Measuring the usability of a novel ergonomic chinrest during violin playing: A feasibility study.

BACKGROUND: Playing the violin often requires a rotated and lateral flexed neck, leading to potential neck and shoulder problems. An ergonomic chinrest (EC) with or without a shoulder rest (SR or WSR) may enhance neutral neck positioning, but the feasibility of the EC needs to be studied. OBJECTIVE: Our goal was to evaluate the usability of the EC for a two-week familiarisation period, including aspects such as playing performance, comfort level, and emotional response (e.g., feelings about using the product) among a group of violinists. METHODS: A one-arm feasibility study was conducted to assess the feasibility of violinists playing with EC every day for two weeks. Six violinists who usually played with SR were included and asked to divide their daily playing time equally between SR and WSR. Feasibility outcomes were measured as adherence (days), compliance (playing hours per day) and usability (5-point Likert scale and open-ended questions). Compliance was achieved with a minimum of 25% playing time. RESULTS: Daily violin playing with EC showed high adherence of 89.3%. Compliance with the 25% play time criterion was met for SR, but not for WSR. Low playing performance (median 45.8 points difference), long confidence time (two violinists failed to reach a confidence level) and mainly negative feedback (26 out of 33 comments) were found in WSR compared to SR. CONCLUSIONS: The feasibility of playing WSR was low and negatively impacted playing performance. As a result, a larger-scale study will only evaluate the EC with SR due to greater feasibility.

The IBD-FITT study - moderate-intensity exercise for patients with inflammatory bowel disease with moderate disease activity: an open-label randomized controlled trial.

BACKGROUND: Inflammatory bowel disease (IBD), Crohn's disease, and ulcerative colitis are chronic autoimmune lifelong diseases with fluctuating activity over time. The treatment includes medical therapy and surgery, however, there is no definite cure. Therefore, the quest for new and supplementary treatment options is imperative to improve patients' general health and quality of life. Physical activity and exercise have been suggested to be elements in both the prevention and supplementary treatment of IBD; however, this is based on limited underpowered trials. Thus, the role of exercise as a treatment option still has to be settled. We aim to investigate the effect of a 12-week exercise intervention in adult patients with moderately active IBD on three categories of outcomes (1) disease-specific health-related quality of life (IBDQ); (2) general health status of the patients, i.e., waist circumference, disease activity by clinical scorings systems (Harvey Bradshaw Index, Simple Clinical Colitis Activity Index), blood pressure, blood lipids, and non-disease specific quality of life (EQ5D) scores; and (3) explorative outcomes on biomarkers (C-reactive protein and fecal calprotectin) plus different biomarkers of immunology (cytokine panel). METHODS: We will apply a superiority design in this open-label randomized clinical trial including 150 patients equally allocated to intervention and usual care. The intervention will be based on a 12-week aerobic exercise program and will include two supervised exercise sessions of 60 min per week, combined with one weekly home training session. We have defined a moderate exercise level as 60-80% of patients' maximum heart rate. The patients in the intervention group will also be offered an online video lesson of 15-25 min on lifestyle guidance, and the same online video lesson will be offered in the comparator group. Questionnaires on quality of life will be forwarded electronically both at inclusion and at the end of the study, and the patients will have blood samples, and fecal samples for calprotectin at baseline, weeks 4 and 8, as well as after 12 weeks (study end). DISCUSSION: This will be a clinical trial investigating the effect of exercise on patients with Crohn's disease and ulcerative colitis. This trial will add to the evidence on the possible effect of exercise and might clarify whether exercise can benefit as a supplementary treatment addendum. Thus, the trial may provide a new patient-active disease management approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT04816812. Date of first registration: March 23, 2021.

Spinal Manipulative Therapy for Nonspecific Low Back Pain: Does Targeting a Specific Vertebral Level Make a Difference?: A Systematic Review With Meta-analysis.

