Asking the right questions: investigating needs assessments and health-related quality-of-life questionnaires for use in oncology clinical practice

Goals of work Questionnaires used in oncology practice for individual patient management need to address issues patients find important and want help with and issues cancer center health professionals can address. We investigated the item content from two health-related quality-of-life (HRQOL) questionnaires and two needs assessments for this purpose. Patients and methods In this preliminary study, 61 cancer patients and 19 cancer center health professionals rated the item content from the EORTC-QLQ-C30, FACT-G, Supportive Care Needs Survey-34 (SCNS), and Kingston Needs Assessment–Cancer. Patients rated each item’s importance and whether they wanted help with it; health professionals rated each item’s importance and whether they felt able to help patients address it. Patients and health professionals also reported their overall questionnaire preference. Main results Patients rated information about treatments (options, benefits, side effects) and care coordination as the most important issues and those for which they most wanted help from their health professionals. Health professionals rated pain and other symptom/side effect items as most important to patients and those for which they were most able to help. Findings were consistent across tumor type and treatment status. Patients had an overall preference for the SCNS. Health professionals had no clear questionnaire preference. Conclusions This preliminary study suggests that the issues patients most want help with may not be the issues that health professionals feel most able to address. If these findings are confirmed in more representative samples, interventions may be needed to assist health professionals in managing cancer patients’ HRQOL issues and needs.     

Health-related quality-of-life assessment in clinical trials of supportive care in oncology

 A primary objective of symptom control and supportive care in clinical trials is to improve health-related quality of life. However, in the past, most such clinical trials have concentrated on limited outcomes, such as control of anorexia or pain, and have not taken into account the broader outcome of health-related quality of life. The multidimensional tools needed to carry out these trials are now available, and several studies have yielded results that are informative and useful. These include studies on ameliorating anorexia and weight loss, fatigue and anemia, postchemotherapy nausea and vomiting, and pain from bone metastases. Examples of such studies are given. However, there is still much to learn, and investigators are urged to continue to measure health-related quality of life in clinical trials of symptom control and supportive care. Published online: 23 June 1999     

Effects of preventive home visits on health-related quality-of-life and mortality in home-dwelling older adults

Objective: We explored the effectiveness of preventive home visits on the health-related quality-of-life (HRQoL) and mortality among independently community-dwelling older adults.

Design: A randomised controlled trial.

Subjects: Independently home-dwelling older adults 75 years and older, consisting of 211 in the intervention and 211 in the control group.

Setting: Hyvinkää town municipality, Finland.

Main outcome measures: We used the change in HRQoL measured by the 15D scale as our primary outcome. Mortality at two years was retrieved from central registers.

Results: At the one-year time point, the HRQoL according to the 15D scores deteriorated in the control group, whereas we found no change in the intervention group. The difference between the 15D score changes between the groups was ?0.015 (95% CI ?0.029 to ?0.0016; p?=?0.028, adjusted for age, sex, and baseline value). At the two-year time point as the visits ended, that difference diminished. There was no difference in mortality between the groups during the 24-month follow-up.

Conclusion: Preventive home visits implemented by a multidisciplinary team with CGA appear to help slow down the decline in HRQoL among older adults, although the effect diminishes when the visits end.

• Key points

• We are exploring preventive home visits as means to support the health-related quality-of-life (HRQoL) of home-dwelling older adults

• Multiprofessional preventive home visits in this intervention study helped to maintain the HRQoL when measured using 15D

• The effects on HRQoL diminished when the intervention ended, so could further benefits be attained with a longer intervention?The clinical trial registration number: ACTRN12616001411437

     

One-year prospective health-related quality-of-life outcomes in patients treated with conservative method, endovascular treatment or open surgery for symptomatic lower limb atherosclerotic disease.

