RESUMEN
Invasive disease caused by Streptococcus pneumoniae is a major cause of morbidity and mortality in high-risk individuals with severe comorbidities, including asplenia, chronic alcoholism, and altered immune status. The risk of invasive pneumococcal disease has been significantly higher in transplant patients compared with the general population. Here, we report an unusual case of a disseminated pneumococcal infection with meningitis, endocarditis, spondylodiscitis, and muscle abscess in an asplenic patient on chronic immunosuppressive therapy for liver transplantation performed 17 years before.
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Discitis/microbiología , Endocarditis Bacteriana/diagnóstico por imagen , Endocarditis Bacteriana/microbiología , Trasplante de Hígado/efectos adversos , Meningitis Neumocócica/microbiología , Infecciones Neumocócicas/complicaciones , Streptococcus pneumoniae/aislamiento & purificación , Edad de Inicio , Encéfalo/diagnóstico por imagen , Discitis/líquido cefalorraquídeo , Discitis/diagnóstico por imagen , Endocarditis Bacteriana/líquido cefalorraquídeo , Femenino , Humanos , Vértebras Lumbares/patología , Imagen por Resonancia Magnética , Meningitis Neumocócica/líquido cefalorraquídeo , Meningitis Neumocócica/diagnóstico por imagen , Persona de Mediana Edad , Infecciones Neumocócicas/líquido cefalorraquídeo , Infecciones Neumocócicas/microbiología , Radiografía , UltrasonografíaRESUMEN
PURPOSE: To study the possible association of CT-derived quantitative epicardial adipose tissue (EAT) and glycemia at the admission, with severe outcomes in patients with COVID-19. METHODS: Two hundred and twenty-nine patients consecutively hospitalized for COVID-19 from March 1st to June 30th 2020 were studied. Non contrast chest CT scans, to confirm diagnosis of pneumonia, were performed. EAT volume (cm3) and attenuation (Hounsfield units) were measured using a CT post-processing software. The primary outcome was acute respiratory distress syndrome (ARDS) or in-hospital death. RESULTS: The primary outcome occurred in 56.8% patients. Fasting blood glucose was significantly higher in the group ARDS/death than in the group with better prognosis [114 (98-144) vs. 101 (91-118) mg/dl, p = 0.001]. EAT volume was higher in patients with vs without the primary outcome [103 (69.25; 129.75) vs. 78.95 (50.7; 100.25) cm3, p < 0.001] and it was positively correlated with glycemia, PCR, fibrinogen, P/F ratio. In the multivariable logistic regression analysis, age and EAT volume were independently associated with ARDS/death. Glycemia and EAT attenuation would appear to be factors involved in ARDS/death with a trend of statistical significance. CONCLUSIONS: Our findings suggest that both blood glucose and EAT, easily measurable and modifiable targets, could be important predisposing factors for severe Covid-19 complications.
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Glucemia , COVID-19 , Tejido Adiposo/diagnóstico por imagen , Mortalidad Hospitalaria , Hospitales , Humanos , Pericardio/diagnóstico por imagen , SARS-CoV-2RESUMEN
INTRODUCTION: A more structured role of radiographers is advisable to speed up the management of patients with suspected COVID-19. The purpose of our study was to evaluate the diagnostic performance of radiographers in the detection of COVID-19 pneumonia on chest CT using CO-RADS descriptors. METHODS: CT images of patients who underwent RT-PCR and chest CT due to COVID-19 suspicion between March and July 2020 were analysed retrospectively. Six readers, including two radiologists, two highly experienced radiographers and two less experienced radiographers, independently scored each CT using the CO-RADS lexicon. ROC curves were used to investigate diagnostic accuracy, and Fleiss'κ statistics to evaluate inter-rater agreement. RESULTS: 714 patients (419 men; 295 women; mean age: 64 years ±19SD) were evaluated. CO-RADS> 3 was identified as optimal diagnostic threshold. Highly experienced radiographers achieved an average sensitivity of 58.7% (95%CI: 52.5-64.7), an average specificity of 81.8% (95%CI: 77.9-85.2), and a mean AUC of 0.72 (95%CI: 0.68-0.75). Among less experienced radiographers, an average sensitivity of 56.3% (95%CI: 50.1-62.2) and an average specificity of 81.5% (95%CI: 77.6-84.9) were observed, with a mean AUC of 0.71 (95%CI: 0.68-0.74). Consultant radiologists achieved an average sensitivity of 60.0% (95%CI: 53.7-65.8), an average specificity of 81.7% (95%CI: 77.8-85.1), and a mean AUC of 0.73 (95%CI: 0.70-0.77). CONCLUSION: Radiographers can adequately recognise the classic appearances of COVID-19 on CT, as described by the CO-RADS assessment scheme, in a way comparable to expert radiologists. IMPLICATIONS FOR PRACTICE: Radiographers, as the first healthcare professionals to evaluate CT images in patients with suspected SARS-CoV-2 infection, could diagnose COVID-19 pneumonia by means of a categorical reporting scheme at CT in a reliable way, hence playing a primary role in the early management of these patients.
