Evaluating guidelines across primary care-secondary care interface. Methodological weaknesses and poor reporting undermine authors' conclusions.
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Biomedical subjects
Publications and source records attributed to N Freemantle.
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BACKGROUND: Maintaining therapeutic concentrations of toxic drugs is a complex task. Several computer systems have been designed to help doctors determine optimum drug dosage. Significant improvements in health could be achieved if computer advice was shown to be beneficial. OBJECTIVES: To assess whether computer support for drug dosage benefits patients and hence whether it should be more widely available. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register (June 1996), MEDLINE (1966 to June 1996), EMBASE (1980 to June 1996), hand searched the journal Therapeutic Drug Monitoring (1979 to June 1996), reference lists of articles and contacted experts in the field. SELECTION CRITERIA: Randomised trials, interrupted time series and controlled before and after studies of computerised advice on drug dosage. The participants were health professionals responsible for patient care. The outcomes were: any objectively measured change in the behaviour of the health care provider (such as changes in the dose of drug used); any change in the health of patients, resulting from computer support (such as adverse reactions to drugs). DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Fifteen trials involving 1229 patients were included. The drugs studied were theophylline, warfarin, heparin, aminoglycosides, nitroprusside, lignocaine, oxytocin, fentanyl and midazolam. Interventions usually targeted doctors although some studies attempted to influence prescribing by pharmacists and nurses. All included studies took place on acute medical conditions in hospital settings. Although all studies used reliable outcome measures, sample size was often small and only two studies reported a sample size calculation. Computer support for drug dosage gave significant benefits reducing: 1. The time to achieve therapeutic control (standardised mean difference -0.44, 95% CI -0.70 to -0.17); 2. Toxic drug levels (risk difference -0.12, 95% CI -0.24 to -0.01); 3. Adverse reactions (risk difference -0.06, 95% CI -0.12 to 0.00); 4. Length of hospital stay (standardised mean difference -0.32, 95% CI -0.60 to -0.04). There was a tendency for computer support to result in higher doses of drugs, although this did not reach statistical significance. REVIEWER'S CONCLUSIONS: This systematic review provides evidence to support the use of computer assistance in determining drug dosage. Further clinical trials are necessary to determine whether the benefits seen in specialist applications can be realised in general use.
BACKGROUND: Educational meetings and printed educational materials are the two most common types of continuing education for health professionals. An important aim of continuing education is to improve professional practice so that patients can receive improved health care. OBJECTIVES: To assess the effects of educational meetings on professional practice and health care outcomes. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, MEDLINE (from 1966), the Research and Development Resource Base in Continuing Medical Education in January 1999 and reference lists of articles. SELECTION CRITERIA: Randomised trials or well designed quasi-experimental studies examining the effect of continuing education meetings (including lectures, workshops, and courses) on the clinical practice of health professionals or health care outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied inclusion criteria, assessed the quality of each study, and extracted study data. We attempted to collect missing data from investigators. We conducted both qualitative and quantitative analyses. MAIN RESULTS: Thirty-two studies were included with a total of 36 comparisons. The studies involved from 13 to 411 health professionals (total N= 2995) and were judged to be of moderate or high quality, although methods were generally poorly reported. There was substantial variation in the complexity of the targeted behaviours, baseline compliance, the characteristics of the interventions and the results. The heterogeneity of the results was best explained by differences in the interventions. For 10 comparisons of interactive workshops, there were moderate or moderately large effects in six (all of which were statistically significant) and small effects in four (one of which was statistically significant). For interventions that combined workshops and didactic presentations, there were moderate or moderately large effects in 12 comparisons (eleven of which were statistically significant) and small effects in seven comparisons (one of which was statistically significant). In seven comparisons of didactic presentations, there were no statistically significant effects, with the exception of one out of four outcome measures in one study. REVIEWER'S CONCLUSIONS: Interactive workshops can result in moderately large changes in professional practice. Didactic sessions alone are unlikely to change professional practice.
BACKGROUND: Cardiac resynchronisation is a promising new intervention for patients with heart failure, left ventricular systolic dysfunction and ventricular dyssynchrony. OBJECTIVE: The CARE-HF trial is designed to evaluate the long-term effects of cardiac (atrio-bi-ventricular) resynchronisation on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy with ACE inhibitors and beta-blockers (where indicated and tolerated). METHODS AND RESULTS: Approximately 800 patients will be randomised to device therapy or control and followed for a minimum of 18 months. A pragmatic study design has been chosen that does not attempt to conceal allocation from investigators or patients because it is impossible to guarantee maintenance of blinding for the duration of the study. The end-points committee will adjudicate events in a blinded fashion. Since cardiac resynchronisation may alter other aspects of the management of the patient, as would occur in clinical practice, the study should be considered a comparison of strategies rather than simply of a device. The primary end-point is all-cause mortality or unplanned cardiovascular hospitalisation. The study should complete recruitment during 2002 and report in 2004.
