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At least 307 records · Page 17Linked to original sources

Testing effectiveness of a community-based aggression management program for children 7 to 11 years old and their families.

OBJECTIVE: There are few well-evaluated uncomplicated community-based interventions for childhood aggression. The authors assess the impact of a community-based anger management group on child aggressive behaviors, using a randomized, controlled trial (RCT). METHOD: Families with children 7 to 11 years old were recruited through advertisements and randomized (N = 123). Inclusion required parent concern about anger/aggressive behavior, RCT agreement, and a telephone behavior screen. Intervention participants were offered three parent education/skill-building group sessions, 10 weekly child group sessions, and three in-home family practice sessions. Nine groups ran from August 2002 to August 2004. Interviewers naïve to randomization collected data on all participants pre- and postgroup. Outcomes included child-rated anger and parent-rated child aggressive behavior, externalizing behavior and hostility, parent-child relationship, and parenting stress. Intent-to-treat analyses were done. RESULTS: Pre/postoutcome comparisons indicated no significant differences between intervention versus control, with small effect sizes for most outcomes (0.27-0.29). Although not significant, the magnitude of improvement favored intervention families on all parent-rated measures. CONCLUSIONS: Overall, there was no differential impact of participating in a community-based anger management group versus control on child aggressive behaviors and other associated measures. The impact of regression to the mean, effect, and sample size estimates; child comorbidity; and programmatic and methodological issues are discussed.

Aggression↗

Randomized controlled trials in long-term care residents with dementia: a systematic review.

OBJECTIVE: To evaluate the quality of reporting of randomized controlled trials for pharmacologic interventions in long-term care residents with dementia. DATA SOURCES: We performed electronic searches of AMED, CINAHL, E-PSYCHE, Cochrane Controlled Trials Register, and MEDLINE. We also searched the reference lists of included studies and bibliographies of relevant review articles. STUDY SELECTION: All randomized controlled trials for pharmacologic interventions in patients with dementia residing in long-term care facilities. DATA ABSTRACTION: We abstracted data independently, in duplicate, using a data abstraction sheet and a quality checklist. DATA SYNTHESIS: Fifteen trials met inclusion criteria. Five trials lacked institutional ethical review, while two lacked informed consent. Eleven trials gave adequate description of withdrawals and 14 trials reported adverse events adequately. We found incomplete reporting of methods of randomization, allocation concealment, restriction, blinding, sample size estimation and intention-to-treat analysis. Sensitivity analysis indicated that reporting of allocation concealment was associated with increased quality of trial according to the quality scale (P = 0.007). CONCLUSIONS: Clinicians and the public do not have high-quality information to guide pharmacologic decision making for long-term care residents with dementia. The reporting quality is highly variable in the trials reviewed, and concerns exist surrounding the conduct of several trials.

Aged↗

Inadequate size of 'negative' clinical trials in dermatology.

Fifty-eight clinical trials with negative conclusions, published in three British dermatological journals over the last 4 years, were reviewed to determine the risk of their having missed an effective treatment. All but one of the 44 evaluable trials had a greater than 1 in 10 risk of missing a 25% relative treatment difference (median risk 81%), and 31 of the trials (70%) were so small that they had a greater than 1 in 10 risk of missing a 50% relative treatment difference (median risk 42%). The 'negative' trial result was compatible (within 95% confidence limits) with a 25% beneficial relative treatment effect in 36 studies (82%), and a 50% treatment benefit in 22 studies (50%). Only one study used confidence intervals to describe the main findings, and only three studies (7%) mentioned the basis for sample size estimation at the outset of the study. Of particular concern was that in half (23/44) of the studies there was an incorrect interpretation of the findings. It is worrying to observe such a profusion of clinical trials in dermatology which are too small to answer the questions being posed, especially when this is coupled with misreporting of results. Apart from ethical concerns, many treatments compatible with a considerable treatment benefit may have been erroneously discarded as a result of such studies. We recommend the use of confidence intervals to summarize clinical trial findings, so that readers can quickly decide whether clinically important treatment effects are plausible.

