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International Journal of Cardiology Nov 2016Acute myocardial infarction (AMI) is an important health problem. Cardiac rehabilitation (CR) programs following AMI have shown to be effective in reducing mortality. We... (Review)
Review
Acute myocardial infarction (AMI) is an important health problem. Cardiac rehabilitation (CR) programs following AMI have shown to be effective in reducing mortality. We aim to systematically review the existing literature that analyzes the factors that affect participation and adherence to cardiac rehabilitation programs. We reviewed Medline, EMBASE and Cochrane databases from 01/01/2004 to June 2016 using predefined inclusion and exclusion criteria. We classified the results into factors affecting participation and factors influencing adherence to CR programs. We included 29 studies, and there was a general agreement in those factors predicting participation and adherence to CR programs. These factors can be classified into person-related factors and aspects related to CR programs. Older participants, women, patients with comorbidities, unemployed and uncoupled persons, less educated people and those with lower income had a lower participation. A similar pattern was observed for CR adherence. Also, those potential participants who live farther from CR facilities, do not have transportation, or do not drive, attended less to CR programs. These factors were very similar when analyzing adherence to CR programs. These aspects were similar in Europe and the USA. These results clearly show that participation in CR programs follows a determined pattern that is very homogeneous in different settings. Health professionals should also be aware of patients reluctant to participate in CR programs and adapt their messages and redesign CR programs, to promote participation and adherence.
Topics: Cardiac Rehabilitation; Humans; Myocardial Infarction; Patient Compliance; Program Evaluation; Referral and Consultation
PubMed: 27557484
DOI: 10.1016/j.ijcard.2016.08.120 -
Journal of the American Geriatrics... Sep 2021To examine randomized controlled trials with active music-making interventions, in which older adults with probable mild cognitive impairment (MCI) or dementia... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To examine randomized controlled trials with active music-making interventions, in which older adults with probable mild cognitive impairment (MCI) or dementia physically participate in music, and their effects on cognitive functioning, emotional well-being, and social engagement. Participating in music-making is engaging and has shown diverse benefits. Additionally, this review categorized the music activities of each intervention.
DESIGN
Systematic review and meta-analysis.
SETTING
Long-term care facilities, day centers, specialty outpatient units, and community.
METHODS
Published randomized controlled trials of active music-making interventions to support older adults with probable MCI or dementia were identified (to March 15, 2021) using searches on Medline (Ovid), APA PsycInfo (Ovid), CINAHL (Ebsco), and Embase (Elsevier). The outcomes were cognitive functioning, emotional well-being, and social engagement, including self- and clinician-reported measures such as the Mini-Mental State Examination, Positive and Negative Affect Schedule, and the Beck Depression Inventory. Studies were critically appraised and studies with similar methodology were meta-analyzed.
PARTICIPANTS
Older adults with probable MCI and mild or moderate dementia.
RESULTS
A total of 21 studies with 1472 participants were analyzed for potential effect sizes and intervention activities. Of the 21 studies, nine studies recruiting a total of 495 participants were used to produce a random-effects meta-analytic model for cognitive functioning. Music showed a small, positive effect on cognitive functioning; the combined standard mean difference for the experimental and control group was 0.30 (95% confidence interval [CI] 0.10, 0.51). There was low study heterogeneity, with an I of 24% (p = 0.004). Individual studies for emotional well-being in terms of quality of life and mood showed positive effect sizes, d = 1.08 and d = 1.74, respectively. [Corrections added on July 8, 2021, after first online publication: The preceding sentences were revised from: "… control group was 0.31 (95% confidence interval [CI] 0.10,0.52). There was low study heterogeneity, with an I2 of 25% (p = 0.004)."] CONCLUSION: This review shows that music-making has a small but statistically significant effect on cognitive functioning for older adults with probable MCI or dementia. Future music interventions can benefit from rigorous intervention protocols that isolate specific activities.
Topics: Aged; Cognitive Dysfunction; Dementia; Humans; Music Therapy
PubMed: 34008208
DOI: 10.1111/jgs.17208 -
The American Journal of Sports Medicine Nov 2014The role of evidence-based medicine in sports medicine and orthopaedic surgery is rapidly growing. Systematic reviews and meta-analyses are also proliferating in the... (Review)
Review
BACKGROUND
The role of evidence-based medicine in sports medicine and orthopaedic surgery is rapidly growing. Systematic reviews and meta-analyses are also proliferating in the medical literature.
