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Purpose: Erythropoietic protoporphyria (EPP), a rare inherited disorder, presents in early childhood with severe, painful phototoxicity, with significant impacts on health-related quality of life (HRQoL). Previous studies have not captured all concepts important to patients. Therefore, this study sought to develop a novel, comprehensive, and content valid patient-reported outcome (PRO) measure to assess the efficacy of new therapies. Patients and Methods: Qualitative interviews were conducted with EPP participants and clinical experts to obtain views on concepts relevant to patients. Results informed the development of novel PROs, which were debriefed during subsequent combined concept elicitation and cognitive debriefing interviews. Results: Twenty-three interviews were conducted with 17 adults and 6 adolescents with EPP. Concept elicitation revealed that participants experienced many symptoms with significant variability. The most common were burning, pain, swelling, and tingling. Tingling was the most common prodromal symptom, while burning was the most bothersome, and pain was the worst full reaction symptom. Participants reported being negatively impacted in their ability to do daily activities, and social and emotional functioning. Many reported impacted ability to work and be productive at their job. Participants reviewed and completed the newly developed PRO measures assessing full reactions and ability to do activities, as well as items to assess severity and change in severity of prodromal symptoms, full reactions, and EPP overall. All measures were found to be comprehensive, clear, and relevant. Conclusion: PRO measures are needed to assess important aspects of HRQoL and evaluate therapeutic response. These PRO measures are unique in assessing overall severity and change in EPP.
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BACKGROUND: Erythropoietic protoporphyria is a rare, inherited disorder presenting in early childhood with severe, painful phototoxicity. EPP has significant impacts on health-related quality of life, though there is variable disease severity. Accurately capturing how much time individuals with EPP can spend outdoors before they develop symptoms is critical to understanding HRQoL and measuring therapeutic response. Therefore, the goal of this study was to develop a comprehensive and content valid sun exposure diary to assess the efficacy of new therapies in individuals with EPP. METHODS: Qualitative interviews were conducted with adult and adolescent EPP participants, as well as five clinical experts, to obtain their input on the content of an existing sun exposure diary. Revisions to the diary were made based on evidence generated in cognitive debriefing interviews analyzed in eight consecutive groups of EPP participant. RESULTS: Interviews were conducted with 17 adults and 6 adolescents with EPP. The average age of adults was 40 years and of adolescents was 14 years. Clinical experts thought the original diary needed clarification on the description of symptoms, how time outdoors was captured, and the distinction between direct vs. indirect sunlight. Participants with EPP also noted these items needed revision, and that the distinction between prodromal symptoms and full reaction symptoms should be clarified. In the final diary version, participants with EPP found most items to be clear and easy to complete/think about. Seventy-six percent of participants (13/17) asked thought the diary was easy to complete. The remainder thought the majority of the diary was easy to complete with the exception of select questions. CONCLUSIONS: Evaluating a new treatment for EPP requires accurately capturing time in sunlight and symptoms in this unique disorder. The newly developed sun exposure diary is content valid and can be used to assess important aspects of symptoms and daily life and therefore evaluate clinically meaningful therapeutic response.
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Dermatitis Fototóxica , Protoporfiria Eritropoyética , Preescolar , Adolescente , Adulto , Humanos , Protoporfiria Eritropoyética/diagnóstico , Calidad de Vida , Luz Solar/efectos adversos , Pacientes , Enfermedades RarasRESUMEN
INTRODUCTION: NSCLCs account for most lung cancers; approximately 30% involve a mutation in the EGFR gene. This study sought to identify one or more patient-reported outcome (PRO) measures relevant for use in clinical trials to assess symptoms and health-related quality of life in this population. METHODS: Patients with NSCLC from the United States, Europe, and Asia and including those with an exon 20 insertion mutation and other EGFR mutations participated in a combination of concept elicitation and cognitive debriefing interviews to report symptoms and impacts of their NSCLC and provide feedback on the clarity and relevance of several PRO measures. RESULTS: A total of 30 individuals participated (mean age = 57 years, 87% female, 80% white). The most often reported symptoms included fatigue, shortness of breath, cough, and weight loss. Individuals with the exon 20 insertion mutation (n = 21) more frequently reported negative impacts on daily life, physical functioning, and social functioning but less frequently reported negative impacts to emotional functioning. The PROMIS Short-Form version 2.0-Physical Function 8c and the NSCLC Symptom Assessment Questionnaire were deemed clear, relevant, and easy to complete. The concepts identified during the concept elicitation portion of the interviews were mapped to the content of each PRO, and all items within both PROs were endorsed by at least 20% of the participants. CONCLUSIONS: These results support the content validity, clarity, and relevance of the PROMIS Short-Form version 2.0-Physical Function 8c and the NSCLC Symptom Assessment Questionnaire in a population with EGFR-mutated NSCLC. Both would be appropriate for inclusion in future studies.
