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While the literature is abundant on hand therapy assessment and treatment of nonsurgical thumb carpometacarpal (CMC) osteoarthritis (OA), clarity and uniformity are meager, making it a desirable diagnosis to establish expert consensus. This study aimed to ascertain if consensus exists for the assessment and treatment of nonsurgical management of thumb CMC OA in the hand therapy clinical setting. This was a consensus paper via the modified Delphi approach. A modified Delphi method was used to determine consensus among an expert panel, including hand therapists and hand surgeons, via two online surveys. A consensus paper steering committee (from the American Society of Hand Therapist's research division) designed the surveys and analyzed responses. Consensus was established as 75% agreement among the expert panel. Demographic information was collected from the expert panel. The expert panel included 34 hand therapists and seven hand surgeons. The survey response rates were 93.6% for the first survey and 90.2% for the second survey. Consensus recommendations were classified according to the World Health Organization categorization. These included evaluating the body structures for clinical signs/clinical testing and body functions for pain, range of motion for palmar abduction, radial abduction, opposition, and thumb metacarpal phalangeal flexion/extension, and grip and tripod pinch strength. Further consensus recommendations were for the assessment of function using a region-specific, upper extremity patient-reported outcome measure (activity and participation), environmental factors, outcome expectation, and illness perception within the patient's unique environmental and social contexts. Treatment recommendations included the use of an orthosis during painful activities, a dynamic stability program (stable C posture, release of tight adductors, and strengthening of stabilizers), patient education, joint protection techniques, adaptive equipment, and functional-based intervention. The findings describe the consensus of a group of experts and provide a clinical reference tool on the hand therapy assessment and treatment of nonsurgical thumb CMC joint OA. • A consensus paper using a modified Delphi process to determine consensus on non-surgical assessment and treatment of thumb CMC OA. • Assessment recommendations: evaluate clinical signs/testing, pain, thumb range of motion grip and tripod pinch, a region-specific PROM, environmental factors, outcome expectation, and illness perception. • Treatment: orthosis during painful activities as needed, a dynamic stability program, patient education, joint protection techniques, adaptive equipment, and functional based intervention. • Findings provide a clinical reference tool on hand therapy assessment and treatment of non-surgical CMC joint OA. [ABSTRACT FROM AUTHOR]

In research, outcomes are often categorized as primary and secondary. The primary outcome is the most important one; it determines whether the study is considered 'successful' or not. Secondary outcomes are chosen because they provide supporting evidence for the results of the primary outcome or additional information about the subject being studied. For reasons that are explained in this paper, secondary outcomes should be cautiously interpreted. There are varying practices regarding publishing secondary outcomes. Some authors publish these separately, while others include them in the main publication. In some contexts, the former can lead to concerns about the quality and relevance of the data being published. In this article, we discuss primary and secondary outcomes, the importance and interpretation of secondary outcomes, and considerations for publishing multiple outcomes in separate papers. We also discuss the special case of secondary analyses and post hoc analyses and provide guidance on good publishing practices. Throughout the article, we use relevant examples to make these concepts easier to understand. While the article is primarily aimed at early career researchers, it offers insights that may be helpful to researchers, reviewers, and editors across all levels of expertise. [ABSTRACT FROM AUTHOR]

Background: Visual analogue scales (VASs) are used in a variety of patient-, observer- and clinician-reported outcome measures. While typically included in measures originally developed for pen-and-paper completion, a greater number of clinical trials currently use electronic approaches to their collection. This leads researchers to question whether the measurement properties of the scale have been conserved during the migration to an electronic format, particularly because electronic formats often use a different scale length than the 100 mm paper standard. Methods: We performed a review of published studies investigating the measurement comparability of paper and electronic formats of the VAS. Results: Our literature search yielded 26 studies published between 1997 and 2018 that reported comparison of paper and electronic formats using the VAS. After excluding 2 publications, 23 of the remaining 24 studies included in this review reported electronic formats of the VAS (eVAS) and paper formats (pVAS) to be equivalent. A further study concluded that eVAS and pVAS were both acceptable but should not be interchanged. eVAS length varied from 21 to 200 mm, indicating that 100 mm length is not a requirement. Conclusions: The literature supports the hypothesis that eVAS and pVAS provide comparable results regardless of the VAS length. When implementing a VAS on a screen-based electronic mode, we recommend following industry best practices for faithful migration to minimise the likelihood of non-comparability with pVAS. [ABSTRACT FROM AUTHOR]

Objective: The International Society of CNS Clinical Trials Methodology (ISCTM) Working Group on Rare Disease/Orphan Drug Development is dedicated to improving and streamlining trials to best develop new treatments for rare diseases. The rarity of these disorders requires a drug development strategy that differs from those of nonrare conditions. Rare disease drug development programs are challenged with small sample sizes, heterogeneous clinical presentations, and few, if any, off-the-shelf endpoints. When disease-specific clinical endpoints exist, they might not be validated and are typically not well known or broadly used in clinical practice. This paper aims to provide an overview of the special issues surrounding endpoints in rare disease drug development, with guidance, practical applications, and discussion. Discussion: The paper covers regulatory considerations in endpoint selection; identification of relevant measurement domains; methods of quantifying clinical meaningfulness; incorporation of patient- and clinician-reported outcomes; considerations for global clinician- and patient-rated clinical assessments; cognition assessment challenges in rare diseases; translation considerations; training, standardization, and calibration of assessors; and endpoint quality assurance. Additionally, it provides guidance and resources for those involved in drug development for rare diseases. Conclusion: In keeping with the mission of ISCTM and the rare disease/orphan drug development working group, this article is designed to encourage thoughtful consideration and provide insight and guidance to promote and further efforts in in central nervous system (CNS) rare disease drug development efforts. [ABSTRACT FROM AUTHOR]