PURPOSE
To provide the outline necessary for a practitioner to properly understand and/or conduct a systematic review for publication in a sports medicine journal.
STUDY DESIGN
Review.
METHODS
The steps of a successful systematic review include the following: identification of an unanswered answerable question; explicit definitions of the investigation's participant(s), intervention(s), comparison(s), and outcome(s); utilization of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines and PROSPERO registration; thorough systematic data extraction; and appropriate grading of the evidence and strength of the recommendations.
RESULTS
An outline to understand and conduct a systematic review is provided, and the difference between meta-analyses and systematic reviews is described. The steps necessary to perform a systematic review are fully explained, including the study purpose, search methodology, data extraction, reporting of results, identification of bias, and reporting of the study's main findings.
CONCLUSION
Systematic reviews or meta-analyses critically appraise and formally synthesize the best existing evidence to provide a statement of conclusion that answers specific clinical questions. Readers and reviewers, however, must recognize that the quality and strength of recommendations in a review are only as strong as the quality of studies that it analyzes. Thus, great care must be used in the interpretation of bias and extrapolation of the review's findings to translation to clinical practice. Without advanced education on the topic, the reader may follow the steps discussed herein to perform a systematic review.
Topics: Evidence-Based Medicine; Humans; Medical Writing; Meta-Analysis as Topic; Orthopedics; Publishing; Review Literature as Topic; Sports Medicine
PubMed: 23925575
DOI: 10.1177/0363546513497567 -
Sports Medicine (Auckland, N.Z.) Sep 2011Amputation of a limb may have a negative impact on the psychological and physical well-being, mobility and social life of individuals with limb amputations.... (Review)
Review
Amputation of a limb may have a negative impact on the psychological and physical well-being, mobility and social life of individuals with limb amputations. Participation in sports and/or regular physical activity has a positive effect on the above mentioned areas in able-bodied individuals. Data concerning participation in sports or regular physical activity together with its benefits and risks for individuals with limb amputations are scarce. No systematic review exists that addresses a wide range of outcomes such as biomechanics, cardiopulmonary function, psychology, sport participation and sport injuries. Therefore, the aim of this article is to systematically review the literature about individuals with limb amputations and sport participation. MEDLINE (PubMed), EMBASE, CINAHL® and SportDiscus® were searched without time or language restrictions using free text words and MeSH terms. The last search date was 31 March 2010. Books, internet sites and references of included papers were checked for papers relevant to the topic under review. Papers were included if the research topic concerned sports and a minimum of ten individuals with limb amputations were part of the study population. Papers were excluded if they included individuals with amputations of body parts other than upper or lower limbs or more distal than the wrist or ankle, or if they consisted of case reports, narrative reviews, books, notes or letters to the editor. Title, abstract and full-text assessments were performed by two independent observers following a list of preset criteria. Of the 3689 papers originally identified, 47 were included in the review. Most of the included studies were older than 10 years and had cross-sectional designs. Study participants were generally younger and often had more traumatic amputations than the general population of individuals with limb amputations. Heterogeneity in population characteristics, intervention types and main outcomes made data pooling impossible. In general, sports were associated with a beneficial effect on the cardiopulmonary system, psychological well-being, social reintegration and physical functioning. Younger individuals with unilateral transtibial amputations achieve better athletic performance and encounter fewer problems when participating in sports compared with older individuals with bilateral transfemoral amputations. Regardless of their amputation level, individuals with limb amputations participate in a wide range of recreational activities. The majority of them were not aware of the sport facilities in their area and were not informed about available recreational activities. Sport prosthetic devices were used mostly by competitive athletes. For football, the injury rate and pattern of the players with an amputation were similar to those of able-bodied players. Individuals with limb amputations appear to benefit both physically and psychologically from participation in sports and/or regular physical activity. Therefore, sports should be included in rehabilitation programmes, and individuals with limb amputations should be encouraged to pursue a physically active life following hospital discharge.
