Clinical trials during pandemic in primary care: Low number and low validity after one-year experience.
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ABSTRACT:
SUBMITTER: Tatsioni A
PROVIDER: S-EPMC8510587 | biostudies-literature | 2021 Dec
REPOSITORIES: biostudies-literature
Publications
Clinical trials during pandemic in primary care: Low number and low validity after one-year experience.
Tatsioni Athina A Siountri Iliana I Tsamoulis Donatos D Vafeidou Kyriaki K
The European journal of general practice 20211201 1
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Project description:ObjectiveWe used the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to conduct a systematic review of external validity reporting in integrated primary care (IPC) interventions for mental health concerns.MethodsWe searched Medline, CINAHL, PsycINFO, the Cochrane Center Register of Controlled Trials, and relevant literature to identify publications from 1998 to 2018 reporting on open, randomized, or quasi-randomized trials of IPC interventions that targeted child (ages 0-18 years) psychological symptoms. For each publication, we extracted the information reported in each RE-AIM domain and calculated the proportion of the total studies reviewed.ResultsThirty-nine publications describing 25 studies were included in the review. Publications rarely reported some indicators of external validity, including the representativeness of participants (12%), rate of adoption clinics or providers (16%), cost of implementation (8%), or evidence of maintenance (16%). Few studies reported on key pragmatic factors such as cost or organizational change processes related to implementation and maintenance. Strengths of some studies included comparisons of multiple active treatments, use of tailorable interventions, and implementation in "real world" settings.ConclusionsAlthough IPC interventions appear efficacious under research conditions, there are significant knowledge gaps regarding the degree to which they reach and engage target recipients, what factors impact adoption and implementation of IPC interventions by clinicians, how fidelity can be maintained over time, and cost-effectiveness. Pediatric IPC researchers should embrace dissemination and implementation science methods to balance internal and external validity concerns moving forward.
| S-EPMC8202128 | biostudies-literature
Project description:Nowadays, chronic disease management is the primary challenge of the healthcare system. From 2015, in the Veneto region (Italy), patients with a diagnosis of type 2 diabetes mellitus (T2DM) have been included in the diagnostic-therapeutic pathway (PDTA) program, and their clinical condition has been continuously monitored. The aim of this retrospective study is to determine the effectiveness of PDTA intervention, alone or in combination with a specialized one, in subjects with diagnosis of T2DM. Clinical and behavioral characteristics were collected at baseline and after 1 year of follow-up. Two subgroups were considered: subjects enrolled in PDTA only and subjects enrolled in both the PDTA program and in the care plan proposed by the specialized medical center (CAD group). Longitudinal analysis showed a relevant positive effect of time on diastolic blood pressure, while CAD enrollment appears to be related to higher levels of glycated hemoglobin. When included together in the same model, interaction between time and CAD covariates results in completely nonsignificant effects. As long-term management of chronic disorders, such as T2DM, is often difficult due to disease characteristics and problems in healthcare organization, monitoring programs, such as PDTA, and specialized care programs, such as CAD, do not show a clinically relevant effect in the first year of follow-up. Therefore, they should be analyzed over a longer period. However, they should also carefully consider the need for adequate tools for data collection and sharing, in addition to the context of application, patient expectations and the need for a long-term educational program.
| S-EPMC8583604 | biostudies-literature
Project description:BACKGROUND: Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results) and internal validity (reliability or accuracy of the results) needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. DISCUSSION: External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. SUMMARY: Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results) and external validity (generalizability). The attempt to achieve methodological purity can result in clinically meaningless results, while attempting to achieve full generalizability can result in invalid and unreliable results. Achieving a creative tension between the two is crucial.
