Treatment-related Problems Research Articles

A brief measure of patients self-reported chemotherapy-related memory problem: Psychometric studies

19655 Background: Memory is a central component of individuals’ functional systems of behavior, (i.e., cognition, emotionality, and executive functioning) that can be deleteriously affected by cancer treatment. It is important to identify and understand the effects of cancer treatment on memory in order to develop effective interventions to ameliorate these problems. This study involves structural and reliability analyses of a brief measure of chemotherapy-related memory problem to facilitate prompt and reliable preliminary assessments in oncology research and practice. Methods: Patients (N = 821) included in this analysis were part of a larger randomized clinical trial on cancer-related fatigue. These patients completed the Fatigue Symptom Checklist (FSCL) at four time points. Five items from the FSCL that assess memory problems were aggregated into a brief self-report memory problem measure (SRMP). Results: Reliability assessment of the SRMP revealed a Cronbach coefficient alpha of 0.90. The data was found suitable for latent structure analysis using various criteria: Kaiser-Myer-Olkin, Bartlett’s Test of sphericity, Kaiser’s (1959) simplest criterion test of γ >1, and the presence of item-correlation coefficients of r = .30. Principal components analysis showed one component with eigenvalue (γ) exceeding 1, that explained 72% of the variance. Subsequent reliability assessments of the SRMP revealed Cronbach coefficients alpha of 0.90 and above, all with a single component explaining 71.36% to 73.36% of the variances. Conclusions: The results supported the use of the SRMP as a reliable one- dimensional measure of cancer treatment-related memory problem. The SMRP could be used for preliminary assessment of possible underlying memory problems that might need further examinations. Studies to establish the construct validity of the SRMP are under way. Supported by NCI grant R25CA102618. No significant financial relationships to disclose.

Validation of a comprehensive classification tool for treatment-related problems

Several drug-related problem classification systems can be found in the literature. However, it is generally agreed that a comprehensive, well constructed and validated instrument is currently lacking. The aim of this study is the development and validation of a comprehensive treatment-related problems assessment and classification tool for use in teaching, practicing and researching pharmaceutical care and to improve identification, resolving and preventing of treatment-related problems. The development and validation involved five steps starting with literature search to define a treatment related problem and also to form a database of treatment-related problems identified in the literature. In the next step, all problems that were identified in the first step and passed the evaluation of the three authors were pooled together and then divided into groups according to their common or shared construct, in the third step a suitable assessment method was developed according to the construct of the different problems, in the next step the developed instrument was validated for content, internal and external validity. Finally the tool was finalized and tested for reproducibility and inter-rater agreement. The final validated version included six main categories for treatment-related problems (Indication, Effectiveness, Safety, Knowledge, Adherence and Miscellaneous). These categories include a total of nine subcategories and a total of 29 treatment related problems. The treatment-related problems assessment and classification tool introduced in this paper was applied to actual patient cases and proved to be valid. This tool also has several features that are new.

Nurses’ recognition and registration of depression, anxiety and diabetes-specific emotional problems in outpatients with diabetes mellitus

Objective The aim of this study was to investigate how often emotional problems were recognized and registered by diabetes nurses. Methods We studied medical charts and questionnaire data of 112 diabetes patients. The hospital anxiety, depression scale and the problem areas in diabetes survey were used to measure anxiety, depression and diabetes-specific emotional distress. Results In patients with moderate to severe levels of anxiety or depression, the presence of an emotional problem was recorded in the medical chart in 20–25% of the cases. The registration-rate of diabetes-specific emotional distress was also found to be low, ranging from 0% (treatment-related problems) to 29% (diabetes-related emotional problems). Conclusion Registration-rates of emotional problems by diabetes nurses were found to be low, but quite similar to detection rates of physicians and nurses in studies with non-diabetic samples. Practice implications These findings suggest that recognition-rates of emotional problems in diabetes patients need to be increased. Future studies should investigate whether recognition and subsequent treatment of emotional problems in diabetes patients can be facilitated by utilizing validated, standardized self-report questionnaires.

