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Purpose: Financial hardship as a result of cancer treatment can have a significant and lasting negative impact on adolescents and young adults (AYAs) and their families. To address a lack of developmentally informed and psychometrically sound measures of financial hardship for AYAs and their caregivers, we used rigorous measurement development methods recommended by the National Institutes of Health's Patient-Reported Outcomes Measurement Information System® (PROMIS®) to determine comprehensibility and relevance of measure content. Methods: Our multi-step approach involved item identification, refinement, and generation; translatability and reading level review; and cognitive interviews. A purposive sample of 25 AYAs and 10 caregivers participated, ensuring representation across age, education, gender, race/ethnicity, and cancer type. Results: Fifty patient-reported and caregiver-reported items were developed across material, psychosocial, and behavioral subdomains of financial hardship. Translatability and reading level reviews resulted in 22 patient-reported and 25 caregiver-reported items being rewritten. Eighty-eight percent of patients and all caregivers described the items as easy to answer. Younger AYAs (15 to 25 years of age) were more likely to say the items were less relevant for them. Forty-six patient-reported and 48 caregiver-reported items were recommended for further testing. Conclusion: This study is the first to use in-depth qualitative methods to center AYA patient and caregiver experiences in the creation of new measures of financial hardship. Data support the comprehensibility and content validity of these preliminary item banks. Future large-scale, quantitative testing will lead to additional refinements and support the use of short forms and computer-adaptive testing for a diverse sample of AYAs and their caregivers.
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PURPOSE: The Functional Assessment of Cancer Therapy item (FACT-GP5) has the potential to provide an understanding of global treatment tolerability from the patient perspective. Longitudinal evaluations of the FACT-GP5 and challenges posed by data missing-not-at-random (MNAR) have not been explored. Robustness of the FACT-GP5 to missing data assumptions and the responsiveness of the FACT-GP5 to key side-effects are evaluated. METHODS: In a randomized, double-blind study (NCT00065325), postmenopausal women (n = 618) with hormone receptor-positive (HR+), advanced breast cancer received either fulvestrant or exemestane and completed FACT measures monthly for seven months. Cumulative link mixed models (CLMM) were fit to evaluate: (1) the trajectory of the FACT-GP5 and (2) the responsiveness of the FACT-GP5 to CTCAE grade, Eastern Cooperative Oncology Group (ECOG) Performance Status scale, and key side-effects from the FACT. Sensitivity analyses of the missing-at-random (MAR) assumption were conducted. RESULTS: Odds of reporting worse side-effect bother increased over time. There were positive within-person relationships between level of side-effect bother (FACT-GP5) and severity of other FACT items, as well as ECOG performance status and Common Terminology Criteria for Adverse Events (CTCAE) grade. The number of missing FACT-GP5 assessments impacted the trajectory of the FACT-GP5 but did not impact the relationships between the FACT-GP5 and other items (except for nausea [FACT-GP2]). CONCLUSIONS: Results support the responsiveness of the FACT-GP5. Generally speaking, the responsiveness of the FACT-GP5 is robust to missing assessments. Missingness should be considered, however, when evaluating change over time of the FACT-GP5. TRIAL REGISTRATION: NCT00065325. TRIAL REGISTRATION YEAR: 2003.
Researchers have been exploring the use of a single question, FACT-GP5 ("I am bothered by side effects of treatment"), as a quick way to learn about drug tolerability from the patients' perspective. This study explores if this single question can capture changes in tolerability during treatment, and if the assessment is missed by patients, whether that impacts the interpretation of tolerability. In our study, we found that the FACT-GP5 can be used to understand how tolerability changes during treatment. Missing assessments of the FACT-GP5 are important to account for when interpreting results. The FACT-GP5 may be a useful question for capturing the patient experience of drug tolerability.