Humans↗

Barostat testing of rectal sensation and compliance in humans: comparison of results across two centres and overall reproducibility.

We assessed reproducibility of measurements of rectal compliance and sensation in health in studies conducted at two centres. We estimated samples size necessary to show clinically meaningful changes in future studies. We performed rectal barostat tests three times (day 1, day 1 after 4 h and 14-17 days later) in 34 healthy participants. We measured compliance and pressure thresholds for first sensation, urgency, discomfort and pain using ascending method of limits and symptom ratings for gas, urgency, discomfort and pain during four phasic distensions (12, 24, 36 and 48 mmHg) in random order. Results obtained at the two centres differed minimally. Reproducibility of sensory end points varies with type of sensation, pressure level and method of distension. Pressure threshold for pain and sensory ratings for non-painful sensations at 36 and 48 mmHg distension were most reproducible in the two centres. Sample size calculations suggested that crossover design is preferable in therapeutic trials: for each dose of medication tested, a sample of 21 should be sufficient to demonstrate 30% changes in all sensory thresholds and almost all sensory ratings. We conclude that reproducibility varies with sensation type, pressure level and distension method, but in a two-centre study, differences in observed results of sensation are minimal and pressure threshold for pain and sensory ratings at 36-48 mmHg of distension are reproducible.

Adult↗

Prenatal exposure to prescribed drugs in Tennessee Medicaid, 1983-1988.

This report describes the prenatal exposure histories of 107,804 women to prescribed drugs other than vitamins, iron and other minerals. The data were obtained from Tennessee Medicaid pharmacy files linked to birth and fetal death certificates for 1983-1988. The utility of these data to other investigators in predicting power or estimating sample size for studies of drug exposure in pregnancy associated with adverse birth outcomes is discussed.

Abnormalities, Drug-Induced↗

Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument.

OBJECTIVE: The interpretation of health-related quality of life (HRQL) data from clinical trials can be enhanced by understanding the degree of change in HRQL scores that is considered meaningful. Our objectives were to combine distribution-based and two anchor-based approaches to identify minimally important differences (MIDs) for the 27-item Trial Outcome Index (TOI), the seven-item Social Well-Being (SWB) subscale, and the six-item Emotional Well-being (EWB) subscale from the Functional Assessment of Cancer Therapy-Biological Response Modifiers (FACT-BRM) instrument. METHODS: Distribution-based MIDs were based on the standard error of measurement. Anchor-based approaches utilized patient-reported global rating of change (GRC) and change in physician-reported performance status rating (PSR). Correlations and weighted kappa statistics were used to assess association and agreement between the two anchors. FACT-BRM changes were evaluated for three time periods: baseline to month 1, month 2 to month 3, and month 5 to month 6. RESULTS: Association between GRC and change in PSR was poor. Correlation between the anchors and HRQL change scores was largest at month 1 and decreased through month 6. Combining results from all approaches, the MIDs identified were 5-8 points for the TOI, 2 points for the SWB subscale, and 2-3 points for the EWB subscale. CONCLUSIONS: We combined patient-reported estimates, physician-reported estimates, and distribution-based estimates to derive MIDs for HRQL outcomes from the FACT-BRM. These results will enable interpretation of treatment group effects in a clinical trial setting, and they can be used to estimate sample size or power when designing future studies.

Adolescent↗

Headache prevalence in adolescents aged 12 to 17: a student-based epidemiological study in Bursa.

BACKGROUND AND OBJECTIVES: The objective of this study was to investigate the prevalence and sociodemographic characteristics of headaches among Turkish adolescents aged 12 to 17 years old in Bursa province of Turkey. METHODS: A multistep, stratified, cluster sampling method was used for subject selection. The estimated sample size for 12- to 14-year-old students was 1,270 and for 15- to 17-year-old students was 1,117. Our study sample included 6.5% of the secondary schools and 1.8% of the students aged 12 to 17 years old. The study was conducted in two phases; the questionnaire phase and the face-to-face interview phase. RESULTS: The prevalence of recurrent headache in the study population was 52.2%. Girls (59.8%) had significantly more recurrent headache than boys (45.1%) The prevalence of recurrent headache increased from 42.2% up to 60.7% by age. In multivariate logistic regression analysis age and gender differed significantly between adolescents with and without recurrent headache groups. Frequent episodic tension-type headache was the most common (25.9%) headache among Turkish adolescents, followed by migraine (14.5%). CONCLUSIONS: Age and gender appeared to be demographic factors increasing adolescent headache prevalence. Frequent episodic-tension type headache was the most common headache followed by migraine. Our migraine prevalence was slightly higher than most of the previously reported prevalence rates. This might be due to the new classification criteria of headache released by International Headache Society.