Topics: Amputation, Surgical; Amputees; Athletic Injuries; Athletic Performance; Biomechanical Phenomena; Female; Heart; Humans; Lung; Male; Quality of Life; Sports
PubMed: 21846162
DOI: 10.2165/11590420-000000000-00000 -
International Journal of Nursing Studies Nov 2020Resuming participation in society is an important goal of post-stroke rehabilitation. Exercise-based interventions have been shown to be effective non-pharmacological... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Resuming participation in society is an important goal of post-stroke rehabilitation. Exercise-based interventions have been shown to be effective non-pharmacological methods for improving social participation in post-stroke survivors, however it is unclear what the most effective types of exercise interventions are.
OBJECTIVE
To assess the comparative effects and ranks of all exercise-based interventions in improving social participations in patients after a stroke.
METHODS
A random-effects network meta-analysis was performed to identify evidence from relevant randomized control trials. We searched MEDLINE, CINAHL, EMBASE, PsycINFO, CINHAL, Cochrane Library, AMED, SPORTDiscus, Web of Science and Clinical Trials.gov from their earliest records to January 2020. Included trials must include at least one types of exercise for patients with stroke. The primary e was social participation. Bias will be assessed according to the revised Cochrane risk of bias tool. Data were analysed using Stata v14.0. Registration number of this study is CRD42020152523.
RESULTS
A total of 16 randomized control trials involving 1704 patients and 12 intervention arms were included in our study. We performed three subgroup analyses divided based on follow up time (1 to <6 months post-treatment, and ≥6 months post-treatment), and intervention adherence. Based on the ranking probabilities, motor relearning programme was ranked as the most effective among all exercise interventions (surface under cumulative ranking curve values [SUCRCV]: 95.6%, standardized mean difference [SMD]: 2.72, 95% confidence interval [CI]: 1.76 to 3.69) in overall and short-term treatment efficacy. In the long-term subgroup, home-based combined exercise ranked the best for the efficacy of social participation improvements among stroke survivors (SUCRCV: 71.8%, SMD: -0.23, 95% CI: -0.61 to 0.15). In the analysis of all interventions with adherence of >90%, cognitive-based exercise ranked the best (SUCRCV: 100%, SMD: 2.64, 95% CI: 1.62 to 3.66).
CONCLUSIONS
Interventions that emerged with the highest ranks in our analysis might be considered in practice when resources allow. More large, well-designed multicentre trials are needed to support the conclusion of this study.
Topics: Exercise; Humans; Network Meta-Analysis; Randomized Controlled Trials as Topic; Stroke; Stroke Rehabilitation; Survivors
PubMed: 32858433
DOI: 10.1016/j.ijnurstu.2020.103738 -
Systematic Reviews Jun 2023Sport is a subset of physical activity that can be particularly beneficial for short-and-long-term physical and mental health, and social outcomes in adults. This study... (Review)
Review
BACKGROUND
Sport is a subset of physical activity that can be particularly beneficial for short-and-long-term physical and mental health, and social outcomes in adults. This study presents the results of an updated systematic review of the mental health and social outcomes of community and elite-level sport participation for adults. The findings have informed the development of the 'Mental Health through Sport' conceptual model for adults.
METHODS
Nine electronic databases were searched, with studies published between 2012 and March 2020 screened for inclusion. Eligible qualitative and quantitative studies reported on the relationship between sport participation and mental health and/or social outcomes in adult populations. Risk of bias (ROB) was determined using the Quality Assessment Tool (quantitative studies) or Critical Appraisal Skills Programme (qualitative studies).
RESULTS
The search strategy located 8528 articles, of which, 29 involving adults 18-84 years were included for analysis. Data was extracted for demographics, methodology, and study outcomes, and results presented according to study design. The evidence indicates that participation in sport (community and elite) is related to better mental health, including improved psychological well-being (for example, higher self-esteem and life satisfaction) and lower psychological ill-being (for example, reduced levels of depression, anxiety, and stress), and improved social outcomes (for example, improved self-control, pro-social behavior, interpersonal communication, and fostering a sense of belonging). Overall, adults participating in team sport had more favorable health outcomes than those participating in individual sport, and those participating in sports more often generally report the greatest benefits; however, some evidence suggests that adults in elite sport may experience higher levels of psychological distress. Low ROB was observed for qualitative studies, but quantitative studies demonstrated inconsistencies in methodological quality.
