Expected Side Effect Research Articles

Expectations of side effects evoked by perceptual characteristics of curatives and their psychological background

Cel: A gyogyszermellekhatasok egy resze nem-specifikus eredetű (nocebo-hatas), s ezen belul is reszben a gyogyszerek perceptualis jellemzői (szin, meret stb.) altal kivaltott elvarasokra, reszben egyes hajlamosito szemelyisegvonasokra vezethető vissza. Jelen munka celja e tenyezők es a vart mellekhatasok kozotti kapcsolatok vizsgalata volt. Modszer: A resztvevők (118 alsoeves egyetemi hallgato) 6 kulonboző szinű/meretű tabletta eseten 10 gyakori nem-specifikus gyogyszermellekhatas jelentkezesenek valoszinűseget becsultek meg, valamint szemelyiseg-kerdőiveket (STAI-T, LOT-R, PHQ-15, SSAS) toltottek ki. Eredmenyek: A kulonboző kinezetű tablettak mind a 10 mellekhatas tekinteteben szignifikansan kulonboztek egymastol, a vart mellekhatasok sulyossagat leginkabb a szomatizacios hajlam (Szubjektiv Testi Tunetek 15 kerdőiv, PHQ-15) es a szomatoszenzoros amplifikacio (SSAS) alapjan lehetett előre jelezni. Az utvonalelemzes alapjan a vonasszorongas (STAI) es a nem hatasa csak kozvetetten, a fenti ket tenyezőn kere...

Therapeutic potential of JAK2 inhibitors.

The discovery of an activating tyrosine kinase mutation JAK2V617F in myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) has resulted in the development of JAK2 inhibitors, of which several are being evaluated in phase I/II clinical studies. It is important to recognize that because the V617F mutation is localized in a region outside the adenosine triphosphate (ATP)-binding pocket of JAK2 enzyme, ATP-competitive inhibitors of JAK2 kinase (like the current JAK2 inhibitors in the clinic) are not likely to discriminate between wild-type and mutant JAK2 enzymes. Therefore, JAK2 inhibitors, by virtue of their near equipotent activity against wild-type JAK2 that is important for normal hematopoiesis, may have adverse myelosuppression as an expected side effect, if administered at doses that aim to completely inhibit the mutant JAK2 enzyme. While they may prove to be effective in controlling hyperproliferation of hematopoietic cells in PV and ET, they may not be able to eliminate mutant clones. On the other hand, JAK inhibitors may have great therapeutic benefit by controlling the disease for patients with MPNs who suffer from debilitating signs (eg, splenomegaly) or constitutional symptoms (which presumably result from high levels of circulating cytokines that signal through JAK enzymes). Indeed, the primary clinical benefits observed so far in MF patients have been significant reduction is splenomegaly, elimination of debilitating disease-related symptoms, and weight gain. Most importantly, patients with and without the JAK2V617F mutation appear to benefit to the same extent. In this review we summarize current clinical experience with JAK2 inhibitors in MPNs.

Phase II Trial of T138067, a Novel Microtubule Inhibitor, in Patients with Metastatic, Refractory Colorectal Carcinoma

This study was conducted before the approval of oxaliplatin, cetuximab, and bevacizumab and was designed to evaluate a novel microtubule targeting agent, T138067, in patients with metastatic colorectal cancer (CRC) previously treated with irinotecan and 5-fluorouracil. Patients from 3 institutions were enrolled over 4 months and treated with T138067 on days 1, 8, and 15 of a 21-day cycle. Disease evaluation was performed after 9 weeks. Treatment was tolerable with moderate hematologic and gastrointestinal toxicity. Neurotoxicity, an expected side effect, was minimal. Among 23 evaluable patients, there were no responses. Median time to tumor progression was 1.4 months and median survival was 9.3 months. T138067 at this dose and schedule was well tolerated by patients with CRC. However, there was no evidence of clinical activity for T138067 in 5-fluorouracil/irinotecan-refractory CRC. The long median survival likely reflects availability of other agents and/or patient selection.

