Response shift, recall bias and their effect on measuring change in health-related quality of life amongst older hospital patients

Background: Assessments of change in subjective patient reported outcomes such as health-related quality of life (HRQoL) are a key component of many clinical and research evaluations. However, conventional longitudinal evaluation of change may not agree with patient perceived change if patients' understanding of the subjective construct under evaluation changes over time (response shift) or if patients' have inaccurate recollection (recall bias). This study examined whether older adults' perception of change is in agreement with conventional longitudinal evaluation of change in their HRQoL over the duration of their hospital stay. It also investigated this level of agreement after adjusting patient perceived change for recall bias that patients may have experienced. Methods: A prospective longitudinal cohort design nested within a larger randomised controlled trial was implemented. 103 hospitalised older adults participated in this investigation at a tertiary hospital facility. The EQ-5D utility and Visual Analogue Scale (VAS) scores were used to evaluate HRQoL. Participants completed EQ-5D reports as soon as they were medically stable (within three days of admission) then again immediately prior to discharge. Three methods of change score calculation were used (conventional change, patient perceived change and patient perceived change adjusted for recall bias). Agreement was primarily investigated using intraclass correlation coefficients (ICC) and limits of agreement. Results: Overall 101 (98%) participants completed both admission and discharge assessments. The mean (SD) age was 73.3 (11.2). The median (IQR) length of stay was 38 (20-60) days. For agreement between conventional longitudinal change and patient perceived change: ICCs were 0.34 and 0.40 for EQ-5D utility and VAS respectively. For agreement between conventional longitudinal change and patient perceived change adjusted for recall bias: ICCs were 0.98 and 0.90 respectively. Discrepancy between conventional longitudinal change and patient perceived change was considered clinically meaningful for 84 (83.2%) of participants, after adjusting for recall bias this reduced to 8 (7.9%). Conclusions: Agreement between conventional change and patient perceived change was not strong. A large proportion of this disagreement could be attributed to recall bias. To overcome the invalidating effect of response shift (on conventional change) and recall bias (on patient perceived change) a method of adjusting patient perceived change for recall bias has been described.

Evidence of disagreement between patient-perceived change and conventional longitudinal evaluation of change in health-related quality of life among older adults

Objective: To identify agreement levels between conventional longitudinal evaluation of change (post–pre) and patient-perceived change (post–then test) in health-related quality of life. Design: A prospective cohort investigation with two assessment points (baseline and six-month follow-up) was implemented. Setting: Community rehabilitation setting. Subjects: Frail older adults accessing community-based rehabilitation services. Intervention: Nil as part of this investigation. Main measures: Conventional longitudinal change in health-related quality of life was considered the difference between standard EQ-5D assessments completed at baseline and follow-up. To evaluate patient-perceived change a ‘then test’ was also completed at the follow-up assessment. This required participants to report (from their current perspective) how they believe their health-related quality of life was at baseline (using the EQ-5D). Patient-perceived change was considered the difference between ‘then test’ and standard follow-up EQ-5D assessments. Results: The mean (SD) age of participants was 78.8 (7.3). Of the 70 participants 62 (89%) of data sets were complete and included in analysis. Agreement between conventional (post–pre) and patient-perceived (post–then test) change was low to moderate (EQ-5D utility intraclass correlation coefficient (ICC)¼0.41, EQ-5D visual analogue scale (VAS) ICC¼0.21). Neither approach inferred greater change than the other (utility P¼0.925, VAS P¼0.506). Mean (95% confidence interval (CI)) conventional change in EQ-5D utility and VAS were 0.140 (0.045,0.236) and 8.8 (3.3,14.3) respectively, while patient-perceived change was 0.147 (0.055,0.238) and 6.4 (1.7,11.1) respectively. Conclusions: Substantial disagreement exists between conventional longitudinal evaluation of change in health-related quality of life and patient-perceived change in health-related quality of life (as measured using a then test) within individuals.

Physical function and health-related quality of life of older adults undergoing hospital rehabilitation : how strong is the association?

The purpose of this research is to report preliminary empirical evidence regarding the association between common physical performance measures and health-related quality of life (HRQoL) of hospitalized older adults recovering from illness and injury. Frequently, these patients do not return to premorbid levels of independence and physical ability. Rehabilitation for this population often focuses on improving physical functioning and mobility with the intention of maximizing their HRQoL for discharge and thereafter. For this reason, longitudinal use of physical performance measures as an indicator of improvement in physical functioning (and thus HRQoL) is common. Although this is a logical approach, there have been mixed results from previous investigations into the association between common measures of physical function and HRQoL amongst other adult patient populations.1,2 There has been no previous investigation reporting the association between HRQoL and a variety of common physical performance measures in hospitalized older adults.