Adolescent↗

Clinical characteristics of tension-type headache and migraine in adolescents: a student-based study.

BACKGROUND AND OBJECTIVES: Adolescent headaches, particularly migraine, might present with different features from adult headaches. The objectives of this study were to investigate the characteristics of tension-type headache and migraine, to find the sensitivity and specificity of the diagnostic criteria of the IHS classification according to age and gender. METHODS: A multistep, stratified, cluster sampling method was used for subject selection. The estimated sample size was 2387. The study was conducted in two phases: the questionnaire and the face to face interview phases. During the semistructured interview, a clinical diagnosis has been made and clinical characteristics have been recorded. RESULTS: All headaches fulfilled the criteria of duration. The most common feature of migraine was moderate to severe (92.4%), pulsating pain (79.2%). For ETTH, bilateral localization (91.3%) and mild to moderate pain intensity (90.6%) were the most common features. Younger adolescents showed mixed headache characteristics. Highest sensitivities for migraine were duration (100%), moderate to severe pain (92.4%), and pulsating quality of pain (79.2%). Vomiting, trigger factors food and alcohol had a high specificity for migraine. CONCLUSIONS: Our data strongly support continuum hypothesis. In early adolescence headaches might present with mixed headache characteristics. Age and gender have some influence on headache characteristics, particularly on migraine. The sensitivity and specificity of case definition criteria of ICHD-2 for adolescent migraine is moderate and need to be reconsidered.

Adolescent↗

Reliability of caries data in three clinical trials.

The reliability of caries data obtained during three clinical trials is presented. Each of the three trials, conducted by different examiners, lasted 3 years and involved children aged 12 to 15 years. Reliability was quantified in terms of reliability coefficient and error variance, which allowed the effect of error upon the efficiency of each study to be measured. Reliability tended to be reduced when precaviation (initial) lesions were included in the DMFS count, but there was little difference between the reliability coefficients for each of four different surface-types. Error was more important in 3-year incremental rather than prevalence data, but nevertheless had a rather small influence upon sample size estimation or confidence limits of percent caries reductions.

Adolescent↗

Prevention-oriented practice of Iranian senior dental students.

OBJECTIVES: To investigate self-reported preventive practice of Iranian senior dental students in dental caries management. SUBJECTS AND METHODS: To obtain an estimated sample size of 250 subjects, seven state dental schools were selected based on a stratified random sampling approach. All the senior dental students (n = 327) were asked to voluntarily fill in a self-administered pre-tested questionnaire during the spring term in 2005. In the questionnaire two hypothetical patient cases (a high-risk and a low-risk patient) were presented and the students were asked to express their conceptions on a five-point Likert scale about including each of nine given alternatives in the patients' treatment plans. The respondents' self-reported oral self-care (OSC), preventive knowledge, attitude towards prevention and self-perceived competency in giving preventive care were also assessed. Chi-squared test and logistic regression model served for statistical analyses. RESULTS: A total of 270 students filled in the questionnaire (response rate = 82%). Acquiring high scores of preventive practice as assessed by patient cases was found to be more frequent among those reporting recommended OSC (P = 0.007) and those with higher attitude scores (P < 0.001). Also, those reporting being competent in giving preventive care had higher scores of preventive practice compared with the others (P = 0.02). In the regression model, recommended OSC (P = 0.05, OR = 1.9) and positive attitudes towards preventive dentistry (P = 0.001, OR = 3.3) showed significant association with acquiring highest scores of preventive practice. CONCLUSION: To improve their preventive practice in the future, more emphasis should be placed on the dental students' own oral health behaviour and attitudes related to it.

