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Biomedical subjects

A Liberati

Publications and source records attributed to A Liberati.

At least 37 records · Page 2Linked to original sources
PubMed2000

Follow-up strategies for women treated for early breast cancer.

BACKGROUND: Follow-up examinations are commonly performed after primary treatment for women with breast cancer. They are used to detect recurrences at an early (asymptomatic) stage. OBJECTIVES: To assess the effectiveness of different policies of follow-up for distant metastases on mortality, morbidity and quality of life in women treated for early breast cancer. SEARCH STRATEGY: We searched the Breast Cancer Groups specialised register, the Cochrane Controlled Trials Register ( Cochrane Library Issue 4, 1999), MEDLINE (January 1975-September 1999) and EMBASE (1988-September 1999) using "Breast Neoplasms" and "follow-up". References from retrieved articles were also checked, as were the lists of presentations from recent breast cancer meetings. SELECTION CRITERIA: All randomised controlled trials (RCTs) assessing the effectiveness of different policies of follow-up after primary treatment were reviewed for inclusion. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and eligibility for inclusion in the review. Data were pooled in an individual patient data meta-analysis for the two RCTs testing the effectiveness of different follow-up schemes. Subgroup analyses by age, tumour size and lymph node status before primary treatment are also presented. MAIN RESULTS: Four RCTs involving 3204 women with early breast cancer (clinical stage I, II or III) have been included. Two RCTs involving 2563 women compared follow-up based on clinical visits and mammography with a more intensive scheme including radiological and laboratory tests. After pooling the data, no significant differences in overall survival (hazard ratio 0.96, 95% confidence interval 0.80 to 1.15) or disease-free survival (hazard ratio 0.84, 95% confidence interval 0.71 to 1.00) emerged. No differences in overall survival and disease-free survival emerged in subgroup analyses according to patient age, tumour size and lymph node status before primary treatment. One RCT (296 women) compared follow-up performed by a hospital-based specialist to follow-up performed by general practitioners. No significant differences in time to detection of recurrence and quality of life emerged. One RCT (196 women) compared regularly scheduled follow-up visits to less frequent visits restricted to the time of mammography. No significant differences emerged in interim use of telephone and frequency of GP's consultations. REVIEWER'S CONCLUSIONS: Follow-up programs based on regular physical examinations and yearly mammography alone appear to be as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life. In one RCT, follow up care performed by general practitioners had comparable effectiveness to that delivered by hospital based specialists in terms of quality of life and time to detection of distant metastases.

Breast Neoplasms↗
PubMed2000

Antibiotic prophylaxis in intensive care units: meta-analyses versus clinical practice.

OBJECTIVE: At least 7 meta-analyses (MA) have been published since 1991 on the effectiveness of antibiotic prophylaxis in Intensive care units (ICU) patients, but controversy still remains about the overall effectiveness and risk-benefits profile of the treatment. This paper aims to summarise available data on effectiveness and discuss reasons why the controversy is still open and possible directions for future research. DESIGN: Review of available published MA on the effectiveness of various regimens of antibiotic prophylaxis with particular emphasis on the results of the individual patient data analysis published in 1998. SETTING: MA or randomised control trials (RCTs), published and unpublished, conducted anywhere in the world. PATIENTS AND PARTICIPANTS: Unselected adult ICU populations included in studies, published and unpublished, comparing different forms of antibiotic prophylaxis. MAIN OUTCOME MEASURE: Respiratory tract infections (RTIs) - however defined in individual studies - and total mortality. DATA SOURCES: General information from the 7 MAs published between 1991 and 1999 and detailed information from the MA published in the British Medical Journal in 1998 that reported data on 5727 patients enrolled in 33 RCTs; access to individual patients data could be obtained from 25 of 33 RCTs and allowed a confirmatory individual patient MA on 4343 patients. RESULTS: Pooled estimates from 16 RCTs (including 3361 patients) testing the effect of the topical and systemic antibiotic combination indicates a significant reduction of both RTIs (OR=0.35, 95% CI=0.29-0.41) and total mortality (OR=0.80, 95% CI=0.69-0.93). Five and 23 patients need to be treated to prevent one infection and one death, respectively, using this treatment. Pooled data from the 17 RCTs (including 2366 patients) testing the effect of a regimen based on topical antimicrobials indicated a statistically significant reduction in RTIs (OR=0.57, 95% CI=0.46-0.69) but not in total mortality (OR=1.01; 95% CI=0.84-1.22). Individual patient data analyses confirmed these results. CONCLUSIONS: After over 30 RCTs and seven MAs, there is strong evidence that antibiotic prophylaxis can reduce both RTIs and total mortality in ICUs patients in a statistically and clinically significant way. Concerns about the possible occurrence of antimicrobial resistance are not supported by available data but cannot, at the same time, be ruled out due to methodologic inadequacies of the studies carried out so far. Whether new trials are needed, and how they should be designed to answer the question of the potential for antibiotic resistance following widespread use of the treatment, are now the main issues to be settled. Convening an international panel of clinical experts and methodologists could be appropriate, in order to explore the best way to resolve the controversy that seems to be preventing the widespread use of a treatment that the best analysis of available data now indicates is effective.

