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An economic evaluation of the JNC hypertension guidelines using data from a randomized controlled trial. Joint National Committee.

BACKGROUND: We wanted to determine the clinical cost of managing hypertension when following the Joint National Committee on Hypertension (JNC) guidelines, including drug therapy, the cost of monitoring for and treating side effects, compliance, and the cost of switching after therapeutic failures. METHODS: The base-case analysis considers antihypertensive agents from four therapeutic classes that were recently evaluated in a large randomized trial: enalapril, amlodipine, acebutolol, and chlorthalidone. Clinical evaluation, therapy, and monitoring for hypertension are modeled with an incidence-based Markov model. Clinical inputs include agent efficacy, side effects, and compliance with dosing schedules. JNC-recommended clinical and laboratory monitoring schedules are followed for each agent. Switches between classes occur for therapeutic failures. Drug and medical care costs are valued in 1995 US dollars. RESULTS: Although patients whose hypertension was initially treated with amlodipine achieved control more readily than patients who were given the other agents, the initial costs to achieve and maintain hypertension control were lowest for chlorthalidone ($641), followed by acebutolol ($920), amlodipine ($946), and enalapril ($948). Maintenance costs were lowest for chlorthalidone. For all agents except chlorthalidone, drug costs were the largest component of overall costs, followed by the costs of office visits, laboratory monitoring, and switching between classes for therapeutic failures. CONCLUSIONS: By following JNC guidelines, a slightly higher percentage of patients will achieve hypertension control with a newer class calcium channel blocker (amlodipine) but at a substantially higher cost than with a generic diuretic (chlorthalidone).

Acebutolol↗

Economic analysis in randomized control trials.

In medical technology assessment, randomized control trials (RCTs) play an important role in determining the relative efficacy of compared treatments. As scarce resources necessitate choosing among options for care, comparing costs of alternative tests, treatments, or programs also becomes important. This study assessed the prevalence and completeness of economic analyses in RCTs published from January 1966 through June 1988. It was found that only 121 of over 50,000 published randomized trials (0.2%) included economic analyses. For a random sample of 51 of these 121 studies, results revealed a mean quality of research score of 0.32 (SD of measurement = 0.14) and a mean economic analysis completeness score of 0.52 (SD = 0.13) on scales of 0 to 1. It was also found that higher economic completeness scores were positively correlated with later dates of publication (r = 0.28, P = 0.046) and with the presence of a statement of study perspective (r = 0.38, P = 0.006). A near-zero correlation between the economic completeness and the quality of research scores was revealed. Also noted were several deficiencies among the economic analyses, including improper allocation of overhead costs, absence of sensitivity analyses, and the fact that only 28% of the 51 studies included some form of aggregation of treatment costs and consequences. Progress in health care depends on accurate assessments of both relative efficacy and costs. The quality of both needs improvement.

Cost-Benefit Analysis↗

Prevention of catheter-related bloodstream infections: analysis of studies published between 2002 and 2005.

As the most recent guidelines for the prevention of catheter-related bloodstream infections (CR-BSIs) were published four years ago, a systematic review was conducted to determine whether any recently published articles should further influence existing guidelines. Articles published between 2002 and 2005 dealing with infection control measures for prevention of CR-BSI were evaluated in order to identify evidence for the possible modification of routine practice. Special emphasis was placed on randomized controlled trials (RCTs), meta-analyses or systematic reviews, and studies applying multi-module interventions. Thirty-three RCTs and 10 meta-analyses or systematic reviews were retrieved. In addition, 10 cohort studies were identified where multi-module programmes were introduced for reducing CR-BSI rates. It was found that RCTs and meta-analyses only have a minor influence on the existing guidelines for the prevention of CR-BSIs and confirm the earlier recommendations on several points. Studies investigating multi-module programmes, however, found a substantial reduction in CR-BSIs ranging from 29% to 95%. The data show that many CR-BSIs are preventable and that there is room for improvement in many institutions. Simple interventions are often useful for reducing CR-BSI rates and the opportunities to decrease CR-BSI rates appear to be greatest when multi-module programmes are applied. An average reduction of more than 50% seems to be possible.

Bacteremia↗

The CSAT methamphetamine treatment program: research design accommodations for "real world" application.