Adult↗

Participation of epidemiologists and/or biostatisticians and methodological quality of published controlled clinical trials.

STUDY OBJECTIVE: This study assessed several methodological aspects related to the quality of published controlled clinical trials (CCTs) in relation to the participation of an epidemiologist/biostatistician (E/B). DESIGN: Handsearch of CCTs published in four medical leading journals for 1993-1995. METHODS: Quality variables, abstracted from a review, were related to authors' specialties. Five hundred and ninety four CCTs were identified via a hand search. The department/unit membership was used to attribute authors' specialties. Of 594 CCTs identified, in 127 the authors' specialties could not be known, leaving 467 trials for analysis. RESULTS: E/B participation occurred in 178 trials (38.1%). This participation was more frequent in multicentric, bigger, and in those trials describing any funding agency. These factors were controlled for in the analysis. E/B participation was positively associated with pre-study sample size estimation (OR = 1.5, 95% confidence intervals (CI) 1.0, 2.3), with reporting the dates for starting/ending the study (OR = 2.1, 95% CI 1.4, 3.3), with using an objectively assessed outcome (OR = 2.4, 95% CI 1.2, 4.6) and with the intention to treat principle (OR = 2.0, 95% CI 1.3, 3.0). The overall quality score was higher in trials where E/B participated. CONCLUSIONS: The results suggest that E/B improve the quality (at least of reports) of clinical trials. Given that quality of research is frequently used to evaluate potential sources of heterogeneity between trials, these results are relevant for meta-analysis.

Controlled Clinical Trials as Topic↗

Methodological quality and reporting of ethical requirements in clinical trials.

OBJECTIVES: To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. DESIGN: Systematic review using a standardised checklist. MAIN MEASURES: Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included. RESULTS: We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups. CONCLUSION: Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects.

Bibliometrics↗

The prevalence of Chlamydia trachomatis infection in male undergraduates: a postal survey.

OBJECTIVES: To determine the prevalence of Chlamydia trachomatis infection in male undergraduates and to investigate whether prevalence increases with time spent at university. To investigate the feasibility of screening men for C trachomatis by self sampling and posting of urine specimens. METHODS: The study design was a postal survey undertaken by the Department of Genito-Urinary Medicine (GUM) and Student University Health Service (SUHS) in SHEFFIELD: 2607 male undergraduates from the SUHS patient list were invited to participate in the study by providing a first void urine specimen and posting it to the laboratory. The main outcome measure was the detection of C trachomatis infection. RESULTS: 758 students participated in the study, a response rate of 29.1%. Nine students (1.2%) tested positive for C trachomatis. The prevalence of infection in the first, second, and third year of study was 0.7%, 1.5%, and 1.6% of participants respectively. There was no statistically significant difference in prevalence of infection between first and third year students (chi(2) test, p = 0.32). However, students with chlamydia had a higher median age (Mann-Whitney U test, p < or = 0.05). Contact tracing identified four further cases of C trachomatis infection. CONCLUSION: Screening for C trachomatis infection by postal survey is feasible. However, the response rate in this study was poor and the estimated sample size was not reached. Therefore, it has not been possible to determine the true prevalence of infection in this population or to accurately assess changes in prevalence with time spent at university.

Adolescent↗

Randomized clinical trial of postoperative subfascial infusion with bupivacaine following ambulatory open mesh repair of inguinal hernia.

