducted and describes the theory behind habit formation in relation to weight regain. The review evaluated the effectiveness of using habits as tools to maintain weight loss. Three specific habit-based weight loss programmes are described: '10 Top Tips', 'Do Something Different' and 'Transforming Your Life'. Participants in these interventions achieved significant weight loss compared to a control group or other conventional interventions. Habit-based interventions show promising results in sustaining behaviour change. Weight loss maintenance may benefit from incorporating habit-focused strategies and should be investigated further.

[Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide]. / Die TIDieR Checkliste und Anleitung - ein Instrument für eine verbesserte Interventionsbeschreibung und Replikation.

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face-to-face panel meeting. The resultant 12-item TIDieR checklist (brief name, why, what (materials), what (procedure), who intervened, how, where, when and how much, tailoring, modifications, how well (planned), how well (actually carried out)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with a detailed explanation of each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure the accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

Optimal prostate-specific antigen screening interval for prostate cancer.

BACKGROUND: To identify the optimal interval for repeat prostate-specific antigen (PSA) testing to screen for prostate cancer in healthy adults. PATIENTS AND METHODS: A retrospective cohort study was conducted on 7332 healthy males without prostate cancer at baseline from 2005 to 2008. Participants underwent annual health checkups including PSA testing at the Center for Preventive Medicine in Japan. Participants with high PSA (≥ 4.0 ng/ml) underwent further examination for prostate cancer. A subgroup analysis was conducted age group (<50 years, ≥ 50 years). RESULTS: Mean age was 50 years. Mean PSA at baseline was 1.2 ng/ml. In over 50-year group, for those with initial PSA of <1.0, 1.0-1.9, 2.0-2.9, and 3.0-3.9 ng/ml at baseline, the 3-year cumulative incidence of prostate cancer was 0%, 0.1%, 0.3%, and 5.7%, respectively. No prostate cancer was identified in those <50 years, regardless of PSA level. CONCLUSIONS: If PSA screening is recommended, males >50 years with PSA of 3.0-3.9 ng/ml at baseline should undergo rescreening at 2 years. For men with PSA <3.0 ng/ml, PSA rescreening at intervals of ≥ 3 years is appropriate. PSA screening may not be indicated in males of <50 years of age.

Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study.

AIMS/HYPOTHESIS: Fenofibrate caused an acute, sustained plasma creatinine increase in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and Action to Control Cardiovascular Risk in Diabetes (ACCORD) studies. We assessed fenofibrate's renal effects overall and in a FIELD washout sub-study. METHODS: Type 2 diabetic patients (n = 9,795) aged 50 to 75 years were randomly assigned to fenofibrate (n = 4,895) or placebo (n = 4,900) for 5 years, after 6 weeks fenofibrate run-in. Albuminuria (urinary albumin/creatinine ratio measured at baseline, year 2 and close-out) and estimated GFR, measured four to six monthly according to the Modification of Diet in Renal Disease Study, were pre-specified endpoints. Plasma creatinine was re-measured 8 weeks after treatment cessation at close-out (washout sub-study, n = 661). Analysis was by intention-to-treat. RESULTS: During fenofibrate run-in, plasma creatinine increased by 10.0 µmol/l (p < 0.001), but quickly reversed on placebo assignment. It remained higher on fenofibrate than on placebo, but the chronic rise was slower (1.62 vs 1.89 µmol/l annually, p = 0.01), with less estimated GFR loss (1.19 vs 2.03 ml min(-1) 1.73 m(-2) annually, p < 0.001). After washout, estimated GFR had fallen less from baseline on fenofibrate (1.9 ml min(-1) 1.73 m(-2), p = 0.065) than on placebo (6.9 ml min(-1) 1.73 m(-2), p < 0.001), sparing 5.0 ml min(-1) 1.73 m(-2) (95% CI 2.3-7.7, p < 0.001). Greater preservation of estimated GFR with fenofibrate was observed with baseline hypertriacylglycerolaemia (n = 169 vs 491 without) alone, or combined with low HDL-cholesterol (n = 140 vs 520 without) and reductions of ≥ 0.48 mmol/l in triacylglycerol over the active run-in period (pre-randomisation) (n = 356 vs 303 without). Fenofibrate reduced urine albumin concentrations and hence albumin/creatinine ratio by 24% vs 11% (p < 0.001; mean difference 14% [95% CI 9-18]; p < 0.001), with 14% less progression and 18% more albuminuria regression (p < 0.001) than in participants on placebo. End-stage renal event frequency was similar (n = 21 vs 26, p = 0.48). CONCLUSIONS/INTERPRETATION: Fenofibrate reduced albuminuria and slowed estimated GFR loss over 5 years, despite initially and reversibly increasing plasma creatinine. Fenofibrate may delay albuminuria and GFR impairment in type 2 diabetes patients. Confirmatory studies are merited. TRIAL REGISTRATION: ISRCTN64783481.