OBJECTIVE: We aimed to examine whether targeting spinal manipulative therapy (SMT), by applying the intervention to a specific vertebral level, produces superior clinical outcomes than a nontargeted approach in patients with nonspecific low back pain. DESIGN: Systematic review with meta-analysis. LITERATURE SEARCH: MEDLINE, Embase, CENTRAL, CINAHL, Scopus, PEDro, and Index to Chiropractic Literature were searched up to May 31, 2023. STUDY SELECTION CRITERIA: Randomized controlled trials comparing targeted SMT (mobilization or manipulation) to a nontargeted approach in patients with nonspecific low back pain, and measuring the effects on pain intensity and patient-reported disability. DATA SYNTHESIS: Data extraction, risk of bias, and evaluation of the overall certainty of evidence using the GRADE approach were performed by 2 authors independently. Meta-analyses were performed using the restricted maximum likelihood method. RESULTS: Ten randomized controlled trials (n = 931 patients) were included. There was moderate-certainty evidence of no difference between targeted SMT and a nontargeted approach for pain intensity at postintervention (weighted mean difference = -0.20 [95% CI: -0.51, 0.10]) and at follow-up (weighted mean difference = 0.05 [95% CI: -0.26, 0.36]). For patient-reported disability, there was moderate-certainty evidence of no difference at postintervention (standardized mean difference = -0.04 [95% CI: -0.36, 0.29]) and at follow-up (standardized mean difference = -0.05 [95% CI: -0.24, 0.13]). Adverse events were reported in 4 trials, and were minor and evenly distributed between groups. CONCLUSION: Targeting a specific vertebral level when administering SMT for patients with nonspecific low back pain did not result in improved outcomes on pain intensity and patient-reported disability compared to a nontargeted approach. J Orthop Sports Phys Ther 2023;53(9):1-11. Epub: 28 July 2023. doi:10.2519/jospt.2023.11962.

Psychological factors and symptom duration are associated with exercise-based treatment effect in people with hypermobile shoulders: A secondary analysis of a randomised controlled trial.

BACKGROUND: Shoulder symptoms are common in patients with hypermobility spectrum disorders (HSD), but few studies focus on identifying factors associated with treatment effects. AIM: To identify baseline and clinical characteristics associated with a better outcome 16 weeks after starting an exercise-based treatment in patients with HSD and shoulder symptoms. DESIGN: Exploratory secondary analysis of data from a randomised controlled trial. METHOD: Self-reported treatment outcome was reported as change between baseline and follow-up after 16 weeks of high-load or low-load shoulder strengthening. Multiple linear and logistic regressions were used to investigate associations of patient expectations of treatment effect, self-efficacy, fear of movement, and symptom duration with change in shoulder function, shoulder pain, quality of life, and patient reported health change. All regression models were performed firstly with adjustments for covariates (age, sex, body mass index, hand dominance, treatment group, and baseline score of the outcome variable) and secondly with additional adjustments for exposure variables. RESULTS: Expectations of complete recovery were associated with an increased odds of perceiving an important improvement in physical symptoms after a 16-week exercise-based treatment program. Higher self-efficacy at baseline seemed to be associated with improved shoulder function, shoulder pain and quality of life. A higher fear of movement seemed to be associated with increased shoulder pain and decreased quality of life. A longer symptom duration was associated with decreased quality of life. CONCLUSION: Expectations of complete recovery, higher self-efficacy, lower fear of movement and shorter symptom duration seem to be important for better treatment outcomes.

The Effects of Exercise during Pregnancy on Gestational Diabetes Mellitus, Preeclampsia, and Spontaneous Abortion among Healthy Women-A Systematic Review and Meta-Analysis.

The aim was to compare the effects of different exercise modalities (aerobic, resistance, aerobic and resistance combined, or mind-body exercise) on gestational diabetes mellitus (GDM), preeclampsia, spontaneous abortion, withdrawal from the study, and adverse events in healthy pregnant women. A systematic search was conducted in February 2022 using MEDLINE, EMBASE, Cochrane library, and SPORT Discus to identify eligible randomized trials. The meta-analysis of 18 studies that examined exercise compared to no exercise showed a reduced risk of GDM (RR: 0.66 (95% CI: 0.50 to 0.86)). No subgroup differences were found regarding modality, intensity, or supervision. Exercise did not reduce the risk of preeclampsia (nine studies, RR: 0.65 (95% CI: 0.42 to 1.03)); however, in subgroup analyses, mind-body exercise and low-intensity exercise seemed to be effective in reduction of preeclampsia. There was no effect of exercise on withdrawal or adverse events found. No studies reported on spontaneous abortion, therefore, exercise during pregnancy is beneficial and safe. In the prevention of GDM, any modality and intensity seem equally effective. Subgroup analyses support an association between mind-body exercise and physical activity with low intensity and reduced risk of preeclampsia, but more high-quality randomized studies are needed. PROSPERO: CRD42022307053.

Effectiveness of Non-Budesonide Therapies in Management of Microscopic Colitis: A Systematic Review and Meta-analysis.