The Methamphetamine Treatment Program (MTP), funded by the Center for Substance Abuse Treatment, has the objectives of implementing the Matrix outpatient model and evaluating that model in comparison to the existing community "treatments as usual." Seven organizations in three western states (California, Montana, and Hawaii) were selected to participate in this randomized, controlled, multisite project in what constitutes the largest trial to date of treatment for methamphetamine (MA) dependence. One hundred fifty MA-dependent patients recruited at each site are randomly assigned to receive either the Matrix model, a manualized program of intensive outpatient treatment, or the site's standard treatment, "treatment as usual." Participants are evaluated at admission, weekly during treatment, at the time of scheduled discharge, and at six and 12 months after admission. Dependent measures assess changes in drug use, HIV risk behaviors, quality of life, and patient satisfaction. Cost analyses to quantify treatment costs and determine the association between costs and clinical outcomes will be conducted. A number of adjustments in the original study design have been necessitated by the realities of community sites' strengths and limitations. Experiences from this multisite project will also provide a model for other efforts to transfer research-based treatments into community settings. This article describes the main aims of the project, the background and rationale for the study design, a brief description of the research plan, and methods implemented to protect the integrity of the science.

Central Nervous System Stimulants↗

Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis.

PURPOSE: Our main purpose was to determine whether the addition of thoracic radiation therapy to systemic chemotherapy improves 2-year survival, improves local (intrathoracic) tumor control, and affects treatment-related mortality in patients with limited-stage small-cell carcinoma of the lung. DESIGN: Eleven randomized trials addressing this issue were identified using a computerized literature search (Medline and Cancerline) and by polling senior investigators in the field. A meta-analysis was then performed and the results of the trials were analyzed in two ways, the odds ratio (OR) (Peto) method and the risk difference method (Dersimonian and Laird). RESULTS: The overall OR for benefit of thoracic radiation on 2-year survival (ie, the odds of surviving 2 years among patients allocated to radiation compared with the odds of surviving 2 years among patients allocated to control) is 1.53 (95% confidence interval [CI], 1.30 to 1.76; chi 2 = 12.76; P less than .001). The risk difference method showed that radiation therapy improved 2-year survival by 5.4% (95% CI, 1.1% to 9.7%). Local control results were available for only nine studies, the OR for treatment benefit is 3.02 (95% CI, 2.80 to 3.24; chi 2 = 101.48; P less than .0001), and intrathoracic tumor control was improved by 25.3% (95% CI, 16.5% to 34.1%). The OR for excess treatment-related deaths in the thoracic radiation-treated patients was 2.54 (95% CI, 1.90 to 3.18; chi 2 = 8.24; P less than .01). The risk difference for treatment-related deaths was 1.2% (95% CI, -0.6% to 3.0%). CONCLUSIONS: This meta-analysis shows a small but significant improvement in survival and a major improvement in tumor control in the thorax in patients receiving thoracic radiation therapy. However, this is achieved at the cost of a small increase in treatment-related mortality.

Carcinoma, Small Cell↗

The cost effectiveness of implantable cardioverter-defibrillators: results from the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II.

OBJECTIVES: We sought to evaluate the cost implications of the implantable cardioverter-defibrillator (ICD), using utilization, cost, and survival data from the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II. BACKGROUND: This trial showed that prophylactic implantation of a defibrillator reduces the rate of mortality in patients who experienced a previous myocardial infarction and low left ventricular ejection fraction. Given the size of the eligible population, the cost effectiveness of the ICD has substantial implications. METHODS: Our research comprises the cost-effectiveness component of the randomized controlled trial, MADIT-II, based on utilization, cost, and survival information from 1,095 U.S. patients who were assigned randomly to receive an ICD or conventional medical care. Utilization data were converted to costs using a variety of national and hospital-specific data. The incremental cost-effectiveness ratio (iCER) was calculated as the difference in discounted costs divided by the difference in discounted life expectancy within 3.5 years. Secondary analyses included projections of survival (using three alternative assumptions), corresponding cost assumptions, and the resulting cost-effectiveness ratios until 12 years after randomization. RESULTS: During the 3.5-year period of the study, the average survival gain for the defibrillator arm was 0.167 years (2 months), the additional costs were 39,200 dollars, and the iCER was 235,000 dollars per year-of-life saved. In three alternative projections to 12 years, this ratio ranged from 78,600 dollars to 114,000 dollars. CONCLUSIONS: The estimated cost per life-year saved by the ICD in the MADIT-II study is relatively high at 3.5 years but is projected to be substantially lower over the course of longer time horizons.

Cost-Benefit Analysis↗

Dietetic guidelines: diet in secondary prevention of cardiovascular disease.

