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Purpose: To give an overview of the multicenter Prostate Cancer Outcomes (PCO) study, involving paper-based and web-based collection of patient-reported outcome measures (PROM) in patients undergoing local treatment for prostate cancer in certified centers in Germany. The PCO study is part of the larger Movember-funded TrueNTH Global Registry. The article reports on the study's design and provides a brief progress report after the first 2 years of data collection. Methods: Prostate cancer centers (PCCs) certified according to German Cancer Society requirements were invited to participate in collecting patient-reported information on symptoms and function before and at least once (at 12 months) after treatment. The data were matched with disease and treatment information. This report describes progress in patient inclusion, response rate, and variations between centers relative to online/paper use, and also data quality, including recruitment variations relative to treatment in the first participating PCCs. Results: PCC participation increased over time; 44 centers had transferred data for 3094 patients at the time of this report. Patient recruitment varied widely across centers. Recruitment was highest among patients undergoing radical prostatectomy. The completeness of the data was good, except for comorbidity information. Conclusions: The PCO study benefits from a quality improvement system first established over 10 years ago, requiring collection and harmonization of a predefined clinical dataset across centers. Nevertheless, establishing a PROM routine requires substantial effort on the part of providers and constant monitoring in order to achieve high-quality data. The findings reported here may be useful for guiding implementation in similar initiatives. [ABSTRACT FROM AUTHOR]

Background: To assess quality of life and unmet needs after stroke, patient-reported outcome measures (PROMs) have gained increasing attention. However, patients' perspectives on assessing PROMs remain unclear, potentially hindering implementation into clinical practice. Therefore, this study explored patients' preferences on assessing PROMs after ischemic stroke. Methods: A paper-based questionnaire was sent to stroke survivors treated at the Department of Neurology, University of Leipzig, Germany. Health-related quality of life (HRQoL, EQ-5D-5L) and preferences regarding different aspects of data collection to assess PROMs were investigated and linked to socio-demographic and medical characteristics. Results: 158 persons were contacted and 80 replies were subsequently analyzed. Mean age was 70.16 years and mean HRQoL was 68.79 (visual analogue scale with a theoretical maximum of 100). Participants showed positive attitudes towards PROMs as they saw potential to improve care of other patients (n = 66/79; 83.54%) or to improve their own situation (n = 53/74; 71.62%). Participants preferred an annual interview after stroke (n = 39/80; 48.75%) and would preferably spend 15–30 min (n = 41/79; 51.90%) to answer a written survey (n = 69/80; 86.25%). The initially treating clinic was preferred as initiator of such surveys (n = 43/79; 54.43%). Stratification revealed that participants with more than 1 h of daily digital media usage preferred email as way of communication. Conclusions: For the first time, this study showed individual preferences on assessing PROMs after ischemic stroke, focusing on the way, time interval, duration, and initiation site of surveys. These insights might help to successfully implement PROMs after stroke and subsequently detect unmet needs and deficits in stroke care. [ABSTRACT FROM AUTHOR]

Backgound: Headache disorders are not only among the most prevalent, they are also among the most disabling disorders worldwide. This paper investigates the association between headache impact on daily life and the socioeconomic status (SES) of headache sufferers. Methods: Data stem from a random general population sample in Germany. Respondents who reported having headache for at least a year and were aged ≥ 18 years were included in the study. A standardized questionnaire addressing headache and headache treatment was filled in during the face-to-face survey. The impact of headache on daily life was measured using the German version of the Headache Impact Test (HIT-6). Results: Higher headache impact was found in low and medium SES compared to high SES. After adjustment for sociodemographics, headache-related factors (analgesic use, headache duration, headache frequency, migraine diagnosis), depressive symptoms, physical inactivity and obesity, an increased odds ratio of having higher headache impact in low SES compared to high SES was found: OR = 1.83, 95% CI [1.43, 2.23], p =.014. When the interactions "SES*obesity", "SES*depressive symptoms", and "SES*physical inactivity" were added, the results showed a significant interaction effect of "SES*obesity". Obese persons with low SES were 3.64 times more likely to have higher headache impact than non-obese persons with low SES. No significant differences between obese and non-obese persons were found in the medium and high SES groups. Conclusions: SES is an important factor that should not be neglected in headache awareness campaigns and headache treatment. Longitudinal studies are needed in the future to investigate whether lifestyle interventions, such as weight reduction, can help to reduce headache impact in people in lower SES. [ABSTRACT FROM AUTHOR]

