Importance of differentiating health status from quality of life

Of nine exhibits in the Quality of Life with Diabetes poster event at the recent European Association for the Study of Diabetes meeting in Jerusalem,1 five used measures of health status (EQ5D and SF-36) and two others used measures of well-being (W-BQ22). All nine referred to the measures used as quality-of-life measures. The EQ5D2 and SF-363 measure how people feel about their health (physical and mental) and the W-BQ224 measures feelings of depression, anxiety, energy, and positive well-being. If people feel that their health or well-being is poor, they may feel that their quality of life is also impaired, though this is not necessarily the case. The opposite – that just because they feel that their health is excellent and they are not depressed or anxious, their quality of life is excellent – may not be true either

Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures

I believe that the FDA guidelines have already had an impact in encouraging good practice in the use of PROs. There are, however, important improvements that need to be made to the guidelines, particularly in the use of health status and quality of life terminology. It is essential to distinguish between health status and quality of life and to use both terms. Nothing is to be gained and a great deal will be lost if the term quality of life (which has been misused as an umbrella term in the past) is abandoned and replaced with the term health status. Patients want us to consider their quality of life as well as their health. To abandon the term would be to forget about their quality of life and focus only on their health. Patients are well able to tell us what quality of life means to them and to rate the impact of a condition on their quality of life if we use individualised quality of life measures and individualised condition-specific quality of life measures to allow them to do so. Although my experience with PRO measures would support many of the recommendations in the guidelines there are others that I would not fully agree with or would contradict on the basis of my own research evidence. I have provided references to that research and hope that the FDA will feel able to do the same when they finalise their guidelines

Trends in hospitalisations due to falls by older people, Australia 1999-00 to 2010-11

SummaryThis report focuses on trends in fall-related hospital care for people aged 65 and older that occurred over the period 1999-00 to 2010-11. Information is also presented on the incidence and burden of hospitalised fall injury in the financial year 2010-11.Falls in 2010-11 The estimated number of serious injuries due to falls in people aged 65 and older in 2010-11 was 92,150. Females accounted for most of these fall injury cases, and rates of cases were higher for females than for males for all age groups. About 70% of fall injury cases in 2010-11 were recorded as having occurred in either the home or an aged care facility. The age-standardised rate of falls in the home for older people living in the community was 1,647 per 100,000 population while the rate of falls for older people living in aged care facilities was 9,226 per 100,000 population. In addition to the separations representing these fall injury cases, there were more than 100,000 other fall-related hospital separations for people aged 65 and older in 2010-11. One in every 10 days spent in hospital by a person aged 65 and older in 2010-11 was directly attributable to an injurious fall. These episodes of care accounted for 1.4 million patient days over the year and the average total length of stay per fall injury case was estimated to be 14.7 days.Trends in hospitalised fall-related injury 1999-00 to 2010-11 The patient days for hospital care directly attributable to fall-related injury doubled, from 0.7 million patient days in 1999-00 to 1.4 million patient days in 2010-11. Age-standardised rates of fall injury cases increased over the 12 years to June 2011 (2% per year), however there was a decrease in the rate of hip fractures due to falls (-1% per year). There were nearly 25,000 extra fall injury cases for people aged 65 and older in 2010-11 than there would have been if the rate of falls had remained stable since 1999-00. The decrease in the rate of hip fracture was confined to the period 1999-00 to 2005-06. No change in trend was observed from 2006-07. Most other types of fall-related fracture increased over the study period. Falls resulting in head injuries increased at a particularly high rate (7% per year). Increases in the rate of fall injury cases and fall-related head injury were most apparent for residents of Major cities (3% and 8% per year, respectively). Rates of fall injury for Aboriginal and Torres Strait Islander people were generally lower than those for Other Australians although both sets of rates showed similar trends. Continuing weakness in the identification of Indigenous status limited analysis. Rates of fall-related hospital care episodes additional to the initial episode for each fall injury case (such as follow-up care) increased significantly over the study period. However, the average total length of stay per case was relatively stable over the study period (around 15 days). Hence this increase may have been due to changes in hospital practices (for example, the division of care into multiple episodes) rather than because fall injuries required more care

Hospitalisations due to falls by older people, Australia: 2009-10

This report is the sixth in a series of reports on hospitalisations due to falls by older people in Australia. It focuses on hospitalised falls that occurred in the financial year 2009-10.Falls in 2009-10 The estimated number of hospitalised injury cases due to falls in people aged 65 and over in 2009-10 was 83,800-more than 5,100 extra cases than in 2008-09. Women accounted for most of the hospitalised fall injury cases and rates of fall cases were higher for women than for men for all age groups. As in the previous year, the age-standardised rate of hospitalised fall injuries involving older women exceeded 3,000 per 100,000 population. About one-third of fall injury cases had injuries to the hip and thigh, and the majority of these were hip fractures. Head injuries accounted for 1 in 5 hospitalised cases and were proportionately more common for men than for women.Circumstances of falls As in previous years, a fall on the same level due to slipping, tripping and stumbling was the most common cause of hospitalised injury. About 70% of hospitalised falls in 2009-10 were recorded as having occurred in either the home or an aged care facility. About half of the falls in the home were recorded as having occurred in \u27other and unspecified\u27 places in the home (48%). Outdoor areas of the home, the bathroom and the bedroom were common places of occurrence. However, this level of detail was only available for about half the cases that occurred in the home.Burden of fall-related injury One in every 10 days spent in hospital by a person aged 65 and older in 2009-10 was directly attributable to an injurious fall (1.3 million patient days over the year), and the average total length of stay per fall injury case was estimated to be 15.5 days. The first period of hospital care for a fall-related injury at ages 65 and older in 2009-10 accounted for 0.57 million patient days. In about 10,000 cases the patient was transferred to another hospital, accounting for another 0.14 million patient days. Fall-related follow-up care hospitalisations numbered almost 34,000 and accounted for a further 0.57 million patient days. In addition to the burden directly attributable to fall-related injury, \u27other fall-related\u27 and \u27tendency to fall\u27 separations added a further 47,000 episodes of hospital care (0.62 million patient days) to the total due to falls. Of note, the age-standardised rates of fall-related hospitalisations of these types are increasing, substantially in the case of fall-related follow-up care separations

