To describe the quality of reporting and the nature of reported harms in clinical studies on the effectiveness of supervised exercises in patients with rheumatoid arthritis (RA) or axial... Show moreTo describe the quality of reporting and the nature of reported harms in clinical studies on the effectiveness of supervised exercises in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). We performed a systematic review, searching eight databases up to February 2023. Randomized controlled trials (RCTs) evaluating supervised exercises in adults with RA or axSpA were considered eligible. Data on harms were extracted according to the CONSORT Harms 2022 Checklist. Among others, it was recorded if harms were prespecified or non-prespecified. Moreover, the nature of reported harms was listed. Forty RCTs were included for RA and 25 for axSpA, of which 29 (73%) and 13 (52%) reported information on harms. In 13 (33%) RCTs in RA and four (16%) in axSpA, the collection of harms outcomes was described in the methods section. Prespecified outcomes were reported by eight (RA) and two (axSpA) RCTs. Non-specified harms outcomes were reported by six (RA) and four (axSpA) RCTs. Prespecified harms outcomes included measures of pain, disease activity, inflammation, and structural joint changes. The nature of non-prespecified harms outcomes varied largely, with pain being most common. A considerable proportion of trials on supervised exercise in RA or axSpA does not or inadequately report harms outcomes. Pain was the most commonly reported prespecified or non-specified harm. For a considerate interpretation of the balance between benefits and harms of supervised exercise in RA or axSpA, use of the CONSORT Harms 2022 Checklist for the design, conduct and reporting of trials is advocated. Show less
BackgroundIn neurosurgical patients, the risk of developing venous thromboembolism (VTE) is high due to the relatively long duration of surgical interventions, usually long immobilization time... Show moreBackgroundIn neurosurgical patients, the risk of developing venous thromboembolism (VTE) is high due to the relatively long duration of surgical interventions, usually long immobilization time after surgery, and possible neurological deficits which can negatively influence mobility. In neurosurgical clinical practice, there is lack of consensus on optimal prophylaxis against VTE, mechanical or pharmacological.ObjectiveTo systematically review available literature on the incidence of VTE in neurosurgical interventions and to establish an optimum prevention strategy.MethodsA literature search was performed in PubMed, Embase, Web of Science, Cochrane Library, and EmCare, based on a sensitive search string combination. Studies were selected by predefined selection criteria, and risk of bias was assessed by Newcastle-Ottawa Quality Assessment Scale and Cochrane risk of bias.ResultsTwenty-five studies were included, half of which had low risk of bias (21 case series, 3 comparative studies, 1 RCT). VTE was substantially higher if the evaluation was done by duplex ultrasound (DUS), or another systematic screening method, in comparison to clinical evaluation (clin). Without prophylaxis DVT, incidence varied from 4 (clin) to 10% (DUS), studies providing low molecular weight heparin (LMWH) reported an incidence of 2 (clin) to 31% (DUS), providing LMWH and compression stockings (CS) reported an incidence of 6.4% (clin) to 29.8% (DUS), and providing LMWH and intermittent pneumatic compression devices (IPC) reported an incidence of 3 (clin) to 22.3% (DUS). Due to a lack of data, VTE incidence could not meaningfully be compared between patients with intracranial and spine surgery. The reported incidence of pulmonary embolism (PE) was 0 to 7.9%.ConclusionLow molecular weight heparin, compression stockings, and intermittent pneumatic compression devices were all evaluated to give reduction in VTE, but data were too widely varying to establish an optimum prevention strategy. Systematic screening for DVT reveals much higher incidence percentages in comparison to screening solely on clinical grounds and is recommended in follow-up of neurosurgical procedures with an increased risk for DVT development in order to prevent occurrence of PE. Show less
BackgroundOver the past 40 years, the tasks of pharmacists have shifted from logistic services to pharmaceutical care (PhC). Despite the increasing importance of measuring quality of care, there is... Show moreBackgroundOver the past 40 years, the tasks of pharmacists have shifted from logistic services to pharmaceutical care (PhC). Despite the increasing importance of measuring quality of care, there is no general definition of Quality Indicators (QIs) to measure PhC. Recognising this, a working group in a European association of PhC researchers, the Pharmaceutical Care Network Europe (PCNE), was established in 2020.AimThis research aimed to review existing definitions of QIs and develop a definition of QIs for PhC.MethodA two-step procedure was