CONCLUSIONS
The findings of this review confirm that participation in sport of any form (team or individual) is beneficial for improving mental health and social outcomes amongst adults. Team sports, however, may provide more potent and additional benefits for mental and social outcomes across adulthood. This review also provides preliminary evidence for the Mental Health through Sport model, though further experimental and longitudinal evidence is needed to establish the mechanisms responsible for sports effect on mental health and moderators of intervention effects. Additional qualitative work is also required to gain a better understanding of the relationship between specific elements of the sporting environment and mental health and social outcomes in adult participants.
Topics: Adult; Humans; Mental Health; Sports; Exercise; Anxiety
PubMed: 37344901
DOI: 10.1186/s13643-023-02264-8 -
The Cochrane Database of Systematic... Feb 2022Discharge planning is a routine feature of health systems in many countries that aims to reduce delayed discharge from hospital, and improve the co-ordination of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Discharge planning is a routine feature of health systems in many countries that aims to reduce delayed discharge from hospital, and improve the co-ordination of services following discharge from hospital and reduce the risk of hospital readmission. This is the fifth update of the original review.
OBJECTIVES
To assess the effectiveness of planning the discharge of individual patients moving from hospital.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase and two trials registers on 20 April 2021. We searched two other databases up to 31 March 2020. We also conducted reference checking, citation searching and contact with study authors to identify additional studies.
SELECTION CRITERIA
Randomised trials that compared an individualised discharge plan with routine discharge that was not tailored to individual participants. Participants were hospital inpatients.
DATA COLLECTION AND ANALYSIS
Two review authors independently undertook data analysis and quality assessment using a pre-designed data extraction sheet. We grouped studies by older people with a medical condition, people recovering from surgery, and studies that recruited participants with a mix of conditions. We calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous data using fixed-effect meta-analysis. When combining outcome data it was not possible because of differences in the reporting of outcomes, we summarised the reported results for each trial in the text.
MAIN RESULTS
We included 33 trials (12,242 participants), four new trials included in this update. The majority of trials (N = 30) recruited participants with a medical diagnosis, average age range 60 to 84 years; four of these trials also recruited participants who were in hospital for a surgical procedure. Participants allocated to discharge planning and who were in hospital for a medical condition had a small reduction in the initial hospital length of stay (MD - 0.73, 95% confidence interval (CI) - 1.33 to - 0.12; 11 trials, 2113 participants; moderate-certainty evidence), and a relative reduction in readmission to hospital over an average of three months follow-up (RR 0.89, 95% CI 0.81 to 0.97; 17 trials, 5126 participants; moderate-certainty evidence). There was little or no difference in participant's health status (mortality at three- to nine-month follow-up: RR 1.05, 95% CI 0.85 to 1.29; 8 trials, 2721 participants; moderate certainty) functional status and psychological health measured by a range of measures, 12 studies, 2927 participants; low certainty evidence). There was some evidence that satisfaction might be increased for patients (7 trials), caregivers (1 trial) or healthcare professionals (2 trials) (very low certainty evidence). The cost of a structured discharge plan compared with routine discharge is uncertain (7 trials recruiting 7873 participants with a medical condition; very low certainty evidence).
AUTHORS' CONCLUSIONS
A structured discharge plan that is tailored to the individual patient probably brings about a small reduction in the initial hospital length of stay and readmissions to hospital for older people with a medical condition, may slightly increase patient satisfaction with healthcare received. The impact on patient health status and healthcare resource use or cost to the health service is uncertain.