Grading quality of evidence and strength of recommendations in clinical practice guidelines part 3 of 3. The GRADE approach to developing recommendations.

This is the third and last article in the series about the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to grading the quality of evidence and the strength of recommendations in clinical practice guidelines and its application in the field of allergy. We describe the factors that influence the strength of recommendations about the use of diagnostic, preventive and therapeutic interventions: the balance of desirable and undesirable consequences, the quality of a body of evidence related to a decision, patients' values and preferences, and considerations of resource use. We provide examples from two recently developed guidelines in the field of allergy that applied the GRADE approach. The main advantages of this approach are the focus on patient important outcomes, explicit consideration of patients' values and preferences, the systematic approach to collecting the evidence, the clear separation of the concepts of quality of evidence and strength of recommendations, and transparent reporting of the decision process. The focus on transparency facilitates understanding and implementation and should empower patients, clinicians and other health care professionals to make informed choices.

Does copper treatment of commonly touched surfaces reduce healthcare-acquired infections? A systematic review and meta-analysis.

BACKGROUND: Healthcare-acquired infections (HAIs) cause substantial morbidity and mortality. Copper appears to have strong antimicrobial properties under laboratory conditions. AIM: To examine the potential effect of copper treatment of commonly touched surfaces in healthcare facilities. METHODS: Controlled trials comparing the effect of copper-treated surfaces (furniture or bed linens) in hospital rooms compared with standard rooms on HAIs were included in this systematic review. Two reviewers independently screened retrieved articles, extracted data, and assessed the risk of bias of included studies. The primary outcome was the occurrence of HAIs. FINDINGS: In total, 638 records were screened, and seven studies comprising 12,362 patients were included. All included studies were judged to be at high risk of bias in two or more of the seven domains. All seven studies reported the effect of various copper-treated surfaces on HAIs. Overall, this review found low-quality evidence of potential clinical importance that copper-treated hard surfaces and/or bed linens and clothes reduced HAIs by 27% (risk ratio 0.73, 95% confidence interval 0.57-0.94; I2 = 44%, P=0.01). CONCLUSION: Given the clinical and economic costs of HAIs, the potentially protective effect of copper treatment appears to be important. The current evidence is insufficient to make a strong positive recommendation. However, it would appear worthwhile and urgent to conduct larger publicly funded clinical trials into the impact of copper treatment.

Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses.

AIMS/HYPOTHESIS: We compared the effect of biphasic, basal or prandial insulin regimens on glucose control, clinical outcomes and adverse events in people with type 2 diabetes. METHODS: We searched the Cochrane Library, MEDLINE, EMBASE and major American and European conference abstracts for randomised controlled trials up to October 2008. A systematic review and meta-analyses were performed. RESULTS: Twenty-two trials that randomised 4,379 patients were included. Seven trials reported both starting insulin dose and titration schedules. Hypoglycaemia definitions and glucose targets varied. Meta-analyses were performed pooling data from insulin-naive patients. Greater HbA(1c) reductions were seen with biphasic and prandial insulin, compared with basal insulin, of 0.45% (95% CI 0.19-0.70, p = 0.0006) and 0.45% (95% CI 0.16-0.73, p = 0.002), respectively, but with lesser reductions of fasting glucose of 0.93 mmol/l (95% CI 0.21-1.65, p = 0.01) and 2.20 mmol/l (95% CI 1.70-2.70, p < 0.00001), respectively. Larger insulin doses at study end were reported in biphasic and prandial arms compared with basal arms. No studies found differences in major hypoglycaemic events, but minor hypoglycaemic events for prandial and biphasic insulin were inconsistently reported as either higher than or equivalent to basal insulin. Greater weight gain was seen with prandial compared with basal insulin (1.86 kg, 95% CI 0.80-2.92, p = 0.0006). CONCLUSIONS/INTERPRETATION: Greater HbA(1c) reduction may be obtained in type 2 diabetes when insulin is initiated using biphasic or prandial insulin rather than a basal regimen, but with an unquantified risk of hypoglycaemia. Studies with longer follow-up are required to determine the clinical relevance of this finding.

