Dropouts in sublingual allergen immunotherapy trials - a systematic review.

Participant dropouts can reduce the power of allergen immunotherapy clinical trials. Evaluation of the dropout rate and reasons for dropout are important not only in the planning of clinical studies but are also relevant for adherence to immunotherapy in daily clinical practice. A systematic review was carried out in order to establish the overall dropout rate among published double-blind, placebo-controlled randomized clinical trials of sublingual immunotherapy for respiratory allergic diseases. Dropouts were analysed in regards to allergen, formulation, treatment schedule, participant age, study size, number of centres and type of allergic disease. Relative dropout rates in placebo and active groups as well as reasons for dropout were also assessed. A total of 81 studies, comprising 9998 patients, were included. Dropout rates in sublingual immunotherapy controlled studies do not appear to be a major problem with a composite dropout percentage of 14% (95% CI:11.9-16). Furthermore, they are not different for active compared to placebo-treated participants. This lends support to the positive clinical outcomes seen in meta-analyses of these trials.

Are social deprivation and psychiatric service utilisation associated in neurotic disorders? A case register study in south Verona.

Measures of service utilisation from the South Verona psychiatric case register in North-East Italy for the years 1983, 1986 and 1989 were used to identify possible associations with sociodemographic variables from the 1981 census for neurotic disorders. There were no consistent patterns of associations between local social and demographic predictors and rates of psychiatric service utilisation. This contrasts markedly with the associations found previously in England (for all psychiatric admissions) and in Italy (for various measures of service utilisation concerning contacts both in and outside hospital for schizophrenic as well as for all psychiatric patients) where social deprivation factors proved to be strong predictors of service use.

[Primary community health districts and changes in the utilization of a psychiatric service for diagnosis and therapy]. / Distretti socio-sanitari di base e variazioni nell'utilizzo di un servizio psichiatrico di diagnosi e cura.

The Authors analyze the activity of Pavia's General Hospital Psychiatric Unit over a ten year period. Data, presented as rates standardized by sex and age, are processed according to patients' residential socio-health districts. The analysis of the results shows marked differences in the Service utilization among different districts. Correlations between these differences and some socio-demographic and clinical variables enable the Authors to put forward some hypotheses in order to understand this pattern of Service utilization. In particular, "high-users" and patients with a past history of admissions to psychiatric hospitals tend to be found especially in the districts which provide the Service with a heavy workload. A closer attention to these patients and to their pathways to care will enable the Service staff to optimize its supply of care and to plan new kinds of treatments.

Subjective and objective dimensions of quality of life in psychiatric patients: a factor analytical approach: The South Verona Outcome Project 4.

BACKGROUND: Both subjective and objective information is necessary to assess quality of life (QOL). AIMS: To explore the role of subjective and objective QOL dimensions and their cross-sectional and longitudinal predictors. METHOD: The relationship between QOL, as measured by the Lancashire Quality of Life Profile (LQL), and demographic variables, diagnosis, psychopathology, disability, functioning, affect balance, self-esteem, service use and service satisfaction was investigated at two points in time, using factor analysis and multiple regression techniques. RESULTS: One subjective and two objective LQL factors with strong face validity were identified. Cross-sectional predictors of the subjective factor were primarily subjective measures; longitudinally, few predictors of this factor were identified. The cross-sectional and longitudinal predictors of the objective factors were primarily demographic and observer-rated measures. CONCLUSIONS: Subjective and objective data are distinct types of information. Objective measures may be more suitable in detecting treatment effects. Subjective information is necessary to complete the QOL picture and to enhance the interpretation of objective data.

Urban-rural differences in the associations between social deprivation and psychiatric service utilization in schizophrenia and all diagnoses: a case-register study in Northern Italy.

Service utilization measures from the psychiatric case registers for urban South-Verona and rural Portogruaro in North East Italy for the period 1983-9 were used to identify associations with socio-demographic variables from the 1981 census in schizophrenia and related disorders as well as in all diagnoses. The patterns of service use were broadly similar, except that Portogruaro has significantly more community contacts, and has about twice the treated incidence and prevalence of schizophrenia. The census data showed that unmarried and unemployed people were more likely to live alone in the urban than in the rural area. In South-Verona the most strongly associated predictor variables, both for schizophrenia and all diagnoses, are: living alone, unemployment, percentage of the total population who are dependents and the percentage who are divorced, separated or widowed. In contrast, in Portogruaro there were no consistent associations between census and service use variables. Stepwise multiple regression models using three census predictor variables accounted for over 85% of the variance in South-Verona utilization rates. The results indicate that the strongly predictive associations previously described in England hold in urban South-Verona, but not in rural Portogruaro, and may be related to the effect of cities in clustering seriously disabled psychiatric patients in areas of low-cost housing where they live in relative social isolation.