Background: The Integrated Palliative Care Outcome Scale (IPOS) validly and reliably measures symptoms and concerns of those receiving palliative care. Aim: To determine the equivalence of the paper version with an electronic version of the IPOS (eIPOS). Design: Multicentre randomised crossover trial (NCT03879668) with a within-subject comparison of the two modes (washout period 30 min). Setting/Participants: Convenience sample of specialist inpatient and palliative home care patients aged over 18 years with cancer and non-cancer conditions was recruited. Scores were compared using intraclass correlation coefficients (ICC), Bland-Altman plots and via a mixed-effects analysis of variance. Results: Fifty patients were randomised to complete paper-electronic (n = 24) and electronic-paper (n = 26) IPOS with median age 69 years (range 24–95), 56% male, 16% non-cancer. The ICCs showed very high concordance for the total score (ICC 0.99, 95% CI 0.98–1.00), lowest ICCs being observed for symptoms 'Appetite loss' and 'Drowsiness' (ICC 0.95, 95% CI 0.92–0.97). Nine of seventeen items had ICCs above 0.98, as did all subscales. No statistically significant mode, order, age, and interaction effects were observed for IPOS total score and subscales, except for 'Communication' (Fmode = 5.9, p = 0.019). Fifty-eight percent preferred the electronic version. In the group 75+ years, 53% preferred the paper version. Only three entries in the free-text main problems differed between the versions. Conclusion: The very high equivalence in scores and free text between the IPOS and the eIPOS demonstrates that eIPOS is feasible and reliable in an older palliative population. [ABSTRACT FROM AUTHOR]

Perioperative nurses must provide culturally competent care to all surgical patients, and understanding gender identity and gender diversity may be the first step to creating an inclusive perioperative practice for transgender and gender diverse patients. In the nurse--patient relationship, limited exposure to and knowledge of diverse populations may negatively affect the health of this important demographic. When nurses are unaware of how care can be affected by explicit (conscious) or implicit (unconscious) bias, they may use transphobic stereotyping behaviours or act with microaggressions, like using excessive protective attire. Such care may invalidate gender identity and impede trust. In contrast, nurses practising gender-affirming care validate the patient's gender identity and life experiences, which supports autonomy and creates trust. The aim of this paper is to provide perioperative nurses with a deeper understanding of factors that may affect gender diverse patient's perioperative outcomes. In addition, understanding the social determinants of health affecting this demographic may result in better health outcomes. As such, the holistic care of the transgender and gender diverse patient is the optimal goal, with clinicians employing a non-judgemental, sensitive and compassionate attitude. [ABSTRACT FROM AUTHOR]

Violence against nurses is a disturbing trend in healthcare that has reached epidemic proportions globally. These violent incidents can result in physical and psychological injury, exacerbating already elevated levels of stress and burnout among nurses, further contributing to absenteeism, turnover, and intent to leave the profession. To ensure the physical and mental well-being of nurses and patients, attention to the development of strategies to reduce violence against nurses must be a priority. Caring knowledge—rooted in the philosophy of care—is a potential strategy for mitigating violence against nurses in healthcare settings. We present what caring knowledge is, analyze its barriers to implementation at the health system and education levels and explore potential solutions to navigate those barriers. We conclude how the application of models of caring knowledge to the nurse-patient relationship has the potential to generate improved patient safety and increased satisfaction for both nurses and patients. [ABSTRACT FROM AUTHOR]

Electronic data capture is fast becoming the preferred method of collecting patient-reported outcome (PRO) data in clinical trials. Data collection can be site-based (clinical study site), and typically collected on a tablet, or field-based (subject's typical environment such as home, school, or workplace), and most often accomplished with handheld devices, such as a smartphone. While site and study subject compliance with protocol-specific data collection procedures using these devices is critical to trial success, so is the robustness of the device hardware and the software these devices use to capture the trial data. Technology failures and/or site or subject resistance to the electronic data capture protocol may lead a subject to record data on paper, which can result in undesirable data challenges. As such, both site and subject compliance issues and technology-related factors must be anticipated to adhere to the ePRO data collection plan. The objective of this paper is to provide the technology industry's best practice recommendations for optimizing ePRO data collection in clinical trials by proposing the inclusion of a planned approach to data collection that includes viable electronic backup strategies so that defaulting to a paper-based backup becomes unnecessary. [ABSTRACT FROM AUTHOR]

The article discusses the positive pain reduction outcomes of a personalized care pathway for chronic knee pain post-total knee replacement.

Introduction: Replacement of conventional LASER films with digital paper prints as supplement to radiology reports may serve as an economical and environment friendly method. However, it is essential that such a change does not compromise patient's intended diagnostic outcome. Aim: The aim of this study was to assess the reliability and acceptability of digital paper prints for the radiographic images by the treating physicians and radiologists. Materials and Methods: This observational analytical study was done at a tertiary care hospital of New Delhi, India. A total of 58 consecutively ordered wrist radiographs of paediatric patients (6 months to 12 years of age) for ruling out rickets were retrieved from the PACS (Picture Archiving and Communication System). These 58 radiographs, out of which 21 (36.2%) had radiological evidence of rickets over PACS were printed on two different media i.e., LASER films and glossy photographic paper. An objective scoring for the severity of rickets was done on both LASER films and paper prints by six observers independently. Overall comfort level with paper prints was rated on a 1-5 point Likert scale. Data was analysed using STATA 14.0 (Stata Corp, College Station, TX). Results: Intra-observer percentage agreement and value of Cohen's kappa for PACS vs. LASER films and PACS vs. paper prints was equal i.e., 98.3% and 0.97, respectively. Intra-observer agreement between LASER films and paper prints for all six observers was excellent, ranging from 0.92 to 1.00; percentage agreement ranging from 94.8% to 100%. Fracture of ulna/ radius present in 4 sets of the X-rays was well demonstrated in both LASER films and paper prints. Comfort level with paper prints was rated as 5 out of 5 by all due to no requirement of any special illuminated view box and dark room. Conclusion: This study concludes that the use of paper prints may serve as a reliable alternative to LASER films to communicate the report of wrist radiographs for the treating physicians without any compromise over diagnostic information in cases of rickets. [ABSTRACT FROM AUTHOR]

The article discusses a randomized controlled trial that examined the effectiveness of combining corticosteroid injections with exercise therapy compared to placebo injections and exercise therapy for Achilles tendinopathy. The study found that the corticosteroid injections and exercise therapy group showed greater improvement in patient-reported outcomes, specifically the Victorian Institute of Sports Assessment-Achilles (VISA-A) score, compared to the placebo group at the 6-month follow-up.

