Pragmatic and Observational Research最新文献

Introduction: Asthma poses a significant burden for the Australian population. Understanding severe exacerbation rates, and steroid-related burden for adults diagnosed with asthma stands to offer insights into how this could be reduced.

Methods: Electronic medical records (EMR) and questionnaires from the Optimum Patient Care Research Database Australia (OPCRDA) were utilised retrospectively. OPCRDA is a real-world database with >800,000 medical records from Australian primary care practices. Outcomes were severe asthma exacerbations in Australian adults, over a 12-month period, stratified by Global Initiative for Asthma (GINA) treatment intensity steps, and steroid associated comorbidities.

Results: Of the 7868 adults treated for asthma, 19% experienced at least one severe exacerbation in the last 12-months. Severe exacerbation frequency increased with treatment intensity (≥1 severe exacerbation GINA 1 13%; GINA 4 23%; GINA 5a 33% and GINA 5b 28%). Questionnaire participants reported higher rates of severe exacerbations than suggested from their EMR (32% vs 23%) especially in steps 1, 4 and 5. Patients repeatedly exposed to steroids had an increased risk of osteoporosis (OR 1.95, 95% CI 1.43-2.66) and sleep apnoea (OR 1.78, 95% CI 1.30-2.46).

Conclusion: The Australian population living with GINA 1, 4, 5a and 5b asthma have high severe exacerbation rates and steroid-related burden, especially when compared to other first world countries, with these patients needing alternative strategies or possibly specialist assessment to better manage their condition.

Background: Favipiravir, an RNA-dependent RNA polymerase inhibitor (RdRp), is a broad-spectrum oral antiviral agent approved in India under emergency use authorization, for the treatment of mild-to-moderate coronavirus disease (COVID-19). The present study was planned to evaluate the effectiveness and safety of favipiravir in real-world clinical practice.

Materials and methods: This was a multicentric, retrospective, single-arm study conducted across four centres in India, after obtaining permission from the independent ethics committee. Medical records were analysed to evaluate effectiveness and safety of patients who were prescribed favipiravir.

Results: The medical records of a total of 360 patients met the inclusion criteria, with 358 of them available for the final analysis. Males made up 58.46% of the study population. The average age of enrolled patients was 51.80 ± 16.45 years. The most common symptoms were fever, cough, and myalgia-fatigue. The median time to clinical cure and fever relief was five and four days, respectively. The average length of stay in the hospital was six days. In total, 8% of the patients experienced adverse events. Hepatic enzyme elevation, diarrhoea, decreased appetite, headache, fatigue, and giddiness were the common symptoms.

Conclusion: In our real-world study, favipiravir was found to have a clinical cure rate of more than 90% in mild-to-moderate COVID-19 patients. This supports the use of favipiravir in the treatment of COVID-19. Favipiravir was well tolerated, with only minimal side effects, which were transient in nature.

Background: Electronic health record (EHR) databases provide rich, longitudinal data on interactions with healthcare providers and can be used to advance research into respiratory conditions. However, since these data are primarily collected to support health care delivery, clinical coding can be inconsistent, resulting in inherent challenges in using these data for research purposes.

Methods: We systematically searched existing international literature and UK code repositories to find respiratory disease codelists for asthma from January 2018, and chronic obstructive pulmonary disease and respiratory tract infections from January 2020, based on prior searches. Medline searches using key terms provided in article lists. Full-text articles, supplementary files, and reference lists were examined for codelists, and codelists repositories were searched. A reproducible methodology for codelists creation was developed with recommended lists for each disease created based on multidisciplinary expert opinion and previously published literature.

Results: Medline searches returned 1126 asthma articles, 70 COPD articles, and 90 respiratory infection articles, with 3%, 22% and 5% including codelists, respectively. Repository searching returned 12 asthma, 23 COPD, and 64 respiratory infection codelists. We have systematically compiled respiratory disease codelists and from these derived recommended lists for use by researchers to find the most up-to-date and relevant respiratory disease codelists that can be tailored to individual research questions.

Conclusion: Few published papers include codelists, and where published diverse codelists were used, even when answering similar research questions. Whilst some advances have been made, greater consistency and transparency across studies using routine data to study respiratory diseases are needed.

Background: We examined the perceptions of healthcare workers about the side-effects of COVID-19 vaccine and the types of side-effects they experienced in the post-vaccination period.

Methods: An institutional-based cross-sectional survey research design was used in which a semi-structured questionnaire was distributed to collect quantitative data from healthcare workers in Southern Ethiopia that were selected on the basis of a multi-stage cluster sampling technique. After inserting the completed cases into SPSS software, descriptive statistical techniques, such as frequencies, percentages, charts and inferential statistical tool, particularly binary logistic regression analysis, were used to analyze and present the data.

Results: Majority (43.6%) of respondents perceive that COVID-19 vaccine will have muscle pain around the injection site, followed by fever (39.9%), problems of blood clots (37.8%), headache (35.6%), fatigue (33.5%), and aching limbs (16%). And 63.6%) of them reported that they have experienced muscle pain around the injection site after receiving the COVID-19 vaccine, followed by fatigue (42%), headache (37.2%), fever (34.2%), redness around the injection site (21.6%), and swelling around the injection site (17.8%). Moreover, 25% reported that the fear of potential side-effects of COVID-19 vaccine inhibited them from taking the vaccine. Above all, it is found that respondents' expectation of COVID-19 vaccine to have such serious side-effects is significantly associated to their educational status (OR = 0.229; P < 0.01; 95%C.I.: 0.080-0.651).

Conclusion: While the expectations of most of the healthcare workers regarding the side-effects of the vaccine are parallel to the normal reactions of the vaccine, a significant proportion of the study participants have reported that they perceive COVID-19 vaccine will have life-threatening side-effects. Such fears have also played a role in affecting vaccine uptake. Therefore, the Ministry of Health, and other concerned government bodies should create further awareness on COVID-19 vaccine and related safety issues.

