Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement: protocol of a randomised controlled trial.

BACKGROUND: The increasing prevalence of knee osteoarthritis and total knee arthroplasty (TKA) impose a significant socioeconomic burden in developed and developing countries. Prehabilitation (rehabilitation in the weeks immediately before surgery) may be crucial to prepare patients for surgery improving outcomes and reducing assistance costs. Moreover, considering the progress of telemedicine, candidates for TKA could potentially benefit from a tele-prehabilitation programme. We aim to evaluate the effects of a home-based tele-prehabilitation program for patients waiting for total knee replacement. METHODS AND ANALYSIS: Forty-eight male patients, aged 65-80, on a waiting list for TKA will be recruited and randomly assigned to the tele-prehabilitation intervention or control groups. Both groups will undergo the same 6-week exercise program (five sessions/week) and the same educational session (one per week). The tele-prehabilitation group will perform asynchronous sessions using a tablet, two accelerometers and a balance board (Khymeia, Padova, Italy), while the control group will use a booklet. The Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire, at the end of the prehabilitation, will be the primary outcome. Secondary outcomes will include self-reported outcomes, performance tests and change in expressions of blood and muscle biomarkers. Ten healthy subjects, aged 18-30, will be also recruited for muscle and blood samples collection. They will not undergo any intervention and their data will be used as benchmarks for the intervention and control groups' analyses. ETHICS AND DISSEMINATION: This randomised controlled trial will be conducted in accordance with the ethical principles of the Declaration of Helsinki. This study has been approved by the Ethics Committee of Vita-Salute San Raffaele University (Milan, Italy. No. 50/INT/2022). The research results will be published in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05668312.

One-Third of Systematic Reviews in Rehabilitation Applied the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) System to Evaluate Certainty of Evidence: A Meta-Research Study.

OBJECTIVE: To determine how many systematic reviews (SRs) of the literature in rehabilitation assess the certainty of evidence (CoE) and how many apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to do this. DATA SOURCES: For this meta-research study, we searched PubMed and Cochrane Database of Systematic Reviews databases for SRs on rehabilitation published in 2020. STUDY SELECTION AND DATA EXTRACTION: Two reviewers independently selected the SRs and extracted the data. Reporting characteristics and appropriate use of the GRADE system were assessed. DATA SYNTHESIS: The search retrieved 827 records: 29% (239/827) SRs evaluated CoE, 68% (163/239) of which applied the GRADE system. GRADE was used by SRs of randomized controlled trials (RCTs, 88%; 144/163), non-randomized intervention studies (NRIS, 2%; 3/163), and both RCT and NRIS (10%; 16/163). In the latter case, a separate GRADE assessment according to the study design was not provided in 75% (12/16). The reasons for GRADE judgment were reported in 82% (134/163) of SRs. CONCLUSIONS: One-third of SRs in rehabilitation assessed CoE with the GRADE system. GRADE assessment was presented transparently by most SRs. Journal editors and funders should encourage the uptake of the GRADE system when considering SRs in rehabilitation for publication. The authors should pre-define GRADE assessment in a registered and/or published protocol.

Measuring citizens' engagement during emergencies: Psychometric validation of the Public Health Engagement Scale for Emergency Settings (PHEs-E).

The Covid-19 pandemic has highlighted the importance of citizens' behaviors in the containment of the virus. Individuals might change their intention to adhere to public health prescriptions depending on various personal characteristics, including their own emotional status, which has been recognized to be a crucial psychological factor in orienting people's adherence to public health recommendation during emergency settings. In particular, it is crucial to support citizens' alliance with authorities and feeling of trust: public engagement is a concept that refers to the general involvement of citizens into public affairs which is generally considered an effective approach to enhance citizens' understanding of their crucial role in public affairs. However, so far there is no agreement on the metrics and indexes that should be used to measures public engagement during a health crisis. The aim of this paper is to validate a psychometric scale (PHEs-E), which intends to measure the readiness of individuals to adhere to the prescribed behavioral change to contain the emergency. Data were collected throughout the pandemic in Italy: in particular, five independent samples were recruited starting from March 2020 to March 2021. Results showed that the proposed measure has good psychometric characteristics. A general linear model was computed to assess the differences of public engagement across the different data points and among citizens with different sociodemographic characteristics. Correlations with other psychological constructs (i.e. Anxiety, Depression and Self-Efficacy) were also tested, showing that more engaged citizens have a lower level of anxiety and depression, and a higher self-efficacy. This study's findings indicate that individuals' characteristics may differentiate citizens' motivation to engage in public health behavioral recommendation to prevent the COVID-19 contagion. However the scale could be useful to perform a psychological monitoring of psychological readiness to engage in public health strategies to face critical events and settings.

