PubMed Health⌕ Search

Biomedical subjects

G Apolone

Publications and source records attributed to G Apolone.

At least 55 records · Page 3Linked to original sources

Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients.

BACKGROUND: Despite the large amount of data available about the EORTC QLQ-C30 questionnaire, there have been very few studies focussed on long-survival cancer patients, and no data are available on its performance in the Italian setting. PATIENTS AND METHODS: Within the framework of a project aimed at evaluating the characteristics of available HR-QOL questionnaires in the Italian language, the EORTC QLQ-C30 questionnaire together with the Short Form 36-item Health Survey (SF-36) were mail-administered to a sample of patients previously recruited in two large multicenter randomized clinical trials on early breast and colon cancers. The properties of the questionnaire were evaluated using standard psychometric techniques and correlation analyses with demographic and clinical independent variables. RESULTS: In the sample of patients who sent back the questionnaires under evaluation, the EORTC QLQ-C30 showed satisfactory acceptability (response rate = 64% and very low prevalence of missing at item and scale level), and the psychometric analyses confirmed the multi-dimensional conceptualisation in terms of convergent and discriminant validity. Moreover, EORTC QLQ-C30 scales showed substantial correlation with the homologous SF-36 scales. Few socio-demographic (age, gender, schooling) and clinical (type of cancer disease) variables were associated with HR-QOL. Breast cancer patients reported, on average, worse physical health-related scores, but after adjustment for age and education, most of the differences disappeared. CONCLUSIONS: These findings confirm the validity and robustness of the EORTC QLQ-C30 in this sample of long-survival Italian cancer patients. Further ad hoc validation studies are required to evaluate its significance in these particular patients.

Adult↗

Pediatric risk of mortality: an assessment of its performance in a sample of 26 Italian intensive care units.

OBJECTIVE: To assess the validity of the Pediatric Risk of Mortality (PRISM) scoring system in accurately predicting the probability of mortality in an Italian intensive care unit (ICU) sample. DESIGN: Prospective, observational, multicenter study. SETTING: Twenty-six Italian ICUs classified into two groups: a) ICUs specifically dedicated to treating pediatric patients; and b) adult ICUs treating children on a regular basis. PATIENTS: Consecutive patients (n = 1,533) <15 yrs of age admitted during 1 yr. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: To assess the performance of the PRISM scoring system, the discrimination and calibration measures were adopted both in the whole population and in 12 preselected subgroups. A good discrimination capability of the scoring system was observed for both the whole population and subgroups (areas under the receiver operating characteristic curves were never <0.82). On the other hand, we documented an unsatisfactory calibration capability in the whole population and in most subgroups (p values of the Hosmer-Lemeshow goodness-of-fit test were <.001 in all but two subgroups). CONCLUSIONS: The analyses suggest that the unsatisfactory calibration of PRISM can be attributed to various reasons. Among those reasons, a poor performance of the system, as well as its sensitivity to factors not connected to clinical ICU performance, seem particularly important. A special caution is needed in adopting a severity of illness scoring system to assess quality of care, particularly in contexts different from the one in which the instrument was originally developed.

Adolescent↗

Predicting outcome in the intensive care unit using scoring systems: is new better? A comparison of SAPS and SAPS II in a cohort of 1,393 patients. GiViTi Investigators (Gruppo Italiano per la Valutazione degli interventi in Terapia Intensiva). Simplified Acute Physiology Score.

OBJECTIVES: This study sought to compare the performance of the old and new versions of the Simplified Acute Physiology Score, SAPS and SAPS II, in classifying patients according to the risk of hospital mortality. METHODS: To compare the performance of the two systems, measures of association between the scores and observed mortality were adopted, together with discrimination (area under the Receiver Operating Characteristics curve) and calibration (goodness-of-fit statistics) estimates. Subjects were 1,393 eligible patients recruited during 1 month in 1994. The outcome measure was vital status at hospital discharge. RESULTS: SAPS II was associated more strongly with hospital mortality than the earlier version. SAPS II also had better discrimination ability than SAPS (area under Receiver Operating Characteristics curve 0.80 versus 0.74) and predicted an overall number of deaths (416.5) closer to the observed figure (475) than SAPS (267.7). Conversely, neither SAPS nor SAPS II fitted our data. Both P values derived from goodness-of-fit statistics were lower than 0.05. CONCLUSIONS: SAPS II offers a real improvement compared with SAPS in its ability to explain hospital mortality, but its standard parameters do not fit our data from Italy. The role and impact of potential determinants of this lack of fit, such as random errors and confounders related to casemix and/or quality of care should be clarified before this scoring system be used outside formal research projects. Special caution is suggested when SAPS II is adopted to predict mortality to compare intensive care unit performance across different countries and systems of care.