AIM: To produce dietetic guidelines summarizing the systematic review evidence on dietary advice for secondary prevention of cardiovascular disease. METHODS: The Cochrane Library, MEDLINE and EMBASE were comprehensively searched for systematic reviews on aspects of diet and heart health. Reviews were included if they searched systematically for randomised controlled trials relating to diet and secondary prevention of cardiovascular disease. Two members of the UK Heart Health and Thoracic Dietitians Group critically appraised each review. The quality and results of each review were discussed and summarized in a whole group meeting. The guidelines were trialled in seven dietetic departments and modified where necessary. RESULTS: Providing evidence-based dietary information (including increasing omega-3 fat plus fruit and vegetable intake) to all people after myocardial infarction will save more lives than concentrating dietary advice on those in need of weight loss or lipid lowering. The practice of prioritizing dietetic time to those with raised lipids is out of date since the advent of statin therapy. CONCLUSION: There is good systematic review evidence that dietary advice to those with cardiovascular disease can reduce mortality and morbidity as well as modify risk factors. Dietary advice that does this most effectively should be prioritized.

Cardiovascular Diseases↗

A refined method for the meta-analysis of controlled clinical trials with binary outcome.

For the meta-analysis of controlled clinical trials with binary outcome a test statistic for testing an overall treatment effect is proposed, which is based on a refined estimator for the variance of the treatment effect estimator usually used in the random-effects model of meta-analysis. In simulation studies it is shown that the proposed test keeps the prescribed significance level much better than the commonly used tests in the fixed-effects and random-effects model, respectively. Moreover, when using the test it is not necessary to choose between fixed effects and random effects approaches in advance. The proposed method applies in the same way to the analysis of a controlled multi-centre study with binary outcome, including a possible interaction between drugs and centres.

Cisapride↗

A simplified search strategy for identifying randomised controlled trials for systematic reviews of health care interventions: a comparison with more exhaustive strategies.

BACKGROUND: It is generally believed that exhaustive searches of bibliographic databases are needed for systematic reviews of health care interventions. The CENTRAL database of controlled trials (RCTs) has been built up by exhaustive searching. The CONSORT statement aims to encourage better reporting, and hence indexing, of RCTs. Our aim was to assess whether developments in the CENTRAL database, and the CONSORT statement, mean that a simplified RCT search strategy for identifying RCTs now suffices for systematic reviews of health care interventions. METHODS: RCTs used in the Cochrane reviews were identified. A brief RCT search strategy (BRSS), consisting of a search of CENTRAL, and then for variants of the word random across all fields (random$.af.) in MEDLINE and EMBASE, was devised and run. Any trials included in the meta-analyses, but missed by the BRSS, were identified. The meta-analyses were then re-run, with and without the missed RCTs, and the differences quantified. The proportion of trials with variants of the word random in the title or abstract was calculated for each year. The number of RCTs retrieved by searching with "random$.af." was compared to the highly sensitive search strategy (HSSS). RESULTS: The BRSS had a sensitivity of 94%. It found all journal RCTs in 47 of the 57 reviews. The missing RCTs made some significant differences to a small proportion of the total outcomes in only five reviews, but no important differences in conclusions resulted. In the post-CONSORT years, 1997-2003, the percentage of RCTs with random in the title or abstract was 85%, a mean increase of 17% compared to the seven years pre-CONSORT (95% CI, 8.3% to 25.9%). The search using random$.af. reduced the MEDLINE retrieval by 84%, compared to the HSSS, thereby reducing the workload of checking retrievals. CONCLUSION: A brief RCT search strategy is now sufficient to locate RCTs for systematic reviews in most cases. Exhaustive searching is no longer cost-effective, because in effect it has already been done for CENTRAL.

Abstracting and Indexing↗

Review on the value of graduated elastic compression stockings after deep vein thrombosis.

Graduated elastic compression stockings (GECS) are commonly used in the primary prevention of deep vein thrombosis (DVT); however, their role in preventing recurrent DVT and also post-thrombotic syndrome is less well established. The aim of this review was to investigate the effect of GECS after DVT. A literature search was performed by two independent searchers in order to identify randomised controlled trials on the effect of GECS in preventing recurrent DVT and post-thrombotic syndrome. Four randomised trials, including 537 patients, were identified. Two of the studies demonstrated that below-knee GECS significantly reduced post-thrombotic syndrome during follow-up, while a smaller study showed equivocal results. GECS reduced the incidence of post-thrombotic syndrome from 54% to 25.2% [relative risk (RR) 0.47, 95% confidence interval (CI) 0.36-0.61] with the number needed to treat (NNT) being 4 (95% CI 2.7-5.0). The rate of recurrent asymptomatic DVT was also significantly reduced by GECS (RR 0.20, 95% CI 0.06-0.64; NNT 5); the reduction in symptomatic DVT was not significant (RR 0.79, 95% CI 0.50-1.26; NNT 34). In conclusion, there is level Ia evidence to suggest that GECS can significantly reduce the incidence of post-thrombotic syndrome (PTS) after DVT, and therefore these should be routinely prescribed. The evidence for recurrent DVT is less conclusive. Further research is needed towards standardising PTS diagnostic criteria and evaluating more effective preventive measures after DVT.