Effects of the COVID-19 Emergency and National Lockdown on Italian Citizens' Economic Concerns, Government Trust, and Health Engagement: Evidence From a Two-Wave Panel Study.

Policy Points Preventive measures such as the national lockdown in Italy have been effective in slowing the spread of COVID-19. However, they also had psychological and economic impacts on people's lives, which should not be neglected as they may reduce citizens' trust and compliance with future health mandates. Engaging citizens in their own health management and in the collaboration with health care professionals and authorities via the adoption of a collaborative approach to health policy development is fundamental to fostering such measures' effectiveness. Psychosocial analysis of citizens' concerns and emotional reactions to preventive policies is important in order to plan personalized health communication campaigns. CONTEXT: Because of the COVID-19 pandemic, between February 23 and March 8, 2020, some areas of Italy were declared "red zones," with citizens asked to stay home and avoid unnecessary interpersonal contacts. Such measures were then extended, between March 10 and May 4, 2020, to the whole country. However, compliance with such behaviors had an important impact on citizens' personal, psychological, and economic well-being. This could result in reduced trust in authorities and lowered compliance. Keeping citizens engaged in their own health and in preventive behaviors is thus a key strategy for the success of such measures. This paper presents the results from a study conducted in Italy to monitor levels of people's health engagement, sentiment, trust in authorities, and perception of risk at two different time points. METHODS: Two independent samples (n = 968 and n = 1,004), weighted to be representative of the adult Italian population, were recruited in two waves corresponding to crucial moments of the Italian COVID-19 epidemic: between February 28 and March 4 (beginning of "phase 1," after the first regional lockdowns), and between May 12 and May 18 (beginning of "phase 2," after the national lockdown was partially dismissed). Respondents were asked to complete an online survey with a series of both validated measures and ad hoc items. A series of t-tests, general linear models, and contingency tables were carried out to assess if and how our measures changed over time in different social groups. FINDINGS: Although sense of self and social responsibility increased between the two waves, and trust toward authorities remained substantially the same, trust in science, consumer sentiment, and health engagement decreased. Our results showed that while both the level of general concern for the emergency and the perceived risk of infection increased between the two waves, in the second wave our participants reported being more concerned for the economic consequences of the pandemic than the health risk. CONCLUSIONS: The potentially disruptive psychological impact of lockdown may hamper citizens' compliance with, and hence the effectiveness of, behavioral preventive measures. This suggests that preventive measures should be accompanied by collaborative educational plans aimed at promoting people's health engagement by making citizens feel they are partners in the health preventive endeavor and involved in the development of health policies.

Towards a New System for the Assessment of the Quality in Care Pathways: An Overview of Systematic Reviews.

Clinical or care pathways are developed by a multidisciplinary team of healthcare practitioners, based on clinical evidence, and standardized processes. The evaluation of their framework/content quality is unclear. The aim of this study was to describe which tools and domains are able to critically evaluate the quality of clinical/care pathways. An overview of systematic reviews was conducted, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, using Medline, Embase, Science Citation Index, PsychInfo, CINAHL, and Cochrane Library, from 2015 to 2020, and with snowballing methods. The quality of the reviews was assessed with Assessment the Methodology of Systematic Review (AMSTAR-2) and categorized with The Leuven Clinical Pathway Compass for the definition of the five domains: processes, service, clinical, team, and financial. We found nine reviews. Three achieved a high level of quality with AMSTAR-2. The areas classified according to The Leuven Clinical Pathway Compass were: 9.7% team multidisciplinary involvement, 13.2% clinical (morbidity/mortality), 44.3% process (continuity-clinical integration, transitional), 5.6% financial (length of stay), and 27.0% service (patient-/family-centered care). Overall, none of the 300 instruments retrieved could be considered a gold standard mainly because they did not cover all the critical pathway domains outlined by Leuven and Health Technology Assessment. This overview shows important insights for the definition of a multiprinciple framework of core domains for assessing the quality of pathways. The core domains should consider general critical aspects common to all pathways, but it is necessary to define specific domains for specific diseases, fast pathways, and adapting the tool to the cultural and organizational characteristics of the health system of each country.