Late effects of radiotherapy: how to assess and improve outcomes

The British Institute of Radiology was the venue in May 2004 for an excellent conference addressing issues regarding the recording and analysis of late effects of radiotherapy treatments. Currently there is increasing interest in radiotherapy dose escalation using conformal treatments and novel therapies such as intensity-modulated radiotherapy. In view of the steep dose–response relationship with radiotherapy, dose escalation can be dangerous unless undertaken carefully with accurate reporting of late serious adverse effects, so that the therapeutic ratio of treatments can be determined. The meeting attempted to address issues around assessment of treatment outcomes with a view to consensus regarding current and future practice. Professor Anne Barrett outlined some of the work in this area achieved by the Recording, Education and Amelioration of the Consequences of Treatment group (REACT). REACT was set up under the auspices of the European ESQUIRE Project [1]. ESQUIRE is co-ordinated by the European Society for Therapeutic Radiology and Oncology with the objective of improving treatment outcomes for cancer patients by addressing various facets of radiotherapy implementation and training. Currently there are a variety of systems in place for the recording of late effects of treatment, including from the RTOG/ EORTC, NCI-CTC3 (Common Toxicity Criteria) and the Anglo-Franco system, in addition to inhouse nonvalidated approaches. Professor Barrett also presented results of an audit undertaken of follow-up practice in Europe. Four centres in the UK were involved in this study. In over 50% of visits patients and doctors reported disease or treatment related problems. There was an attribution bias in patients who, compared with doctors, were more likely to consider their problems related to disease than treatment. The use of a short scale to assess late morbidity of treatment, developed by Professors Dische and Saunders (Table 1), increased the recording of side effects from 23% before the study, to 90% [2]. Grade 3 or 4 late morbidity was reported to be in the range of 4–9%. Detailed recording of late effects is difficult, given the complexity and time pressures existing in clinics. The LENT SOMA system is one of the most common systems for recording late effects [3]. It is recognized as being an extremely useful tool, as it includes both subjective as well as objective scoring measures, but is cumbersome and difficult to use in daily practice. Dr Susan Davidson from the Christie Hospital, Manchester, discussed their experience of the use of the LENT SOMA system for analysing late effects of radiotherapy treatment. There remain problems in defining what ‘‘acceptable toxicity’’ is, and this varies depending on whether it is a medical or patient view. Validated systems for assessing late effects need to be sensitive, reproducible, feasible and convenient. Although the LENT SOMA system has many of these features, it still could be improved further. The Christie Hospital has developed patient questionnaires based on the LENT SOMA for certain tumour sites, and suggest these could be developed into more useful tools. Details of these questionnaires can be found at: www.christie.nhs.uk/ proinfo/departments/clinical_oncology/lent_soma.htm What was clear is that the use of different reporting systems across the UK, Europe and worldwide makes cross comparisons of differing treatments difficult. This lack of a standardized approach was a theme throughout the conference, as was the need to simplify data collection and educate regarding the importance of recording late effects. Dr Catharine West, from the Christie Hospital, tried to address the question of whether it is possible to predict normal tissue effects of radiotherapy in advance of treatment. She provided an excellent historical overview of the development of radiobiology understanding through the 20th century to the modern day. Recent developments make the possibility of predictive assays tangible, although as yet not practicable. In the post genomic

Prospective evaluation of urological effects of aging in chronic spinal cord injury by method of bladder management