Adult↗

Endometrial resection versus vaginal hysterectomy for menorrhagia: long-term clinical and quality-of-life outcomes.

OBJECTIVE: Our purpose was to compare patients' satisfaction with the effect of treatment, health-related quality of life, psychologic status, and sexual functioning 2 years after endometrial resection or vaginal hysterectomy for menorrhagia. STUDY DESIGN: Menorrhagic women < or = 50 years old with a mobile uterus smaller than a 12-week pregnancy were enrolled in a randomized trial to compare endometrial resection and vaginal hysterectomy. Two years after surgery the women were requested to rate the degree of satisfaction with the effect of the operation and to complete the Short Form 36 general health survey questionnaire, the Hospital Anxiety and Depression Scale, and the revised Sabbatsberg Sexual Rating Scale. RESULTS: Forty-one subjects underwent endometrial resection and 44 underwent vaginal hysterectomy without major complications. Of the 77 women attending the 2-year follow-up visit, 33 of 38 (86.8%) in the endometrial resection arm were very satisfied or satisfied with the treatment compared with 37 of 39 (94.8%) of those in the hysterectomy arm. According to the Short Form 36 questionnaire, social functioning and vitality scores were significantly better in the hysterectomy group than in the resection group. Significantly lower Hospital Anxiety and Depression Scale anxiety scores were observed in the former than in the latter subjects. The Sabbatsberg Sexual Rating Scale scores were similar in the two groups. CONCLUSIONS: In patients requiring surgical treatment for menorrhagia vaginal hysterectomy appeared slightly more satisfying and offered a better health-related quality of life than did endometrial resection at 2-year follow-up. Hysterectomy did not adversely affect psychologic status and sexual functioning.

Adult↗

Impact of different customization strategies in the performance of a general severity score.

OBJECTIVE: To compare the impact of two different customization strategies in the performance of the admission Mortality Probability Model II (MPM II0) using formal statistical assessment. DESIGN: Analysis of the database of a multicenter, multinational, prospective cohort study, EURICUS-1, involving 89 intensive care units (ICUs) from 12 European countries. SETTING: Eighty-nine ICUs from 12 European countries. PATIENTS: Data from 16,060 patients consecutively admitted to 89 ICUs from 12 European countries were collected during a 4-month period. In accordance with original MPM II0 criteria, the following patients were excluded from analysis: patients <18 yrs of age; patients considered readmissions; patients with acute myocardial infarction or burns; and patients in the postoperative period recovering from coronary artery bypass surgery. A total of 10,397 patients were analyzed. INTERVENTIONS: Collection of the data necessary for the calculation of MPM II0 and basic demographic statistics. Vital status at hospital discharge was registered. Two new logistic regression equations were developed to relate MPM II0 to mortality after splitting the database into development and validation samples, the first with the original logit of MPM II0 as an independent variable (first-level customization), and the second with all 15 original variables (second-level customization). Discrimination (area under the receiver operating curve), Hosmer-Lemeshow goodness-of-fit tests H and C, and observed/expected mortality ratios were evaluated in both samples and within relevant subgroups. MEASUREMENTS AND MAIN RESULTS: The discriminative capability of the models was only slightly affected by customization (0.810 vs. 0.803), remaining lower than in the original description of the MPM II0 (0.824). Calibration improved, with Hosmer-Lemeshow goodness-of-fit tests H and C showing a good fit of the models. However, the formal evaluation of discrimination, calibration, and observed/expected mortality ratios across relevant subgroups appeared to be poor in some groups. CONCLUSIONS: In this ICU patient database, second-level customization was more effective than first-level customization in improving the overall goodness-of-fit of MPM II0 and should probably be chosen as the preferential strategy to improve the fit of a model when the sample size is large enough. However, second level customization had only a slight impact on discrimination. Its effects on the uniformity of fit are insufficient to overcome the problems that can arise when the model is applied in populations in which the case-mix is distinct from the population where it was originally developed.

