RESUMO
Although hypertension is the leading cause of cardiovascular disease and premature death worldwide, it remains difficult to control. The prevalence of uncontrolled and resistant hypertension (RH) may be underestimated and can reach up to 50% of all hypertensive patients. The aim of this observational study was to analyze the prevalence of hypertension, uncontrolled hypertension and RH, and their associations with risk factors or diseases in a large cohort of patients referred to primary care physician. In a population of 228406 adults, we only collected data from people with a diagnosis of arterial hypertension for a total of 43,526 patients. For this purpose, we used the MySQL database, run by Azalea.NET, built on the medical records of 150 General Practitioners (GPs). Patient data included sex, age, blood pressure (BP) values, number of antihypertensive drugs and presence of major cardiovascular comorbidities. We classified patients with RH as those treated with 3 different antihypertensive agents, with recorded BP ≥ 140/90 mmHg, or patients taking ≥ 4 medications. The prevalence of hypertension was 19.06%, that of resistant hypertension was 2.46% of the whole population and 20.85% of the hypertensive group. Thirteen thousand hundred, forty-six patients (30.20% of the hypertensive group) had uncontrolled BP (≥ 140/90 mmHg), whereas 16,577 patients did not have BP measurements done in the last 2 years (38.09% of the hypertensive group). Patients with uncontrolled BP were mainly female, used less drugs and showed a lower prevalence of all major cardiovascular comorbidities, except for diabetes. Instead, patients with RH had a significantly higher prevalence of all considered comorbidities compared to those without RH. Our results evidence that a broad number of patients with hypertension, especially those without comorbidities or with a low number of antihypertensive drugs, do not achieve adequate BP control. To improve the clinical management of these patients it is very important to increase the collaboration between GPs and clinical specialists of hypertension.
Assuntos
Doenças Cardiovasculares , Hipertensão , Humanos , Adulto , Feminino , Masculino , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/farmacologia , Prevalência , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Pressão Sanguínea , Doenças Cardiovasculares/tratamento farmacológico , Fatores de RiscoRESUMO
BACKGROUND: Among healthcare professionals working with COVID-19 patients, general practitioners (GPs) are under considerable pressure and may develop adverse mental health outcomes. OBJECTIVES: To assess mental health outcomes on GPs working during the COVID-19 pandemic and to explore their associations with personal characteristics and features of GP practices. METHODS: Observational cross-sectional study conducted on a sample of GPs working in Verona province (Italy) during the first pandemic wave. Participants were invited to complete a web-based form addressing socio-demographic and work-related information, previous practice organization, practice re-organization during the COVID-19 pandemic, and a set of measures for post-traumatic stress (IES-R), anxiety (SAS), depression (PHQ-9), and burnout (MBI-GS). RESULTS: A total of 215 GPs (38.3% of the eligible population) participated. Overall, 44.7% reported COVID-19-related traumatic events; among these, 35.9% (95% CI, 26%â46%) developed symptoms of post-traumatic distress. Furthermore, 36% (95% CI, 29%â43%) reported symptoms of anxiety, 17.9% (95% CI, 12%â23%) symptoms of at least moderate depression, and 25.4% (95% CI, 19%â32%) symptoms of burnout. Multivariate regressions showed that being quarantined or admitted for COVID-19 was associated with all the mental health outcomes considered. Being female, working in rural settings, and having less professional experience were associated with higher anxiety and depression. The ability to diagnose COVID-19 increased self-perceived professional efficacy, thus contributing to burnout reduction. CONCLUSION: The high prevalence of adverse mental health outcomes among GPs during the pandemic highlights the importance of timely interventions in this population and promoting targeted preventive actions in the event of future healthcare crises.