Risk of treatment-related problems in spinal cord injury (SCI) mandates assessment of complication rates of different bladder management methods (BMMs). The current study evaluated aging-related complications of various BMMs over a 6-year period in a population with spinal cord injury for at least 20 years. Clinical parameters were compared using a linear mixed effects model, controlling for various confounding variables, to establish complication trends with aging and their association with BMM. Results for people whose BMM was changed during the study were evaluated separately as well as in combination with the whole population. One hundred and ninety six people (mean age 57.4 and years post injury (YPI) 33) were evaluated on three occasions. Both age and YPI were significantly associated with rising complication rates regardless of BMM. The BMMs assessed differed in terms of complication rates. In comparison with balanced reflex voiding, straining was significantly better for renal structural abnormality. Intermittent catheterization was associated with significantly worse renal function, possibly for demographic reasons. Overall, 28.8% changed BMM during the study period, particularly, those using straining or balanced reflex voiding. The probability of change increased with age and YPI. Reasons for change of BMM were varied and there was no specific association between reason for change and BMM. Aging and duration of injury substantially influence urological complication rates, and BMM options differ in respect of prevalence and incidence of complications. At a late stage post injury there remains a high probability of change in BMM. The findings indicate the importance of long-term planning from the time of injury to minimize late complications.

Medicolegal issues in cluster headache.

This paper identifies legal issues of relevance to the diagnosis and treatment of cluster headache, including areas of actual and potential malpractice liability. Legal topics that are relevant to cluster headache can be divided into five categories: diagnostic-related issues, risks inherent in the disease process, prescribing and treatment-related problems, research-related issues, and disability determination.

Early and late complications after radiofrequency ablation of malignant liver tumors in 608 patients.

Radiofrequency ablation (RFA) has become a common treatment of patients with unresectable primary and secondary hepatic malignancies. We performed this prospective analysis to determine early (within 30 days) and late (more than 30 days after) complication rates associated with hepatic tumor RFA. All patients treated between January 1, 1996 and June 30, 2002 with RFA for hepatic malignancies were entered into a prospective database. Patients were evaluated during RFA treatment, throughout the immediate post RFA course, and then every 3 months after RFA to assess for the development of treatment-related complications. A total of 608 patients, 345 men (56.7%) and 263 women (43.3%), with a median age of 58 years (range 18-85 years) underwent RFA of 1225 malignant liver tumors. Open intraoperative RFA was performed in 382 patients (62.8%), while percutaneous RFA was performed in 226 (37.2%). The treatment-related mortality rate was 0.5%. Early complications developed in 43 patients (7.1%). Early complications were more likely to occur in patients treated with open RFA (33 [8.6%] of 382 patients) compared with percutaneous RFA (10 [4.4%] 226 patients, P < 0.01), and in patients with cirrhosis (25 [12.9%] complications in 194 patients) compared with noncirrhotic patients (31 [7.5%] complications in 414 patients, P < 0.05). Late complications arose in 15 patients (2.4%) with no difference in incidence between open and percutaneous RFA treatment. The combined overall early and late complication rate was 9.5%. Hepatic tumor RFA can be performed with low mortality and morbidity rates. Though relatively rare, late complications can develop and physicians performing hepatic RFA must be cognizant of these delayed treatment-related problems.

Endovascular treatment in direct carotid cavernous fistula.

Direct carotid cavernous fistula (CCF) is the most common types of arteriovenous fistula (AVF) in the craniofacial area and endovascular treatment is primarily indicated in managing the disease. CCFs are abnormal, direct communications between the internal carotid arteries (ICA) and the cavernous sinuses formed as a consequence of blunt head trauma1,2. They occur secondary to traumatic laceration of the internal carotid artery at the intracavernous segment or from rupture of intracavernous branches. AVFs supplied by external carotid artery and dural branches of ICA are traditionally called indirect, or dural arteriovenous fistula of the cavernous sinus and are totally different entity with different therapeutic strategy. To understand the clinical and angiographic features and to treat this lesion properly, knowledge of vascular anatomy of the skull base and clinical features of this disease are necessary. Angiographic evaluation of the lesion, therapeutic strategies, and treatment-related problems will be discussed.