Children of substance-using mothers : child health engagement and child protection outcomes

Aim: Maternal substance use has been associated with a range of child risk factors. The study investigated the relationship between engagement with child health services and child protection outcomes for children of substance using mothers. ----- ----- Methods: A sample of 119 children of mothers who disclosed opiate, amphetamine or methadone use during a maternity admission between 2000 and 2003, as included in a previous matched co-hort study1, were included in the current study. Statutory child protection agency and child health engagement information for the first two years of life, was obtained. The relationship between type of maternal substance use, child health engagement and child protection outcomes was examined. ----- ----- Results: Seventy two percent of study group infants were engaged with child health services during the first two years of life. Chi square analysis showed no significant relationship between child health engagement and child protection reports. Child health engagement was associated with decreased substantiated child protection notifications for children of methadone using mothers, but not for children of illicit substance users. ----- ----- Conclusions: Almost a quarter of identified children of substance using mothers are not accessing standard child health services in their first two years of life. This study provides support for increased attention to the provision of child health services for children of methadone using mothers. Further research into effective intervention strategies for children of illicit substance using mothers is indicated.

A national roll out of an insufficiently evaluated practice : how evidence based are our end-of-life care policies?

There has been increasing international efforts to ensure that health care policies are evidence based. One area where there is a lack of ‘effectiveness’ evidence is in the use of end-of-life care pathways (EOLCP) (1). Despite the lack of evidence supporting the efficacy of the EOCLP, their use has been endorsed in the recent national palliative care strategy document in the UK (2). In addition, a publication endorsed by the Australian Government (titled: Supporting Australians to live well at the End of Life- National Palliative Care Strategy 2010) (3), recommended a national roll out of EOLCP across all sectors (primary, acute and aged care) in Australia. According to this document, it is a measure of “appropriateness” and “effectiveness” for promoting quality end-of-life care.

Defending the sanctity of life principle : a reply to John Keown

This article is a response to Professor Keown’s criticism of my paper “Finding a Way Through the Ethical and Legal Maze: Withdrawal of Medical Treatment and Euthanasia” (2005) 13 (3) Medical Law Review 357. The article takes up and responds to a number of criticisms raised by Keown in an attempt to further the debate concerning the moral and legal status of withdrawing life-sustaining measures, its distinction from euthanasia, and the implications of the lawfulness of withdrawal for the principle of the sanctity of life.

A spoofing detection method for civilian L1 GPS and the E1-B Galileo Safety of Life service

This paper describes an effective method for signal-authentication and spoofing detection for civilian GNSS receivers using the GPS L1 C/A and the Galileo E1-B Safety of Life service. The paper discusses various spoofing attack profiles and how the proposed method is able to detect these attacks. This method is relatively low-cost and can be suitable for numerous mass-market applications. This paper is the subject of a pending patent.

The role of life friendly policies on employees’ work-life balance

Employees' inability to balance work and non-work related responsibilities have resulted in an increase in stress related illnesses. Historically, research into the relationship between work and non-work has primarily focused on work/family conflict, predominately investigating the impact of this conflict on parents, usually mothers. To date research has not sufficiently examined the management practices that enable all 'individuals' to achieve a 'balance' between work and life. This study explores the relationship between contemporary life friendly HR management policies and work/life balance for individuals as well as the effect of managerial support to the policies. Self-report questionnaire data from 1,241 men and women is analysed and discussed to enable organizations to consider the use of life friendly policies and thus create a convergence between the well-being of employees and the effectiveness of the organization.

