Use Of Health-related Quality Of Life Measures Research Articles

Health-related quality of life measures used with Indigenous children/youth in the Pacific Rim: a scoping review

ObjectiveTo identify and describe (1) which health-related quality of life (HRQoL) measures have been used with Indigenous children/youth (aged 8–17 years) within the Pacific Rim; and (2) studies that refer...

POSA301 A Review of Pharmaceutical Benefits Advisory Committee (PBAC) Public Summary Documents to Investigate the Use of Child-Specific Utility Measures in Decision Making in Australia

Methods for valuing health-related quality-of-life (HRQoL) are accepted for use in the general population but use of these methods is more challenging in children (aged under eighteen). In this study, we investigated the use of HRQoL measures for medicines used by children by reviewing Public Summary Documents released by the Australian Pharmaceutical Benefits Advisory Committee (PBAC), where a cost-utility analysis was performed.

The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis.

BackgroundOcrelizumab is approved for the treatment of both relapsing and progressive multiple sclerosis (MS).ObjectiveTo examine the impact of ocrelizumab on health-related quality of life (HRQOL) in individuals with MS.MethodsNinety-eight individuals with relapsing and 32 with progressive MS were enrolled. Participants were administered a battery of patient-reported outcome (PRO) measures at their first ocrelizumab infusion, and infusions at 6 and 12 months. PRO measures included the Medical Outcomes Study SF-36 and Neuro-QoL.ResultsAt baseline, participants had low mean scores across HRQOL domains. After 12 months, increases were observed on SF-36 Role-Physical, General Health, Vitality, Role-Emotional, Mental health and Mental Component Summary. On Neuro-QoL, improvements were seen in Positive Affect, Anxiety, Emotional and Behavioral Dyscontrol and Fatigue. Several demographic and clinical characteristics were associated with HRQOL at baseline. The strongest associations were between physical HRQOL measures and measures of MS disability. Associations between the longitudinal change in HRQOL scores and baseline demographic and clinical characteristics were mild.ConclusionsWe observed significant improvements across multiple mental HRQOL domains at 12 months in individuals treated with ocrelizumab. These findings support the use of HRQOL measures to provide a subjective measure of treatment impact that complements traditional outcomes.

Health-related quality of life in adolescents and young adults with cancer - Including a focus on economic evaluation.

Health-related quality of life (HRQL) is an amalgam of three elements - the opportunities that a person's health status affords, the constraints that it places upon the person and the value that a person places on his/her health status. HRQL measures are specific, for example for a disease, or generic with broad applicability. The latter include preference-based measures that can be used to generate quality-adjusted life years and so contribute to economic evaluation. Measures of HRQL in adolescents and young adults (AYAs) with cancer may fail to capture some important dimensions, for example sexual health. However, the use of HRQL measures in this population has identified burdens of morbidity according to disease, treatment status and duration of follow-up. There are few economic evaluations of the treatment of cancer in AYAs but preliminary evidence suggests that this is a cost-effective undertaking. Opportunities abound to include measurement of HRQL in routine clinical care.

Examining Changes in Healthy Days After Health Coaching.

To describe changes in health-related quality of life (HRQOL) related to variation in demographic characteristics, program goals, and program participation, among health coaching program participants. A retrospective observational study of a health coaching program. A total of 2169 adults enrolled in an individually purchased or employer-sponsored health plan from a large health and well-being company, who participated in a health coaching program between January 2016 and April 2017. The health coaching program used evidence-based behavior change strategies to encourage skill development, self-monitoring, and goal setting/achievement. Health coaching program modalities included online and telephonic coaching sessions. Demographic characteristics (gender, age, race, income), goal categories (weight management, fitness, nutrition, stress management, other), program modality (online, telephonic, both), engagement level (low, medium, high), and Healthy Days, a validated HRQOL measure developed by the Centers for Disease Control and Prevention. t Tests, mixed analysis of variance (ANOVA). There were significant ( P < .05) reductions in average total unhealthy days (UHDs) across all goal categories. Mixed ANOVAs identified a significant main effect for time, for all demographic characteristics ( P values < .05), and a significant effect for program modality ( P < .0001), time ( P < .0001), and interaction effects, between program modality and time, on average UHD ( P = .01). Our findings indicate significant reductions in UHD, following 6 months of health coaching, and support the use of HRQOL measures, which are known to be highly correlated with traditional measures of health, to evaluate health coaching programs.