Acceptability, sensitivity and content validity of the VECS and VSSS in measuring expectations and satisfaction in psychiatric patients and their relatives.

The Verona Expectations for Care Scale (VECS) and the Verona Service Satisfaction Scale (VSSS) are two newly developed, multidimensional instruments that measure expectations and satisfaction with community-based psychiatric services (CPS) in patients, relatives and professionals. This paper reports on the acceptability, sensitivity and content validity of the VECS and VSSS in 75 patients and 76 relatives attending the South-Verona CPS. The acceptability of the VECS and the VSSS to subjects was good: most items were easily understood and the vast majority of subjects cooperated and gave accurate evaluations. The VECS and VSSS proved to be sensitive to variation both between groups and across dimensions. We demonstrated that the VECS and VSSS questionnaires had a higher sensitivity than unstructured interviews in measuring service expectations and satisfaction and that a domain-specific measurement had a higher sensitivity than an overall one. The content validity of the questionnaires, according to patients' and relatives' views, was very good. We demonstrated that a key characteristic of the content validity was the questionnaire's multidimensionality, with major contributions from the dimensions "Professionals' Skills and Behaviour" and "Types of Intervention". The findings presented in this paper constitute the first complete study available in the literature on the psychometric properties of the measurement of expectations and satisfaction in a psychiatric setting. They indicated that it is possible to measure such subjective aspects in an acceptable, sensitive and valid way and that the VECS and VSSS have good psychometric properties. The data presented appear promising in the qualitative evaluation of the South-Verona CPS and the method should be of interest to those evaluating CPS in other settings.

Collecting psychiatric resources utilisation data to calculate costs of care: a comparison between a service receipt interview and a case register.

BACKGROUND: Economic assessment of interventions and policies is becoming increasingly common, in large measure because of the growing emphasis on cost containment within health care. Comprehensive and reliable outcome and cost data are required to advise policy makers and clinicians as to the best use of their limited resources. The process of costing can be broken down into three connected tasks: the collection of service receipt or utilisation data relative to individual clients or patients over a defined period; the costing of each of the services used; and the combination of these two sets of information in order to calculate individual costs. The aim of this study was to compare two methodologies of collecting data on individual service use - a customized interview schedule, ICAP, and the psychiatric case register (PCR) - and to calculate costs, testing the extent of agreement between them. METHOD: The agreement between the ICAP and the PCR costs measurement was evaluated using the concordance correlation coefficient rho(c). From all patients (n = 543) who had at least one contact with a psychiatrist or a psychologist during the period October-December 1996, 339 patients were interviewed using the ICAP. The overall number of patients in contact with the South-Verona CPS in the same period was 630. RESULTS: The agreement between the two sources was very different for each diagnostic group and each professional category. However, the overall agreement on total costs was satisfactory (rho(c) < 0.95). This result is probably due to the effect of the good agreement observed on more costly services: inpatient care and sheltered accommodation. CONCLUSION: The results suggested practical implications for the use of the service receipt interview: interviewers should be trained in order to avoid misinterpretation of the definitions given in the form; the sources of information should be clearly defined to tease out all the items of services provided for the users; the professionals (i.e. psychiatrists) could influence the reliability of data collection by underestimating services provided by different professionals (nurses, social workers, etc.). The findings confirm that it is possible to use this approach when the aim is to estimate the whole cost of the services; however, the importance of adopting adequate procedures for analysing the complexity of cost components should be pointed out. Only a trained interviewer who thoroughly knows each component of the health and social services provided could guarantee an accurate data collection.

Mortality among patients with psychiatric illness. A ten-year case register study in an area with a community-based system of care.