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AIMS: Caregivers rate improved communication ability as one of the most desired outcomes for successful interventions for individuals with Angelman syndrome (AS). When measuring communication ability in clinical trials, the reliability of such measures is critical for detecting significant changes over time. This study examined the reliability of the Observed-Reported Communication Ability (ORCA) measure completed by caregivers of individuals with AS. METHODS: The ORCA measure was completed by 249 caregivers with 170 caregivers completing the ORCA measure again after 5-12 days. Generalizability theory was used to examine the following sources of measurement error in ORCA scores: concepts, subdomains, assessment points, and the interactions among those facets and the object of measurement: communication ability. Three generalizability studies were conducted to understand the reliability of the ORCA measure for different measurement designs. Decision studies were carried out to demonstrate the optimization of measurement procedures of the ORCA measure. RESULTS: G and Phi coefficients of the original measurement design exceeded the 0.80 threshold considered sufficiently reliable to make relative and absolute decisions about the communication ability of individuals with AS based on their caregivers' observed scores. The optimization procedures indicated that increasing the number of communication concepts and/or assessment points leads to more reliable estimates of communication. CONCLUSION: The ORCA measure was able to reliably distinguish different levels of communication ability among individuals with AS. Multiple assessment points and or more concepts would provide more precise estimates of an individual's communication ability but at the cost of survey fatigue.
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Síndrome de Angelman , Cuidadores , Comunicação , Humanos , Síndrome de Angelman/diagnóstico , Cuidadores/psicologia , Reprodutibilidade dos Testes , Masculino , Feminino , Criança , Adulto , Adolescente , Pré-Escolar , Psicometria/métodos , Inquéritos e Questionários , Adulto JovemRESUMO
ABSTRACT: Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.
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PURPOSE: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S. Food & Drug Administration's definition of clinical benefit includes how patients feel, function, or survive. Patients are considered the experts in describing how they feel and function. In cancer trials, patient-reported measures of physical function provide insight into how patients function at baseline, benefit from the interventions being studied, and the impact of treatment side effects. We conducted a qualitative study with adults diagnosed with cancer to describe facets of physical function from their perspective and to identify which facets are most important to this patient population. METHODS: Using concept elicitation and cognitive interviewing techniques, we conducted semi-structured interviews with 72 adults ≥ 22 years of age with cancer who received treatment with an anticancer drug or biologic within six months of the interview. We selected participants using purposive sampling with the aim to elicit diverse experiences regarding how they may interpret and respond to questions related to physical function. Participants were presented with patient-reported outcome (PRO) items representative of PRO measures used in cancer and general populations. RESULTS: Five facets of how physical function relates to activities were defined from the patient perspective: ability, difficulty, limitation, satisfaction, and completion. More than half of the participants indicated that ability was the most important facet of physical function. The next most important were satisfaction (18.3%), limitation (14.1%), difficulty (5.6%), and completion (2.8%). CONCLUSION: This study demonstrates that we must be more specific about the facets of physical function that we set out to assess when we use PRO measures to describe the patient experience. These results have implications for the specificity of physical function facets when measured in cancer clinical trials.
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Neoplasias , Pesquisa Qualitativa , Humanos , Neoplasias/psicologia , Neoplasias/tratamento farmacológico , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Idoso , Medidas de Resultados Relatados pelo Paciente , Entrevistas como Assunto , Qualidade de Vida , Atividades Cotidianas , Idoso de 80 Anos ou maisRESUMO
PURPOSE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure. METHODS: As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a "card sort" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item. RESULTS: The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation. CONCLUSION: Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.