Purpose: Patient-reported outcome (PRO) measures are essential for assessing subjective patient experiences. Interactive voice response (IVR) data collection provides advantages for clinical trial design by standardizing and centralizing the assessment. Prior to adoption of IVR as a mode of PRO administration in the Testosterone Trials (TTrials), we compared IVR to paper versions of the instruments to be used.Methods: IVR versions of the FACIT-Fatigue scale and Psychosexual Daily Questionnaire, Question 4, were developed. In one pilot study, IVR versions of these scales were compared to paper versions in 25 men ≥ 65 years at each of two clinical sites. In another study, IVR versions of the SF-36 Vitality Scale (SF-36), Positive and Negative Affect Scale, and Patient Health Questionnaire were evaluated in comparison with previously validated paper versions in 25 men at two clinical sites. Both paper and IVR versions of each instrument were administered in counterbalanced order, and test-retest reliability was evaluated by repeated administration of the test. Bland-Altman plots were used to assess the degree of agreement. Test-retest correlations for each measure were also determined.Results: Satisfactory agreement was observed between IVR and paper versions of each study measure. Specifically, linear and highly positive associations were observed consistently across the study for IVR and paper versions of all study measures. These ranged from r = 0.91-0.99. Test-retest reliability for all measures was acceptable or better (r = 0.70-0.90).Conclusions: The IVR versions of TTrials endpoints in these two studies performed consistently well in comparison with paper versions. [ABSTRACT FROM AUTHOR]

Purpose: We created and validated the new pencil and paper test, which allows assessment of the ability of patients with a neurological disorder to practice clean intermittent self-catheterization. Materials and Methods: We developed a simple test including common gestures mimicking the usual maneuvers needed during clean intermittent self-catheterization, and involving the same cognitive and physical resources needed for this technique. We evaluated the test in 118 patients with a neurological condition. Instruments needed to perform the pencil and paper test are limited to a sheet of paper and a pencil. Each test item was quantified and graded with a total score of 15. A specific clean intermittent catheterization learning scale was used to classify the outcome of the ability to perform clean intermittent self-catheterization with a score range of 5—learning easy and self-catheterization complete to 0—learning impossible. Results: Enrolled in the study were 118 patients with a neurological condition. There was strong correlation between the global pencil and paper test score, and the ability to perform clean intermittent self-catheterization, as evaluated by the learning scale (r = 0.82, p = 0.000091). At a test cutoff of 10 and a clean intermittent self-catheterization cutoff of 3, which was the limit needed to practice self-catheterization alone, the positive predictive value of the pencil and paper test was 85% and its negative predictive value was 94% (Cronbach''s α = 0.88). Conclusions: The pencil and paper test is a valid way to predict the ability to practice clean intermittent self-catheterization in patients with a neurological disorder. [Copyright &y& Elsevier]

This paper presents a comprehensive exploration into the utilization of machine learning (ML) techniques to revolutionize medical diagnostics, with a specific focus on enhancing the detection of heart disease. Recognizing the imperative need for early diagnosis to address the global prevalence of heart disease, this study delves into the development and application of advanced ML principles. The paper aims to construct a robust ML model capable of analyzing diverse patient data sets, including electronic health records and genetic information, to discern intricate patterns and correlations imperceptible to human clinicians. By leveraging a comprehensive dataset encompassing various patient profiles, the ML model is poised to significantly enhance the precision, speed, and efficiency of heart disease detection. The findings of this paper hold promise for fostering more effective intervention strategies and improving patient care outcomes in the realm of cardiovascular health. [ABSTRACT FROM AUTHOR]

Narrative abstract: Skilled palpation is a powerful assessment method for trained Chiropractors. There are times when a little finesse is needed to reduce the noise of other tissues and allow the doctor to make a more clear assessment. Here I present several 'clinical tricks' that better isolate the segments and tissues I am assessing. [ABSTRACT FROM AUTHOR]

Objectives The purpose of this article is to determine how many of the current peer-reviewed studies of ankle foot orthoses (AFOs) on children with cerebral palsy (CP) have included adequate details of the design and material of the AFO, to enable the study to be reproduced and outcomes clearly understood. Methods A thorough search of studies published in English was conducted in March 2015, with no restriction on dates, within all major databases using relevant phrases. These searches were then supplemented by tracking all key references from the appropriate articles identified. Study selection The inclusion criteria were as follows: (1) population - children with CP; (2) intervention - AFOs; and (3) outcome measure. One reviewer extracted data regarding the characteristics of the included studies, with the extracted data checked for accuracy and completeness by a second reviewer. None of the studies reviewed gave adequate details of the AFOs. Only 3.6% (n = 2) of papers tested the stiffness. Many studies (54.5%) did not describe the material used nor the material thickness (72.7%). None of them gave any clinical justification for the chosen design of AFO. Conclusions There is a clear paucity of detail regarding the design and material used in AFOs on studies involving children with CP. Such a lack of detail has the potential to affect the validity of the reported outcomes, the ability to reproduce the studies and may misinform clinical practice. [ABSTRACT FROM AUTHOR]

Background The use of patient-reported outcome measures in electronic format has been increasing. However, these formats are usually not validated or compared with the original paper-based formats, so there is no evidence that they are completed in the same way. Objectives To compare the conventional paper version with a web-based application ( iPad®) version of the Dermatology Life Quality Index ( DLQI) to assess equivalence of scores. Methods The study employed a randomized crossover design using a within-subjects comparison of the two formats of the questionnaire. International Society for Pharmacoeconomics and Outcomes Research ( ISPOR) guidelines were followed. Participants aged over 18 years with any confirmed skin condition were recruited from a teaching hospital dermatology outpatient clinic. Expected intraclass correlation coefficient ( ICC) was 0·9 (α = 0·05). Results A total of 104 patients were recruited, median age 53·5 years (interquartile range 37·3-67·8; 43% male). The ICC showed high concordance between the total DLQI scores from paper and iPad versions ( ICC 0·98; 95% confidence interval 0·97-0·99). Patients took a median of 78 s to complete the electronic version and 73 s for paper ( P = 0·008): 76% preferred the electronic version and perceived completion to take a shorter time. Conclusions There is high concordance and thus equivalence between the iPad and paper versions of the DLQI, with an ICC of 0·98, and a clear patient preference for the iPad version. [ABSTRACT FROM AUTHOR]

An introduction is presented in which author discusses articles on topics including focuses on analyzing the factors influencing ERCP outcomes in PAD patients and compare the technical success of ERCP between PAD and non‑PAD patients.