BACKGROUND: Budesonide is accepted as first-choice therapy for microscopic colitis (MC); however, symptoms often recur and some patients may be dependent, intolerant, or even fail budesonide. We performed a systematic review and meta-analysis to determine the effectiveness of non-budesonide therapies (thiopurines, bismuth subsalicylate [BSS], bile acid sequestrants [BAS], loperamide and biologics) for MC suggested by international guidelines. METHODS: We searched the CENTRAL, MEDLINE, and EMBASE databases from their inception to 18 April 2023 for the above-mentioned therapeutics in MC. We pooled the response and remission rates by medication using a random-effects model. RESULTS: Twenty-five studies comprising 1475 patients were included in the meta-analysis. Treatment with BSS showed the highest response rate of 75% (95% confidence interval [CI] 0.65-0.83; I2 = 70.12%), with 50% achieving remission of symptoms (95% CI 0.35-0.65; I2 = 71.06%). Treatment with tumor necrosis factor (TNF) inhibitors (infliximab and adalimumab) demonstrated a response rate of 73% (95% CI 0.63-0.83; I2 = 0.00%), with a remission rate of 44% (95% CI 0.32-0.56; I2 = 0.00%). The response rate for those treated with vedolizumab was similar; 73% responded to treatment (95% CI 0.57-0.87; I2 = 35.93%), with a remission rate of 56% (95% CI 0.36-0.75; I2 = 46.30%). Loperamide was associated with response and remission rates of 62% (95% CI 0.43-0.80; I2 = 92.99%) and 14% (95% CI 0.07-0.25), respectively, whereas BAS use was associated with response and remission rates of 60% (95% CI 0.51-0.68; I2 = 61.65%) and 29% (95% CI 0.12-0.55), respectively. Finally, the outcomes for thiopurine use were 49% (95% CI 0.27-0.71; I2 = 81.45%) and 38% (95% CI 0.23-0.54; I2 = 50.05%), respectively DISCUSSION: The present systematic review and meta-analysis provides rates of effectiveness of non-budesonide therapies for MC based on available data in the field. Studies in the meta-analysis showed a large amount of heterogeneity due to the variability in assessing the clinical effects of intervention between the studies caused by differences in the definitions of response or remission rates between the studies included. This may likely result in overestimating the benefit of a treatment. Furthermore, the number of participants and drug dosages varied, and only a few studies applied disease-specific activity indices. Only one randomized controlled trial (RCT) was identified. All other 24 included studies were either case series or (retrospective) cohort studies, which complicated efforts to perform further sensitivity analyses to adjust for potential confounders and risk of bias. In addition, the overall evidence on the effect of these treatment options was judged as low, mostly due to comparability bias and the observational nature of the available studies, which limited statistically robust comparisons of rates of effectiveness of the different non-budesonide agents ranked against each other. However, our observational findings may inform clinicians regarding the most rational selection of non-budesonide therapies to patients with MC. CLINICAL TRIALS REGISTRATION: PROSPERO protocol #CRD42020218649.

Adjuvant treatment with trastuzumab of patients with HER2-positive, T1a-bN0M0 breast tumors: A systematic review and meta-analysis.

The benefit of adjuvant trastuzumab treatment in patients with HER2-positive breast tumors ≤ 10 mm without lymph node involvement (T1abN0) is insufficiently investigated. The aim of this systematic review and meta-analysis was to examine if adjuvant trastuzumab improves the prognosis in these patients. Databases were searched to identify interventional and observational studies evaluating the effect of trastuzumab on breast cancer specific survival (BCSS), disease free survival (DFS), distant recurrence free survival (DRFS), overall survival (OS) or recurrence free survival (RFS). Twelve studies examining the effect of trastuzumab and nine control studies without trastuzumab were identified (n = 6927). Median follow-up was 36-123 months. Significantly improved DFS (Hazard Ratio (HR) 0.14, p < 0.0001) and OS (HR 0.17, p = 0.011) were found for patients receiving trastuzumab and chemotherapy compared to no trastuzumab/chemotherapy based on four and two studies. The prognosis was good even for patients without trastuzumab treatment: 5-year DFS 88.3% and 5-year OS 95.9%.

Prevalence of bilateral vestibulopathy among older adults above 65 years on the indication of vestibular impairment and the association with Dynamic Gait Index and Dizziness Handicap Inventory.

PURPOSE: To estimate the prevalence of bilateral vestibulopathy (BV) and evaluate the association with, and concurrent validity of the Dynamic Gait Index (DGI) and the Dizziness Handicap Inventory (DHI) in diagnosing BV based on video head impulse test (vHIT) among older adults ≥65 years referred to a geriatric falls clinic on suspicion of vestibular impairment. MATERIALS AND METHODS: The vHIT was applied as a reference standard of BV to estimate diagnostic parameters for optimal cut-off scores of DGI and DHI applied separately and in combination. RESULTS: Two-hundred medical records were reviewed (70% women, mean age 79.4 years). The prevalence of BV was 9%. DGI was weakly associated with BV: Odds Ratio (OR) 1.15 (95% confidence interval (CI): 1.01; 1.31), with a 93% sensitivity and 47% specificity of a cut-off score of 16. The total score of DHI showed no association with BV: OR 1.01 (95% CI: 0.98; 1.04). The concurrent validity for BV and DGI and/or DHI were found to be inadequate. CONCLUSIONS: A prevalence of 9% underlines the relevance for assessment of BV. Only a weak association between DGI and/or DHI and BV was found. Thus, vHIT remains the preferred test for detecting BV in geriatric fall assessments.IMPLICATIONS FOR REHABILITATIONBilateral vestibulopathy (BV) has numerous negative consequences for older adults and the prevalence is high among older adults referred to a geriatric falls clinic on suspicion of vestibular impairment.The Dynamic Gait Index (DGI) and the Dizziness Handicap Inventory (DHI) are not valid alternatives to the Video Head Impulse Test (vHIT) when assessing BV among geriatric outpatients.

