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AIMS: The aim of this study was to assess the cultural validity and reliability of a Finnish version of the nine-item Shared Decision-Making Questionnaire (SDM-Q-9) in a sample of patients with different sociodemographic characteristics. METHOD: The original SDM-Q-9 was translated into Finnish with the agreement of the developers of the original scale. The standardised translation procedure was followed by a pilot test of the questionnaire. The data were collected from an online questionnaire. Reliability was estimated by Cronbach's alpha. Structural validity of the questionnaire was assessed by confirmatory factor analysis. RESULTS: The pilot study assessing the cultural validity of the scale was a success, as it did not find any expressions needing to be revised. The Finnish version of the SDM-Q-9 - the SDM-Q-9-FIN - was tested in the study where a total of 736 patients responded to the questionnaire. The questionnaire yielded high reliability with a Cronbach's alpha of 0.92. Confirmatory factor analysis confirmed the unidimensional factor structure with Item 1 excluded. CONCLUSIONS: The SDM-Q-9-FIN was shown to be a reliable instrument for evaluating shared decision-making among Finnish patients. Further testing and research are recommended among a greater diversity of patient groups.
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BACKGROUND: Previous studies have shown that shared decision-making (SDM) between a practitioner and a patient strengthens the ideal of treatment adherence. This study employed a multi-method approach to SDM in healthcare to reinforce the theoretical and methodological grounds of this argument. As the study design, self-reported survey items and experimental vignettes were combined in one electronic questionnaire. This technique aimed to analyze the effects of previous experiences and the current preferences regarding SDM on the intentions to follow-through with the medical recommendations. METHOD: Using quantitative data collected from the members of the Finnish Pensioners' Federation (N = 1610), this study focused on the important and growing population of older adults as healthcare consumers. Illustrated vignettes were used in the evaluation of expected adherence to both vaccination and the treatment of an illness, depending on the decision-making style varying among the repeated scenarios. In a within-subjects study design, each study subject acted as their own control. RESULTS: The findings demonstrated that SDM correlates with expected adherence to a treatment and vaccination. Both the retrospective experiences and prospective aspirations of SDM in clinical encounters supported the patients' expected adherence to vaccination and treatment while decreasing the probability of pseudo-compliance. The association between SDM and expected adherence was not affected by the perceived health of the respondents. However, the associations among the expected adherence and decision-making styles were found to differ between the treatment and vaccination scenarios. CONCLUSIONS: SDM enables expected treatment adherence among older adults. Thus, the multi-method study emphasizes the importance of SDM in various healthcare encounters. The findings further imply that SDM research benefits from questionnaires combining self-report methods and experimental study designs. Further cross-validation studies using various types of written and illustrated scenarios are encouraged.
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Toma de Decisiones Conjunta , Vacunación , Humanos , Anciano , Masculino , Femenino , Persona de Mediana Edad , Intención , Finlandia , Anciano de 80 o más Años , Encuestas y Cuestionarios , Participación del PacienteRESUMEN
OBJECTIVE: To investigate possible changes in the rate of conducted neuropsychological assessments and rehabilitation process for patients with multiple sclerosis (pwMS) during the last two decades. The change in the rate of vocational rehabilitation process was also evaluated. BACKGROUND: Cognitive deficits are frequent among pwMS and negatively affect patients' working ability and quality of life. Preliminary evidence suggests that neuropsychological rehabilitation positively affects cognitive symptoms. Vocational approaches are widely recommended for pwMS. METHODS: A retrospective survey of all multiple sclerosis (MS) patients diagnosed and treated at the Department of Neurology in Kanta-Häme Central Hospital over the period 1988-2013 was conducted using hospital records. The rate of neuropsychological assessment and rehabilitation processes as well as vocational rehabilitation processes were evaluated. RESULTS: A total of 417 pwMS were identified. A neuropsychological assessment was performed for 104 (24.9%) of these patients, of whom 21 (20.2%) were evaluated between 1988 and 1999 and 83 (79.8%) between 2000 and 2013. Of the 417 patients, eight (1.9%) received neuropsychological rehabilitation, each of these after the year 2000. Only 25 (6.0%) of the 417 pwMS received vocational rehabilitation. Fourteen (56.0%) of the 25 patients received vocational rehabilitation between 1988 and 1999 and 11 (44.0%) between 2000 and 2013. CONCLUSIONS: Neuropsychological assessment has been a rarity in MS in Finland, but a marked increase in frequency has occurred since the year 2000. Although understanding of MS-related cognitive impairment and its impact on working ability has increased, the rate of neuropsychological and vocational rehabilitation has remained low.