Administration, Topical↗
PubMed2000

What contributions do languages other than English make on the results of meta-analyses?

Including only a portion of all available evidence may introduce systematic errors into the meta-analytic process and threaten its validity. We set out to examine whether language restricted meta-analyses, compared to language inclusive meta-analyses, provide different estimates of the effectiveness of interventions evaluated in randomized trials. We identified and retrieved all 79 meta-analyses from several disease areas in which explicit eligibility criteria regarding trial selection were reported. General characteristics and quality of reporting of the meta-analyses were assessed using a validated instrument. We explored the effects of language of publication of the randomized trials on the quantitative results using logistic regression analyses. Language restricted meta-analyses, compared to language inclusive meta-analyses, did not differ with respect to the estimate of benefit of the effectiveness of an intervention (ROR = 0.98; 95% CI: 0.81-1.17). These results were also robust after a series of sensitivity analyses. This study provides no evidence that language restricted meta-analyses lead to biased estimates of intervention effectiveness. We encourage others to replicate this study using different sampling frames, clinical topics and interventions.

Humans↗
PubMed2000

Functional status in patients with spinal cord injury: a new standardized measurement scale. Gruppo Interdisciplinare Valutazione Interventi Riabilitativi.

OBJECTIVE: To report on the validation process of a new functional assessment scale (Valutazione Funzionale Mielolesi [VFM]) for patients with spinal cord injury (SCI). DESIGN: Prospective study testing for the VFM in a sample of patients with SCI to evaluate the scale characteristics in terms of psychometric and clinical validity. SETTING: Eight SCI units located in northern Italy. PATIENTS: One hundred patients were recruited and followed up for 18 months. Seventy-seven subjects were men, subjects' mean age was 37 years, 67 were paraplegic, and for 81 their SCI was of traumatic etiology. MAIN OUTCOME MEASURES: VFM's characteristics are described using estimates of construct and criterion validity (estimates of the strength and direction of associations between different VFM tasks and between VFM and other medical and nonmedical variables). The Barthel index was used as concurrent and independent measure. RESULTS: VFM met all psychometric criteria usually recommended and, at least in the current sample, was found to be strongly correlated with independent clinical variables (diagnosis and lesion level) and with the Barthel index. Moreover, most of the domains were able to document large and significant changes over time. CONCLUSIONS: VFM is a reliable and valid tool that can be used confidently in the rehabilitation setting for patients with SCI to screen for functional problems and monitor changes in patients' functional status and impact of rehabilitation.

Activities of Daily Living↗
PubMed1999

A European version of the Appropriateness Evaluation Protocol. Goals and presentation. The BIOMED I Group on Appropriateness of Hospital Use.