Bandages↗

Calcium channel antagonists in the treatment of hypertension.

Calcium channel antagonists are widely used antihypertensive agents. Their popularity among primary care physicians is not only due to their blood pressure-lowering effects, but also because they appear to be effective regardless of the age or ethnic background of the patients. The first available calcium channel antagonists utilized immediate-release formulations which, although effective in patients with angina pectoris, were not approved by the US FDA for use in hypertension. When long-acting once-daily formulations were approved in this indication, the short-acting preparations--which had by then become generic and inexpensive--retained some residual unapproved use for hypertension. An observational case-controlled trial, based on such usage, noted that these agents were associated with a greater risk of myocardial infarctions than conventional agents such as diuretics and beta-adrenoceptor antagonists. Further case-controlled trials showed, in fact, that the dangers of calcium channel antagonists were confined to the short-acting agents and that approved long-acting agents were at least as well tolerated and effective as other antihypertensive drugs. Cardiovascular outcomes during treatment with calcium channel antagonists have been examined in randomized, controlled trials. Compared with placebo, the calcium channel antagonists clearly prevented strokes and other cardiovascular events and reduced mortality. The effects of these agents on survival and clinical outcomes were similar to those with other antihypertensive drugs. There is a slight tendency for the calcium channel antagonists to be more effective than other drug types in preventing stroke, but slightly less effective in preventing coronary events. These observations extend to high-risk patients with hypertension including those with diabetes mellitus. Even so, patients with evidence of nephropathy should not receive monotherapy with calcium channel antagonists. Such patients are optimally treated with angiotensin receptor antagonists or ACE inhibitors, although addition of other drugs, including calcium channel antagonists, is often required to achieve the tight blood pressure control necessary to provide adequate renal protection. Calcium channel antagonists have a highly acceptable tolerability profile and careful reviews of available data have shown that their use is not associated with increased bleeding or promotion of tumor formation. It is now recognized that reduction of blood pressure in patients with hypertension to levels often <130/85 mm Hg should be undertaken in presence of other cardiovascular risk factors or evidence of end organ damage. Because of this important concept, calcium channel antagonists, like the other antihypertensive drug classes, are progressively being prescribed less often as monotherapy, but more typically as part of combination regimens.

Calcium Channel Blockers↗

The ADEMEX study and its implications for peritoneal dialysis adequacy.

In an attempt to improve patient outcomes in peritoneal dialysis (PD), national organizations (such as the National Kidney Foundation Dialysis Outcomes Quality Initiative [NKF-DOQI] process) have formulated clinical practice guidelines based on clinical evidence available at the time of development. For "adequacy" of PD it was acknowledged that there was no prospective randomized interventional clinical trial that evaluated the effect of an increase in peritoneal clearance on outcome. The ADEMEX study is the first such study designed to do this. It was well done and adequately powered for the primary analysis. The study findings indicate that over the range of solute clearances studied, an increase in peritoneal clearance is not associated with an incremental improvement in patient outcome. However, it is noted that the cause of dropout was different between groups, with more dropout for "uremia" in the control group. There are also some limitations in the generalizability of the results. First, the exclusion criteria were likely to exclude patients who were small in body size or were high transporters, patients with the highest relative risk of death. Second, although there was an increase in small solute clearance between control and intervention groups, there was not likely to be an increase in clearance of other potential uremic solutes such as middle molecules. Third, the study did not examine outcomes for patients on cycler therapy. Nevertheless it was a provocative, well-run clinical study which does have implications for clinical practice. It confirms that one prescription does not fit all patients, that many patients below current NKF-DOQI targets for small solute clearance are likely to be adequately dialyzed, and provides evidence-based clinical information for national societies to consider when preparing for the next revision of their guidelines.

Humans↗

Ifosfamide in the adjuvant therapy of soft tissue sarcomas.