BACKGROUND: There are no many reports on the long-term impacts of different treatments of lower limb atherosclerotic disease (LLAD) on patients' health behaviour, clinical outcome and health-related quality of life (HRQoL). AIMS: The purpose of this study was to follow up the HRQoL of LLAD patients before and after the conservative, endovascular or surgical treatment. METHODS: Patients who were treated conservatively (64 patients), scheduled for endovascular treatment (85 patients), or for elective surgery (31 patients) filled in the Nottingham Health Profile (NHP) questionnaire before treatment and 12 months after. The patients' background data were recorded, and their resting ankle-brachial pressure (ABI) was measured at baseline and 12 months later. RESULTS: Smoking increased statistically significantly (p=0.031) in the group of conservatively treated patients. The ABI and asymptomatic walking distance scores of the patients treated with endovascular (p=0.000/p=0.000) and surgical (p=0.000/p=0.000) procedures improved statistically significantly. Conservatively treated patients reported improvement of sleep (p=0.047) and emotional reactions (p=0.032). The patients with endovascular treatment reported improved emotional reactions (p=0.016), energy (p=0.027) and less social isolation (p=0.050). The surgically treated patients reported improvement of pain (p=0.001), mobility (p=0.048), sleep (p=0.030) and emotional reactions (p=0.007). CONCLUSION: Deterioration of any clinical characteristics or HRQoL was not observed after any of the treatment modalities. Surgery gave LLAD patients a good clinical outcome and HRQoL for at least a year, whereas patients who were treated with endovascular and especially conservative treatment gained limited benefits.     

Tyrosine kinase inhibitors in cancer therapy

Cancer is the second leading cause of death in the western world. Despite advances in diagnosis and treatment, overall survival of patients remains poor. Scientific advances in recent years have enhanced our understanding of the biology of cancer. Human protein tyrosine kinases (PTKs) play a central role in human carcinogenesis and have emerged as the promising new targets. Several approaches to inhibit tyrosine kinase have been developed. These agents have shown impressive anticancer effects in preclinical studies and are emerging as promising agents in the clinic. The remarkable success of BCR-ABL tyrosine kinase inhibitor imatinib (STI571) in the treatment of chronic myeloid leukaemia has particularly stimulated intense research in this field. At least 30 inhibitors are in various stages of clinical development in cancer, and about 120 clinical trials are ongoing worldwide. In this review, we focus on the role of tyrosine kinases in cancer and the development of specific small molecule inhibitors for therapy. We also provide a critical analysis of the current data on tyrosine kinase inhibitors and highlight areas for future research. Issues with regards to the design of clinical trials with such agents are also discussed. Innovative approaches are needed to fully evaluate the potential of these agents, and a concerted international effort will hopefully help to integrate these inhibitors in cancer therapy in the near future.     

Successful pulmonary vein isolation using transvenous catheter cryoablation improves quality-of-life in patients with atrial fibrillation

BACKGROUND: Recent studies have demonstrated that transvenous catheter cryoablation is a safe and effective technique for creating pulmonary veins (PVs) electrical isolation for the treatment of atrial fibrillation (AF). However, the impacts of this procedure on quality-of-life (QoL) have not been evaluated. METHODS AND RESULTS: We studied the effects of PV isolation using transvenous catheter cryoablation on QoL in 46 patients (34 men, mean age: 50 +/- 12 years) with drug-refractory AF. QoL was assessed by Medical Outcomes Study Short Form-36 (SF-36) and Symptom Checklist at baseline and 3-month after cryoablation, and compared with those in a sex-age matched normal control. At 3-month follow-up, 24 of 46 patients (52%) had no recurrence of AF, including 11 patients who were not taking antiarrhythmic drugs. At baseline, patients with AF had significantly lower QoL scores in overall and in 5/8 subscales of SF-36 than the sex-age matched control group (P < 0.05). In patients with successful outcome after cryoablation showed a significant improvement in overall and in 5/8 subscales of SF-36 QoL scores have significantly increased as compared with the baseline (P < 0.05). Furthermore, their QoL scores in overall and in 6/8 subscales of SF-36 were similar to the sex-age matched control group (P > 0.05). The Symptom Checklist also showed significant reduction in both the symptoms frequency scores and symptoms severity scores at 3-month follow-up as compared with baseline (P < 0.05). CONCLUSIONS: Successful PV isolation using transvenous catheter cryoablation is associated with significant reduction in the frequency and severity of AF symptoms and improvement in the general QoL, reaching the levels of normal controls.     

