scholarly journals The impact of conducting preclinical systematic reviews on researchers and their research: A mixed method case study

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0260619
Author(s):  
Julia M. L. Menon ◽  
Merel Ritskes-Hoitinga ◽  
Pandora Pound ◽  
Erica van Oort

Background Systematic reviews (SRs) are cornerstones of evidence-based medicine and have contributed significantly to breakthroughs since the 1980’s. However, preclinical SRs remain relatively rare despite their many advantages. Since 2011 the Dutch health funding organisation (ZonMw) has run a grant scheme dedicated to promoting the training, coaching and conduct of preclinical SRs. Our study focuses on this funding scheme to investigate the relevance, effects and benefits of conducting preclinical SRs on researchers and their research. Methods We recruited researchers who attended funded preclinical SR workshops and who conducted, are still conducting, or prematurely stopped a SR with funded coaching. We gathered data using online questionnaires followed by semi-structured interviews. Both aimed to explore the impact of conducting a SR on researchers’ subsequent work, attitudes, and views about their research field. Data-analysis was performed using Excel and ATLAS.ti. Results Conducting preclinical SRs had two distinct types of impact. First, the researchers acquired new skills and insights, leading to a change in mindset regarding the quality of animal research. This was mainly seen in the way participants planned, conducted and reported their subsequent animal studies, which were more transparent and of a higher quality than their previous work. Second, participants were eager to share their newly acquired knowledge within their laboratories and to advocate for change within their research teams and fields of interest. In particular, they emphasised the need for preclinical SRs and improved experimental design within preclinical research, promoting these through education and published opinion papers. Conclusion Being trained and coached in the conduct of preclinical SRs appears to be a contributing factor to many beneficial changes which will impact the quality of preclinical research in the long-term. Our findings suggest that this ZonMw funding scheme is helpful in improving the quality and transparency of preclinical research. Similar funding schemes should be encouraged, preferably by a broader group of funders or financers, in the future.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nicole E. van Gelder ◽  
Ditte L. van Haalen ◽  
Kyra Ekker ◽  
Suzanne A. Ligthart ◽  
Sabine Oertelt-Prigione

Abstract Background The COVID-19 pandemic and lockdown evoked great worries among professionals in the field of domestic violence and abuse (DVA) as they expected a rise of the phenomenon. While many countries reported increased DVA, the Netherlands did not. To understand this discrepancy and the overall impact of the lockdown on DVA support services, we interviewed DVA professionals about their experiences with DVA during the rise of COVID-19, the impact of the lockdown on clients and working conditions, and views on eHealth and online tools. Methods Semi-structured interviews were conducted among 16 DVA professionals with various specializations. This data was analyzed using open thematic coding and content analysis. Results Most professionals did not see an increase in DVA reports but they did notice more severe violence. They experienced less opportunities to detect DVA and worried about their clients’ wellbeing and the quality of (online) care. Furthermore, their working conditions rapidly changed, with working from home and online, and they expressed frustration, insecurity and loneliness. Professionals feel eHealth and online tools are not always suitable but they do see them as an opportunity to increase reach and maintain services when physical contact is not possible. Conclusion This study suggests DVA was probably under-detected during the lockdown rather than not having increased. The Dutch system heavily relies on professionals to detect and report DVA, suggesting a need for critical evaluation of the accessibility of professional help. Professionals experienced significant challenges and should themselves be supported psychologically and in their changed work practices to maintain their ability to aid survivors.


Author(s):  
Adar Abdulkadir ◽  
Ibrahim J. Long

Canadian federal prison chaplaincy underwent a major shift in 2013 when the provision of its services was privatized and outsourced to a single for-profit company. This article presents a summary of the experiences and concerns expressed by minority faith chaplains serving in federal correctional institutions following privatization. It is based on ten in-depth, semi-structured interviews with minority faith prison chaplains. The results show that minority faith federal prison chaplains are concerned about increased levels of bureaucratization that have compromised the quality of spiritual care available to prisoners, reductions in resources for chaplains, and increased levels of emotional exhaustion and frustration among themselves and fellow minority faith chaplains serving in Canadian correctional facilities.


2021 ◽  
pp. 238008442110419
Author(s):  
M. Hijryana ◽  
M. MacDougall ◽  
N. Ariani ◽  
L.S. Kusdhany ◽  
A.W.G. Walls