Adult↗

Postoperative analgesia in Italy. National survey on the anaesthetist's beliefs, opinions, behaviour and techniques in postoperative pain control in Italy.

BACKGROUND: Using a personal, anonymous questionnaire developed ad hoc, we tried to document the role, the problems and the activities of Italian anaesthetists in postoperative pain control. METHODS: A random selection-stratified by region-was made from a list of 971 hospitals. The final sample was made up of 395 departments of anaesthesia and intensive care from 369 hospitals. The completeness and consistency of each questionnaire were assessed. RESULTS: The response rate achieved was 78.9% (312 centres in 293 hospitals) with 2435 evaluable questionnaires corresponding to 30% of all Italian anaesthesia departments and 25% of Italian anaesthetists. Only 15.2% of anaesthetists are completely responsible for the postoperative analgesia (POA) (prescriptions and evaluations) and an established attitude for POA (protocols/guidelines) exists in 18 departments only. 60% of anaesthetists use routinely the intramuscular route, 55.2% the intravenous route (infusion plus bolus), and 23.7% the spinal/epidural route. Only 6.2% of the anaesthetists use the patient-controlled analgesia system. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used agents (47% NSAID vs 37.9% opioids; NSAID-opioid association 14.7%). A local anesthetics-opioids association is preferred for the spinal/epidural route (15.1%) only (local anaesthetic 4.9% only; opioids alone 2.7%). Lack of time, work organization, technique knowledge/training, trust in nursing-ward staff, difficulty in monitoring the patient on the ward, concern about opioid use leading to ventilatory depression, and administration errors are reported to be the main factors that limit an appropriate approach to postoperative pain (POP), the correct use of analgesics and a free choice of POA technique. CONCLUSION: This survey shows that Italian anaesthetists do not consider the postoperative period to be their own personal work area and that POA is to be considered as a matter of individual choice.

Analgesics↗

[An index of daily intensive care unit activity].

OBJECTIVE: To set up an index for the evaluation of type of interventions and procedures applied a prerequisite for the evaluation of appropriateness of ICU's activity. DESIGN: Observation prospective study. PATIENTS: 2507 patients out of the 5030 enrolled in the cohort study. MEASUREMENTS: A cross-sectional assessment of the volume and intensity of treatment--level of care--delivered to patients was performed at a preidentified index day. A check list of procedures was utilized. Intensive high level treatment was demonstrated by the application of procedures suggesting one or more organs or vital functions intensively supported. Sub-intensive treatment was defined by the application of procedures indicating monitoring or treatments not exclusively performed in intensive environment. RESULTS: 3955 samples were collected over 9 index days; 2707 (68.3%) resulted in intensive, 1227 (30.7%) subintensive or intermediate and 41 (1%) ward treatments. Out of the intensive samples, 63.4% received only one intensive procedure, while 27.9% two. Ventilatory support was the most frequently (90.4%) utilized intensive procedure. Overall 99% of the samples were characterized by treatments/procedures too invasive for normal ward. CONCLUSIONS: The proposed method gives the opportunity to easily evaluate the level of care and then the appropriateness of ICU care.

Cross-Sectional Studies↗

The performance of SAPS II in a cohort of patients admitted to 99 Italian ICUs: results from GiViTI. Gruppo Italiano per la Valutazione degli interventi in Terapia Intensiva.

OBJECTIVE: To assess the validity of SAPS II (new Simplified Acute Physiology Score) in a cohort of patients admitted to a large sample of Italian intensive care units (ICU). DESIGN AND SETTING: The ability of the SAPS II scoring system to predict the probability of hospital mortality was assessed with calibration and discrimination measures obtained using published coefficients. A new logistic regression equation was then developed and further formal calibration and discrimination measures were estimated for the customized model. PATIENTS: From the 2202 consecutive patients recruited during a 1-month period in 99 ICUs, a total of 1393 patients were included in this validation study. RESULTS: When the parameters based on the standard model were applied, the expected probability of mortality did not fit those actually observed in the cohort (p < 0.001), although it showed satisfactory discrimination (area under the receiver operating characteristic curve = 0.80). Such lack of fit yields an overall under prediction of mortality (observed/expected ratio = 1.14) that reflects a uniform pattern across a preselected set of subgroups. Customization allowed new mortality estimates to be calculated, with satisfactory calibration (p = 0.82) and a more uniform pattern across subgroups. CONCLUSIONS: SAPS II maintained its validity in an independent sample of patients recruited in a large network of Italian ICUs only after appropriate adaptation (first-level customization). Whether the determinants of this relatively poor performance are related to differences in unmeasured case-mix, methods of application, or quality of care delivered is a matter for discussion that cannot be solved with the data presently available. However, these findings suggest that caution is warranted before implementing the standard SAPS II scoring system parameters outside formal research projects.