Paternal Medications in Inflammatory Bowel Disease and Male Fertility and Reproductive Outcomes: A Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Studies evaluating reproductive outcomes among male patients with inflammatory bowel disease (IBD) are limited. We evaluated use of IBD medications and association with semen parameters, a proxy of male fertility, and adverse pregnancy outcomes (early pregnancy loss [EPL], preterm birth [PB], congenital malformations [CM]). METHODS: We searched Medline, Embase, Scopus, and Web of Science (PROSPERO CRD42020197098) from inception to April 2022 for studies reporting semen parameters and adverse pregnancy outcomes among male patients exposed to biologics, thiopurine, or methotrexate. Standardized mean difference, prevalence, and odds ratios (ORs) of outcomes were pooled and analyzed using a random effects model. RESULTS: Ten studies reporting semen parameters (268 patients with IBD) and 16 studies reporting adverse pregnancy outcomes (over 25,000 patients with IBD) were included. Biologic, thiopurine, or methotrexate use were not associated with decreased sperm count, motility, or abnormal morphology compared with nonexposed patients. The prevalence of adverse pregnancy outcomes with paternal biologic (5%), thiopurine (6%), or methotrexate (6%) exposure was comparable to nonexposed patients (5%). Biologic use was not associated with risk of EPL (OR, 1.26; I2 = 0%; P = .12), PB (OR, 1.10; I2 = 0%; P = .17), or CM (OR, 1.03; I2 = 0%; P = .69). Thiopurine use was not associated with risk of EPL (OR, 1.31; I2 = 19%; P = .17), PB (OR, 1.05; I2 = 0%; P = .20), or CM (OR, 1.07; I2 = 7%; P = .34). Methotrexate use was not associated with risk of PB (OR, 1.06; I2 = 0%; P = .62) or CM (OR, 1.03; I2 = 0%; P = .81). CONCLUSIONS: Biologic, thiopurine, or methotrexate use among male patients with IBD are not associated with impairments in fertility or with increased odds of adverse pregnancy outcomes.

The reliability and agreement of scores in a novel balance measure for older adults: Specific Training According to BaLance Evaluation (STABLE).

PURPOSE: Falls are the leading cause of injury and premature death among community dwelling elderly but can be prevented through comprehensive balance rehabilitation which ideally targets the patient's specific needs. In this study, we evaluate the reliability and agreement of six novel clinical measures of different balance domains which applied in a patient-specific balance profile guides exercise prescription in balance rehabilitation. MATERIALS AND METHODS: The intra-rater reliability and agreement of the six measures were evaluated on the same day in six different cohorts of elderly with balance disability (n = 65-100). Further, the inter-day intra-rater and inter-rater and test-retest reliability and agreement of the measures and the balance profile were evaluated (n = 100). RESULTS: The intra-day intra-rater reliability and agreement was moderate to excellent (ICC2.1 = 0.525-0.968, with SDC% = 6.5-284.9%) but poor to good for the inter-day conditions (ICC2.1 = 0.123-0.832, with SDC% = 6.6-229.2%). The reliability of classifying the lower domain in the balance profile was fair, with kappa = 0.56 (95%CI 0.36-0.76). CONCLUSIONS: Five of the six measures may reliably be applied to measure balance disability and to guide rehabilitation.Implications for rehabilitationBalance disability is the primary reason for accidental falls among elderly but can be prevented through comprehensive individualized balance rehabilitation.Specific Training According to BaLance Evaluation (STABLE) is a novel approach for designing effective balance exercises based on clinical measurements.Five of the six measures are reliable when applied in a patient-specific balance profile to guide rehabilitation following the STABLE approach.

Variability in effect sizes of exercise therapy for knee osteoarthritis depending on comparator interventions.