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COVID-19 , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , SARS-CoV-2 , Tórax , Tomografía Computarizada por Rayos XAsunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/complicaciones , Hepatitis C Crónica/tratamiento farmacológico , Legionella pneumophila/aislamiento & purificación , Enfermedad de los Legionarios/diagnóstico , Oligopéptidos/uso terapéutico , Anciano , Humanos , Enfermedad de los Legionarios/microbiología , Enfermedad de los Legionarios/patología , MasculinoAsunto(s)
Gripe Humana/complicaciones , Legionelosis/complicaciones , Rotura del Bazo/etiología , Tromboembolia/complicaciones , Adulto , Amicacina/administración & dosificación , Antibacterianos/administración & dosificación , Anticoagulantes/administración & dosificación , Enoxaparina/administración & dosificación , Humanos , Subtipo H1N1 del Virus de la Influenza A/aislamiento & purificación , Gripe Humana/diagnóstico , Gripe Humana/tratamiento farmacológico , Legionella/aislamiento & purificación , Legionelosis/diagnóstico , Legionelosis/tratamiento farmacológico , Masculino , Meropenem , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , Esplenectomía , Rotura del Bazo/cirugía , Tienamicinas/administración & dosificación , Tromboembolia/diagnóstico , Tromboembolia/tratamiento farmacológico , Tomografía Computarizada por Rayos X , Resultado del TratamientoAsunto(s)
Antibacterianos/uso terapéutico , COVID-19/epidemiología , Control de Enfermedades Transmisibles , Infecciones por Klebsiella/prevención & control , Antibacterianos/farmacología , Proteínas Bacterianas , Heces/microbiología , Humanos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Italia/epidemiología , Klebsiella pneumoniae/efectos de los fármacos , Klebsiella pneumoniae/enzimología , Klebsiella pneumoniae/patogenicidad , Pruebas de Sensibilidad Microbiana , Pandemias , beta-LactamasasRESUMEN
The advent of potent antiretroviral drugs in recent years has had an impressive impact on mortality and disease progression in HIV-infected patients, so that issues related to long-term effects of drugs are of growing importance. Hyperlipidemia, hyperglycemia, and lipodystrophy are increasingly described adverse effects of highly active antiretroviral therapy (HAART), in particular when protease inhibitors are used. Hyperlipidemia is strikingly associated with the use of most available protease inhibitors, with an estimated prevalence of up to 50%. Because of the short observation period and the small number of cardiovascular events, epidemiological evidence for an increased risk of coronary heart disease in HIV-infected patients treated with HAART is not adequate at present; however, it is likely that shortly more data will accumulate to quantify this risk. Before starting HAART and during treatment it is reasonable to evaluate all patients for traditional coronary risk factors, including lipid profile. Among the drugs that are currently used in HIV+ patients, antibacterials, antifungals, psychotropic drugs and anti-histamines have been associated with QT prolongation or torsade de pointe, a life-threatening ventricular arrhythmia. Among the risk factors that may precipitate an asymptomatic electrocardiographic abnormality into a dangerous arrhythmia is the concomitant use of drugs that share the CYP3A metabolic pathway. Since most protease inhibitors are potent inhibitors of CYP3A, clinicians should be aware of this potentially dangerous effect of HAART. Anthracyclines are potent cytotoxic antibiotics that have been widely used for the treatment of HIV-related neoplasms. Their cardiotoxicity is well known, ranging from benign and reversible arrhythmias to progressive severe cardiomyopathy. The increased survival and quality of life of HIV+ patients emphasize the importance of a high awareness of adverse drug-related cardiac effects.