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Project description:Background and purposeIn-hospital stroke-onset assessment and management present numerous challenges, especially in community hospitals. Comprehensive analysis of key stroke care metrics in community-based primary stroke centers is under-studied.MethodsMedical records were reviewed for patients admitted to a community hospital for non-cerebrovascular indications and for whom a stroke alert was activated between 2013 and 2019. Demographic, clinical, radiologic and laboratory information were collected for each incident stroke. Descriptive statistical analysis was employed. When applicable, Kruskal-Wallis and Chi-Square tests were used to compare median values and categorical data between pre-specified groups. Statistical significance was set at alpha = 0.05.ResultsThere were 192 patients with in-hospital stroke-alert activation; mean age (SD) was 71.0 years (15.0), 49.5% female. 51.6% (99/192) had in-hospital ischemic and hemorrhagic stroke. The most frequent mechanism of stroke was cardioembolism. Upon stroke activation, 45.8% had ischemic stroke while 40.1% had stroke mimics. Stroke team response time from activation was 26 minutes for all in-hospital activations. Intravenous thrombolysis was utilized in 8% of those with ischemic stroke; 3.4% were transferred for consideration of endovascular thrombectomy. In-hospital mortality was 17.7%, and the proportion of patients discharged to home was 34.4% for all activations.ConclusionThe in-hospital stroke mortality was high, and the proportions of patients who either received or were considered for acute intervention were low. Quality improvement targeting increased use of acute stroke intervention in eligible patients and reducing hospital mortality in this patient cohort is needed.
| S-EPMC8442154 | biostudies-literature
Project description:In the early months of the coronavirus disease 2019 (COVID-19) pandemic, our center reported a mortality rate of 34% in a cohort of 32 lung transplant recipients with COVID-19 between March and May 2020. Since then, there has been evolving knowledge in prevention and treatments of COVID-19. To evaluate the impact of these changes, we describe the clinical presentation, management, and outcomes of a more recent cohort of lung transplant recipients during the second surge and provide a comparison with our first cohort.MethodsWe conducted a retrospective cohort study that included all consecutive lung transplant recipients who tested positive for severe acute respiratory syndrome coronavirus 2 between November 2020 and February 28, 2021. We compared baseline demographics and major outcomes between the first- and second-surge cohorts.ResultsWe identified 47 lung transplant recipients (median age, 60; 51% female) who tested positive for severe acute respiratory syndrome coronavirus 2 between November 2020 and February 28, 2021. The current cohort had a higher proportion of patients with mild disease (34% versus 16%) and fewer patients with a history of obesity (4% versus 25%). Sixty-six percent (n = 31) required hospitalization and were treated with remdesivir (90%) and dexamethasone (84%). Among those hospitalized, 77% (n = 24) required supplemental oxygen, and 22% (n = 7) required invasive mechanical ventilation. The overall 90-d mortality decreased from 34% to 17% from the first cohort to the second (adjusted odds ratio, 0.26; 95% confidence interval, 0.08-0.85; P = 0.026).ConclusionsAlthough COVID-19-associated mortality rate in lung transplant recipients at our center has decreased over time, COVID-19 continues to be associated with significant morbidity and mortality.
| S-EPMC8966964 | biostudies-literature
Project description:We aimed to evaluate the overall clinical characteristics of patients treated by a neuro-emergency expert dedicated to the emergency department (ED) as an attending neurologist during the COVID-19 pandemic. We included adult patients who visited the ED between 1 January and 31 December 2020 and were treated by a neuro-emergency expert. We retrospectively obtained and analyzed the data on patients' clinical characteristics and outcome. The neuro-emergency expert treated 1155 patients (mean age, 62.9 years). The proportion of aged 18-40 years was the lowest, and the most common modes of arrival were public ambulance (50.6%) and walk-in (42.3%). CT and MRI examinations were performed in 94.4 and 33.1% of cases, respectively. The most frequent complaints were dizziness (31.8%), motor weakness (24.2%), and altered mental status (15.8%). The ED diagnoses were acute ischemic stroke (19.8%), benign paroxysmal positional vertigo (14.2%), vestibular neuritis (9.9%), and seizure (8.8%). The mean length of stay in the ED was 207 min. Of the patients, 55.0% were admitted to the hospital, and 41.8% were discharged for outpatient follow-up. Despite the longer stay and the complexity and difficulty of neurological diseases during the COVID-19 pandemic, the accurate diagnosis and treatment provided by a neuro-emergency expert can be presented as a good model in the ED.