APACHE↗

[Evaluation of activity in intensive care. A comparison of administrative and epidemiologic data].

This paper reports on results of a formal comparison of data excerpted from 3 different data sources regarding patients cared for in Italian Intensive Care Units (ICU) in 1992. The analysis was carried out in order to assess whether the administrative data routinely collected for reimbursement and policy issues are valid when compared with data from epidemiologic studies. First, using data from the Central Service for Health Planning (SCPS) a general description of the whole national scenario is shown. All the Italian data from 265 Italian hospitals having at least one ICU were analyzed. In these hospitals there were 2,357 ICU beds (4.3 beds/1000 inhabitants, with large regional variability). About 100,000 cases were identified (1% of all the hospital admissions received ICU care at some moment during the stay), with an overall hospital mortality rate of 17%. This estimate was largely different from those obtained from GiViTI data base (5100 patients from a national sample of 114 ICUs), where mortality rates were always higher (25 and 30%, for ICU and hospital mortality). Second, a more detailed analyses and comparison was carried out in the subsample of cases admitted in the Hospitals of the Regione Lombardia. In this case, beside the data from SCPS (No = 20580) and from GiViTI (No = 1121), the Regional data-base formed by all the discharge from 41 hospitals having at least one ICU were available (NO = 16674), allowing a formal comparison between estimates obtained from 3 different sources. In this sub-sample, although administrative data showed a good capability and satisfactory accuracy to describe the volume and socio-demographic and clinical characteristics of the cases when compared with GiViTI estimates, still a systematic underestimate of the overall ICU and hospital mortality was present. Moreover, an unexpected high rate of cases were apparently discharged alive from ICU (16.5 versus 32.6% in GiViTI). Tentative explanations and implications of these phenomena are discussed in the text. Finally, in the Lombardia sub-sample a formal description of the case-mix using the Diagnosis Related Group (DRG) system was carried out in order to identify strengths and limitations of this approach when adopted in the ICU setting. Overall, when data are analyzed according to the kind of Major Diagnostic Category (MDC), 75% of all cases were concentrated in 5 alone, with very peculiar concentration in some specific categories. For example, 45% of all the hospital admissions related to the multiple trauma were actually admitted in the ICU setting. At DRG level, fifty of the 493 DRGs available explained 65% of all the cases, showing an unexpected capability of this system to detect the ICU case-mix. The most represented surgical DRG was the number 107 (Coronary Arterial Bypass Graft, without catheterization) and the corresponding medical was the 28 (Cerebro Vascular Accident, excluding TIA).

Adolescent↗

A European project assessing the appropriateness of hospital utilization: background, objectives and preliminary results. The Project Steering Group and the Coordinating Center.

This paper presents the background, objectives and preliminary results of a coordinated European Project involving researchers in seven countries aimed at harmonizing methods to assess inappropriate use of hospital care and qualifying its determinants. After briefly reviewing the philosophy of the European Union "Concerted Action" program in the context of current attempts at reforming the way health care is financed and delivered in several member states, the paper presents results obtained so far. Besides a method workshop where the approaches and methodologies used were compared, during the first year the following tasks have been undertaken: (a) identification and appraisal of a few dozen empirical studies conducted in various countries; (b) qualitative comparison of the instruments used to assess appropriateness; (c) initial development of a common list of reasons for inappropriate hospital use of potential relevance in European health care systems. While the project has already undoubtedly indicated the great potential of European collaboration in health services research, the large number of unpublished studies traced indicates--among other things--the need to create channels through which results of this type of research can be disseminated.

Algorithms↗

Appropriateness of hospital use: an overview of Italian studies.