Topics: Aged; Aged, 80 and over; Hospitals; Humans; Length of Stay; Middle Aged; Patient Discharge; Patient Readmission; Patient Satisfaction; Randomized Controlled Trials as Topic
PubMed: 35199849
DOI: 10.1002/14651858.CD000313.pub6 -
Sports (Basel, Switzerland) Dec 2023Sports participation and the risk of osteoarthritis (OA) have been a concern for decades. Few research efforts have been dedicated to clarify this issue for females,... (Review)
Review
Sports participation and the risk of osteoarthritis (OA) have been a concern for decades. Few research efforts have been dedicated to clarify this issue for females, although they are considered at greater risk of developing OA than males. In contrast, several reviews have established an association between sports participation and OA for males. The aim of the systematic review was to assess the association between OA and participation in popular sports for females. PubMed, Embase, and Google Scholar were searched and yielded 578 articles. Nine eligible studies were included and covered ballet (age range: 19-54 years), running or tennis (age range: 40-65 years), Olympic sports (age range: not specified), volleyball (age range: 16.0 ± 0.8 to 46.8 ± 5.1 years), and cross-country skiing (age range: 15 to ≥60 years). For females, participating in sports at an elite level was associated with a higher risk of OA and an increased need for surgical treatment. At non-elite level, it was associated with a higher risk of OA, but it did not materialize to an increased risk for surgical treatment. Few studies compared females and males, and these studies suggested that sex did not affect the risk of developing OA from participating in sports. Nevertheless, to isolate the precise effect of sports participation on the development of OA remains difficult as injuries are common among athletes and are independently associated with an increased risk of OA.
PubMed: 38251289
DOI: 10.3390/sports12010015 -
The Cochrane Database of Systematic... May 2022Comprehensive Geriatric Assessment (CGA) is a multidimensional interdisciplinary diagnostic process focused on determining an older person's medical, psychological and... (Review)
Review
BACKGROUND
Comprehensive Geriatric Assessment (CGA) is a multidimensional interdisciplinary diagnostic process focused on determining an older person's medical, psychological and functional capability in order to develop a co-ordinated and integrated care plan. CGA is not limited simply to assessment, but also directs a holistic management plan for older people, which leads to tangible interventions. While there is established evidence that CGA reduces the likelihood of death and disability in acutely unwell older people, the effectiveness of CGA for community-dwelling, frail, older people at risk of poor health outcomes is less clear.
OBJECTIVES
To determine the effectiveness of CGA for community-dwelling, frail, older adults at risk of poor health outcomes in terms of mortality, nursing home admission, hospital admission, emergency department visits, serious adverse events, functional status, quality of life and resource use, when compared to usual care.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, CINAHL, three trials registers (WHO ICTRP, ClinicalTrials.gov and McMaster Aging Portal) and grey literature up to April 2020; we also checked reference lists and contacted study authors.
SELECTION CRITERIA
We included randomised trials that compared CGA for community-dwelling, frail, older people at risk of poor healthcare outcomes to usual care in the community. Older people were defined as 'at risk' either by being frail or having another risk factor associated with poor health outcomes. Frailty was defined as a vulnerability to sudden health state changes triggered by relatively minor stressor events, placing the individual at risk of poor health outcomes, and was measured using objective screening tools. Primary outcomes of interest were death, nursing home admission, unplanned hospital admission, emergency department visits and serious adverse events. CGA was delivered by a team with specific gerontological training/expertise in the participant's home (domiciliary Comprehensive Geriatric Assessment (dCGA)) or other sites such as a general practice or community clinic (community Comprehensive Geriatric Assessment (cCGA)).
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted study characteristics (methods, participants, intervention, outcomes, notes) using standardised data collection forms adapted from the Cochrane Effective Practice and Organisation of Care (EPOC) data collection form. Two review authors independently assessed the risk of bias for each included study and used the GRADE approach to assess the certainty of evidence for outcomes of interest.
MAIN RESULTS
We included 21 studies involving 7893 participants across 10 countries and four continents. Regarding selection bias, 12/21 studies used random sequence generation, while 9/21 used allocation concealment. In terms of performance bias, none of the studies were able to blind participants and personnel due to the nature of the intervention, while 14/21 had a blinded outcome assessment. Eighteen studies were at low risk of attrition bias, and risk of reporting bias was low in 7/21 studies. Fourteen studies were at low risk of bias in terms of differences of baseline characteristics. Three studies were at low risk of bias across all domains (accepting that it was not possible to blind participants and personnel to the intervention). CGA probably leads to little or no difference in mortality during a median follow-up of 12 months (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.76 to 1.02; 18 studies, 7151 participants (adjusted for clustering); moderate-certainty evidence). CGA results in little or no difference in nursing home admissions during a median follow-up of 12 months (RR 0.93, 95% CI 0.76 to 1.14; 13 studies, 4206 participants (adjusted for clustering); high-certainty evidence). CGA may decrease the risk of unplanned hospital admissions during a median follow-up of 14 months (RR 0.83, 95% CI 0.70 to 0.99; 6 studies, 1716 participants (adjusted for clustering); low-certainty evidence). The effect of CGA on emergency department visits is uncertain and evidence was very low certainty (RR 0.65, 95% CI 0.26 to 1.59; 3 studies, 873 participants (adjusted for clustering)). Only two studies (1380 participants; adjusted for clustering) reported serious adverse events (falls) with no impact on the risk; however, evidence was very low certainty (RR 0.82, 95% CI 0.58 to 1.17).