Assessing quality of life in diabetes: I. A practical guide to selecting the best instruments and using them wisely.

The rapid development of new medications and devices in diabetes research and clinical care has led to an increased need to assess their impact on health-related quality of life (HRQOL). Unfortunately, the lack of consensus definitions and guidelines has led to the use of HRQOL measures that are often imprecise and inappropriate. The goal of this report is to provide a practical structure to the definition and measurement of HRQOL in diabetes research and clinical care. Following a brief historical background to provide context, we define HRQOL and provide a three-step framework for scale selection: identify the specific, proximal intervention targets; decide how reaching these targets will affect HRQOL; and select appropriate measures based on sample diversity, the intervention and the targets using a 2×2 grid (generic vs. diabetes specific measures; global vs. component measures). Practical tips for scale selection include: gaining patient input to document important potential HRQOL effects, varying scale selection by patient characteristics, considering common HRQOL measurement problems, and considering the timing of HRQOL assessment. We emphasize the importance of a careful, planned evaluation of HRQOL in diabetes, rather than an "off the shelf" approach.

Health-related quality of life of patients in opioid substitution treatment in Germany

Introduction: Health-related quality of life (HRQOL) is an important treatment outcome criterion in chronic diseases. While the fields of medicine and mental health have embraced HRQOL as a valuable source of information in treatment and research, the field of addiction is lagging behind in this respect. Research on HRQOL in drug users has only been emerging in the past 10 years and the systematic use of HRQOL measures in clinical practice is scarce. Opioid substitution treatment (OST), the standard treatment for opioid dependence, typically measures its quality and treatment success by means of objective parameters, such as mortality. With opioid dependence as a chronic, relapsing disease, a long-term approach to patient care is needed, focusing on improvements in treatment adherence and patient wellbeing. HRQOL lends itself as a useful tool in this respect, seen that it is a measure of subjective wellbeing and a predictor of remission and treatment adherence. As such, HRQOL could be used to monitor the patient and provide tailored support in treatment. While measures of HRQOL have been implemented in an increasing number of studies on opioid dependence, the objective was often to demonstrate the effectiveness of OST in improving patients' wellbeing upon entering treatment. Epidemiological data on the HRQOL of OST patients is limited, and lacking entirely for Germany. Such cross-sectional data is of interests, as it includes the large population of long-term OST patients, whose wellbeing is rarely captured in the literature. The aim is to examine the HRQOL of OST patients in Germany, and assess its relation to mental and physical health.

Health-related quality of life in women with breast cancer: a literature-based review of psychometric properties of breast cancer-specific measures.

Breast cancer is one of the most common cancers in women in the world. Health-related quality of life (HRQL) at treatment endpoint in cancer clinical trials is widely considered to be increasingly important. The aim of this review was to provide a literature-based assessment of the validity, reliability and responsiveness of breast cancer-specific HRQL instruments in women breast cancer patients. The databases consulted were Medline, PubMed, and Embase. The inclusion criteria required studies to: (1) involve use of HRQL measures; (2) cover women with breast cancer under standard treatment (surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy); (3) involve the validity, reliability, or responsiveness of HRQL; (4) deal with validation of breast cancer-specific HRQL instruments. A total of 16 studies were identified through the literature search that met the 4 inclusion criteria. Some seven instruments were assessed among these 16 studies: EORTC QLQ-BR23, FACT-B, FACT-ES, HFRDIS, LSQ- 32, QLICP-BR, and SLDS-BC. EORTC QLQ-BR23, FACT-B, LSQ-32, QLICP-BR, and SLDS-BC are more general breast cancer-specific HRQL instruments. FACT-EB is the endocrine subscale combined with FACT-B in order to measure the side effects and putative benefits of hormonal treatment administered in breast cancer patients. HFRDIS is the HRQL measure focusing on hot flash concerns. This paper provides an overall understanding on the currently available breast cancer-specific HRQL instruments in women breast cancer patients.

