Assessing chronic fatigue syndrome: Self-reported physical functioning and correlations with physical testing.

The pathophysiology of chronic fatigue syndrome (CFS) remains unclear; no biomarkers have thus far been identified or physical tests designed to underpin its diagnosis. Assessment mainly uses Fukuda's criteria and is based on the exclusion of symptoms related to other diseases/syndromes, subjective self-reporting, and outcomes of self-report questionnaires. In order to improve the baseline assessment and progress evaluation of individuals suspected of CFS and using an association-oriented research strategy and a cross-correlational design, this study investigates possible associations between the performance on two physical tests, i.e. 'Timed Loaded Standing' (TLS), assessing trunk-arm endurance, and the 'Stops Walking with Eyes Closed while performing a secondary Cognitive Task' (SWECCT), measuring impaired automaticity of gait, and the results of two self-report questionnaires, the Checklist Individual Strength (CIS, total score and fatigue subscale score) and the physical functioning and vitality subscales of the Short Form Health Survey (SF-36) to gauge the participants' subjective feelings of fatigue and beliefs regarding their abilities to perform daily-life activities. Comparisons of the outcomes obtained in 27 female patients with a confirmed diagnosis of CFS revealed that trunk-arm endurance as measured with the TLS correlated with the SF-36 physical functioning subscale only (raw p value: 0.004). None of the other correlations were statistically significant. It is concluded that the TLS may have potential as an objective assessment tool to support the diagnosis and monitoring of treatment effects in CFS.

Is Online Treatment as Effective as In-Person Treatment?: Psychological Change in Two Relationship Skills Groups.

Psychotherapy has undergone a widespread change recently, with many interventions now available as wireless device apps or online courses. The current study compared the efficacy of an online program with a personal group treatment intervention. The in-person group (n = 37) attended a 6-day workshop called Tapping Deep Intimacy that focused on the development of interpersonal skills. The online group (n = 37) consumed to the same information in the form of a 12-week online course. The content of both courses was drawn from the curriculum for Whole Energy Lifestyle, which trains participants in 12 evidence-based interpersonal and stress-reduction skills designed to reduce emotional triggering and promote health. These include mindfulness, breathwork, meditation (EcoMeditation), heart coherence, Clinical Emotional Freedom Techniques, active listening, and qigong. In both groups, depression, anxiety, and relationship satisfaction were assessed pre, post, and at 1-year follow-up. Anxiety reduced in the in-person but not the online group. Significant improvements in depression (p < 0.001) were found in both groups, although sharper symptom declines were found in the in-person group. A 29% improvement in relationship satisfaction was found in both groups (p < 0.003), and both maintained their gains over time. Anxiety and depression symptoms were much higher in the in-person group pretest despite similar demographic characteristics, suggesting differences in the population that uses online courses. These preliminary findings suggest that while online programs may play a role in the development of stress-reduction and interpersonal skills, it cannot be assumed that they mirror the therapeutic efficacy of in-person treatment in every dimension.

Cross-Sectional Evaluation of the Psychometric Properties of the Headache-Specific Locus of Control Scale in People With Migraine.

OBJECTIVE: This study aims to investigate the psychometric properties (component structure, reliability, and construct validity) of the Headache-Specific Locus of Control scale in several clinical migraine populations. BACKGROUND: Headache-specific locus of control beliefs may impact a person's behavioral decisions that affect the likelihood of migraine attack onset, emotional responses to migraine attacks, coping strategies used, and treatment adherence. The 33-item Headache-Specific Locus of Control scale is the most widely used measure of locus of control specific to headache yet psychometric evaluations remain limited. METHODS: Six hundred and ninety-five adults with a diagnosis of migraine from 5 different research studies completed cross-sectional self-report measures including the Headache-Specific Locus of Control scale and measures of quality of life and disability (Migraine-Specific Quality of Life Questionnaire and Migraine Disability Assessment). RESULTS: Five Headache-Specific Locus of Control components emerged from Horn's Parallel Analysis, Minimum Average Partial test, and Principal Component Analysis (eigenvalues: Presence of Internal = 5.7, Lack of Internal = 4.0, Luck = 2.9, Doctor = 2.0, and Treatment = 1.5). The 33 Headache-Specific Locus of Control items demonstrated adequate internal consistency for total (α = 0.79) and subscale scores (α's = 0.69 to 0.88). This study found preliminary evidence of convergent validity. For example, Lack of Internal (r = -0.12, P = 0.004), Doctor (r = -0.20, P < .001), and Treatment (r = -0.12, P = .004) beliefs were associated with higher overall migraine-specific quality of life impairments. CONCLUSIONS: The Headache-Specific Locus of Control scale is a reliable and valid measure of headache-specific locus of control. Findings suggest that headache-specific locus of control is more multidimensional than previous conceptualizations and contribute to our understanding of control beliefs as a potential mechanism for migraine treatment.