BACKGROUND: Systematic reviews of exercise therapy for knee osteoarthritis (OA) have largely ignored the variability in comparator interventions. OBJECTIVE: To assess how effect estimates of exercise therapy for knee OA as reported in randomized controlled trials vary depending on the comparator interventions. METHODS: We followed the Cochrane Handbook and PRISMA guidance to conduct and report this meta-epidemiological study. Randomised controlled trials (RCTs) were identified from systematic reviews published in 2015 or later and reference lists of included studies. Exercise therapy RCTs testing interventions that adhered to the American College of Sports Medicine (ACSM) guidelines compared to any comparator intervention in people with knee OA and reporting outcomes of knee pain, physical function and/or quadriceps strength at the end of intervention were included. RESULTS: Thirty-five RCTs with 2412 participants were included. Comparator interventions included no intervention, non-ACSM compliant exercise therapy, education/self-management, and passive modalities. For pain, standardized mean difference (SMD) for ACSM compliant exercise therapy compared to passive modalities was 1.76 (95% CI 0.49, 3.04), no intervention 0.93 (95% CI 0.50; 1.36), education/self-management 0.27 (95% CI 0.07, 0.47), and non-ACSM compliant exercise therapy 0.09 (95% CI -0.06, 0.23). For physical function, SMD for ACSM compliant exercise therapy compared to passive modalities was 1.29 (95% CI 0.41, 2.17), no intervention 0.76 (95% CI 0.15, 1.36), non-ACSM compliant exercise therapy 0.25 (95% CI -0.00, 0.51) and education/self-management 0.21 (95% CI -0.14, 0.55). For quadriceps strength, SMD for ACSM compliant exercise therapy compared to no intervention was 0.69 (95% CI 0.42, 0.96), non-ACSM compliant exercise therapy 0.23 (95% CI -0.01, 0.46), education/self-management -0.02 (95% CI -0.45, 0.42) and passive modalities 0.80 (95% CI -0.10, 1.71). CONCLUSION: The effect of exercise therapy for knee OA varies significantly depending on the comparator intervention. This variability should be assessed routinely in systematic reviews.

Meta-research evaluating redundancy and use of systematic reviews when planning new studies in health research: a scoping review.

BACKGROUND: Several studies have documented the production of wasteful research, defined as research of no scientific importance and/or not meeting societal needs. We argue that this redundancy in research may to a large degree be due to the lack of a systematic evaluation of the best available evidence and/or of studies assessing societal needs. OBJECTIVES: The aim of this scoping review is to (A) identify meta-research studies evaluating if redundancy is present within biomedical research, and if so, assessing the prevalence of such redundancy, and (B) to identify meta-research studies evaluating if researchers had been trying to minimise or avoid redundancy. ELIGIBILITY CRITERIA: Meta-research studies (empirical studies) were eligible if they evaluated whether redundancy was present and to what degree; whether health researchers referred to all earlier similar studies when justifying and designing a new study and/or when placing new results in the context of earlier similar trials; and whether health researchers systematically and transparently considered end users' perspectives when justifying and designing a new study. SOURCES OF EVIDENCE: The initial overall search was conducted in MEDLINE, Embase via Ovid, CINAHL, Web of Science, Social Sciences Citation Index, Arts & Humanities Citation Index, and the Cochrane Methodology Register from inception to June 2015. A 2nd search included MEDLINE and Embase via Ovid and covered January 2015 to 26 May 2021. No publication date or language restrictions were applied. CHARTING METHODS: Charting methods included description of the included studies, bibliometric mapping, and presentation of possible research gaps in the identified meta-research. RESULTS: We identified 69 meta-research studies. Thirty-four (49%) of these evaluated the prevalence of redundancy and 42 (61%) studies evaluated the prevalence of a systematic and transparent use of earlier similar studies when justifying and designing new studies, and/or when placing new results in context, with seven (10%) studies addressing both aspects. Only one (1%) study assessed if the perspectives of end users had been used to inform the justification and design of a new study. Among the included meta-research studies evaluating whether redundancy was present, only two of nine health domains (medical areas) and only two of 10 research topics (different methodological types) were represented. Similarly, among the included meta-research studies evaluating whether researchers had been trying to minimise or avoid redundancy, only one of nine health domains and only one of 10 research topics were represented. CONCLUSIONS THAT RELATE TO THE REVIEW QUESTIONS AND OBJECTIVES: Even with 69 included meta-research studies, there was a lack of information for most health domains and research topics. However, as most included studies were evaluating across different domains, there is a clear indication of a high prevalence of redundancy and a low prevalence of trying to minimise or avoid redundancy. In addition, only one meta-research study evaluated whether the perspectives of end users were used to inform the justification and design of a new study. SYSTEMATIC REVIEW REGISTRATION: Protocol registered at Open Science Framework: https://osf.io/3rdua/ (15 June 2021).