Patients' motives for choosing a physician: comparison between conventional and complementary medicine in Swiss primary care

BackgroundThe study is part of a nationwide evaluation of complementary and alternative medicine (CAM) in primary care in Switzerland. The Objective was to identify patients' expectations and reasons governing the choice of complementary medicine compared with conventional primary care (CONV).MethodsThe data were derived from the PEK study (Programm Evaluation Komplementärmedizin), which was conducted in 2002–2003 with 7879 adult patients and parents of 1291 underage patients, seeking either complementary (CAM) or conventional (CONV) primary care. The study was performed as a cross-sectional survey. The respondents were asked to document their (or their children's) self-perceived health status, reasons governing their choice, and treatment expectations. Physicians were practicing conventional medicine and/or complementary methods (homeopathy, anthroposophic medicine, neural therapy, and traditional Chinese medicine). Reasons governing the choice of physician were evaluated on the basis of a three-part classification (physician-related, procedure-related, and pragmatic/other reasons)Results and DiscussionPatients seeing CAM physicians tend to be younger and more often female. CAM patients referred to procedure-related reasons more frequently, whereas pragmatic reasons dominated among CONV patients. CAM respondents expected fewer adverse side effects compared to conventional care patients.ConclusionThe majority of alternative medicine users appear to have chosen CAM mainly because they wish to undergo a certain procedure; additional reasons include desire for more comprehensive treatment, and expectation of fewer side-effects.

GlycoPEGylated Filgrastim XM22 Demonstrates Dose-Dependent Activity in Comparison to Pegfilgrastim in a Dose-Escalating Study in Healthy Volunteers after Body-Weight Dependent Single Dose.

XM22 is a glycoPEGylated recombinant human G-CSF that interacts with the G-CSF receptor by binding and activation. In pilot studies in non-neutropenic animals, XM22 demonstrated a similar PK/PD profile compared to pegfilgrastim. Because of its longer duration of action compared to filgrastim, XM22 is intended to be dosed once per cycle for the reduction of duration of severe neutropenia and incidence of febrile neutropenia in cancer patients undergoing chemotherapy.METHODS: A single center, randomized, single-blind study of XM22, administered as single escalating body-weight (bw) dependent doses given by the s.c. route was conducted to assess safety, pharmacokinetic profile and pharmacodynamic properties based on absolute neutrophil count (ANC) and CD34+ cell count. Male or female healthy volunteers were assigned to one of 3 XM22 dose groups, at 25 μg/kg bw dose (n=8), at 50 μg/kg bw (n=15), and 100 μg/kg bw (n=15) compared to 100 μg/kg bw pegfilgrastim (n=15).RESULTS: 53 healthy volunteers were enrolled in the three dose groups and completed 21 day follow-up. Injections were generally well-tolerated with no discontinuations due to adverse events or serious adverse events. XM22 at a dose of 100 μg/kg bw exhibited a PK profile with increased bioavailability and extended half life compared to the same dose of pegfilgrastim. ANC area over baseline effect curve (AOBEC) and CD34+ AOBEC were higher after treatment with XM22 100 μg/kg bw (6818.55 hr*neut./nl and 7340.16 hr*cell count/μl geometric mean respectively) compared to the same dose of pegfilgrastim. Antibody data will be presented.CONCLUSIONS: Single body-weight dependent doses up to 100 mg/kg of XM22 administered to healthy volunteers were generally well-tolerated with regard to the expected side effect profile and demonstrated dose-dependent increases in absolute neutrophil count and CD34+ cell count. These data supplement results from another study in healthy volunteers in which XM22 was administered as a fixed dose.

GlycoPEGylated Filgrastim XM22 Fixed Dose Demonstrates Similar Activity in Comparison to Pegfilgrastim in Healthy Volunteers after Single Administration.