Purpose: Patient-reported outcome (PRO) measures originally developed for paper administration are increasingly being administered electronically in clinical trials and other health research studies. Three published meta-analyses of measurement equivalence among paper and electronic modes aggregated findings across hundreds of PROs, but there has not been a similar meta-analysis that addresses a single PRO, partly because there are not enough published measurement equivalence studies using the same PRO. Because the SF-36(R) Health Survey (SF-36) is a widely used PRO, the aim of this study was to conduct a meta-analysis of measurement equivalence studies of this survey.Methods: A literature search of several medical databases used search terms for variations of "SF-36" or "SF-12" and "equivalence" in the title or abstract of English language publications. The eight scale scores and two summary measures of the SF-36 and SF-12 were transformed to norm-based scores (NBS) using developer guidelines. A threshold of within ± 2 NBS points was set as the margin of equivalence. Comprehensive meta-analysis software was used.Results: Twenty-five studies were included in the meta-analysis. Results indicated that mean differences across domains and summary scores ranged from 0.01 to 0.39 while estimates of agreement ranged from 0.76 to 0.91, all well within the equivalence threshold. Moderator analyses showed that time between administration, survey language, and type of electronic device did not influence equivalence.Conclusions: The results of the meta-analysis support equivalence of paper-based and electronic versions of the SF-36 and SF-12 across a variety of disease populations, countries, and electronic modes. [ABSTRACT FROM AUTHOR]

The European Society of Radiology (ESR) established a Working Group on Value-Based Imaging (VBI WG) in August 2016 in response to developments in European healthcare systems in general, and the trend within radiology to move from volume- to value-based practice in particular. The value-based healthcare (VBH) concept defines 'value' as health outcomes achieved for patients relative to the costs of achieving them. Within this framework, value measurements start at the beginning of therapy; the whole diagnostic process is disregarded, and is considered only if it is the cause of errors or complications. Making the case for a new, multidisciplinary organisation of healthcare delivery centred on the patient, this paper establishes the diagnosis of disease as a first outcome in the interrelated activities of the healthcare chain. Metrics are proposed for measuring the quality of radiologists' diagnoses and the various ways in which radiologists provide value to patients, other medical specialists and healthcare systems at large. The ESR strongly believes value-based radiology (VBR) is a necessary complement to existing VBH concepts. The Society is determined to establish a holistic VBR programme to help European radiologists deal with changes in the evolution from volume- to value-based evaluation of radiological activities. Main Messages • Value-based healthcare defines value as patient's outcome over costs. • The VBH framework disregards the diagnosis as an outcome. • VBH considers diagnosis only if wrong or a cause of complications. • A correct diagnosis is the first outcome that matters to patients. • Metrics to measure radiologists' impacts on patient outcomes are key. • The value provided by radiology is multifaceted, going beyond exam volumes. [ABSTRACT FROM AUTHOR]

Background: The study tests the effects of data collection modes on patient responses associated with the multi-item measures such as Patient-Reported Outcomes Measurement System (PROMIS®), and single-item measures such as Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Numerical Rating Scale (NRS) measures. Methods: Adult cancer patients were recruited from five cancer centers and administered measures of anxiety, depression, fatigue, sleep disturbance, pain intensity, pain interference, ability to participate in social roles and activities, global mental and physical health, and physical function. Patients were randomized to complete the measures on paper (595), interactive voice response (IVR, 596) system, or tablet computer (589). We evaluated differential item functioning (DIF) by method of data collection using the R software package, lordif. For constructs that showed no DIF, we concluded equivalence across modes if the equivalence margin, defined as ± 0.20 × pooled SD, completely surrounds 95% confidence intervals (CI's) for difference in mean score. If the 95% CI fell totally outside the equivalence margin, we concluded systematic score difference by modes. If the 95% CI partly overlaps the equivalence margin, we concluded neither equivalence nor difference. Results: For all constructs, no DIF of any kind was found for the three modes. The scores on paper and tablet were more comparable than between IVR and other modes but none of the 95% CI's were completely outside the equivalence margins, in which we established neither equivalence nor difference. Percentages of missing values were comparable for paper and tablet modes. Percentages of missing values were higher for IVR (2.3% to 6.5% depending on measures) compared to paper and tablet modes (0.7% to 3.3% depending on measures and modes), which was attributed to random technical difficulties experienced in some centers. Conclusion: Across all mode comparisons, there were some measures with CI's not completely contained within the margin of small effect. Two visual modes agreed more than visual-auditory pairs. IVR may induce differences in scores unrelated to constructs being measured in comparison with paper and tablet. The users of the surveys should consider using IVR only when paper and computer administration is not feasible. [ABSTRACT FROM AUTHOR]

Objective: To conduct a systematic review and meta-analysis of the equivalence between electronic and paper administration of patient reported outcome measures (PROMs) in studies conducted subsequent to those included in Gwaltney et al's 2008 review.Methods: A systematic literature review of PROM equivalence studies conducted between 2007 and 2013 identified 1,997 records from which 72 studies met pre-defined inclusion/exclusion criteria. PRO data from each study were extracted, in terms of both correlation coefficients (ICCs, Spearman and Pearson correlations, Kappa statistics) and mean differences (standardized by the standard deviation, SD, and the response scale range). Pooled estimates of correlation and mean difference were estimated. The modifying effects of mode of administration, year of publication, study design, time interval between administrations, mean age of participants and publication type were examined.Results: Four hundred thirty-five individual correlations were extracted, these correlations being highly variable (I2 = 93.8) but showing generally good equivalence, with ICCs ranging from 0.65 to 0.99 and the pooled correlation coefficient being 0.88 (95% CI 0.87 to 0.88). Standardised mean differences for 307 studies were small and less variable (I2 = 33.5) with a pooled standardised mean difference of 0.037 (95% CI 0.031 to 0.042). Average administration mode/platform-specific correlations from 56 studies (61 estimates) had a pooled estimate of 0.88 (95% CI 0.86 to 0.90) and were still highly variable (I2 = 92.1). Similarly, average platform-specific ICCs from 39 studies (42 estimates) had a pooled estimate of 0.90 (95% CI 0.88 to 0.92) with an I2 of 91.5. After excluding 20 studies with outlying correlation coefficients (≥3SD from the mean), the I2 was 54.4, with the equivalence still high, the overall pooled correlation coefficient being 0.88 (95% CI 0.87 to 0.88). Agreement was found to be greater in more recent studies (p < 0.001), in randomized studies compared with non-randomised studies (p < 0.001), in studies with a shorter interval (<1 day) (p < 0.001), and in respondents of mean age 28 to 55 compared with those either younger or older (p < 0.001). In terms of mode/platform, paper vs Interactive Voice Response System (IVRS) comparisons had the lowest pooled agreement and paper vs tablet/touch screen the highest (p < 0.001).Conclusion: The present study supports the conclusion of Gwaltney's previous meta-analysis showing that PROMs administered on paper are quantitatively comparable with measures administered on an electronic device. It also confirms the ISPOR Taskforce´s conclusion that quantitative equivalence studies are not required for migrations with minor change only. This finding should be reassuring to investigators, regulators and sponsors using questionnaires on electronic devicesafter migration using best practices. Although there is data indicating that migrations with moderate changes produce equivalent instrument versions, hence do not require quantitative equivalence studies, additional work is necessary to establish this. Furthermore, there is the need to standardize migration practices and reporting practices (i.e. include copies of tested instrument versions and screenshots) so that clear recommendations regarding equivalence testing can be made in the future.raising questions about the necessity of conducting equivalence testing moving forward. [ABSTRACT FROM AUTHOR]