Background: Musculoskeletal conditions are a leading contributor to disability worldwide. The treatment of these conditions accounts for 7% of health care costs in Germany and is often provided by physiotherapists. Yet, an overview of the cost-effectiveness of treatments for musculoskeletal conditions offered by physiotherapists is missing. This review aims to provide an overview of full economic evaluations of interventions for musculoskeletal conditions offered by physiotherapists. Methods: We systematically searched for publications in Medline, EconLit, and NHS-EED. Title and abstracts, followed by full texts were screened independently by two authors. We included trial-based full economic evaluations of physiotherapeutic interventions for patients with musculoskeletal conditions and allowed any control group. We extracted participants' information, the setting, the intervention, and details on the economic analyses. We evaluated the quality of the included articles with the Consensus on Health Economic Criteria checklist. Results: We identified 5141 eligible publications and included 83 articles. The articles were based on 78 clinical trials. They addressed conditions of the spine (n = 39), the upper limb (n = 8), the lower limb (n = 30), and some other conditions (n = 6). The most investigated conditions were low back pain (n = 25) and knee and hip osteoarthritis (n = 16). The articles involved 69 comparisons between physiotherapeutic interventions (in which we defined primary interventions) and 81 comparisons in which only one intervention was offered by a physiotherapist. Physiotherapeutic interventions compared to those provided by other health professionals were cheaper and more effective in 43% (18/42) of the comparisons. Ten percent (4/42) of the interventions were dominated. The overall quality of the articles was high. However, the description of delivered interventions varied widely and often lacked details. This limited fair treatment comparisons. Conclusions: High-quality evidence was found for physiotherapeutic interventions to be cost-effective, but the result depends on the patient group, intervention, and control arm. Treatments of knee and back conditions were primarily investigated, highlighting a need for physiotherapeutic cost-effectiveness analyses of less often investigated joints and conditions. The documentation of provided interventions needs improvement to enable clinicians and stakeholders to fairly compare interventions and ultimately adopt cost-effective treatments. Key Points: Several high-quality economic evaluations of physiotherapeutic treatments for the back and knee exist Economic evaluations of other joints are rare Physiotherapeutic interventions are often cost-effective over treatments provided by other health professionals The description of provided interventions in cost-effectiveness analyses needs improvement, to allow fair treatment comparisons [ABSTRACT FROM AUTHOR]

Background: Presbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual Questionnaire (NAVQ) was adapted to incorporate modern technology (e.g. smartphones) and to be appropriate for use in phakic presbyopia, leading to the development of the NAVQ-Presbyopia (NAVQ-P). Additional single-item instruments of near vision correction independence (NVCI), correction preference (NVCP), and vision satisfaction (NVS) were also developed. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia. Methods: Participants in the US (n = 15), Germany (n = 10) and France (n = 10) took part in face-to-face, qualitative, cognitive debriefing interviews. Seven healthcare professionals (HCPs) were also interviewed to assess the clinical relevance of the PRO instruments. Interviews started with open-ended qualitative concept elicitation questioning; participants then completed the PRO instruments on an electronic tablet using a "think-aloud" process and were asked about their understanding and relevance of each item, instruction, response scale and recall period. Interviews were conducted in two rounds allowing for modifications between rounds. Results: The participants interpreted the majority of the PRO instruments and recall period correctly and consistently. They were able to select an appropriate response option without difficulty. Minor modifications were made to the PRO instruments based on interview findings. Instruction/item wording was modified to include reference to use of a magnifying glass, in addition to glasses and contact lenses. Two items were added to assess difficulty with precision tasks (e.g. sewing) and taking longer to adjust from distance to near vision. HCPs confirmed the relevance of the concepts being measured for presbyopia and recommended the addition of an item assessing contrast sensitivity. Conclusions: Developed in accordance with the FDA PRO Guidance, the findings support content validity of the NAVQ-P as a suitable, well-understood instrument of relevant near vision functioning concepts in individuals with phakic presbyopia. The NVCI and additional PRO instruments are appropriate to assess near vision correction independence, correction preference, and vision satisfaction. Future work will assess the psychometric properties of the NAVQ-P and additional PRO instruments. [ABSTRACT FROM AUTHOR]

