Final results of 18-month follow-up of Greek women concluding teriparatide treatment in the European Forsteo Observational Study (EFOS)

ObjectivesTo describe fracture rates, back pain, and health-related quality of life (HRQoL) in postmenopausal women with osteoporosis and prior bisphosphonate therapy, treated with teriparatide for up to 18 months and followed up for a further 18 months.DesignProspective, multinational, and observational study.MethodsData on prior bisphosphonate use, clinical fractures, back pain visual analog scale (VAS), and HRQoL (EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month intervals and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed using a repeated measures model.ResultsOf the 1581 enrolled patients with follow-up data, 1161 (73.4%) had a history of prior bisphosphonate use (median duration: 36 months). Of them, 169 (14.6%) sustained ≥1 fracture during 36-month follow-up. Adjusted odds of fracture were significantly decreased at each 6-month interval compared with the first 6 months of teriparatide treatment: 37% decrease in the 12 to <18 months period during teriparatide treatment (P=0.03) and a 76% decrease in the 12- to 18-month period after teriparatide was discontinued (P<0.001). Significant reductions in back pain and improvement in HRQoL were observed.ConclusionsPostmenopausal women with severe osteoporosis previously treated with bisphosphonates had a significant reduction in the incidence of fractures compared with the first 6 months of therapy, a reduction in back pain and an improvement in HRQoL during up to 18 months of teriparatide treatment. These outcomes were still evident for at least 18 months after teriparatide was discontinued. The results should be interpreted in the context of an uncontrolled, observational study in a routine clinical setting.

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IS STEP RATE ASSOCIATED WITH RUNNING INJURY INCIDENCE? AN OBSERVATIONAL STUDY WITH 9- MONTH FOLLOW UP

International Journal of Sports Physical Therapy ◽

10.26603/ijspt20200221 ◽

2020 ◽

Vol 15 (2) ◽

pp. 221-228

Author(s):

Eliza B. Szymanek ◽

Erin M. Miller ◽

Amy N. Weart ◽

Jamie B. Morris ◽

Donald L. Goss

Keyword(s):

Observational Study ◽

Injury Incidence ◽

Step Rate ◽

Running Injury

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A Prospective, Cross-sectional, Observational Study With a 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops

Case Medical Research ◽

10.31525/ct1-nct04293549 ◽

2020 ◽

Author(s):

Keyword(s):

Nerve Growth Factor ◽

Growth Factor ◽

Observational Study ◽

Structure And Function ◽

Cross Sectional ◽

Corneal Nerves ◽

And Function ◽

Human Nerve ◽

Neurotrophic Keratopathy

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Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽

10.1159/000516368 ◽

2021 ◽

pp. 1-5

Author(s):

Aharon Erez ◽

Gregory Golovchiner ◽

Robert Klempfner ◽

Ehud Kadmon ◽

Gustavo Ruben Goldenberg ◽

...

Keyword(s):

Observational Study ◽

Elderly Patients ◽

Prospective Observational Study ◽

Bleeding Risk ◽

The Elderly ◽

High Dose ◽

World Population ◽

Younger Patients ◽

End Point

Introduction: In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). Methods: In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age <75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. Results: There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (p = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [p for age-group-by-treatment interaction = 0.83). Conclusions: Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

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The effect of COVID-19 pandemic and lockdown on consultation numbers, consultation reasons and performed services in primary care: results of a longitudinal observational study

BMC Family Practice ◽

10.1186/s12875-021-01471-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ingmar Schäfer ◽

Heike Hansen ◽

Agata Menzel ◽

Marion Eisele ◽

Daniel Tajdar ◽

...

Keyword(s):

Primary Care ◽

Observational Study ◽

Rural Areas ◽

Longitudinal Observational Study ◽

Multivariable Analyses ◽

Gastrointestinal Complaints ◽

Urban And Rural Areas ◽

Quota Sampling ◽

Primary Care Practices

Abstract Objectives The aims of our study were to describe the effect of the COVID-19 pandemic and lockdown on primary care in Germany regarding the number of consultations, the prevalence of specific reasons for consultation presented by the patients, and the frequency of specific services performed by the GP. Methods We conducted a longitudinal observational study based on standardised GP interviews in a quota sampling design comparing the time before the COVID-19 pandemic (12 June 2015 to 27 April 2017) with the time during lockdown (21 April to 14 July 2020). The sample included GPs in urban and rural areas 120 km around Hamburg, Germany, and was stratified by region type and administrative districts. Differences in the consultation numbers were analysed by multivariate linear regressions in mixed models adjusted for random effects on the levels of the administrative districts and GP practices. Results One hundred ten GPs participated in the follow-up, corresponding to 52.1% of the baseline. Primary care practices in 32 of the 37 selected administrative districts (86.5%) could be represented in both assessments. At baseline, GPs reported 199.6 ± 96.9 consultations per week, which was significantly reduced during COVID-19 lockdown by 49.0% to 101.8 ± 67.6 consultations per week (p < 0.001). During lockdown, the frequency of five reasons for consultation (-43.0% to -31.5%) and eleven services (-56.6% to -33.5%) had significantly decreased. The multilevel, multivariable analyses showed an average reduction of 94.6 consultations per week (p < 0.001). Conclusions We observed a dramatic reduction of the number of consultations in primary care. This effect was independent of age, sex and specialty of the GP and independent of the practice location in urban or rural areas. Consultations for complaints like low back pain, gastrointestinal complaints, vertigo or fatigue and services like house calls/calls at nursing homes, wound treatments, pain therapy or screening examinations for the early detection of chronic diseases were particularly affected.