XM22 is a glycoPEGylated recombinant human G-CSF that interacts with the G-CSF receptor by binding and activation. In pilot studies in non-neutropenic animals, XM22 demonstrated a similar PK/PD profile compared to pegfilgrastim. By its longer duration of action compared to filgrastim a once per cycle dosing as fixed dose in chemotherapy treated cancer patients for the reduction of duration of severe neutropenia and incidence of febrile neutropenia is intended.METHODS: A single center, randomized, single-blind study of XM22, administered as single fixed dose given by the s.c. route, was conducted to assess safety, pharmacokinetic profile and pharmacodynamic properties based on absolute neutrophil count (ANC) and CD34+ cell count. Male or female healthy volunteers were assigned to either XM22 6 mg or pegfilgrastim 6 mg fixed dose treatment.RESULTS: 36 healthy volunteers were enrolled in two treatment groups and completed 21 day follow-up. Injections were generally well-tolerated with no discontinuations due to adverse events or serious adverse events. Pharmacodynamic data were compared between the fixed doses of 6 mg XM22 and pegfilgrastim and in body weight strata within the treatment groups. Pharmacokinetic and antibody data will be presented.CONCLUSIONS: Single doses of 6 mg fixed dose of XM22 administered to healthy volunteers were generally well-tolerated with regard to the expected side effect profile and demonstrated increases in absolute neutrophil count and CD34+ cell count. These results supplement data from another study in healthy volunteers in which XM22 was administered in ascending single doses adjusted according to body-weight.

Facial resurfacing: An overview

Facial resurfacing is a broad topic referring to procedures that change the texture and appearance of skin. Resurfacing procedures are broadly classified as ablative or nonablative. Ablative procedures are considered the first line treatment for the most common indications for facial resurfacing, which are photoaging and acne scarring. The goal of this review is to provide an overview of the factors that optimize the clinical efficacy of an ablative procedure, including careful patient selection, preoperative skin preparation, correct operative technique, and vigilant postoperative care, as well as review both the traditional and some of the latest technologies that effectively resurface facial skin.

Contraceptive efficacy and side effects of Implanon®

Objective To determine the efficacy and side effects of Implanon® used for long-term contraception.Material and method Prospective study of 80 patients who used Implanon® for long-term contraception between January 2004 and January 2006. Side effects, efficacy and removals were recorded.Results Amenorrhoea, infrequent bleeding and frequent bleeding were reported by 33 (41.25%), 19 (23.75%) and 14 patients (17.5%), respectively. Non-menstrual side effects comprised breast tenderness in 15 patients (18.75%), acne in eight (10%), headache and dizziness in three (3.75%); depressive mood disorders, pelvic pain and loss of libido were mentioned each by two of the women (2.5%). During the study period, Implanon® was removed from 20 participants. No problem was encountered during its placement or removal.Conclusion Patients considering use of Implanon® must be carefully selected and informed about its expected side effects before placement.

Evaluating Bone Mass and Bone Quality in Patients with Breast Cancer

Bone remodeling is a process by which bone renews itself focally in distinct areas on cancellous (ie, trabecular) bone and/or in the Haversian systems of cortical (or compact) bone. Normal bone turnover involves the ordered metabolism of bone-resorbing cells (osteoclasts) and bone-forming cells (osteoblasts). Estrogen exerts a multitude of actions on bone tissues and is integral to bone health, and estrogen deprivation leads to accelerated bone loss. Bone strength reflects the integration of bone density and bone quality. Methods to assess bone strength fall into 3 categories: radiologic (ie, bone mineral density [BMD]), biochemical (ie, markers of bone turnover), and histologic (ie, bone biopsies for histomorphometry). The beneficial effect of aromatase inhibitors (AIs) and inactivators on breast cancer depends on reducing levels of circulating estrogens in the peripheral blood. There appears to be variability in the effects of AIs on bone in experimental animals, and this variability may not be the same in humans. In general, bone loss is an expected side effect of the AIs. For postmenopausal women receiving adjuvant anastrozole or other AIs, a BMD measurement using dual-energy x-ray absorptiometry is recommended, to be repeated every 1–2 years. Regular physical exercise is advised together with added calcium 1500 mg and vitamin D 800 U daily. If the T-score reaches a level of > −2.5, or if it is between −1.5 and —2.5 in the presence of a fragility fracture or vertebral compression fracture, or if height loss > 2 cm occurs or BMD decreases > 3% in 1 year at the lumbar spine or > 5% at the femoral neck, bisphosphonate therapy should be considered.