OBJECTIVES: To compare the population consenting for a study of the effectiveness of a pharmacist-run medication review clinic with the population not consenting for patients aged over 65 years old with respect to age, sex and number of repeat medicines. To explore the reasons why some patients declined to consent to the study. METHODS: Letters were sent to 2,403 patients aged 65 and over and taking at least one repeat medicine from 4 general practices. If no reply was received to a second letter they were followed up by telephone. If they declined to consent they were asked for their reasons. Data for consenting and non-consenting patients was collected on the stratification factors: age, sex and number of repeat medicines. Multiple logistic regression was used to assess the association of each factor with consent rates. RESULTS: Consenting patients were dissimilar to non-consenting patients. Patients were less likely to consent if they were older, OR (95% CI) = 0.54 (0.46, 0.64), or female, OR (95% CI) = 0.74 (0.63, 0.88). Patients were more likely to consent if on 5 or more repeat medicines: OR (95% CI) = 1.3 (1.1, 1.5). Ten broad categories of reasons why patients did not wish to participate were identified from the patient interviews. CONCLUSIONS: Patients were less likely to give their consent if they were elderly, female and on fewer repeat medicines. A number of administrative and behavioural factors were identified which reduced the chances of informed consent being given. These factors need to be addressed to maximise numbers of consenting patients in medication review studies.
OBJECTIVE: To develop an evidence base for recommendations on the use of atypical antipsychotics for patients with schizophrenia. DESIGN: Systematic overview and meta-regression analyses of randomised controlled trials, as a basis for formal development of guidelines. SUBJECTS: 12 649 patients in 52 randomised trials comparing atypical antipsychotics (amisulpride, clozapine, olanzapine, quetiapine, risperidone, and sertindole) with conventional antipsychotics (usually haloperidol or chlorpromazine) or alternative atypical antipsychotics. MAIN OUTCOME MEASURES: Overall symptom scores. Rate of drop out (as a proxy for tolerability) and of side effects, notably extrapyramidal side effects. RESULTS: For both symptom reduction and drop out, there was substantial heterogeneity between the results of trials, including those evaluating the same atypical antipsychotic and comparator drugs. Meta-regression suggested that dose of conventional antipsychotic explained the heterogeneity. When the dose was </=12 mg/day of haloperidol (or equivalent), atypical antipsychotics had no benefits in terms of efficacy or overall tolerability, but they still caused fewer extrapyramidal side effects. CONCLUSIONS: There is no clear evidence that atypical antipsychotics are more effective or are better tolerated than conventional antipsychotics. Conventional antipsychotics should usually be used in the initial treatment of an episode of schizophrenia unless the patient has previously not responded to these drugs or has unacceptable extrapyramidal side effects.
OBJECTIVE: To estimate the costs and consequences of diagnosing symptomatic heart failure with left ventricular systolic dysfunction and initiating angiotensin converting enzyme inhibitors in primary care. DESIGN: Analysis of individual patient data from studies of left ventricular dysfunction (SOLVD) to identify complications during test dose and titration phases. SETTING: Two randomised controlled trials in secondary care. PARTICIPANTS: 7487 patients taking a test dose of enalapril at enrolment to the treatment and prevention trials; 2569 patients with clinical signs of heart failure and established left ventricular dysfunction entered the treatment trial. MAIN OUTCOME MEASURES: Discontinuation during the test dose period. Discontinuation or reduction of dose during the first year of treatment for heart failure. Costs of diagnosis and titration of treatment. RESULTS: During the test dose phase, 585 patients (7.8%) reported side effects; 136 (1.8%) of these discontinued because of severe side effects. During the titration phase, compared with placebo, enalapril was associated with an increased risk of dose reduction due to hypotension (odds ratio 2.09, 95% confidence interval 1.15 to 3.82). However, overall, there was no difference in the rates of side effects leading to dose reduction or withdrawal between the enalapril and placebo groups. The costs of diagnosing heart failure with left ventricular systolic dysfunction and initiating and titrating an angiotensin converting enzyme inhibitor in primary care are pound300 to pound400. CONCLUSIONS: Treatment with angiotensin converting enzyme inhibitors can be safely started for patients with heart failure and left ventricular systolic dysfunction in primary care.