The purpose of this study was to produce a descriptive overview of the types of water-based interventions for people with neurological disability, autism, and intellectual disability and to determine how outcomes have been evaluated. Literature was searched through MEDLINE, EMBASE, Ovid Emcare, SPORTDiscus, Google Scholar, and Google. One hundred fifty-three papers met the inclusion criteria, 115 hydrotherapy, 62 swimming, 18 SCUBA (self-contained underwater breathing apparatus), and 18 other water-based interventions. Common conditions included cerebral palsy, spinal cord injury, Parkinson's disease, and intellectual disability. Fifty-four papers explored physical outcomes, 36 psychosocial outcomes, and 24 both physical and psychosocial outcomes, with 180 different outcome measures reported. Overall, there is a lack of high-quality evidence for all intervention types. This review provides a broad picture of water-based interventions and associated research. Future research, guided by this scoping review, will allow a greater understanding of the potential benefits for people with neurological disability, autism, and intellectual disability. [ABSTRACT FROM AUTHOR]

Purpose: Despite a known risk of cellulitis recurrence, the management of the wider impact and risk factors has been neglected. The innovative National Cellulitis Improvement Programme (NCIP) addresses this by providing evidence-based and individualised care to improve patient reported outcomes and reduce the risk of recurrence. The aim of this paper is to examine the longer-term impact of cellulitis and to identify a suitable and clinically relevant Patient Reported Outcome Measure (PROM). Methods: A review of existing cellulitis-specific PROMs was undertaken, alongside literature detailing the patient-focused impact of cellulitis, to identify a suitable PROM for clinical use. A group of expert therapists and patient representatives (n = 14) shared their individual and collective experiences over a series of events to discuss and debate the impact of cellulitis and review available PROMs. CELLUPROM© is introduced with anonymised PROM data and case study information reported to establish the impact of CELLUPROM© within usual NCIP care. Results: No cellulitis-specific PROMs were identified. Literature focused on the signs and symptoms of an acute episode of cellulitis, with outcome measures primarily used to evidence the impact of an intervention. An enduring physical, social and emotional impact of cellulitis was identified in this study, providing the basis for the new cellulitis-specific PROM (CELLUPROM©), which has been implemented with good effect in clinical care. Conclusion: This study has highlighted the lasting impact of cellulitis. Using CELLUPROM© within the risk-reduction NCIP has helped develop Value-Based Healthcare and support programme evaluation. [ABSTRACT FROM AUTHOR]

Malnutrition, muscle loss, and cachexia are prevalent in cancer and remain key challenges in oncology today. These conditions are frequently underrecognized and undertreated and have devastating consequences for patients. Early nutrition screening/assessment and intervention are associated with improved patient outcomes. As a multifaceted disease, cancer requires multimodal care that integrates supportive interventions, specifically nutrition and exercise, to improve nutrient intake, muscle mass, physical functioning, quality of life, and treatment outcomes. An integrated team of healthcare providers that incorporates societies' recommendations into clinical practice can help achieve the best possible outcomes. A multidisciplinary panel of experts in oncology, nutrition, exercise, and medicine participated in a 2-day virtual roundtable in October 2020 to discuss gaps and opportunities in oncology nutrition, alone and in combination with exercise, relative to current evidence and international societies' recommendations. The panel recommended five principles to optimize clinical oncology practice: (1) position oncology nutrition at the center of multidisciplinary care; (2) partner with colleagues and administrators to integrate a nutrition care process into the multidisciplinary cancer care approach; (3) screen all patients for malnutrition risk at diagnosis and regularly throughout treatment; (4) combine exercise and nutrition interventions before (e.g., prehabilitation), during, and after treatment as oncology standard of care to optimize nutrition status and muscle mass; and (5) incorporate a patient-centered approach into multidisciplinary care. [ABSTRACT FROM AUTHOR]

Background: The 45 and Up Study (the Study) is the largest study of healthy ageing in Australia and one of the biggest in the world. This review considered papers on physical activity in the first 15 years since the cohort was launched. Methods: This narrative review extracted papers in the Study inventory of publications and supplemented by searches in Scopus and Medline databases. Results: A total of 114 papers were identified, but after dual assessor extraction, 92 published articles were included that used physical activity as an exposure or outcome measure or reported physical activity prevalence in the sample studied. Results indicated that half of these physical activity studies used a cross sectional design. The 45 and Up survey responders were a highly active group, with three quarters meeting WHO recommended levels of physical activity. Optimal use of the longitudinal nature of this cohort linked physical activity exposures to a range of new health, environmental and wellbeing outcomes, and these papers were the most cited among 45 and Up physical activity papers. Nineteen of these 92 papers have been cited 50+ times, indicating good usage of 45 and Up physical activity data by the field. Discussion & Conclusion: Physical activity-related research has been an important part of the overall output of the 45 and Up Study, but recommendations for future research include greater use of the longitudinal nature of the cohort, more standardisation in the way physical activity estimates are described, and using waves of the 45 and Up Study physical activity data to explore patterns of activity over time as the exposure variable in relation to health outcomes. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study is to review all peer-reviewed published reports of women receiving ovarian tissue transplantation (OTT) with frozen/thawed tissue (OTC) with respect to age, diagnosis, transplantation site, fertility outcome, and potential side effects, including data from all women in the Danish program.Methods: A systematic review of the literature was performed in PubMed combined with results from all patients who had received OTT in Denmark up to December 2017.Results: OTT has been reported from 21 different countries comprising a total of 360 OTT procedures in 318 women. In nine women, malignancy was diagnosed after OTT; none were considered to be directly caused by the OTT. Despite a potential under reporting of cancer recurrence, there is currently no evidence to suggest that OTT causes reseeding of the original cancer. Renewed ovarian endocrine function was reported in 95% of the women. Half of all children born following OTT resulted from natural conception, and newborns were reported to be healthy except for one neonate with a chromosome anomaly with a family disposition. Women who conceived after OTT were significantly younger than those who failed.Conclusion: This study found no indications of sufficient numbers of malignant cells present in the ovarian tissue to cause recurrence of cancer after OTT. Further, it is unlikely that OTC affects the well-being of children born. OTC is now an established method of fertility preservation in Denmark with public reimbursement. The current data encourage that women who require gonadotoxic treatment should be offered an individual evaluation considering fertility preservation. [ABSTRACT FROM AUTHOR]