Identifying patient concerns during consultations in tertiary burns services: development of the Adult Burns Patient Concerns Inventory.

OBJECTIVES: Identifying the issues and concerns that matter most to burns survivors can be challenging. For a number of reasons, but mainly relating to patient empowerment, some of the most pressing concerns patients may have during a clinical encounter may not naturally be the focal point of that encounter. The Patient Concerns Inventory (PCI) is a tried and tested concept initially developed in the field of head and neck cancer that empowers patients during a clinical encounter through provision of a list of prompts that allows patients to self-report concerns prior to consultation. The aim of this study was to develop a PCI for adult burns patients. DESIGN: Content for the PCI was generated from three sources: burns health-related quality of life tools, thematic analysis of one-to-one interviews with 12 adult burns patients and 17 multidisciplinary team (MDT) members. Content was refined using a Delphi consensus technique, with patients and staff members, using SurveyMonkey. SETTING: Within outpatient secondary care. PARTICIPANTS: Twelve adult burns patients and MDT members from two regional burns centres. RESULTS: A total of 111 individual items were generated from the three sources. The Delphi process refined the total number of items to 58. The main emergent domains were physical and functional well-being (18 items), psychological, emotional and spiritual well-being (22 items), social care and social well-being (7 items) and treatment-related concerns (11 items). CONCLUSIONS: The Adult Burns Patient Concerns Inventory is a 58-item, holistic prompt list, designed to be used in the outpatient clinic. It offers a new tool in burn care to improve communication between healthcare professionals and patients, empowering them to identify their most pressing concerns and hence deliver a more focused and targeted patient-centred clinical encounter.

[Validity of patient-reported anemia and therapeutic use of iron supplements during pregnancy: 2015 Pelotas (Brazil) birth cohort]. / Validade do autorrelato de anemia e do uso terapêutico de sais de ferro durante a gestação: coorte de nascimentos de 2015 de Pelotas, Rio Grande do Sul, Brasil.

This study aimed to investigate the validity of patient-reported anemia and therapeutic use of iron supplements, compared to hemoglobin values recorded on the patient's prenatal card. The study used data from the 2015 Pelotas (Brazil) birth cohort. For validation of self-reported anemia, we included all mothers with hemoglobin values recorded on their prenatal card (N = 3,419), while validation of self-reported therapeutic use of iron supplements included those who had hemoglobin values recorded on their prenatal care and who reported having used medicines containing ferrous sulfate during pregnancy. Anemia was defined as at least one record of hemoglobin ≤ 11g/dL on the prenatal card (gold standard). Prevalence of anemia according to the gold standard was 35.9% (34.3-37.5), while patient-reported anemia was 42.2% (40.8-43.7), and patient-reported therapeutic use of iron supplements was 43.2% (41.3-45.1). Sensitivity of patient-reported anemia was 75.2% (72.8-77.6) and specificity was 75.1% (73.3-76.9). For patient-reported therapeutic use of iron supplements, sensitivity was 66.4% (63.5-69.2) and specificity was 71.9% (69.7-74.0). Specificity of patient-reported anemia and patient-reported therapeutic use of iron supplements in mothers with ≥ 12 years of schooling was 78.4% (75.4-81.4) and 79.5% (76.1-82.9), respectively. In the study population, for every five postpartum women that reported anemia or therapeutic use of iron supplements, three were telling the truth. The specificity of both self-reports was high in mothers with ≥ 12 years of schooling.