This paper describes the development and testing of a European version of the Appropriateness Evaluation Protocol (AEP). It stemmed from the original U.S. version and the multiple adaptations and modifications made previously and separately by researchers in European countries. The group was particularly concerned with developing a common list of reasons for inappropriate admissions and days of stay, since the principal goal was to enable an understanding of inappropriate hospital use and potential solutions within local health and social care systems. Developing a common EU-AEP included several steps. First, each national instrument was translated from the national language to English. These back translations were compared with each other and with the US-AEP. A working group analyzed the content of the lists of reasons published in the literature and proposed a novel conceptual approach. On the basis of workshop discussions, a draft of a common European version was circulated to each participant for agreement. In the EU-AEP, the clinical criteria for the appropriateness of admission include 10 related to patient condition and five to clinical services. The criteria for the appropriateness of days of care include 10 covering medical services, six for life support/nursing services, and eight related to patient condition. The proposed core list of reasons of inappropriateness distinguish clearly between two concepts: a) the level of care required by the patient; and b) the reason why this level of care was not used. The first list would thus refer to the nature of resources and facilities required, while the second would focus more on the efficient organization of those resources. A validated European tool to assess inappropriate hospital admissions and hospital days of stay and their causes might be used to assess the need for resources for inpatient care as well as for outpatient care. Assessing the reasons for inadequacies might lead also to the examination of organizational questions. Finally, a common tool allows comparisons between countries concerning the frequency of inappropriate admissions and days of stay and their reasons in relation to the different organizations of health care across Europe.

Clinical Protocols↗
PubMed1999

Quality of life in women with recurrent breast cancer.

Although the psychosocial concomitants of early-stage breast cancer have been well-documented, the relationship between cancer recurrence and quality of life remains less clear. We conducted a prospective, longitudinal study in order to clarify the relationship between recurrent cancer and quality of life, and to determine predictors of quality of life following recurrence. Sixty-nine women with recurrent breast cancer completed questionnaires assessing multiple components of quality of life at three time points: prior to recurrence, immediately after the diagnosis of recurrence, and at follow-up 6 months later. Perceptions of overall quality of life, general health status, emotional, social, and physical functioning were poorer immediately following the diagnosis of recurrence than they had been prior to recurrence. These women also evidenced significant improvement in several domains of quality of life between initial recurrence and follow-up; nonetheless, most areas of quality of life were impaired compared to pre-recurrence. Self-reported physical symptoms were a strong predictor of post-recurrence ratings of overall quality of life. These data suggest that the recurrence of breast cancer is associated with significant changes in quality of life. Quality of life did not progressively deteriorate, however, attesting to the resilience of women coping with this major stressor. These data shed light on issues of potential importance to patients managing this serious illness and may have implications for health-care professionals working with this population.

Aged↗
PubMed1999

Reliability study of the European appropriateness evaluation protocol.

OBJECTIVE: To help to co-ordinate and harmonize research on utilization review in Europe, the US Appropriateness Evaluation Protocol (f¿EP) was adapted for use in the European setting. The aim of this paper is to assess the reliability of the European version of the AEP (EU-AEP). DESIGN: Nineteen English-language medical records were reviewed by a physician reviewer from each of six participating countries: Austria, France, Italy, Spain, Switzerland and the UK. Each of the six reviewers was asked to assess the appropriateness of the 19 admissions and 31 hospitalization days (19 admission days and 12 randomly selected days of hospital stay, excluding days of discharge) using the revised review instrument. To evaluate inter-rater reliability, the kappa statistic was used to measure overall and pair-wise agreement for the assessment of appropriateness of admission and of day of care, respectively. RESULTS: For admission, the overall kappa statistic among the six reviewers was 0.64, with kappa values for each pair of reviewers in the range 0.46-0.86. For day of care, the kappa was 0.59, with pair-wise kappa coefficients in the range 0.25-0.95. CONCLUSION: The observed agreement could be considered substantial, especially if the fact that medical records were hand-written in a language native to only one of the reviewers is considered. Besides all the study limitations, this finding provides at least preliminary support for the application of the EU-AEP as a reliable instrument in the European setting, including application in comparative studies involving two or more countries.

Europe↗
PubMed1999

Evidence-based medicine and its horizons: a useful tool for nephrologists?

Though the concept of 'evidence-based medicine' (EBM) nowadays has become very popular and even fashionable, its practice is far from being an established reality. There are many reasons why, despite its potential, EBM finds obstacles in expressing its full potential as a tool to better inform health care decisions. Broadly speaking, these obstacles fall into three categories: (i) inadequacy of available information with respect the complexities of health care delivery; (ii) poor quality of clinical research; and (iii) insufficient and inappropriate efforts to promote the uptake of effective interventions in clinical practice. In the first part of the paper, we will discuss: (i) what evidence-based medicine is; (ii) why systematic reviews are the fundamental tool of EBM and what is really special about them; (iii) what are the tools for the practice of EBM; (iv) what its limitations are; and (v) what are the hindrances to its implementation. In the second part, a brief assessment of the state of the art of systematic reviews in nephrology will be presented, with special reference to the activities of the recently launched Cochrane Collaborative Review Group in Renal Diseases.

