The effectiveness of intratissue percutaneous electrolysis for the treatment of tendinopathy: a systematic review

Background: Tendinopathy is highly prevalent in the general public and common in athletes. It makes up nearly 50% of all sport injuries. A number of treatment techniques with varying evidence of effectiveness are currently available. Intratissue percutaneous  electrolysis (EPI) is one such modality, however little consensus exists for EPI’s efficacy or the most effective treatment parameters. Objective: To review and appraise available evidence for Intratissue Percutaneous Electrolysis (EPI) in the treatment of tendinopathy, examining the effectiveness of EPI in conjunction with other modalities and identifying the strengths and limitations of the evidence base for EPI in order to make evidence-based recommendation for future studies of EPI. Methods: PubMed, Embase and Scopus were searched with keywords related to EPI and tendinopathy. Grey literature searches were conducted with Embase, OpenGrey, and ProQuest. Extensive citation searching was undertaken. Randomised controlled trials (RCTs), uncontrolled and observational studies of the application of EPI in patients aged 18-65 years with Magnetic Resonance Imaging (MRI) or clinical Ultrasonography (US) confirmed diagnosis of tendinopathy were eligible. Results: Eleven studies met inclusion criteria: six randomised control trials (RCTs) and five uncontrolled studies. Clinical trials of EPI as an adjunct modality with physical therapy reporting greater decreased pain and return to function than treatment with physical therapy alone. The evidence for EPI is limited and influenced by small sample sizes, varying treatment protocols, clinical heterogeneity and high risk of bias. Conclusion: It is currently not possible to conclude that EPI is an effective modality for the treatment of tendinopathy. RCTs with clearly described EPI treatment protocols, larger sample sizes and intervention reporting sufficient to support reproducibility are needed to determine the effectiveness of EPI for the treatment of tendinopathy

Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial

BackgroundAnterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability.MethodsWe did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score—4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367.FindingsBetween Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5–13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications.InterpretationSurgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management

The effects of preceding prospective collaborative studies (IDEAL Stage 2b) on the quality and impact of subsequent randomized controlled trials (IDEAL Stage 3) evaluating surgical innovations: a protocol for a case-control systematic review of the literature

A systematic review assessing the effect of IDEAL stage 2b on IDEAL stage 3 in surger

Evidence-Based Evaluation of Practice and Innovation in Physical Therapy Using the IDEAL-Physio Framework

The IDEAL framework is an established method for initial and ongoing evaluations of innovation and practice for complex health care interventions. First derived for surgical sciences and embedded at a global level for evaluating surgery/surgical devices, the IDEAL framework is based on the principle that innovation and evaluation in clinical practice can, and should, evolve together in an ordered manner: from conception to development and then to validation by appropriate clinical studies and, finally, longer-term follow-up. This framework is highly suited to other complex, nonpharmacological interventions, such as physical therapist interventions. This perspective outlines the application of IDEAL to physical therapy in the new IDEAL-Physio framework. The IDEAL-Physio framework comprises 5 stages. In stage 1, the idea phase, formal data collection should begin. Stage 2a is the phase for iterative improvement and adjustment with thorough data recording. Stage 2b involves the onset of formal evaluation using systematically collected group or cohort data. Stage 3 is the phase for formal comparative assessment of treatment, usually involving randomized studies. Stage 4 involves long-term follow-up. The IDEAL-Physio framework is recommended as a method for guiding and evaluating both innovation and practice in physical therapy, with the overall goal of providing better evidence-based care

Design, methods, and reporting of impact studies of cardiovascular clinical prediction rules are suboptimal: a systematic review