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BACKGROUND: Anemia is a frequent complication of chronic kidney disease (CKD) that negatively affects patients' health-related quality of life. METHODS: We conducted qualitative concept elicitation (CE) and cognitive debriefing (CD) interviews to assess the frequency, duration, and severity of symptoms and impacts associated with anemia of CKD and to facilitate the development of a new patient-reported outcome (PRO) measure. We interviewed 36 patients with CKD and hemoglobin levels ≥8.0 to <12.0 g/dL using a semi-structured interview guide developed specifically for this study until saturation was reached. We used MAXQDA to perform qualitative analysis of interview transcripts to determine the most relevant symptoms and impacts (based on the frequency of concept mentions) experienced by participants. RESULTS: Most participants had stage 4/5 CKD (81%) and were being treated with an erythropoietin stimulating agent (69%). Spontaneously reported symptoms included feeling tired (79%), shortness of breath (39%), and weak/lacking strength (36%). We developed the Chronic Kidney Disease and Anemia Questionnaire (CKD-AQ), which includes 23 items assessing frequency and severity of the most relevant symptoms and impacts identified by patients with anemia of CKD. The CD interviews confirmed the clarity and relevance of the concepts identified in the CE phase. CONCLUSION: The CKD-AQ is a novel PRO measure that captures the frequency and severity of the most relevant symptoms and impacts associated with anemia of CKD. Future studies will evaluate its psychometric properties and its potential utility in anemia management.
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PURPOSE: Somatostatin analogs (SSAs) represent a mainstay of medical treatment for acromegaly, currently available as either intramuscular or deep subcutaneous injections. Patient-reported outcomes (PROs) are increasingly common as relevant outcomes in studies of acromegaly and its treatment, but there are no validated PRO measures available that focus on the disease burden and the impact of treatment, specifically designed for use in patients with acromegaly. We sought to develop a new and unique PRO measure, the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ). METHODS: Concept elicitation (CE) interviews were conducted with acromegaly patients in the United States receiving SSA injections at a stable dose for ≥ 6 months. A questionnaire was drafted based on these interviews; combined CE and cognitive debriefing (CE/CD) interviews were then conducted to confirm the content, clarity, and relevance of the questionnaire. RESULTS: Nineteen subjects completed interviews [n = 9 CE, n = 10 CE/CD; n = 15 Lanreotide Depot/Autogel (Somatuline), n = 4 Octreotide LAR (Sandostatin LAR)]. Most subjects responded positively when asked about the effectiveness of their current treatment; however, breakthrough symptoms, injection site reactions, and side effects were commonly reported and had negative impacts on social and emotional well-being and daily activities. All 10 subjects involved in debriefing interviews found the questionnaire to be relevant, easy to complete, and found the response options to be clear. The resulting 26-item Acro-TSQ covers symptoms and symptom control, gastrointestinal side effects and their impact on daily activities, the emotional impact of treatment, convenience and ease of use, and overall satisfaction. CONCLUSIONS: The Acro-TSQ is a novel PRO, focused on both disease burden and impact of treatment; it was found to be comprehensive, clear, and relevant for patients with acromegaly receiving injectable SSA treatment.