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Técnica Delphi , Neoplasias , Medidas de Resultados Relatados pelo Paciente , Humanos , Neoplasias/psicologia , Qualidade de Vida , Oncologia , Desempenho Físico Funcional , Inquéritos e QuestionáriosRESUMO
PURPOSE: Emotional and functional well-being (EWB and FWB) are important components of mental health and quality of life. This study aims to evaluate long-term EWB and FWB in breast cancer (BC) survivors. METHODS: The Carolina Breast Cancer Study Phase 3 oversampled Black and younger (< 50 years in age) women so that they each represent approximately 50% of the study population and assessed participants' EWB and FWB with the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 5- (baseline), 25-, and 84-months post diagnosis. Multinomial logit models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between demographic and clinical characteristics and well-being change relative to baseline. RESULTS: Among 2,781 participants with BC, average EWB and FWB improved with time since diagnosis. Persistent FWB decrements were associated with Black race [OR 1.4 (95% CI 1.2-1.7) and 1.3 (95% CI 1.1-1.6), at 25-months and 84-months respectively], older age [OR 1.4 (95% CI 1.1-1.7) and 1.5 (95% CI 1.2-1.8), respectively], no chemotherapy, and recurrence [OR 2.9 (95% CI 1.8-4.8) and 3.1 (95% CI 2.1-4.6), respectively]. EWB decrements were associated with advanced stage and recurrence. Decrements in combined (FWB+EWB) well-being were associated with recurrence at both follow-up survey timepoints [ORs 4.7 (95% CI 2.7-8.0) and 4.3 (95% CI 2.8-6.6), respectively]. CONCLUSIONS: Long-term well-being varies by demographics and clinical features, with Black women and women with aggressive disease at greatest risk of long-term decrements.
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Neoplasias da Mama , Sobreviventes de Câncer , Qualidade de Vida , Humanos , Feminino , Neoplasias da Mama/psicologia , Pessoa de Meia-Idade , Sobreviventes de Câncer/psicologia , Sobreviventes de Câncer/estatística & dados numéricos , Adulto , Emoções , Sobrevivência , Idoso , Saúde MentalRESUMO
PURPOSE: Our purpose was to describe the prevalence and predictors of symptom and function clusters related to physical, emotional, and social components of general health-related quality of life (HRQOL) in a population-based sample of prostate cancer (PCa) survivors. METHODS: Participants (N = 1,162) completed a baseline survey at a median of 9 months after diagnosis to ascertain the co-occurrence of eight symptom and functional domains that are common across all cancers and not treatment-specific. We used latent profile analysis (LPA) to identify subgroup profiles of survivors with low, moderate, or high HRQOL levels. Multinomial logistic regression models were used to identify clinical and sociodemographic factors associated with survivors' membership in the low versus moderate or high HRQOL profile. RESULTS: The LPA identified 16% of survivors who were categorized in the low HRQOL profile at baseline, indicative of the highest symptom burden and lowest functioning. Factors related to survivors' membership in the low versus higher HRQOL profile groups included less than age 65 years at diagnosis, identifying as non-Hispanic Black race, not working, being a former versus never smoker, systemic therapy, less companionship, more comorbidities, lower health care financial well-being, or less spirituality. Several factors remained associated with remaining in the low versus higher HRQOL profiles on the follow-up survey (n = 699), including younger age, Black race, comorbidity, and lower financial and spiritual well-being. CONCLUSION: About one of six PCa survivors experienced elevated physical and psychosocial symptoms that were independent of local curative therapy, but with younger age, race, comorbidity, and lower financial and spiritual well-being as stable risk factors for poor HRQOL over time.
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Sobreviventes de Câncer , Neoplasias da Próstata , Qualidade de Vida , Humanos , Masculino , Neoplasias da Próstata/psicologia , Neoplasias da Próstata/epidemiologia , Neoplasias da Próstata/terapia , Sobreviventes de Câncer/psicologia , Idoso , Pessoa de Meia-IdadeRESUMO
INTRODUCTION: As the older adult population increases, hospitals treat more older adults with injuries. After leaving, these patients suffer from decreased mobility and independence, relying on care from others. Family members often assume this responsibility, mostly informally and unpaid. Caregivers of other older adult populations have increased stress and decreased caregiver-related quality of life (CRQoL). Validated CRQoL measures are essential to capture their unique experiences. Our objective was to review existing CRQoL measures and their validity in caregivers of older adult trauma patients. METHODS: A professional librarian searched published literature from the inception of databases through August 12, 2022 in MEDLINE (via PubMed), Embase (via Elsevier), and CINAHL Complete (via EBSCO). We identified 1063 unique studies of CRQoL in caregivers for adults with injury and performed a systematic review following COnsensus-based Standards for the selection of health Measurement Instruments guidelines for CRQoL measures. RESULTS: From the 66 studies included, we identified 54 health-related quality-of-life measures and 60 domains capturing caregiver-centered concerns. The majority (83%) of measures included six or fewer CRQoL content domains. Six measures were used in caregivers of older adults with single-system injuries. There were no validated CRQoL measures among caregivers of older adult trauma patients with multisystem injuries. CONCLUSIONS: While many measures exist to assess healthcare-related quality of life, few, if any, adequately assess concerns among caregivers of older adult trauma patients. We found that CRQoL domains, including mental health, emotional health, social functioning, and relationships, are most commonly assessed among caregivers. Future measures should focus on reliability and validity in this specific population to guide interventions.