O objetivo deste estudo é investigar a validade do autorrelato de anemia e de uso terapêutico de sais de ferro, frente à informação de hemoglobina da carteira da gestante. O estudo utiliza dados da coorte de nascimentos de 2015 de Pelotas, Rio Grande do Sul, Brasil. Para a validação do autorrelato de anemia, foram incluídas todas as mães que tinham registro de hemoglobina na carteira da gestante (N = 3.419), ao passo que, para a validação do autorrelato de uso terapêutico de sais de ferro, foram incluídas as que tinham registro de exames de hemoglobina na carteira da gestante e que relataram haver utilizado algum medicamento com sulfato ferroso em sua composição durante a gestação. Anemia foi definida como, pelo menos, um registro de hemoglobina ≤ 11g/dL na carteira da gestante (padrão-ouro). A prevalência de anemia conforme padrão-ouro foi 35,9% (34,3-37,5), ao passo que a de anemia autorrelatada foi 42,2% (40,8-43,7), e o autorrelato de uso terapêutico de sais de ferro, 43,2% (41,3-45,1). A sensibilidade do autorrelato de anemia foi 75,2% (72,8-77,6) e a especificidade, 75,1% (73,3-76,9). Para o autorrelato de uso terapêutico de sais de ferro, a sensibilidade foi 66,4% (63,5-69,2) e a especificidade, 71,9% (69,7-74,0). A especificidade do autorrelato de anemia e do autorrelato de uso terapêutico de sais de ferro entre mães com ≥ 12 anos de escolaridade foi 78,4% (75,4-81,4) e 79,5% (76,1-82,9). Na população estudada, com alta prevalência de anemia, de cada cinco puérperas que relataram anemia ou uso terapêutico de sais de ferro, três relatavam a verdade. A especificidade de ambos os autorrelatos foi mais elevada entre mães com ≥ 12 anos de escolaridade.

El objetivo de este estudio es investigar la validez del autoinforme de anemia y uso terapéutico de sales de hierro, respecto a la información sobre la hemoglobina, presente la cartilla de la embarazada. El estudio utiliza datos de la cohorte de nacimientos en Pelotas, Rio Grande ddo Sul, Brasil, 2015. Para la validación del autoinforme de anemia, se incluyeron a todas las madres que tenían un registro de hemoglobina en la cartilla de la embarazada (N = 3.419), al mismo tiempo que, para la validación del autoinforme del uso terapéutico de sales de hierro, se incluyeron a quienes tenían registro de exámenes de hemoglobina en la cartilla de la embarazada, y que informaron haber utilizado algún medicamento con sulfato ferroso en su composición durante la gestación. La anemia se definió como, por lo menos, un registro de hemoglobina ≤ 11g/dL en la cartilla de la embarazada (patrón ideal). La prevalencia de anemia, según el patrón ideal, fue de un 35,9% (34,3-37,5), mientras que la de la anemia autoinformada fue de un 42,2% (40,8-43,7), y el autoinforme de uso terapéutico de sales de hierro, 43,2% (41,3-45,1). La sensibilidad del autoinforme de anemia fue de un 75,2% (72,8-77,6) y la especificidad, 75,1% (73,3-76,9). Para el autoinforme de uso terapéutico de sales de hierro, la sensibilidad fue 66,4% (63,5-69,2) y la especificidad, 71,9% (69,7-74,0). La especificidad del autoinforme de anemia y del autoinforme de uso terapéutico de sales de hierro entre madres con ≥ 12 años de escolaridad fue 78,4% (75,4-81,4) y 79,5% (76,1-82,9). En la población estudiada, con una alta prevalencia de anemia, de cada cinco puérperas que informaron anemia o uso terapéutico de sales de hierro, tres relataban la verdad. La especificidad de ambos autoinformes fue más elevada entre madres con ≥ 12 años de escolaridad.

Using the device-oriented subjective outcome (DOSO) scale to measure outcomes of different hearing aids.

OBJECTIVE: The device-oriented subjective outcome (DOSO) is a device-oriented questionnaire, intended to minimise the influence of personality on self-reported measures. The aim of this study was to provide normative data with 2015-era hearing aid technologies. DESIGN: This retrospective study evaluated data from records of three clinical trials. The DOSO was administered for the participants' own devices as a part of the intake and after using research devices in the field. STUDY SAMPLE: The DOSO data were collected from 132 experienced bilateral hearing aid wearers who participated in the clinical trials. RESULTS: The DOSO data collected with the participants' own devices were compared to the interim normative data collected between 2004 and 2005. The DOSO subscale scores from the participants' own devices were significantly higher than those from the interim norms, except Listening Effort subscale. To demonstrate the utility of the new norms, a separate set of DOSO data collected from the same participants after using research hearing aids were contrasted to the new normative data. After accounting for possible placebo effects, the DOSO data with research devices revealed additional self-reported benefit of technological advancements. CONCLUSIONS: Norms for the DOSO are recommended for evaluating hearing aids with more recent technologies.