Caregiver burden is a main outcome domain in caregiver intervention research. A recommended instrument for measuring burden is the Sense of Competence Questionnaire (SCQ). In this study, we evaluated the psychometric properties of the German version of the SCQ with informal caregivers of stroke patients. Baseline data of a randomized controlled trial ( n = 122) and survey data ( n = 76) of caregivers of stroke patients were used. Data were collected at the caregiver's or the care receiver's home or over the telephone. We evaluated the homogeneity, the construct validity, and the clinical validity of the German version and the homogeneity of a new abbreviated version. The homogeneity of the SCQ indicates good reliability (Cronbach's alpha: 0.89). The three-factor structure of the SCQ was mostly confirmed through principal components analyses using oblimin rotation. Clinical validity was supported through correlations between sense of competence and burden ( r = −0.51), depression ( r = −0.52), and care recipient's cognitive function ( r = 0.36). Sixteen items with consistent factor loadings were extracted and proposed as a new abbreviated version of the SCQ (Cronbach's alpha: 0.84). The abbreviated German rendition of the SCQ version that was validated in this study offers a consistent version that can be applied across different languages and among caregivers of stroke survivors or people with dementia. [ABSTRACT FROM AUTHOR]

Background: Tension-type headache and migraine are among the most prevalent chronic disorders in children/adolescents. Data on health care utilization for headache in this age group, however, are sparse. Methods: In 1399 grammar school students (aged 12-19 years) with headache in the last six months in Germany a) the burden of disease for headache (mean intensity, mean frequency in the last three months and PedMIDAS means), b) medical care utilization defined by proportion of students consulting a physician in the last 12 months and/or taking analgetic drugs in the last three months by headache types (migraine and tension-type headache) and by burden of disease were assessed. Results: Primary headache substantially impaired daily living activities in adolescents which was mainly related to migraine. Medical care utilization and drug use, however, was low (consulting a physician: 12.0 %, 95 %-CI = [10.3-13.8]; taking analgetic drugs: 29.9 %, 95 %-CI = [27.5-32.4]) - even among students with severe headache (physician consultation: <35 %; taking analgetic drugs: <63 %). Two thirds of students with any headache and 40 % of those with migraine had neither seen a physician nor used analgetic drugs because of their headache in the preceding 12 months. Conclusions: Adolescents with headache might too rarely seek professional help for treatment of headache. Health promotion in adolescents should increase awareness for evidence-based treatment options for headache. [ABSTRACT FROM AUTHOR]

Objectives: We compared the nutritional status of elderly people living in two different settings (shared-housing arrangements and home-living arrangements). Design: For this secondary analysis, a cross-sectional study was performed. Setting: For the home-living setting, home-dwelling elderly people from Hamburg, Germany who were participants in a prior study were included. For the shared-housing arrangements (SHA) setting, we used baseline data from the WGQual Study. Participants: The sample from the home-living setting comprised patients who were discharged from a geriatric rehabilitation clinic within the six months prior to data collection. The sample from the shared-housing arrangements comprised all residents that lived in SHAs. Measurements: Nutritional status was examined by administering the Mini Nutritional Assessment (MNA). Cognitive status was measured by the Mini Mental State Examination (MMSE). Results: Overall, 142 individuals participated in this study. Statistical analysis showed differences in both overall MNA scores and MNA assessment scores. Significantly more participants from the SHA setting were at risk of malnutrition compared to the home-living setting. Conclusion: Screening and assessment of nutritional status and prevention interventions should be considered in SHA settings. [ABSTRACT FROM AUTHOR]