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Trastornos del Conocimiento/diagnóstico , Trastornos del Conocimiento/etiología , Trastornos del Conocimiento/rehabilitación , Esclerosis Múltiple/psicología , Adulto , Femenino , Finlandia , Humanos , Masculino , Persona de Mediana Edad , Esclerosis Múltiple/complicaciones , Pruebas Neuropsicológicas/estadística & datos numéricos , Calidad de Vida , Estudios Retrospectivos , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To explore adherence, persistence, and treatment patterns in patients with multiple sclerosis (MS) in Finland treated with disease-modifying therapies (DMTs) for active MS in 2005-2018. MATERIALS AND METHODS: The study cohort was identified using the Drug Prescription Register of Social Insurance Institute, Finland. All patients had at least one prescription of glatiramer acetate (GA), beta-interferons, teriflunomide, or delayed-release dimethyl fumarate (DMF). Adherence was calculated using proportion of days covered (PDC) (cutoff ≥0.8). Time to non-persistence was calculated by the number of days on index DMT treatment before the first treatment gap (≥90 days) or switch and analyzed with time-to-event methodology. RESULTS: The cohort included 7474 MS patients (72.2% female; mean age 38.9 years). Treatment switches were steady over 2005-2012, peaked in 2015. PDC means (standard deviations) were GA, 0.87 (0.17); beta-interferons, 0.88 (0.15); DMF, 0.89 (0.14); teriflunomide, 0.93 (0.10). Adherence frequencies were GA, 78.4%; beta-interferons, 81.3%; DMF, 86.9%; teriflunomide, 91.7%. Logistic regression showed that age group, DMT and the starting year, sex, and hospital district independently affected adherence. Patients receiving teriflunomide and DMF, males, and older patients were more likely to persist on treatment. There was no difference in persistence between patients prescribed teriflunomide and DMF, or between GA and beta-interferons. CONCLUSIONS: Oral DMTs had greater adherence and persistence than injectable DMTs.
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Inmunosupresores/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Esclerosis Múltiple/tratamiento farmacológico , Adulto , Estudios de Cohortes , Femenino , Finlandia , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
STUDY OBJECTIVE: Thrombolysis with tissue plasminogen activator should occur promptly after ischemic stroke onset. Various strategies have attempted to improve door-to-needle time. Our objective is to evaluate a strategy that uses an emergency physician-based protocol when no stroke neurologist is available. METHODS: This was a retrospective before-after intervention analysis in an urban hospital. Reorganization of the acute ischemic stroke treatment process was carried out in 2013. We evaluated time delay, symptomatic intracerebral hemorrhage, and clinical recovery of patients before and after the reorganization. We used multivariable linear regression to estimate the change in door-to-needle time before and after the reorganization. RESULTS: A total of 107 patients with comparable data were treated with tissue plasminogen activator in 2009 to 2012 (group 1) and 46 patients were treated during 12 months in 2013 to 2014 (group 2). Median door-to-needle time was 54 minutes before the reorganization and 20 minutes after it (statistical estimate of difference 32 minutes; 95% confidence interval 26 to 38 minutes). After adjusting for several potential cofounders in multivariable regression analysis, the only factor contributing to a significant reduction in delay was group (after reorganization versus before). Median onset-to-treatment times were 135 and 119 minutes, respectively (statistical estimate of difference 23 minutes; 95% confidence interval 6 to 39 minutes). The rates of symptomatic intracerebral hemorrhage were 4.7% (5/107) and 2.2% (1/46), respectively (difference 2.5%; 95% confidence interval -8.7% to 9.2%). Approximately 70% of treated patients were functionally independent (modified Rankin Scale score 0 to 2) when treated after the reorganization. CONCLUSION: Implementation of a stroke protocol with emergency physician-directed acute care decreased both door-to-needle time and onset-to-treatment time without increasing the rate of symptomatic intracerebral hemorrhage.