Grading quality of evidence and strength of recommendations in clinical practice guidelines: Part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies.

The GRADE approach to grading the quality of evidence and strength of recommendations provides a comprehensive and transparent approach for developing clinical recommendations about using diagnostic tests or diagnostic strategies. Although grading the quality of evidence and strength of recommendations about using tests shares the logic of grading recommendations for treatment, it presents unique challenges. Guideline panels and clinicians should be alert to these special challenges when using the evidence about the accuracy of tests as the basis for clinical decisions. In the GRADE system, valid diagnostic accuracy studies can provide high quality evidence of test accuracy. However, such studies often provide only low quality evidence for the development of recommendations about diagnostic testing, as test accuracy is a surrogate for patient-important outcomes at best. Inferring from data on accuracy that using a test improves outcomes that are important to patients requires availability of an effective treatment, improved patients' wellbeing through prognostic information, or - by excluding an ominous diagnosis - reduction of anxiety and the opportunity for earlier search for an alternative diagnosis for which beneficial treatment can be available. Assessing the directness of evidence supporting the use of a diagnostic test requires judgments about the relationship between test results and patient-important consequences. Well-designed and conducted studies of allergy tests in parallel with efforts to evaluate allergy treatments critically will encourage improved guideline development for allergic diseases.

Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial.

BACKGROUND: Blood pressure is an important determinant of the risks of macrovascular and microvascular complications of type 2 diabetes, and guidelines recommend intensive lowering of blood pressure for diabetic patients with hypertension. We assessed the effects of the routine administration of an angiotensin converting enzyme (ACE) inhibitor-diuretic combination on serious vascular events in patients with diabetes, irrespective of initial blood pressure levels or the use of other blood pressure lowering drugs. METHODS: The trial was done by 215 collaborating centres in 20 countries. After a 6-week active run-in period, 11 140 patients with type 2 diabetes were randomised to treatment with a fixed combination of perindopril and indapamide or matching placebo, in addition to current therapy. The primary endpoints were composites of major macrovascular and microvascular events, defined as death from cardiovascular disease, non-fatal stroke or non-fatal myocardial infarction, and new or worsening renal or diabetic eye disease, and analysis was by intention-to-treat. The macrovascular and microvascular composites were analysed jointly and separately. This trial is registered with ClinicalTrials.gov, number NCT00145925. FINDINGS: After a mean of 4.3 years of follow-up, 73% of those assigned active treatment and 74% of those assigned control remained on randomised treatment. Compared with patients assigned placebo, those assigned active therapy had a mean reduction in systolic blood pressure of 5.6 mm Hg and diastolic blood pressure of 2.2 mm Hg. The relative risk of a major macrovascular or microvascular event was reduced by 9% (861 [15.5%] active vs 938 [16.8%] placebo; hazard ratio 0.91, 95% CI 0.83-1.00, p=0.04). The separate reductions in macrovascular and microvascular events were similar but were not independently significant (macrovascular 0.92; 0.81-1.04, p=0.16; microvascular 0.91; 0.80-1.04, p=0.16). The relative risk of death from cardiovascular disease was reduced by 18% (211 [3.8%] active vs 257 [4.6%] placebo; 0.82, 0.68-0.98, p=0.03) and death from any cause was reduced by 14% (408 [7.3%] active vs 471 [8.5%] placebo; 0.86, 0.75-0.98, p=0.03). There was no evidence that the effects of the study treatment differed by initial blood pressure level or concomitant use of other treatments at baseline. INTERPRETATION: Routine administration of a fixed combination of perindopril and indapamide to patients with type 2 diabetes was well tolerated and reduced the risks of major vascular events, including death. Although the confidence limits were wide, the results suggest that over 5 years, one death due to any cause would be averted among every 79 patients assigned active therapy.

Evidence based practice: the practicalities of keeping abreast of clinical evidence while in training.