Introduction: The impact of periodontal disease on oral health–related quality of life (OHRQoL) has often been investigated from a quantitative research perspective, which is based on clinical findings and an OHRQoL questionnaire. Very few studies have examined the issue from the view of qualitative research. To our knowledge, there have been no previous qualitative studies focusing the effect of periodontal disease on OHRQoL in Indonesian older people. Objectives: To explore and understand the impact of periodontal disease on the OHRQoL of older people as a subjective reflection in relation to periodontal disease experiences. Methods: Semi-structured interviews were conducted in a sample of 31 older people with generalized chronic periodontitis. Thematic analysis was used to identify the key issues in participants’ accounts. The analysis was undertaken by 2 independent coders to ensure reliability. To achieve thematic saturation, successive interviews were undertaken until 5 sequential interviews did not bring new themes. Results: Participants reported the negative effects likely related to periodontal disease. The impacts of periodontal disease were described by these older people as affecting more than pain, physical discomfort, and physical function restrictions. Periodontal disease also affected their psychological and social aspects of daily living. In addition, this study identified themes related to individual and environmental factors that may modify and personalize periodontal disease experiences. Furthermore, this study identified a misleading belief that problems related to periodontal disease were a normal part of aging, which might influence individuals’ expectations toward oral health. Relatedly, participants frequently reported that the progression of tooth mobility to tooth loss was an inevitable part of the aging process. Conclusions: Periodontal disease negatively affected participants’ OHRQoL. It is fundamental to understand older people’s perceptions toward their periodontal disease as well as individual and environmental factors that may have an influence on their periodontal disease experiences. Knowledge Transfer Statement: This study is a reflection of Indonesian older people’s subjective periodontal disease experiences. Therefore, the present study can be used to understand older people’s perceptions, attitudes, behaviors, and experiences toward periodontal disease and how this disease may affect their quality of life. This study also highlights a widespread and misleading belief that oral problems related to periodontal disease are an inevitable part of aging in this study population.


2017 ◽  
Vol 34 (3) ◽  
pp. 406-417 ◽  
Author(s):  
José Barradas ◽  
Paulo Sampaio

Purpose According to the ISO 9001 standard, all the certified companies should calibrate their measuring equipment. By doing so, companies can guarantee, with rigor and quality, its measurement and use reliable data for monitoring the quality of their products. However, a metrology laboratory is not required to have an ISO 9001 certification or ISO/IEC 17025 accreditation. At this moment, there are companies with their quality management systems certified according to the ISO 9001 standard which have metrology laboratories to make internal checks of their measuring equipment. On the other hand, there are companies with ISO/IEC 17025-accredited laboratories. Finally, there are companies that have their QMS certified according to ISO 9001 and also their metrology laboratory accredited by ISO/IEC 17025. In this case the metrology laboratory must comply with the requirements of both standards. Thus, the purpose of this paper is to analyze the level of importance of the ISO 9001 and ISO/IEC 17025 standards from the perspective of a metrology laboratory. Design/methodology/approach The research methodology used to conduct this research was supported in case studies that had been carried out in nine metrology laboratories. The information was gathered based on semi-structured interviews. Findings After an analysis and discussion over the data obtained, the authors verified that the impact on customer perception is significantly positive, if the metrology laboratory is simultaneous certified and accredited. Originality/value From the laboratories perspective, the issue analyzed in this paper is of the utmost importance and the aim is to give the contribution in order to clarify this kind of organizations of which could be the best option for their context.


2021 ◽  
Author(s):  
Hossein Motahari-Nezhad ◽  
Márta Péntek ◽  
László Gulácsi ◽  
Zsombor Zrubka

BACKGROUND Digital biomarkers are defined as objective, quantifiable physiological and behavioral data that are collected and measured by means of digital devices such as portables, wearables, implantables or digestibles. For their widespread adoption in publicly financed healthcare systems, it is important to understand how their benefits translate into improved patient outcomes, which is essential for demonstrating their value. OBJECTIVE To assess the quality and strength of evidence of the impact of digital biomarkers on clinical outcomes compared to interventions without digital biomarkers, reported in systematic reviews. METHODS A comprehensive search for 2019-2020 will be conducted in the PubMed and the Cochrane Library using keywords related to digital biomarkers and a filter for systematic reviews. Original full-text English publications of systematic reviews comparing clinical outcomes of interventions with and without digital biomarkers via meta-analysis will be included. The AMSTAR-2 tool will be used to assess the methodological quality of reviews. To assess the quality of evidence, we will evaluate systematic reviews using the GRADE tool. To detect the possible presence of reporting bias, we will record whether the protocol of the systematic reviews was published before the start of the study. A qualitative summary of results by digital biomarker technology and outcome will be provided. RESULTS This protocol was submitted before data collection. The next steps in this review will be initiated after the protocol is accepted for publication. CONCLUSIONS Our study will provide a comprehensive summary of the highest level of evidence available on digital biomarker interventions. Our results will help identify clinical areas where the use of digital biomarkers leads to favorable clinical outcomes. In addition, our findings will highlight areas of evidence gaps where the clinical benefits of digital biomarkers have not yet been demonstrated.