Late Mortality in Childhood Cancer: Time to Count Our Chips

Late Mortality in Childhood Cancer: Time to Count Our Chips

PATIENT REPORTED COMPLICATIONS AFTER PROSTATE BRACHYTHERAPY

Prostate brachytherapy has gained popularity due partly to the low rates of short-term complications shown in studies from highly select clinical practices. These series rely on medical records generated by the treating physician and are prone to underreport complications. We summarize the complication reports obtained directly from patients to establish a more realistic incidence of treatment related problems. In 1997, 160 consecutive patients treated with prostate brachytherapy at the University of Washington were studied. A questionnaire was designed to determine the rate of complications occurring within 1 year of the procedure. The questions were formulated for ease of use and conciseness, while accounting for easily recalled events associated with complications. A total of 147 (92%) patients completed the questionnaire. There were 8 (5%) patients who required hospital admission for an average of 2 days (range 1 to 7) as a result of the procedure. A total of 56 (38%) patients required nonroutine visits with a physician in an office setting or at an emergency room. Radiation proctitis diagnosed by endoscopy developed in 8 (5%) patients but no one needed surgical intervention. A total of 47 (32%) patients required urinary catheterization at some point after implantation. We demonstrated a higher rate of short-term complications than those previously reported. Fortunately, the majority of side effects were self-limited and no treatment related mortality or cardiovascular morbidity was seen. Our findings may provide a more realistic account of the complications likely to occur after implantation than might be surmised from previous reports.

Surgical approaches and strategies for skull base chordomas

The management of chordomas involving the skull base continues to present a number of treatment-related problems. Recently, both radical resection and charged-particle irradiation or stereotactic radiosurgery have reportedly been found effective for tumor control and for promoting a better quality of life in patients. In this article the authors analyzed the outcomes in 17 patients with skull base chordomas who were surgically treated at Kobe University Hospital between 1972 and 2000. Preoperative radiological examinations included magnetic resonance imaging, computerized tomography, angiography, and balloon occlusion test of the internal carotid artery. Among the various surgical approaches used to remove the tumor were the frontoorbitozygomatic, transmaxillary, transcondylar, transsphenoidal, and the transbasal. Total removal was achieved in two (12%), near-total removal in three (18%), subtotal removal in nine (52%), and partial removal in three patients (18%). Since 1990, chordomas have been radically resected via various skull base approaches; the combined total or near-total removal rate has been 80% in this period. Radical removal of the tumors has not led to an increased risk. At the final follow-up review (mean 59.5 month), 75% of the patients were still alive, and 25% had died of chordoma recurrence. The overall recurrence-free survival rate was 82% at 3 years and 51% at 5 years. The 5-year recurrence-free survival rate in the five patients who underwent the operation during the past decade was 77% (mean follow up of 5.2 years). In two patients with recurrent tumors who underwent radiosurgery, no evidence of tumor regrowth was demonstrated at 3 years posttreatment. The authors suggest that for the treatment of skull base chordomas radical resection is a key factor for longer survival and improved quality of life. Patients with sufficiently small tumors, which show a favorable configuration and location, can be suitable candidates for stereotactic radiosurgery.

Immune tolerance induction in the treatment of paediatric haemophilia A patients with factor VIII inhibitors.

The development of an inhibitor to transfused factor VIII (FVIII) is a serious treatment-related problem in haemophiliac children. The management of patients with high titre FVIII inhibitors is difficult, and immune tolerance induction (ITI) is the only method available for the eradication of these inhibitors. The results of the ITI regimen used at the Children's Hospital of Michigan Haemophilia Treatment Center are described and discussed. ITI was attempted in 14 children with severe haemophilia A (13 high responders, one low responder), with daily doses of FVIII alone. FVIII dosage was chosen according to the patient's historical peak inhibitor titre. ITI included three phases; induction phase, dose reduction phase and maintenance phase. During the first phase, the starting dose was 50 or 100 U kg-1 d-1; during the second phase the FVIII dosage was reduced gradually to 25 U kg-1 every other day according to the inhibitor titre, FVIII recovery and/or half-life study. In the third (maintenance) phase, the children received either prophylactic therapy or episodic therapy for 12 months. The inhibitor elimination was defined as the time taken to achieve a negative inhibitor assay with no anamnestic response and normal FVIII recovery and/or normal half-life. Immune tolerance was achieved in 11 of 14 patients (79%) patients within a median time of 6 months; two children are still on therapy, three failed ITI. We observed either failure or prolongation of immune tolerance if the historical peak titre or the maximum titre during ITI was >200 BU. The success rate of our low dose ITI regimen is not different from that reported by other investigators and the inhibitor elimination time is similar to some of the studies reported previously.