This paper gives a practical account of why and how to learn to practise evidence based medicine while still in clinical training. It highlights practical benefits to learning the skills (such as passing exams, coping with information overload and helping patients), and explains how to manage each of the four essential steps (asking questions, acquiring information, appraising evidence, and applying the results). Key resources to give the trainee rapid access to evidence based answers are highlighted, as are efficient ways of keeping up to date with the emerging literature.

Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.

BACKGROUND: Near-patient testing has made self-monitoring of anticoagulation with warfarin feasible, and several trials have suggested that such monitoring might be equal to or better than standard monitoring. We did a systematic review and meta-analysis of all randomised controlled trials that assessed the effects of self-monitoring or self-management (self-testing and self-dosage) of anticoagulation compared with standard monitoring. METHODS: We searched the Cochrane Register of Controlled Trials, MEDLINE, EMBASE to April 2005, and contacted manufacturers and authors of relevant studies. Outcomes analysed were: major haemorrhage, thromboembolic events, death, tests in range, minor haemorrhage, frequency of testing, and feasibility of self-monitoring. FINDINGS: We identified 14 randomised trials of self-monitoring: pooled estimates showed significant reductions in thromboembolic events (odds ratio 0.45, 95% CI 0.30-0.68), all-cause mortality (0.61, 0.38-0.98), and major haemorrhage (0.65, 0.42-0.99). Trials of combined self-monitoring and self-adjusted therapy showed significant reductions in thromboembolic events (0.27, 0.12-0.59) and death (0.37, 0.16-0.85), but not major haemorrhage (0.93, 0.42-2.05). No difference was noted in minor haemorrhage. 11 trials reported improvements in the mean proportion of international normalisation ratios in range. INTERPRETATION: Self-management improves the quality of oral anticoagulation. Patients capable of self-monitoring and self-adjusting therapy have fewer thromboembolic events and lower mortality than those who self-monitor alone. However, self-monitoring is not feasible for all patients, and requires identification and education of suitable candidates.

A systematic review of the routine monitoring of growth in children of primary school age to identify growth-related conditions.

OBJECTIVES: To clarify the role of growth monitoring in primary school children, including obesity, and to examine issues that might impact on the effectiveness and cost-effectiveness of such programmes. DATA SOURCES: Electronic databases were searched up to July 2005. Experts in the field were also consulted. REVIEW METHODS: Data extraction and quality assessment were performed on studies meeting the review's inclusion criteria. The performance of growth monitoring to detect disorders of stature and obesity was evaluated against National Screening Committee (NSC) criteria. RESULTS: In the 31 studies that were included in the review, there were no controlled trials of the impact of growth monitoring and no studies of the diagnostic accuracy of different methods for growth monitoring. Analysis of the studies that presented a 'diagnostic yield' of growth monitoring suggested that one-off screening might identify between 1:545 and 1:1793 new cases of potentially treatable conditions. Economic modelling suggested that growth monitoring is associated with health improvements [incremental cost per quality-adjusted life-year (QALY) of 9500 pounds] and indicated that monitoring was cost-effective 100% of the time over the given probability distributions for a willingness to pay threshold of 30,000 pounds per QALY. Studies of obesity focused on the performance of body mass index against measures of body fat. A number of issues relating to human resources required for growth monitoring were identified, but data on attitudes to growth monitoring were extremely sparse. Preliminary findings from economic modelling suggested that primary prevention may be the most cost-effective approach to obesity management, but the model incorporated a great deal of uncertainty. CONCLUSIONS: This review has indicated the potential utility and cost-effectiveness of growth monitoring in terms of increased detection of stature-related disorders. It has also pointed strongly to the need for further research. Growth monitoring does not currently meet all NSC criteria. However, it is questionable whether some of these criteria can be meaningfully applied to growth monitoring given that short stature is not a disease in itself, but is used as a marker for a range of pathologies and as an indicator of general health status. Identification of effective interventions for the treatment of obesity is likely to be considered a prerequisite to any move from monitoring to a screening programme designed to identify individual overweight and obese children. Similarly, further long-term studies of the predictors of obesity-related co-morbidities in adulthood are warranted. A cluster randomised trial comparing growth monitoring strategies with no growth monitoring in the general population would most reliably determine the clinical effectiveness of growth monitoring. Studies of diagnostic accuracy, alongside evidence of effective treatment strategies, could provide an alternative approach. In this context, careful consideration would need to be given to target conditions and intervention thresholds. Diagnostic accuracy studies would require long-term follow-up of both short and normal children to determine sensitivity and specificity of growth monitoring.