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BACKGROUND: Both the theory of diffusion of innovations and the social influences model of behaviour change suggest that using local opinion leaders to transmit norms and model appropriate behaviour may improve health professional practice. OBJECTIVES: To assess the effects using local opinion leaders on the practice of health professionals or patient outcomes. SEARCH STRATEGY: We searched MEDLINE to May 1998, the Research and Development Resource Base in Continuing Medical Education, and reference lists of related systematic reviews and articles. SELECTION CRITERIA: Randomised trials of the use of local opinion leaders (defined as health professionals nominated by their colleagues as being educationally influential). The participants were health care professionals responsible for patient care. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Eight studies were included involving more than 296 health professionals. A variety of patient problems were targeted, including acute myocardial infarction, cancer pain, osteoarthritis, rheumatoid arthritis, chronic lung disease, vaginal birth after caesarean section, labour and delivery, and urinary catheter care. Six of seven trials that measured health professional practice demonstrated some improvement for at least one outcome variable, and in two trials, the results were statistically significant and clinically important. In three trials that measured patient outcomes, only one achieved an impact upon practice that was of practical importance: local opinion leaders were effective in improving the rate of vaginal birth after previous caesarean section. REVIEWER'S CONCLUSIONS: Using local opinion leaders results in mixed effects on professional practice. However, it is not always clear what local opinion leaders do and replicable descriptions are needed. Further research is required to determine if opinion leaders can be identified and in which circumstances they are likely to influence the practice of their peers.
BACKGROUND: It is often assumed that merely providing information in an accessible form will influence practice. Although such a strategy is still widely used in an attempt to change behaviour, there is a growing awareness that simply providing information may not lead to appropriate changes in the practice of health care professionals. OBJECTIVES: To assess the effects of printed educational materials in improving the behaviour of health care professionals and patient outcomes. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, reference lists of articles, and contacted content area experts. SELECTION CRITERIA: Randomised trials, interrupted time series analyses and non equivalent group designs with pre-post measures of interventions comparing 1. Printed educational materials versus a non-intervention control; and 2. Printed educational materials plus additional implementation strategies versus printed educational materials alone. The participants were any health care professionals provided with printed educational materials aimed at improving their practice and/or patient outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Eleven studies were included involving more than 1848 physicians. It proved impractical to examine the impact of interventions quantitatively because of poor reporting of results and inappropriate primary analyses. Nine studies examined comparison 1. Estimates of the benefit from printed educational materials ranged from -3% to 243.4% for provider outcomes, and from -16.1% to 175.6% for patient outcomes, although the practical importance of these changes is, at best, small. Six studies (seven comparisons) examined comparison 2. Benefits attributable to additional interventions ranged from -11.8% to 92.7% for professional behaviour, and -24.4% to 74.5% for patient outcomes. Two of the 14 estimates of professional behaviour, and two of the 11 estimates of patient outcomes were statistically significant. REVIEWER'S CONCLUSIONS: The effects of printed educational materials compared with no active intervention appear small and of uncertain clinical significance. These conclusions should be viewed as tentative due to the poor reporting of results and inappropriate primary analyses. The additional impact of more active interventions produced mixed results. Audit and feedback and conferences/workshops did not appear to produce substantial changes in practice; the effects in the evaluations of educational outreach visits and opinion leaders were larger and likely to be of practical importance. None of the studies included full economic analyses, and thus it is unclear to what extent the effects of any of the interventions may be worth the costs involved.
BACKGROUND: Audit and feedback has been identified as having the potential to change the practice of health care professionals. OBJECTIVES: To assess the effects of audit and feedback on the practice of health professionals and patient outcomes. SEARCH STRATEGY: We searched MEDLINE up to June 1997, the Research and Development Resource Base in Continuing Medical Education, and reference lists of related systematic reviews and articles. SELECTION CRITERIA: Randomised trials of audit and feedback (defined as any summary of clinical performance of health care over a specified period of time). The participants were health care professionals responsible for patient care. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Thirty-seven studies were included, involving more than 4977 physicians. The reporting of study methods was inadequate for almost all studies. In 31 out of 37 studies the randomisation process could not be determined. Information regarding data analysis was also lacking. For example, power calculations were not mentioned in 27 out of 37 studies. A variety of behaviours were targeted including the reduction of diagnostic test ordering, prescribing practices, preventive care, and the general management of a problem, for example hypertension. Twenty-eight studies measured physician performance, one study targeted patient outcomes in diabetes and the remaining eight studies measured both physician performance and patient outcomes. The relative percentage differences ranged from -16% to 152%. The clinical importance of the changes was not always clear. REVIEWER'S CONCLUSIONS: Audit and feedback can sometimes be effective in improving the practice of health care professionals, in particular prescribing and diagnostic test ordering. When it is effective, the effects appear to be small to moderate but potentially worthwhile. Those attempting to enhance professional behaviour should not rely solely on this approach.