BACKGROUND: Most studies which showed an excess mortality in psychiatric patients have been conducted on hospitalised samples. METHOD: This was a case register study. All South Verona patients with an ICD diagnosis who had psychiatric contacts with specialist services in 1982-1991 were included. Mortality was studied in relation to sex, age, diagnosis, pattern of care and interval from registration. Standardised Mortality Rates (SMRs) and Poisson regression analysis were calculated. RESULTS: The overall SMR was 1.63 (95% Cl = 1.5-1.8), which is the lowest value reported so far. Mortality was higher among men (SMR = 2.24; 95% Cl = 1.9-2.6), among patients who were admitted to hospital (SMR = 2.23; 95% Cl = 1.9-2.6), among younger age groups (SMR = 8.82; 95% Cl = 4.9-14.6) and in the first year after registration (SMR = 2.32; 95% CL = 1.8-2.9). Higher mortality was found in patients with a diagnosis of alcohol and drug dependence (SMR = 3.87; 95% Cl = 3.0-4.9). The SMR for suicide was 17.41. Using a Poisson regression model, diagnosis, pattern of care and interval from registration were all found to be significantly associated with mortality. When all these variables were entered together in the model, each maintained its predictive role. CONCLUSIONS: The overall mortality of psychiatric patients treated in a community-based system of care was higher than expected, but lower than the mortality reported in other psychiatric settings. The highest mortality risk was found in the first year after registration.

[For a more rational funding system of mental health services. Analyses of costs for services supplied by community mental health services during a 7-year period]. / Per un più razionale sistema di finanziamento dei Dipartimenti di Salute Mentale. Analisi dei costi delle prestazioni erogate da un Servizio Psichiatrico Territoriale in un periodo di 7 anni.

AIMS: In the last years, in Italy as well as in many other developed countries, there has been a growing interest for health economics by researchers. As for as the psychiatric care is concerned, more recently, many research's groups have pointed their attention on new possible funding systems for mental health services and on their effects on services' functioning. The aim of this study is to define a new list of services' costs based on services actually delivered by a Community Mental Health Service (CMHS). METHODS: All psychiatric contacts recorded by the South-Verona Psychiatric Case Register during a 7-year period (1992-1998) have been included in the study (125,623 contacts made by 2,819 patients). Contacts were grouped into 19 type of services. The cost function methodology was used to describe, also reporting elasticity values, costs' behaviour in the South-Verona CMHS. The cost of each service includes expenses for professionals involved (directly or indirectly) in the contacts with the patients and capital costs. RESULTS: For each service were reported a) the cost of the service as it is actually supplied in our CMHS, b) the cost per minute, c) an estimate of the cost of service delivered with standard modalities (duration equal to the mode value registered; staff composition take into account either the actual functioning of the CMHS either indication about a good clinical practice) and, finally, d) cost of the eight services included into the reimbursement system currently in use in Italy. CONCLUSIONS: Our results showed that services' definition used in this study allow to describe different types of psychiatric care supplied from the South-Verona CMHS. The national list currently adopted for the reimbursement in Italy should allowed to describe only 28% of the registered psychiatric contacts (35,230 vs. 125,632). The urgent need for a new list of psychiatric services, accepted at a national level, was confirmed. Cost values obtained clearly show that the funding system currently used underestimates the true costs of care delivered by the CMHS. The cost function makes available a tool to test a prospective per-capita funding system as provided in the Act No. 229 of the Italian Government.

Definition and prevalence of severe and persistent mental illness.

BACKGROUND: There is little consistency in how severe mental illness (SMI) is defined in practice, and no operational definitions. AIMS: To test two operationalized definitions, based on the National Institute of Mental Health (1987) definition: the first uses three criteria (diagnosis of psychosis; duration of service contact > or = 2 years; GAF score < or = 50), the second only the last two. METHOD: Annual prevalence rates of SMI in two European catchment areas for each criterion and the criteria combined were calculated. RESULTS: The first definition produced rates of 2.55 and 1.34/1000 in London and Verona, respectively; the second permitted an additional 0.98/1000 non-psychotic disorders to be included in Verona. CONCLUSIONS: The three-dimensional definition selects a small group of patients with SMI who have psychotic disorders. The two-dimensional approach allows estimates of SMI prevalence rates which include all forms of mental disorder.

Community-based mental health care: to what extent are service costs associated with clinical, social and service history variables?