Brief Communication: Patient Satisfaction with the Use of Tablet Computers: A Pilot Study in Two Outpatient Home Dialysis Clinics

BackgroundElectronic capture of patients’ reports of their health is significant in clinical nephrology research because health-related quality of life (HRQOL) for patients with end-stage renal disease is compromised and assessment by patients of their HRQOL in practice is relatively uncommon.ObjectiveThe purpose of this study was to evaluate patient satisfaction with and time involved in administering HRQOL and symptom assessment measures using tablet computers in two outpatient home dialysis clinics.DesignA cross-sectional observational study design was employed.SettingThe study was conducted in two home dialysis clinics.PatientsFifty-six patients participated in the study; 35 males (63%) and 21 females (37%) with a mean age of 66 ± 12 (36-90 years old) were included. Forty-nine participants were on peritoneal dialysis (87%), 6 on home hemodialysis (11%), and 1 on nocturnal home hemodialysis (2%).MeasurementsMeasures included the Kidney Disease Quality of Life-36 (KDQOL-36), the Edmonton Symptom Assessment Scale (ESAS) and Participant’s Level of Satisfaction in Using a Tablet Computer.MethodsUsing a tablet computer, participants completed the three measures. Descriptive statistics and bivariate correlations were calculated.ResultsParticipants’ satisfaction with use of the tablet computer was high; 66% were “very satisfied”, 7% “satisfied”, 2% “slightly satisfied”, and 18% “neutral”. On the 7-point Likert-type scale, the mean satisfaction score was 5.11 (SD = 1.6). Mean time to complete the measures was: Level of Satisfaction 1.15 minutes (SD = 0.41), ESAS 2.55 minutes (SD = 1.04), and KDQOL 9.56 minutes (SD = 2.03); the mean time to complete all three instruments was 13.19 minutes (SD = 2.42). There were no significant correlations between level of satisfaction and age, gender, HRQOL, time taken to complete surveys, computer experience, or comfort with technology. Comfort with technology and computer experience were highly correlated, r = .7, p (one-tailed) < 0.01.LimitationsLimitations include lack of generalizability because of a small self-selected sample of relatively healthy patients and a lack of psychometric testing on the measure of satisfaction.ConclusionsParticipants were satisfied with the platform and the time involved for completion of instruments was modest. Routine use of HRQOL measures for clinical purposes may be facilitated through use of tablet computers.

Effect of Therapeutic Interventions on Health-related Quality of Life in Parkinson’s Disease

Health-related quality of life (HRQoL) used to be considered a secondary parameter in clinical trials of Parkinson’s disease (PD) and in routine clinical practice, but is now increasingly recognised as an important measure of patient status. A number of studies have shown that the severity of PD is strongly associated with poor HRQoL scores and that measuring HRQoL domains provides a valuable assessment of overall patient status. Current guidelines from the Movement Disorder Society Task Force and the European Parkinson’s Disease Association recommend the use of HRQoL measures in the diagnosis and monitoring of patients. The European Medicines Agency PD Guidelines, however, do not yet recommend the use of such indirect endpoints in clinical trials. A series of phase III and post-marketing studies evaluating the selective monoamine oxidase type B inhibitor, rasagiline in PD, including between 404 and 1,176 patients, showed that treatment with rasagiline leads to significant improvements in HRQoL parameters such as the Parkinson’s Disease Quality of Life questionnaire (PDQUALIF), the 39-Item Parkinson’s Disease Questionnaire (PDQ-39), the PDQ-8 and other HRQoL-related parameters. Other clinical trials have shown significant improvements in parameters including: Short-Form-36, EuroQuol 5D, PDQUALIF, PDQ-39 and HRQoL-related parameters in PD patients treated with dopamine agonists, selegiline, tocopherol or levodopa/carbidopa/entacapone or levodopa/carbidopa combinations. Experience gained with these instruments is likely to increase the attention paid to HRQoL in PD assessment and could improve diagnosis and monitoring of PD and may ultimately improve patient outcomes.

Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: Secondary outcomes of a randomised controlled trial