Diagnostic test accuracy of an automated device as a screening tool for fall risk assessment in community-residing elderly: A STARD compliant study.

We aimed to determine the accuracy and failure of OAK device, an automated screening, for the assessment of fall risk in a prospective cohort of healthy adults aged over 65 years. The algorithm for fall risk assessment of the centers for disease control and prevention (CDC) was used as reference standard. Of the 183 individuals recruited, the CDC algorithm classified 80 as being at moderate/high risk and 103 at low risk of falling. OAK device failure incidence was 4.9% (confidence interval [CI] upper limit 7.7%), below the preset threshold for futility-early termination of the study (i.e., not above 15%). The OAK device showed a sensitivity of 84% and a specificity of 67% (receiver operating characteristic [ROC] area 82%; 95% confidence interval [CI] 76-88%), not reaching the preplanned target sensitivity (not lower than 85%). Diagnostic accuracy was not far from the sensitivity levels similar to those obtained with other fall risk assessment. However, some limitations can be considered.ClinicalTrials.gov identifier: NCT02655796.

Comparative effectiveness of conservative and pharmacological interventions for chronic non-specific neck pain: Protocol of a systematic review and network meta-analysis.

BACKGROUND: Neck Pain (NP) has been ranked as one of the top chronic pain conditions in terms of prevalence and years lived with disability in the latest Global Burden of Disease. NP has remarkable socio-economic consequences however, research efforts are limited. Discrepancies among guidelines recommendations on management of chronic neck pain exist. The purpose of this study protocol is to provide the methods for a review with network meta-analysis to identify the most effective interventions for chronic neck pain. METHODS: The following databases will be searched from their inception to February 2019: Cochrane Controlled Trials Register (CENTRAL), PubMed, CINAHL, Scopus, ISI Web of Science and PEDro.Randomized controlled trials (RCTs) on pharmacological and not pharmacological interventions will be included and their risk of bias will be evaluated using the Cochrane Risk of bias tool. Primary outcomes will be reduction in pain and disability. A network meta-analysis will be carried out and pairwise meta-analysis will be conducted using Stata 15 software. Grading of recommendations assessment, development, and evaluation (GRADE) will be applied to assess quality of the body of the evidence. RESULTS: The results of this review will be submitted to a peer-review journal for publication. CONCLUSION: This network meta-analysis will provide a comprehensive review on the most effective treatments for the management of chronic neck pain providing key evidence-based information to patients, clinicians and other relevant stakeholders. Registration: PROSPERO (registration number CRD42019124501).

Fall prevention: is the STRATIFY tool the right instrument in Italian Hospital inpatient? A retrospective observational study.