BACKGROUND: The growing movement in many European countries towards capitation-based systems for financing mental health care has generated increasing interest in developing appropriate models capitation formulae. The aims of the study were: to detect and compare any differences in service costs between patients with different diagnoses; and to analyse the associations between patient characteristics and service costs. METHODS: All patients in contact with the South-Verona Community Mental Health Service during the last quarter of 1996 were included in the study. Clinical and service-related variables were collected at first index contact; 3 months later, patients were interviewed using the Client Services Recipient Interview. For those who completed both the clinical assessments and the services receipt schedule (N = 339), 1-year psychiatric and non-psychiatric direct care costs were calculated. Weighted backward regression analyses were performed. RESULTS: The most significant variables associated with psychiatric costs were: admission to hospital in the previous year; intensity and duration of previous contacts with South-Verona CMHS; being unemployed; having a diagnosis of affective disorder; and, Global Assessment of Functioning score. The final model explained 66% of the variation in costs of psychiatric care and 13 % of variation in non-psychiatric medical costs. CONCLUSIONS: The model presented in this study explains a higher degree of cost variance than previously published studies. In community-based services more resources are targeted towards the most disabled patients. Previous psychiatric history (number of admissions in the previous year and intensity of psychiatric contacts lifetime) is strongly associated with psychiatric costs.

Determinants of subjective quality of life in patients attending community-based mental health services. The South-Verona Outcome Project 5.

OBJECTIVE: Investigate the relationship of various domains of quality of life (QoL) with socio-demographics, clinical and social characteristics, service use and satisfaction in a representative sample of patients in contact with the South-Verona community mental health service. METHOD: Measures included: Lancashire Quality of Life Profile (LQOLP), demographics, diagnosis and service utilization data from the Case Register, Brief Psychiatric Rating Scale (BPRS), Disability Assessment Schedule (DAS), Global Assessment of Functioning (GAF) and Verona Service Satisfaction Scale (VSSS). Analyses were conducted using a block-stratified multiple regression model. RESULTS: Demographics, diagnosis, psychopathology, disability, functioning and service use together explained different amounts of variance in each LQOLP domain, but always less than 14%. VSSS explained more variance than any other indicator in health (13.1%), social relations (12.1%), leisure/participation (9.1%), and general wellbeing (9.0%). CONCLUSION: Different domains of QoL are predicted by different indicators. In some important domains, self-perceived satisfactory and effective care might have an impact on the QoL of patients.

Validity and test-retest reliability of the Italian version of the 12-item General Health Questionnaire in general practice: a comparison between three scoring methods.

Validity coefficients of the 12-item General Health Questionnaire (GHQ-12) were established against the Clinical Interview Schedule (CIS) in a sample of primary care patients. Comparison between the conventional scoring method, Likert scoring, and the revised scoring procedure proposed by Goodchild and Duncan-Jones (C-GHQ) showed very similar screening properties: sensitivity ranged between 71% and 75%, and specificity ranged between 73% and 76%. The test-retest reliability of the GHQ-12, as expressed by Pearson's r and intraclass correlation coefficient, was satisfactory irrespective of the scoring method used, even though mean scores on the second test tended to be significantly lower than the corresponding mean scores on the first test. The C-GHQ by itself did not result in an improvement of the screening capacity of the GHQ; however, the best results were obtained by combining the conventional scoring and C-GHQ case criteria.

Episodes of care for first-ever psychiatric patients. A long-term case-register evaluation in a mainly urban area.

BACKGROUND: Psychiatric case registers (PCRs) are particularly useful for studying patterns of care over time. Methods of 'survival analysis' have rarely been used for assessing such data. METHOD: A longitudinal study was conducted over 10 years (1 January 1982 to 31 December 1991) on 1423 first-ever psychiatric patients, using the PCR of South Verona, Italy. The product-limit method, the log-rank test, the Cox regression model and the Poisson regression analysis were used to analyse episodes of care and relapses. RESULTS: The duration of the episodes of care increased consistently from the first to the fifth episode. The probability of opening a new episode of care after the first one increased consistently from the second to the sixth episode. The only variable significantly associated with the length of the first episode of care was diagnosis (highest probability of having longer episodes for schizophrenic patients), while the length of the breaks following the first episode of care was associated with diagnosis, sex and occupational status (highest probability of opening a second episode of care for schizophrenic subjects and those with alcohol and personality disorders, for males, and for unemployed patients). The probability of opening a new episode of care decreased with time since last contact and increased with number of previous contacts. CONCLUSIONS: The community psychiatric service in South Verona is fulfilling its original aim, that is, to give priority to the continuity of care for patients with chronic and severe mental illnesses. Survival analyses proved to be useful methods for assessing episodes of care.