This paper reports on the general features and findings of 11 studies conducted in Italy on appropriateness of hospital admission and days of stay using the Appropriateness Evaluation Protocol (AEP). Studies have been grouped for presentation in two categories. The first comprises six heterogeneous studies illustrating different ways of targeting the use of the AEP: two used it to assess appropriateness of admission in an emergency room setting, two measured appropriateness of days of stay in patients with AIDS and nosocomial infections and finally two others evaluated hospital days in a group of elderly patients and "before and after" the institution of a domiciliary nursing service, respectively. The second group comprises five more homogeneous utilization review studies aimed at assessing inappropriateness of admissions and days of stay in medical/surgical departments of large hospitals in northern Italy. Besides detecting a substantial amount of inappropriateness in admission (range = 25-38%) and days of stay (range = 28-49%) this latter group of studies suggests that delays in execution and reporting of laboratory investigations, unavailability of operating rooms and delays due to difficulties in transferring patients to long-term care facilities are the most common causes of inappropriate days of stay. Despite the differences in their objectives, design and methods of sampling, these studies indicate that an explicit, diagnosis-independent and standardized instrument such as the AEP can help to uncover a substantial amount of the potentially avoidable use of hospital resources in the Italian context.

Health Services Research↗

ASA Physical Status and age predict morbidity after three surgical procedures.

OBJECTIVE: American Society of Anesthesiologists-Physical Status scores (ASA-PS) and age were used to adjust for case-mix differences when evaluating surgical morbidity and resource use after total hip replacement (THR), transurethral prostatectomy (TURP), or cholecystectomy. SUMMARY BACKGROUND DATA: Variations in complication rates or resource use among patients treated for a particular primary condition should be adjusted for coexistent disease. Age and ASA-PS scores are readily available and can be useful to stratify surgical patients for risk. METHODS: One thousand ninety patients at five academic medical centers in California and Massachusetts who underwent THR, TURP, or cholecystectomy between 1985 and 1987 were studied. Data were obtained from medical records and a self-administered questionnaire to measure length of stay (LOS), postoperative complication rates, and follow-up physician visits. Data were analyzed with one- and two-way analysis of variance with the Bonferroni correction. RESULTS: Increasing age and ASA-PS scores were associated significantly with increased LOS, complication rates, and frequency of post-discharge physician office visits. No interaction effect between age and ASA-PS scores was observed. CONCLUSIONS: Age and ASA-PS scores can predict postoperative morbidity, specific for each operation studied. Assessment of co-morbidity in surgical patients can be accomplished easily and with minimal expense. While remaining budget neutral, the distribution of reimbursements should be based on those preoperative risk factors that predict longer LOS and higher complication rates.

Adult↗

Intermediate intensive units: definition, legislation and need in Italy.

This paper deals with the definition of intensive care medicine and the organization of different levels of care; intermediate and high level. The organization, facilities and personnel for intermediate care are discussed. The available public data on the organization of intensive medicine and modifications planned by the Legislator are considered. Finally, the usefulness of intermediate care and an estimate of the actual need, based on prospective multicentre ad hoc studies, are discussed.

Health Services Needs and Demand↗

[Comorbidity and the physician's decision: the case of undertreatment in care of breast tumors].

When a physician has to come to a decision while caring for a given patient, he is supposed to take into account several kind of information related to the disease, illness or patients' personal characteristics. Although it is wellknown that the framework in which such decision has to be taken is complex, most of the scientific knowledge is based on pieces of evidence that derive from studies where complexity is avoided by applying restriction rules. The goal of this approach is to enhance the internal validity while preserving the generalizability of the findings. But in some cases this approach raises more doubts than certainty. It is the case of the process to assemble practice guidelines to reduce the gap between the best care and what is observed into practice using the available knowledge (i.e., available literature or experts' recommendations). As a variety of relevant clinical and patients' personal characteristics are not available at all or little is known on their impact on patients global health status, variables that actually do drive the practice are not included in guidelines that are intended to change it. This paper introduces the conceptual model of such debate and assesses the impact of co-morbidity--a variable seldom taken into account in effectiveness, quality and appropriateness studies- on the kind of medical care given to a sample of 1019 patients with early stage breast cancer. Empirical results and future implications are eventually discussed.

Adult↗