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BACKGROUND: In Finland, at least 1 in 4 residents will be >75 years of age in 2030. The national aging policy has emphasized the need to improve supportive services to enable older people to live in their own homes for as long as possible. OBJECTIVE: This study aimed to develop a preventive health screening procedure for home-dwelling older adults aged 75 years to enable the use of clinical patient data for purposes of strategic planning of supportive services in primary care. METHODS: The action research method was applied to develop the health screening procedure with selected validated health measures in cooperation with the local practicing interprofessional health care teams from 10 primary care centers in the Social Security Center of Pori, Western Finland (99,485 residents, n=11,938, 12% of them >75 years). The selection of evidence-based validated health measures was based on the national guide to screen factors increasing fall risk and the national functioning measures database. The cut-off points of the selected health measures and laboratory tests were determined in consecutive consensus meetings with the local primary care physicians, with decisions based on internationally validated measures, national current care guidelines, and local policies in clinical practice. RESULTS: The health screening procedure for 75-year-old residents comprised 30 measures divided into three categories: (1) validated self-assessments (9 measures), (2) nurse-conducted screenings (14 measures), and (3) laboratory tests (7 measures). The procedure development process comprised the following steps: (1) inventory and selection of the validated health measures and laboratory tests, (2) training of practical nurses to perform screenings for the segment of 75-year-old residents and to guide them to possible further medical actions, (3) creation of research data from clinical patient data for secondary use purposes, (4) secondary data analysis, and (5) consensus meeting after the pilot test of the health screening procedure for 75-year-old residents procedure in 2019 based on the experiences of health care professionals and collected research data. CONCLUSIONS: The developed preventive health screening procedure for 75-year-old residents enables the use of clinical patient data for purposes of strategic planning of supportive services in primary care if the potential bias by a low participation rate is controlled. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48753.
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Background: Poor medication management may negatively impact the health and functional capacity of older adults. This cross-sectional study aimed to identify medication-related risk factors in home-dwelling residents using a validated self-assessment as part of comprehensive health screening. Methods: The data were derived from comprehensive health screening (PORI75) for older adults of 75 years living in Western Finland in 2020 and 2021. One of 30 validated measures in health screening focused on identifying medication-related risk factors (LOTTA Checklist). The Checklist items were divided into (1) systemic risk factors (10 items) and (2) potentially drug-induced symptoms (10 items). Polypharmacy was categorized according to the number of used drugs: (1) no polypharmacy (<5 drugs), (2) polypharmacy (≥5 and <10), and (3) excessive polypharmacy (≥10). The linearity across these three polypharmacy groups was evaluated using the Cochran-Armitage test. Results: Altogether, 1024 out of 1094 residents who participated in the health screening consented to this study (n = 569 in 2020 and n = 459 in 2021). The mean number of all drugs in use was 7.0 (range 0-26; SD 4.1), with 71% of the residents using >5 drugs, that is, having polypharmacy. Of the systemic risk factors most common was that the resident had more than one physician responsible for the treatment (48% of the residents), followed by missing drug list (43%), missing regular monitoring (35%), and unclear durations of the medication (35%). The most experienced potentially drug-induced symptoms were self-reported constipation (21%), urinating problems (20%), and unusual tiredness (17%). An increasing number of drugs in use, particularly excessive polypharmacy, was associated with various medication-related risk factors. Conclusion: As a part of comprehensive health screening the LOTTA Checklist provides useful information to prevent medication-related risk factors in home-dwelling older adults. The Checklist could be used to guide planning and implementing health services in the future.
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OBJECTIVES: The primary objective of this study is to evaluate the therapeutic potential of hydroxychloroquine (HCQ) in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting, as compared to placebo. The study hypothesis is that treatment with HCQ will reduce the risk of hospitalization because of Covid-19 infection, and the sample size estimate of the study is based on the need to test this hypothesis. The secondary objectives of the study are: to evaluate the safety and tolerability of HCQ in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting, as compared to placebo; to collect experience of the use of HCQ in the treatment of Covid-19 infection in outpatients, in order to be able to identify patient characteristics that predict specific treatment responses (favourable or unfavourable); this objective will also be addressed by post-hoc subgroup analysis of the study results and by meta-analysis of pooled patient data from other clinical trials of HCQ in outpatients; and to evaluate the impact of Covid-19 infection and its treatment on the mental health and well-being of the study participants. In addition, if the data allow, the study has the following exploratory objectives: to evaluate the extent and duration of SARS-CoV-2 viral shedding by PCR testing of nasopharyngeal swab samples in study subjects treated with HCQ, as compared to placebo; to evaluate the extent and time course of SARS-CoV-2 virus-specific antibody responses in serum of study subjects treated with HCQ, as compared to placebo; to evaluate other possible biomarker changes in blood in study