Statistical considerations in the design, conduct and analyses of antiemetic clinical trials

Various aspects of trial design and planning for clinical testing of antiemetic therapies administered to cancer patients are considered. It is generally felt that a randomized double-blind parallel-arm design is the best. Ways of achieving adequate power of such studies are discussed briefly, as is the need for previous identification of primary and secondary end-points. Finally, summary recommendations are given.     

Quality-of-Life Six Months After CABG Surgery in Patients Randomized to ICD Versus No ICD Therapy: Findings from the CABG Patch Trial

ICDs can affect a patient's perceived quality-of-life (QOL). This article describes the QOL in patients who participated in The CABG Patch Trial. This trial evaluated the potential benefit of empiric ICD implantation in patients with an increased risk of arrhythmic cardiac death as determined by reduced ejection fraction (<0.36) and an abnormal signal-averaged ECG. Patients were randomized to control (no ICD) or treatment (ICD) limbs. QOL was measured using the SF-36 and other measures among 490 (68%) of 719 patients available at 6-month follow-up. Analysis was performed on 228 control patients (those without ICDs) and 262 patients with ICDs. RESULTS: Six months after having CABG surgery, patients in the ICD group had lower levels of psychological well-being than those in the control group. In addition, compared to controls, patients whose ICDs had delivered therapy reported feeling less healthy, had reduced physical and emotional role functioning, and had lower levels of psychological well-being. CONCLUSION: Strategies aimed at easing patients' adjustment to ICDs should be developed and tested for efficacy in the setting of ICD prophylaxis.     

Current status of randomized controlled trials for laparoscopic gastric surgery for gastric cancer in Korea

Laparoscopic gastrectomy for gastric cancer has rapidly gained popularity as a result of the increased incidence of early gastric cancer in Korea. Although laparoscopic gastrectomy has been considered as an investigational treatment because of the lack of solid evidence of efficacy and safety, it is increasingly regarded as a standard treatment for early gastric cancer. Moreover, solid evidence is anticipated from two studies in Korea, KLASS 01 and KLASS 02, the latter of which examines the suitability of laparoscopic gastrectomy for advanced gastric cancer. The use of cutting‐edge techniques for laparoscopic gastrectomy enables surgeons to deliver various treatment options that offer the best possible quality of life after gastrectomy. In this review, we summarize the current status of clinical trials on laparoscopic gastrectomy in Korea and examine future perspectives regarding laparoscopic gastrectomy for the treatment of gastric cancer.     

Performance of health-related quality-of-life instruments in a spinal cord injured population.

OBJECTIVE: General health-related quality-of-life (HRQoL) surveys have not been well tested in populations with spinal cord injury (SCI). This study evaluated the performance of 5 such instruments. DESIGN: A cross-sectional survey with instruments administered in random order during computer-assisted interviews. SETTING: A midwestern US veteran SCI program. SUBJECTS: One hundred eighty-three veterans with SCI ranging in age from 21 to 81 yrs (mean = 50.5). MEASURES: The Behavioral Risk Factor Surveillance System (BRFSS) HRQoL modules, the Quality of Well-Being scale (QWB), the Medical Outcomes Study Short-Form 36 and Short-Form 12 (SF-36, SF-12), and instrumental activities of daily living (IADL). RESULTS: Construct validity was supported by scores from the QWB, IADL, and physical health measures of the BRFSS and SF-36 showing greater impairment for quadriplegia than paraplegia. Similar constructs on the SF-36 and BRFSS were more strongly correlated than between the IADL and QWB; eg, correlation between the SF-36 Vitality scale and the BRFSS "Days full of energy" question was r = .789 (p < .01), whereas correlation between the IADL and QWB was r = -.454 (p < .01). Longer surveys (SF-36, QWB) were rated lower in subject acceptability. CONCLUSIONS: These instruments have potential for research use among patients with SCI. More studies are needed to explore the best use of instruments with apparently different domains.     