Structured reporting is emerging as a key element of optimising radiology's contribution to patient outcomes and ensuring the value of radiologist's work. It is being developed and supported by many national and international radiology societies, based on the recognised need to use uniform language and structure to accurately describe radiology findings. Standardisation of report structures ensures that all relevant areas are addressed. Standardisation of terminology prevents ambiguity in reports and facilitates comparability of reports. The use of key data elements and quantified parameters in structured reports (Bradiomics⋀) permits automatic functions (e.g. TNM staging), potential integration with other clinical parameters (e.g. laboratory results), data sharing (e.g. registries, biobanks) and data mining for research, teaching and other purposes. This article outlines the requirements for a successful structured reporting strategy (definition of content and structure, standard terminologies, tools and protocols). A potential implementation strategy is outlined. Moving from conventional prose reports to structured reporting is endorsed as a positive development and must be an international effort, with international design and adoption of structured reporting templates that can be translated and adapted in local environments as needed. Industry involvement is key to success, based on international data standards and guidelines. [ABSTRACT FROM AUTHOR]

In recent decades cancer care has seen improvements in the speed and accuracy of diagnostic procedures; the effectiveness of surgery, radiation therapy and medical treatments; the power of information technology; and the development of multidisciplinary, specialist-led approaches to care. Such innovations are essential if we are to continue improving the lives of cancer patients across Europe despite financial pressures on our healthcare systems. Investment in innovation must be balanced with the need to ensure the sustainability of healthcare budgets, and all health professionals have a responsibility to help achieve this balance. It requires scrutiny of the way care is delivered; we must be ready to discontinue practices or interventions that are inefficient, and prioritise innovations that may deliver the best outcomes possible for patients within the limits of available resources. Decisions on innovations should take into account their long-term impact on patient outcomes and costs, not just their immediate costs. Adopting a culture of innovation requires a multidisciplinary team approach, with the patient at the centre and an integral part of the team. It must take a whole-system and whole-patient perspective on cancer care and be guided by high-quality real-world data, including outcomes relevant to the patient and actual costs of care; this accurately reflects the impact of any innovation in clinical practice. The European CanCer Organisation is committed to working with its member societies, patient organisations and the cancer community at large to find sustainable ways to identify and integrate the most meaningful innovations into all aspects of cancer care. [ABSTRACT FROM AUTHOR]

Summary: This paper reviews a personal selection of three potentially important cystic fibrosis (CF) interventional studies that have been published in the 12 month period preceding the November 2012 RSM CF conference. The review highlights the difficulties in the interpretation of outcome measures in CF. [ABSTRACT FROM AUTHOR]

Background: Outcome measurement plays an increasing role in improving the quality, effectiveness, efficiency and availability of palliative care. Aim: To provide expert recommendations on outcome measurement in palliative care in clinical practice and research. Methods: Developed by a European Association for Palliative Care Task Force, based on literature searches, international expert workshop, development of outcome measurement guidance and international online survey. A subgroup drafted a first version and circulated it twice to the task force. The preliminary final version was circulated to wider expert panel and 28 international experts across 20 European Association for Palliative Care member associations and the European Association for Palliative Care Board of Directors and revised according to their feedback. The final version was approved by the European Association for Palliative Care Board for adoption as an official European Association for Palliative Care position paper. Results: In all, 12 recommendations are proposed covering key parameters of measures, adequate measures for the task, introduction of outcome measurement into practice, and national and international outcome comparisons and benchmarking. Compared to other recommendations, the White Paper covers similar aspects but focuses more on outcome measurement in clinical care and the wider policy impact of implementing outcome measurement in clinical palliative care. Patient-reported outcome measure feedback improves awareness of unmet need and allows professionals to act to address patients’ needs. However, barriers and facilitators have been identified when implementing outcome measurement in clinical care that should be addressed. Conclusion: The White Paper recommends the introduction of outcome measurement into practice and outcomes that allow for national and international comparisons. Outcome measurement is key to understanding different models of care across countries and, ultimately, patient outcome having controlled for differing patients characteristics. [ABSTRACT FROM AUTHOR]

White blood cell count is an important indicator of each individual's health condition. An abnormal white blood cell count usually results from an infection, cancer, or other conditions that trigger systemic inflammation responses. White blood cell count also provides predictive information on the incidence of cardiovascular diseases and Type 2 diabetes. Therefore, monitoring white blood cell count on a regular basis can potentially help individuals to take preventive measures and improve healthcare outcomes. Currently, white blood cell count is primarily conducted in centralized laboratories, and it requires specialized equipment and dedicated personnel to perform the test and interpret the results. So far there has been no rapid test that allows white blood cell count in low-resource settings. In this study, we have demonstrated a vertical flow platform that quantifies white blood cells by trapping them in the paper. White blood cells were tagged with gold nanoparticles, and flowed through the paper via a small orifice. The white blood cell count was determined by measuring the colorimetric intensity of gold nanoparticles on the surface of white blood cells that were trapped in the paper mesh. Using this platform, we were able to quantify white blood cells in 15 μL of blood, and visually differentiate the abnormal count of white blood cells from the normal count. The proposed platform enabled rapid white blood cell count in low resource settings with a small sample volume requirement. Its low-cost, instrument-free operations would be attractive for point-of-care applications. [ABSTRACT FROM AUTHOR]

The long-term consequences of exposure to excess stress, particularly during sensitive developmental windows, on the initiation and progression of many complex, common physical and mental disorders that confer a major global burden of disease are well established. The period of intrauterine life represents among the most sensitive of these windows, at which time the effects of stress may be transmitted inter-generationally from a mother to her as-yet-unborn child. As explicated by the concept of fetal or developmental programming of health and disease susceptibility, a growing body of evidence supports the notion that health and disease susceptibility is determined by the dynamic interplay between genetic makeup and environment, particularly during intrauterine and early postnatal life. Except in extreme cases, an adverse intrauterine exposure may not, per se , ‘cause’ disease, but, instead, may determine propensity for disease(s) in later life (by shaping phenotypic responsivity to endogenous and exogenous disease-related risk conditions). Accumulating evidence suggests that maternal psychological and social stress during pregnancy represents one such condition that may adversely affect the developing child, with important implications for a diverse range of physical and mental health outcomes. In this paper we review primarily our own contributions to the field of maternal stress during pregnancy and child mental and physical health-related outcomes. We present findings on stress-related maternal-placental-fetal endocrine and immune/inflammatory processes that may mediate the effects of various adverse conditions during pregnancy on the developing human embryo and fetus. We enunciate conceptual and methodological issues related to the assessment of stress during pregnancy and discuss potential mechanisms of intergenerational transmission of the effects of stress. Lastly, we describe on-going research and some future directions of our program. [ABSTRACT FROM AUTHOR]