Affective startle modulation in young people with first-presentation borderline personality disorder.

This study investigated psychophysiological and subjective emotional responses to an affective startle modulation paradigm in first-presentation borderline personality disorder (BPD). Twenty BPD and 20 healthy control participants, aged 15-24 years, viewed a set of standardized pictures with pleasant, neutral, or unpleasant valence, and were instructed to either "maintain" or "suppress" their emotional response to the stimuli. Despite showing markedly higher levels of baseline distress on self-report questionnaires, BPD participants had significantly lower skin conductance responses and showed an absence of the fear potentiated startle response during early picture processing. Both groups showed similar startle responses later in picture processing, and when instructed to "maintain" or "suppress" their emotions. BPD participants were hypo-responsive to aversive stimuli during early processing, and did not react with more intense emotional responses to affective stimuli or show a diminished ability to regulate their responses. These results might be consistent with the finding that hypersensitivity of emotional response in BPD is specific to stimuli with themes of particular relevance to this disorder, such as rejection and abandonment.

Knowing Every Child: Validation of the Holistic Student Assessment (HSA) as a Measure of Social-Emotional Development.

Knowing every child's social-emotional development is important as it can support prevention and intervention approaches to meet the developmental needs and strengths of children. Here, we discuss the role of social-emotional assessment tools in planning, implementing, and evaluating preventative strategies to promote mental health in all children and adolescents. We, first, selectively review existing tools and identify current gaps in the measurement literature. Next, we introduce the Holistic Student Assessment (HSA), a tool that is based in our social-emotional developmental theory, The Clover Model, and designed to measure social-emotional development in children and adolescents. Using a sample of 5946 students (51% boys, M age = 13.16 years), we provide evidence for the psychometric validity of the self-report version of the HSA. First, we document the theoretically expected 7-dimension factor structure in a calibration sub-sample (n = 984) and cross-validate its structure in a validation sub-sample (n = 4962). Next, we show measurement invariance across development, i.e., late childhood (9- to 11-year-olds), early adolescence (12- to 14-year-olds), and middle adolescence (15- to 18-year-olds), and evidence for the HSA's construct validity in each age group. The findings support the robustness of the factor structure and confirm its developmental sensitivity. Structural equation modeling validity analysis in a multiple-group framework indicates that the HSA is associated with mental health in expected directions across ages. Overall, these findings show the psychometric properties of the tool, and we discuss how social-emotional tools such as the HSA can guide future research and inform large-scale dissemination of preventive strategies.

Validade do autorrelato de anemia e do uso terapêutico de sais de ferro durante a gestação: coorte de nascimentos de 2015 de Pelotas, Rio Grande do Sul, Brasil / Validity of patient-reported anemia and therapeutic use of iron supplements during pregnancy: 2015 Pelotas (Brazil) birth cohort / Validez del autoinforme de anemia y uso terapéutico de sales de hierro durante la gestación: cohorte de nacimientos de 2015 en Pelotas, Río Grande do Sul, Brasil

O objetivo deste estudo é investigar a validade do autorrelato de anemia e de uso terapêutico de sais de ferro, frente à informação de hemoglobina da carteira da gestante. O estudo utiliza dados da coorte de nascimentos de 2015 de Pelotas, Rio Grande do Sul, Brasil. Para a validação do autorrelato de anemia, foram incluídas todas as mães que tinham registro de hemoglobina na carteira da gestante (N = 3.419), ao passo que, para a validação do autorrelato de uso terapêutico de sais de ferro, foram incluídas as que tinham registro de exames de hemoglobina na carteira da gestante e que relataram haver utilizado algum medicamento com sulfato ferroso em sua composição durante a gestação. Anemia foi definida como, pelo menos, um registro de hemoglobina ≤ 11g/dL na carteira da gestante (padrão-ouro). A prevalência de anemia conforme padrão-ouro foi 35,9% (34,3-37,5), ao passo que a de anemia autorrelatada foi 42,2% (40,8-43,7), e o autorrelato de uso terapêutico de sais de ferro, 43,2% (41,3-45,1). A sensibilidade do autorrelato de anemia foi 75,2% (72,8-77,6) e a especificidade, 75,1% (73,3-76,9). Para o autorrelato de uso terapêutico de sais de ferro, a sensibilidade foi 66,4% (63,5-69,2) e a especificidade, 71,9% (69,7-74,0). A especificidade do autorrelato de anemia e do autorrelato de uso terapêutico de sais de ferro entre mães com ≥ 12 anos de escolaridade foi 78,4% (75,4-81,4) e 79,5% (76,1-82,9). Na população estudada, com alta prevalência de anemia, de cada cinco puérperas que relataram anemia ou uso terapêutico de sais de ferro, três relatavam a verdade. A especificidade de ambos os autorrelatos foi mais elevada entre mães com ≥ 12 anos de escolaridade.