Assuntos
COVID-19 , Clínicos Gerais , Médicos de Atenção Primária , Ansiedade/epidemiologia , Estudos Transversais , Depressão/epidemiologia , Feminino , Pessoal de Saúde , Humanos , Pandemias , SARS-CoV-2RESUMO
BACKGROUND: The use of e-learning, defined as any educational intervention mediated electronically via the Internet, has steadily increased among health professionals worldwide. Several studies have attempted to measure the effects of e-learning in medical practice, which has often been associated with large positive effects when compared to no intervention and with small positive effects when compared with traditional learning (without access to e-learning). However, results are not conclusive. OBJECTIVES: To assess the effects of e-learning programmes versus traditional learning in licensed health professionals for improving patient outcomes or health professionals' behaviours, skills and knowledge. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, five other databases and three trial registers up to July 2016, without any restrictions based on language or status of publication. We examined the reference lists of the included studies and other relevant reviews. If necessary, we contacted the study authors to collect additional information on studies. SELECTION CRITERIA: Randomised trials assessing the effectiveness of e-learning versus traditional learning for health professionals. We excluded non-randomised trials and trials involving undergraduate health professionals. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, extracted data and assessed risk of bias. We graded the certainty of evidence for each outcome using the GRADE approach and standardised the outcome effects using relative risks (risk ratio (RR) or odds ratio (OR)) or standardised mean difference (SMD) when possible. MAIN RESULTS: We included 16 randomised trials involving 5679 licensed health professionals (4759 mixed health professionals, 587 nurses, 300 doctors and 33 childcare health consultants).When compared with traditional learning at 12-month follow-up, low-certainty evidence suggests that e-learning may make little or no difference for the following patient outcomes: the proportion of patients with low-density lipoprotein (LDL) cholesterol of less than 100 mg/dL (adjusted difference 4.0%, 95% confidence interval (CI) -0.3 to 7.9, N = 6399 patients, 1 study) and the proportion with glycated haemoglobin level of less than 8% (adjusted difference 4.6%, 95% CI -1.5 to 9.8, 3114 patients, 1 study). At 3- to 12-month follow-up, low-certainty evidence indicates that e-learning may make little or no difference on the following behaviours in health professionals: screening for dyslipidaemia (OR 0.90, 95% CI 0.77 to 1.06, 6027 patients, 2 studies) and treatment for dyslipidaemia (OR 1.15, 95% CI 0.89 to 1.48, 5491 patients, 2 studies). It is uncertain whether e-learning improves or reduces health professionals' skills (2912 health professionals; 6 studies; very low-certainty evidence), and it may make little or no difference in health professionals' knowledge (3236 participants; 11 studies; low-certainty evidence).Due to the paucity of studies and data, we were unable to explore differences in effects across different subgroups. Owing to poor reporting, we were unable to collect sufficient information to complete a meaningful 'Risk of bias' assessment for most of the quality criteria. We evaluated the risk of bias as unclear for most studies, but we classified the largest trial as being at low risk of bias. Missing data represented a potential source of bias in several studies. AUTHORS' CONCLUSIONS: When compared to traditional learning, e-learning may make little or no difference in patient outcomes or health professionals' behaviours, skills or knowledge. Even if e-learning could be more successful than traditional learning in particular medical education settings, general claims of it as inherently more effective than traditional learning may be misleading.
Assuntos
Educação a Distância/métodos , Pessoal de Saúde/educação , Internet , Competência Clínica , Pessoal de Saúde/estatística & dados numéricos , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Studies on data collection and quality of care in Italian family medicine are lacking. The aim of this study was to assess the completeness of data collection of patients with diabetes in a large sample of family physicians in the province of Verona, Veneto region, a benchmark for the Italian National Health System. METHODS: We extracted the data on all the patients with diabetes from the electronic health records of 270 family physicians in 2006 and 2009. We reported the percentage of patients with data recorded for 12 indicators of performance derived from the National Institute for Clinical Excellence diabetes guidelines. Secondarily, we assessed quality of care using the Q-score (the lower the score, the greater the risk of cardiovascular events). RESULTS: Patients with diabetes were 18,507 in 2006 and 20,744 in 2009, and the percentage of patients registered as having diabetes was 4.9% and 5.4% of the total population, respectively (p < 0.001). Data collection improved for all the indicators between 2006 and 2009 but the performance was still low at the end of the study period: patients with no data recorded were 42% in 2006 and 32% in 2009, while patients with data recorded for ≥5 indicators were 9% in 2006 and 17% in 2009. The Q-score improved (mean ± SD, 20.7 ± 3.0 in 2006 vs 21.3 ± 3.6 in 2009, p < 0.001) but most patients were at increased risk of cardiovascular events in both years (Q-score ≤ 20). CONCLUSIONS: We documented an improvement in data collection and quality of care for patients with diabetes during the study period. Nonetheless, data collection was still unsatisfactory in comparison with international benchmarks in 2009. Structural interventions in the organization of family medicine, which have not been implemented since the study period, should be prioritised in Italy.