subjects treated with HCQ, as compared to placebo; to explore the possible effects of genetic variation in drug metabolizing enzymes on HCQ-related outcomes in the study population; to explore the associations of HCQ-related outcome variables with other patient characteristics, e.g. HLA haplotypes, HCQ concentrations, demographic variables, disease history and concomitant medications. TRIAL DESIGN: This is a phase 2, placebo-controlled, double-blind, randomized, parallel-group treatment trial comparing HCQ with placebo in outpatients with Covid-19 infection. Participants will be randomized in a 1:1 ratio to the two treatment arms. PARTICIPANTS: Main inclusion criteria: 1. Males and females >40 years of age, or 18-40 years of age with one or both of the following: i. diabetes mellitus (type 1 or type 2); ii. BMI > 35 kg/m2; 2. Valid independent informed consent obtained; 3. Symptoms typical of Covid-19 infection, according to criteria specified in the study protocol. The onset of symptoms must be within 5 days of enrolment; 4. Positive SARS-CoV-2 PCR test result of a nasopharyngeal swab sample. Main exclusion criteria: 1. Suspected severe or moderately severe pneumonia, presenting with any of the following: respiratory rate > 26 breaths/min; significant respiratory distress; or SpO2 ≤94% on room air; 2. Requiring treatment in the hospital, according to the treating physician's judgement; 3. Any contraindication to treatment with HCQ; 4. Pregnancy or lactation. The trial will be conducted at seven study sites in a primary public health care setting in the region of Satakunta, Finland. INTERVENTION AND COMPARATOR: Participants will be randomized to receive either HCQ capsules at 300 mg twice a day for one day and then 200 mg twice a day for 6 days, or placebo capsules for 7 days. MAIN OUTCOMES: The primary endpoint of the study is the number of hospitalizations due to Covid-19 infection within four weeks of entry into the study. The secondary endpoints of the study include the following: duration and severity of Covid-19-related symptoms, as reported by daily self-assessments; number of Intensive Care Unit treatment episodes due to Covid-19 infection within four weeks of entry into the study; number of deaths due to Covid-19 infection within four weeks of entry into the study; number of treatment-related adverse events (AEs) and serious AEs (SAEs); all-cause hospitalizations and mortality within six months of entry into the study; and self-assessed symptoms of anxiety, as assessed with repeated administration of the Generalized Anxiety Disorder 7-item scale (GAD-7). The exploratory endpoints of the study include the following: extent and duration of SARS-CoV-2 viral shedding and virus-specific antibody responses in serum; and possible other blood biomarker changes. RANDOMISATION: Eligible study participants are randomly allocated into two treatment arms (1:1 ratio). The randomization list has been generated using Viedoc™ (Viedoc Technologies AB, Uppsala, Sweden) that is used as an electronic data capture system for this study. BLINDING (MASKING): The participants and all study personnel remain blinded to the treatment allocation by having both IMPs packed in identical containers. Masking of the treatments was performed by re-formulation of the IMPs so that the HCQ capsules and the placebo capsules have identical appearance. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 600 participants are to be randomised with 300 in each arm. TRIAL STATUS: Protocol version 2, dated 14 July 2020; recruitment is expected to start in December, 2020, and to be completed in June, 2021. TRIAL REGISTRATION: EudraCT 2020-002038-33 , registered 26 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). The protocol has been redacted to conform with privacy regulations by deleting the names and contact information of individuals mentioned in the protocol but not listed as authors in this communication. In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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Atención Ambulatoria , Tratamiento Farmacológico de COVID-19 , Inhibidores Enzimáticos/uso terapéutico , Hospitalización/estadística & datos numéricos , Hidroxicloroquina/uso terapéutico , Atención Primaria de Salud , Adolescente , Adulto , Anciano , Ansiedad/psicología , COVID-19/epidemiología , COVID-19/mortalidad , COVID-19/psicología , Causas de Muerte , Comorbilidad , Diabetes Mellitus/epidemiología , Método Doble Ciego , Humanos , Persona de Mediana Edad , Mortalidad , Obesidad/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , SARS-CoV-2 , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Esparcimiento de Virus , Adulto JovenRESUMEN
OBJECTIVES: The aim of this study was to determine whether the baseline oral health-related knowledge, attitudes and beliefs of the participants in a randomized clinical trial (RCT) were associated with D(3)MFS increment. Additionally, the aim was to study whether the association was mediated by the two baseline behaviors, i.e. brushing teeth and eating candies. METHODS: Children in Pori, Finland (n = 493) aged 11-12 years, with active initial caries lesion(s) at baseline, were studied. The data were based on clinical examinations in 2001 and 2005 and on a questionnaire administered in 2001. Associations between success in caries control and baseline oral health-related knowledge, attitudes and the belief in keeping one's own teeth throughout life were evaluated using negative binomial regression analyses while considering the effects of the two baseline oral health behaviors. RESULTS: The degree of concern about getting decay in one's own teeth was associated with caries increment. The less concerned the child was about new caries lesions, the more likely he/she was to develop new cavities. This association was not mediated by the two behaviors. Those children who did not know whether or not their mother had cavities were more likely to fail in caries control than were children who knew about their mother's cavities. CONCLUSIONS: It is important to determine child's level of concern about getting cavities because children who are concerned about developing cavities are likely to succeed in caries control while the opposite is true for those children who do not share this concern.