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Cuidadores , Qualidade de Vida , Ferimentos e Lesões , Humanos , Cuidadores/psicologia , Ferimentos e Lesões/psicologia , Ferimentos e Lesões/terapia , IdosoRESUMO
PURPOSE: We describe development of a short health-related quality of life measure, the patient-reported outcomes measurement information system® (PROMIS®)-16 Profile, which generates domain-specific scores for physical function, ability to participate in social roles and activities, anxiety, depression, sleep disturbance, pain interference, cognitive function, and fatigue. METHODS: An empirical evaluation of 50 candidate PROMIS items and item pairs was conducted using data from a sample of 5775 respondents from Amazon's Mechanical Turk (MTurk). Results and item response theory information curves for a subset of item pairs were presented and discussed in a stakeholder meeting to narrow the candidate item sets. A survey of the stakeholders and 124 MTurk adults was conducted to solicit preferences among remaining candidate items and finalize the measure. RESULTS: Empirical evaluation showed minimal differences in basic descriptive statistics (e.g., means, correlations) and associations with the PROMIS-29 + 2 Profile, thus item pairs were further considered primarily based on item properties and content. Stakeholders discussed and identified subsets of candidate item pairs for six domains, and final item pairs were agreed upon for two domains. Final items were selected based on stakeholder and MTurk-respondent preferences. The PROMIS-16 profile generates eight domain scores with strong psychometric properties. CONCLUSION: The PROMIS-16 Profile provides an attractive brief measure of eight distinct domains of health-related quality of life, representing an ideal screening tool for clinical care, which can help clinicians quickly identify distinct areas of concern that may require further assessment and follow-up. Further research is needed to confirm and extend these findings.
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BACKGROUND: Adolescents and young adults (AYAs) with cancer, defined as individuals aged 15-39 years at initial cancer diagnosis, form a unique population; they face age-specific issues as they transition to adulthood. This paper presents the protocol for the development of a core outcome set (COS) for AYAs with cancer. METHODS: The methodological standards from the Core Outcome Measures in Effectiveness Trials (COMET) and the International Consortium for Health Outcomes Measurement (ICHOM) for COS development will guide the development of the COS for AYAs with cancer. The project will consist of the following phases: (1) define the scope of the COS; (2) establish the need for a COS in this field (3) assemble an international, multi-stakeholder working group; (4) develop a detailed protocol; (5) determine "what to measure" (i.e., outcomes); (6) determine "how to measure" (i.e., measures); and (7) determine "case-mix" variables. CONCLUSIONS: The development of a COS for AYAs with cancer will facilitate the implementation of efficient and relevant standards for data collection, both for clinical trials and in routine healthcare, thereby increasing the usefulness of these data to improve the value of the care given to these underserved young cancer patients.