Background: Electronic healthcare records (EHR) are increasingly used in epidemiological studies but are often viewed as lacking quality compared to randomised control trials and prospective cohorts. Studies of patients with chronic obstructive pulmonary disease (COPD) often use the rate of forced expiratory volume in 1 second (FEV₁) decline as an outcome; however, its definition and robustness in EHR have not been investigated. We aimed to investigate how the rate of FEV₁ decline differs by the criteria used in an EHR database.

Methods: Clinical Practice Research Datalink and Hospital Episode Statistics were used. Patient populations were defined using 8 sets of criteria around repeated FEV₁ measurements. At a minimum, patients had a diagnosis of COPD, were ≥35 years old, were current or ex-smokers, and had data recorded from 2004. FEV₁ measurements recorded during follow-up were identified. Thereafter, eight populations were defined based on criteria around: i) the exclusion of patients or individual measurements with potential measurement error; ii) minimum number of FEV₁ measurements; iii) minimum time interval between measurements; iv) specific timing of measurements; v) minimum follow-up time; and vi) the use of linked data. For each population, the rate of FEV₁ decline was estimated using mixed linear regression.

Results: For 7/8 patient populations, rates of FEV₁ decline (age and sex adjusted) were similar and ranged from -18.7mL/year (95% CI -19.2 to -18.2) to -16.5mL/year (95% CI -17.3 to -15.7). Rates of FEV₁ decline in populations that excluded patients with potential measurement error ranged from -79.4mL/year (95% CI -80.7 to -78.2) to -46.8mL/year (95% CI -47.6 to -46.0).

Conclusion: FEV₁ decline remained similar in a COPD population regardless of number of FEV₁ measurements, time intervals between measurements, follow-up period, exclusion of specific FEV₁ measurements, and linkage to HES. However, exclusion of individuals with questionable data led to selection bias and faster rates of decline.

Objective: The objectives of this research were to investigate pharmacy professionals' counseling practices as well as to evaluate pharmacy professionals' counseling skills and the content of counseling services provided to patients visiting medicine retail outlets.

Methods: A facility-based observational cross-sectional study was used to assess medication counseling practice by pharmacy professionals. Data were gathered through an observation and a semi-structured questionnaire. Epi data version 4.0.2 was used to enter data, which was subsequently exported to SPSS version 21.0 for analysis. ANOVA and post hoc statistical analyses were used to investigate the association between independent and dependent variables; and a 0.05 p-value was considered.

Results: This study has a total of 105 pharmacy professionals that were included in the analysis. The majority of those who responded were between the ages of 25 and 29. The most common drug information offered by pharmacy staff to patients was frequency of administration (90%), length of therapy (90%), and unit dose dispensed, according to the current study (86%). Pharmacy professionals' age was significant on components of counseling practice as on mentioning the name of drugs during dispensing the medication (p=0.000), the route of administration (p=0.000), a drug dose (p=0.003), frequency of drug administration (p=0.016), proper medicine storage (p=0.024), type of dosage form (p=0.025), and duration of treatment (p=0.012). In comparison with the other age groups, an age greater than 40 years was significant on components of counseling practice (p=0.001) as a factor associated with penurious counseling practice than the other groups.

Conclusion: This study shows that counseling practice is still quite low in comparison to what is expected. Some of the issues that affect counseling include a high patient load, the lack of a private counseling room, a lack of updated drug knowledge, and a lack of experience were factors that influence counseling.

Introduction: Symptoms may persist after the initial phases of COVID-19 infection, a phenomenon termed long COVID. Current knowledge on long COVID has been mostly derived from test-confirmed and hospitalized COVID-19 patients. Data are required on the burden and predictors of long COVID in a broader patient group, which includes both tested and untested COVID-19 patients in primary care.

Methods: This is an observational study using data from Platform C19, a quality improvement program-derived research database linking primary care electronic health record data (EHR) with patient-reported questionnaire information. Participating general practices invited consenting patients aged 18-85 to complete an online questionnaire since 7th August 2020. COVID-19 self-diagnosis, clinician-diagnosis, testing, and the presence and duration of symptoms were assessed via the questionnaire. Patients were considered present with long COVID if they reported symptoms lasting ≥4 weeks. EHR and questionnaire data up till 22nd January 2021 were extracted for analysis. Multivariable regression analyses were conducted comparing demographics, clinical characteristics, and presence of symptoms between patients with long COVID and patients with shorter symptom duration.

Results: Long COVID was present in 310/3151 (9.8%) patients with self-diagnosed, clinician-diagnosed, or test-confirmed COVID-19. Only 106/310 (34.2%) long COVID patients had test-confirmed COVID-19. Risk predictors of long COVID were age ≥40 years (adjusted Odds Ratio [AdjOR]=1.49 [1.05-2.17]), female sex (adjOR=1.37 [1.02-1.85]), frailty (adjOR=2.39 [1.29-4.27]), visit to A&E (adjOR=4.28 [2.31-7.78]), and hospital admission for COVID-19 symptoms (adjOR=3.22 [1.77-5.79]). Aches and pain (adjOR=1.70 [1.21-2.39]), appetite loss (adjOR=3.15 [1.78-5.92]), confusion and disorientation (adjOR=2.17 [1.57-2.99]), diarrhea (adjOR=1.4 [1.03-1.89]), and persistent dry cough (adjOR=2.77 [1.94-3.98]) were symptom features statistically more common in long COVID.

Conclusion: This study reports the factors and symptom features predicting long COVID in a broad primary care population, including both test-confirmed and the previously missed group of COVID-19 patients.