The applicability of quality-of-life assessment in palliative care: comparing two quality-of-life measures

Two self-administered quality-of-life measures, the McGill Quality of Life Questionnaire (MQOL) and the Patient Evaluated Problem Scores (PEPS) were compared in patients receiving palliative care. The MQOL is a multidimensional questionnaire consisting of 16 items in five quality-of-life (QOL) domains: physical symptoms, physical well-being, psychological, existential and support domains. The PEPS is an individualized questionnaire asking patients to identify and rate major problems affecting their QOL. Both questionnaires were completed by 36 patients during outpatient clinic visits in three palliative care settings in Wales. Of those patients who stated their questionnaire preference 60% favoured MQOL due to its comprehensiveness, while others (28%) preferred PEPS due to its simplicity. The MQOL showed excellent internal consistency (alpha = 0.90). The intrapatient analysis of answers from both questionnaires showed that MQOL was better than PEPS in reporting physical symptoms and support domain, while PEPS detected more psychosocial issues. The MQOL overall QOL score correlated highly with its existential domain (rs = 0.57, P < 0.0005) and the PEPS overall quality of life (rs = 0.77, P < 0.0005). Similarly, the PEPS overall QOL correlated well with MQOL total score (rs = 0.76, P < 0.0005) and existential domain of the MQOL (rs = 0.63, P < 0.0005). The findings support the importance of an existential domain in assessing the QOL of this population. Both MQOL and PEPS were found to be relevant and acceptable in advanced cancer patients receiving palliative care. However, with its favourable psychometric properties MQOL may be more suitable for QOL assessment in this population.     

The importance of health-related quality-of-life data in determining the value of drug therapy

BACKGROUND: The rapid evolution of outcomes research during the last decade has led to increasing emphasis on measures of health-related quality of life (HRQOL). However, the relatively recent advent of these measures makes it difficult to decide how much weight to attribute to them in decisions about the value of drug therapy. OBJECTIVE: The aim of this article is to discuss the factors that affect the relative importance of HRQOL data in determining the value of drug therapy. CONCLUSIONS: The relative importance of HRQOL data depends on the type of condition and the type of treatment. In chronic conditions, HRQOL may be considered a primary measure of efficacy. In acute conditions, HRQOL is not likely to be a primary efficacy measure, although excluding HRQOL measures may lead to an underestimation of treatment effects. Measures of HRQOL are also likely to be important in the assessment of palliative treatments and, to some extent, preventive treatments (primarily in the measurement of adverse effects). HRQOL measures will be less important in the assessment of curative treatments because these types of treatment are most relevant in acute conditions.     

Radionuclides in oncology

Summary Radionuclides already have a major role in the daily practice of oncology and will, undoubtedly, be of even greater importance in the future. The variety of current and potential applications is shown in tab. 1. Their major use at this time is, in the broadest sense, for ‘tumour scanning’, which includes the evaluation of specific organs for the presence of tumour (usually with different radiopharmaceuticals for each organ) and the entire body (generalized tumour searches with radiopharmaceuticals like⁶⁷Ga-citrate or¹¹¹In-labeled bleomycin). The clinician uses these agents in the initial evaluation of extent of tumour (staging) and in the subsequent management of the patient with cancer to assess response to treatment, to reveal early relapse, and to assist in making decisions concerning treatment. The other potential roles for radionuclides are also briefly considered in this review. Reproduced in part fromSeminars in Nuclear Medicine 6, 331, 1976. With permission of Grune and Stratton, Inc., New York.     

系统性红斑狼疮患者健康相关生存质量分析

目的：评价系统性红斑狼疮患者健康相关生存质量（HRQOL）,筛选SLE患者健康相关生存质量的影响因素。方法：采用中文版36条目简明量表（Medical Outcomes Study,Short Form 36,SF-36）测量107例SLE患者,结果与中国健康居民常模比较,SLE患者进行系统性红斑狼疮疾病活动度评分（SLEDAI）,不同疾病活动度之间进行比较。结果：SLE患者与常模比较,差异有统计学意义。根据SLEDAI,不同疾病活动度比较,差异有统计学意义。Logistic回归分析显示：SLEDAI、病程、年龄、收入、学历与系统红斑狼疮患者健康相关生存质量相关。结论：SLE患者健康相关生存质量较健康人群差,SLEDAI、病程、年龄、收入、学历是SLE患者HRQOL的影响因素,应采取积极有效的护理干预,提高患者生活质量。