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Instalações de Saúde , Neoplasias , Humanos , Adolescente , Adulto Jovem , Coleta de Dados , Neoplasias/diagnóstico , Neoplasias/terapia , Populações VulneráveisRESUMO
OBJECTIVE: Describe clinicians' perspectives of facilitators and barriers to eliciting physical function goals from patients with multiple chronic conditions pre- and post-surgery. METHODS: Semi-structured qualitative interviews were conducted with clinicians, recruited from an academic medical center, who treat adult patients with multiple chronic conditions. Purposive sampling ensured multiple provider types were represented. Interviews were conducted in person or via web conference and were audio recorded. Findings were summarized using descriptive qualitative content analysis. RESULTS: Of the 12 participating clinicians, 92% were female and 83% specialized in geriatrics. Clinicians had a mean of 10.7 (min-max: 1-30) years of experience. Key facilitators to goal-setting conversations were sufficient time, familial support, and patient cognitive ability. Barriers included lack of time, lack of training, patient challenges in choosing realistic and specific actionable goals, emotional barriers, and cognitive challenges. CONCLUSION: Some facilitators and barriers are modifiable, including time, inclusion of family members in the clinical encounter, and clinician training to enable actionable goal setting. These results highlight areas for intervention to facilitate goal elicitation for physical function in clinical care settings. PRACTICE IMPLICATIONS: Clinicians should be aware of the barriers impacting eliciting goals. Healthcare organizations could consider providing effective goal elicitation training and tools to facilitate goal setting conversation.
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Objetivos , Múltiplas Afecções Crônicas , Adulto , Humanos , Feminino , Masculino , Pesquisa Qualitativa , Comunicação , Cuidados PaliativosRESUMO
Area-level socioeconomic status (SES) impacts cancer outcomes, such as stage at diagnosis, treatments received, and mortality. However, less is known about the relationship between area-level SES and health-related quality of life (HRQOL) for cancer survivors. To assess the additive value of area-level SES data and the relative contribution of area- and individual-level SES for estimating cancer survivors' HRQOL, we conducted a secondary analysis of data from a population-based survey study of cancer survivors (the Measuring Your Health [MY-Health] Study). Multilevel multinomial logistic regression models were used to examine the relationships between individual-level SES, area-level SES as measured by the Centers for Disease Control and Prevention's Social Vulnerability Index, and HRQOL group membership (high, average, low, or very low HRQOL). Area-level SES did not significantly increase model estimation accuracy compared to models using only individual-level SES. However, area-level SES could be an appropriate proxy when the individual-level SES is missing.
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Sobreviventes de Câncer , Neoplasias , Estados Unidos , Humanos , Qualidade de Vida , Classe Social , Inquéritos e Questionários , Neoplasias/epidemiologia , Neoplasias/terapiaRESUMO
BACKGROUND: Online administration of surveys has a number of advantages but can also lead to increased exposure to bad actors (human and non-human bots) who can try to influence the study results or to benefit financially from the survey. We analyze data collected through an online discrete-choice experiment (DCE) survey to evaluate the likelihood that bad actors can affect the quality of the data collected. METHODS: We developed and fielded a survey instrument that included two sets of DCE questions asking respondents to select their preferred treatments for multiple myeloma therapies. The survey also included questions to assess respondents' attention while completing the survey and their understanding of the DCE questions. We used a latent-class model to identify a class associated with perverse preferences or high model variance, and the degree to which the quality checks included in the survey were correlated with class membership. Class-membership probabilities for the problematic class were used as weights in a random-parameters logit to recover population-level estimates that minimizes exposure to potential bad actors. RESULTS: Results show a significant proportion of respondents provided answers with a high degree of variability consistent with responses from bad actors. We also found that a wide-ranging selection of conditions in the survey screener is more consistent with choice patterns expected from bad actors looking to qualify for the study. The relationship between the number of incorrect answers to comprehension questions and problematic choice patterns peaked around 5 out of 10 questions. CONCLUSIONS: Our results highlight the need for a robust discussion around the appropriate way to handle bad actors in online preference surveys. While exclusion of survey respondents must be avoided under most circumstances, the impact of "bots" on preference estimates can be significant.