| S-EPMC8493796 | biostudies-literature
Project description:ObjectiveTo quantify the different types of health outcomes assessed as primary outcomes in randomized controlled trials (RCTs) in the primary care (PC) setting during the last 20 years and identify whether potential gaps exist in specific types of health care and types of intervention.MethodsWe systematically searched PubMed, Scopus, and Cochrane Central Register of Controlled Trials, from January 2000 to September 2020 for published RCTs in PC. We recorded characteristics of eligible studies and mapped evidence by health outcome category (patient health outcomes, health services outcomes); and for each outcome category, by types of health care (preventive, acute, chronic, palliative), and by types of intervention (drug, behavioural, on structure, and on process). For RCTs assessing patient health outcomes as primary outcomes, we further mapped using the quality-of-care dimensions, that is, effectiveness, safety, and patient-centredness.ResultsOf the 518 eligible RCTs in PC, 357 (68.9%) evaluated a patient health outcome as the primary outcome, and 161 (31.1%) evaluated only health services outcomes as primary outcomes. Many focused on population with chronic illness (224 trials; 43.2%) and evaluated interventions on processes of health care (239 trials; 46.1%). Research gaps identified include preventive and palliative care, behavioural interventions, and safety and patient-centredness outcomes as primary outcomes.ConclusionOur evidence map showed research gaps in certain types of health care and interventions. It also showed research gaps in assessing safety and measures to place patient at the centre of health care delivery as primary outcomes.
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Project description:ObjectiveTo assess the predictive validity and feasibility of the newly developed language screening tool, SPES-2 (Sprachentwicklungsscreening), for 2-year-old children in pediatric primary care.MethodsA prospective cohort study recruited 2,044 non-selected German-speaking children undergoing a regular well-baby check-up at the age of 2 years. Thirty primary care pediatricians spread over urban and rural areas screened the children using a short parent-reported questionnaire and direct assessment of word comprehension. To validate the screening tool, language skills were assessed using a standardized language screening tool in the complete sample 1 year later. Data of a random sample of 621 children were analyzed. Feasibility of the screening tool was evaluated using questionnaires completed by the participating pediatricians.ResultsThe new screening tool, SPES-2, demonstrated good diagnostic accuracy with AUC (Area under the Roc Curve) of 0.885, a sensitivity of 0.74, and specificity of 0.86, using a parent-reported questionnaire (expressive vocabulary, two-word combinations, parental concerns) as stage 1, followed by a stage 2 direct assessment of word comprehension by the pediatrician. The second stage was restricted to children who failed the parental screening. The screening identified children with high, moderate, and low risk of significant language deficits (SLD) at the age of 3 years, permitting tailored follow-up assessment and parental counseling. Practicality and acceptability of the screening were mostly rated as high. Pediatricians regarded the availability of follow-up diagnostic services and parent guidance as most important for a general implementation of the new instrument.ConclusionThe language screening tool, SPES-2, was valid for the identification of significant language deficits 1 year later, and considered as feasible within primary pediatric care.
| S-EPMC9485630 | biostudies-literature
Project description:BackgroundIntegrated Primary Care Teams (IPCTs) have four key characteristics (intensive interdisciplinary practice; advanced nursing practice with an expanded role; group practice; increased proximity and availability) aimed at strengthening primary care in Quebec, Canada. The purpose of this paper is to examine the care experience over time of patients who have an IPCT as their primary source of care.MethodsWe used a quasi-experimental longitudinal design based on a pre-and-post administered survey at a 2-year interval without a control group. We measured patient-reported accessibility, continuity, comprehensiveness, responsiveness and outcomes of care.ResultsResults showed that patients who were newly registered with an IPCT had a significant increase in reported care experience, whereas patients who have been registered with an IPCT for 2 years prior to the first round of data collection had already high reported care experience that was maintained over time. Moreover, linear regression models showed statistically significant different increases in the dimensions of care experience by site and patients' characteristics.ConclusionsOur results suggest that the IPCT model is tailored to the needs of its target populations, resulting in improved Patient Reported Experience Measures. These results imply that broader implementation of innovative and flexible community-based care models should be considered by policymakers.
| S-EPMC9053536 | biostudies-literature