OPTIKNEE 2022: consensus recommendations to optimise knee health after traumatic knee injury to prevent osteoarthritis.

The goal of the OPTIKNEE consensus is to improve knee and overall health, to prevent osteoarthritis (OA) after a traumatic knee injury. The consensus followed a seven-step hybrid process. Expert groups conducted 7 systematic reviews to synthesise the current evidence and inform recommendations on the burden of knee injuries; risk factors for post-traumatic knee OA; rehabilitation to prevent post-traumatic knee OA; and patient-reported outcomes, muscle function and functional performance tests to monitor people at risk of post-traumatic knee OA. Draft consensus definitions, and clinical and research recommendations were generated, iteratively refined, and discussed at 6, tri-weekly, 2-hour videoconferencing meetings. After each meeting, items were finalised before the expert group (n=36) rated the level of appropriateness for each using a 9-point Likert scale, and recorded dissenting viewpoints through an anonymous online survey. Seven definitions, and 8 clinical recommendations (who to target, what to target and when, rehabilitation approach and interventions, what outcomes to monitor and how) and 6 research recommendations (research priorities, study design considerations, what outcomes to monitor and how) were voted on. All definitions and recommendations were rated appropriate (median appropriateness scores of 7-9) except for two subcomponents of one clinical recommendation, which were rated uncertain (median appropriateness score of 4.5-5.5). Varying levels of evidence supported each recommendation. Clinicians, patients, researchers and other stakeholders may use the definitions and recommendations to advocate for, guide, develop, test and implement person-centred evidence-based rehabilitation programmes following traumatic knee injury, and facilitate data synthesis to reduce the burden of knee post-traumatic knee OA.

Justification of research using systematic reviews continues to be inconsistent in clinical health science-A systematic review and meta-analysis of meta-research studies.

BACKGROUND: Redundancy is an unethical, unscientific, and costly challenge in clinical health research. There is a high risk of redundancy when existing evidence is not used to justify the research question when a new study is initiated. Therefore, the aim of this study was to synthesize meta-research studies evaluating if and how authors of clinical health research studies use systematic reviews when initiating a new study. METHODS: Seven electronic bibliographic databases were searched (final search June 2021). Meta-research studies assessing the use of systematic reviews when justifying new clinical health studies were included. Screening and data extraction were performed by two reviewers independently. The primary outcome was defined as the percentage of original studies within the included meta-research studies using systematic reviews of previous studies to justify a new study. Results were synthesized narratively and quantitatively using a random-effects meta-analysis. The protocol has been registered in Open Science Framework (https://osf.io/nw7ch/). RESULTS: Twenty-one meta-research studies were included, representing 3,621 original studies or protocols. Nineteen of the 21 studies were included in the meta-analysis. The included studies represented different disciplines and exhibited wide variability both in how the use of previous systematic reviews was assessed, and in how this was reported. The use of systematic reviews to justify new studies varied from 16% to 87%. The mean percentage of original studies using systematic reviews to justify their study was 42% (95% CI: 36% to 48%). CONCLUSION: Justification of new studies in clinical health research using systematic reviews is highly variable, and fewer than half of new clinical studies in health science were justified using a systematic review. Research redundancy is a challenge for clinical health researchers, as well as for funders, ethics committees, and journals.

Long-term quality of life, work limitation, physical activity, economic cost and disease burden following ACL and meniscal injury: a systematic review and meta-analysis for the OPTIKNEE consensus.

OBJECTIVE: Determine the long-term health-related quality-of-life (HRQoL), work limitation, physical activity, health/economic cost and disease burden of traumatic ACL and/or meniscal injury. Findings will inform OPTIKNEE evidence-based consensus recommendations. DESIGN: Random-effects meta-analysis evaluated HRQoL (SF-36/SF-12/VR-12 Physical Component Scores (PCS) and Mental Component Scores (MCS), EuroQol-5D (EQ-5D)) stratified by time postinjury, and pooled mean differences (95% CI) between ACL-injured and uninjured controls. Other outcomes were synthesised descriptively. Risk-of-bias (RoB) and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation) were assessed. DATA SOURCES: MEDLINE, EMBASE, CENTRAL, SPORTDiscus, CINAHL searched inception: 22 November 2021. ELIGIBILITY: Studies reporting HRQoL, work limitations, physical activity levels, health/economic costs or disease burden, ≥2 years post-ACL and/or meniscal injury. RESULTS: Fifty studies were included (10 high-RoB, 28 susceptible-to-some-bias and 12 low-RoB). Meta-analysis (27 studies, very low certainty of evidence) estimated a pooled mean (95% CI) PCS of 52.4 (51.4 to 53.4) and MCS of 54.0 (53.0 to 55.0) 2-14 years post-ACL injury. Pooled PCS scores were worse >10 years (50.8 (48.7 to 52.9)) compared with 2-5 years (53.9 (53.1 to 54.7)) postinjury. Excluding high-RoB studies, PCS scores were worse in ACL-injured compared with uninjured controls (-1.5 (-2.9 to -0.1)). Six studies (low certainty of evidence) informed a pooled EQ-5D score of 0.83 (0.81 to 0.84). Some individuals experienced prolonged work absenteeism and modified activities ≥2 years post-ACL injury. ACL injury was associated with significant direct and indirect costs, and early ACL reconstruction may be less cost-effective than rehabilitation. Only three studies evaluated meniscal injury outcomes (all evaluated HRQoL). CONCLUSION: There is a very-low certainty of evidence that PCS scores ≥2 years post-ACL injury are worse than uninjured controls and decline over time, whereas MCS scores remain high. ACL injury can result in prolonged work absenteeism and high health/economic costs. Further studies are needed to determine the long-term burden of traumatic meniscal injury.