applied. Firstly, a systematic literature review was conducted to identify existing QI definitions that were summarised. Secondly, an expert panel, comprised of 17 international experts from 14 countries, participated in two surveys and a discussion using a modified Delphi technique to develop the definition of QIs for PhC.ResultsA total of 182 QI definitions were identified from 174 articles. Of these, 63 QI definitions (35%) cited one of five references as the source. Sixteen aspects that construct QI definitions were derived from the identified definitions. As a result of the Delphi study, the panel reached an agreement on a one-sentence definition of QIs for PhC: “quality indicators for pharmaceutical care are validated measurement tools to monitor structures, processes or outcomes in the context of care provided by pharmacists”.ConclusionBuilding upon existing definition of QIs, an international expert panel developed the PCNE definition of QIs for PhC. This definition is intended for universal use amongst researchers and healthcare providers in PhC. Show less
Central serous chorioretinopathy (CSC) is a prevalent exudative maculopathy and the ongoing verteporfin shortage restricts current treatment possibilities. Topical non-steroidal anti-inflammatory... Show moreCentral serous chorioretinopathy (CSC) is a prevalent exudative maculopathy and the ongoing verteporfin shortage restricts current treatment possibilities. Topical non-steroidal anti-inflammatory drugs (NSAID) have previously been proposed as a treatment for CSC, although its exact efficacy remains unclear. In this systematic review and meta-analysis, we outlined the efficacy of topical NSAIDs for the treatment of CSC. We searched 11 literature databases on 13 December 2022, for any study describing topical NSAID treatment for CSC. Thirteen eligible studies were included with a total of 1001 eyes of 994 patients with CSC. Six studies were case reports, two were cohort studies and five were non-randomized comparative studies. Where specified, topical NSAIDs used were bromfenac 0.09%, diclofenac 0.1%, ketorolac 0.4% and 0.5%, pranoprofen 0.1%, and nepafenac 0.1% and 0.3%. Studies were predominantly of cases with acute CSC and several case studies reported treatment outcomes simultaneously with discontinuation of corticosteroid use, which complicated treatment evaluation. Meta-analyses of comparative studies revealed a statistically significant but clinically irrelevant best-corrected visual acuity improvement of -0.04 logMAR (95% CI: -0.07 to -0.01 logMAR; p = 0.01) at 1-month follow-up, which became statistically insignificant at 3-month follow-up (-0.03 logMAR; 95% CI: -0.06 to 0.003 logMAR; p = 0.08). Further, we found no benefit in complete subretinal fluid resolution at 1-month follow-up (OR: 1.20; 95% CI: 0.81-1.76; p = 0.37) or 3-month follow-up (OR: 1.17; 95% CI: 0.86 to 1.59; p = 0.33). Taken together, available evidence does not support the use of topical NSAIDs for the treatment of CSC. Show less
Purpose: Although the use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures is widely advocated, little is known on their use in patients with inflammatory arthritis. We... Show morePurpose: Although the use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures is widely advocated, little is known on their use in patients with inflammatory arthritis. We systematically describe the use and outcomes of PROMIS measures in clinical studies involving people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). Methods: A systematic review was conducted according to the PRISMA guidelines. Through a systematic search of nine electronic databases, clinical studies including patients with RA or axSpA and reporting the use of PROMIS measure were selected. Study characteristics, details of PROMIS measures and their outcomes, if available, were extracted. Results: In total, 29 studies described in 40 articles met the inclusion criteria, of which 25 studies included RA patients, three studies included axSpA patients and one study included both RA and axSpA patients. The use of two general PROMIS measures (PROMIS Global Health, PROMIS-29) and 13 different domain-specific PROMIS measures was reported, of which the PROMIS Pain Interference (n = 17), Physical Function (n = 14), Fatigue (n = 13), and Depression (n = 12) measures were most frequently used. Twenty-one studies reported their results in terms of T-scores. Most T-scores were worse than the general population mean, indicating impairments of health status. Eight studies did not report actual data but rather measurement properties of the PROMIS measures. Conclusion: There was considerable variety regarding the different PROMIS measures used, with the PROMIS Pain interference, Physical function, Fatigue, and Depression measures being the most frequently used. In order to facilitate the comparisons across studies, more standardization of the selection of PROMIS measures is needed. Show less