Assuntos
Coleta de Dados , Diabetes Mellitus/epidemiologia , Medicina de Família e Comunidade , Qualidade da Assistência à Saúde , Adulto , Idoso , Diabetes Mellitus/tratamento farmacológico , Registros Eletrônicos de Saúde , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Médicos de Família , Indicadores de Qualidade em Assistência à SaúdeRESUMO
BACKGROUND: Interferons-beta (IFNs-beta) and glatiramer acetate (GA) were the first two disease-modifying therapies (DMTs) approved 20 years ago for the treatment of multiple sclerosis (MS). DMTs' prescription rates as first or switching therapies and their costs have both increased substantially over the past decade. As more DMTs become available, the choice of a specific DMT should reflect the risk/benefit profile, as well as the impact on quality of life. As MS cohorts enrolled in different studies can vary significantly, head-to-head trials are considered the best approach for gaining objective reliable data when two different drugs are compared. The purpose of this systematic review is to summarise available evidence on the comparative effectiveness of IFNs-beta and GA on disease course through the analysis of head-to-head trials.This is an update of the Cochrane review 'Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis' (first published in the Cochrane Library 2014, Issue 7). OBJECTIVES: To assess whether IFNs-beta and GA differ in terms of safety and efficacy in the treatment of people with relapsing-remitting (RR) MS. SEARCH METHODS: We searched the Trials Register of the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group (08 August 2016) and the reference lists of retrieved articles. We contacted authors and pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing directly IFNs-beta versus GA in study participants affected by RRMS. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by Cochrane. MAIN RESULTS: Six trials were included and five trials contributed to this review with data. A total of 2904 participants were randomly assigned to IFNs (1704) and GA (1200). The treatment duration was three years for one study, two years for the other four RCTs while one study was stopped early (after one year). The IFNs analysed in comparison with GA were IFN-beta 1b 250 mcg (two trials, 933 participants), IFN-beta 1a 44 mcg (three trials, 466 participants) and IFN-beta 1a 30 mcg (two trials, 305 participants). Enrolled participants were affected by active RRMS. All studies were at high risk for attrition bias. Three trials are still ongoing, one of them completed.Both therapies showed similar clinical efficacy at 24 months, given the primary outcome variables (number of participants with relapse (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.87 to 1.24) or progression (RR 1.11, 95% CI 0.91 to 1.35). However at 36 months, evidence from a single study suggests that relapse rates were higher in the group given IFNs than in the GA group (RR 1.40, 95% CI 1.13 to 1.74, P value 0.002).Secondary magnetic resonance imaging (MRI) outcomes analysis showed that effects on new or enlarging T2- or new contrast-enhancing T1 lesions at 24 months were similar (mean difference (MD) -0.15, 95% CI -0.68 to 0.39, and MD -0.14, 95% CI -0.30 to 0.02, respectively). However, the reduction in T2- and T1-weighted lesion volume was significantly greater in the groups given IFNs than in the GA groups (MD -0.58, 95% CI -0.99 to -0.18, P value 0.004, and MD -0.20, 95% CI -0.33 to -0.07, P value 0.003, respectively).The number of participants who dropped out of the study because of adverse events was similar in the two groups (RR 0.95, 95% CI 0.64 to 1.40).The quality of evidence for primary outcomes was judged as moderate for clinical end points, but for safety and some MRI outcomes (number of active T2 lesions), quality was judged as low. AUTHORS' CONCLUSIONS: The effects of IFNs-beta and GA in the treatment of people with RRMS, including clinical (e.g. people with relapse, risk to progression) and MRI (Gd-enhancing lesions) measures, seem to be similar or to show only small differences. When MRI lesion load accrual is considered, the effect of the two treatments differs, in that IFNs-beta were found to limit the increase in lesion burden as compared with GA. Evidence was insufficient for a comparison of the effects of the two treatments on patient-reported outcomes, such as quality-of-life measures.