This study aimed to investigate the validity of patient-reported anemia and therapeutic use of iron supplements, compared to hemoglobin values recorded on the patient's prenatal card. The study used data from the 2015 Pelotas (Brazil) birth cohort. For validation of self-reported anemia, we included all mothers with hemoglobin values recorded on their prenatal card (N = 3,419), while validation of self-reported therapeutic use of iron supplements included those who had hemoglobin values recorded on their prenatal care and who reported having used medicines containing ferrous sulfate during pregnancy. Anemia was defined as at least one record of hemoglobin ≤ 11g/dL on the prenatal card (gold standard). Prevalence of anemia according to the gold standard was 35.9% (34.3-37.5), while patient-reported anemia was 42.2% (40.8-43.7), and patient-reported therapeutic use of iron supplements was 43.2% (41.3-45.1). Sensitivity of patient-reported anemia was 75.2% (72.8-77.6) and specificity was 75.1% (73.3-76.9). For patient-reported therapeutic use of iron supplements, sensitivity was 66.4% (63.5-69.2) and specificity was 71.9% (69.7-74.0). Specificity of patient-reported anemia and patient-reported therapeutic use of iron supplements in mothers with ≥ 12 years of schooling was 78.4% (75.4-81.4) and 79.5% (76.1-82.9), respectively. In the study population, for every five postpartum women that reported anemia or therapeutic use of iron supplements, three were telling the truth. The specificity of both self-reports was high in mothers with ≥ 12 years of schooling.

El objetivo de este estudio es investigar la validez del autoinforme de anemia y uso terapéutico de sales de hierro, respecto a la información sobre la hemoglobina, presente la cartilla de la embarazada. El estudio utiliza datos de la cohorte de nacimientos en Pelotas, Rio Grande ddo Sul, Brasil, 2015. Para la validación del autoinforme de anemia, se incluyeron a todas las madres que tenían un registro de hemoglobina en la cartilla de la embarazada (N = 3.419), al mismo tiempo que, para la validación del autoinforme del uso terapéutico de sales de hierro, se incluyeron a quienes tenían registro de exámenes de hemoglobina en la cartilla de la embarazada, y que informaron haber utilizado algún medicamento con sulfato ferroso en su composición durante la gestación. La anemia se definió como, por lo menos, un registro de hemoglobina ≤ 11g/dL en la cartilla de la embarazada (patrón ideal). La prevalencia de anemia, según el patrón ideal, fue de un 35,9% (34,3-37,5), mientras que la de la anemia autoinformada fue de un 42,2% (40,8-43,7), y el autoinforme de uso terapéutico de sales de hierro, 43,2% (41,3-45,1). La sensibilidad del autoinforme de anemia fue de un 75,2% (72,8-77,6) y la especificidad, 75,1% (73,3-76,9). Para el autoinforme de uso terapéutico de sales de hierro, la sensibilidad fue 66,4% (63,5-69,2) y la especificidad, 71,9% (69,7-74,0). La especificidad del autoinforme de anemia y del autoinforme de uso terapéutico de sales de hierro entre madres con ≥ 12 años de escolaridad fue 78,4% (75,4-81,4) y 79,5% (76,1-82,9). En la población estudiada, con una alta prevalencia de anemia, de cada cinco puérperas que informaron anemia o uso terapéutico de sales de hierro, tres relataban la verdad. La especificidad de ambos autoinformes fue más elevada entre madres con ≥ 12 años de escolaridad.

Patient self-reported concerns in inflammatory bowel diseases: A gender-specific subjective quality-of-life indicator.