Bansema, C.H.; Vermeiren, R.R.J.M.; Soet, R. de; Ewijk, H. van; Nijland, L.; Nooteboom, L.A. 2023
A small group of youth and emerging adults deals with severe and enduring mental health problems (SEMHP). Current mental health care struggles to recognize and treat this group timely and... Show moreA small group of youth and emerging adults deals with severe and enduring mental health problems (SEMHP). Current mental health care struggles to recognize and treat this group timely and adequately, leaving these youth between the cracks of the system. A first step to improve care for this group is to gain a deeper understanding of the characteristics of youth with SEMHP. Therefore, this study aimed at reviewing current literature about this target group and what is known so far about their characteristics. We included 39 studies with a focus on youth aged 12-25 years with SEMHP. After critical appraisal, a content analysis and in-depth thematic analysis were conducted. According to the included studies, youth with SEMHP were characterized by severe distress and recurrent comorbid mental health problems, with pervasive suicidality. Further, underlying trauma, family conflicts, peer rejection, deep feelings of hopelessness, and psychosocial malfunctioning characterized SEMHP. It was described that for youth with SEMHP a pervasive pattern of dysfunction in multiple domains is present leading to a detrimental impact. Subsequently, this pattern exerts a reciprocal influence on the mental health problems, causing a vicious circle further worsening SEMHP. Our findings emphasize the need for a holistic approach and to look beyond the traditional classification system in order to meet the needs of these youth with wide-ranging comorbid mental health problems. Show less
Zantis, L.J.; Borchi, C.; Vijver, M.G.; Peijnenburg, W.J.G.M.; Di Lonardo, S.; Bosker, T. 2023
Over the last years there has been significant research on the presence and effects of plastics in terrestrial systems. Here we summarize current research findings on the effects of nano- and... Show moreOver the last years there has been significant research on the presence and effects of plastics in terrestrial systems. Here we summarize current research findings on the effects of nano- and microplastics (NMPs) on terrestrial plants, with the aim to determine patterns of response and sensitive endpoints. We conducted a systematic review (based on 78 studies) on the effects of NMPs on germination, plant growth and biochemical biomarkers. This review highlights that the majority of studies to date have used pristine polystyrene or polyethylene particles, either in a hydroponic or pot-plant setup. Based on these studies we found that effects on plants are widespread. We noted similar responses between and within monocots and dicots to NMPs, except for consistent lower germination seen in dicots exposed to NMPs. During early development, germination and root growth are more strongly affected compared to shoot growth. NMPs induced similar adverse growth effects on plant biomass and length in the most tested plant species (lettuce, wheat, corn, and rice) irrespective of the polymer type and size used. Moreover, biomarker responses were consistent across species; chlorophyll levels were commonly negatively affected, while stress indicators (e.g., ROS or free radicals) and stress respondents (e.g., antioxidant enzymes) were consistently upregulated. In addition, effects were commonly observed at environmentally relevant levels. These findings provide clear evidence that NMPs have wide-ranging impacts on plant performance. However, as most studies have been conducted under highly controlled conditions and with pristine plastics, there is an urgent need to test under more environmentally realistic conditions to ensure the lab-based studies can be extrapolated to the field. Show less
Soet, R. de; Vermeiren, R.R.J.M.; Bansema, C.H.; Ewijk, H. van; Nijland, L.; Nooteboom, L.A. 2023
Youth with severe and enduring mental health problems (SEMHP) tend to drop out of treatment or insufficiently profit from treatment in child and adolescent psychiatry (CAP). Knowledge about factors... Show moreYouth with severe and enduring mental health problems (SEMHP) tend to drop out of treatment or insufficiently profit from treatment in child and adolescent psychiatry (CAP). Knowledge about factors related to treatment failure in this group is scarce. Therefore, the aim of this systematic review was to thematically explore factors associated with dropout and ineffective treatment among youth with SEMHP. After including 36 studies, a descriptive thematic analysis was conducted. Themes were divided into three main categories: client, treatment, and organizational factors. The strongest evidence was found for the association between treatment failure and the following subthemes: type of treatment, engagement, transparency and communication, goodness of fit and, perspective of practitioner. However, most other themes showed limited evidence and little research has been done on organizational factors. To prevent treatment failure, attention should be paid to a good match between youth and both the treatment and the practitioner. Practitioners need to be aware of their own perceptions of youth's perspectives, and transparent communication with youth contributes to regaining their trust. Show less
