Integrating health-related quality of life into cross-national clinical trials

When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials. The investigator embarking on a treatment trial can extend the outcome inquiry into broader areas of function and well-being than those defined by the more traditional symptom profiles, morbidity and mortality outcomes.     

Integrating response shift into health-related quality of life research: a theoretical model.

Patients confronted with a life-threatening or chronic disease are faced with the necessity to accommodate to their illness. An important mediator of this adaptation process is 'response shift' which involves changing internal standards, values and the conceptualization of quality of life (QOL). Integrating response shift into QOL research would allow a better understanding of how QOL is affected by changes in health status and would direct the development of reliable and valid measures for assessing changes in QOL. A theoretical model is proposed to clarify and predict changes in QOL as a result of the interaction of: (a) a catalyst, referring to changes in the respondent's health status; (b) antecedents, pertaining to stable or dispositional characteristics of the individual (e.g. personality); (c) mechanisms, encompassing behavioral, cognitive, or affective processes to accommodate the changes in health status (e.g. initiating social comparisons, reordering goals); and (d) response shift, defined as changes in the meaning of one's self-evaluation of QOL resulting from changes in internal standards, values, or conceptualization. A dynamic feedback loop aimed at maintaining or improving the perception of QOL is also postulated. This model is illustrated and the underlying assumptions are discussed. Future research directions are outlined that may further the investigation of response shift, by testing specific hypotheses and predictions about the QOL domains and the clinical and psychosocial conditions that would potentiate or prevent response shift effects.     

The patient's view on quality of life and eating disorders

OBJECTIVE: This study investigated the personal views of eating disorder (ED) patients on their quality of life (QOL). METHOD: The views of 146 current ED patients and 146 former ED patients on their QOL were studied using a self-report questionnaire. Patients were requested to name the most important aspects of their life and they subsequently rated themselves on these aspects. Qualitative analysis clustered items into meaningful categories. RESULTS: A sense of belonging was mentioned most often (93.0%) by the participants. Work or education, health and well-being were also mentioned frequently. Furthermore, participants stated a sense of self, disease-specific psychopathology, life skills, leisure activities, a sense of purpose, financial situation, living condition, and pets. Current ED patients more frequently mentioned disease-specific psychopathology than former ED patients. Current ED patients reported poor QOL on most domains, particularly on self-image and well-being. Former ED patients reported better QOL than current ED patients, but ratings were just above average. CONCLUSION: The views on QOL of ED patients broadens the scope of relevant domains of QOL. The assessment of these views may be a useful adjunct to the use of standardized QOL measures.     

Health-related quality of life measurement

PURPOSE: The purpose of this article is to discuss the value of health-related quality of life (HR-QOL) measurement and describe its development with a few examples. DESIGN/METHODOLOGY/APPROACH: The methodology is a literature review of various articles published in the last 25 years on health-related quality of life. FINDINGS: HR-QOL tools are health status instruments, which are utilized to assess the changes in the health status of patients. These surveys are of increasingly importance as healthcare providers are challenged to justify treatment approaches and rationale for any intervention. Objective criteria can be used to determine whether there is clinical evidence of disease. However, the impact of disease on the individual's life is not included in such a clinical assessment. The use of validated and reliable health instruments is directed at measuring this impact in a reproducible and valid fashion. In patient-centred research, "experimental" conditions are constantly changing because human beings with values, feelings, perspectives and social relationships are being treated. It is especially important to use valid measurement tools when assessing these impacts. ORIGINALITY/VALUE: This article is written from the authors' own experience and knowledge and adds those benefits to the literature already available.     

Representations and perceived consequences of menopause by peri- and post-menopausal portuguese women: a qualitative research

Our aim in conducting this study is to describe the representations and perceived consequences of menopause, elicited through a semistructured interview with 36 Portuguese women, in peri- and post-menopause. The most prevalent response of the interviewed women was to see menopause as a normal/neutral phase of their life cycle (28.3%). Menses' cessation (58.7%) was identified as the most prevalent positive consequence of menopause, and a range of psychological changes (18.3%) was the most mentioned negative consequence. Health care provider's awareness of women's attitudes will allow them to communicate more effectively and to reinforce women's positive attitudes.     