BACKGROUND: Audit and feedback has been identified as having the potential to change the practice of health care professionals. OBJECTIVES: To assess the effects of audit and feedback compared with other interventions in changing health professional practice and to assess whether the effectiveness of audit and feedback can be improved by modifying how it is done. SEARCH STRATEGY: We searched MEDLINE up to June 1997, the Research and Development Resource Base in Continuing Medical Education, and reference lists of related systematic reviews and articles. SELECTION CRITERIA: Randomised trials of audit and feedback (defined as any summary of clinical performance of health care over a specified period of time) compared with other interventions. The participants were health care providers responsible for patient care. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Twelve studies were included involving more than 2194 physicians. Seven trials with direct comparisons were included. The targeted behaviours were the management of low haemoglobin, the delivery of preventive care services (two studies), the management of high cholesterol, the performance of cervical smears, and the ordering of diagnostic tests (two studies). From the results of four trials, there is little evidence of a measurable effect of adding a complementary intervention such as a local consensus process to audit and feedback compared to audit and feedback alone. Two of three trials that compared audit and feedback to reminders reported that reminders were more effective in improving the delivery of some preventive services. REVIEWER'S CONCLUSIONS: It is not possible to recommend a complementary intervention to enhance the effectiveness of audit and feedback. Reminders might be more effective than audit and feedback to improve the delivery of some preventive services but the results are not striking. Few trials have investigated the effect of varying different characteristics of the audit and feedback process. Consideration should be given to testing the effects of modifying important characteristics such as the content, source, timing, recipient and format.
BACKGROUND: The mass media frequently cover health related topics, are the leading source of information about important health issues, and are targeted by those who aim to influence the behaviour of health professionals and patients. OBJECTIVES: To assess the effects of mass media on the utilisation of health services. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, MEDLINE, EMBASE, Eric, PsycLit, and reference lists of articles. We hand searched the journals Communication Research (February 1987 to August 1996), European Journal of Communication (1986 to 1994), Journal of Communication (winter 1986 to summer 1996), Communication Theory (February 1991 to August 1996), Critical Studies in Mass Communication (March 1984 to March 1995) and Journalism Quarterly (1986 to summer 1996). SELECTION CRITERIA: Randomised trials, controlled clinical trials, controlled before-and-after studies and interrupted time series analyses of mass media interventions. The participants were health care professionals, patients and the general public. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Seventeen studies were included. All used interrupted time series designs. Fourteen evaluated the impact of formal mass media campaigns, and three of media coverage of health related issues. The overall methodological quality was variable. Six studies did not perform any statistical analysis, and seven used inappropriate statistical tests (ie not taking into account the effect of time trend). All of the studies apart from one concluded that mass media was effective. These positive findings were confirmed by our re-analysis in seven studies. The direction of effect was consistent across studies towards the expected change. The pooled effect sizes for studies assessing the impact of mass media on similar aspects of care revealed an effect upon the utilisation of health services that could not be explained by chance alone, ranging from -1.96 (95%CI -1. 19 to -2.73) for campaigns promoting immunisation programmes, to -1. 12 (95%CI -0.49 to -2.36) for those concerning cancer screening. REVIEWER'S CONCLUSIONS: Despite the limited information about key aspects of mass media interventions and the poor quality of the available primary research, there is evidence that these channels of communication may have an important role in influencing the use of health care interventions. Those engaged in promoting better uptake of research information in clinical practice should consider mass media as one of the tools that may encourage the use of effective services and discourage those of unproven effectiveness.