Treatment satisfaction and psychological well-being with insulin glargine compared with NPH in patients with Type 1 diabetes

Aims: To assess satisfaction with treatment and psychological well-being associated with insulin glargine and NPH. Insulin glargine, a new long-acting insulin analogue, provides constant, peakless insulin release following once-daily administration and is associated with fewer hypoglycaemic episodes, despite metabolic control equivalent to that achieved with NPH human basal insulin. Methods: The Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Well-being Questionnaire (W-BQ) were completed at baseline and at weeks 8, 20 or 28 by 517 patients with Type 1 diabetes participating in a randomized, controlled European trial comparing insulin glargine and NPH. Analysis of covariance was performed on change from baseline scores (main effects: treatment and pooled site; covariate: baseline scores). Results: Treatment Satisfaction improved with insulin glargine at all time points, including endpoint, but deteriorated slightly with NPH. These differences were significant throughout the study (change from baseline to endpoint: +1.27 vs. –0.56; p = 0.0001). Outcomes were better with insulin glargine for the DTSQ items, Perceived Frequency of Hyperglycaemia and Hypoglycaemia, with statistically significant differences at week 28 and endpoint for hyperglycaemia (p = 0.0373 and 0.0379) and at week 20 for hypoglycaemia (p = 0.0024). There was no difference in psychological well-being between the treatment groups, with mean scores increasing in both. Conclusions: Study participants had treatment-independent improvements in General Well-being. Advantages for insulin glargine were seen in significantly improved Treatment Satisfaction throughout the study, together with lower Perceived Frequency of Hyperglycaemia than for patients on NPH, without a significant increase in Perceived Frequency of Hypoglycaemia

Comments on 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support labeling Claims'.

I have a particular interest in the FDA's guidance on patient-reported outcome (PRO measures as I specialize in the design, development and use of such measures and license them to pharmaceutical companies, research organizations, academics and clinicians for use in clinical trials, other research and routine clinical practice. My measures include: the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in it's status (DTSQs) and change (DTSQc) forms and related measures for other conditions including the HIVTSQ, RTSQ, RetTSQ, GHerpTSQ, ThyTSQ, and the newly designed DTSQ-Teen and DTSQ-Parent. The DTSQs and c are fully linguistically validated in more than 60 language versions. - the Well-being Questionnaire (e.g. W-BQ12) generic measure of well-being is psychometrically validated for a range of populations including those who have diabetes (type 1 and type 2) macular disease and growth hormone deficiency and fully linguistically validated in 25 language versions. - the ADDQoL measure of the impact of diabetes on quality o life with related measures for other conditions including RDQoL, RETQol, MacDQoL, HDQoL, ARHDQoL, ThyDQoL, ADDQoL Teen and recently designed ADDToL Jnr (for 5-8 year olds) and ADDQoL Jnr+ for (9-12 year olds). The ADDQoL, MacQoL and RetQoL are linguistically validated in 16-25 language versions. I welcome the FDA guidance as a much needed source of information about the standards required on PRO design, linguistic validation, psychometric validation and use and recognise that the guidance may be very useful in encouraging good practice. I comment on issues in the order in which they first appear in the guidance and thereafter identify omissions that I ask be considered for inclusion

Psychophysiological effects of stress in diabetic patients, ischaemic heart patients and healthy subjects

This thesis is concerned with the relationships between physiological changes and subjective and behavioural responses to stress. The effects of noise stress were examined under laboratory conditions, and retrospective studies of stress induced by life events were also carried out. Changes in blood glucose levels were of particular significance under stressful conditions and interesting relationships were found between changes in blood glucose levels and performance at experimental tasks under stressful conditions. Performance and the experience of stress were shown to be affected by the experimental manipulations of blood glucose levels. The effects of stressful conditions on diabetic subjects with impaired control of blood glucose levels were of particular interest. The poor control of blood glucose levels in the 'high glucose diabetics' was exaggerated when working under noise stress. Studies of life events demonstrated that diabetic subjects' experience of life events was associated with physiological disturbance of diabetic control. Diabetics' subjective experiences of stressful conditions were also examined and compared with the experiences of control subjects. Previous research showed considerable evidence to suggest that stress was a promoting factor in ischaemic heart disease (IHD). Subjects with IHD and controls were included in the present research. Experiments similar to those with diabetic subjects were carried out. The IHD subjects had enhanced physiological responses to noise stress which were associated with significantly low levels of reported stress. Subjective experiences of stress were further examined with investigations of the degree of stress associated with life events by Myocardial infarction patients. Differences in subjective experience of stress by patient groups and their controls were discussed in relation to the concept of alexithymia. Experiments with healthy subjects were carried out in order to examine the mechanisms involved in the relationships found between glucose, performance and the perception and experience of stress. The effects of glucose preloading were shown to be primarily of physiological rather than of psychological origin, and a vagal-insulin model was proposed to account for the relationship between glucose preloading and performance efficiency. Experimenter effects were examined in the studies of healthy subjects and the implications of such effects discussed in relation to the results of the experiments with hospital subjects in this work and with reference to other psychophysiological research. The experimental findings were evaluated and suggestions made for further research. In particular research directed towards the possibility of developing a more flexible, individual approach to diabetic management, taking account of unavoidable sources of stress, was outlined