Frequency of contact with community-based psychiatric services and the lunar cycle: a 10-year case-register study.

The relationship between the lunar cycle and the frequency of contact with community-based psychiatric services was assessed using the South Verona Psychiatric Case Register data. For each day of the study period (January 1982-December 1991) we recorded the number of contacts made by South Verona residents with psychiatric services and the corresponding day of the lunar cycle. First, the synodic month was divided into four interval phases (usually called new moon, first quarter, full moon and third quarter), and interphase differences in the mean number of contacts were tested using one-way analysis of variance. Second. the null hypothesis of no relationship between the lunar cycle and the frequency of contact with psychiatric services was tested against the alternative hypothesis of a sinusoidal distribution according to the lunar phase. The average number of contacts with psychiatric services on each day of the lunar cycle over the 10-year period was obtained and a sine-wave curve was fitted to the data. Both for total and drop-in contacts, no significant differences in mean number of contacts were found between the four interval phases of the synodic month (new moon, first quarter, full moon and third quarter). Similarly, no significant results were found by setting the expected surge in consultations at 1-3 days after the full moon and the period of the sine-wave curve equal to 30 days. When the period of the sine-wave curve was allowed to vary in order to fit the data best, none of the statistical tests reached the level of significance required to dismiss the possibility of false-positive results. These findings did not support the theory that a relationship exists between the lunar cycle and the frequency of contact with community-based psychiatric services.

Six-month and 12-month mental health outcome of medical and surgical patients admitted to general hospital.

BACKGROUND: We have recently reported a two-phase study on psychiatric morbidity in a sample of general hospital patients. This paper reports the results of the 6-month and 12-month follow-up of these patients. METHODS: The screening questionnaire was the GHQ-12. The main diagnostic instrument used in the second phase was the CIDI-PHC. All patients who had been interviewed with CIDI-PHC (N = 363) were followed-up and the baseline assessment was compared with the scoring on questionnaires administered in the 6-month postal enquiry and with the psychopathological status at 12-month, elicited with a telephone structured interview. RESULTS: Sixty-two and 87% of patients completed the 6- and 12-month follow-up assessment respectively. The first follow-up indicated no significant decrease in the level of symptoms. The 12-month follow-up interview showed that 23% of males and 40% of females had poor/mostly poor mental health. The logistic model showed that females with a definite ICD-10 diagnosis, admitted to a medical department, who had consumed psychotropic drugs in the previous year, had the most unfavourable outcome. The risk of a poor/mostly poor outcome steadily increased with the severity of the psychopathology during hospitalization. CONCLUSION: In medical and surgical general hospital patients the risk factors associated with a poor mental health outcome are similar to those found in primary care patients. Greater attention should be paid in assessing routinely mental health status of general hospital patients during hospitalization.

Evaluating psychiatric morbidity in a general hospital: a two-phase epidemiological survey.

BACKGROUND: This study aimed to assess psychiatric morbidity and to collect information on disability, life events and family support in a representative sample of patients admitted to a general hospital. METHODS: On the basis of information collected in a pilot study a systematic sample of patients consecutively admitted to seven general medical and seven surgical wards of the Academic General Hospital of Verona was selected and interviewed using a two-phase screening procedure and standardized instruments (GHQ-12, HADS, BDQ and CIDI-PHC). All data were analysed using appropriately weighted logistic regression procedures. RESULTS: A total of 1039 patients completed the GHQ-12 and 298 (28.7%) were high-scorers: 363 patients were interviewed with CIDI-PHC. The prevalence of ICD-10 cases was 26.1%. The most common psychiatric diagnoses were current depression (12.8%) and generalized anxiety disorder (10.8%), followed by alcohol related disorders (5 %). A higher prevalence of ICD-10 cases was found in medical wards, among females, patients older than 24 years, unemployed and separated/divorced people. Life events were associated with psychopathology, and so was the number of disability days. Although 49.8% of ICD-10 cases were identified by the hospital doctors as having a psychological disorder, 23.1% of ICD-10 cases were referred to the liaison psychiatric service. CONCLUSION: The results of the present study stress the need to collect epidemiologically-based data on psychological disorders and their recognition not only in general practice, but also in general hospital settings, in order to have a more complete picture of the pathways to specialist care.