Introduction and aim In a randomised trial investigating the effects of regular use of health-related quality of life (HRQOL) in oncology practice, we previously reported an improvement in communication (objective analysis of recorded encounters) and patient well-being. The secondary aims of the trial were to measure any impact on patient satisfaction and patients’ perspectives on continuity and coordination of their care. Methods In a prospective trial involving 28 oncologists, 286 cancer patients were randomised to: (1) intervention arm: regular touch-screen completion of HRQOL with feedback to physicians; (2) attention-control arm: completion of HRQOL without feedback; and (3) control arm: no HRQOL assessment. Secondary outcomes were patients’ experience of continuity of care (Medical Care Questionnaire, MCQ) including ‘Communication’, ‘Coordination’ and ‘Preferences to see usual doctor’ subscales, patients’ satisfaction, and patients’ and physicians’ evaluation of the intervention. Analysis employed mixed-effects modelling, multiple regression and descriptive statistics. Results Patients in the intervention arm rated their continuity of care as better than the control group for ‘Communication’ subscale ( p = 0.03). No significant effects were found for ‘Coordination’ or ‘Preferences to see usual doctor’. Patients’ evaluation of the intervention was positive. More patients in the intervention group rated the HRQOL assessment as useful compared to the attention-control group (86% versus 29%), and reported their doctors considered daily activities, emotions and quality of life. Conclusion Regular use of HRQOL measures in oncology practice brought changes to doctor-patient communication of sufficient magnitude and importance to be reported by patients. HRQOL data may improve care through facilitating rapport and building inter-personal relationships.

Health Related Quality of Life Assessment in Metastatic Disease of the Spine

Systematic literature review. To examine the available literature on health related quality of life (HRQOL) assessment in metastatic disease of the spine and identify the optimal functional outcome scales to be used in developing a disease-specific tool. There is a lack of consensus in the use of HRQOL measures in patients with metastatic spine disease. A systematic review was conducted using MEDLINE, EMBASE, the Science Citation Index (ISI), the Cumulative Index to Nursing and Allied Health Literature, the PsycINFO, the Allied and Complementary Medicine (AMED), Cochrane Reviews and Global Health databases for clinical studies addressing metastatic spine disease from 1966 through 2008. The validity of outcome tools was established by linkage analysis with the International Classification of Functioning Disability and Health (ICF). One hundred forty-one clinical studies met inclusion criteria including 10,347 patients. Only 5 moderate grade and 1 high grade study were identified. Thirty- four studies used a patient self-assessment instrument to assess health status. None of the instruments were validated for metastatic spine patients. The most commonly used Pi-by-no tools were SF-36, SIP 5, and the ADL. None of the studies defined health related quality of life (HRQOL) or justified the choice of instrument. The most commonly used cancer-specific tools were ECOG, EORTC QCQ-C30, and EUROQOL 5D. Based on frequency of citation and on correlation with the International Classification of Functioning Disability and Health, the ECOG and SF36 were judged as most valid and reliable. A systematic review of the available evidence suggests that valid and reliable health related quality of life measures exist for the assessment of oncology patients; however, a disease-specific tool for metastatic spine disease awaits development. Until such time as a disease-specific tool is available, we recommend that the ECOG and SF-36 be considered for use in studies addressing the outcome assessment of patients with metastatic spine disease.

Commentary on Evidence-based assessment of health-related quality of life and functional impairment in pediatric psychology

Commentary on Evidence-based assessment of health-related quality of life and functional impairment in pediatric psychology

Poor Health-Related Quality of Life Is a Predictor of Early, But Not Late, Cardiac Events After Percutaneous Coronary Intervention

Poor health-related quality of life (HRQL) is associated with mortality in cardiac patients. Patients (N=667) with poor HRQL after percutaneous coronary intervention had a higher incidence of early (< or =6 months) major adverse cardiac events (MACE) than did patients with good HRQL, whereas there was no difference for late (>6 months) MACE over a 2-year follow-up period. Poor HRQL remained an independent predictor of early, but not late MACE, adjusting for other risk factors. The same pattern was found for early and late death/non-fatal myocardial infarction. However, further research is warranted before recommending the use of HRQL measures as screening tools in clinical practice.

Proxy assessment of quality of life in pediatric clinical trials: Application of the Health Utilities Index 3

With increased cure rates, pediatric oncology protocols increasingly seek to document the impact of treatment on patients' disease, symptoms, and functional capacity. Nurses as proxy respondents used the Health Utilities Index 3 (HUI3) to assess the health-related quality of life (HRQL) in twenty-five patients (age 6 years or older) enrolled on a frontline protocol for leukemia. HRQL observations (n = 70) were made at three different time points to coincide with high-dose methotrexate therapy. Additionally, the proxy respondents evaluated the ease of use of the instrument and the data quality. As patients' health status declined, the number of unassessable HRQL items increased. These missing data made scoring cumbersome and precluded calculation of the overall HRQL scores for nearly 50% of the patients. Use of the provider proxy-assessed HUI3 in pediatric cancer trials may result in a high proportion of missing data. Trials may benefit more from the use of HRQL measures that consider the acuity of the child's illness, domains specific and sensitive to both disease and treatment, and items that can be proxy-assessed independent of input from parent or patient. Evaluations that combine child self-reports with both parent and provider reports may ultimately provide the most reliable and comprehensive perspective on children's quality of life.