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Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Antivirales/efectos adversos , Cardiomiopatías/inducido químicamente , Infecciones por VIH/tratamiento farmacológico , Adyuvantes Inmunológicos/uso terapéutico , Antineoplásicos/uso terapéutico , Enfermedades Cardiovasculares/inducido químicamente , Enfermedades Cardiovasculares/epidemiología , Interacciones Farmacológicas , Infecciones por VIH/complicaciones , Humanos , Hiperlipidemias/inducido químicamente , Hiperlipidemias/epidemiología , Neoplasias/tratamiento farmacológico , Neoplasias/etiología , Psicotrópicos/uso terapéutico , Factores de RiesgoRESUMEN
We conducted a multicenter, hospital-based case-control study to identify specific characteristics of AIDS patients which determine referral to hospital care at home. The cases were patients referred to a hospital-based home care scheme, in the metropolitan area of Rome, during 1997. Each case was matched with two controls. Social, demographic and clinical characteristics were collected at referral. Univariate and multivariate analysis were performed. In the study period, 119 cases and 238 controls were recruited. In logistic regression analysis, social characteristics were not found to affect referral to the hospital-at-home scheme. A severely impaired functional status--assessed by the Functional Independent Measure--identified by a score below 100 (Odds Ratio [OR]=15.2, 95% confidence interval [CI] 2.8-82.7), and the need for prolonged intravenous therapy (OR=12.4, 95% CI=3.3-46.3) were the only two independent predictors of home-care referral. We conclude that home care, even in a period when new potent combination antiretroviral therapies are widely available, is an important integrated service component for persons with AIDS with severe functional impairment or requiring intravenous therapy.
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Síndrome de Inmunodeficiencia Adquirida/terapia , Servicios de Atención de Salud a Domicilio , Derivación y Consulta , Adulto , Anciano , Terapia Antirretroviral Altamente Activa , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: To evaluate short-term toxicity from and discontinuation of antiretroviral combination prophylaxis in HIV-exposed individuals in Italy. DESIGN: Longitudinal, open study conducted by prospective collection of data in the National Registry of PEP. SETTING: All the Italian centres dedicated to HIV related care and licensed by the Ministry of Health to dispense antiretroviral drugs. STUDY POPULATION: Health care workers and other persons consenting to be treated with post exposure prophylaxis (PEP) after exposures to HIV. RESULTS: Until October, 2000, 207 individuals receiving two nucleoside reverse transcriptase inhibitors (NRTIs), and 354 receiving two NRTIs plus a protease inhibitor (PI) were enrolled. More individuals experienced side-effects in the 3-drug group (53% and 62%, respectively; OR 0.68, (95% CI 0.48-0.98), p < 0.03). However, the proportion of individuals discontinuing prophylaxis because of side-effects did not differ significantly between the 2 groups (21% and 25% respectively; OR 0.82 (95% CI 0.53-1.26); p=0.4). The 43 individuals in the 2 NRTI group discontinued PEP after a mean of 10.4 days of treatment (median 8, range 1-27), similarly to the 88 discontinuations observed in the 3-drug group (mean duration 10.5 days, median 7.5, range 1-26). Type and incidence of specific adverse effects were similar to those reported in the literature. CONCLUSION: Our study indicates that the difference in the proportion of individuals developing side effects and discontinuing PEP is not significant. The rate of discontinuation because of protease inhibitor side-effects does not justify per se the initial use of a less potent PEP regimen. We suggest initiating PEP with a three-drug regimen and discontinuing the protease inhibitor in the case of adverse effects.
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Fármacos Anti-VIH/efectos adversos , Infecciones por VIH/prevención & control , Personal de Salud , Exposición Profesional , HumanosRESUMEN
The purpose of this study is to retrospectively review the clinical, radiographic and laboratory characteristics, the therapy and evolution of sinusitis in HIV-infected patients hospitalized between January 1, 1985 and July 31, 1994. We have observed 65 cases of sinusitis in 58 HIV-infected patients (77.6% classified as group C). Forty-five of 65 cases (69.2%) showed radiographic evidence of acute sinusitis; the remaining 20 cases (30.8%) showed chronic sinusitis. In 61 cases (93.8%) there were symptoms related to sinusitis. In 61 sinusitis cases antibiotics were administered. Although the majority of patients responded at least partially to antibiotic therapy, a complete resolution of clinical and radiographic signs was observed in only 47.4% of acute sinusitis cases. No resolution was observed in chronic sinusitis after treatment stop. Sinusitis appears to occur quite frequently in HIV-infected patients, is often related to non-specific symptoms, may be recurrent and is commonly refractory to treatment.