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Isquemia Encefálica/terapia , Protocolos Clínicos , Servicios Médicos de Urgencia , Fibrinolíticos/uso terapéutico , Accidente Cerebrovascular/terapia , Activador de Tejido Plasminógeno/uso terapéutico , Anciano , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/fisiopatología , Competencia Clínica/normas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/fisiopatología , Terapia Trombolítica , Tiempo de Tratamiento/estadística & datos numéricos , Resultado del TratamientoRESUMEN
OBJECTIVES: Finland is a high-risk multiple sclerosis (MS) region, but a national MS register has not existed until 2014. In this paper, we present the Finnish MS register variables and data collected by 31 December 2018. MATERIALS AND METHODS: Numbers and data counts of MS patients in the register (ICD-10 code G35) are presented. The disease types and proportion of patients receiving disease-modifying treatments (DMTs) were analysed in five hospital districts with most complete data sets. MS prevalence in Finland was estimated using administrative hospital discharge data as an additional resource. RESULTS: There were a total of 8722 MS patients in the Finnish MS register by 31 December 2018 (71.5% females). Mean age at MS diagnosis was 38.7 years and peak prevalence was at age 50-54 years. Disease course was relapsing remitting (RRMS) in 66.7%, secondary progressive (SPMS) in 13.5%, and primary progressive (PPMS) in 7.9% of the 5365 MS patients in the selected districts with most complete data. A total of 66.0% of RRMS patients, 19.6% of SPMS patients and 9.9% of PPMS patients were receiving DMTs. By combining MS register data with databases of those hospitals that had not joined the register, the nationwide prevalence estimate was between 10 and 11 thousand patients (corresponding to crude prevalence 180-200/100 000). CONCLUSIONS: The Finnish MS register is currently used in 15/21 Finnish hospital districts. By register integration into the electronic patient files, the coverage of the register has increased to approximately 80% of the estimated Finnish MS population.
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Esclerosis Múltiple/epidemiología , Adulto , Femenino , Finlandia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Sistema de RegistrosRESUMEN
Magnetic resonance imaging of the brain is currently the most sensitive method in detecting the lesions caused by multiple sclerosis. Assessment of the immunological treatment response used in the treatment of multiple sclerosis should be based on the clinical picture and brain MRI. T2-, flair- and T1-biased images, gadolinium enhancement and assessment of atrophy are required for MRI monitoring. In the first-line immune therapy MRI is taken at 6 to 12 months after starting the drug therapy, in fingolimod therapy after 6 to 12 months and 1 to 2 years, respectively, and in alemtuzumab and natalizumab therapy after one and two years.
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Inmunoterapia , Imagen por Resonancia Magnética/métodos , Esclerosis Múltiple/inmunología , Esclerosis Múltiple/terapia , Alemtuzumab , Anticuerpos Monoclonales Humanizados/uso terapéutico , Medios de Contraste , Clorhidrato de Fingolimod/uso terapéutico , Humanos , Inmunosupresores/uso terapéutico , Natalizumab/uso terapéuticoRESUMEN
Objective: In this short report contributing to the literature on treatment and vaccination adherence, nonadherence was examined from the perspective of decision-making (DM) practice in healthcare. The objective of this study was to survey the rationalities given for treatment nonadherence and their association with DM practice. Methods: The Ottawa decision Support Framework was used as a theoretical background for the study. Multiple choice and open-text responses indicating nonadherence were drawn from vignette survey data. The results have been analyzed and reported as descriptive statistics and findings of data-driven content analysis. The number of observatory units was 1032 in the within-subject study design. Results: DM practice was predominantly associated with nonadherence to vaccination, whereas nonadherence to treatment was consistently associated with attitudinal reasons independent of DM practice. Nonadherence to vaccination was most often rationalized by prior negative experiences in simple DM scenarios. After other DM practices, nonadherence was rationalized by uncertainty and criticism about the benefits of the recommended vaccine. Mistrust toward healthcare providers stood out, first in treatment nonadherence generally and, second, in vaccination nonadherence after simple DM where the final decision was left to the patient. Conclusion: In medical DM, adherence to treatment and vaccination may be achieved through a recognition of patients' previous healthcare encounters and potential trust-related concerns, which could pose a risk for nonadherence. To be able to observe these risks, patient engagement and mutual trust should be priorities in decision support in healthcare.