BACKGROUND: Outreach visits have been identified as an intervention that may improve the practice of health care professionals, in particular prescribing. This type of 'face to face' visit has been referred to as university-based educational detailing, public interest detailing, and academic detailing. OBJECTIVES: To assess the effects of outreach visits on improving health professional practice or patient outcomes. SEARCH STRATEGY: We searched MEDLINE up to March 1997, the Research and Development Resource Base in Continuing Medical Education, and reference lists of related systematic reviews and articles. SELECTION CRITERIA: Randomised trials of outreach visits (defined as a personal visit by a trained person to a health care provider in his or her own setting). The participants were health care professionals. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Eighteen studies were included involving more than 1896 physicians. All of the outreach visit interventions consisted of several components, including written materials and conferences. Reminders or audit and feedback complemented some visits. In 13 studies, the targeted behaviours were prescribing practices. In three studies, the behaviours were preventive services, including counselling for smoking cessation. In two studies, the outreach visits were directed toward improving the general management of common problems encountered in general practice, including asthma, diabetes, otitis media, hypertension, anxiety, and acute bronchitis. All studies examined physician behaviour and in three studies other health professionals such as nurses, nursing home attendants or health care workers were targeted. Positive effects on practice were observed in all studies. Only one study measured a patient outcome. Few studies examined the cost effectiveness of outreach. REVIEWER'S CONCLUSIONS: Educational outreach visits, particularly when combined with social marketing, appear to be a promising approach to modifying health professional behaviour, especially prescribing. Further research is needed to assess the effects of outreach visits for other aspects of practice and to identify key characteristics of outreach visits that are important to its success. The cost-effectiveness of outreach visits is not well evaluated.
OBJECTIVES: To examine the relative efficacy of selective serotonin reuptake inhibitors (SSRIs) compared to other antidepressants. SEARCH STRATEGY: The search strategy included a search of (a) Electronic bibliographic databases (MEDLINE, EMBASE); (b) reference lists of related reviews (c) reference lists of all located studies (d) contact with the manufacturer and (e) the Cochrane Group register of controlled trials SELECTION CRITERIA: Randomised controlled trials comparing selective serotonin reuptake inhibitors with other kinds of antidepressants in the treatment of patients with depressive disorders. The outcome measures assessed included measures of the severity of depression. DATA COLLECTION AND ANALYSIS: Data were collected from each study the main outcome measurefrom each study. These included: mean Hamilton depression rating scale, mean Montgomery & Asberg depression rating scale, Clinical Global Impression rating scale. An analysis of standardised mean difference of these scales was performed using Review Manager 3. 1 software. The presence of heterogeneity of treatment effect was assessed MAIN RESULTS: Ninety-eight trials contributed data to the analysis of the relative efficacy of SSRIs and related drugs with comparator antidepressants (Figure 3 & Appendix 3). Analysis of efficacy was based upon 5044 patients treated with an SSRI or related drug, and 4510 treated with an alternative antidepressant. The standardised effect size for SSRIs and related drugs together versus alternative antidepressants using a fixed effects model was 0. 035 (95% CI -0.006 to 0.076; Q = 149.25, df = 97, p < 0.001). REVIEWER'S CONCLUSIONS: There are no clinically significant differences in effectiveness between selective serotonin reuptake inhibitors and tricyclic antidepressants. Treatment decisions need to be based on considerations of relative patient acceptability, toxicity and cost.
BACKGROUND: Selective serotonin reuptake inhibitors are thought to have better discontinuation rates (i.e. less people dropping out) than tricyclic and heterocyclic antidepressant drugs. It is important to quantify the drop-out rates of different antidepressant drugs in order to have a better understanding of the relative tolerability of these drugs. OBJECTIVES: To assess the comparative tolerability of selective serotonin reuptake inhibitors and tricyclic/heterocyclic antidepressant drugs. SEARCH STRATEGY: We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Registers (1997 to 1999), MEDLINE (1966 to 1999), EMBASE (1974 to 1999) We also searched specialist journals, the reference lists of relevant papers and previous systematic reviews, conference abstracts and government documents. Representatives of the pharmaceutical industry were contacted. SELECTION CRITERIA: Parallel group randomised controlled trials comparing selective serotonin reuptake inhibitors with tricyclic or heterocyclic antidepressants in people with depression. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and a third reviewer checked any cases of disagreement. MAIN RESULTS: We included 136 trials. The selective serotonin reuptake inhibitors showed less participants dropping out compared to the tricyclic/heterocyclic group (odds ratio 1.21, 95% confidence interval 1.12 to 1.30). A statistically significant difference was found in total drop-outs between the selective serotonin reuptake inhibitors and the old tricyclics as well as the newer tricyclics. When the selective serotonin reuptake inhibitors were compared to the heterocyclic antidepressants, there was a non significant difference favouring the selective serotonin reuptake inhibitors. The poor tolerability profile of the old tricyclics was explained by differences in drop-outs for side-effects, but not for inefficacy. REVIEWER'S CONCLUSIONS: Whilst selective serotonin reuptake inhibitors do appear to show an advantage over tricyclic drugs in terms of total drop-outs, this advantage is relatively modest. This has implications for pharmaco-economic models, some of which may have overestimated the difference of drop-out rates between selective serotonin reuptake inhibitors and tricyclic antdepressants. These results are based on short-term randomised controlled trials, and may not generalise into clinical practice.