Standardised Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD): study protocol for establishing a core outcome set in polycystic kidney disease

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is the most common potentially life threatening inherited kidney disease and is responsible for 5-10% of cases of end-stage kidney disease (ESKD). Cystic kidneys may enlarge up to 20 times the weight of a normal kidney due to the growth of renal cysts, and patients with ADPKD have an increased risk of morbidity, premature mortality, and other life-time complications including renal and hepatic cyst and urinary tract infection, intracranial aneurysm, diverticulosis, and kidney pain which impair quality of life. Despite some therapeutic advances and the growing number of clinical trials in ADPKD, the outcomes that are relevant to patients and clinicians, such as symptoms and quality of life, are infrequently and inconsistently reported. This potentially limits the contribution of trials to inform evidence-based decision-making. The Standardised Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) project aims to establish a consensus-based set of core outcomes for trials in PKD (with an initial focus on ADPKD but inclusive of all stages) that patients and health professionals identify as critically important. METHODS: The five phases of SONG-PKD are: a systematic review to identify outcomes that have been reported in existing PKD trials; focus groups with nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with health professionals to elicit individual values and perspectives on outcomes for trials involving patients with PKD; an international three-round Delphi survey with all stakeholder groups (including patients, caregivers, healthcare providers, policy makers, researchers, and industry) to gain consensus on critically important core outcome domains; and a consensus workshop to review and establish a set of core outcome domains and measures for trials in PKD. DISCUSSION: The SONG-PKD core outcome set is aimed at improving the consistency and completeness of outcome reporting across ADPKD trials, leading to improvements in the reliability and relevance of trial-based evidence to inform decisions about treatment and ultimately improve the care and outcomes for people with ADPKD

Macrocytosis may be associated with mortality in chronic hemodialysis patients: a prospective study

<p>Abstract</p> <p>Background</p> <p>Macrocytosis occurs in chronic hemodialysis (CHD) patients; however, its significance is unknown. The purpose of this study was to establish the prevalence and distribution of macrocytosis, to identify its clinical associations and to determine if macrocytosis is associated with mortality in stable, chronic hemodialysis patients.</p> <p>Methods</p> <p>We conducted a single-centre prospective cohort study of 150 stable, adult CHD patients followed for nine months. Macrocytosis was defined as a mean corpuscular volume (MCV) > 97 fl. We analyzed MCV as a continuous variable, in tertiles and using a cutoff point of 102 fl.</p> <p>Results</p> <p>The mean MCV was 99.1 ± 6.4 fl, (range 66-120 fl). MCV was normally distributed. 92 (61%) of patients had an MCV > 97 fl and 45 (30%) > 102 fl. Patients were not B12 or folate deficient in those with available data and three patients with an MCV > 102 fl had hypothyroidism. In a logistic regression analysis, an MCV > 102 fl was associated with a higher Charlson-Age Comorbidity Index (CACI) and higher ratios of darbepoetin alfa to hemoglobin (Hb), [(weekly darbepoetin alfa dose in micrograms per kg body weight / Hb in g/L)*1000]. There were 23 deaths at nine months in this study. Unadjusted MCV > 102 fl was associated with mortality (HR 3.24, 95% CI 1.42-7.39, P = 0.005). Adjusting for the CACI, an MCV > 102 fl was still associated with mortality (HR 2.47, 95% CI 1.07-5.71, P = 0.035).</p> <p>Conclusions</p> <p>Macrocytosis may be associated with mortality in stable, chronic hemodialysis patients. Future studies will need to be conducted to confirm this finding.</p

Core outcome domains for trials in autosomal dominant polycystic kidney disease: An international Delphi survey

Rationale & Objective Outcomes reported in trials involving patients with autosomal dominant polycystic kidney disease (ADPKD) are heterogeneous and rarely include patient-reported outcomes. We aimed to identify critically important consensus-based core outcome domains to be reported in trials in ADPKD. Study Design An international 2-round online Delphi survey was conducted in English, French, and Korean languages. Setting & Participants Patients/caregivers and health professionals completed a 9-point Likert scale (7-9 indicating critical importance) and a Best-Worst Scale. Analytical Approach The absolute and relative importance of outcomes were assessed. Comments were analyzed thematically. Results 1,014 participants (603 [60%] patients/caregivers, 411 [40%] health professionals) from 56 countries completed round 1, and 713 (70%) completed round 2. The prioritized outcomes were kidney function (importance score, 8.6), end-stage kidney disease (8.6), death (7.9), blood pressure (7.9), kidney cyst size/growth (7.8), and cerebral aneurysm (7.7). Kidney cyst–related pain was the highest rated patient-reported outcome by both stakeholder groups. Seven themes explained the prioritization of outcomes: protecting life and health, directly encountering life-threatening and debilitating consequences, specificity to ADPKD, optimizing and extending quality of life, hidden suffering, destroying self-confidence, and lost opportunities. Limitations Study design precluded involvement from those without access to internet or limited computer literacy. Conclusions Kidney function, end-stage kidney disease, and death were the most important outcomes to patients, caregivers, and health professionals. Kidney cyst–related pain was the highest rated patient-reported outcome. Consistent reporting of these top prioritized outcomes may strengthen the value of trials in ADPKD for decision making