Prioritization and surgical wait lists: A cross-sectional survey of patient's health-related quality of life

IntroductionIn many countries, there are waits for elective (planned) surgery. In these settings, processes for triaging patients are applied to determine how long patients wait for their surgery. There are very few instances that evaluate the effectiveness of surgical triage processes.MethodsA sample of patients from four acute care hospitals in Vancouver, Canada, completed a number of patient-reported outcomes shortly after being registered on the surgical wait list. Patients’ diagnosis was used to triage and determine their expected wait for surgery. The associations between patient-reported outcomes with surgical triage were measured.ResultsThe mean wait times for participants were similar across wait times categories. Participants whose expected waits for surgery were the longest reported successively lower levels of self-rated health (p < 0.01) and successively higher levels of pain (p < 0.01.) There was no difference in symptoms of anxiety among participants expected to wait the longest.DiscussionThe diagnosis-based system for prioritizing patients found higher levels of pain and lower health status among those expected to wait the longest for their surgery. Screening waiting patients for treatable mental health conditions should be implemented and the process of surgical triage could be redesigned to allow for a broader set of attributes of health to determine how long a patient waits for their elective surgery.     

Concomitants of menopause-specific quality of life in premenopausal and post-menopausal women living in South Korea

ABSTRACT

The present study investigated the concomitants of menopause-specific quality of life among premenopausal and postmenopausal women. Based on the Wilson and Cleary model of quality of life, this cross-sectional study recruited 329 women of age 40–65 years following operational convenience. The study was conducted in the office of the Korea Population, Health and Welfare Association (KPHWA) in Incheon, South Korea. Data collected on sociodemographic characteristics, social support, biological/physiological characteristics, the Pittsburgh Sleep Quality Index (PSQI-K), and self-rated health. Menopause-specific quality of life questionnaire (MENQOL) was used in this study. Hierarchical multiple linear regression analysis was performed. The study found that social support and self-rated health were negatively correlated with MENQOL in premenopausal women, while the income level and self-rated health were negatively associated with MENQOL in postmenopausal women. Sleep quality was positively correlated with MENQOL in both premenopausal and postmenopausal women. The study results indicate the need for tailored approaches based on menopausal status. Especially, social support may help improve the MENQOL of premenopausal women, while in postmenopausal women, improved sleep quality may enhance their menopause-specific quality of life.     

Putting the quality into quality-adjusted life years

Over recent decades, a great deal of effort has been devoted towards developing instruments that can be used to elicit health state values. All of these instruments are conceptually very different from one another and all suffer from serious inherent biases. In this paper I outline the conceptual foundations and empirical limitations of the three principal health state value elicitation instruments. Given that the conceptual parameters internalized within an instrument influence the elicited health state values, I argue that it is necessary to attain a broad agreement on what the appropriate parameters ought to be. When the appropriate conceptual parameters have been identified we will be in a position to develop the methodology of a single standardized instrument.     