Impact of information sources on expectation of cancer treatment side effects: A URCC CCOP study

8094 Background: Cancer patients can expect many side effects from their chemotherapy or radiation treatment. This study investigated possible causes of these expectations. Methods: 1015 Cancer patients from 17 Community Clinical Oncology Program (CCOP) institutions affiliated with the University of Rochester CCOP research base were surveyed for symptoms they expected from treatment (given 12 common symptoms); the symptoms they were already experiencing; their age, education, disease site and gender; Karnofsky score; self-rated general health; and which of 25 sources of cancer information grouped into 3 broad areas of medical (10), community (7) and media (8) they have used. Results: 3 significant predictors (p<.05) of the number of side effects expected by the patients emerged from a stepwise multiple regression: the number of side effects the patient was already experiencing (Δr2=0.14), patient age (Δr2=0.05) and the number of information sources used (Δr2=0.03). Only the cancer care physician, the PCP (primary care physician) and newspapers had a negative correlation with individual side effects (PCP and newspapers related to a lower expectancy of hair loss, p<0.05) all other information sources had none or a positive correlation with the expectancy of a side effect. The total number of expected side effects was most highly related (all p<0.01) to using the Internet (r=0.20) the American Cancer Society (r=0.19) and the NCI (National Cancer Institute, r=0.18) as sources of treatment information. Use of information sources from the NCI was positively associated with expecting every side effect (9 with p<0.01, 3 with p<0.05). Conclusions: Information sources can have an impact on the expectancy of side effects by people undergoing cancer treatment. Since this expectancy may influence the actual experience of the patient during the treatment, knowing how many and which sources of information patients have used may promote optimal management of treatment related symptoms. Supported, in part, by a supplement from the Division of Cancer Control and Population Sciences, NCI, to Public Health Service grant U10 CA37420 and by grant RSG-01-071-PBP from the ACS. No significant financial relationships to disclose.

Impact of information sources on expectation of cancer treatment side effects: A URCC CCOP study

Impact of information sources on expectation of cancer treatment side effects: A URCC CCOP study

Expectations of chemotherapy-related nausea: emotional and experiential predictors.

Despite literature indicating that expectations are important determinants of experiences of nonvolitional outcomes (e.g., pain, nausea), little research has explored their source. The dual process model suggests that concurrent experience of emotional distress should be a strong contributor, whereas social learning theory supports the position that expectations of nonvolitional outcomes should be based primarily on prior experience. These alternative hypotheses were tested in a sample of 80 breast cancer patients undergoing outpatient adjuvant chemotherapy, as such protocols provide a unique opportunity to study the impact of emotional distress and prior experience on patients' expectations of side effects. Bivariate analyses suggested that emotional distress contributed early in the course of treatment, but once prior experience of posttreatment nausea (PTN) was accounted for in the statistical model, distress no longer made significant contributions to patients' expectations of PTN, whereas prior experience did (p < .001). These findings suggest that experience of chemotherapy infusions is an important source of expectations for PTN, which may be representative of the source of expectations for nonvolitional outcomes in broader contexts.

Summaries for patients. The reliability of medical record review for estimating the frequency of medical mistakes.