Aim: Electronic formats (ePROs) of paper-based patient-reported outcomes (PROs) should be validated before they can be reliably used. This review aimed to examine studies investigating measurement equivalence between ePROs and their paper originals to identify methodologies used and to determine the extent of such validation. Methods: Three databases (OvidSP, Web of Science and PubMed) were searched using a set of keywords. Results were examined for compliance with inclusion criteria. Articles or abstracts that directly compared screen-based electronic versions of PROs with their validated paper-based originals, with regard to their measurement equivalence, were included. Publications were excluded if the only instruments reported were stand-alone visual analogue scales or interactive voice response formats. Papers published before 2007 were excluded, as a previous meta-analysis examined papers published before this time. Results: Fifty-five studies investigating 79 instruments met the inclusion criteria. 53 % of the 79 instruments studied were condition specific. Several instruments, such as the SF-36, were reported in more than one publication. The most frequently reported formats for ePROs were Web-based versions. In 78 % of the publications, there was evidence of equivalence or comparability between the two formats as judged by study authors. Of the 30 publications that provided preference data, 87 % found that overall participants preferred the electronic format. Conclusions: When examining equivalence between paper and electronic versions of PROs, formats are usually judged by authors to be equivalent. Participants prefer electronic formats. This literature review gives encouragement to the further widespread development and use of ePROs. [ABSTRACT FROM AUTHOR]

The efficient management of hospitals is vital to the delivery of high-quality healthcare services and exceptional patient outcomes. This paper aims to explore the significance of health care management, its impact on people's health, and organizational fulfillment. Case studies and empirical research are used to evaluate the influence of numerous management strategies on organizational subculture, teamwork engagement, and patient outcomes. The importance of management in stimulating innovation, and dealing with complicated healthcare structures is also discussed. This paper emphasizes the need for visionary management to achieve organizational excellence and innovation and future developments in patient-targeted care models. [ABSTRACT FROM AUTHOR]

The article focuses on no benefits for home-based rehabilitation for people with inoperable lung cancer over usual care.

The article offers information on association of unilateral spatial neglect with motor recovery of the affected upper extremity poststroke. and examines if sensorimotor interventions improve upper limb function in people with unilateral spatial neglect after stroke.

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]

The author discusses the top five "American Journal of Sports Medicine" (AJSM) papers in epidemiology and statistics related to sports medicine over the past 50 years, as of 2022. These include topics on cervical quadriplegia from 1971 to 1975, knee ligament surgery results on use of a scoring scale, and descriptive epidemiology of the multicenter anterior cruciate ligament (ACL) revision study (MARS) cohort.

Ischaemic heart disease (IHD) remains the leading cause of death and disability worldwide. As a result, novel therapies are still needed to protect the heart from the detrimental effects of acute ischaemia–reperfusion injury, in order to improve clinical outcomes in IHD patients. In this regard, although a large number of novel cardioprotective therapies discovered in the research laboratory have been investigated in the clinical setting, only a few of these have been demonstrated to improve clinical outcomes. One potential reason for this lack of success may have been the failure to thoroughly assess the cardioprotective efficacy of these novel therapies in suitably designed preclinical experimental animal models. Therefore, the aim of this Position Paper by the European Society of Cardiology Working Group Cellular Biology of the Heart is to provide recommendations for improving the preclinical assessment of novel cardioprotective therapies discovered in the research laboratory, with the aim of increasing the likelihood of success in translating these new treatments into improved clinical outcomes. [ABSTRACT FROM AUTHOR]

In this laboratory experiment we examined the effect of resume format (paper resume only, video resume only, or both) on applicant evaluation. Differences in applicant personality trait evaluation were found for extraversion and agreeableness when video resumes were reviewed compared to when only paper resumes were reviewed. In addition, social skill and mental capability ratings were lower when only video resumes were reviewed. These findings indicate that video resumes may result in different assessments of applicant personality and harsher evaluations of applicant skills and abilities than paper resumes. Human resource personnel are cautioned in the use of video resumes until more research has been completed. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this study was to evaluate the measurement equivalence of an interactive voice response system (IVRS) version and the original paper-based version of the EORTC QLQ-C30. Methods: The QLQ-C30 is a cancer-specific, health-related quality of life questionnaire consisting of nine multi-item scales (physical, role, emotional, cognitive and social functioning, fatigue, nausea/vomiting, pain, and quality of life) and six single item measures (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial problems). This study utilized a crossover design with subjects randomly assigned to one of two assessment orders: (1) paper then IVRS or (2) IVRS then paper. Equivalence between the two administration modes was established by comparing the 95 % lower confidence interval (CI) of the intraclass correlation coefficients (ICCs) for each scale, with a critical value of 0.70. Results: The ICCs for the nine multi-item scales were all above 0.79, ranging from 0.791 to 0.899 (ICC 95 % lower CI range 0.726-0.865) and significantly different from our threshold reliability of 0.70. The ICCs for the six single items ranged from 0.689 to 0.896 (ICC 95 % lower CI range 0.611-0.888). Two of the items, insomnia and appetite loss, were not statistically different from 0.70. When considered together, the per-protocol analysis results support the equivalence of the paper and IVRS versions of the QLQ-C30 for 13 of the 15 scores. Conclusion: This analysis provides evidence that the scores obtained from the IVRS version of the QLQ-C30 are equivalent to those obtained with the original paper version except for the insomnia and appetite loss items. [ABSTRACT FROM AUTHOR]

A cross-sectional study was performed to assess the correlation between telephone and self-administration of patient-related outcomes (PROs) used in the assessment of ankylosing spondylitis (AS) patients. Participants underwent a telephone interview in which the following measures were evaluated: numerical rating scales (NRSs) for global health, pain intensity, global pain, back pain, and back pain at night; BASDI, BASFI, Health Assessment Questionnaire (HAQ), ASQoL, EuroQol, SF-12, and Work Productivity and Activity Impairment (WPAI) questionnaire. Within 48 h after the telephone interview, patients were appointed for a clinical visit in which the same questionnaires and in the same order were self-administered. The degree of correlation of outcomes measures between telephone interview and self-administration was assessed with the intraclass correlation coefficient (ICC). The two modes of assessing PROs were highly reliable, with ICC of 0.81 for BASDAI, 0.82 for BASFI, and 0.75 for HAQ. NRSs for global health, global pain intensity, back pain, and back pain at night also showed ICCs between 0.51 and 0.70, and only NRS for global disease activity showed an ICC of 0.45. This results were similar in patients with AS and patients with psoriatic arthritis. Social functioning and mental health domains of the SF-12 as well as EuroQol had poor correlations. The ICCs for WPAI outcomes were very good or good. We conclude that PROs in AS patients are comparable in both self-administered paper questionnaires and via a telephone interview. Different modes of assessing PRO measures facilitate the assessment of patients with AS in routine practice. [ABSTRACT FROM AUTHOR]