Ifosfamide and anthracyclines are the only active agents in advanced soft tissue sarcomas. Doxorubicin was always used in sarcomas, whereas ifosfamide was reintroduced in the clinic after the discovery of mesna which prevents its typical dose-limiting toxicity: hemorrhagic cystitis. In the adjuvant setting, doxorubicin was used alone or in combination in the first-generation trials, whereas its parent compounds epirubicin and ifosfamide were employed in the second-generation adjuvant trials, which started in the early 90s. Other relevant aspects of the second-generation trials are the use of the hematopoietic growth factors and the increase of the dose intensity, the introduction of more restrictive selection criteria and the use of the two most active agents, ifosfamide and anthracyclines. Only the Italian cooperative trial has been concluded, and the results reported and updated. After a median follow-up of 89.6 months (range 56-119), the intention-to-treat analysis still reveals a difference in overall survival which, however, is not statistically significant. However, the 5-year overall survival estimate, which is a reasonable end point for the survival analysis of adjuvant treatment in soft tissue sarcomas, was 66.0 and 46.1% for the treatment and the control groups, respectively (p = 0.04).

Antineoplastic Agents, Alkylating↗

Trials of angioplasty and surgery: CABRI.

The medium term (4-year post randomization) results from CABRI indicate that the principal difference between those randomized to coronary angioplasty and those to coronary surgery has been the much greater need for repeat revascularization in the former. A number of factors may play a role in the greater repeat revascularization rate post coronary angioplasty, these include coronary restenosis, residual coronary artery disease, coronary artery disease progression. In the longer term, graft failure in those who have undergone coronary surgery will be important, and it remains to be seen what the effect of this will be.

Angioplasty, Balloon, Coronary↗

Self-help treatments for disorders of recurrent binge eating: a systematic review.

OBJECTIVE: To evaluate self-help interventions for patients with binge eating disorder (BED) and bulimia nervosa (BN), tested in randomized controlled trials, and compared with waiting list or any other type of control group. METHODS: A systematic review including quality appraisal was conducted of randomized controlled trials, using self-help techniques in patients with BED and/or BN. Six databases were searched during the period between January 1994 and June 2004. RESULTS: A total of 2686 articles were identified, 1701 abstracts were evaluated in detail and, nine studies fulfilled the inclusion criteria for this review. All studies indicated that patients treated with active interventions had a reduced number of binge eating episodes at end of treatment. CONCLUSION: The results support self-help interventions but shall be interpreted with caution. Because of the small number of studies using self-help techniques for BED and BN, further larger randomized, multi-center controlled studies that apply standardized inclusion criteria, evaluation instruments and self-help materials, are needed.

Bulimia↗

Long-acting beta2-agonists in asthma: not so SMART?

Asthma is a worldwide chronic disorder that is characterised by airway inflammation and hyper-responsiveness, which results in intermittent airflow obstruction and subsequent perception of symptoms and exacerbations. Inhaled corticosteroids are a fundamental component in the prevention of the short- and long-term complications associated with inadequately controlled asthma. However, many individuals experience persistent symptoms and exacerbations despite receiving low-to-medium doses of an inhaled corticosteroid (400-800 microg/day of beclometasone or equivalent). In these symptomatic asthmatic patients, guidelines advocate the initiation of a long-acting beta2-adrenoceptor agonist (LABA) as additional second-line controller therapy. The recent SMART (Salmeterol Multi-centre Asthma Research Trial) study was designed to compare the effects of add-on salmeterol 42 microg (ex-actuator) twice daily with placebo over 28 weeks in a randomised, double-blind, parallel-group fashion, with the intention to enrol 60,000 asthmatic patients. However, the study was halted prematurely because preliminary data revealed an increased mortality associated with regular use of salmeterol. Moreover, concerning rates of respiratory-related deaths, asthma-related deaths and life-threatening events were observed among African Americans, who constituted up to 18% of the study population. This in turn prompted the US FDA to announce important safety information regarding inhalers containing LABAs and advise that new labelling be produced outlining the "small but significant risk in asthma-related deaths" associated with their regular use. This evidence-based review discusses the data from SMART and highlights potentially important drawbacks with regular use of LABAs in persistent asthma.

Administration, Inhalation↗

All great truths are iconoclastic: selective decontamination of the digestive tract moves from heresy to level 1 truth.

