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Postmarketing Surveillance of Drugs*
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
Early effects are those which occur shortly after drug is started. Late effects are those which occur as a result of chronic therapy. Obviously, this has both design and implementation implications. To observe late effects one must make observations in a chronically exposed population.
Micronutrients in Improvement of the Standard Therapy in Traumatic Brain Injury
Published in Kedar N. Prasad, Micronutrients in Health and Disease, 2019
The neuropathology of pTBI is very complex, depending upon the type and velocity of inducing agents, area and the size of the affected brain tissue, and amounts of loss of brain tissue. Generally, swelling, edema, hematoma, hemorrhage, contusion, focal cerebral vasospasm, increased blood-brain-barrier (BBB) disruption, and diffuse axonal injury are observed immediately after injury.20 It has been reported that penetrating ballistic-like injury and hemorrhagic shock can cause persistent damage of cerebral blood flow and brain tissue oxygen tension. These changes increase the probability of cortical spreading depolarization that may contribute to secondary neuropathology and compromise neurological recovery.21 The damage to the brain after pTBI occurs into three phases. The first phase involves primary injury to the brain tissue that cannot be reversed. The second phase occurs soon after injury and continues for days to weeks and contributes to the development of secondary damage that eventually leads to neurological disorders and neuronal death. During this period, intervention with appropriate agents can slow down the progression of the damage. The third phase appears as late effects, which depend upon the initial areas of the brain damaged. The late effects may include cognitive dysfunction, PTSD, and other behavior abnormalities.
Building a Predictive Model of Toxicity
Published in Tiziana Rancati, Claudio Fiorino, Modelling Radiotherapy Side Effects, 2019
Sunan Cui, Randall K. Ten Haken, Issam El Naqa
Radiation-induced toxicity can be categorized according to its onset time into early and late effects. Early effects can occur during or a few days to weeks after irradiations, typically in the rapidly proliferating tissues. These effects include skin erythema, mucositis, esophagitis, diarrhoea and immunosuppression. Late effects typically occur months to years after treatment, usually in slowly or non-proliferating tissues. Common late effects are lung fibrosis, kidney damage, heart disease, liver disease, spinal cord injury and proctitis (Halperin et al. 2008).
Fear of cancer recurrence eight years after early-stage breast cancer – results from a national survey
Published in Acta Oncologica, 2023
Kathrine Vandraas, Kristin Valborg Reinertsen, Solveig Smedsland, Synne Bøhn, Cecilie Kiserud, Ragnhild Sørum Falk, Hanne Cathrine Lie
Of 2803 invited participants, 1361 (49%) completed the survey. Three responders were excluded due to incomplete consent, three due to self-reported BC recurrence and 44 due to missing information on FCR. The final sample thus consisted of 1311 BCSs (47%). Mean age at survey was 60 years (range 30–74 years). The majority had higher education (52%) and lived with a partner (73%). Pain and cognitive dysfunction were the most frequently reported late effects (46 and 43% respectively) (Table 1). The most prevalent cancer-related concern was BC recurrence, affecting 81% of the BCSs of whom 51% reported worrying ‘a little bit’ and close to 10% reported very much worry. Worrying about experiencing another cancer illness was the second most prevalent cancer related concern, affecting 78% to some degree (Table 2). The mean FCR score based on sub scale 1 of the ASC was 6.1 (SD 2.3) (results not shown).
From shaky grounds to solid foundations: A salutogenic perspective on return to work after cancer
Published in Scandinavian Journal of Occupational Therapy, 2020
Birgit Brusletto, Camilla Martha Ihlebæk, Nina Helen Mjøsund, Steffen Torp
Some participants had to learn to live with chronic late effects from the treatments, and all described major exhaustion and loss of energy caused by treatment, as well as needing time to adjust. Participants returned to work at different times during or after their course of treatment, and in different ways. They all stated that they perhaps returned too early, even though they were bored at home or felt ready for work. Some experienced major late effects influencing their working ability, such as aphasia, fatigue, concentration difficulties, anxiety, and more. Two participants decided to quit their former jobs after making efforts to fulfill their job responsibilities for up to 2 years. Despite employers’ efforts to adjust the working hours at the beginning of the RTW process, they were unable to perform as before and needed sick leaves repeatedly due to late effects from cancer or its treatment. For example, Finn experienced after some time that when he began appearing physically better, his, employer increased his working expectations, which Finn was unable to fulfill. Similarly, Britt also reported that the increased working hours led to difficulties in her RTW as a customer advisor:
Differences in baseline characteristics and 1-year psychological factors between participants and non-participants in the randomized, controlled trial regarding patient-led follow-up after rectal cancer (FURCA)
Published in Acta Oncologica, 2019
Ida Hovdenak Jakobsen, Therese Juul, Henriette Vind Thaysen, Christoffer Johansen, Søren Laurberg
Early cancer detection and improvements in treatment for rectal cancer (RC) have led to a decrease in morbidity and mortality for this patient group [1,2]. Following this, the number of RC survivors has increased substantially, of whom many experience late effects and impaired quality of life (QoL) [3–5]. Traditional follow-up programs following RC show great variance internationally, and the evidence is low [6]. In general, the focus is on early detection and treatment of recurrent disease and metachronous cancers [6]. However, the marked drop in the risk of local recurrence and the growing number of RC survivors call for a broader purpose of cancer follow-up and survivorship care. There is a need to draw more attention to the management of late effects, and alternative approaches for patient-centered care are emerging [7–9].