LE PRINCIPALI NOVITÀ INTRODOTTE DALLA PSD2 TRA SVILUPPO TECNOLOGICO ED ESIGENZE DI TUTELA DEGLI
1. PSD2: l’avvento della FinTech e il nuovo level playing field
The data collection process began with an electronic search of the academic databases PubMed, Medline, Pedro, PsycInfo, BioMedCentral and Cochrane.
The date of each search, databases searched, key words, key word combinations used, along with the number of records resulting from each search can be found in the search strategy tables in Appendix 1. The keywords used for the search were: ‘stroke,’
‘cerebrovascular,’ ‘tai chi,’ ‘taiji,’ ‘tai ji,’ ‘t’ai chi,’ ‘fall*,’ ‘balance’ and ‘quality of life.’
A total of 17,826 studies was retrieved using the above key words over various searches between 2015 and 2018. To strategically manage this large volume of literature, ‘linked full text’ or ‘linked free text’ was applied to the search. Additionally, inclusion and exclusion criteria were applied. Studies included in the literature review were included if they met the following criteria:
• the article is from a peer-reviewed journal
• the article was available
• participants were based in the community
• Tai Chi was the intervention
• falls, balance or quality of life were outcomes
• the population had a degree of balance impairment
• usual care was normal daily activities or usual therapy
• articles were in English
• articles with the most comprehensive reporting were used if multiple articles of one study
• the population did not have a degree of balance deficit (cancer, chronic heart failure, relatively healthy, COPD, fibromyalgia)
• the control group was another intervention (unless exercise was stretching, breathing or usual physiotherapy)
• the purpose of the study was stroke prevention
• the general elderly population used was relatively healthy
• upper limb improvement was the focus of the study
Subsequently, relevant studies were identified if they were relevant and suitable to the topic. This was done by screening the title for a combination of the following terms: ‘tai chi’,
‘stroke’, ‘fall*’, ‘balance’ and ‘quality of life’.
Evidence sources are ranked on a hierarchy of evidence according to the strength of the evidence they provide. The hierarchy of evidence is graded from the highest level (one) to the lowest (seven) (Burns, Rohrich & Chung, 2011). The higher up on the hierarchy, the more likely the evidence will provide reliable answers to the research question (Melynk &
Fineout-Overholt, 2011). However, the appropriate hierarchy level of evidence depends on the nature of inquiry (Polit & Beck, 2017). Level two evidence are the best choice to find out the efficacy of an intervention (in this case Tai Chi) because they involve RCTs which include randomisation, and thus an ability to control bias. However, there are poorly conducted RCTs (Burns et al., 2011). Even stronger evidence are summaries of the best current randomized controlled trials, known as systematic reviews (level one on the hierarchy of evidence). Systematic reviews are conducted by carefully synthesising multiple studies, the strongest being a synthesis of RCTs (Polit & Beck, 2017). Meta-analysis is also at the top of the hierarchy but integrate quantitative findings statistically rather than narratively (Polit &
Beck, 2017).
Evidence sources become less reliable the further down the hierarchy they are (Polit & Beck, 2017). However, should there be a lack of systematic reviews and RCTs on which to base decisions on treatments, evidence from qualitative studies, despite being lower down on the hierarchy of evidence, should be considered when making clinical decisions (Melynk &
Fineout-Overholt, 2011). Therefore, articles high on the hierarchy of evidence were searched. Searching for articles high on the hierarchy of evidence also removes the high volume of literature retrieved during the search because the search excludes newspaper articles, books and reports.
The highest quality evidence should be critically appraised before implementing evidence-based practice in healthcare settings (Polit & Beck, 2017). However, due to the low amount of evidence high on the hierarchy, evidence in the middle of the hierarchy or not included
on the hierarchy at all will be included in the review (Melynk & Fineout-Overholt, 2011).
Therefore, also included in this review are pilot studies for prospective RCTs (not graded on the hierarchy of evidence). These are included because they represent a fundamental phase of the research process, and inform the researcher of the feasibility of an approach intended to be used in a larger scale study, such as recruitment, randomization, retention, methods and the implementation of the intervention (Leon, Davis & Kraemer, 2011). Other evidence used in the literature review are one quasi-experimental study (level three on the hierarchy of evidence), intervention designs (ungraded on the hierarchy), cross-sectional studies (ungraded on the hierarchy), and one qualitative study (Level six on the hierarchy of evidence) (Polit & Beck, 2017).
Evidence collated was synthesised to identify:
• the main methodologies and outcome measures used and how they differ
• methodological strengths and weaknesses
• how Tai Chi has been applied as an intervention (intensity/duration, setting, style, delivery, home practice)
• any adverse effects or barriers to Tai Chi
• the most appropriate time to start Tai Chi following a stroke
• the methods of analysis (it is necessary to evaluate the research methods used in the past and to establish the best method to utilise for a future study)
• the findings, integrate and generalise them, thus drawing conclusions
• recommendations for further research
The potentially relevant studies were separated from the irrelevant studies by reading the titles. If titles hinted at containing the above concepts but did not contain the keywords, the abstracts were read to determine if the articles were relevant or not. Once articles were retrieved from the above databases, reference lists found in the articles were searched to find further relevant articles. In turn, the references from those articles were searched until a point of saturation was reached.
In total, 345 relevant articles were identified by title, dating from 1996 to 2019. After reading the abstracts, 254 of these articles were eliminated because they did not meet the inclusion/exclusion criteria listed above. Therefore, a total of 67 articles were included in this literature review. Figure 3 presents the PRISMA diagram for the search:
PRISMA 2009 Flow Diagram
Systematic Search for “Tai Chi” using
Medline, PubMed, BioMed Central, PEDro and PsychInfo
Records identified through database searching
(n=17,826)
Screening IncludedEligibilityIdentification Additional records identified through other sources
(n=0)
Records after irrelevant ones removed (n=345)
Articles not available (n=2)
Records excluded (n=2)
Full text articles assessed for eligibility
(n=110)
Full-text articles excluded (n=19)
Studies eligible (n=93)
Studies included in literature review
(n=67)
Records after duplicates removed (n=120)
Figure 3 PRISMA 2009 flow diagram
Once all the relevant articles were identified for the review, articles were critically
appraised. Li et al. (2012) conducted a systematic review on the quality of reporting RCTs in Tai Chi interventions. The authors found sub-optimal reporting quality. Similarly, Zhang et al. (2015) reported that the quality of existing studies is below standard and do not meet CONSORT guidelines. The least reported items were details of the Tai Chi intervention, method of randomisation and blinding, recruitment criteria, and sample size determination.
According to the authors, the intervention should be described clearly and concisely to facilitate comparison and its relocation by other researchers. It was found that stroke studies failed to describe clearly the Tai Chi intervention or style. Therefore, each RCT was critically appraised using the CONSORT statement. Other designs were appraised using the Critical Appraisal Skills Programme [CASP].
In summary, specific key words and key word combinations were searched in various databases to yield articles within the higher end of the hierarchy of evidence. These papers are central and pivotal to the empirical and methodological insights into the impact of Tai Chi on falls, balance and quality of life in stroke survivors.