The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory?

This paper applies a theory-driven approach to explore why the use of patient-reported outcome (PRO) measures in clinical practice, in particular, health-related quality of life (HRQoL) instruments, has little or no apparent influence on clinical decision making. A theory-driven approach involves combining knowledge of whether and how an intervention works. It is argued that such an approach is currently lacking within the literature evaluating the effectiveness of feeding back HRQoL information to clinicians. The paper identifies a number of mechanisms that might give rise to the expected outcomes that are currently implicit within the design of the intervention and hypotheses specified within the trials evaluating the use of HRQoL measures in clinical practice. It then examines how far current clinical practice matches these mechanisms and in doing so, a number of possible explanations for the lack of impact of HRQoL on clinical decision making are reviewed. The influence of HRQoL information on clinical decision making depends on a large number of factors related to the design of the intervention, patients’ and clinicians’ desire to discuss HRQoL issues within the consultation and the legitimacy that clinicians give to HRQoL instruments. To date, knowledge of how the feedback of HRQoL information to clinicians might improve doctor-patient communication or clinical decision making has yet to sufficiently inform an assessment of whether these aspects of patient care are improved. The paper concludes by specifying how the feedback of HRQoL information to clinicians might be modified to maximise its impact on clinical decision making.

Health-related quality of life (HR-QOL) and regulatory issues. An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval.

Interest in measuring qualitative aspects of life that are most closely related to health and healthcare has increased in recent years. Methods of describing patients' subjective health status now incorporate standardised measures, and several psychometric measures are available. Despite the thousands of empirical and conceptual papers in the medical and pharmacological literature on health-related quality of life (HR-QOL), the value of such measures in the regulatory process is still being debated. We conducted an assessment to understand and document the position of the European Agency for the Evaluation of Medicinal Products (EMEA) on the use of HR-QOL measures in studies conducted for regulatory purposes. Official documents produced and circulated by the EMEA containing recommendations on trial design, conduct and analysis for sponsors and scientific experts were independently reviewed by authors to document the position of the Agency on the specific topic of HR-QOL. All documents found in the Agency website on 30 September 1999 were identified and then assessed to: (i) identify diseases or drugs for which formal HR-QOL assessment is recommended; (ii) identify measures and methods recommended; and (iii) evaluate the reliability of recommendations across documents. Of the 189 documents retrieved, none focused directly on health-related quality of life. A few explicit recommendations were identified for 13 specific drugs or conditions. These recommendations were mostly general and vague, and used nonstandard terminology. In addition, terminology and recommendations were not consistent across documents and, in at least one case, were in contrast with the US Food and Drug Administration (FDA) guidelines. EMEA guidelines incorporating quality-of-life outcomes are welcomed but it is obvious that more detailed guidance is required. Closer collaboration between the EMEA and the FDA is also recommended. Experts from different disciplines should be involved in the preparation of such documents to assure the necessary technical expertise and the representativeness of the various counterparts.

Intellectual property considerations in the development and use of HRQL measures for clinical trial research.

As a result of the expanded use of health-related quality of life (HRQL) measures in clinical trial research, a variety of legal and ethical issues have surfaced. These issues can be put in the form of the following questions: (1) Under what circumstances should access to HRQL measures be restricted? (2) Under what circumstances is it appropriate for the developers of HRQL measures to assert their intellectual property rights to the instruments? (3) Under what circumstances is personal profit from the sale and use of HRQL measures legally and socially appropriate? Access to HRQL research is to be encouraged since this is necessary for this field to progress. However, the need for protection against misuse of ongoing work is real and may justify the assertion of intellectual property rights. HRQL measures developed entirely with public monies should remain in the public domain or be managed for the public good. Instruments developed with private funds or with a mix of public and private funds should be treated in a manner that reflects a fair balance between the rights of the private developer and those of the scientific community and the public. HRQL questionnaires are regularly being refined; such work is costly. Investigators continuing research directly related to instrument refinement might reasonably ask for compensation from those who wish to use their work.