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Infecciones por VIH/complicaciones , Sinusitis/complicaciones , Adulto , Anciano , Antibacterianos/uso terapéutico , Bacterias/aislamiento & purificación , Femenino , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Senos Paranasales/microbiología , Recurrencia , Estudios Retrospectivos , Sinusitis/diagnóstico , Sinusitis/tratamiento farmacológico , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
A study protocol to record prospectively, frequency and intensity of symptoms in terminally ill AIDS patients was developed. Other information included mode of transmission, active intravenous drug use, regular visits of family/friends to the ward, the use of symptom-control drugs, and death without family or partner. The study population was selected from patients admitted to the wards or followed in the Clinic or Day Center of the Department of Infectious Diseases of the Catholic University, Rome. Inclusion criteria were diagnosis of AIDS prior to 12 months and advanced stage AIDS (defined with standardized criteria). To standardize the analysis of data, the terminal phase was considered to start 3 months before death (T1). From January 1, 1993 to December 12, 1993, 266 patients (208 males, 58 females) were enrolled. By June 30, 1995 168 patients had died and were considered for analysis. The most frequent symptoms at T1 were anorexia (63.1%), fatigue (60.1%), pain (60.1%), fever (47.6%), and cough (37.5%). At the end week (T6) the most frequent symptoms were fever (81.5%), fatigue (70.2%), dyspnea (68.1%), and pain (58.9%). In two-thirds of the patients, symptom-control drugs were used, most frequently nonopioid analgesics (39.9% at T1 and 56.5% at T6) and antipyretics (38.7% at T1 and 53.6% at T6). Opioid analgesics were used in 19% of patients at T1 and in 28.6% at T6. Almost one-third of the patients (29.2%) died alone without having family, their partner, or a friend near. Considering the high frequency of treatable symptoms in terminally ill AIDS patients, the use of palliative therapy should be emphasized. Flexibility and patient-directed care should be used in deciding care plans to avoid overhospitalization and promote alternative care.
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Síndrome de Inmunodeficiencia Adquirida/diagnóstico , Enfermo Terminal , Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Síndrome de Inmunodeficiencia Adquirida/mortalidad , Analgésicos no Narcóticos/uso terapéutico , Familia , Femenino , Estudios de Seguimiento , Humanos , Relaciones Interpersonales , Masculino , Cuidados Paliativos , Estudios Prospectivos , Parejas Sexuales , Factores de TiempoRESUMEN
A chart review study of 100 consecutive AIDS patients cared for by our Home Care (HC) unit was performed. The main characteristics of the sample were: M/F ratio = 3/1; mean age = 39.7 +/- 6.6; mode of transmission = 56% intravenous drug users (IVDU); Centers For Disease Control (CDC) classification = 98% C3; mean length of HC = 5.2 months. Psychopathological evaluation led to an overall rate of morbidity during HC of 73%. The most common psychiatric diagnoses were dementia and adjustment disorders. Nearly two thirds of the patients received psychopharmacological treatment; one fifth were still on methadone. Psychological discomfort was perceived by more than half of patients. Interpersonal problems with cohabitants were noticed by caregivers in 41%. Female patients showed an increased prevalence of anxiety and depressive disorders. IVDUs had more prominent psychosocial problems. Interpersonal problems with cohabitants were correlated to substance use or other mental disorders in the family and to the patient's psychological discomfort. We conclude that mental health professional intervention for AIDS patients is strongly needed in a home-care setting.