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Acromegalia/tratamiento farmacológico , Adulto , Bromocriptina/uso terapéutico , Cabergolina/uso terapéutico , Femenino , Hormona de Crecimiento Humana/análogos & derivados , Hormona de Crecimiento Humana/uso terapéutico , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Octreótido/uso terapéutico , Péptidos Cíclicos/uso terapéutico , Satisfacción Personal , Somatostatina/análogos & derivados , Somatostatina/uso terapéutico , Encuestas y CuestionariosRESUMEN
BACKGROUND: Oral glucocorticoids (steroids) are the mainstay of treatment for systemic lupus erythematosus (SLE), but their use is often associated with short- and long-term side effects. Following a literature review and discussions with patients with SLE, clinicians, and payers, a need was identified for a comprehensive SLE-specific tool that can be used to evaluate the side effects and benefits of steroids over time from a patient perspective. The objective of this study was to develop a patient-reported outcome (PRO) measure to assess general impact (baseline burden), benefits, side effects, and impacts associated with the use of oral steroids in patients with SLE. METHODS: A qualitative research protocol was developed in which adults with SLE currently receiving or who had received steroids in the past year were recruited from six US rheumatology practices to participate in concept elicitation (CE) interviews. The SLE Steroid Questionnaire (SSQ) was developed based on CE interview results and clinical input. Cognitive debriefing interviews with a second group of patients with SLE evaluated the content, clarity, and relevance of the items. The SSQ was refined using patient feedback, clinician review, and a translatability assessment. The protocol received central independent review board approval. RESULTS: Thirty-three patients (52% moderate disease severity; 58% currently receiving steroids, mean dose 8.7 mg/day) completed CE interviews. Patients reported benefits, side effects, and impacts from steroids. The refined SSQ contains 50 items assessing steroid dose/duration (4 items), general impact (baseline burden; 19 items), benefits (7 items), work/productivity (3 items), side effects (10 items), emotions (6 items), and overall satisfaction (1 item). CONCLUSION: The SSQ is a unique PRO, developed using robust scientific methodology in accordance with the Food and Drug Administration PRO Guidance. It was designed to comprehensively assess the patient experience with steroid therapy and better understand the benefits and burden of steroids for patients with SLE.
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Glucocorticoides/uso terapéutico , Lupus Eritematoso Sistémico/tratamiento farmacológico , Lupus Eritematoso Sistémico/psicología , Medición de Resultados Informados por el Paciente , Encuestas y Cuestionarios/normas , Adulto , Femenino , Indicadores de Salud , Humanos , Lupus Eritematoso Sistémico/complicaciones , Masculino , Persona de Mediana Edad , Psicometría , Investigación Cualitativa , Calidad de Vida/psicologíaRESUMEN
OBJECTIVE: The aim of this study was to develop a patient-reported outcome measure specific for systemic lupus erythematosus (SLE) to assess patient satisfaction with treatment, treatment options, and medical care. METHODS: Patients with SLE were recruited from four US rheumatology practices. Concept elicitation interviews identified aspects that patients considered important and relevant regarding satisfaction with treatment and medical care. Concept elicitation interviews and clinical input were used to draft the Lupus Satisfaction Questionnaire (LSQ). A second cohort of patients with SLE participated in combined concept elicitation/cognitive debriefing interviews, after which the LSQ was revised. RESULTS: Fourteen patients completed concept elicitation interviews: 93% were female, 57% were white, and 85% had moderate/severe SLE. Current treatments included hydroxychloroquine (93%), steroids (79%), and belimumab (57%), and 43% were biologic naive. Patients were generally satisfied with their treatment and medical care; however, they were dissatisfied with treatment adverse effects and the number of available treatment options. Cognitive debriefing interviews (n = 8) demonstrated that the LSQ was comprehensive, clear, and relevant; therefore, only minor revisions were made to the questionnaire. The LSQ assesses satisfaction with current SLE treatments (25 items), medical care (11 items), and insurance coverage (3 items). The draft LSQ was evaluated in 195 adults with SLE. Fifty-eight percent of patients reported that they were "somewhat satisfied" with their SLE treatment. CONCLUSIONS: The LSQ has been developed to assess treatment satisfaction among patients with SLE. Following further testing to support its validity and reliability, it will provide a useful tool to facilitate assessment of satisfaction with treatments for SLE and help inform treatment decisions.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Glucocorticoides/uso terapéutico , Hidroxicloroquina/uso terapéutico , Prioridad del Paciente/estadística & datos numéricos , Calidad de Vida , Encuestas y Cuestionarios , Adulto , Antirreumáticos/uso terapéutico , Femenino , Humanos , Cobertura del Seguro/estadística & datos numéricos , Lupus Eritematoso Sistémico/economía , Lupus Eritematoso Sistémico/epidemiología , Lupus Eritematoso Sistémico/psicología , Lupus Eritematoso Sistémico/terapia , Masculino , Manejo de Atención al Paciente/métodos , Manejo de Atención al Paciente/normas , Medición de Resultados Informados por el Paciente , Reproducibilidad de los Resultados , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: This study assessed measurement properties of the 17-item Diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q), which measures intention to engage in self-care behaviors, including following a diabetes diet and engaging in appropriate physical activity. METHODS: The DIAB-Q includes questions based on the Theory of Planned Behavior. Items were developed using published literature, input from health care professionals, and qualitative research findings in