Background/Objectives: The message is being used as a mode of intervention leading to preventive health behaviors and can lead to modifications in knowledge, attitudes and behaviors in a large proportion of health behaviors. The purpose of this study is to identify the effective and persuasive message types among positive and negative message types in information on specific health behaviors, to evaluate the effects by systematically classifying and analyzing related studies and to lead evidence-based practices. Method/Statistical Analysis: In this study, meta-analysis was conducted to evaluate the trends and reporting levels of the study in order to evaluate and systematically classify the effects of message types in information on health behavior. Only clinical studies with randomization comparing the effects of positive and negative message framing with respect to health behavior were selected. In addition, a case where the interventions were compared by dividing them into two groups was selected. Improvements/Applications: Among the final selected papers, 7 papers were included in the included studies through methodological quality evaluation. Comparison of the positive and negative message interventions is related to health behaviors related to breast cancer (SMD -0.04 (95% CI -1.57 to 1.50), health behaviors related to vaccination (MMR, HPV)(SMD 0.20 (95% CI -0.69 to 1.08), cancer screening, vaccination, physical activity and all health activities related to Type 2 diabetes screening (SMD -0.21 (95% CI -0.89 to 0.47). All of these were not statistically significant. In order to confirm the change in health behavior according to message framing, a study considering the same target population and outcome indicators is necessary. [ABSTRACT FROM AUTHOR]

Objectives: Patient-reported outcomes (PROs; self-report assessments) are increasingly important in evaluating medical care and treatment efficacy. Electronic administration of PROs via computer is becoming widespread. This article reviews the literature addressing whether computer-administered tests are equivalent to their paper-and-pencil forms. Methods: Meta-analysis was used to synthesize 65 studies that directly assessed the equivalence of computer versus paper versions of PROs used in clinical trials. A total of 46 unique studies, evaluating 278 scales, provided sufficient detail to allow quantitative analysis. Results: Among 233 direct comparisons, the average mean difference between modes averaged 0.2% of the scale range (e.g., 0.02 points on a 10-point scale), and 93% were within ±5% of the scale range. Among 207 correlation coefficients between paper and computer instruments (typically intraclass correlation coefficients), the average weighted correlation was 0.90; 94% of correlations were at least 0.75. Because the cross-mode correlation (paper vs. computer) is also a test–retest correlation, with potential variation because of retest, we compared it to the within-mode (paper vs. paper) test–retest correlation. In four comparisons that evaluated both, the average cross-mode paper-to-computer correlation was almost identical to the within-mode correlation for readministration of a paper measure (0.88 vs. 0.91). Conclusions: Extensive evidence indicates that paper- and computer-administered PROs are equivalent. [ABSTRACT FROM AUTHOR]

Background: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. Objectives: This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis. Methods: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy. Results: FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34) except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61) pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55) pairwise comparisons and were statistically significant in 5. The “signal” in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical. Conclusion: There was no empirical evidence to suggest biased estimates between the two sources. Increased and detailed transparency in publications would improve the understanding and credibility of published results. Further, the FDA report was found to be a useful source when data are missing in the published report (i.e. reporting bias). [ABSTRACT FROM AUTHOR]

Psoriasis is a common, immune-mediated chronic inflammatory disease with a primary involvement of skin and joints, affecting approximately 2% of the population worldwide. Up to one third of patients with psoriasis are diagnosed with psoriatic arthritis (PsA). Psoriasis and PsA are heterogeneous diseases whose severity depends on a number of clinical factors, such as areas affected and pattern of involvement, and are associated with a range of comorbid diseases and risk factors, including obesity, metabolic syndrome, cardiovascular disease and liver disease. Thus measuring the severity of psoriatic disease needs to take into account the multidimensional aspects of the disease. Subjective measures including the impairment in quality of life or in daily living activities as well as the presence of cardio-metabolic comorbidities, are important for the outcome and add further levels of complexity that, to a certain extent, need to be assessed. Because of the wide range of comorbid conditions associated with psoriasis, comprehensive screening and treatment must be implemented for a most effective managing of psoriasis patients. A joint dermatologist–rheumatologist roundtable discussion was convened to share evidence on the real-life use of methods for measuring psoriasis severity comprehensively. Our objective was to provide an expert position on which clinical variables are to be taken into account when considering patients affected by psoriasis and/or PsA globally and on the assessment tools more suitable for measuring disease activity and/or severity in clinical practice. [ABSTRACT FROM AUTHOR]

Lung cancer is the most frequently fatal cancer, with poor survival once the disease is advanced. Annual low-dose computed tomography has shown a survival benefit in screening individuals at high risk for lung cancer. Based on the available evidence, the European Society of Radiology and the European Respiratory Society recommend lung cancer screening in comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres. Minimum requirements include: standardised operating procedures for low-dose image acquisition, computer-assisted nodule evaluation, and positive screening results and their management; inclusion/exclusion criteria; expectation management; and smoking cessation programmes. Further refinements are recommended to increase quality, outcome and cost-effectiveness of lung cancer screening: inclusion of risk models, reduction of effective radiation dose, computer-assisted volumetric measurements and assessment of comorbidities (chronic obstructive pulmonary disease and vascular calcification). All these requirements should be adjusted to the regional infrastructure and healthcare system, in order to exactly define eligibility using a risk model, nodule management and a quality assurance plan. The establishment of a central registry, including a biobank and an image bank, and preferably on a European level, is strongly encouraged. Key points: • Lung cancer screening using low dose computed tomography reduces mortality. • Leading US medical societies recommend large scale screening for high-risk individuals. • There are no lung cancer screening recommendations or reimbursed screening programmes in Europe as of yet. • The European Society of Radiology and the European Respiratory Society recommend lung cancer screening within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres. • High risk, eligible individuals should be enrolled in comprehensive, quality-controlled longitudinal programmes. [ABSTRACT FROM AUTHOR]