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Síndrome de Inmunodeficiencia Adquirida/epidemiología , Síndrome de Inmunodeficiencia Adquirida/psicología , Trastorno Depresivo/epidemiología , Trastornos Mentales/epidemiología , Trastornos Relacionados con Sustancias/epidemiología , Síndrome de Inmunodeficiencia Adquirida/complicaciones , Adaptación Psicológica , Adulto , Distribución por Edad , Antidepresivos/administración & dosificación , Comorbilidad , Trastorno Depresivo/tratamiento farmacológico , Trastorno Depresivo/etiología , Femenino , Servicios de Atención de Salud a Domicilio/estadística & datos numéricos , Humanos , Italia/epidemiología , Masculino , Trastornos Mentales/tratamiento farmacológico , Trastornos Mentales/etiología , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Muestreo , Distribución por Sexo , Trastornos Relacionados con Sustancias/diagnósticoRESUMEN
To study the prevalence, intensity, and quality of pain in patients with human immunodeficiency virus (HIV) infection and to evaluate factors influencing the different components of pain, a self-administered multidimensional pain questionnaire (Italian Pain Questionnaire [IPQ]) was administered to 153 HIV patients admitted to the Department of Infectious Diseases of a teaching hospital over a 7-month period. Ninety-three (60.8%) patients experienced pain for a total of 131 pain sites. The intensity and the nonsensorial components of pain were greater in ward patients compared to outpatients. In 70% of pain syndromes it was not possible to define the etiology at the time of the visit. Pain was observed more frequently in intravenous drug users (IDUs) (72.9%) compared to patients with other HIV modalities of transmission (50.6%) (p = 0.008). The mean value of sensory class was greater in patients who were not IDUs. Within IDUs group there was a predominance of descriptors of the affective class over the sensory class. The prevalence of pain is high in HIV-infected individuals. The different components of pain are influenced by the modality of transmission and the setting of care. The assessment of scores of different components of pain could help to select and monitor appropriate interventions in pain control.
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Infecciones por VIH/complicaciones , Dolor/etiología , Análisis de Varianza , Antiinflamatorios no Esteroideos/uso terapéutico , Femenino , Hospitalización , Humanos , Italia/epidemiología , Modelos Lineales , Masculino , Dolor/clasificación , Dolor/tratamiento farmacológico , Dolor/epidemiología , Dimensión del Dolor , PrevalenciaRESUMEN
The Karnofsky Scale of Performance Status (KPS) is a measure of health status that is widely used for HIV-infected persons, although few studies have documented its reliability and validity for HIV. We developed a modified KPS in an attempt to make it more appropriate for use in HIV-infected persons and evaluated its inter-rater reliability in a multicenter study. Patients (N = 657) were recruited from five hospitals in three Italian cities; responses were scored using the modified scale by three different raters in each hospital: one experienced physician, one young physician, and one nurse. Kendall's correlation test showed a strong inter-rater agreement for the total of observations: 0.82 between the two physicians, 0.77 between the experienced physician and the nurse, and 0.76 between the young physician and the nurse. The analysis of variance showed a strong effect of the stage of the disease on the KPS score. The specific hospital had little effect, whereas the effect of the type of rater disappeared when the nurse was excluded from the analysis. This modified scale demonstrated a good reliability, although training of raters could help to eliminate differences among raters and among hospitals.
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Infecciones por VIH/diagnóstico , Estado de Ejecución de Karnofsky/estadística & datos numéricos , Análisis de Varianza , Humanos , Variaciones Dependientes del Observador , Reproducibilidad de los ResultadosRESUMEN
We investigated the prevalence and intensity of symptoms and the use of drugs for symptom control among all HIV-infected patients reporting to the outpatient clinics or wards of 15 clinical centres in central Italy, recording clinical and epidemiological data on three consecutive days. A total of 1128 patients were observed and tabulated. Their most frequent symptoms were asthenia (65%), anorexia (34%), cough (32%), pain (29%), and fever (29%). Opioid analgesics were used in 3% of these patients and non-opioid analgesics in 13%. A large majority of HIV-infected patients presented with symptoms regardless of the stage of their disease. Pain was present in fewer than one third of patients but nonetheless seemed to be undertreated. Pain was more frequent and more intense among intravenous drug users. Based on our study, a greater effort to control symptoms in HIV patients seems to be warranted.