Assuntos
Adjuvantes Imunológicos/uso terapêutico , Acetato de Glatiramer/uso terapêutico , Interferon beta-1a/uso terapêutico , Interferon beta-1b/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Humanos , Imageamento por Ressonância Magnética , Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem , Esclerose Múltipla Recidivante-Remitente/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , RecidivaRESUMO
OBIETTIVI: descrivere, nella ASL 21 di Legnago (VR), l'andamento di alcuni indicatori sanitari tra il 2009, anno precedente all'avvio di un progetto triennale per la gestione integrata dell'assistenza al paziente con diabete mellito di tipo 2, e il 2012, ultimo anno del progetto. DISEGNO: studio longitudinale trasversale ripetuto. SETTING E PARTECIPANTI: tutti i pazienti diabetici di tipo 2 della ASL 21, identificati nei database aziendali (in base a esenzioni per patologia, accessi al servizio diabetologico, consumo di farmaci antidiabetici e strisce per la determinazione della glicemia) e nelle cartelle cliniche dei medici di famiglia. PRINCIPALI MISURE DI OUTCOME: numero di test diagnostici e di follow-up erogati, consumo di farmaci, prestazioni specialistiche, accessi al pronto soccorso, ricoveri e mortalità. RISULTATI: nonostante un calo generalizzato (-3,1%) nei test erogati dalla ASL 21 ai suoi assistititi nel periodo 2009-2012, l'analisi ha documentato un marcato aumento per gli esami previsti nella gestione del diabete, quali curve da carico glicemico (+104,3%), emoglobina glicata (+19,0%) e microalbuminuria (+296,1%). I soggetti identificati come diabetici sono aumentati da 8.084 nel 2009 (5,2%) a 9.221 nel 2012 (5,9%). Sono stati osservati aumenti nella prevalenza di pazienti visitati presso un servizio diabetologico (dal 22,6% al 39,0%), nonché negli utilizzatori di metformina (dal 28,0% al 37,5%), insuline (dal 13,5% al 18,3%) e incretine (dall'1,4% al 9,0%). Il consumo di sulfaniluree è, invece, calato (dal 49,9% al 40,8%), come anche l'erogazione di alcune prestazioni specialistiche, gli accessi al pronto soccorso e i ricoveri, mentre il tasso di mortalità è rimasto stabile (29,6 decessi x1.000/anno). CONCLUSIONE: durante il periodo di implementazione del progetto sembra essersi verificato un aumento della sensibilità diagnostica e una maggiore presa in carico del paziente diabetico. Anche se la natura osservazionale dello studio non consente di dimostrare una relazione causa-effetto, i risultati sembrano supportare l'ipotesi che la gestione integrata della patologia migliori l'appropriatezza dell'assistenza.
Assuntos
Diabetes Mellitus Tipo 2/terapia , Atenção Primária à Saúde , Estudos Transversais , Diabetes Mellitus Tipo 2/epidemiologia , Seguimentos , Humanos , Itália/epidemiologia , Estudos Longitudinais , Médicos de Família , Prevalência , Medição de Risco , Resultado do TratamentoRESUMO
We evaluated the quality of telephone triage and the appropriateness of the decisions resulting from it at a primary care out-of-hours service. Four simulated clinical cases were used in the Incognito Standardized Patient method: an adult with nosebleed, an adult with fever, a child with fever and a child with vomiting. There was a set of obligatory questions for each case, translated from those used in a previous study. Quality was assessed by the proportion of questions asked by the call-handlers during telephone triage versus those that should have been asked. A total of 22 out-of-hours doctors were involved in the study, working in two different locations in the Verona city area. Over a 4-month period each of the four simulated clinical cases was used five times in calls to the two centres involved. The proportion of obligatory questions asked compared to those expected to be asked was 27-36%. On three occasions out of the 40 simulations, all of which were considered to be manageable by telephone, the patient was advised to go to an outpatient clinic for a face-to-face evaluation. The average duration of the calls was 3 min 47 s. The quality of telephone triage in the regions studied was low and provided considerable room for improvement. This is relevant to patient safety and risk management of the service.
Assuntos
Plantão Médico/normas , Atenção Primária à Saúde/organização & administração , Qualidade da Assistência à Saúde/normas , Telefone , Triagem/normas , Adulto , Plantão Médico/métodos , Criança , Competência Clínica , Estudos Transversais , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Atenção Primária à Saúde/normas , Triagem/métodosRESUMO
Interferon ß (INFß) and glatiramer acetate (GA) are widely used in patients with relapsing-remitting multiple sclerosis (RRMS). However, it is still unclear whether they have different efficacy. We performed a systematic search of head-to-head trials for gaining objective reliable data to compare the two drugs, using the Cochrane Collaboration methodology. We identified five randomised-controlled trials (RCTs) (2858 participants) comparing directly INFß versus GA in RRMS. All studies were at high risk for attrition bias. Both therapies showed similar efficacy at 24â months, considering clinical (patients with relapse or progression) and one MRI activity (enhancing lesions) measure. At 3â years, evidence from a single study showed that the relapse rate was higher in the INFß group than in the GA group (risk ratio 1.40, 95% CI 1.13 to 1.74, p 0.002). However, the average reduction in T2-weighted and T1-weighted lesion volume was significantly greater in the INFß group than in the GA group (mean difference (MD) -0.58, 95% CI -0.99 to -0.18, p 0.004, and MD -0.20, 95% CI -0.33 to -0.07, p 0.003, respectively). The number of participants who dropped out of the studies because of adverse events was similar in the two groups. These data support clinicians in the use of these therapies, based on their similar safety and efficacy in the prevention of disease activity, although the different effect on MRI measures and the different tolerability might have a role in the therapeutic choice at the individual level.