BACKGROUND: Wound pain remains the commonest problem after ambulatory open repair of inguinal hernia. Postoperative subfascial infusion of the wound with bupivacaine extends local analgesia at home and may achieve superior analgesia compared with oral analgesics alone. The objective of the present trial was to evaluate the efficacy of postoperative subfascial infusion of the wound with 0.5% bupicavaine at 2 ml per hour for 48 h after operation. METHODS: Forty-four patients who underwent ambulatory open tension-free mesh hernioplasties were randomized to two arms of treatment. The pump group had an infusion pump containing 100 ml 0.5% bupivacaine being placed between the external oblique aponeurosis and the Prolene mesh, whereas the nonpump group was treated with oral analgesics alone. Assuming that an observed difference of 2.0 existed between the mean pain scores of the two groups, the estimated sample size would be at least 20 patients in each group. RESULTS: Postoperative pain scores at rest and on coughing were significantly lower in the pump group than in the nonpump group on days 0 and 1 after surgery (p < 0.01). Before being discharged, none of the pump group patients requested analgesics, but 6 patients of the nonpump group required analgesic supplement (p = 0.025). Ten patients (50%) of the pump group experienced no pain during the period of bupivacaine infusion. Recovery variables, including time taken to resume ambulation and micturition, were comparable between the two groups. The pump and nonpump group patients returned to their normal activities after a median of 3 and 4 days, respectively (p = 0.217). The postoperative morbidity rates of the two groups were similar. CONCLUSION: Postoperative subfascial infusion of the wound with 0.5% bupivacaine achieved superior analgesia compared with oral analgesics alone. Portable infusion pump is a safe technique to continue local analgesia at home after ambulatory open repair of inguinal hernia. The drawbacks of the ON-Q Pain Management System included its high cost and frequent seepage of blood-stained anesthetic fluid into the wound dressing.

Adult↗

Elk velvet antler in rheumatoid arthritis: phase II trial.

The purpose of this phase II clinical trial was to examine safety of elk velvet antler taken concurrently with rheumatoid arthritis medications and to determine efficacy by dose to enable sample size estimation and dose standardization for a larger study. Forty patients with stage II rheumatoid arthritis were randomly assigned to 1 of 4 arms of 10 patients each. One group received placebo and the other 3 groups received 2, 4, or 6 capsules (215 mg) of elk velvet antler with appropriate placebos to total 6 capsules daily. All subjects continued to take their arthritis medications. Outcome variables were reported adverse events and health status. At 1 month, there were no significant differences between groups in number of adverse events or health status. The greatest improvement was in the 6 elk velvet antler group, the least was in the placebo group. Differences were not statistically significant. It was concluded that elk velvet antler can be taken safely in conjunction with a number of rheumatoid arthritis medications and should be studied further to assess efficacy.

Aged↗

Specific power calculations for magnetic resonance imaging (MRI) in monitoring active relapsing-remitting multiple sclerosis (MS): implications for phase II therapeutic trials.

Inhomogeneous patient samples have been used in previous studies to determine the power of magnetic resonance imaging (MRI) for trial monitoring in multiple sclerosis (MS). These power-calculations might not be applicable to the active relapsing-remitting patient who is preferably included in trials. In order to reevaluate the power-calculations for MRI in the monitoring of treatment in strictly relapsing-remitting MS and to compare the power of different trial designs we studied 12 relapsing-remitting MS patients prospectively for a median period of 12 months using monthly clinical assessments and gadolinium-enhanced MRI. A median number of two clinical relapses/patient occurred of which a median of one was treated with steroids. A median of 1.59 new lesions/scan/patient was detected (range 0-8). The total number of new active lesions correlated significantly with study period relapses (SRCC = 0.72, P = 0.023). Computer simulations using the bootstrap technique yielded mostly lower power values for a parallel groups design than in previous studies except for short follow-periods in larger samples. In this-sample the open cross-over design was found to be between 20 and 40% more powerful. Results of power-calculations are clearly sample dependent implying that for treatment trial monitoring using MRI in relapsing-remitting MS conservative sample size estimates are to be used. In an active patient group open cross-over trial designs could be a very powerful alternative to parallel groups design.

Adult↗

Incidence and determinants of mortality and cardiovascular events in diabetes mellitus: a meta-analysis.