Evidence-Based Medicine↗
PubMed1998

Effectiveness of antibiotic prophylaxis in critically ill adult patients: systematic review of randomised controlled trials.

OBJECTIVE: To determine whether antibiotic prophylaxis reduces respiratory tract infections and overall mortality in unselected critically ill adult patients. DESIGN: Meta-analysis of randomised controlled trials from 1984 and 1996 that compared different forms of antibiotic prophylaxis used to reduce respiratory tract infections and mortality with aggregate data and, in a subset of trials, data from individual patients. SUBJECTS: Unselected critically ill adult patients; 5727 patients for aggregate data meta-analysis, 4343 for confirmatory meta-analysis with data from individual patients. MAIN OUTCOME MEASURES: Respiratory tract infections and total mortality. RESULTS: Two categories of eligible trials were defined: topical plus systemic antibiotics versus no treatment and topical preparation with or without a systemic antibiotic versus a systemic agent or placebo. Estimates from aggregate data meta-analysis of 16 trials (3361 patients) that tested combined treatment indicated a strong significant reduction in infection (odds ratio 0.35; 95% confidence interval 0.29 to 0.41) and total mortality (0.80; 0.69 to 0.93). With this treatment five and 23 patients would need to be treated to prevent one infection and one death, respectively. Similar analysis of 17 trials (2366 patients) that tested only topical antibiotics indicated a clear reduction in infection (0.56; 0.46 to 0.68) without a significant effect on total mortality (1.01; 0.84 to 1.22). Analysis of data from individual patients yielded similar results. No significant differences in treatment effect by major subgroups of patients emerged from the analyses. CONCLUSIONS: This meta-analysis of 15 years of clinical research suggests that antibiotic prophylaxis with a combination of topical and systemic drugs can reduce respiratory tract infections and overall mortality in critically ill patients. This effect is significant and worth while, and it should be considered when practice guidelines are defined.

Administration, Topical↗
PubMed1998

Practice guidelines: a more rational approach to diagnosis and treatment and a more effective use of health care resources.

Practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. The implementation of practice guidelines is justified by factors such as variations in clinical practice, malpractice and its associated costs, and the need to contain health care expenditures. In this context, practice guidelines promote a more rational approach to clinical decision making and better quality of care. Although there are several limitations to the use of guidelines in current practice, different organizations (professional societies, government agencies, licensing authorities, educational institutions) have a potential interest in their development. A working group on the development of practice guidelines endorsed by the Italian Society of Neurology has been active since 1995. The aims of this group include the development of guidelines to be accepted by the medical community and to be placed within the framework of initiatives of the Italian Ministry of Health.

Health Care Costs↗
PubMed1998

Promoting consumers' demand for evidence-based medicine.

The widespread implementation of rationing and priority-setting policies in health care opposes the stochastic practice of medicine induced by professional uncertainty and professional vested interests in market-oriented clinical environments. It also clashes with consumers' overly optimistic and "mythical" view of the effectiveness of medicine, which is bound to support a potentially unlimited provision of health services. Thus, for consumers and society at large, it is necessary to create conditions favorable for a more conscious demand of evidence-based health care. In pursuit of this goal, we suggest the adoption of a community-oriented strategy based upon delivery of information to the public in order a) to generate greater awareness ("healthy skepticism") among consumers, through disclosure of data on the true effectiveness of health care interventions and on the existing variation in their utilization, and b) to provide tools to empower consumers in dealing better with both the uncertainty in their own individual patient-physician relationships and with the health policy issues to be faced in the future. Such a community-oriented strategy could also reinforce and support, through the generation of a "bottom-up" pressure from consumers toward physicians, a wider adoption of evidence-based interventions by health care professionals. This paper, using data from surveys on public opinions and attitudes toward the practice of medicine, focuses on how consumer demand for more evidence-based medical practice can be promoted.

Consumer Advocacy↗
PubMed1998

Do specialists do it better? The impact of specialization on the processes and outcomes of care for cancer patients.