Screening for colorectal cancer using the faecal occult blood test, Hemoccult.

BACKGROUND: Colorectal cancer is a leading cause of morbidity and mortality, especially in the Western world. The human and financial costs of this disease have prompted considerable research efforts to evaluate the ability of screening tests to detect the cancer at an early curable stage. Tests that have been considered for population screening include variants of the faecal occult blood test, flexible sigmoidoscopy and colonoscopy. Reducing mortality from colorectal cancer (CRC) may be achieved by the introduction of population-based screening programmes. OBJECTIVES: To determine whether screening for colorectal cancer using the faecal occult blood test (guaiac or immunochemical) reduces colorectal cancer mortality and to consider the benefits, harms and potential consequences of screening. SEARCH STRATEGY: Published and unpublished data for this review were identified by: Reviewing studies included in the previous Cochrane review; Searching several electronic databases (Cochrane Library, Medline, Embase, CINAHL, PsychInfo, Amed, SIGLE, HMIC); and Writing to the principal investigators of potentially eligible trials. SELECTION CRITERIA: We included in this review all randomised trials of screening for colorectal cancer that compared faecal occult blood test (guaiac or immunochemical) on more than one occasion with no screening and reported colorectal cancer mortality. DATA COLLECTION AND ANALYSIS: Data from the eligible trials were independently extracted by two reviewers. The primary data analysis was performed using the group participants were originally randomised to ('intention to screen'), whether or not they attended screening; a secondary analysis adjusted for non-attendence. We calculated the relative risks and risk differences for each trial, and then overall, using fixed and random effects models (including testing for heterogeneity of effects). We identified nine articles concerning four randomised controlled trials and two controlled trials involving over 320,000 participants with follow-up ranging from 8 to 18 years. MAIN RESULTS: Combined results from the 4 eligible randomised controlled trials shows that participants allocated to screening had a 16% reduction in the relative risk of colorectal cancer mortality (RR 0.84, CI: 0.78-0.90). In the 3 studies that used biennial screening (Funen, Minnesota, Nottingham) there was a 15% relative risk reduction (RR 0.85, CI: 0.78-0.92) in colorectal cancer mortality. When adjusted for screening attendance in the individual studies, there was a 25% relative risk reduction (RR 0.75, CI: 0.66 - 0.84) for those attending at least one round of screening using the faecal occult blood test. AUTHORS' CONCLUSIONS: Benefits of screening include a modest reduction in colorectal cancer mortality, a possible reduction in cancer incidence through the detection and removal of colorectal adenomas, and potentially, the less invasive surgery that earlier treatment of colorectal cancers may involve. Harmful effects of screening include the psycho-social consequences of receiving a false-positive result, the potentially significant complications of colonoscopy or a false-negative result, the possibility of overdiagnosis (leading to unnecessary investigations or treatment) and the complications associated with treatment.

Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial.