Summaries for Patients4 June 2002The Reliability of Medical Record Review for Estimating the Frequency of Medical MistakesSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-136-11-200206040-00004 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail What is the problem and what is known about it so far?In 1999, the U.S. Institute of Medicine reported that mistakes in U.S. hospitals are alarmingly frequent. This report relied on studies that used doctors and nurses to review patients' medical records to identify mistakes. In these studies, the doctors and nurses looked at the medical records to first decide whether a patient had experienced a complication. Second, they had to decide whether the complication was related to medical care. Third, they needed to decide whether the complication was an expected side effect or was caused by someone's mistake. ... Author, Article, and Disclosure InformationAffiliations: The summary below is from the full report titled “The Reliability of Medical Record Review for Estimating Adverse Event Rates.” It is in the 4 June 2002 issue of Annals of Internal Medicine (volume 136, pages 812-816). The authors are EJ Thomas, SR Lipsitz, DM Studdert, and TA Brennan.Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians-American Society of Internal Medicine. Previousarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoThe Reliability of Medical Record Review for Estimating Adverse Event Rates Eric J. Thomas , Stuart R. Lipsitz , David M. Studdert , and Troyen A. Brennan Metrics 4 June 2002Volume 136, Issue 11Page: I-40KeywordsAdverse eventsChartsHospital medicine ePublished: 4 June 2002 Issue Published: 4 June 2002 Copyright & PermissionsCopyright © 2002 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

Management of opioid-induced constipation.

Constipation is an expected side effect of opioid use and as such should be treated prophylactically. However, because it is often overlooked and under-appreciated it is one of the most common reasons patients avoid or abandon opioid use and, as a result, suffer pain needlessly. Thorough assessment, ongoing evaluation, and patient teaching are key factors in establishing an effective bowel regimen. A bowel clean-out is indicated for patients who have not had a bowel movement in more than 5 days. Once any impactions have been eliminated, a regular regimen of senna and docusate is recommended. Dietary modifications, fluids, and exercise are important but usually not sufficient to overcome opioid-induced constipation. Although many of the medicines that are used to treat pain and related symptoms come with a significant potential for distressing side effects, it is important to understand that most side effects, especially constipation, can be managed and quality of life can be preserved without sacrificing needed analgesia.

Maritime safety/rescue service performance and technological enhancement

The performance of safety activities such as crime regulation and rescue services at sea by the Maritime Safety Agency (MSA) of Japan is quantitatively evaluated and found to be little improved or to be saturated on several criteria for several decades. The political background and legal constraints of MSA are discussed as constraining its activities. In coping with the expansion of maritime activities into the distant ocean, policies for improving its performance are explored and the effects of high technological enhancement on performance and its expected side effects on technological innovation and international affairs are conceptually discussed. The constraints for technological and organisational innovations are also discussed.

Characteristics of clients with schizophrenia who express certainty or uncertainty about continuing treatment with depot neuroleptic medication

In this exploratory study, the factors corresponding to clients' certainty or uncertainty in continuing with depot neuroleptic medication for schizophrenia were examined. Ninety-four participants from a tertiary care schizophrenia clinic received an educational intervention aid containing information about treatment risks and benefits and were interviewed to elicit their levels of decisional conflict, self-efficacy, and emotional support, as well as expectations of risks and benefits of treatment. Eighty-seven percent of participants decided to continue treatment. Clients who expressed uncertainty (10%) about continuing with treatment had higher levels of decisional conflict (p = .000), lower levels of decision self-efficacy (p = .037) and decision emotional control (p = .003), lower expectations of hospitalization if treatment was stopped (p = .04) as well as lower expectations of benefits and higher expectations of side effects (p = .04), if treatment continued. In addition, reasons identified by participants for certainty or uncertainty were reported. The research may be useful in increasing the awareness of clinicians about the factors contributing to treatment decision making by clients diagnosed with schizophrenia and ultimately improve collaborative decision making.

Side effects of adjuvant chemotherapy: perceptions of node-negative breast cancer patients.

