Development of a Preventive Health Screening Procedure Enabling Supportive Service Planning for Home-Dwelling Older Adults (PORI75): Protocol for an Action Research Study.

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.

Self-assessed medication risk factors as part of comprehensive health screening in home-dwelling older adults.

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.

Hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting (LIBERTY): A structured summary of a study protocol for a randomised controlled trial.

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.

The medico-professional quality of GP consultations assessed by analysing patient records.

OBJECTIVE: To assess the medico-professional quality of consultations by analysing textual data from patient records. DESIGN: Qualitative analyse of textual data. SETTING: Four primary health care centres using electronic patient records (EPR) in Finland. SUBJECTS: EPR and paired questionnaires of 175 consultations filled in by GPs and their patients independently. MAIN OUTCOME MEASURES: Medico-professional quality of consultations, quality of care of acute respiratory infections, and hypertension. RESULTS: The medico-professional quality of the consultations was quite good. However, 9% of the records could not been assessed at all because of missing or poor documentation and 9% were assessed as poor. The treatment of acute respiratory infections and hypertension is not in line with current care guidelines. Smoking habits or other health behaviour or lifestyle factors were seldom recorded. CONCLUSIONS: The medico-professional quality of the consultation was quite good. Quality improvement is needed in the treatment of acute respiratory infections and hypertension. User-friendly EPR systems would improve the content of patient records.