AUTHORS' CONCLUSIONS
CGA had no impact on death or nursing home admission. There is low-certainty evidence that community-dwelling, frail, older people who undergo CGA may have a reduced risk of unplanned hospital admission. Further studies examining the effect of CGA on emergency department visits and change in function and quality of life using standardised assessments are required.
Topics: Aged; Frail Elderly; Geriatric Assessment; Hospitalization; Humans; Independent Living; Quality of Life
PubMed: 35521829
DOI: 10.1002/14651858.CD012705.pub2 -
Trials Jan 2023For children and young people with eye and vision conditions, research is essential to advancing evidence-based recommendations in diagnosis, prevention, treatments and... (Review)
Review
BACKGROUND
For children and young people with eye and vision conditions, research is essential to advancing evidence-based recommendations in diagnosis, prevention, treatments and cures. Patient 'experience' reflects a key measure of quality in health care (Department of Health. High Quality Care for All: NHS Next Stage Review Final Report: The Stationery Office (2008)); research participant 'experiences' are equally important. Therefore, in order to achieve child-centred, high-quality paediatric ophthalmic research, we need to understand participation experiences. We conducted a systematic review of existing literature; our primary outcome was to understand what children and young people, parents and research staff perceive to support or hinder positive paediatric eye and vision research experiences. Our secondary outcomes explored whether any adverse or positive effects were perceived to be related to participation experiences, and if any interventions to improve paediatric ophthalmic research experiences had previously been developed or used.
METHODS
We searched (from inception to November 2018, updated July 2020) in MEDLINE, Embase, CINAHL, Web of Science, NICE evidence and The Cochrane Library (CDSR and CENTRAL), key journals (by hand), grey literature databases and Google Scholar; looking for evidence from the perspectives of children, young people, parents and staff with experience of paediatric ophthalmic research. The National Institute for Health Research (NIHR) Participant in Research Experience Survey (PRES) (National Institute for Health Research. Research Participant Experience Survey Report 2018-19 (2019); National Institute for Health Research. Optimising the Participant in Research Experience Checklist (2019)) identified 'five domains' pivotal to shaping positive research experiences; we used these domains as an 'a priori' framework to conduct a 'best fit' synthesis (Carroll et al., BMC Med Res Methodol. 11:29, 2011; Carroll et al., BMC Med Res Methodol. 13:37, 2013).
RESULTS
Our search yielded 13,020 papers; two studies were eligible. These evaluated research experiences from the perspectives of parents and staff; the perspectives of children and young people themselves were not collected. No studies were identified addressing our secondary objectives. Synthesis confirmed the experiences of parents were shaped by staff characteristics, information provision, trial organisation and personal motivations, concurring with the 'PRES domains' (National Institute for Health Research. Optimising the Participant in Research Experience Checklist (2019)) and generating additional dimensions to participation motivations and the physical and emotional costs of study organisation.
CONCLUSIONS
The evidence base is limited and importantly omits the voices of children and young people. Further research, involving children and young people, is necessary to better understand the research experiences of this population, and so inform quality improvements for paediatric ophthalmic research care and outcomes.
TRIAL REGISTRATION
Review registered with PROSPERO, International prospective register of systematic reviews: CRD42018117984. Registered on 11 December 2018.
Topics: Adolescent; Child; Humans; Delivery of Health Care; Health Facilities; Motivation
PubMed: 36709306
DOI: 10.1186/s13063-022-07021-1