Systematic reviews are rarely used to contextualise new results-a systematic review and meta-analysis of meta-research studies.

BACKGROUND: Results of new studies should be interpreted in the context of what is already known to compare results and build the state of the science. This systematic review and meta-analysis aimed to identify and synthesise results from meta-research studies examining if original studies within health use systematic reviews to place their results in the context of earlier, similar studies. METHODS: We searched MEDLINE (OVID), EMBASE (OVID), and the Cochrane Methodology Register for meta-research studies reporting the use of systematic reviews to place results of original clinical studies in the context of existing studies. The primary outcome was the percentage of original studies included in the meta-research studies using systematic reviews or meta-analyses placing new results in the context of existing studies. Two reviewers independently performed screening and data extraction. Data were synthesised using narrative synthesis and a random-effects meta-analysis was performed to estimate the mean proportion of original studies placing their results in the context of earlier studies. The protocol was registered in Open Science Framework. RESULTS: We included 15 meta-research studies, representing 1724 original studies. The mean percentage of original studies within these meta-research studies placing their results in the context of existing studies was 30.7% (95% CI [23.8%, 37.6%], I2=87.4%). Only one of the meta-research studies integrated results in a meta-analysis, while four integrated their results within a systematic review; the remaining cited or referred to a systematic review. The results of this systematic review are characterised by a high degree of heterogeneity and should be interpreted cautiously. CONCLUSION: Our systematic review demonstrates a low rate of and great variability in using systematic reviews to place new results in the context of existing studies. On average, one third of the original studies contextualised their results. Improvement is still needed in researchers' use of prior research systematically and transparently-also known as the use of an evidence-based research approach, to contribute to the accumulation of new evidence on which future studies should be based. SYSTEMATIC REVIEW REGISTRATION: Open Science registration number https://osf.io/8gkzu/.

Factors influencing self-perceived functioning after volar locking plate fixation of distal radius fractures: a scoping review protocol.

OBJECTIVE: The objective of this review is to give an overview of the demographic, peri-, and postoperative factors that have been assessed for influence on self-perceived functioning at least 3 months after volar locking plate fixation of a distal radius fracture. INTRODUCTION: Most patients treated with a volar locking plate for a distal radius fracture recover within months after surgery; however, a subgroup of patients experience complications and slow recovery. A variety of demographic, peri-, and postoperative factors may influence self-perceived functioning. To facilitate functioning after surgery, supervised rehabilitation can be offered by a hand therapist. In the decision-making process about which patients to offer supervised rehabilitation, demographic, peri-, and postoperative factors may provide additional information, but no updated overview of explored factors has been found. INCLUSION CRITERIA: This review will consider all studies reporting on peri- and postoperative factors identified within 6 weeks after surgery, or demographic factors assessed for influence on self-perceived functioning experienced by patients at least 3 months after volar locking plate fixation of distal radius fractures. METHODS: MEDLINE, CINAHL, Embase, Cochrane Library, PsycINFO, SPORTSdiscus, and Web of Science will be searched for eligible studies. The review will consider peer-reviewed studies published after 2005 in English and Scandinavian languages. Two reviewers will independently perform study selection and data extraction. Following a content analysis of each identified factor, the factors will be mapped to the International Classification of Functioning, Disability and Health (ICF) components by using the ICF linking rules. An overview will be depicted graphically or in tabular format for different timepoints based on assessment of the self-perceived functioning.

Effectiveness of different types, delivery modes and extensiveness of exercise in patients with breast cancer receiving systemic treatment - A systematic review and meta-analysis.