Complementary and Alternative Medicine in Oncology

Complementary and alternative medicine (CAM) has reentered mainstream medicine and is gaining interest with cancer patients for the treatment of their disease. The use of CAM by cancer patients varies depending on survey, but has been reported as high as 54 percent. As pharmacists we are expected to educate and counsel patients on herbal, pharmacologic and immunologic therapies. Several therapies that claim to treat cancer include laetrile, iscador, essiac, antineoplastins, immunoaugmentative therapy, IP6, PC-SPES, and cartilage products; these therapies and their limitations are discussed. Cancer patients are a unique population with special considerations when patients are utilizing CAM because disease and treatment related problems, such as bleeding, nutrition, and quality-of-life, could be worsened. Resources for pharmacists and cancer patients on CAM are outlined.

Health-related quality of life in Australian men remaining disease-free after radical prostatectomy.

To determine the health-related quality of life (HRQOL) of Australian men after radical prostatectomy. Cross-sectional study. Private and public practices of three urologists in south-east Queensland, July 1989 to June 1995. 140 men with no evidence of disease recurrence 1 to 6 years after radical prostatectomy. Voiding and erectile potency and HRQOL. Recall of preoperative status and status at survey were established by an independently administered multi-item questionnaire. 112 men (80%) completed the study questionnaire. Difficulty with bladder control before the operation was reported by 25 (22%; 95% confidence interval [CI], 15%-31.2%), and the incontinence rate after treatment was 22/112 (20%; 95% CI, 12.7%-28.2%). Men with incontinence after operation were more likely to recall preoperative urinary symptoms. Eighty-four (75%) men were happy or coping with their sexual function after radical prostatectomy despite an erectile potency rate of only 12% (95% CI, 7%-20%). Twenty-eight (25%) had tried penile injections and three have had penile prostheses since their operation. Impotence was reported more frequently (40%) as the treatment-related problem most affecting life, followed by "concern about cancer" (12%) and incontinence (8%). Impotence was also the most common cause given for diminished HRQOL. Loss of sexual function after radical prostatectomy is more commonly perceived as a major problem and is more likely than urinary incontinence to adversely affect HRQOL. Loss of sexual function and its effect on HRQOL needs to be given greater emphasis in counselling before radical prostatectomy.

Anthelmintic treatment strategies: current status and future

Despite the array of anthelmintics and endectocides and delivery systems available for use in the prevention and control of nematode parasites of ruminants, the number of highly effective control programs that have been developed and even the number of such programs that have been successfully implemented in commercial animal production, there have been no recent innovations or discoveries in regard to strategies, new anthelmintics, or systems for controlling nematode parasites through anthelmintic use. In the traditional sense of chemotherapy-chemoprophylaxis, we have probably achieved the maximum effect of what is possible from excellent anthelmintics developed by the pharmaceutical industry over the last 35 years, i.e. from thiabendazole through levamisole and morantel tartrate, to more advanced benzimidazoles and to the avermectins and milbemycins. At the core of all anthelmintic treatment-related problems is the lingering conception among a large body of animal producers that anthelmintic treatment is the only effort needed to control parasitism and its effects on host animals. This concept has given rise to the long-standing difficulty of drug resistance in sheep nematodes and the not remote possibility of its development in nematodes of cattle. Along with this are serious concerns over environmental toxicity, tissue residues and enormous financial investment to develop new and novel anthelmintic compounds. Progress is being made in current and intensive searches for development and testing of control approaches alternative to anthelmintics, e.g. helminth vaccines, biological control agents such as fungi, selection of resistant sires, alternative chemicals and nematode growth regulators. A timetable for when alternative controls can be developed fully and put into practical use cannot be predicted. It is universally acknowledged among parasitologists that existing anthelmintics must be preserved and utilized judiciously to ensure continued effectiveness. A major example is to be found in strategic or integrated control programs in Australia developed over the last 10 years to combat widespread drug resistance in sheep. Major imperatives for future programs and systems of controlling nematode parasites of ruminants are improved means of getting producers to adopt proven and sustainable methods.