Twenty-one node-negative breast cancer patients were interviewed shortly after completing adjuvant chemotherapy and asked about side effects they had experienced, expectation of side effects, and strategies for coping with the side effects. Eighteen of the women were interviewed 6 months later to determine their feelings about the chemotherapy experience and ending treatment and what side effects persisted or developed after chemotherapy. Hair loss, fatigue, treatment-related problems, nausea and infections/low blood counts were the most frequently described problems during the first interviews. Patients used coping strategies suggested by physicians and nurses. Six months later, hair problems, fatigue, weight gain, menopausal problems, emotional problems and nail problems were most often reported. Most patients (16/18) did not expect to be experiencing chemotherapy-related problems 6 months after ending treatment. Fatigue interfered with daily lives and weight gain caused concern. A total of 35% of participants experienced fear or anxiety at the end of chemotherapy, but most (62%) recalled at least some positive feelings 6 months later. Given the same circumstances, all but two would make the same decision to undergo adjuvant chemotherapy. Support groups would be especially useful for patients completing chemotherapy who would lose continued frequent support from clinic personnel.

Framing effects on expectations, decisions, and side effects experienced: The case of influenza immunization

Objective: To examine the effects of using positive or negative frames to describe influenza vaccine benefits and side effects on patients' expectations, decisions, decisional conflict, and reported side effects. Methods: 292 previously unimmunized patients with chronic respiratory or cardiac disease were randomly assigned to receive benefit/risk information that was framed: (1) positively as the percentage who remain free of influenza and have no vaccine side effects, or (2) negatively as the percentage who acquire influenza and have vaccine side effects. Questionnaires elicited expectations, decisions, and decisional conflict. Vaccines were telephoned 3 days later for a self-report of local and systemic side effects and work absenteeism. Results: Both groups had similar immunization rates and decisional conflict scores. The positive frame group had lower and more realistic expectations of vaccine side effects, fewer systemic side effects, and less work absenteeism ( p < 0.05). Conclusion: In contrast to previous studies of health care workers, framing did not influence patients' decisions, possibly due to the patients' awareness of their higher risk of influenza complications and greater desire to follow recommendations. The common practice of using negative frames when describing probabilities of side effects may need to be reexamined, considering its deleterious influence on self-reported side effects and work absenteeism.

Reduction of Sympathetic Influences on Penile Erection by Phentolamine

The lumbosacral sympathetic trunks seem to play a major role in penile detumescence. In animal experiments an erection induced by cavernous nerve stimulation can be abolished by neurostimulation of the canine sympathetic trunks. This canine experiment was designed to study the possible reduction of the sympathetic effect by intravenous injection of phentolamine. The aborted erection by sympathetic trunks stimulation was partially antagonized by phentolamine. The arterial flow to the penis as well as the intracavernous pressure were elevated by this drug. As an expected side effect the systemic arterial blood pressure decreased by 4-14 cm H2O after phentolamine injection.

Managing the side effects of chemotherapy

More chemotherapy is being administered today than ever before. Megadoses of these drugs are becoming commonplace. Better methods of drug delivery, patient monitoring, and sophisticated support services such as infectious disease specialists, transfusion therapy, intensive care facilities, oncology clinical nurse specialists, and others, enable the physician to treat the patient in a variety of settings, including ambulatory care centers and the home. Just as the nurse needs advanced skills and the knowledge to know the subtle differences between an expected side effect and a toxic reaction, the patient needs to learn preventive health care and which symptoms to report at a time when management strategies can be most effective. Research by Dodd indicates that patients who received information on side-effect management techniques performed more self-care behaviors, and many acted promptly before side effects became persistent or severe. In addition, Stromberg advocates teaching self care to encourage persons with cancer to increase their sense of self-control and lessen feelings of helplessness that often accompany cancer and its treatment. The nurse is further challenged to teach patients to actively participate in their care rather than remaining dependent on the health-care professional. Using skill as a patient educator, the nurse enlists the patient and family members in a partnership to promote self-care. This requires the nurse to use great creativity and flexibility to individualize the approach to patient management problems.