Background: Huntington's disease (HD) is a genetic, neurodegenerative disease. Due to the progressive nature of HD and the absence of a cure, (health-related) quality of life ((HR)QoL) is an... Show moreBackground: Huntington's disease (HD) is a genetic, neurodegenerative disease. Due to the progressive nature of HD and the absence of a cure, (health-related) quality of life ((HR)QoL) is an important topic. Several studies have investigated (HR)QoL in HD, yet a clear synthesis of the existing literature is lacking to date. We performed a systematic review on self-reported (HR)QoL, and factors and intervention effects associated with (HR)QoL in premanifest and manifest HD gene expansion carriers (pHDGECs and mHDGECs, respectively). Methods: PubMed, EMBASE, Web of Science, and PsycINFO were searched systematically from September 17th, 2021, up to August 11th, 2022. Methodological and conceptual quality of the included studies was assessed with two appraisal tools.Results: 30 out of 70 eligible articles were included. mHDGECs experienced lower (HR)QoL compared to pHDGECs and controls, whereas mixed findings were reported when compared to other neurological diseases. Several factors were associated with (HR)QoL that might contribute to lower (HR)QoL in mHDGECs, including depressive symptoms, physical and psychological symptoms, lower functional capacity, lower support, and unmet needs. Multidisciplinary rehabilitation programs and a respiratory muscle training were beneficial for (HR)QoL in mHDGECs. Discussion: (HR)QoL is experienced differently across the course of the disease. Although (HR)QoL is key for understanding the impact of HD and the effect of symptomatic treatment, there is a need to improve the methodological and conceptual shortcomings that were found in most studies, especially regarding the conceptual clarity when reporting on QoL and HRQoL. Suggestions for strengthening these shortcomings are provided in this review. Show less
Theuns, D.A.; Verstraelen, T.E.; Lingen, A.C.J. van der; Delnoy, P.P.; Allaart, C.P.; Erven, L. van; ... ; Meeder, J.G. 2022
Background: Primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with non-ischaemic cardiomyopathy (NICMP) remains controversial. This study sought to assess the benefit... Show moreBackground: Primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with non-ischaemic cardiomyopathy (NICMP) remains controversial. This study sought to assess the benefit of ICD therapy with or without cardiac resynchronisation therapy (CRT) in patients with NICMP. In addition, data were compared with real-world clinical data to perform a risk/benefit analysis. Methods: Relevant randomised clinical trials (RCTs) published in meta-analyses since DANISH, and in PubMed, EMBASE and Cochrane databases from 2016 to 2020 were identified. The benefit of ICD therapy stratified by CRT use was assessed using random effects meta-analysis techniques. Results: Six RCTs were included in the meta-analysis. Among patients without CRT, ICD use was associated with a 24% reduction in mortality (hazard ratio [HR]: 0.76; 95% confidence interval [CI]: 0.62-0.93; P = 0.008). In contrast, among patients with CRT, a CRT-defibrillator was not associated with reduced mortality (HR: 0.74, 95% CI 0.47-1.16; P = 0.19). For ICD therapy without CRT, absolute risk reduction at 3-years follow-up was 3.7% yielding a number needed to treat of 27. Conclusion: ICD use significantly improved survival among patients with NICMP who are not eligible for CRT. Considering CRT, the addition of defibrillator therapy was not significantly associated with mortality benefit compared with CRT pacemaker. Show less
Benavent, D.; Capelusnik, D.; Heijde, D. van der; Landewe, R.; Poddubnyy, D.; Tubergen, A. van; ... ; Navarro-Compan, V. 2022
Aim: To identify all possible definitions of "early SpA" employed in the literature, including "early axial SpA (axSpA)" and "early peripheral SpA (pSpA)".Methods: A systematic literature review... Show moreAim: To identify all possible definitions of "early SpA" employed in the literature, including "early axial SpA (axSpA)" and "early peripheral SpA (pSpA)".Methods: A systematic literature review was conducted in Medline, EMBASE and the Cochrane Library for studies that included any mention of "early SpA" or its subtypes. The proportion of studies including a definition was calculated, and the different definitions were assessed.Results: Out of 9651 titles identified, 336 publications reporting data from 183 studies were included. Over time, an increasing number of publications were identified. In total, 114 (62%) studies reported a specific definition: 33% of them based it on symptom duration, 31% on radiographic