Patients with diabetes mellitus are at increased risk of developing atherosclerotic disease. The extent of this additional risk and its determinants are not well known, but this information is needed for sample-size estimations in intervention studies. Therefore, a meta-analysis of epidemiologic studies on this subject was performed. Medline was searched from 1966 onwards, including the reference lists of all relevant publications. A total of 27 prospective follow-up studies in the English language that allowed calculation of the unadjusted incidence of one of the predefined outcome events were included. The influence of age, sex, type of diabetes, duration of diabetes, year of study, HbA1c, cholesterol level, blood pressure and smoking on these incidences was studied by means of univariate Poisson regression analysis. Overall total mortality was 2.9% per year (95% CI 2.8-3.0; 27 studies), and for death from all vascular causes was 1.4% per year (95% CI 1.3-1.4; 16 studies). Only two studies were found that reported on the incidence of the composite outcome 'event death from all vascular causes, non-fatal myocardial infarction, or non-fatal stroke'. In univariate analysis, age, year of study, total cholesterol and systolic blood pressure were positively related to total mortality and death from all vascular causes. After adjustment for age, or limiting the analyses to studies in patients with type 2 diabetes only (n = 11), these relationships remained statistically significant. In conclusion, the overall yearly total mortality in diabetes mellitus is 2.9% and for death from all vascular causes is 1.4%. There are few data on the incidence of composite cardiovascular outcome events.

Cerebrovascular Disorders↗

Effects of different training modalities on lower-limb explosive power, acceleration, 20-m sprint performance, and change-of-direction ability in youth soccer players: a systematic review and network meta-analysis.

BACKGROUND: Youth soccer players repeatedly perform explosive actions, short accelerations, linear sprints, decelerations, and multidirectional movements. However, the comparative effects of different structured physical-conditioning programmes remain uncertain. METHODS: Seven databases were searched from inception to 3 July 2026 using a final expanded search strategy encompassing plyometric, strength or resistance, sprint, acceleration, speed, change-of-direction, neuromuscular, multicomponent, and combined training. Randomised controlled trials involving healthy youth soccer players were eligible. Intervention arms were classified using operational, content-based node definitions. Construct-restricted primary networks and expanded sensitivity networks were analysed using frequentist random-effects network meta-analysis. Hedges' adjusted g was preferentially calculated from post-intervention or final-follow-up means, standard deviations, and sample sizes. Estimates were presented so that positive values indicated better performance. P-scores were treated as descriptive ranking summaries. Risk of bias was assessed using an adapted study-level application of the five-domain RoB 2 framework, and confidence in the evidence was assessed using CINeMA. A post hoc strict-age sensitivity analysis excluded two age-boundary studies. RESULTS: Eighty-nine studies were included in the expanded quantitative analysis, of which 74 contributed to at least one construct-restricted primary network. The primary lower-limb explosive-power, acceleration, 20-m sprint, and planned change-of-direction networks included 55, 20, 25, and 38 studies, respectively. Compared with usual soccer training, plyometric training combined with sprint and/or change-of-direction training showed favourable estimates for lower-limb explosive power (SMD 0.79, 95% CI 0.55 to 1.03), acceleration (1.19, 0.90 to 1.49), 20-m sprint performance (0.80, 0.33 to 1.28), and planned change-of-direction ability (1.46, 1.13 to 1.80). Corresponding I&#xb2; values were 34.6%, 21.8%, 65.0%, and 41.0%. Between-design inconsistency was detected in the 20-m sprint (P&#x2009;=&#x2009;0.0036) and change-of-direction (P&#x2009;=&#x2009;0.0007) networks. CINeMA confidence for these four comparisons was low, low, very low, and low, respectively. Expanded sensitivity networks showed substantially greater heterogeneity. The highest-ranked intervention differed across outcome domains but remained consistent within each outcome across the three analysis sets. Excluding the two age-boundary studies did not materially alter the principal estimates. CONCLUSIONS: Plyometric training combined with sprint and/or planned change-of-direction training produced favourable comparative estimates across the four performance outcomes. However, evidence for several nodes and active-versus-active comparisons was sparse, heterogeneity in programmes and outcomes was present, inconsistency was detected in some networks, and confidence in the evidence was low or very low. These limitations do not support a conclusion that any training category is universally superior. The findings should be interpreted as provisional category-level signals rather than definitive training prescriptions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD420261347297, registered on 21 March 2026, https://www.crd.york.ac.uk/PROSPERO/view/CRD420261347297 .

Change-of-direction ability↗