Integrating health profile with survival for quality of life assessment

In cohort studies or clinical trials, measurements of quality of life (QoL) were averaged across available individuals for each group at given points in time to produce single measures for comparisons. However, estimates of these single measures may be severely biased if substantial mortality occurs over time. The objective of this study is to develop a method that integrates QoL measurement and survival for long-term evaluation of health services. We defined a mean QoL score function over time for an index population as the average QoL score of all individuals both alive and dead at each time point in the population. While a living subject's QoL can be assessed by asking one's subjective preference, the score of a decedent can be assigned a fixed value depending on the specific facet on health profile. The mean QoL score function over time is reduced to a single measure of expected cumulative QoL score, which is the area under the curve of mean QoL score function over a given time interval and can be estimated by taking a random sample from a cross-sectional survey. For the QoL score function to be extrapolated to life-long, it requires the assumption that the disease causes premature death or a long-term moderate impairment of QoL. We provided methods and computer programs for estimating mean QoL score functions and the reduced single measures for use in comparisons. A cohort of 779 breast cancer patients from Chiangmai, Thailand were followed for 12 years to demonstrate the proposed methods. The data included the 12-year complete survival records and QoL scores on 233 patients collected from a cross-sectional survey using WHOQOL questionnaire and standard gamble method. The expected cumulative QoL scores using utility and psychometric scales were compared among patients in four groups of clinical stages in this cohort for time from onset up to 12 years and life-long. We conclude that such an integration of QoL measurement with survival can be useful for the evaluation of health service and clinical decision.     

Nursing research into quality of life

This report describes the scope of nursing research in the area of quality of life. The strategy used to identify research reports relied heavily on nursing publications included in the Cumulative Index for Nursing and Allied Health Literature (CINAHL) from 1983 (when the database first included the subject, quality of life) to December, 1991. During this period, over 1,000 references concerning quality of life can be identified through a key-word search of the data set. Nursing investigators defined quality of life in terms of psychological, physical, social/interpersonal, and financial/material well-being. Nursing instruments have been developed to measure one or more of these dimensions of the concept. Nursing journals like Advances in Nursing Science (1985), Seminars in Oncology Nursing (1990), and Progress in Cardiovascular Nursing (1992) dedicated whole issues to the topic. Major nursing associations have supported conferences/talks (American Heart Association Council on Cardiovascular Nursing, Santa Fe, NM, 1991; Oncology Nursing Society, Fall Institute, Annual Quality of Life Lectureship) and provided awards on the subject (Oncology Nursing Society Annual Quality of Life Research Award). The National Center for Nursing Research is launching an intramural programme to address quality of life questions.     

Integrating renal nutrition guidelines into daily family life: a qualitative exploration

Background

Renal dietary compliance is challenging for individuals with chronic renal disease. Advice may change depending on renal function and medical treatment. Although patients seek support from family members with these changes, no literature exists with respect to how family members experience the offering of this support. The present study aimed to describe and interpret this lived experience of family members.

Methodology

Phenomenological qualitative semi‐structured interviews were conducted with 12 adult family members via telephone (transcribed verbatim). Framework analysis and the qualitative software nvivo , version 10 (QSR International Pty Ltd, Melbourne, VIC, Australia) were used. Participants commented on the themes for accuracy of experience representation.

Results

Four major themes emerged: (i) intrusion of the renal diet; (ii) dealing with the recommendations of a renal diet; (iii) seeking a new identity; and (iv) transition of family dynamics. Perceived conflicting advice intruded into family life. Children in the family resulted in more complex nutritional decisions. Continuing a diet to avoid perceived family and wider social judgement was not an option. Balance between nurturing the family as a whole and the necessity of attending to the specific needs of one individual with renal disease was challenging. Transition to a new identity included family members being drawn to scientifically guided understandings of nutrition and a medicalisation of daily food requirements, which included low prioritisation of children's nutritional needs.

Conclusion

Family members who cooked found the integration of renal nutrition guidelines challenging, with children presenting further challenges. The present study highlights the need to offer practical and psychological support to families who are coping with end‐stage renal failure and renal nutritional guidelines.     

Integrating providers into quality improvement: a pilot project at one hospital

Brigham and Women's Hospital initiated a study of the quality of care centering on self-reporting of potential medical injuries by providers. The goal of the study is to decrease the incidence of such injuries through a continuous quality methodology that integrates providers into the identification phase and incorporates all hospital employees in the development of new practices. This article provides an overview of the investigation methodology and discusses the conceptual relationships between clinical epidemiological analyses and industrial quality improvement.