2021 ◽  
Author(s):  
Jacqueline Jonklaas

Abstract Hypothyroidism is a common endocrinopathy and levothyroxine is frequently prescribed. Despite the basic tenets of initiating and adjusting levothyroxine being agreed upon, there are many nuances and complexities to consistently maintaining euthyroidism. Understanding the impact of patient weight and residual thyroid function on initial levothyroxine dosage and consideration of age, co-morbidities, TSH goal, life stage, and quality of life as levothyroxine is adjusted can be challenging and continually evolving. As levothyroxine is a life-long medication it is important to avoid risks from periods of overtreatment or undertreatment. For the subset of patients not restored to baseline health with levothyroxine, causes arising from all aspects of the patient’s life (co-existent medical conditions, stressors, lifestyle, psychosocial factors) should be broadly considered. If such factors do not appear to be contributing, and biochemical euthyroidism has been successfully maintained, there may be benefit to a trial of combination therapy with levothyroxine and liothyronine. This is not supported by the majority of randomized clinical trials, but may be supported by other studies providing lower quality evidence and by animal studies. Given this discrepancy, it is important that any trial of combination therapy only be continued as long as a patient benefit is being enjoyed. Monitoring for adverse effects, particularly in older or frail individuals, is necessary and combination therapy should not be utilized during pregnancy. A sustained release liothyronine preparation has completed phase 1 testing and may soon be available for better designed and powered studies assessing whether combination therapy provides superior therapy for hypothyroidism.


2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Pandora Pound ◽  
Merel Ritskes-Hoitinga

AbstractSystematic reviews are powerful tools with the potential to generate high quality evidence. Their application to animal studies has been instrumental in exposing the poor quality of these studies, as well as a catalyst for improvements in study design, conduct and reporting. It has been suggested that prospective systematic reviews of animal studies (i.e. systematic reviews conducted prior to clinical trials) would allow scrutiny of the preclinical evidence, providing valuable information on safety and efficacy, and helping to determine whether clinical trials should proceed. However, while prospective systematic reviews allow valuable scrutiny of the preclinical animal data, they are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans. Consequently, they may not reliably safeguard humans participating in clinical trials and might potentially result in lost opportunities for beneficial clinical treatments. Furthermore, animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the manner presumed. We suggest that this points to a confused attitude regarding animal studies, whereby tradition demands that they precede human studies but practice indicates that their findings are often ignored. We argue that it is time to assess the relative contributions of animal and human research in order to better understand how clinical knowledge is actually produced.


2020 ◽  
Vol 40 (4) ◽  
pp. 394-404
Author(s):  
Janusz Witowski ◽  
Dorota Sikorska ◽  
András Rudolf ◽  
Izabela Miechowicz ◽  
Julian Kamhieh-Milz ◽  
...  

The concerns about reproducibility and validity of animal studies are partly related to poor experimental design and reporting. Here, we undertook a scoping review of the literature to determine the extent and quality of reporting of animal studies on peritoneal dialysis (PD). Online databases were searched to identify 567 relevant original articles published between 1979 and 2018. These were analyzed with respect to bibliographic parameters and general aspects of animal experimentation. A subgroup of 120 studies was analyzed in detail in terms of the impact on the reporting quality of the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines for animal studies. The number of animal studies on PD increased continuously over the years with a thematic shift toward long-term preservation of the peritoneum as a dialyzing organ. There were significant deficiencies in research design with the lack of sample size estimation, randomization, and blinding being the commonest shortcomings. The description of animal numbers, housing conditions, use of medication, and statistical analysis was incomplete. The introduction in 2010 of the ARRIVE guidelines produced very little improvement in the completeness of reporting regardless of journal impact factor. The animal studies on PD suffer from deficits in experimental protocols and transparent reporting. These drawbacks need to be corrected to ensure high-quality and much-needed animal research in PD.


2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Amy E. Pergande ◽  
Zoe Belshaw ◽  
Holger A. Volk ◽  
Rowena M. A. Packer

Abstract Background Idiopathic epilepsy is a common neurological condition in dogs. Previous research has focused on clinical aspects of seizure management in dogs with idiopathic epilepsy with little attention given to the emotional and logistical challenges for their owners. The current study aimed to explore the impacts of owning a dog with idiopathic epilepsy on owner quality of life and lifestyle, using qualitative methods. Methods Owners of dogs with idiopathic epilepsy living in England were recruited via social media and word of mouth, and then selected using purposive sampling to participate in face-to-face semi-structured interviews. Epilepsy management was explored through in-depth accounts of owner experiences and influencing factors. Interviews were recorded and transcribed verbatim and thematic analysis was used to construct key themes. Results Twenty-one interviews were completed. Almost all owners had made lifestyle changes in order to care for their dog, including substantial modifications to routines and, in some cases, employment. Many owners discussed a very emotionally close dog-owner bond, and described experiencing frequent feelings of fear, stress and uncertainty regarding their dog’s health. Friends, family and colleagues did not always understand the magnitude of commitment required to care for a dog with idiopathic epilepsy. This, combined with a fear of leaving their dog unsupervised, had social implications in some instances and lead to increased use of the Internet and online groups for peer support. Conclusions The commitment required to care for a dog with idiopathic epilepsy, and the lifestyle changes made by their owners, may be far greater than previously estimated. Further consideration of these factors by veterinary professionals and the friends and families of owners of dogs with idiopathic epilepsy could improve owner quality of life, and facilitate the provision of additional support.


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