Practical Guidelines for Assessing the Clinical Significance of Health-Related Quality of Life Changes within Clinical Trials

Sloan, Jeff A.; Symonds, Tara; Vargas-Chanes, Delfino; Fridley, Brooke L.

doi:10.1177/009286150303700105

Cited by 214 publications

(177 citation statements)

References 20 publications

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“…For descriptive purposes, proportions of explained variance of variables other than presence of comorbidities were grouped into "disease-related" and "sociodemographic" variables. Clinical significance of differences in HRQOL outcomes was also evaluated in this study, defined as at least eight points on each SF-36 scale [24]. Statistical significance for SF-36 scales was Bonferroni corrected to account for multiple testing.…”

Section: Resultsmentioning

confidence: 99%

The impact of comorbidity on health-related quality of life in elderly patients with chronic myeloid leukemia

Efficace¹,

Rosti

Breccia

et al. 2015

Ann Hematol

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The primary objective of this study was to investigate whether the presence of comorbidities was associated with a lower health-related quality of life (HRQOL) in elderly patients with chronic myeloid leukemia (CML). A sample of 174 CML patients aged 60 years or above was analyzed. HRQOL was assessed with the Medical Outcomes Study 36-Item ShortForm Health Survey (SF-36). A number of pre-selected sociodemographic and disease-related factors were considered as potential confounding factors for the association between comorbidity and HRQOL. Mean age of the 174 patients analyzed was 70 years (range 60-87 years) and 55 % were male. Overall, 111 patients (64 %) reported at least one comorbidity. Analysis stratified by age group category showed a greater proportion of patients with comorbidities in the older subgroup population (≥70 years) compared to younger patients (60 to 69 years). Differences in HRQOL outcomes between patients with no comorbidity at all and those with two or more comorbid conditions were at least twice the magnitude of a clinically meaningful difference in all the physical and mental health scales of the SF-36. In multivariate analysis, after adjusting for key confounding factors, the following scales were significantly lower in those with comorbidity: general health (p<0.001), bodily pain (p<0.001), physical functioning (p=0.002), and vitality (p=0.002). Assessing comorbidity in elderly patients with CML is important to facilitate identification of those most in need of HRQOL improvements.

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Section: Resultsmentioning

confidence: 99%

The impact of comorbidity on health-related quality of life in elderly patients with chronic myeloid leukemia

Efficace¹,

Rosti

Breccia

et al. 2015

Ann Hematol

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“…This criterion was based on Sloan et al, who showed through their research that for any patientreported outcome instrument, a difference of half an SD can be considered clinically significant. 36,37 Equivalency was declared if a 90% CI of the difference between patients and caregivers was inside our reference CI of (À0.5SD, þ0.5SD). This reference CI was constructed based on the SD of the mean scores for the patients used as reference group.…”

Section: Testing For Equivalencymentioning

confidence: 99%

Congruence of primary brain tumor patient and caregiver symptom report

Armstrong

Wefel

Gning

et al. 2012

Cancer

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BACKGROUND: Evaluating the severity of symptoms in patients with primary brain tumors (PBTs) is important in clinical care and research but may be difficult due to patient neurocognitive (NC) impairment. This study was conducted to evaluate the congruence of symptom reporting in patient and caregiver dyads, examining potential impact of NC impairment and Karnofsky performance status (KPS). METHODS: PBT patients undergoing NC testing and their caregivers were included in this study. These dyads (paired patient and caregiver group) completed the MD Anderson Symptom Inventory-Brain Tumor Module prior to testing, and impairment was categorized based on NC test scores. Concordance and equivalency was then assessed using Bland-Altman analysis and 2 onesided techniques. RESULTS: A total of 115 dyads participated. Median patient and caregiver age was 49 and 51 years, respectively, and 63% of patients were male (73% female caregivers). Most patients had a good KPS (!90, 66%) but were classified as NC impaired (58%). Caregiver's report of patient symptoms are congruent to the self-report of the patient. Equivalency between patient and caregiver report were found using prespecified confidence intervals. KPS group (good, !90; poor, 80) comparisons of equivalency indicated no significant differences in symptoms and interference reporting between dyads (good ¼ 0.49, P >.05; and poor ¼ 0.3, P >.05) overall, but there was a tendency for higher report by caregivers if the patients had a poor KPS. CONCLUSIONS: Caregivers of PBT patients have similar assessments of symptom severity (highly congruent) with patient self-report regardless of NC function or KPS. These findings suggest that caregivers may serve as proxy report of symptoms for primary brain tumor patients.

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“…While palliative surgery poses some unique dilemmas within the larger scope of palliative care research, even these barriers can usually be overcome with well-constructed studies carried out by thoughtful research teams (12,13). Indeed, the methodological difficulties in palliative care research are all surmountable through existing techniques and appropriately careful scientific design (14). Communication that these hurdles can be surmounted remains a barrier to the implementation in palliative care settings.…”

Section: Dilemmas and Barriers To Palliative Care Researchmentioning

confidence: 99%

The International Conference on Malignant Bowel Obstruction: A Meeting of the Minds to Advance Palliative Care Research

Krouse

2007

Journal of Pain and Symptom Management

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There is a dearth of well-designed clinical research focusing on palliative care in cancer patients, especially those who are near the end of life. Reasons for this include ethical dilemmas in conducting such trials, communication barriers between specialties, and unclear standards for best care practices. To ensure that patients with incurable illnesses are offered the best available care, it is essential to develop and disseminate research methodologies well suited to this population. Given the multidimensional and culture-dependent nature of the end-of-life experience, it is necessary to adopt an interdisciplinary approach to developing research methods. As a means of initiating the process of palliative clinical research methodology development, malignant bowel obstruction (MBO) was used as a model to develop a research protocol. Although many treatment options for MBO have been proposed, existing literature offers little guidance with regard to algorithms for optimal management. To this end, an interdisciplinary summit of international leaders in quality-of-life research, ethno-cultural variability, palliative medicine, surgical oncology, gastroenterology, major consortium research, medical ethics, and patient advocacy/cancer survivors was convened in Pasadena, California, on November 12-13, 2004. Participants also represented the broad ethnic and racial perspectives required to develop culturally sensitive research methods. Consensus on methodological approaches was attained through vigorous debate. Using the conference-developed MBO model to implement trials will advance palliative care research. KeywordsPalliative care research; malignant bowel obstruction; quality of life; end of life care

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Practical Guidelines for Assessing the Clinical Significance of Health-Related Quality of Life Changes within Clinical Trials

Cited by 214 publications

References 20 publications

The impact of comorbidity on health-related quality of life in elderly patients with chronic myeloid leukemia

The impact of comorbidity on health-related quality of life in elderly patients with chronic myeloid leukemia

Congruence of primary brain tumor patient and caregiver symptom report

The International Conference on Malignant Bowel Obstruction: A Meeting of the Minds to Advance Palliative Care Research

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