Research on treatment and vaccination adherence aim at increasing knowledge about improving adherence and treatment outcomes. This study examined explanations given for not adhering to treatment and an association between the explanations and medical decision-making practices. Decision-making practices are known to impact patientphysician interaction and the patients' motivation to have an active role at the appointment. In a shared decision-making (SDM) practice, patients' participation is encouraged. SDM is built on both medical expertise of the practitioner and individual views, values and preferences of the patient. As opposed to SDM, authoritarian decision-making refers to a practice in which decisions are made solely by the physician. In guided decision-making, the physician shares information with the patient but makes the final decision. In simple decision-making, the final decision is left to the patient after consultation. This empirical study used illustrated vignette survey data from Finland. Out of the 1935 respondents, 64% were female with an average age of 68. In the study design, nonadherence was presumed to depend on a decision-making practice presented. Primary findings showed that nonadherence to treatment is most correlated with attitudinal predetermination of the patient and mistrust toward healthcare providers. Nonadherence to vaccination had a stronger association with decision-making practices. After simple decision-making, declining vaccination was most often explained by prior negative experiences and mistrust toward healthcare providers. After other decision-making practices, explanations for declining included uncertainty and criticism about the benefits of the recommended vaccine. This study underscores the pivotal role of trust in the patient-physician interaction.
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Teleneurology is an adaption of telemedicine used in neurological practices. Due to the widespread availability of the Internet and the development of information and communication technology (ICT), the use of teleneurology has increased in healthcare systems. This study aimed to determine how the Covid-19 pandemic has affected neurologists' attitudes towards teleneurology as well as their experiences of remote health care before and after the pandemic. The study was conducted as a web-based questionnaire sent to all Finnish neurologists. Two identical surveys were sent via e-mail from the National Neurology Society. The first survey was conducted in spring 2021 and second in spring 2023. The results show that the pandemic moderately increased the use of teleneurology, which enhanced neurologists' technical skills. Neurologists estimated that the use of teleneurology will continue to increase in the future.
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COVID-19 , Enfermedades del Sistema Nervioso , Neurología , Telemedicina , Humanos , COVID-19/epidemiología , Neurólogos , Pandemias , Telemedicina/métodos , Neurología/métodosRESUMEN
A 'Do Not Attempt Resuscitation' (DNAR) order is one of the most important yet difficult medical decisions. Despite the recent European guidelines, health care professionals (HCPs) in general perceive challenges in making a DNAR order. We aimed to evaluate the types of problems related to DNAR order making. A link to a web-based multiple-choice questionnaire including open-ended questions was sent by e-mail to all physicians and nurses working in the Tampere University Hospital special responsibility area covering a catchment area of 900,000 Finns. The questionnaire covered issues on DNAR order making, its meaning and documentation. Here we report the analysis of the open-ended questions, examined based on the Ottawa Decision Support Framework with expanded individual decisional needs categories. Qualitative data describing respondents' opinions (N=648) regarding problems related to DNAR order decision making were analysed using Atlas.ti 23.12 software. In total, 599 statements (phrases) dealing with inadequate advice, information, emotional support, and instrumental help were identified. Our results show that HCPs experience lack of support in DNAR decision making on multiple levels. Digital decision-making support integrated into electronic patient records (EPR) to assure timely and clearly visible DNAR orders could be beneficial.