BACKGROUND: Effects of exercise in patients with breast cancer have been thoroughly investigated. The aim was to explore differences in effects regarding type, delivery mode and extensiveness (e.g. intensity; volume) of the interventions. METHODS: We searched for randomised controlled trials including patients with breast cancer receiving systemic treatment, exercise-based interventions, and measures on patient reported- and objectively measured outcomes. RESULTS: Exercise showed significant and moderate effects on the primary outcomes quality of life and physical function, Standardised Mean Difference: 0.52 (95 % CI 0.38-0.65) and 0.52 (95 % CI 0.38-0.66), respectively. Type of exercise had little influence on the effects, however combined aerobic- and resistance exercise seemed superior for increasing physical function, compared to aerobic or resistance exercise. Supervised interventions were superior to partly and unsupervised. Extensiveness of the intervention only influenced physical function. CONCLUSIONS: Supervised interventions, more than type or extensiveness of interventions, seem to increase effects.

Immune checkpoint Inhibitor-Induced diarrhea and Colitis: Incidence and Management. A systematic review and Meta-analysis.

BACKGROUND: Immune checkpoint inhibitors (ICIs) have improved cancer outcomes. However, immune-related adverse effects are common. The aim was to investigate the incidence of diarrhea and colitis of ICIs alone and in combination with chemotherapy or tyrosine kinase inhibitors (TKIs), histopathological findings, and management. METHODS: Two separate studies, including meta-analyses, were performed. Key inclusion criteria were for Study I) phase I-IV trials, and data on diarrhea and/or colitis; for Study II) studies describing histopathologic and endoscopic findings and/or biologic treatment for ICI-induced colitis. RESULTS: The incidence of anti-PD-1/PD-L1 antibody-induced diarrhea and colitis was 10% and 2%, respectively, with no clinically relevant differences between the compounds. The CTLA-4 inhibitor, ipilimumab, induced diarrhea and colitis in 33% and 7% of patients, respectively, whereas the incidence of diarrhea and colitis following ipilimumab combined with nivolumab was 21%-37% and 4%-8%, depending on regimen. The incidence of all-grade diarrhea following ICIs combined with chemotherapy or TKIs was high (17%-56%), whereas only 0.5% of patients developed severe (≥grade 3) colitis. The main patterns of histopathologic presentation after PD-1/CTLA-4 inhibitor mono- or combination therapy were acute and chronic active colitis and microscopic colitis-like. Infliximab and vedolizumab were equally effective against ICI-induced colitis. CONCLUSION: Expanding treatment options include combinations of ICIs and chemotherapy/TKI with a high incidence of diarrhea and a low incidence of colitis; thus, a potential risk of overtreatment with corticosteroids exists. We suggest a more tailored approach, particularly for the management of low-grade diarrhea. Prospective clinical trials are needed to refine management.

Meaningful thresholds for patient-reported outcomes following interventions for anterior cruciate ligament tear or traumatic meniscus injury: a systematic review for the OPTIKNEE consensus.

OBJECTIVE: We synthesised and assessed credibility (ie, trustworthiness) of thresholds that define meaningful scores for patient-reported outcome measures (PROMs) following interventions for anterior cruciate ligament (ACL) tear or traumatic meniscus injury. DESIGN: Systematic review, narrative synthesis. DATA SOURCES: We searched five databases, handsearched references of included studies and tracked citations. ELIGIBILITY: Included studies investigated: individuals with ACL tear or meniscus injury; mean age <35 years; and PROM thresholds calculated using any method to define a minimal important change (MIC) or a meaningful post-treatment score (Patient Acceptable Symptom State (PASS) or Treatment Failure). RESULTS: We included 18 studies (15 ACL, 3 meniscus). Three different methods were used to calculate anchor-based MICs across 9 PROMs, PASS thresholds across 4 PROMs and treatment failure for 1 PROM. Credibility was rated 'high' for only one study-an MIC of 18 for the Knee injury and Osteoarthritis Outcome Score Quality-of-life (KOOS-QOL) subscale (using the MID Credibility Assessment Tool). Where multiple thresholds were calculated among 'low' credibility thresholds in ACL studies, MICs converged to within a 10-point range for KOOS-Symptoms (-1.2 to 5.4) and function in daily living (activities of daily living, ADL 0.5-8.1) subscales, and the International Knee Documentation Committee Subjective Knee Form (7.1-16.2). Other PROM thresholds differed up to 30 points. PASS thresholds converged to within a 10-point range in KOOS-ADL for ACL tears (92.3-100), and KOOS-Symptoms (73-78) and KOOS-QOL (53-57) in meniscus injuries. CONCLUSION: Meaningful PROM thresholds were highly susceptible to study heterogeneity. While PROM thresholds can aid interpretability in research and clinical practice, they should be cautiously interpreted.