Quality of life in prostate cancer patients.

Quality of life in prostate cancer patients.

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.

Problems with Current Pharmacologic Treatment of Parkinson's Disease

For the past 30 years levodopa (LD) has been the pharmacologic standard of care for treating idiopathic parkinsonism (Parkinson's disease or PD), a neurodegenerative disease of the central nervous system. LD is a pharmacologically inactive precursor, which is converted enzymatically to the neurotransmitter dopamine by a declining population of neurons in the substantia nigra, the most important site of the pathology of PD. Most patients experience a smooth, lasting response to small amounts of LD during the early years of treatment, but as the underlying disease gets worse, treatment-related problems arise. Motor fluctuations, which slowly emerge after 3–5 years of chronic LD therapy, gradually replace the smooth pattern of response, and more frequent dosing is required. Abnormal involuntary movements (dyskinesia), wearing-off of the motor response after a few hours, organic psychosis (confusion and hallucinations), and progressive loss of independence characterize the complicated interaction between the drug and the disease. Despite its problems, including the theoretical potential for harming neurons by inducing oxidant stress, and the recent development of other antiparkinson drugs, LD remains the most effective pharmacologic agent available for the relief of symptoms in patients with PD.

Health-related quality of life among patients with metastatic prostate cancer

Objectives To assess and compare the quality of life of men with advanced prostate cancer who are in remission receiving treatment with a luteinizing hormone-releasing hormone (LHRH) agonist and flutamide or who are in progression. Methods We conducted a cross-sectional survey to measure health-related quality of life in a cohort of 113 patients with metastatic prostate cancer, 60 in remission and 53 with disease progression, using a battery of questionnaires, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, the Medical Outcomes Study Short Form Health Survey SF-36, and a prostate cancerspecific module. Results Patients in remission receiving an LHRH agonist and flutamide reported a significantly better quality of life compared with patients with disease progression ( P < 0.011 ). Men with hormone-sensitive cancer had significantly less bodily pain, more vitality, more social interactions, and better mental health than patients with hormone-resistant disease. No differences were noted between the two groups concerning treatmentrelated problems such as diarrhea, constipation, urinary symptoms, sexual function, sexual satisfaction, or hot flashes, although men in remission tended to rate each of these items more favorably than did men with disease progression. Men in remission have a health-related quality of life that is similar to an equivalent norm for men in the United States general population as compared with men with disease progression, who demonstrate significant compromise in all domains measured. Conclusions Patients in remission receiving an LHRH agonist and flutamide have a quality of life that is indistinguishable from a matched male population without prostate cancer and a quality of life significantly better than that of men with androgen-resistant disease. Among patients who respond to total androgen ablation, flutamide and an LHRH agonist provide significant, measurable benefits to recipients independent of any possible improvement in longevity.

Tolerability of endocrine treatment for advanced breast cancer: results of an international survey.

In contrast with cytotoxic therapy, the impact of hormonal therapy for advanced breast cancer in postmenopausal women is poorly documented. Two recent surveys of the impact of hormonal therapy in this patient group found that side-effects had an adverse impact on patients' quality of life which needed to be taken into account when discussing treatment options. Patients were perceived to be more comfortable discussing treatment-related problems with nurses rather than doctors, who tended to underestimate the distress caused to patients by the side-effects of treatment. A need was identified for better lines of communication between patients and medical professionals, and for a simple, more widely applicable tool for assessment of side-effects. As a result of these findings, a simple checklist, Checklist for Patients on Endocrine Therapy (C-PET), has been developed to be completed by patients before a physician appointment, to form a basis for discussion. A pilot study has indicated that C-PET is easy and quick for patients to complete and aids communication between patients and healthcare professionals. C-PET has now been formally launched to nurses, oncologists, and other cancer physicians.