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Médicos , Órdenes de Resucitación , Humanos , Órdenes de Resucitación/psicología , Encuestas y Cuestionarios , Hospitales Universitarios , Investigación CualitativaRESUMEN
Objectives: The primary objective was to evaluate long-term treatment persistence and safety of natalizumab in Finnish multiple sclerosis patients. The secondary objectives were to assess patient characteristics, use of natalizumab-related safety protocol, and treatment persistence in patients with different anti-John Cunningham virus antibody statuses (John Cunningham virus status). Materials & Methods: All adult multiple sclerosis patients in the Finnish multiple sclerosis register who started natalizumab between 1/2006 and 12/2018 were included in this study and followed retrospectively until treatment discontinuation or end of follow-up (12/2019). Results: In total, 850 patients were included. Median duration of natalizumab treatment was 7.8 years in John Cunningham virus negative (n = 229) and 2.1 years in John Cunningham virus positive patients (n = 115; p < 0.001). The most common cause for treatment discontinuation was John Cunningham virus positivity. After natalizumab discontinuation, patients who had a washout duration of less than 6 weeks had fewer relapses during the first 6 months (p = 0.012) and 12 months (p = 0.005) compared with patients who had a washout duration of over 6 weeks. During the median follow-up of 3.6 years, 76% of patients remained stable or improved on their Expanded Disability Status Scale. Conclusions: Treatment persistence was very high among John Cunningham virus negative patients. The study supports long-term effectiveness of natalizumab and a washout duration of less than 6 weeks after discontinuation.
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BACKGROUND AND OBJECTIVE: Brain size, white matter hyperintensity, and the development of brain atrophy are known to be highly heritable. The decrease of brain volume starts from the very onset of multiple sclerosis and is 10-fold compared with normal aging. The aim of this study was to assess whether the brain and spinal cord volumes and the volume of white matter lesions differed between twins with multiple sclerosis and their asymptomatic co-twins. MATERIAL AND METHODS: A co-twin control method was used to evaluate whether the brain and spinal cord volumes differ between twins with multiple sclerosis and their co-twins. Nineteen twin pairs were studied neurologically, and the volumes of T1, T2, FLAIR, and gadolinium-enhanced lesions and those of the brain and the spinal cord were obtained by magnetic resonance imaging. RESULTS: Significant differences in the brain (P=0.064) or spinal cord (P=0.648) volumes were not detected. Four of the 7 monozygotic and 5 of the 12 dizygotic co-twins had focal brain white matter lesions, but none fulfilled the magnetic resonance imaging criteria of Barkhof. Spinal cord lesions were not seen in any of the co-twins. CONCLUSIONS: The absence of a significant difference in the brain or spinal cord volume between the twins with multiple sclerosis and their co-twins supports the recent observation of brain size and the development of brain atrophy being highly heritable.
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Encéfalo/patología , Esclerosis Múltiple/patología , Médula Espinal/patología , Adulto , Anciano , Preescolar , Estudios de Cohortes , Femenino , Finlandia , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Tamaño de los Órganos , Gemelos Dicigóticos , Gemelos MonocigóticosRESUMEN
Insights on end-of-life care decisions, such as do not attempt resuscitation (DNAR), vary between institutions and individual health care professionals. At the era of electronic patient records (EPR), the information of DNAR order may still be recorded in multiple locations making it difficult to find and interpret. A link to a structured web-based questionnaire was sent to all physicians and nurses working in Tampere University Hospital special responsibility area covering a catchment area of 900 000 Finns. Perceptions on DNAR order and documentation was surveyed. In total 934 subjects responded, of which 727 (77%) were nurses and 219 (23%) physicians covering all specialties. We found substantial variation in DNAR order interpretation and documentation among all health care professionals possibly causing information breakdown and compromised end-of-life care.