BACKGROUND: Patients with type 2 diabetes mellitus are at increased risk of cardiovascular disease, partly owing to dyslipidaemia, which can be amenable to fibrate therapy. We designed the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study to assess the effect of fenofibrate on cardiovascular disease events in these patients. METHODS: We did a multinational, randomised controlled trial with 9795 participants aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry. After a placebo and a fenofibrate run-in phase, we randomly assigned patients (2131 with previous cardiovascular disease and 7664 without) with a total-cholesterol concentration of 3.0-6.5 mmol/L and a total-cholesterol/HDL-cholesterol ratio of 4.0 or more or plasma triglyceride of 1.0-5.0 mmol/L to micronised fenofibrate 200 mg daily (n=4895) or matching placebo (n=4900). Our primary outcome was coronary events (coronary heart disease death or non-fatal myocardial infarction); the outcome for prespecified subgroup analyses was total cardiovascular events (the composite of cardiovascular death, myocardial infarction, stroke, and coronary and carotid revascularisation). Analysis was by intention to treat. The study was prospectively registered (number ISRCTN 64783481). FINDINGS: Vital status was confirmed on all but 22 patients. Averaged over the 5 years' study duration, similar proportions in each group discontinued study medication (10% placebo vs 11% fenofibrate) and more patients allocated placebo (17%) than fenofibrate (8%; p<0.0001) commenced other lipid treatments, predominantly statins. 5.9% (n=288) of patients on placebo and 5.2% (n=256) of those on fenofibrate had a coronary event (relative reduction of 11%; hazard ratio [HR] 0.89, 95% CI 0.75-1.05; p=0.16). This finding corresponds to a significant 24% reduction in non-fatal myocardial infarction (0.76, 0.62-0.94; p=0.010) and a non-significant increase in coronary heart disease mortality (1.19, 0.90-1.57; p=0.22). Total cardiovascular disease events were significantly reduced from 13.9% to 12.5% (0.89, 0.80-0.99; p=0.035). This finding included a 21% reduction in coronary revascularisation (0.79, 0.68-0.93; p=0.003). Total mortality was 6.6% in the placebo group and 7.3% in the fenofibrate group (p=0.18). Fenofibrate was associated with less albuminuria progression (p=0.002), and less retinopathy needing laser treatment (5.2%vs 3.6%, p=0.0003). There was a slight increase in pancreatitis (0.5%vs 0.8%, p=0.031) and pulmonary embolism (0.7%vs 1.1%, p=0.022), but no other significant adverse effects. INTERPRETATION: Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events. It did reduce total cardiovascular events, mainly due to fewer non-fatal myocardial infarctions and revascularisations. The higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit.

Autoinflation for hearing loss associated with otitis media with effusion.

BACKGROUND: Otitis media with effusion (OME) or 'glue ear' is an accumulation of fluid in the middle ear, in the absence of acute inflammation or infection. It is the commonest cause of acquired hearing loss in childhood and the usual reason for insertion of 'grommets'. Potential treatments include decongestants, mucolytics, steroids, antihistamines and antibiotics. Autoinflation devices have been proposed as a simple mechanical means of improving 'glue ear'. OBJECTIVES: To determine the effects of autoinflation in adults and children with otitis media with effusion. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, CENTRAL (The Cochrane Library Issue 1, 2006), MEDLINE (1951 to 2006), EMBASE (1974 to 2006) and twelve other databases, using the Cochrane Ear, Nose and Throat Disorders Group search strategy. SELECTION CRITERIA: We selected randomised controlled trials that compared any form of autoinflation to no autoinflation in individuals with 'glue ear'. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, assessed quality and extracted data from included studies. MAIN RESULTS: Six studies met the inclusion criteria. Improvement occurred for the composite measure of tympanogram or audiometry at less than one month (Relative Risk of Improvement (RRI) 2.47, 95% confidence interval (CI) 0.93 to 6.58) and at more than one month (RRI 2.20, 95% CI 1.71 to 2.82). Subgroup analysis based on the type of intervention showed a significant effect using a Politzer device under one month (RRI 7.07, 95% CI 3.70 to 13.51) and over one month (RRI 2.25, 95% CI 1.67 to 3.04). Pooled estimates showed non-significant change in tympanometry (type C2 and B) at less than one month (RRI 1.65, 95% CI 0.49 to 5.56) and non-significant improvement in tympanometry at greater than one month (RRI 1.89, 95% CI 0.77 to 4.67). Non-significant improvements occurred for discrete pure tone audiometry (RRI 0.80, 95% CI 0.22 to 2.88) and non-discrete audiometry (WMD 6.95 dB, 95% CI 21.03 to 7.13). None of the studies demonstrated a significant difference in the incidence of side effects between interventions. AUTHORS' CONCLUSIONS: All of the studies were small, of limited treatment duration and short follow up. However, because of the low cost and absence of adverse effects it is reasonable to consider autoinflation whilst awaiting natural resolution of otitis media with effusion. Further research should consider the duration of treatment and the long-term impact of autoinflation on developmental outcomes in children.

Reminder packaging for improving adherence to self-administered long-term medications.

