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A Systematic Review of Psychometric Properties of Health-Related Quality-of-Life and Symptom Instruments in Adult Acute Leukemia Survivors

Bryant, Ashley Leak PhD, RN-BC, OCN; Walton, AnnMarie PhD, MPH, RN, OCN, CHES; Shaw-Kokot, Julia MSLS, RN, AHIP; Mayer, Deborah K. PhD, RN, AOCN, FAAN; Reeve, Bryce B. PhD

doi: 10.1097/NCC.0000000000000327
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Background: Acute leukemia represents 4% of cancer cases in the United States annually. There are more than 302 000 people living with acute and chronic leukemia in the United States. Treatment has been shown to have both positive and negative effects on health-related quality of life (HRQOL).

Objective: The aims of this study were to examine psychometric properties of symptom and HRQOL instruments and to provide implications for the assessment in adults with acute leukemia relevant to clinical practice and future research.

Methods: Systematic literature search was conducted from 1990 to 2014 using electronic databases and manual searches. Psychometric studies were considered eligible for inclusion if (1) the psychometric paper was published using at least 1 HRQOL or symptom instrument, and (2) adults with acute leukemia were included in the sample. Studies were excluded if the age groups were not adults, or if the instrument was in a language other than English.

Results: Review identified a total of 7 instruments (1 cancer generic HRQOL, 2 symptom related, 3 HRQOL combined with symptom questions, and 1 disease specific). The most commonly used instrument was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, followed by the Functional Assessment of Cancer Therapy–Fatigue.

Conclusions: An acute leukemia diagnosis can have a significant impact on HRQOL. Our recommendations include using both an HRQOL and symptom instrument to capture patient experiences during and after treatment.

Implications for Practice: The availability of comprehensive, valid, and reliable HRQOL and symptom instruments to capture the experiences of adults with acute leukemia during and after treatment is limited.

Author Affiliations: Lineberger Comprehensive Cancer Center (Drs Bryant, Walton, Mayer, and Reeve), School of Nursing (Drs Bryant, Walton, Mayer, and Reeve and Ms Shaw-Kokot), and Department of Health Policy and Management (Dr Reeve), The University of North Carolina at Chapel Hill.

Dr Reeve has a conflict of interest with Patient Reported Outcomes and Behavioral Evidence (PROBE) Advisory Board. The other authors have no conflicts of interest to disclose.

Support has been provided from the Cancer Care Quality Training Program Postdoctoral Fellowship (5R25CA116339) and NCI 5K12CA120780-07 (to A.L.B.) and Doctoral Scholarship in Cancer Nursing Renewal (DSCNR-13-276-03) from the American Cancer Society, the National Institute of Nursing Research of the National Institutes of Health under award no. T32NR013456, and the Jonas Nurse Leaders Scholar Program (A.W.).

Correspondence: Ashley Leak Bryant, PhD, RN-BC, OCN, School of Nursing, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27514 (Ashley_Bryant@unc.edu).

Accepted for publication October 6, 2015.

It is estimated that 54 270 individuals in the Unites States received a diagnosis of leukemia in 2015, and an estimated 24 450 will die of the disease.1 Of these new cases, 27 080 have acute lymphoblastic leukemia or acute myeloid leukemia, and 11 910 will die with the disease, with the remaining being chronic leukemias.1 Acute leukemia has a 5-year survival rate of 56% in the United States.2 Newly diagnosed acute leukemia is usually treated in a specialized care center with an average stay of 4 to 6 weeks. It is common for patients to have fluctuating symptoms associated with the disease and its treatment such as myelosuppression, stomatitis, and nausea throughout their hospitalization.3,4

There is the potential to advance acute leukemia science by systematically reviewing symptoms that occur, solely or concurrently, during and after treatment to determine how health-related quality of life (HRQOL) changes over time. It is important to understand patient-reported symptoms and HRQOL of adults with acute leukemia to better address their physical and psychosocial needs. In the study of Bryant et al,4 cancer-related fatigue (CRF), depression, and anxiety were found to be the most prominent symptoms that interfered with HRQOL and activities of daily living. In that review, we found that acute leukemia and its treatment have a significant impact in all quality-of-life (QOL) domains; we concluded that there was a need for future studies focused on longitudinal research and increased minority representation.4

One common way of assessing symptoms and HRQOL is through self-reported instruments, measuring the outcomes at 1 or more points. These instruments vary in the symptoms and HRQOL domains measured, the length of the questionnaire, the wording of questions and their response options, the reference or recall period, and the level of psychometric evidence in support of the validity and reliability of the measure.

The majority of the measures are not leukemia specific, except for the Functional Assessment of Cancer Therapy–Leukemia (FACT-Leu), which was recently developed in 2002.5

This review examined the psychometric properties of instruments used in acute leukemia research and provides clinical and research-relevant implications of symptom and HRQOL instruments used in adults with acute leukemia.