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Médicos , Órdenes de Resucitación , Atención a la Salud , Documentación , Humanos , Encuestas y CuestionariosRESUMEN
The patient as an active participant in decision-making has become an important resource in health care. Shared decision-making (SDM) relies on the patient's easy access to reliable and evidence-based health care information as well as the availability of patient-generated data, such as values and preferences for the health care professional (HCP). The aim of the present pilot study was to evaluate what type of information people with multiple sclerosis (pwMS) use in the SDM process, and what are the sources of that information. A semi-structured web-based survey of SDM was conducted through the MS-society in Finland. The results are presented against the Ottawa Decision Support Framework. A total of 27 pwMS participated. We found that all the participants wished to be involved in the decision-making process, but that they seldom found the information provided by HCP to be helpful. Instead, they searched the internet and visited various conversation platforms in social media, such as Facebook groups, for additional information.
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Esclerosis Múltiple , Participación del Paciente , Toma de Decisiones , Humanos , Proyectos Piloto , Encuestas y CuestionariosRESUMEN
Effective information management promotes safe patient care. Lack of human resources can cause failures when managing patient information. The aim of this study was to analyse the nature of reported patient safety incidents and their location in Choo's information management process model phases when the contributing factor of the incidents was related to human resources and the consequence of the incident was related to harm to the organization's corporate image. Data consisted of the information management related patient safety incident reports (n = 475) from 49 health and social care organizations from 2007-2016 in Finland. Deductive analysis and descriptive statistics were used to analyse the data. The results of the study indicated that the shortage of human resources contributed to incomplete documentation, insufficient information sharing between professionals and documenting of information in the wrong place. The majority of the incidents occurred during the information organizing and storage and information distribution phases of the information management process model. Despite the use of electronic health records and electronic patient data, a lack of human resources can lead to breaches in information management processes and harm an organization's corporate image in health and social care contexts.
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Documentación , Seguridad del Paciente , Registros Electrónicos de Salud , Humanos , Gestión de la Información , Gestión de Riesgos , Administración de la Seguridad , Recursos HumanosRESUMEN
OBJECTIVE: This scoping review will explore the meaning and content of patient-generated data in epilepsy care decisions. INTRODUCTION: Clinical decisions about management of long-term conditions such as epilepsy are based on multiple factors, including efficacy and safety of interventions, experiences of professionals as well as patient preferences and values. Patient-generated data integrates patient values and preferences into clinical decision-making. However, more information is needed about the meaning and content of patient-generated data when making clinical decisions in epilepsy care. INCLUSION CRITERIA: This scoping review will consider studies focusing on patient-generated data and clinical decision-making in epilepsy management. Studies will be included if they concern adult patients with epilepsy, their family members/guardians, or health professionals who treat patients with epilepsy in any health care facility or eHealth services. All studies will be included regardless of methodology. Text and opinion papers will also be considered. Study protocols will be excluded. METHODS: The databases to be searched include MEDLINE, CINAHL, Scopus, PsycINFO, and Cochrane Central Register of Controlled Trials. Sources of unpublished studies and gray literature will include websites of relevant epilepsy organizations and DART-Europe E-theses Portal. The data will be extracted by two independent reviewers using a tool created for the study purpose. Along with a narrative summary, the results will be presented in tabular or graphical format in a manner that aligns with the review objective and questions. There will be no time limit on the search. Studies published in English, Finnish, Swedish, and German will be included.