BACKGROUND: Current methods of improving medication adherence for health problems are mostly complex, labour-intensive, and not reliably effective. Medication 'reminder packaging' which incorporates a date or time for a medication to be taken in the packaging, can act as a reminder system to improve adherence. OBJECTIVES: The objective of this review was to determine the effects of reminder packaging to enhance patient adherence with self-administered medications taken for one month or more. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library Issue 3, 2004), MEDLINE, EMBASE, CINAHL and PsycINFO from the start of the databases to 1 September 2004. We also searched the internet, contacted packaging manufacturers, and checked abstracts from the Pharm-line database and reference lists from relevant articles. We did not apply any language restrictions. SELECTION CRITERIA: We selected randomised controlled trials with at least 80% follow up, comparing a reminder packaging device with no device in participants taking self-administered medications for a minimum of one month. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for inclusion, assessed quality, and extracted data from included studies. Where considered appropriate, data were combined for meta-analysis, or were reported and discussed in a narrative. MAIN RESULTS: Eight studies containing data on 1,137 participants were included. Six intervention groups in four trials provided data on the percentage of pills taken. Reminder packaging showed a significant increase in the percentage of pills taken, weighted mean difference 11% (95% confidence interval (CI) 6% to 17%). Notable heterogeneity occurred among these trials I(2 )= 96.3%. Two trials provided data for the proportion of self-reported adherent patients, reporting a reduction in the intervention group which was not statistically significant, odds ratio = 0.89 (95% CI 0.56 to 1.40). No appropriate data were available for meta-analysis of different clinical outcomes, the most common of these being blood pressure (three out of eight trials). Other clinical outcomes reported were glycated haemoglobin, serum Vitamin C and E levels, and self-reported psychological symptoms (one trial each). AUTHORS' CONCLUSIONS: Reminder packing may represent a simple method for improving adherence for patients with selected conditions examined to date. Further research is warranted to improve the design and targeting of these devices.

Antibiotics for sore throat.

BACKGROUND: Sore throat is a very common reason for people to present for medical care. Although it remits spontaneously, primary care doctors commonly prescribe antibiotics for it. OBJECTIVES: To assess the benefits of antibiotics for sore throat. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library, Issue 1, 2006), MEDLINE (January 1966 to March 2006) and EMBASE (January 1990 to December 2005). SELECTION CRITERIA: Trials of antibiotic against control with either measures of the typical symptoms (throat soreness, headache or fever), or suppurative or non-suppurative complications of sore throat. DATA COLLECTION AND ANALYSIS: Potential studies were screened independently by two authors for inclusion, with differences in opinion resolved by discussion. Data were then independently extracted from studies selected by inclusion by two authors. Researchers from three studies were contacted for additional information. MAIN RESULTS: There were 27 studies with 2835 cases of sore throat. 1. Non-suppurative complications: There was a trend for antibiotics to protect against acute glomerulonephritis, but there were insufficient cases to be sure. Several studies found antibiotics reduced acute rheumatic fever by more than two thirds (relative risk (RR) 0.22; 95% CI 0.02 to 2.08). 2. Suppurative complications: Antibiotics reduced the incidence of acute otitis media (RR 0.30; 95% CI 0.15 to 0.58); of acute sinusitis (RR 0.48; 95% CI 0.08 to 2.76); and of quinsy (peritonsillar abscess) compared to those taking placebo (RR 0.15; 95% CI 0.05 to 0.47). 3. SYMPTOMS: Throat soreness and fever were reduced by antibiotics by about one half. The greatest difference was seen at about 3 to 4 days (when the symptoms of about 50% of untreated patients had settled). By one week about 90% of treated and untreated patients were symptom-free. The overall number need to treat to prevent one sore throat at day 3 was just under six (95% CI 4.9 to 7.0); at week 1 it was 21 (95% CI 13.2 to 47.9). 4. Subgroup analyses of symptom reduction: Analysis by: age; blind versus unblinded; or use of antipyretics, found no significant differences. Analysis of results of throat swabs showed that antibiotics were more effective against symptoms at day 3, RR 0.58 (95% CI 0.48 to 0.71) if the swabs were positive for Streptococcus, compared to RR 0.78 (95% CI 0.63 to 0.97) if negative. Similarly at week 1, RRs 0.29 (95% CI 0.12 to 0.70) for positive, and 0.73 (95% CI 0.50 to 1.07) for negative swabs. AUTHORS' CONCLUSIONS: Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in modern Western society can only be achieved by treating many with antibiotics, most of whom will derive no benefit. In emerging economies (where rates of acute rheumatic fever are high, for example), the number needed to treat may be much lower for antibiotics to be considered effective. Antibiotics shorten the duration of symptoms by about sixteen hours overall.