OBJECTIVE: The objective was to compare evidence of the effectiveness, costs and safety of the traditional parenteral antibiotic-only approach against that gathered from 53 randomised trials involving more than 8,500 patients and six meta-analyses on selective decontamination of the digestive tract (SDD) to control infection on the intensive care unit (ICU). PHILOSOPHY: Traditionalists believe that all infections are due to breaches of hygiene except those established in the first 2 days, and that all micro-organisms can cause death. In contrast, newer insights show that transmission via the hands of carers are responsible only for infections occurring after one week, and that only a limited range of 15 potential pathogens contribute to mortality. INTERVENTIONS TO PREVENT ICU INFECTION: The traditional approach is based on hand disinfection aiming at the prevention of transmission of all micro-organisms, to control all infections that occur after 2 days on the ICU. The second feature is the restrictive use of systemic antibiotics, only in cases of microbiologically proven infection. In contrast, SDD aims to control the three types of infection: primary, secondary endogenous and exogenous due to 15 potential pathogens. The classical SDD tetralogy comprises four components: (i) a parenteral antibiotic, cefotaxime, administered for three days to prevent primary endogenous infections typically occurring "early"; (ii) the oropharyngeal and enteral antimicrobials, polymyxin E, tobramycin and amphotericin B administered in throat and gut throughout the treatment on the ICU to prevent secondary endogenous infections tending to develop "late"; (iii) a high standard of hygiene to control transmission of potential pathogens; and (iv) surveillance samples of throat and rectum to monitor the efficacy of the treatment. ENDPOINTS: (i) Infectious morbidity; (ii) mortality; (iii) antimicrobial resistance; and (iv) costs. RESULTS: Properly designed trials on hand disinfection have never demonstrated a reduction in either pneumonia and septicaemia, or mortality. Two randomised trials using restrictive antibiotic policies failed to show a survival benefit at 28 days. In both trials the proportion of resistant isolates obtained from the lower ways was >60% despite significantly less use of antibiotics in the test group. A formal cost effectiveness analysis of the traditional antibiotic policies has not been performed. On the other hand, two meta-analyses have shown that SDD reduces the odds ratio for lower airway infections to 0.35 (0.29-0.41) and mortality to 0.80 (0.69-0.93), with a 6% overall mortality reduction from 30% to 24%. No increase in the rate of super infections due to resistant bacteria could be demonstrated over a period of 20 years of clinical research. Four randomised trials found the cost per survivor to be substantially lower in patients receiving SDD than for those traditionally managed. CONCLUSIONS: The traditionalists still rely on level 5 evidence, i.e. expert opinion, with a grade E recommendation, whilst the proponents of SDD are able to cite level 1 evidence allowing a grade A recommendation in their attempts to control infection on the ICU. The main reason for SDD not being widely used is the primacy of opinion over evidence.

Anti-Bacterial Agents↗

Prevention of falls and fall-related fractures in community-dwelling older adults: a meta-analysis of estimates of effectiveness based on recent guidelines.

BACKGROUND: Two recent falls prevention guidelines have been published but did not include quantitative estimates of effectiveness based on the published reports that were reviewed to support their recommendations. AIM: To produce quantitative estimates of effectiveness of falls prevention programs from the randomised controlled trials cited in the guidelines together with an updated search of the available published reports to August 2002. METHODS: A meta-analysis of randomised controlled trials cited in falls guidelines and studies identified by an updated search of the available published reports was carried out. Randomised controlled trials were identified from the falls guidelines and a search, which met the following criteria: trials in community-dwelling older people; 1-year follow up; and outcome measures reported as the number of subjects with at least one fall or the number of subjects with a fracture. RESULTS: The guidelines identified four studies of 'exercise as a sole intervention', which when combined with one further study identified in a search of the published reports, gave a fixed effects odds ratio (OR) favouring this strategy of 0.81 (95% confidence interval (CI) 0.58-1.14); the number of patients needed to be treated to prevent one person having a fall was 19.5. The guidelines identified seven studies of a 'multiple intervention' strategy that gave a random effects OR favouring this strategy of 0.64 (95% CI 0.47-0.88). Four further studies were identified by the search of the published reports. The updated OR favouring this intervention strategy was 0.65 (95% CI 0.52-0.81); the number of patients needed to be treated to prevent one person having a fall was 9.8. Only two studies had data for fracture and a fixed effects OR favouring falls interventions for fracture prevention was 0.50 (95% CI 0.18-1.40); the number of patients needed to be treated to prevent one person having a fracture was 45.5. CONCLUSION: Semiquantitative statements of evidence can both understate and overstate the effectiveness of falls prevention strategies. There is moderate evidence of efficacy for falls prevention particularly for multiple intervention strategies.

Accidental Falls↗