patients with and without type 2 diabetes mellitus (T2DM). In Stage I of the study, 23 adults with T2DM were interviewed to evaluate the content and clarity of the DIAB-Q. In Stage II 1,015 individuals with T2DM completed the DIAB-Q and supplemental questionnaires, including the Short Form-36 acute (SF-36), section III of the Multidimensional Diabetes Questionnaire, the Summary of Diabetes Self-Care Activities questionnaire, and self-administered items relevant to the treatment and management of T2DM (eg, blood pressure and glycated hemoglobin [HbA1c]) at baseline and 3-7 days later. Once the DIAB-Q scale structure was determined, its test-retest reliability, construct validity, and known-groups validity were evaluated, and minimal clinically important change was estimated. RESULTS: In Stage I, the 23 respondents surveyed generally reported that the DIAB-Q was clear and comprehensive and endorsed questions as relevant to their intentions to engage in diabetes-related self-care activities. Most subjects in Stage II were male, Caucasian, and married. Mean age was 63 years. Factor analysis revealed six psychological constructs (Behavior, Planning, Intention, Perceived Behavioral Control, Attitude, and Subjective Norm). Test-retest reliability was acceptable (≥0.70) for all scales, except Perceived Behavioral Control. Construct validity was demonstrated based on correlations with diabetes-specific items/scales and the SF-36. Known-groups validity was confirmed for Behavior, Planning, and Intention when respondents were categorized into groups that differed based on body mass index, disease severity, and HbA1c. Item scores were transformed to a 100-point scale, and minimal clinically important change estimates ranged from 6-11 points, representing the change that would be considered important to a respondent. CONCLUSION: The DIAB-Q is a brief, psychometrically sound, patient-reported outcome that can be used among individuals with T2DM to evaluate intention to engage in self-care behaviors.
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BACKGROUND: Collecting reliable and valid symptom information from patients is critical for assessing psoriasis severity in clinical research. OBJECTIVE: To evaluate measurement properties of a new patient-reported outcome (PRO), the Psoriasis Symptoms and Signs Diary (PSSD). METHODS: One hundred six US patients with moderate-to-severe plaque psoriasis completed two versions of the PSSD [a 24-hour recall (PSSD-24h) and 7-day recall (PSSD-7d)] using a 0-10 numerical rating scale. Reliability (test-retest and internal consistency), validity (convergent, divergent and known-groups), responsiveness, and version equivalence were evaluated. Minimally important difference was estimated. RESULTS: Based on exploratory factor analysis and clinical input, symptom, sign, and total severity scores were established. Internal consistency (Cronbach's alpha ≥ 0.944) and test-retest reliability (intraclass correlation coefficients ≥ 0.824) were acceptable. Correlations with Dermatology Life Quality Index (DLQI) (0.489 to 0.644) indicated convergent validity, while low correlations (< 0.30) with several Short Form (SF)-36 scales indicated divergent validity. PSSD scores differed when patients were categorized by Body Surface Area, DLQI, and Psoriasis Area Severity Index scores. PSSD-24h and PSSD-7d versions were equivalent (Pearson correlations ≥ 0.953). LIMITATIONS: PSSD responsiveness should be evaluated in patients receiving treatment. CONCLUSION: The PSSD is reliable and valid in measuring symptoms/signs of patients with moderate-to-severe plaque psoriasis.
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Medición de Resultados Informados por el Paciente , Psoriasis , Psicometría/métodos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psoriasis/tratamiento farmacológico , Calidad de Vida , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Encuestas y CuestionariosRESUMEN
BACKGROUND: The concept of diabetes-related health satisfaction encompasses issues specifically related to living with diabetes (eg, blood glucose, blood pressure levels, body weight). Health satisfaction is more specific than overall health-related quality of life because it considers disease-related factors, and is different from diabetes treatment satisfaction because it addresses issues not specifically related to treatment. Low levels of health satisfaction in people with type 2 diabetes mellitus (T2DM) may negatively affect self-care behaviors and treatment outcomes; however, there are currently no instruments available to assess health satisfaction in this population. This study assessed the measurement properties of a newly constructed, 14-item Current Health Satisfaction Questionnaire (CHES-Q) designed to assess diabetes-related health satisfaction and knowledge of the disease and important laboratory results. METHODS: In-depth interviews were conducted in 23 adults with T2DM to confirm the content and clarity of the CHES-Q. The revised instrument was administered to 1,015 individuals with T2DM, along with supplemental questionnaires, including the Short Form-36. All subjects completed the questionnaires again 3 to 7 days later. CHES-Q test-retest reliability, construct validity, and known-groups validity were evaluated. RESULTS: In general, respondents found the CHES-Q to be clear and comprehensive. Test-retest reliability was generally acceptable for all items (≥0.70), except for three that fell just below the widely accepted cut-point of 0.70 (range 0.63-0.69). Convergent and divergent validity was demonstrated based on hypothesized correlations with the Short Form-36. Known-groups validity was confirmed for most CHES-Q items when respondents were split into groups known to differ clinically by body mass index, disease severity, or glycated hemoglobin. CONCLUSION: Health satisfaction is a unique and important concept to consider when developing individualized strategies for managing T2DM because health satisfaction is a key element of patient-centered care. The CHES-Q allows for the pragmatic assessment of many aspects of diabetes-related health satisfaction in a single questionnaire.
