Pamela S. Hinds

ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research

PurposeAn essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative’s goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER.MethodsWe performed a literature review to find existing guidelines for the selection of PRO measures. We also conducted an online survey of the International Society for Quality of Life Research (ISOQOL) membership to solicit input on PRO standards. A standard was designated as “recommended” when >50xa0% respondents endorsed it as “required as a minimum standard.”ResultsThe literature review identified 387 articles. Survey response rate was 120 of 506 ISOQOL members. The respondents had an average of 15xa0years experience in PRO research, and 89xa0% felt competent or very competent providing feedback. Final recommendations for PRO measure standards included: documentation of the conceptual and measurement model; evidence for reliability, validity (content validity, construct validity, responsiveness); interpretability of scores; quality translation, and acceptable patient and investigator burden.ConclusionThe development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.

Sleep wake disturbances in people with cancer and their caregivers: state of the science.

PURPOSE/OBJECTIVESnTo review the state of the science on sleep/wake disturbances in people with cancer and their caregivers.nnnDATA SOURCESnPublished articles, books and book chapters, conference proceedings, and MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, PsycINFO, and the Cochrane Library computerized databases.nnnDATA SYNTHESISnScientists have initiated studies on the prevalence of sleep/wake disturbances and the etiology of sleep disturbances specific to cancer. Measurement has been limited by lack of clear definitions of sleep/wake variables, use of a variety of instruments, and inconsistent reporting of sleep parameters. Findings related to use of nonpharmacologic interventions were limited to 20 studies, and the quality of the evidence remains poor. Few pharmacologic approaches have been studied, and evidence for use of herbal and complementary supplements is almost nonexistent.nnnCONCLUSIONSnCurrent knowledge indicates that sleep/wake disturbances are prevalent in cancer populations. Few instruments have been validated in this population. Nonpharmacologic interventions show positive outcomes, but design issues and small samples limit generalizability. Little is known regarding use of pharmacologic and herbal and complementary supplements and potential adverse outcomes or interactions with cancer therapies.nnnIMPLICATIONS FOR NURSINGnAll patients and caregivers need initial and ongoing screening for sleep/wake disturbances. When disturbed sleep/wakefulness is evident, further assessment and treatment are warranted. Nursing educational programs should include content regarding healthy and disrupted sleep/wake patterns. Research on sleep/wake disturbances in people with cancer should have high priority.

PROMIS Pediatric Measures in Pediatric Oncology: Valid and Clinically Feasible Indicators of Patient-Reported Outcomes

Establishing the ability of children and adolescents with cancer to complete the NIH‐sponsored PROMIS pediatric measures electronically and the preliminary validity estimates of the measures (both full item banks and short forms) in pediatric oncology will contribute to our knowledge of the impact of cancer treatment on these young patients.

PROMIS® pediatric self-report scales distinguish subgroups of children within and across six common pediatric chronic health conditions

PurposeTo conduct a comparative analysis of eight pediatric self-report scales for ages 8–17xa0years from the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS®) in six pediatric chronic health conditions, using indicators of disease severity.MethodsPediatric patients (Nxa0=xa01454) with asthma, cancer, chronic kidney disease, obesity, rheumatic disease, and sickle cell disease completed items from the PROMIS pediatric mobility, upper extremity functioning, depressive symptoms, anxiety, anger, peer relationships, pain interference, and fatigue self-report scales. Comparisons within the six pediatric chronic health conditions were conducted by examining differences in groups based on the disease severity using markers of severity that were specific to characteristics of each disease. A comparison was also made across diseases between children who had been recently hospitalized and those who had not.ResultsIn general, there were differences in self-reported health outcomes within each chronic health condition, with patients who had higher disease severity showing worse outcomes. Across health conditions, when children with recent hospitalizations were compared with those who had not been hospitalized in the past 6xa0months, we found significant differences in the expected directions for all PROMIS domains, except anger.ConclusionsPROMIS measures discriminate between different clinically meaningful subgroups within several chronic illnesses. Further research is needed to determine the responsiveness of the PROMIS pediatric scales to change over time.