OBJECTIVE: To assess the impact of specialization on processes and outcomes of care for cancer patients. DATA SOURCE: Papers published in English between 1980 and 1995 and identified through MEDLINE and Embase (MeSH terms: NEOPLASM (exploded), and PHYSICIAN PRACTICE PATTERNS (or DECISION MAKING, ATTITUDE OF HEALTH PERSONNEL, QUALITY OF HEALTH CARE, DELIVERY OF HEALTH CARE, HEALTH EDUCATION or OUTCOME ASSESSMENT HEALTH CARE), or through the reference lists of review articles. STUDY SELECTION: Studies providing information on the association between quality of care indicators for cancer patients and clinician/centre degree of specialization. A total of 47 papers concerning 46 empirical studies were considered. DATA EXTRACTION: For studies using process of care indicators, the proportion of specific procedures performed by specialists and non-specialists was abstracted. For studies using outcome indicators (e.g., mortality), the effect of specialization was quantified in terms of odds ratio (OR) expressing relative reduction in risk of death. The quality of individual studies using process or outcome indicators was assessed according to study design, avoidance of selection bias in patient identification and data analysis, degree of adjustment of the comparison between clinicians/centres with different levels of specialization. DATA SYNTHESIS: Specialized centres/clinicians fared better both when process and outcome indicators were used. While the former varied widely in different studies and their clinical relevance was often questionable, mortality was consistently lower when care was provided by specialized centres/clinicians, with the effect size being greater in smaller studies. For breast cancer, where all the studies were of sufficiently good quality, a pooled estimate of the effect of specialization was performed which showed that specialized cancer care was associated with an 18% (95% CI: 12%-23%) reduction in mortality. CONCLUSIONS: Despite the fact that care provided by specialized centres/clinicians appeared to be better both when assessed in relation to process indicators and to mortality, this evidence should be considered far from conclusive because of major methodological flaws in these studies. Relative to current efforts to promote evidence-based policy-making, this review underscores the limited capability of scientific information to provide reliable guidelines for structuring better health care systems.

Confidence Intervals↗
PubMed1998

Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women.

PURPOSE: A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of medical treatment for metastatic breast cancer. METHODS: RCTs published between 1975 and 1997 have been classified according to 12 therapeutic comparisons: (1) polychemotherapy (PCHT) agents versus single agent; (2) PCHT regimens with anthracycline versus PCHT without anthracycline; (3) other PCHT versus cyclophosphamide, methotrexate, and fluorouracil (CMF); (4) chemotherapy (CHT) with epirubicin versus CHT with doxorubicin; (5) CHT versus same CHT delivered with less intensive schedules; (6) other endocrine therapy (OET) versus tamoxifen; (7) OET plus tamoxifen versus tamoxifen alone; (8) OET versus medroxyprogesterone; (9) OET versus aromatase inhibitors; (10) OET versus megestrol; (11) endocrine therapy (ET) versus same ET at lower doses; and (12) CHT plus ET versus CHT. Tumor response rates, mortality hazards ratio (HR) and frequency of severe side effects were the outcome measures. RESULTS: A total of 189 eligible trials (31,510 patients) were identified. All provided response rates and 133 (70%) data or survival curves needed for calculation of the HR. In eight of 12 comparisons, statistically significant differences for response emerged (1, 2, 3, 5, 7, 8, 11, 12); all but no. 8 favored the first term of the comparison. Overall survival analysis showed better results of (a) PCHT versus single-agent CHT (HR=0.82; 95% confidence interval [CI], 0.75 to 0.90); (b) CHT with doxorubicin versus CHT with epirubicin (HR=1.13; 95% CI, 1.00 to 1.27); (c) CHT versus the same CHT delivered with less intensive schedules (HR=0.90; 95% CI, 0.83 to 0.97); (d) ET versus the same ET at lower doses (HR=0.86; 95% CI, 0.77 to 0.97). Quality of life was measured in only 2,995 of 31,510 patients (9.5%). CONCLUSION: Despite some evidence of effectiveness of specific regimens, the relevance of these findings is limited by the modest survival benefit and the lack of evaluation of the quality-of-life impact of these treatments.

Antibiotics, Antineoplastic↗