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Methods

Search Strategy

Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines,6 a systematic literature search was conducted by the first (A.L.B.) and third (J.S.-K.) authors. The search was completed in August 2014. The electronic databases PubMed, PsycINFO, EMBASE, CINAHL, and HAPI were searched using the following text words and their combinations: leukemia or leukaemia and each individual instrument included in this study. In a previous acute leukemia literature review conducted by Bryant et al,4 20 instruments were identified: Brief Fatigue Inventory (BFI), Center for Epidemiologic Studies Depression Scale, Distress Thermometer, Edmonton Symptom Assessment Scale, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), fatigue visual analog scale, FACT-Fatigue (FACT-F), FACT-General (FACT-G), FACT-Spiritual, Functional Living Index-Cancer, Geriatric Depression Scale, Hospital and Anxiety Scale, Life Ingredient Profile, Mental Adjustment to Cancer, the M. D. Anderson Symptom Inventory (MDASI), Psychosocial Adjustment to Illness Scale–Self-report, Perceived Quality of Life, Revised Piper Fatigue Scale, Schedule for the Evaluation of Individual Quality of Life, and Short-Form 36. Fifteen instruments were removed from the initial review of 20 instruments because of not being clearly defined as a symptom or HRQOL domain, lack of testing to determine psychometric properties, or the sample did not specifically include adults with acute leukemia. The 5 remaining instruments were BFI,7 FACT-F,8 FACT-G,9 MDASI,10 and EORTC QLQ-C30.11 Two additional instruments were added based on the search strategy: FACT-Anemia (FACT-An)8 and FACT-Leu.5 The final analysis included 7 instruments.

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Inclusion and Exclusion Criteria

Studies were considered eligible for inclusion if (1) the psychometric article was published using at least 1 HRQOL or symptom instrument, and (2) adults with acute leukemia were included in the sample. Studies were excluded if the age groups were not adults, or if the instrument was in a language other than English. Other exclusions included case reviews, summary reports, clinical reviews, and literature and systematic reviews.

A total of 1547 articles were identified through the 5 electronic databases and manual searches. Five hundred sixty-nine articles were duplicate articles; 324 focused on chronic leukemia, myelodysplastic syndrome, or hematopoietic stem cell transplant; 309 were about cancer survivors and not acute leukemia; and 290 did not meet the criteria and were removed after initial review. Fifty-five full-text articles were assessed for eligibility, and 10 of those were excluded because the studies used non-English instruments, 23 were review or case studies, and 11 focused on childhood cancers. Fourteen studies reported use of an HRQOL and/or symptom instrument7,12–23 (Figure). Seven instruments were identified based on inclusion criteria: (1) BFI7, (2) EORTC QLQ-C30,11 (3) FACT-An,8 (4) FACT-F,8 (5) FACT-G,9 (6) FACT-Leu,5 and (7) MDASI.10

Figure

Figure

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Data Extraction

Both generic and disease-specific HRQOL aspects of leukemia were identified in this review. In addition, the review also yielded symptom instruments that were either solely symptom focused or multidimensional with HRQOL domains. The psychometric properties, reliability and validity, of each instrument were extracted using the Scientific Advisory Committee of the Medical Outcomes Trust criteria.6 Reliability is “the degree of accuracy with which an instrument measures the attribute it is designed to measure,” and validity is the “degree to which an instrument is measuring what is it supposed to be measuring.”24

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Data Synthesis

The findings from the review are in narrative and table form. The different measures identified in this review and their complete description such as number of items, scoring, domains, scaling, reliability, validity, and numbers of studies are provided in Table 1. The number of items and measured domains of all instruments ranged from 10 to 47 and 5 to 15, respectively. Four instruments measured both symptom and HRQOL domains (FACT-An, FACT-F, FACT-Leu, and EORTC QLQ-C30). The 14 studies identified in the review are described in Table 2.

Table 1

Table 1

Table 2

Table 2

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Validated HRQOL Measures Used in Adults With Acute Leukemia

A total of 7 instruments (1 cancer generic HRQOL, 2 symptom related, 3 HRQOL combined with symptom questions, and 1 disease specific) were identified and included in this review. The cancer generic HRQOL instrument was the FACT-G.9 The 2 symptom-related instruments included the BFI7 and MDASI.10 The 3 HRQOL instruments with symptom questions included FACT-An,8 FACT-F,8 and EORTC QLQ-C30.11 The FACT-Leu was the only disease-specific instrument.5

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Description of Symptom and HRQOL Instruments and Their Psychometric Properties

The psychometric properties of the 14 studies and their use of symptom and HRQOL instruments are presented in the Table 2. The symptom measure with the highest number of items was MDASI.10 The most commonly used HRQOL measure was the EORTC QLQ-C30 measures (physical, role, social and emotional function, cognitive, financial impact, and global QOL).