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Prospective observational study on Stelara (ustekinumab) assessing effectiveness in Crohn’s disease (PROSE): a 16-week follow-up

Scandinavian Journal of Gastroenterology ◽

10.1080/00365521.2021.1906946 ◽

2021 ◽

pp. 1-7

Author(s):

Anders Forss ◽

Mark Clements ◽

Pär Myrelid ◽

Hans Strid ◽

Charlotte Söderman ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Observational Study ◽

Prospective Observational Study

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Role of caregiver factors in outpatient medical follow-up post-stroke: observational study in Singapore

BMC Family Practice ◽

10.1186/s12875-021-01405-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Shilpa Tyagi ◽

Gerald Choon-Huat Koh ◽

Nan Luo ◽

Kelvin Bryan Tan ◽

Helen Hoenig ◽

...

Keyword(s):

Observational Study ◽

Management Strategies ◽

Stroke Survivor ◽

Stroke Survivors ◽

Post Stroke ◽

Memory Problems ◽

Healthcare Needs ◽

Stroke Study

Abstract Background Outpatient medical follow-up post-stroke is not only crucial for secondary prevention but is also associated with a reduced risk of rehospitalization. However, being voluntary and non-urgent, it is potentially determined by both healthcare needs and the socio-demographic context of stroke survivor-caregiver dyads. Therefore, we aimed to examine the role of caregiver factors in outpatient medical follow-up (primary care (PC) and specialist outpatient care (SOC)) post-stroke. Method Stroke survivors and caregivers from the Singapore Stroke Study, a prospective, yearlong, observational study, contributed to the study sample. Participants were interviewed 3-monthly for data collection. Counts of PC and SOC visits were extracted from the National Claims Database. Poisson modelling was used to explore the association of caregiver (and patient) factors with PC/SOC visits over 0–3 months (early) and 4–12 months (late) post-stroke. Results For the current analysis, 256 stroke survivors and caregivers were included. While caregiver-reported memory problems of a stroke survivor (IRR: 0.954; 95% CI: 0.919, 0.990) and caregiver burden (IRR: 0.976; 95% CI: 0.959, 0.993) were significantly associated with lower early post-stroke PC visits, co-residing caregiver (IRR: 1.576; 95% CI: 1.040, 2.389) and negative care management strategies (IRR: 1.033; 95% CI: 1.005, 1.061) were significantly associated with higher late post-stroke SOC visits. Conclusion We demonstrated that the association of caregiver factors with outpatient medical follow-up varied by the type of service (i.e., PC versus SOC) and temporally. Our results support family-centred care provision by family physicians viewing caregivers not only as facilitators of care in the community but also as active members of the care team and as clients requiring care and regular assessments.

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Factors That Cause Concerns after Cardioverter Defibrillator Implantation

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18116095 ◽

2021 ◽

Vol 18 (11) ◽

pp. 6095

Author(s):

Olimpia Karczewska ◽

Agnieszka Młynarska

Keyword(s):

Observational Study ◽

Secondary Prevention ◽

Negative Emotions ◽

Female Gender ◽

Multiple Regression Model ◽

Icd Implantation ◽

Cardioverter Defibrillator ◽

Input Method ◽

Two Stages

Background and Objectives: The aim of the study was to assess the factors that influence the occurrence of concerns and their intensification after the implantation of a cardioverter defibrillator. Materials and Methods: This was a prospective and observational study including 158 patients. The study was conducted in two stages: stage I before implantable cardioverter defibrillator (ICD) implantation and stage II follow-up visit six months after ICD implantation. Standardized questionnaires were used in both stages. Results: Age and female gender were significantly correlated with the occurrence and intensity of concerns. Patients who had a device implanted for secondary prevention also experienced higher levels of concern. Additionally, a multiple regression model using the stepwise input method was performed. The model was statistically significant and explained 42% of the observed variance in the dependent variable (p = 0.0001, R2 = 0.4215). The analysis showed that age (p = 0.0036), insomnia (p = 0.0276), anxiety (p = 0.0000) and negative emotions (p = 0.0374) were important predictors of the dependent variable and enabled higher levels of the number of concerns to be predicted. Conclusions: There is a relationship between the severity of the concerns related to an implanted ICD and age, gender, anxiety, negative emotions and insomnia. Indications for ICD implantation may be associated with increased concerns about ICD.

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