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Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Cuidados Paliativos , Analgésicos/uso terapéutico , Femenino , Humanos , Italia/epidemiología , Masculino , Dolor/tratamiento farmacológico , Dolor/etiología , Prevalencia , Índice de Severidad de la EnfermedadRESUMEN
Non-Hodgkin's lymphoma (NHL) is one of the most common malignancies in patients infected with human immunodeficiency virus (HIV): it occurs 25-60 times more frequently in HIV-infected patients than in the general population. This neoplasm in acquired immunodeficiency syndrome (AIDS) patients is a highly aggressive tumour with a poor prognosis and tends to develop in extranodal sites, such as the central nervous system, digestive tract and bone marrow. NHL involving the paranasal sinuses is rare in HIV-infected patients, and is likely to be confused clinically and radiographically with sinusitis; moreover, its optimal treatment is currently uncertain. We present a case of NHL involving the left maxillary sinus in a patient with AIDS. The patient was treated with systemic chemotherapy (low dose-CHOP), but the malignancy did not respond. Subsequently, he was treated with local maxillary sinus irradiation which resulted in partial regression of the neoplasm and in decrease of local symptoms.
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Linfoma Relacionado con SIDA , Linfoma de Células B , Linfoma no Hodgkin , Neoplasias del Seno Maxilar , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Antiprotozoarios/uso terapéutico , Ciclofosfamida/uso terapéutico , Doxorrubicina/uso terapéutico , Humanos , Linfoma Relacionado con SIDA/diagnóstico por imagen , Linfoma Relacionado con SIDA/terapia , Linfoma de Células B/diagnóstico por imagen , Linfoma de Células B/terapia , Linfoma no Hodgkin/diagnóstico por imagen , Linfoma no Hodgkin/terapia , Masculino , Neoplasias del Seno Maxilar/diagnóstico por imagen , Neoplasias del Seno Maxilar/terapia , Persona de Mediana Edad , Prednisona/uso terapéutico , Tomografía Computarizada por Rayos X , Toxoplasmosis Cerebral/tratamiento farmacológico , Vincristina/uso terapéuticoAsunto(s)
Infecciones Oportunistas Relacionadas con el SIDA/tratamiento farmacológico , Neumonía por Pneumocystis/tratamiento farmacológico , Sulfonamidas/efectos adversos , Toxoplasmosis Cerebral/tratamiento farmacológico , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Combinación Trimetoprim y Sulfametoxazol/efectos adversosAsunto(s)
Infecciones por VIH/diagnóstico , VIH-1 , Infecciones Oportunistas Relacionadas con el SIDA/diagnóstico , Infecciones Oportunistas Relacionadas con el SIDA/epidemiología , Infecciones Oportunistas Relacionadas con el SIDA/terapia , Diagnóstico Diferencial , Infecciones por VIH/epidemiología , Infecciones por VIH/terapia , Humanos , PrevalenciaRESUMEN
OBJECTIVE: To design a Health-related Quality of Life (HRQoL) instrument for HIV-infected people in the era of highly active antiretroviral therapy (HAART). METHODS: The self-administered questionnaire was developed by an Italian network including researchers, physicians, people living with HIV, national institutions and community-based organizations (CBO) through several steps: (1) review of existing HRQoL literature and questionnaires for HIV-infected people; (2) selection of relevant domains measuring HRQoL in HIV-infected people, and identification of new domains related to new aspects of HRQoL concerning HAART-treated individuals; (3) conduction of two pre-test analyses in independent groups of Italian HIV-positive people (n approximately =100) distributed throughout the country. The objectives of the first pre-test were to verify the usefulness of the questionnaire, to construct a form easily understandable by everyone, to define the domains and their significance; the second pre-test aimed at evaluating and reshaping the questionnaire based on a statistical analysis of the outcomes of first pre-test; (4) validation analysis. A large cohort of people with HIV infection was recruited for the last step. RESULTS: The internal consistence reliability (Cronbach's alpha) was >or=0.70 for all domains. Most domains had Cronbach's coefficient >0.80. All domains demonstrated convergent and discriminant validity. The final version of ISSQoL includes two sections: HRQoL Core Evaluation Form (9 domains) and Additional Important Areas for HRQoL (6 domains). The ISSQoL was administered together with two additional forms: a Daily Impact of Symptoms Form and a Demographic Information Form. The Additional Important Areas for HRQoL include social support, interaction with medical staff, treatment impact, body changes, life planning, and motherhood/fatherhood. CONCLUSION: The data reported in the present paper provide preliminary evidence of the reliability and validity of the ISSQoL questionnaire for the measurement of HRQoL in HIV-infected people. The direct involvement of HIV-positive people in all the phases of the project was a key aspect of our work.