Objectives To evaluate design, methods, and reporting of impact studies of cardiovascular clinical prediction rules (CPRs). Study Design and Setting We conducted a systematic review. Impact studies of cardiovascular CPRs were identified by forward citation and electronic database searches. We categorized the design of impact studies as appropriate for randomized and nonrandomized experiments, excluding uncontrolled before-after study. For impact studies with appropriate study design, we assessed the quality of methods and reporting. We compared the quality of methods and reporting between impact and matched control studies. Results We found 110 impact studies of cardiovascular CPRs. Of these, 65 (59.1%) used inappropriate designs. Of 45 impact studies with appropriate design, 31 (68.9%) had substantial risk of bias. Mean number of reporting domains that impact studies with appropriate study design adhered to was 10.2 of 21 domains (95% confidence interval, 9.3 and 11.1). The quality of methods and reporting was not clearly different between impact and matched control studies. Conclusion We found most impact studies either used inappropriate study design, had substantial risk of bias, or poorly complied with reporting guidelines. This appears to be a common feature of complex interventions. Users of CPRs should critically evaluate evidence showing the effectiveness of CPRs

Acute evening high-intensity interval training may attenuate the detrimental effects of sleep restriction on long-term declarative memory

Recent evidence shows that a nap and acute exercise synergistically enhanced memory. Additionally, human-based cross-sectional studies and animal experiments suggest that physical exercise may mitigate the cognitive impairments of poor sleep quality and sleep restriction, respectively. We evaluated whether acute exercise may offset sleep restriction’s impairment of long-term declarative memory compared to average sleep alone. A total of 92 (82% females) healthy young adults (24.6 ±4.2 years) were randomly allocated to one of four evening groups: sleep restriction only (S5, 5-6 hours/night), average sleep only (S8, 8-9 hours/night), high-intensity interval training (HIIT) before restricted sleep (HIITS5) or HIIT before average sleep (HIITS8). Groups either followed a 15-minute remote HIIT video or rest period in the evening (7:00 p.m.) prior to encoding 80 face-name pairs. Participants completed an immediate retrieval task the same evening and a delayed retrieval task the next morning, after their respective sleep opportunities (documented subjectively). Long-term declarative memory performance was assessed with the discriminability index (d') during the recall tasks. We found that the d' of S8 (0.58 ±1.37) was not significantly different from those of HIITS5 (-0.03 ±1.64, p = 0.176) and HIITS8 (-0.20 ±1.28, p = 0.092), except the S5 (-0.35 ±1.64, p = 0.038) at the delayed retrieval. Similarly, the d' of HIITS5 was not significantly different from those of HIITS8 (p = 0.716) and S5 (p = 0.469). These results suggest that the acute evening HIIT partially reduced the detrimental effects of partial sleep restriction on long-term declarative memory

Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial

Background Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability. Methods We did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score—4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367. Findings Between Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5–13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications. Interpretation Surgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management

Reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence: DECIDE-AI

A growing number of artificial intelligence (AI)-based clinical decision support systems are showing promising performance in preclinical, in silico evaluation, but few have yet demonstrated real benefit to patient care. Early-stage clinical evaluation is important to assess an AI system's actual clinical performance at small scale, ensure its safety, evaluate the human factors surrounding its use and pave the way to further large-scale trials. However, the reporting of these early studies remains inadequate. The present statement provides a multi-stakeholder, consensus-based reporting guideline for the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI). We conducted a two-round, modified Delphi process to collect and analyze expert opinion on the reporting of early clinical evaluation of AI systems. Experts were recruited from 20 pre-defined stakeholder categories. The final composition and wording of the guideline was determined at a virtual consensus meeting. The checklist and the Explanation & Elaboration (E&E) sections were refined based on feedback from a qualitative evaluation process. In total, 123 experts participated in the first round of Delphi, 138 in the second round, 16 in the consensus meeting and 16 in the qualitative evaluation. The DECIDE-AI reporting guideline comprises 17 AI-specific reporting items (made of 28 subitems) and ten generic reporting items, with an E&E paragraph provided for each. Through consultation and consensus with a range of stakeholders, we developed a guideline comprising key items that should be reported in early-stage clinical studies of AI-based decision support systems in healthcare. By providing an actionable checklist of minimal reporting items, the DECIDE-AI guideline will facilitate the appraisal of these studies and replicability of their findings