Assuntos
Interferon beta/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Peptídeos/uso terapêutico , Progressão da Doença , Acetato de Glatiramer , Humanos , Imageamento por Ressonância Magnética , Esclerose Múltipla Recidivante-Remitente/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Substância Branca/patologiaRESUMO
We systematically reviewed randomized controlled trials (RCTs) assessing the effectiveness of computerized decision support systems (CDSSs) featuring rule- or algorithm-based software integrated with electronic health records (EHRs) and evidence-based knowledge. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Abstracts of Reviews of Effects. Information on system design, capabilities, acquisition, implementation context, and effects on mortality, morbidity, and economic outcomes were extracted. Twenty-eight RCTs were included. CDSS use did not affect mortality (16 trials, 37395 patients; 2282 deaths; risk ratio [RR] = 0.96; 95% confidence interval [CI] = 0.85, 1.08; I(2) = 41%). A statistically significant effect was evident in the prevention of morbidity, any disease (9 RCTs; 13868 patients; RR = 0.82; 95% CI = 0.68, 0.99; I(2) = 64%), but selective outcome reporting or publication bias cannot be excluded. We observed differences for costs and health service utilization, although these were often small in magnitude. Across clinical settings, new generation CDSSs integrated with EHRs do not affect mortality and might moderately improve morbidity outcomes.
Assuntos
Técnicas de Apoio para a Decisão , Registros Eletrônicos de Saúde , Mortalidade/tendências , Garantia da Qualidade dos Cuidados de Saúde , Algoritmos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , SoftwareRESUMO
BACKGROUND: Computerized clinical decision support systems (CDSSs) have been shown to improve the efficiency and quality of patient care by connecting healthcare professionals with high quality, evidence-based information at the point-of-care. The mere provision of CDSSs, however, does not guarantee their uptake. Rather, individual and institutional perceptions can foster or inhibit the integration of CDSSs into routine clinical workflow. Current studies exploring health professionals' perceptions of CDSSs focus primarily on technical and usability issues, overlooking the social or cultural variables as well as broader administrative or organizational roles that may influence CDSS adoption. Moreover, there is a lack of data on the evolution of perceived barriers or facilitators to CDSS uptake across different stages of implementation. METHODS: We will conduct a qualitative, cross-sectional study in three Italian specialty hospitals involving frontline physicians, nurses, information technology staff, and members of the hospital board of directors. We will use semi-structured interviews following the Grounded Theory framework, progressively recruiting participants until no new information is gained from the interviews. DISCUSSION: CDSSs are likely to become an integral and diffuse part of clinical practice. Various factors must be considered when planning their introduction in healthcare settings. The findings of this study will guide the development of strategies to facilitate the successful integration of CDSSs into the regular clinical workflow. The evaluation of diverse health professionals across multiple hospital settings in different stages of CDSS uptake will better capture the complexity of roles and contextual factors affecting CDSS uptake.