Quality of life and genetics in men with prostate cancer

As family history has been established as a risk factor for prostate cancer, attempts have been made to isolate predisposing genetic variants that are related to hereditary prostate cancer. With many genetic variants still to be identified and investigated, it is not yet possible to fully understand the impact of genetic variants on prostate cancer development. The high survival rates among men with prostate cancer have meant that other issues, such as quality of life (QoL), have also become important. Through their effect on a person’s health, a range of inherited genetic variants may potentially influence QoL in men with prostate cancer, even prior to treatment. Until now, limited research has been conducted on the relationship between genetics and QoL. Thus, this study contributes to an emerging field by aiming to identify certain genetic variants related to the QoL found in men with prostate cancer. It is hoped that this study may lead to future research that will identify men who have an increased risk of a poor QoL following prostate cancer treatment, which will aid in developing treatments that are individually tailored to support them. Previous studies have established that genetic variants of Vascular Endothelial Growth Factor (VEGF) and Insulin-like Growth Factor 1 (IGF-1) may play a role in prostate cancer development. VEGF and IGF-1 have also been reported to be associated with QoL in people with ovarian cancer and colorectal cancer, respectively. This study completed a series of secondary analyses using two major data-sets (from 850 men newly diagnosed with prostate cancer, and approximately 550 men from the general Queensland population), in which genetic variants of VEGF and IGF-1 were investigated for associations with prostate cancer susceptibility and QoL. The first aim of this research was to investigate genetic variants in the VEGF and IGF-I gene for an association with the risk of prostate cancer. It was found that one IGF-1 genetic variant (rs35765) had a statistically significant association with prostate cancer (p = 0.04), and one VEGF genetic variant (rs2146323) had a statistically significant association with advanced prostate cancer (p = 0.02). The estimates suggest that carriers of the CA and AA genotype for rs35765 may have a reduced risk of developing prostate cancer (Odds Ratio (OR) = 0.72, 95% Confidence Interval (CI) = 0.55, 0.95, OR = 0.60, 95% CI = 0.26, 1.39, respectively). Meanwhile, carriers of the CA and AA genotype for rs2146323 may be at increased risk of advanced prostate cancer, which was determined by a Gleason score of above 7 (OR = 1.72, 95% CI = 1.12, 2.63, OR = 1.90, 95% CI = 1.08, 3.34, respectively). Utilising the widely used short-form health survey, the SF-36v2, the second aim of this study was to investigate the relationship between prostate cancer and QoL prior to treatment. Assessing QoL at this time-point was important as little research has been conducted to evaluate if prostate cancer affects QoL regardless of treatment. The analyses found that mean SF-36v2 scale scores related to physical health were higher by at least 0.3 Standard Deviations (SD) among men with prostate cancer than the general population comparison group. This difference was considered clinically significant (defined by group differences in mean SF-36v2 scores by at least 0.3 SD). These differences were also statistically significant (p<0.05). Mean QoL scale scores related to mental health were similar between men with prostate cancer and those from the general population comparison group. The third aim of this study was to investigate genetic variants in the VEGF and IGF-1 gene for an association with QoL in prostate cancer patients prior to their treatment. It was essential to evaluate these relationships prior to treatment, before the involvement of these genes was potentially interrupted by treatment. The analyses found that some genetic variants had a small clinically significant association (0.3 SD) to some QoL domains experienced by these men. However, most relationships were not statistically significant (p>0.05). Most of the associations found identified that a small sub-group of men with prostate cancer (approximately 2%) reported, on average, a slightly better QoL than the majority of the prostate cancer patients. The fourth aim of this research was to investigate whether associations between genetic variants in VEGF and IGF-1 and QoL were specific to men with prostate cancer, or were also applicable to the general male population. It was found that twenty out of one-hundred relationships between the genetic variants of VEGF and IGF-1 and QoL health-measures and scales examined differed between these groups. In the majority of the relationships involving VEGF SNPs that differed, a clinically significant difference (0.3 or more SD) between mean scores among the genotype groups in prostate cancer patients was found, while mean scores among men from the general-population comparison group were similar. For example, prostate cancer participants who carried at least one T allele (CT or TT genotype) for rs3024994 had a clinically significant higher (0.3 SD) mean QoL score in terms of the role-physical scale, than participants who carried the CC genotype. This was not seen among men from the general population sample, as the mean score was similar between genotype groups. The opposite was seen in regards to the IGF-1 SNPs examined. Overall, these relationships were not considered to directly impact on the clinical options for men with prostate cancer. As this study utilised secondary data from two separate studies, there are a number of important limitations that should be acknowledged including issues of multiple comparisons, power, and missing or unavailable data. It is recommended that this study be replicated as a better-designed study that takes greater consideration of the many factors involved in prostate cancer and QoL. Investigation into other genetic variants of VEGF or IGF-1 is also warranted, as is consideration of other genes and their relationship with QoL. Through identifying certain genetic variants that have a modest association to prostate cancer, this project adds to the knowledge surrounding VEGF and IGF-1 and their role in prostate cancer susceptibility. Importantly, this project has also introduced the potential role genetics plays in QoL, through investigating the relationships between genetic variants of VEGF and IGF-1 and QoL.

Quality of life of women with lower-limb lymphedema following gynecological cancer

Secondary lower-limb lymphedema can develop following treatment for gynecological cancers, and has debilitating effects on quality of life (QoL). Lymphedema can limit mobility and ability to perform daily activities, and have adverse effects on psychological and social wellbeing. When assessing the effect of lymphedema treatment methods, the focus is on change in clinically measured lymphedema status, rather than QoL outcomes. Considering that treatment for lymphedema involves a significant and ongoing commitment from patients, it is essential to determine whether the benefits to patients outweigh the burden associated with treatment. This article summarizes the results of studies assessing the impact of lower-limb lymphedema on QoL in women with gynecological cancer, evaluates their methodologies and discusses limitations and priorities for future research.

A Cochrane review on the effects of end-of-life care pathways : do they improve patient outcomes?

Clinical pathways for end-of-life care management are used widely around the world and have been regarded as the gold standard. The aim of this review was to assess the effects of end-of-life care pathways (EOLCP), compared with usual care (no pathway) or with care guided by a different end-of-life care pathway, across all healthcare settings (e.g. hospitals, residential aged care facilities, community). We searched the Cochrane Register of Controlled Trials (CENTRAL), the Pain, Palliative and Supportive Care Review group specialised register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The search was carried out in September 2009. All randomised controlled trials (RCTs), quasi-randomised trials or high quality controlled before and after studies comparing use versus non-use of an EOLCP in caring for the dying were considered for inclusion. The search identified 920 potentially relevant titles, but no studies met criteria for inclusion in the review. Without further available evidence, recommendations for the use of end-of-life pathways in caring for the dying cannot be made. There are now recent concerns regarding the big scale roll-out of EOLCP despite the lack of evidence, nurses should report any safety concerns or adverse effects associated with such pathways.