damage, 28% on disease duration, 5% on both symptom/disease duration and radiographic damage, and 3% on other aspects. Overall, 61 (33%) studies included the term "early axSpA", whereas 60 (33%) included "early ankylosing spondylitis (AS)". Regarding the studies that referred to "early axSpA", the most used definition was symptom/disease duration <5 years, whereas for "early AS" was symptom/disease duration <10 years. After 2010, the definition of "early axSpA" based on the absence of radiographic sacroiliitis was less used compared to before 2010 (17% vs 38%).Conclusion: Over time, the term "early SpA" and its subtypes is increasingly used. More than one third of the studies did not include a definition of the term and the studies reporting one showed a large heterogeneity. These results emphasize the need for a standardised definition of early SpA. Show less
Luijken, K.; Wall, B.J.M. van de; Hooft, L.; Leenen, L.P.H.; Houwert, R.M.; Groenwold, R.H.H.; NEXT Study Grp 2022
Purpose: It is challenging to generate and subsequently implement high-quality evidence in surgical practice. A first step would be to grade the strengths and weaknesses of surgical evidence and... Show morePurpose: It is challenging to generate and subsequently implement high-quality evidence in surgical practice. A first step would be to grade the strengths and weaknesses of surgical evidence and appraise risk of bias and applicability. Here, we described items that are common to different risk-of-bias tools. We explained how these could be used to assess comparative operative intervention studies in orthopedic trauma surgery, and how these relate to applicability of results. Methods: We extracted information from the Cochrane risk-of-bias-2 (RoB-2) tool, Risk Of Bias In Non-randomised Studies-of Interventions tool (ROBINS-I), and Methodological Index for Non-Randomized Studies (MINORS) criteria and derived a concisely formulated set of items with signaling questions tailored to operative interventions in orthopedic trauma surgery. Results: The established set contained nine items: population, intervention, comparator, outcome, confounding, missing data and selection bias, intervention status, outcome assessment, and pre-specification of analysis. Each item can be assessed using signaling questions and was explained using good practice examples of operative intervention studies in orthopedic trauma surgery. Conclusion: The set of items will be useful to form a first judgment on studies, for example when including them in a systematic review. Existing risk of bias tools can be used for further evaluation of methodological quality. Additionally, the proposed set of items and signaling questions might be a helpful starting point for peer reviewers and clinical readers. Show less
In this thesis, we aimed to develop and validate a patient and a physician questionnaire to measure the shared decision making (SDM) process in oncology. We identified SDM measurement challenges:... Show moreIn this thesis, we aimed to develop and validate a patient and a physician questionnaire to measure the shared decision making (SDM) process in oncology. We identified SDM measurement challenges: there is limited evidence on measurement properties, patients’ role is not assessed while it is present in SDM models, patients and healthcare professionals have been involved only to a limited extent in the development of SDM measurement instruments, and a reflective measurement model is often assumed, while a formative might be more appropriate. The aim of this thesis was therefore to develop and validate questionnaires to assess the SDM process in oncology from both the patient and the physician viewpoints. We chose the oncology setting because it is a setting in which patients often face preference-sensitive decisions, and in which most patients prefer an active or collaborative role in treatment decision making. To inform the development and validation process of our questionnaires, we used the original Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and we wrote two reviews: one on existing SDM measurement instruments and one on existing SDM models. The iSHARE questionnaires shows adequate measurement properties Show less
BACKGROUND Mycobacterium species (Mycobacterium sp) is an emerging cause of hip and knee prosthetic joint infection (PJI), and different species of this organism may be responsible for the same.... Show moreBACKGROUND Mycobacterium species (Mycobacterium sp) is an emerging cause of hip and knee prosthetic joint infection (PJI), and different species of this organism may be responsible for the same. AIM To evaluate the profile of hip and knee Mycobacterium PJI cases as published in the past 30 years. METHODS A literature search was performed in PubMed using the MeSH terms "Prosthesis joint infection " AND "Mycobacterium " for studies with publication dates from January 1, 1990, to May 30, 2021. To avoid missing any study, another search was performed with the terms "Arthroplasty infection " AND "Mycobacterium " in the same period as the previous search. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses chart was used to evaluate the included studies for further review. In total, 51 studies were included for further evaluation of the cases, type of pathogen, and treatment of PJI caused by Mycobacterium sp. RESULTS Seventeen identified Mycobacterium sp were reportedly responsible for hip/knee PJI in 115 hip/knee PJI cases, whereas in two cases there was no mention of any specific Mycobacterium sp. Mycobacterium tuberculosis (M. tuberculosis) was detected in 50/115 (43.3%) of the cases. Nontuberculous mycobacteria (NTM) included M. fortuitum (26/115, 22.6%), M. abscessus (10/115, 8.6%), M. chelonae (8/115, 6.9%), and M. bovis (8/115, 6.9%). Majority of the cases (82/114, 71.9%) had an onset of infection > 3 mo after the index surgery, while in 24.6% (28/114) the disease had an onset in & LE; 3 mo. Incidental intraoperative PJI diagnosis was made in 4 cases (3.5%). Overall, prosthesis removal was needed in 77.8% (84/108) of the cases to treat the infection. Overall infection rate was controlled in 88/102 (86.3%) patients with Mycobacterium PJI. Persistent infection occurred in 10/108 (9.8%) patients, while 4/108 (3.9%) patients died due to the infection. CONCLUSION At least 17 Mycobacterium sp can be responsible for hip/knee PJI. Although M. tuberculosis is the most common causal pathogen, NTM should be considered as an emerging cause of hip/knee PJI. Show less
We investigated whether the addition of adjuvant chemotherapy to chemoradiation improves overall survival (OS) and progression-free survival (PFS) by conducting a systematic review and meta... Show moreWe investigated whether the addition of adjuvant chemotherapy to chemoradiation improves overall survival (OS) and progression-free survival (PFS) by conducting a systematic review and meta-analysis. Systematic searches in the databases of PubMed, Embase and Web of Science yielded 881 articles. Two reviewer authors independently selected 31 articles for full text review and deemed eight studies eligible for inclusion. Two were randomised controlled trials (RCT), one was a large (n = 609) matched-case study and the remaining were small retrospective cohort studies; in total 2150 patients. Risk of bias assessment showed that the RCTs were at low risk and all other studies were at high risk of bias. Pooled hazard ratios for OS and PFS were 0.78 (95%CI 0.45-1.33, p = 0.36) and 0.85 (95%CI 0.65-1.10, p = 0.22), respectively. Analysis stratified by study design and sensitivity analysis showed similar results. Funnel plots showed significant publication bias due to a lack of small studies with negative outcomes. Show less
Context: There is uncertainty regarding the most appropriate criteria for recruitment, monitoring, and reclassification in active surveillance (AS) protocols for localised prostate cancer (PCa)... Show moreContext: There is uncertainty regarding the most appropriate criteria for recruitment, monitoring, and reclassification in active surveillance (AS) protocols for localised prostate cancer (PCa).Objective: To perform a qualitative systematic review (SR) to issue recommendations regarding inclusion of intermediate-risk disease, biopsy characteristics at inclusion and monitoring, and repeat biopsy strategy.Evidence acquisition: A protocol-driven, Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-adhering SR incorporating AS protocols published from January 1990 to October 2020 was performed. The main outcomes were criteria for inclusion of intermediate-risk disease, monitoring, reclassification, and repeat biopsy strategies (per protocol and/or triggered). Clinical effectiveness data were not assessed.Evidence synthesis: Of the 17 011 articles identified, 333 studies incorporating 375 AS protocols, recruiting 264 852 patients, were included. Only a minority of protocols included the use of magnetic resonance imaging (MRI) for recruitment (n = 17), follow-up (n = 47), and reclassification (n = 26). More than 50% of protocols included patients with intermediate or high-risk disease, whilst 44.1% of protocols excluded low-risk patients with more than three positive cores, and 39% of protocols excluded patients with core involvement (CI) >50% per core. Of the protocols, >= 80% mandated a confirmatory transrectal ultrasound biopsy; 72% (n = 189) of protocols mandated per-protocol repeat biopsies, with 20% performing this annually and 25% every 2 yr. Only 27 protocols (10.3%) mandated triggered biopsies, with 74% of these protocols defining progression or changes on MRI as triggers for repeat biopsy.Conclusions: For AS protocols in which the use of MRI is not mandatory or absent, we recommend the following: (1) AS can be considered in patients with low-volume International Society of Urological Pathology (ISUP) grade 2 (three or fewer positive cores and cancer involvement <= 50% CI per core) or another single element of intermediate-risk disease, and patients