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Comportamento de Escolha , Preferência do Paciente , Inquéritos e Questionários , ProbabilidadeRESUMO
BACKGROUND: High-quality communication in pediatric and adolescent cancer is the standard of care. Yet, we lack pediatric-specific communication measures. We designed self-report and caregiver-report communication measures for use in pediatric oncology settings. METHODS: We recruited adolescent and young adults (AYAs; 12-24 years) with cancer and parents of children and AYAs between 1 month post-diagnosis and 2 months after completing treatment. Participants completed measures including 58 questions addressing eight previously characterized communication functions. For each function, we conducted factor analysis, and assessed reliability and construct validity. Based on psychometric properties, we created final long-form (31 items) and short-form (eight items) communication measures (PedCOM) for both self- and caregiver-report. RESULTS: Participants included 200 parents and 88 AYAs. The final 31-item and eight-item PedCOM measures for parents and AYAs demonstrated good unidimensional model fit. Each communication function (e.g., building relationships) demonstrated high reliability, coefficient alphas ranged from .83 to .93 for parents and .85 to .93 for AYAs. The overall 31-item and eight-item PedCOM measures also demonstrated high reliability (alphas >.9). For construct validity, PedCOM-Parent-31 and PedCOM-Parent-8 correlated positively with satisfaction with care, trust, emotional self-management, and decisional satisfaction, and negatively with anxiety and caregiver burden. PedCOM-AYA-31 and PedCOM-AYA-8 correlated positively with satisfaction with care, trust, emotional self-management, symptoms self-management, and decisional satisfaction, and negatively with anxiety. DISCUSSION: We developed valid and reliable measures of communication functions for parents and AYAs with cancer. These measures can support organizations and stakeholder groups that are striving to improve the quality of cancer care.
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PURPOSE: The study goal was to validate the Observer-Reported Communication Ability (ORCA) measure for use with females with Rett Syndrome (RTT). METHODS: Qualitative interviews, including concept elicitation and cognitive interviewing methods, were conducted with 19 caregivers of individuals with RTT ages 2 and older. A quantitative study was then conducted in 279 caregivers to evaluate construct validity and reliability. RESULTS: After minor modifications were made, the modified ORCA measure was well understood and captured key communication concepts. Quantitative data showed evidence for reliable scores (α = 0.90, test-retest intraclass correlation = 0.88), minimal floor and no ceiling effects, and strong correlation with the Communication and Symbolic Behaviors Scale (r = 0.73). CONCLUSIONS: This study provided initial support that the modified ORCA measure is an acceptable caregiver-reported measure of communication ability for females with RTT. Future work should include evaluation of longitudinal validity of the measure and its associations with clinician- and performance-based measures in diverse samples.
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Síndrome de Rett , Feminino , Humanos , Síndrome de Rett/diagnóstico , Reprodutibilidade dos Testes , Cuidadores/psicologia , Índice de Gravidade de DoençaRESUMO
Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation period (SCSeval) before permanent implantation. We present real-world data from 7,000 patients who underwent SCSeval while utilizing a mobile digital health platform for education, feedback, and outcomes collection during their surgical journey. We analyzed preoperative patient demographics, characterized patient pain profiles using the patient-reported outcomes measurement information system-29 surveys, and calculated the rates of conversion from temporary to permanent spinal cord stimulation (SCS) implantation. Between August 1, 2021, and March 2, 2023, 7,000 patients (mean age 59.1, 59.6% female) underwent SCSeval procedures while utilizing a mobile application. Patients commonly experienced aching, sharp, stabbing, tingling, numb, and burning pain. Patients had tried multiple prior therapies and wanted to reduce their use of opioids and pain medications. Overall, 90.1% of the patients had a successful SCSeval, and 80.4% of those converted to permanent implant, with the highest rates among those who underwent SCSeval in a hospital setting. There was a significant improvement in all domains of pain as evaluated by pre and postoperative patient-reported outcomes measurement information system-29 surveys. This study supports the use of digital health technology as part of the SCS journey to improve the patient experience and allow for robust patient-reported outcomes collection. The overall rate of SCSeval to permanent SCS in our study of 72.4% was higher than national rates of 64%, suggesting that an app may allow clinicians to better quantify changes in chronic pain and provide more insight into choosing to implant SCS permanently. PERSPECTIVE: This article presents real-world evidence from a digital health platform for therapy education and outcomes collection from patients undergoing spinal cord stimulation evaluation procedures. Such tools could allow for better pain characterization and allow for more nuanced tracking of patient outcomes among those with chronic pain.