Good-Parent Beliefs of Parents of Seriously Ill Children

IMPORTANCEnParents beliefs about what they need to do to be a good parent when their children are seriously ill influence their medical decisions, and better understanding of these beliefs may improve decision support.nnnOBJECTIVEnTo assess parents perceptions regarding the relative importance of 12 good-parent attributes.nnnDESIGN, SETTING, AND PARTICIPANTSnA cross-sectional, discrete-choice experiment was conducted at a childrens hospital. Participants included 200 parents of children with serious illness.nnnMAIN OUTCOMES AND MEASURESnRatings of 12 good-parent attributes, with subsequent use of latent class analysis to identify groups of parents with similar ratings of attributes, and ascertainment of whether membership in a particular group was associated with demographic or clinical characteristics.nnnRESULTSnThe highest-ranked good-parent attribute was making sure that my child feels loved, followed by focusing on my childs health, making informed medical care decisions, and advocating for my child with medical staff. We identified 4 groups of parents with similar patterns of good-parent-attribute ratings, which we labeled as: child feels loved (n=68), childs health (n=56), advocacy and informed (n=55), and spiritual well-being (n=21). Compared with the other groups, the childs health group reported more financial difficulties, was less educated, and had a higher proportion of children with new complex, chronic conditions.nnnCONCLUSIONS AND RELEVANCEnParents endorse a broad range of beliefs that represent what they perceive they should do to be a good parent for their seriously ill child. Common patterns of how parents prioritize these attributes exist, suggesting future research to better understand the origins and development of good-parent beliefs among these parents. More important, engaging parents individually regarding what they perceive to be the core duties they must fulfill to be a good parent may enable more customized and effective decision support.

Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method

AbstractObjectivenTo assess minimally important differences (MIDs) for several pediatric self-report item banks from the National Institutes of Health Patient-Reported Outcomes Measurement Information System® (PROMIS®).MethodsWe presented vignettes comprising sets of two completed PROMIS questionnaires and asked judges to declare whether the individual completing those questionnaires had an important change or not. We enrolled judges (including adolescents, parents, and clinicians) who responded to 24 vignettes (six for each domain of depression, pain interference, fatigue, and mobility). We used item response theory to model responses to the vignettes across different judges and estimated MID as the point at which 50xa0% of the judges would declare an important change.ResultsWe enrolled 246 judges (78 adolescents, 85 parents, and 83 clinicians). The MID estimated with clinician data was about 2 points on the PROMIS T-score scale, and the MID estimated with adolescent and parent data was about 3 points on that same scale.ConclusionsThe MIDs enhance the value of PROMIS pediatric measures in clinical research studies to identify meaningful changes in health status over time.

Palliative Care as a Standard of Care in Pediatric Oncology.

The study team conducted a systematic review of pediatric and adolescent palliative cancer care literature from 1995 to 2015 using four databases to inform development of a palliative care psychosocial standard. A total of 209 papers were reviewed with inclusion of 73 papers for final synthesis. Revealed topics of urgent consideration include the following: symptom assessment and intervention, direct patient report, effective communication, and shared decision‐making. Standardization of palliative care assessments and interventions in pediatric oncology has the potential to foster improved quality of care across the cancer trajectory for children and adolescents with cancer and their family members. Pediatr Blood Cancer

Risk factors for smoking among adolescent survivors of childhood cancer: A report from the childhood cancer survivor study.

Few studies have examined risk factors for smoking among adolescent survivors of childhood cancer. The present study reports on the rate of smoking and identifies factors associated with smoking in a sample of adolescent survivors from the Childhood Cancer Survivor Study (CCSS).

Neuropathic pain during treatment for childhood acute lymphoblastic leukemia

Improved cure rates for childhood acute lymphoblastic leukemia (ALL) over the past 2 decades have allowed greater attention to patients quality of life. Neuropathic pain (NP) is an unpleasant side effect of chemotherapeutic agents for leukemia, especially vincristine.

Psychometric and Clinical Assessment of the 10-Item Reduced Version of the Fatigue Scale—Child Instrument

Fatigue is one of the most debilitating conditions associated with cancer and anticancer therapy. The lack of reliable and valid self-report instruments has prevented accurate assessment of fatigue in pediatric oncology patients. The purpose of this study was to identify the most sensitive and specific score, that is, the cut score, on the Fatigue Scale-Child (FS-C) to identify those children with high cancer-related fatigue in need of clinical intervention. We first used Rasch methods to identify the items on the FS-C that distinguished children with high cancer-related fatigue from other children; our findings indicated that the FS-C needed to be reduced from 14 items to 10 items. We then assessed the 10-item FS-C for its psychometric properties and applied the receiver operating characteristics curve analysis to the FS-C responses from 221 children (aged 7-12 years) receiving anticancer treatment. The cut score identified with 75% sensitivity and 73.5% specificity was 12; 73 (33%) patients scored 12 or higher. Findings from this validated instrument provide a needed guide for clinicians to interpret fatigue scores and provide clinical interventions for this debilitating condition to their pediatric patients with cancer.