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IMPORTANCE Little is known about patients' experiences of advanced basal cell carcinoma (aBCC) and basal cell carcinoma nevus syndrome (BCCNS), a rare genetic disorder that greatly increases the number of BCCs. OBJECTIVE To develop a questionnaire to measure patient-reported outcomes (PROs) in these populations. DESIGN, SETTING, AND PARTICIPANTS Concept elicitation interviews were conducted with patients with aBCC and BCCNS from 5 US clinical sites and the BCCNS Life Support Network and 4 physicians. The PRO questionnaires were drafted based on results from a literature review and findings from these interviews. Questionnaires were finalized after cognitive debriefing interviews were conducted with patients. Concept elicitation interviews were conducted with 30 patients (14 with aBCC, 16 with BCCNS) and 4 physicians (2 dermatologists, 1 Mohs surgeon, and 1 oncologist) in the United States. A subset of 10 of these patients (5 with aBCC, 5 with BCCNS) took part in cognitive debriefing interviews. MAIN OUTCOMES AND MEASURES Development of 2 questionnaires to allow clinicians to assess the emotional, social, and physical impacts of the disease on patients with aBCC and BCCNS. RESULTS Most concept elicitation interview patients were male (63%) and white (93%); their mean age was 57 years. There were impacts on emotional, social, and physical functioning in both conditions. Patients were unable to do many activities and avoided other activities. Seventy-nine percent of patients with aBCC and all patients with BCCNS reported scarring. Physician interviews revealed similar findings. During cognitive debriefing interviews, the questionnaires were found to be relevant, clear, and comprehensive. CONCLUSIONS AND RELEVANCE Advanced BCC and BCCNS affect patients in unique and substantial ways. These PRO questionnaires were developed with patient and clinician input and measure the key areas that have an impact on patients with these conditions.
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Síndrome del Nevo Basocelular/patología , Carcinoma Basocelular/patología , Calidad de Vida , Neoplasias Cutáneas/patología , Encuestas y Cuestionarios , Adulto , Anciano , Síndrome del Nevo Basocelular/psicología , Carcinoma Basocelular/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias Cutáneas/psicologíaRESUMEN
BACKGROUND: Patient-reported outcomes (PROs) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient's perspective. This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index (FCSI-9) in a metastatic colorectal cancer (mCRC) population. METHODS: The FCSI-9 and EQ-5D were administered every 2-4 weeks to mCRC subjects in a phase III clinical trial. Three hundred ninety-one mCRC subjects completed the questionnaires at baseline and at least one follow-up assessment. Internal consistency reliability, test-retest reliability, construct validity, known groups validity, responsiveness, and the minimum important difference (MID) of the FCSI-9 were evaluated. RESULTS: The internal consistency and test-retest reliability of the FCSI-9 were acceptable (0.81 and 0.76, respectively). Construct validity was supported based on moderate correlations with the EQ-5D. Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status (PS) score. Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8. Responsiveness, as measured by Guyatt's statistic, was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12. Considering all data together, the MID of the FCSI-9 is estimated to be in the range of 1.5-3.0 points. CONCLUSION: Results provide preliminary evidence of the reliability, validity, and responsiveness of the FCSI-9.
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Neoplasias Colorrectales/psicología , Evaluación de Resultado en la Atención de Salud/métodos , Psicometría/métodos , Anciano , Anticuerpos Monoclonales/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Femenino , Humanos , Masculino , Cuidados Paliativos , Panitumumab , Participación del Paciente , Satisfacción del Paciente , Calidad de Vida , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
Cancer patients treated with parenteral chimeric or humanized monoclonal antibody agents or chemotherapy are at risk of experiencing an infusion reaction. The impact of infusion reactions can be substantial. Infusion reactions, even when mild, can be disruptive and stressful. In-person interviews with 202 nurses were conducted at the 2005 Annual Oncology Nursing Society Congress to evaluate the impact of infusion reactions on patients and nurses in the inpatient and outpatient practice settings. Results from this survey study suggest that infusion reactions have a significant negative impact on both patients and nurses.