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Dor Crônica , Estimulação da Medula Espinal , Humanos , Feminino , Masculino , Dor Crônica/terapia , Estimulação da Medula Espinal/métodos , Resultado do Tratamento , Manejo da Dor/métodos , Analgésicos Opioides , Medula EspinalRESUMO
BACKGROUND: Migraine is the leading cause of disability among adolescents and young adults. We aimed to characterize the impact of migraine on the experience of children, adolescents, and caregivers. METHODS: This descriptive qualitative study recruited youth aged four to 18 years with migraine and their caregivers from the multicenter, prospective Pediatric Migraine Registry between 2020 and 2021. Participants completed semistructured interviews targeting the lived experience of migraine. A conventional content analysis approach was used to analyze data. RESULTS: Thirty enrolled dyads (n = 30 children and adolescents, n = 29 caregivers) completed 59 interviews (n = 29 child and adolescent interviews, n = 30 caregiver interviews). Children and adolescents had a median age of 15 years and experienced a median of 13.5 headache days per month. Caregivers had a median age of 44 years and predominantly identified as mothers (n = 28). We identified three themes: (1) Impact on emotional well-being: participants described how their migraine experience included feelings of isolation, depression, and irritability alongside the need for social support; (2) Impact on daily life: participants described how symptoms and unpredictability impacted their ability to perform activities of daily living; and (3) Impact on school: participants described how migraine impacted their school experience, including threatened attendance and worsened performance. CONCLUSIONS: In this cohort of youth and their caregivers, we identified salient themes to characterize the experience of migraine. Our findings underscore the urgent need for effective migraine treatments and interventions targeting co-occurring mental health conditions, peer relationships, and school support.
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Atividades Cotidianas , Transtornos de Enxaqueca , Adulto Jovem , Humanos , Adolescente , Criança , Adulto , Estudos Prospectivos , Cefaleia , Transtornos de Enxaqueca/terapia , Grupo AssociadoRESUMO
BACKGROUND: The pediatric patient-reported outcomes version of the common terminology criteria for adverse event measure was developed and validated for use in pediatric cancer clinical trials to better capture the symptom experiences through direct self-report. The study aim was to develop and validate a Swahili language version of the patient-reported outcomes version of the common terminology criteria for adverse event measure. METHODS: The pediatric version of 15 core symptom adverse events, and the corresponding questions, were selected from the patient-reported outcomes version of the common terminology criteria for adverse event library, then forward and back translated into Swahili by bilingual translators. The translated items were further refined using concurrent cognitive interviewing. Each round of interviews included five children, ages 8-17 years-old, receiving cancer therapy at Bugando Medical Centre, the cancer referral hospital for Northwest Tanzania, and continued until at least 80% of participants understood the question. RESULTS: Three rounds of cognitive interviews were completed involving 13 patients and 5 caregivers. Among patients, 50% of questions (19/38) were fully comprehended after the first interview round. Two Adverse Events (anxiety and peripheral neuropathy) were the most difficult for participants to understand, associated with education level and experience. Goal comprehension was achieved after three rounds of interviews with no further revisions required. All parents in the first cognitive interview group comprehended the survey, with no additional revisions. CONCLUSION: A Swahili patient-reported outcomes version of the common terminology criteria for adverse event was effective in eliciting patient-reported Adverse Events related to cancer treatment, with good comprehension for children aged 8-17 years. This survey is important to incorporate patient self-reporting of symptomatic toxicities and is an effective tool to increase capacity for pediatric cancer clinical trials throughout East Africa, further reducing global disparities in cancer care.