Performance-enhancing drugs attitudes among young amateur Croatian athletes

Abstract Background Recent studies revealed that amateur athletes, especially young ones, have an increasing tendency of performance-enhancing drugs (PEDs) usage. The aim of this study was to explore PEDs attitudes among young, amateur Croatian athletes. Methods This cross-sectional questionnaire study was done in convenient sample of young amateur Croatian athletes during the August 2019 to January 2020 at the occupational and sports medicine office in Eastern Croatia. Performance Enhancement Attitudes Scale (PEAS) was used for evaluation of athletes' attitudes towards doping. Results There were 306 athletes median age 18.0 (interquartile range (IR) 15.0 - 21.0) years; 62.7% females and 37.3% males. According to the age there were 52.9% of adolescents (aged 13 to 18 years) and 47.1% of young adults (aged 19 to 24 years). Regarding the type of sport there were 19.6% of subjects who played individual sports and 80.4% of them who played team sports. Considering the length of sport engagement 49.7% of subjects were engaged in their sport for 1 to 5 years and 50.3% of them were engaged in their sport for 6 or more years. The prevalence of current PEDs usage was 1.3%, while past PEDs usage prevalence was 3.3%. Current PEDs usage was more frequent among young adults (P = 0.048) and athletes playing individual sports (P = 0.001). Athletes who were engaged in sports for 1 to 5 years had more permissive attitudes toward PEDs (P &amp;lt; 0.001) as measured by the PEAS. The study did not establish any correlation between current or past PEDs usage and attitudes toward PEDs. Conclusions PEDs usage is present among young Croatian amateur athletes. There is a need for interventions directed toward the prevention of PEDs usage in an observed subgroup of athletes. Key messages In order to be more effective doping prevention strategies should take into account athletes’ attitudes towards doping. Public awareness and knowledge about doping in sports should be increased in order to achieve more efficient anti-doping programs. </jats:sec

Mental health outcomes in road traffic accident survivors: prospective cohort study

Abstract Background Mental health outcomes of road traffic accidents (RTAs) are always investigated amongst the injured. The aim of this study was to investigate psychological consequences and associated factors in all RTA survivors irrelevant of their injury status. Methods A cohort of 200 Croatian RTA survivors was assessed one month after experiencing a RTA using the posttraumatic stress disorder (PTSD) Checklist for civilians, the Beck Depression Inventory and the Beck Anxiety Inventory. The New Injury Severity Scale was used for the injury severity assessment. Results RTA survivors reported substantial rates of PTSD (35.5%) and depression (20.0%) symptoms, and low rates of anxiety (4.5%). Symptoms of depression were associated with under-average self-perceived economic status (SES) (P = 0.001), irreligiousness (P = 0.001), medication use (P &amp;lt; 0.001), injury severity (P &amp;lt; 0.001), self-perceived threat to life (P &amp;lt; 0.022), hospitalization (P = 0.003), hospitalization duration (P = 0.004), surgical treatment of the injury (P &amp;lt; 0.001), unconsciousness in the RTA (P = 0.033) and post-RTA amnesia (0.039). PTSD symptoms were associated with unemployment (P = 0.034), under average SES (P = 0.004), lack of previous RTA experience (P = 0.025), previous psychiatric illness (P = 0.001), medication use (P = 0.001), psychiatric medication use (P &amp;lt; 0.001), injury affliction (P = 0.001), injury severity (P &amp;lt; 0.001), self-perceived threat to life (P &amp;lt; 0.001), pain after RTA (P = 0.009), hospitalization duration (P = 0.017) and claiming compensation (P = 0.008). Anxiety symptoms were associated with previous chronic (P = 0.037) or psychiatric illness (P = 0.010), previous permanent pain (P &amp;lt; 0.001), psychiatric medication use (P = 0.013) and rehabilitation after injury (P = 0.032). Conclusions A RTA is a traumatic event that can result in physical injuries, but also with psychological consequences depending on pre-RTA survivor's characteristics. Psychological support to those at risk may prevent psychological disorders after a RTA. Key messages Along with evaluation and treatment of road traffic accidents injuries, health care providers should evaluate pre-accident health status of all road traffic accidents victims. Understanding factors that present risk for poor mental health outcomes after the road traffic accidents is the key step in planning and organizing recovery of accidents survivors. </jats:sec

Attitudes towards vaccination among Croatian high school students

Abstract Background Due to the success of immunization, most of young people have little experience with vaccine preventable diseases. This inexperience may increase vaccine hesitancy in this population subgroup which can potentially jeopardize population vaccination coverage. Understanding young peoples' attitudes towards vaccination is important for vaccination uptake. The aim of this study was to evaluate attitudes towards vaccination among Croatian high school students. Methods This online cross-sectional questionnaire study was conducted during the January 2021 to April 2021 in convenient sample of high school students from north-western part of Croatia. Vaccination Attitudes Examination scale (VAX) was used to assess antivaccination attitudes in study population. Results The study included 1012 high school students; 29.2% males and 70.8% females; median age 17.0 (interquartile range (IQR) 17.0 - 18.0) years. Overall value of the VAX score in study sample was 50.4±11.1. Female students had more negative attitudes towards vaccination in comparison to male students (P = 0.001). When analysing differences between female and male students according to the VAX scale subcategories the study revealed that female students demonstrated more worries over unforeseen future effects of the vaccination (P &amp;lt; 0.001) while there were no differences between females and males according to the mistrust of vaccine benefits, concerns about commercial profit and preference for natural immunity (P = 0.155, P = 0.157 and P = 0.142, respectively). Conclusions The study revealed rather high antivaccination attitudes among Croatian high school students as measured by VAX score. Further studies are needed to better understand factors that influence such attitudes in study population because programs directed towards changing antivaccination attitudes in order to be efficient need to successfully tackle all of those factors. Key messages Public health interventions directed towards suppression of antivaccination movement should more involve younger population subgroups, such as elementary and high school students. Positive attitudes towards vaccination in younger population subgroups are one of the crucial preconditions for adequate vaccination coverage. </jats:sec