BACKGROUND: Patient-reported disease perceptions are important components to be considered within a holistic model of quality of care. Gender may have an influence on these perceptions. We aimed to explore gender-specific concerns of patients included in a national bilingual inflammatory bowel disease cohort. METHODS: Following a qualitative study, we built a questionnaire comprising 37 items of concern. Answers were collected on a visual analog scale ranging from 0 to 100. Principal axis factor analysis was used to explore concern domains. Linear multiple regressions were conducted to assess associations with patient characteristics. RESULTS: Of 1102 patients who replied to the survey, 54% were female and 54% had Crohn's disease. We identified six domains of concern: socialization and stigmatization, disease-related constraints and uncertainty, symptoms and their impact on body and mind, loss of body control (including sexuality), disease transmission, and long-term impact of the disease. Cancer concerns were among the highest scored by all patients (median 61.8). Severity of symptoms was the only factor associated with concerns, unrelated to dimension and gender (p<0.015). In women, being >40 years decreased disease-related constraints and uncertainty concerns, and being at home or unemployed increased them. Treatments were associated with increased socialization and stigmatization and with increased disease-related constraints and uncertainty concerns in men. Overall, psychosomatic characteristics were highly associated with concerns for both men and women. Depending on the concern dimensions, increased levels of concern were associated with the highest signs of anxiety in women or depression in men, as well as lower health-related quality of life in men. CONCLUSIONS: Patients have numerous concerns related to their illness that need to be reassessed regularly. Concerns differ between men and women, suggesting that information and communication about the disease should take gender differences and subjective perceptions of quality of life into consideration.

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

BACKGROUND: The psychometric properties of Patient Reported Outcomes Measurement Information System (PROMIS) instruments have been explored in a number of general and clinical samples. No study, however, has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis (KOA). The aim of this project was to evaluate the construct (structural) validity and floor/ceiling effects of four PROMIS measures in this population. METHODS: We conducted a secondary analysis of baseline data from a randomized trial comparing Tai Chi and physical therapy. Participants completed four PROMIS static short-form instruments (i.e., Anxiety, Depression, Physical Function, and Pain Interference) as well as six well-validated (legacy) measures that assess pain, function, and psychological health. We calculated descriptive statistics and percentages of participants scoring the minimum (floor) and maximum (ceiling) possible scores for PROMIS and legacy measures. We also estimated the association between PROMIS scores and scores on legacy measures using Spearman's rank correlations coefficients. RESULTS: Data from 204 participants were analyzed. Mean age of the sample was 60 years; 70% were female. The PROMIS Anxiety and Depression had floor effects with 17 and 24% of participants scoring the minimum, respectively. PROMIS Anxiety and Depression scores had strongest associations with general mental health, including stress (Perceived Stress Scale, r ≥ 0.65) and depression (Beck Depression Index-II, r = 0.70). PROMIS Pain Interference scores correlated most strongly with measures of whole body pain (Short-Form 36 Bodily Pain, r = -0.73) and physical health (Short-Form 36 Physical-Component Summary, r = -0.73); their correlations were lower with other legacy measures, including with the WOMAC knee-specific pain (r = 0.47). PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function (r = 0.79) than with scores on other legacy measures. CONCLUSION: The four PROMIS static-short forms performed well among individuals with symptomatic knee osteoarthritis as evidenced in correlations with legacy measures. PROMIS Anxiety and Depression target general mental health (e.g., stress, depression), and PROMIS Pain Interference and Physical Function static-short forms target whole-body outcomes among participants with symptomatic knee osteoarthritis. Floor effects in the PROMIS Anxiety and Depression scores should be considered if needing to distinguish among patients with very low levels of these outcomes. TRIAL REGISTRATION: Clinicaltrials.gov NCT01258985. Registered 10 December 2010.

Patient-reported outcome measures for use in gynaecological oncology: a systematic review.