BACKGROUND: Although several risk assessment tools are in use, uncertainties on their accuracy in detecting fall risk already exist. Choosing the most accurate tool for hospital inpatient is still a challenge for the organizations. We aimed to retrospectively assess the appropriateness of a fall risk prevention program with the STRATIFY assessment tool in detecting acute-care inpatient fall risk. METHODS: Number of falls and near falls, occurred from January 2014 to March 2015, was collected through the incident reporting web-system implemented in the hospital's intranet. We reported whether the fall risk was assessed with the STRATIFY assessment tool and, if so, which was the judgement. Primary outcome was the proportion of inpatients identified as high risk of fall among inpatients who fell (True Positive Rate), and the proportion of inpatients identified as low-risk that experienced a fall howsoever (False Negative Rate). Characteristics of population and fall events were described among subgroups of low risk and high risk inpatients. RESULTS: We collected 365 incident reports from 40 hospital units, 349 (95.6%) were real falls and 16 (4.4%) were near falls. The fall risk assessment score at patient's admission had been reported in 289 (79%) of the overall incident reports. Thus, 74 (20.3%) fallers were actually not assessed with the STRATIFY, even though the majority of them presented risk recommended to be assessed. The True Positive Rate was 35.6% (n = 101, 95% CI 30% - 41.1%). The False Negative Rate was 64.4% (n = 183, 95% CI 58.9%-70%) of fallers, nevertheless they incurred in a fall. The STRATIFY mean score was 1.3 ± 1.4; the median was 1 (IQQ 0-2). CONCLUSIONS: The prevention program using only the STRATIFY tool was found to be not adequate to screen our inpatients population. The incorrect identification of patients' needs leads to allocate resources to erroneous priorities and to untargeted interventions, decreasing healthcare performance and quality.

Improving Power and Sample Size Calculation in Rehabilitation Trial Reports: A Methodological Assessment.

OBJECTIVE: To systematically assess the reporting of sample size calculation in randomized controlled trials (RCTs) on rehabilitation interventions for mechanical low back pain. DATA SOURCES: The Cochrane Database of Systematic Reviews was searched through February 2015. STUDY SELECTION: We conducted an electronic database search for RCTs published from January 1, 1968 to February 28, 2015 and included in the Cochrane Systematic Reviews. DATA EXTRACTION: Two investigators independently used an ad hoc 6-item checklist derived from the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement recommendations to extract data on sample size calculation. The primary outcome was the proportion of RCTs that reported sample size calculation; the secondary outcome was the completeness of sample size analysis reporting. We also evaluated improvement in reporting of sample size calculation over time. DATA SYNTHESIS: Sample size calculation was reported in 80 (36.0%) of the 222 eligible RCTs included in 14 Cochrane Systematic Reviews. Only 13 (16.3%) of these RCT reports gave a complete description, and about half reported ≥4 of the 6 elements of sample size calculation (median, 4; interquartile range, 3-5). Completeness of reporting of sample size calculation improved from 1968 to 2013; since 2005, the number of RCTs reporting sample size calculation has increased compared with the number of RCTs not reporting it. CONCLUSIONS: Despite improvement, reporting of sample size calculation and power analysis remains inadequate, limiting the reader's ability to assess the quality and accuracy of rehabilitation studies.

Survey of the reporting characteristics of systematic reviews in rehabilitation.

BACKGROUND: Systematic reviews (SRs) have become increasingly important for informing clinical practice; however, little is known about the reporting characteristics and the quality of the SRs relevant to the practice of rehabilitation health professionals. OBJECTIVE: The purpose of this study was to examine the reporting quality of a representative sample of published SRs on rehabilitation, focusing on the descriptive, reporting, and bias-related characteristics. METHODS: A cross-sectional study was conducted by searching MEDLINE for aggregative and configurative SRs indexed in 2011 that focused on rehabilitation as restorative of functional limitations. Two reviewers independently screened and selected the SRs and extracted data using a 38-item data collection form derived from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The data were analyzed descriptively. RESULTS: Eighty-eight SRs published in 59 journals were sampled. The median compliance with the PRISMA items was 17 (63%) out of 27 items (interquartile ratio=13-22 [48%-82%]). Two thirds of the SRs (n=66) focused on interventions for which efficacy is best addressed through a randomized controlled trial (RCT) design, and almost all of these SRs included RCTs (63/66 [95%]). More than two thirds of the SRs assessed the quality of primary studies (74/88 [84%]). Twenty-eight reviews (28/88 [32%]) meta-analyzed the results for at least one outcome. One half of the SRs reported positive statistically significant findings (46%), whereas a detrimental result was present only in one review. CONCLUSIONS: This sample of SRs in the rehabilitation field showed heterogeneous characteristics and a moderate quality of reporting. Poor control of potential source of bias might be improved if more widely agreed-upon evidence-based reporting guidelines will be actively endorsed and adhered to by authors and journals.