with ISUP 3 should be excluded; (2) per-protocol confirmatory prostate biopsies should be performed within 2 yr, and per-protocol surveillance repeat biopsies should be performed at least once every 3 yr for the first 10 yr; and (3) for patients with low-volume, low-risk disease at recruitment, if repeat systematic biopsies reveal more than three positive cores or maximum CI >50% per core, they should be monitored closely for evidence of adverse features (eg, upgrading); patients with ISUP 2 disease with increased core positivity and/or CI to similar thresholds should be reclassified.Patient summary: We examined the literature to issue new recommendations on active surveillance (AS) for managing localised prostate cancer. The recommendations include setting criteria for including men with more aggressive disease (intermediate-risk disease), setting thresholds for close monitoring of men with low-risk but more extensive disease, and determining when to perform repeat biopsies (within 2 yr and 3 yearly thereafter). (C) 2021 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. Show less
In part 1 of the thesis Predicting Outcomes in Patients with Kidney Disease, key differences between etiological and prediction research are explored and it is shown that observational research... Show moreIn part 1 of the thesis Predicting Outcomes in Patients with Kidney Disease, key differences between etiological and prediction research are explored and it is shown that observational research often conflates etiology and prediction which leads to incorrect causal conclusions. A framework for the external validation of prognostic models is provided and it is shown how competing events can be dealt with when externally validating a time-to-event prognostic model. These results are applicable to many clinical research fields, including nephrology as exemplified in part 2. Within the six applied chapters in part 2, prediction models for various adverse outcomes in patients with advanced kidney disease are identified, validated and developed. The thesis provides a broad overview of prognostic model applications in patients with chronic kidney disease, including comprehensive external validation studies for kidney failure prediction models, mortality prediction models and graft failure prediction models. Models to predict mortality on conservative care and dialysis and models to predict adverse outcomes after kidney transplantation were developed and validated. These results may improve shared decision-making processes and individualized medicine for patients with kidney disease. Show less
Albers, E.A.C.; Fraterman, I.; Walraven, I.; Wilthagen, E.; Schagen, S.B.; Ploeg, I.M. van der; ... ; Ligt, K.M. de 2022
Purpose The use of Patient-Reported Outcome Measures (PROMs) for individual patient management within clinical practice is becoming increasingly important. New evidence about graphic visualization... Show morePurpose The use of Patient-Reported Outcome Measures (PROMs) for individual patient management within clinical practice is becoming increasingly important. New evidence about graphic visualization formats for PROMs scores has become available. This systematic literature review evaluated evidence for graphic visualization formats of PROMs data in clinical practice for patients and clinicians, for both individual and group level PROMs data. Methods Studies published between 2000 and 2020 were extracted from CINAHL, PubMed, PsychInfo, and Medline. Studies included patients >= 18 years old in daily clinical practice. Papers not available in English, without full-text access, or that did not specifically describe visualization of PROMs data were excluded. Outcomes were: visualization preferences; interpretation accuracy; guidance for clinical interpretation. Results Twenty-five out of 789 papers were included for final analysis. Most frequently studied formats were: bar charts, line graphs, and pie charts. Patients preferred bar charts and line graphs as these were easy and quick for retrieving information about their PROMs scores over time. Clinicians' interpretation accuracy and preferences were similar among graphic visualization formats. Scores were most often compared with patients' own previous scores; to further guide clinical interpretation, scores were compared to norm population scores. Different 'add-ons' improved interpretability for patients and clinicians, e.g. using colors, descriptions of measurement scale directionality, descriptive labels, and brief definitions. Conclusion There was no predominant graphical visualization format approach in terms of preferences or interpretation accuracy for both patients and clinicians. Detailed clarification of graph content is essential.Plain English summary Patient-Reported Outcome Measures (PROMs) capture patients' self-reported health through the use of questionnaires. PROMs measure health related quality of life, daily functioning, and symptom experience, which are becoming increasingly important to incorporate