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Dulces , Caries Dental/prevención & control , Caries Dental/psicología , Educación en Salud Dental , Conocimientos, Actitudes y Práctica en Salud , Salud Bucal , Cepillado Dental/estadística & datos numéricos , Niño , Índice CPO , Conducta Alimentaria , Femenino , Finlandia , Predicción , Educación en Salud Dental/métodos , Humanos , Masculino , Atención Dirigida al Paciente , Análisis de Regresión , AutoinformeRESUMEN
The aim of this study was to assess post-trial treatment costs, clinical outcomes [decayed, missing or filled surfaces (DMFS) scores], and utilization of dental services among adolescents who had participated in a randomized clinical trial (RCT) in Pori, Finland, in 2001-2005. At baseline the children were 11-12 yr of age and had had at least one active initial caries lesion. The children in the experimental group (n = 250) had been exposed to multiple measures for caries control, while those in the control group (n = 247) had received standard dental care. During the post-trial period (2005-2008), all participants received the standard dental care offered in public dental clinics in Pori. In both groups the costs of treatment procedures and outcomes for the post-trial period were calculated for each adolescent. Information from patient records was available for 487 adolescents (former experimental n = 246, control n = 241). The mean total costs per adolescent were lower and the clinical outcome was better among the former experimental-group participants. The differences in mean costs between the groups were statistically significant for preventive and restorative procedures. The utilization of dental services was significantly more regular among the former experimental-group participants.
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Atención Odontológica/economía , Caries Dental/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Adolescente , Anestésicos Locales/economía , Niño , Ahorro de Costo , Índice CPO , Atención Odontológica/estadística & datos numéricos , Caries Dental/economía , Restauración Dental Permanente/economía , Costos Directos de Servicios , Finlandia , Estudios de Seguimiento , Costos de la Atención en Salud , Humanos , Odontología Preventiva/economía , Tratamiento del Conducto Radicular/economía , Extracción Dental/economía , Pérdida de Diente/economía , Resultado del TratamientoRESUMEN
The aim of this study was to assess the cost-effectiveness of an experimental caries-control regimen in a randomized clinical trial (RCT) conducted in Pori, Finland, in 2001-2005. Children (n = 497) who were 11-12 yr of age and had at least one active initial caries lesion at baseline were studied. The children in the experimental group (n = 250) were offered an individually designed patient-centered regimen for caries control. The children in the control group (n = 247) received standard dental care. Furthermore, the whole population was exposed to continuous community-level oral health promotion. Individual costs of treatment procedures and outcomes (DMFS increment score) for the follow-up period of 3.4 yr were calculated for each child in both groups. The incremental cost-effectiveness ratio was euro 34.07 per averted DMF surface. The experimental regimen was more effective, and also more costly. However, the total costs decreased year after year, and for the last 2 yr the experimental regimen was less expensive than the standard dental care. The experimental regimen would probably have been more cost-effective than standard dental care if the follow-up period had been longer, the regimen less comprehensive, and/or if dental nurses had conducted the preventive procedures.
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Caries Dental/prevención & control , Antiinfecciosos Locales/economía , Antiinfecciosos Locales/uso terapéutico , Cariostáticos/economía , Cariostáticos/uso terapéutico , Niño , Clorhexidina/economía , Clorhexidina/uso terapéutico , Análisis Costo-Beneficio , Consejo/economía , Índice CPO , Atención Odontológica/economía , Caries Dental/economía , Susceptibilidad a Caries Dentarias , Higienistas Dentales/economía , Restauración Dental Permanente/economía , Conducta Alimentaria , Finlandia , Fluoruros/economía , Fluoruros/uso terapéutico , Fluoruros Tópicos/economía , Fluoruros Tópicos/uso terapéutico , Estudios de Seguimiento , Educación en Salud Dental/economía , Promoción de la Salud/economía , Humanos , Evaluación de Necesidades/economía , Salud Bucal , Higiene Bucal , Participación del Paciente , Atención Dirigida al Paciente/economía , Pérdida de Diente/economía , Cepillado Dental , Pastas de Dientes/economía , Pastas de Dientes/uso terapéutico , Resultado del TratamientoRESUMEN
The aim of this study was to determine whether the baseline oral health-related behaviors of the participants of the intervention group of a randomized clinical trial conducted in Pori, Finland, were predictive of failures in controlling caries. Three definitions of failure were considered, namely if the children developed one or more, three or more, or five or more new caries lesions, as evidenced by the change in number of decayed, missing or filled surfaces (Delta DMFS) during the follow-up period of 3.4 yr. Children (n = 497) aged 11-12 yr, with at least one active initial caries lesion at baseline, were studied. The data were based on clinical examinations in 2001 and 2005 and on a questionnaire on oral health-related behaviors that was administered in 2001. Associations between baseline behaviors and the measures of failure in caries control were evaluated using logistic regression analyses. Self-reported tooth brushing with fluoride toothpaste at least twice a day reduced the risk of failure. Children who, at baseline, reported eating candy at least once a day were more likely to experience failure at the levels of three or more and five or more new lesions.