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Epilepsia , Personal de Salud , Adulto , Europa (Continente) , Humanos , Literatura de Revisión como Asunto , Factores de TiempoRESUMEN
BACKGROUND: Cladribine tablets for adult patients with highly active relapsing multiple sclerosis (MS) have been available in Finland since 2018. Real-world data from different genetic and geographical backgrounds are needed to complement data from clinical trials. METHODS: We investigated the use of cladribine tablets in Finland in a non-interventional cohort study, based on real-world data from the nationwide Finnish MS registry. All eligible patients who had initiated treatment with cladribine tablets in 2018-2020 were included. Descriptive analyses for outcomes were conducted using summary statistics. Time-dependent endpoints were analyzed using cumulated events analysis based on 1-Kaplan-Meier estimates and curves. Subgroups were analyzed separately according to the number of previous disease-modifying therapies (DMTs) and the most common last preceding therapies. RESULTS: Data of 179 patients were analyzed. Median follow-up time was 19.0 months (interquartile range [IQR] 12.0-26.2). Of the 134 patients who were followed for at least 12 months, 112 patients (83.6%) remained relapse-free during follow-up. Mean annualized relapse rate (ARR) was 1.0 (standard deviation [SD] 0.89) at baseline, and 0.1 (SD 0.30) at follow-up. Patients with two or more previous DMTs had shorter time to first relapse (median 2.5 months, IQR 0.6-9.3) when compared to patients with 0-1 previous DMTs (median 11.4 months, IQR 8.7-13.1) (p=0.013). After excluding patients switching from fingolimod (n=33), a statistically significant difference in time to first relapse was no longer observed between the two groups (p=0.252). Adverse events (AEs) were reported in 30 patients (16.8%). The most frequent AE was headache (n=14, 7.8%). One patient (0.6%) died of cardiac arrest. Discontinuation of cladribine tablets was reported in nine patients (5.0%). CONCLUSION: The mean ARR observed in this cohort was similar to what has been reported in clinical trials. Approximately half of the patients had used two or more previous DMTs before cladribine tablets. These patients had a shorter time to first relapse when compared to patients with 0-1 previous DMTs, mostly driven by early relapses in patients switching from fingolimod.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Adulto , Cladribina/efectos adversos , Estudios de Cohortes , Clorhidrato de Fingolimod/efectos adversos , Finlandia/epidemiología , Humanos , Inmunosupresores/efectos adversos , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/inducido químicamente , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Recurrencia , Sistema de Registros , ComprimidosRESUMEN
BACKGROUND: Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. OBJECTIVES: To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. METHODS: In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. RESULTS: Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1-3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. CONCLUSIONS: SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Alemtuzumab/efectos adversos , Finlandia/epidemiología , Humanos , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/epidemiología , Estudios RetrospectivosRESUMEN
Using a philosophical approach or deductive reasoning, we challenge the dominant clinico-radiological worldview that defines multiple sclerosis (MS) as a focal inflammatory disease of the central nervous system (CNS). We provide a range of evidence to argue that the 'real MS' is in fact driven primarily by a smouldering pathological disease process. In natural history studies and clinical trials, relapses and focal activity revealed by magnetic resonance imaging (MRI) in MS patients on placebo or on disease-modifying therapies (DMTs) were found to be poor predictors of long-term disease evolution and were dissociated from disability outcomes. In addition, the progressive accumulation of disability in MS can occur independently of relapse activity from early in the disease course. This scenario is underpinned by a more diffuse smouldering pathological process that may affect the entire CNS. Many putative pathological drivers of smouldering MS can be potentially modified by specific therapeutic strategies, an approach that may have major implications for the management of MS patients. We hypothesise that therapeutically targeting a state of 'no evident inflammatory disease activity' (NEIDA) cannot sufficiently prevent disability accumulation in MS, meaning that treatment should also focus on other brain and spinal cord pathological processes contributing to the slow loss of neurological function. This should also be complemented with a holistic approach to the management of other systemic disease processes that have been shown to worsen MS outcomes.
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Patient incident reporting is an important way to promote safer health care. The barriers for reporting can be organizational (leadership, culture, lack of feedback, etc.) or individual (time pressure, perceived competence, attitude, etc.). In this study, we examined what kinds of ICT-related incidents health professionals observe in Finland, how they react to them and the reasons for non-reporting. Our data was collected using a nationwide survey during the Spring of 2020. The theory of planned behaviour by Ajzen served as our framework for explaining non-reporting behaviour. While we found that attitudes, subjective norms and perceived behavioural control all explain non-reporting, our factor model based on our confirmatory factor analysis did not directly match Ajzen's theory.