in clinical practice for individual patient management. To present PROMs within clinical practice, raw or summarized PROMs scores can be visualized in graphical formats. To be useful during clinical encounters, both patients and clinicians ought to interpret such formats correctly. New evidence about graphic visualization formats for PROMs scores has become available. Therefore, we systematically reviewed the literature to evaluate evidence for graphic visualization formats of PROMs data in clinical practice. In 25 included papers, most studies used graphical formats like bar charts, line graphs, and pie charts for presenting PROMs scores. There was no predominant graphical visualization format approach in terms of preferences or interpretation accuracy for both patients and clinicians. Patients preferred bar charts and line graphs as these were easy and quick for retrieving information about their PROMs scores over time. Clinicians' interpretation accuracy and preferences were similar among graphic visualization formats. The graphical interpretation of PROMs data for patients and clinicians can be improved by using colors, descriptions of measurement scale directionality, descriptive labels, and brief definitions. Show less
Rossen, T.M. van; Ooijevaar, R.E.; Vandenbroucke-Grauls, C.M.J.E.; Dekkers, O.M.; Kuijper, E.J.; Keller, J.J.; Prehn, J. van 2022
Objectives: Clostridioides difficile infection (CDI), its subsequent recurrences (rCDIs), and severe CDI (sCDI) provide a significant burden for both patients and the healthcare system. Identifying... Show moreObjectives: Clostridioides difficile infection (CDI), its subsequent recurrences (rCDIs), and severe CDI (sCDI) provide a significant burden for both patients and the healthcare system. Identifying patients diagnosed with initial CDI who are at increased risk of developing sCDI/rCDI could lead to more cost-effective therapeutic choices. In this systematic review we aimed to identify clinical prognostic factors associated with an increased risk of developing sCDI or rCDI.Methods: PubMed, Embase, Emcare, Web of Science and COCHRANE Library databases were searched from database inception through March, 2021. The study eligibility criteria were cohort and caseecontrol studies. Participants were patients >= 18 years old diagnosed with CDI, in which clinical or laboratory factors were analysed to predict sCDI/rCDI. Risk of bias was assessed by using the Quality in Prognostic Research (QUIPS) tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool modified for prognostic studies. Study selection was performed by two independent reviewers. Overview tables of prognostic factors were constructed to assess the number of studies and the respective effect direction and statistical significance of an association.Results: 136 studies were included for final analysis. Greater age and the presence of multiple comorbidities were prognostic factors for sCDI. Identified risk factors for rCDI were greater age, healthcareassociated CDI, prior hospitalization, proton pump inhibitors (PPIs) started during or after CDI diagnosis, and previous rCDI.Conclusions: Prognostic factors for sCDI and rCDI could aid clinicians to make treatment decisions based on risk stratification. We suggest that future studies use standardized definitions for sCDI/rCDI and systematically collect and report the risk factors assessed in this review, to allow for meaningful metaanalysis of risk factors using data of high-quality trials. (C) 2021 The Author(s). Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. Show less
Groenendaal, M.; Smaling, H.J.A.; Achterberg, W.P.; Caljouw, M.A.A. 2022
This systematic review summarizes the experiences with maintaining meaningful activities for persons with dementia during transitions of care, including related barriers and facilitators, and... Show moreThis systematic review summarizes the experiences with maintaining meaningful activities for persons with dementia during transitions of care, including related barriers and facilitators, and interventions and strategies. A systematic search was performed in eight databases. The methodological quality was assessed with the Mixed Methods Appraisal Tool.Four articles were included; one describing the transition from home to hospital and vice versa, and three describing the transition from home to nursing home. The narrative synthesis revealed a decrease of meaningful activities after transition. Facilitators of and barriers to maintaining meaningful activities during transitions were related to the person with dementia, informal caregivers, healthcare professionals and organization of care, as well as the environment. Interventions and strategies focused on continuously adjusting meaningful activities to the person. To conclude, maintaining meaningful activities during transitions is an under-researched area. Several recommendations are provided for healthcare professionals and organizations. (C) 2022 The Authors. Published by Elsevier Inc. Show less