BACKGROUND: Patient-reported outcome measures (PROMs) are used to assess the impact of health care on a patient's health. Within the gynaecological oncology setting, multiple PROMs have been adopted but no assessment has been made in terms of their psychometric qualities and robustness. OBJECTIVES: To undertake a systematic review to identify the most psychometrically robust and appropriate PROM used in the gynaecological oncology setting. SEARCH STRATEGY: A search of the bibliographic database of the Oxford PROM group, plus nine additional databases, was carried out along with citation-tracking and hand searches. SELECTION CRITERIA: Studies examining the psychometric properties of outcome measures tested in gynaecological cancer populations were selected by three blinded reviewers. DATA COLLECTION AND ANALYSIS: Studies were independently assessed and data extracted. Analysis included an appraisal of the psychometric properties and functionality of the included PROMs to guide recommendations. MAIN RESULTS: Eighteen PROMs tested in gynaecological oncology settings were identified. These were categorised into seven areas of focus, and the most psychometrically robust tools were identified: (1) generic (no recommendation); (2) general cancer (EORTC QLQ-C30 and FACT-G); (3) pelvic cancer (QUEST GY); (4) ovarian cancer (EORTC QLQ-OV28); (5) cervical cancer (EORTC QLQ-CX24); (6) endometrial cancer (EORTC QLQ-EN 24); and (7) vulval cancer (FACT-V). AUTHOR'S CONCLUSIONS: Seven PROMs were recommended for use in six gynaecological populations. No single tool was identified that had been tested in all disease groups. Some showed promise, but a lack of conceptual clarity about the core outcomes and the rationale for use will require further testing using well-constructed studies.

[Development of a short-form self-report measure to assess relaxation effects].

The present study aimed to develop a short-form self-report measure to assess relaxation effects (S-MARE). Participants (N = 190) responded to a questionnaire comprised of 45 items assessing relaxation and non-relaxation based on the Relaxation Inventory (Crist et al., 1989). Exploratory factor analysis identified three factors: physiological tension, psychological relaxation, and anxiety. Each factor was related to 5 items and each had an acceptable Cronbach's coefficient (alpha = .93, .94, and .85). S-MARE scores pre- and post- relaxation instruction were significantly correlated with the Emotional Relaxation Scale (Tokuda, 2011) (r = .446) and with State Anxiety (r = -.531) (N = 172). There was a significant correlation between the amplitude of the high frequency component of heart rate variability during relaxation instruction and physiological tension scores on the S-MARE (r = .456-.474, N = 24). These results confirmed the reliability and validity of the S-MARE in terms of physiological correlation with cardiac parasympathetic tone, suggesting that the S-MARE is a valid measure of relaxation effects.

Validity of the National Acoustic Laboratories procedure for determining percentage loss of hearing.

OBJECTIVE: To evaluate the validity of the National Acoustic Laboratories procedure for determining percentage loss of hearing as a measure of hearing disability. DESIGN: The percentage hearing losses of war veterans who had hearing ranging from normal to profound deafness were determined and compared with their scores on two hearing questionnaires. STUDY SAMPLE: A self-report hearing questionnaire was completed by 282 war veterans and 154 of those veterans were given the hearing measurement scale in the form of a structured interview. RESULTS: A percentage loss of hearing of 0 agreed well with the questionnaire scores representing the limit of normal hearing, and a percentage loss of hearing of 100 agreed well with the questionnaire scores representing total loss of hearing. Percentage loss of hearing accounted for 83% of the variance in scores on the hearing questionnaire and 81% of the variance in scores on the hearing measurement scale. CONCLUSION: The National Acoustic Laboratories procedure for determining percentage loss of hearing provides a valid measure of hearing disability.

Validation of self-reported khat chewing amongst khat chewers: an exploratory study.

ETHNOPHARMACOLOGICAL RELEVANCE: Khat chewing amongst the UK communities originating from Yemen and the East African coast is suggested to create dependency through its main stimulant components (cathinone, norephedrine and norpseudoephedrine) on the central nervous system. AIMS OF THE STUDY: To validate self-reported khat chewing behaviours by measuring levels of cathinone, norephedrine and norpseudoephedrine in saliva and to explore their associations with self-reported khat chewing dependency. MATERIALS AND METHODS: Face-to-face interviews were conducted amongst 30 male UK-resident khat chewers. Saliva samples were collected from each participant and high-performance liquid chromatography (HPLC) employed to extract and quantify the levels of the biomarkers. RESULTS: The mean (SD) for cathinone and the composite norephedrine and norpseudoephedrine levels were 33.93 (±39.20) and 29.28 (±26.32)µg/mL respectively. These biomarkers were significantly associated (p≤0.05) with khat chewing dependency. CONCLUSIONS: Validation of self-reported khat chewing is possible. Khat chewing dependency correlates significantly with biomarker levels in saliva. Replication is required.