Assuntos
Sistemas de Apoio a Decisões Clínicas , Hospitais Especializados/métodos , Estudos Transversais , Sistemas de Apoio a Decisões Clínicas/organização & administração , Sistemas de Apoio a Decisões Clínicas/estatística & dados numéricos , Sistemas de Informação Hospitalar , Humanos , Entrevistas como Assunto , Itália , Projetos de Pesquisa , Transferência de TecnologiaRESUMO
BACKGROUND: Interferons (IFNs)-beta and glatiramer acetate (GA) were the first two disease-modifying therapies (DMTs) approved 15 years ago for the treatment of multiple sclerosis (MS). DMTs prescription rates as first or switching therapies and their costs have increased substantially over the past decade. As more DMTs become available, the choice of a specific DMT should reflect the risk/benefit profile, as well as the impact on quality profile. As MS cohorts enrolled in different studies can vary significantly, head-to-head trials are considered the best approach for gaining objective reliable data when two different drugs are compared. The purpose of this study is to summarise available evidence on the comparative effectiveness of IFNs-beta and GA on disease course through a systematic review of head-to-head trials. OBJECTIVES: To assess whether IFNs-beta and GA differ in terms of safety and efficacy in the treatment of patients with relapsing-remitting MS (RRMS). SEARCH METHODS: We searched the Trials Specialised Register of the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group (29 October 2013) and the reference lists of retrieved articles. We contacted trialists and pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing directly IFNs-beta versus GA in study participants affected by RRMS. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by The Cochrane Collaboration. MAIN RESULTS: Five trials contributed to this review. A total of 2858 participants were randomly assigned to IFNs (1679) and GA (1179). The treatment duration was three years for one study and two years for the other four RCTs. The IFNs analysed in comparison with GA were IFN-beta 1b 250 mcg (two trials, 933 participants), IFN-beta 1a 44 mcg (two trials, 441 participants) and IFN-beta 1a 30 mcg (two trials, 305 participants). Enrolled participants were affected by active RRMS. All studies were at high risk for attrition bias.Both therapies showed similar clinical efficacy at 24 months, given the primary outcome variables (number of participants with relapse (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.87 to 1.24) or progression (RR 1.11, 95% CI 0.91 to 1.35)). However at 36 months, evidence from a single study suggests that relapse rates were higher in the group given IFNs than in the GA group (RR 1.40, 95% CI 1.13 to 1.7, P value 0.002).Secondary magnetic resonance imaging (MRI) outcomes analysis showed that effects on new or enlarging T2- or gadolinium (Gd)-enhancing lesions at 24 months were similar (mean difference (MD) -0.01, 95% CI -0.28 to 0.26, and MD -0.14, 95% CI -0.30 to 0.02, respectively). However, the reduction in T2- and T1-weighted lesion volume was significantly greater in the groups given IFNs than in the GA groups (MD -0.58, 95% CI -0.99 to -0.18, P value 0.004, and MD -0.20, 95% CI -0.33 to -0.07, P value 0.003, respectively).The number of participants who dropped out of the study because of adverse events was similar in the two groups (RR 0.95, 95% CI 0.64 to 1.40).The quality of evidence for primary outcomes was judged as moderate for clinical end points, but for safety and some MRI outcomes (number of active T2 lesions), quality was judged as low. AUTHORS' CONCLUSIONS: The effects of IFNs-beta and GA in the treatment of patients with RRMS, including clinical (e.g. patients with relapse, risk to progression) and MRI (Gd-enhancing lesions) activity measures, seem to be similar or to show only small differences. When MRI lesion load accrual is considered, the effect of the two treatments differs, in that IFNs-beta were found to limit the increase in lesion burden as compared with GA. Evidence was insufficient for a comparison of the effects of the two treatments on patient-reported outcomes, such as quality of life measures.
Assuntos
Adjuvantes Imunológicos/uso terapêutico , Interferon beta/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Peptídeos/uso terapêutico , Acetato de Glatiramer , Humanos , Interferon beta-1a , Interferon beta-1b , Imageamento por Ressonância Magnética , Esclerose Múltipla Recidivante-Remitente/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , RecidivaRESUMO
CONTEXT: Many medical journals provide patient information leaflets on the correct use of medicines and/or appropriate lifestyles. Only a few studies have assessed the quality of this patient-specific literature. OBJECTIVE: The purpose of this study was to evaluate the quality of JAMA Patient Pages on diabetes using the Ensuring Quality Information for Patient (EQIP) tool. METHOD: A multidisciplinary group of 10 medical doctors analyzed all diabetes-related Patient Pages published by JAMA from 1998 to 2010 using the EQIP tool. Inter-rater reliability was assessed using the percentage of observed total agreement (p(o)). A quality score between 0 and 1 (the higher score indicating higher quality) was calculated for each item on every page as a function of raters' answers to the EQIP checklist. A mean score per item and a mean score per page were then calculated. DATA SUMMARY: We found 8 Patient Pages on diabetes on the JAMA web site. The overall quality score of the documents ranged between 0.55 (Managing Diabetes and Diabetes) and 0.67 (weight and diabetes). p(o) was at least moderate (>50%) for 15 of the 20 EQIP items. Despite generally favorable quality scores, some items received low scores. The worst scores were for the item assessing provision of an empty space to customize information for individual patients (score=0.01, p(o)=95%) and patients involvement in document drafting (score=0.11, p(o)=79%). CONCLUSIONS: The Patient Pages on diabetes published by JAMA were found to present weak points that limit their overall quality and may jeopardize their efficacy. We therefore recommend that authors and publishers of written patient information comply with published quality criteria. Further research is needed to evaluate the quality and efficacy of existing written health care information.