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Antineoplásicos/efectos adversos , Actitud del Personal de Salud , Hipersensibilidad a las Drogas/etiología , Infusiones Intravenosas/efectos adversos , Personal de Enfermería/psicología , Enfermería Oncológica , Adaptación Psicológica , Anticuerpos Monoclonales/efectos adversos , Actitud Frente a la Salud , Congresos como Asunto , Costo de Enfermedad , Hipersensibilidad a las Drogas/epidemiología , Hipersensibilidad a las Drogas/prevención & control , Monitoreo de Drogas/enfermería , Femenino , Humanos , Infusiones Intravenosas/enfermería , Infusiones Intravenosas/estadística & datos numéricos , Pacientes Internos/psicología , Masculino , Evaluación en Enfermería , Investigación Metodológica en Enfermería , Personal de Enfermería/educación , Enfermería Oncológica/educación , Enfermería Oncológica/organización & administración , Pacientes Ambulatorios/psicología , Investigación Cualitativa , Administración de la Seguridad , Índice de Severidad de la Enfermedad , Estrés Psicológico/etiología , Estrés Psicológico/psicología , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To test the sensitivity to change of the ORTHO Birth Control Satisfaction Assessment Tool (ORTHO BC-SAT) among dissatisfied women switching to a new hormonal birth control method and to better understand which factors contribute to a woman's satisfaction with the method. MATERIALS AND METHODS: Women switching to a new hormonal birth control method [oral contraceptives (OCs), injections, vaginal ring or transdermal patch] completed the ORTHO BC-SAT, a questionnaire measuring satisfaction, two times over a 3-month period. Sensitivity to change was measured by examining change scores, as well as the Guyatt's statistic. Predictors of satisfaction were examined using forward-stepping linear regression. RESULTS: Fifty-six women completed the ORTHO BC-SAT twice. With the exception of Future Fertility Concerns, women reported statistically significant improvements on all scales of the questionnaire. The scales most sensitive to change were Overall Satisfaction, Assurance/Confidence, Lifestyle Impact, and Ease of Use/Convenience. Being older, switching from a nonhormonal method of birth control at baseline and more bodily pain at baseline predicted the increase in satisfaction scales. CONCLUSION: The ORTHO BC-SAT has demonstrated sensitivity to change in this population. In addition, we identified several factors at baseline that predicted an increase in satisfaction scale scores.
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Anticoncepción/psicología , Evaluación de Resultado en la Atención de Salud/métodos , Satisfacción del Paciente/estadística & datos numéricos , Encuestas y Cuestionarios , Adolescente , Adulto , Conducta Anticonceptiva/estadística & datos numéricos , Femenino , Humanos , Persona de Mediana EdadRESUMEN
PURPOSE: Male erectile dysfunction has a substantial impact on health related quality of life. We examined the psychometric properties of 2 new scales created to measure the psychological impact of erectile dysfunction. MATERIALS AND METHODS: Patients enrolled in a long-term study of men with erectile dysfunction completed clinical and health related quality of life information at baseline and at 3 followup points. The questionnaire incorporated a number of standard scales of psychosocial characteristics as well as questions developed from comments made during focus groups of men with erectile dysfunction and of their female partners. Principal components analysis was used to identify underlying constructs in response to the new questions. RESULTS: A total of 168 men completed the baseline quality of life questionnaire. The principal components analysis of the psychological impact of erectile dysfunction questions resulted in 2 new scales. Reliability was good with an internal consistency reliability of 0.91 for scale 1 and 0.72 for scale 2. Test-retest reliability was 0.76 and 0.66, respectively. Men reporting a greater psychological impact of erectile dysfunction also reported greater impairment in functional status, lower sexual self-efficacy, greater depression and anxiety at the last intercourse. Each new scale significantly differentiated men with mild/moderate versus severe erectile dysfunction. CONCLUSIONS: We developed 2 new scales to measure the psychological impact of erectile dysfunction and they showed good reliability and validity. These new scales, named the Psychological Impact of Erectile Dysfunction instrument, comprehensively capture the psychological effect of erectile dysfunction on health related quality of life, which is not adequately assessed by existing patient centered measures of erectile function.