The number of items and domains in the symptom instruments ranged from 1 to 13 and 1 to 6. The BFI recall period was in the “past 24 hours,”7 MDASI recall period was the “last 24 hours,”10 and FACT instruments were in the “last 7 days.”5,8,9 All the HRQOL instruments reviewed in this study report overall internal consistency reliability in the range of 0.54 to 0.96 and test-retest reliability ranging from 0.77 to 0.96. Content validity and convergent validity were reported for all measures.

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Description of Identified Studies

The 14 studies included in this review were of several types: one was a prospective, cross-sectional study; 2 were tool validation studies; 2 were prospective observational studies; 4 were exercise interventions; and 5 were prospective longitudinal studies. Ten of the studies included only patients with acute leukemia, 1 study included patients with acute and chronic leukemia, and the other 3 studies included patients of various cancer types (Table 2). Stage of cancer treatment was not included because of the variety of cancer types and treatments patients were undergoing. The average number of patients in each of these studies was 104 (range, 10–595). All studies were published between 1998 and 2012.

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Discussion

This study reviewed the published psychometric literature and described 7 instruments that measured symptoms or HRQOL in adults with acute leukemia. There is no universally accepted definition of QOL/HRQOL, but various organizations and researchers have defined it as multidimensional in nature. In 2005, the World Health Organization25 defined QOL as “an individual’s perception of their position in life, in the context of the culture and value systems in their life, and in relation to their goals, expectations, standards, and concerns.”25 Cella’s26 definition of HRQOL refers to the extent to which one’s usual or expected physical, emotional, and social well-being is affected by a medical condition or its treatment, whereas Ferrell and colleagues’ QOL framework27 includes physical, psychological, social, and spiritual domains. Consideration of these QOL domains is necessary in understanding the impact of an acute leukemia treatment and the long-term and late effects that accompany this diagnosis.

While using the Scientific Advisory Committee of the Medical Outcomes Trust guidelines,28 we assessed the HRQOL instruments using the attributes and criteria that focus on reliability, validity, and cultural and language adaptations. We did assess cultural and language adaptations and noted many of these instruments had been translated and adapted in several languages. One challenge faced by researchers and clinicians is use of reliable and valid measures during and after treatment that are responsive to clinical changes. Measures that can capture change over time (ie, an instrument’s “responsiveness” to change) are ideal and allows for comparisons between time points. There are 2 types of HRQOL measures used in this analysis. First, the generic cancer HRQOL measure, FACT-G, is able to measure these domains across different cancers. Few instruments are available that measure HRQOL domains specific to acute leukemia survivors, with 1 exception, the FACT-Leu. Surprisingly, the FACT-F measure was used more often in these studies than FACT-G or FACT-Leu. This may be associated with emerging data on the impact that CRF has on adults with acute leukemia during inpatient treatment12–15,17,29,30 and CRF being a persistent symptom dand CRF being a persistent symptom during and after treatment.3,4,31 The FACT-G and EORTC QLQ-C30 have been validated in a number of cancer groups with a variety of translations, compared with the FACT-Leu, which was only recently developed and validated.

Limitations of this review include focus on adults with acute leukemia without searching gray literature for additional studies such as dissertation abstracts and letters to the editors. We did not focus on chronic leukemias or other hematologic cancers, which limits our generalizability to other cancers. However, a systematic methodological approach using PRISMA was a strength of this review.

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Conclusions

Acute leukemia researchers, clinicians, and oncology nurses need to have comprehensive data to explore clinical changes in their patients’ symptom or HRQOL responses. Oncology nurses are at the frontline of caring for these patients, and it is essential for them to be aware of instruments and tools used in acute leukemia research. Their use of these instruments will allow for early recognition and identification of common symptoms and/or HRQOL changes in these adults. There are certain domains of HRQOL that may be more prominent in acute leukemia survivors, such as increased symptoms and decreased functionality.4 To the authors’ knowledge, this is the first review to explore the psychometric properties of instruments used with the acute leukemia adult population.

Our recommendations for clinical use and research are based on this review including using both an HRQOL and symptom instrument to capture patient experiences during and after treatment. There are sound, reliable instruments that have been used in this population, and we believe there are instruments that could adequately measure the patient’s symptom and HRQOL experience throughout their illness trajectory. However, we question if these measures will be relevant over time with longer-term survivors. The majority of measures have been tested in patients within 2 years of treatment; researchers lack data to support use of these measures in longer-term survivors (≥5 years). Survivorship needs of these patients may need to be re-evaluated after 2 years because the late and long-term effects may differ in each cancer population.

The HRQOL instruments vary in domains, but the FACT-Leu has both general and specific leukemia questions. None of the current studies identified used PROMIS (Patient-Reported Outcomes Measurement Information System), a promising new system designed to validly and reliably measure HRQOL domains in multiple populations; however, no studies to date have examined the psychometric properties of PROMIS measures in acute adult leukemia. This review provides an overall synopsis of previous symptom and HRQOL literature in the acute leukemia population.

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References

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Keywords:

Acute leukemia; Acute leukemia survivors; Cancer-related fatigue; Health-related quality of life; Instruments; Psychometrics; Symptoms

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