Artificial intelligence-enhanced care pathway planning and scheduling system: content validity assessment of required functionalities.

BACKGROUND: Artificial intelligence (AI) and machine learning are transforming the optimization of clinical and patient workflows in healthcare. There is a need for research to specify clinical requirements for AI-enhanced care pathway planning and scheduling systems to improve human-AI interaction in machine learning applications. The aim of this study was to assess content validity and prioritize the most relevant functionalities of an AI-enhanced care pathway planning and scheduling system. METHODS: A prospective content validity assessment was conducted in five university hospitals in three different countries using an electronic survey. The content of the survey was formed from clinical requirements, which were formulated into generic statements of required AI functionalities. The relevancy of each statement was evaluated using a content validity index. In addition, weighted ranking points were calculated to prioritize the most relevant functionalities of an AI-enhanced care pathway planning and scheduling system. RESULTS: A total of 50 responses were received from clinical professionals from three European countries. An item-level content validity index ranged from 0.42 to 0.96. 45% of the generic statements were considered good. The highest ranked functionalities for an AI-enhanced care pathway planning and scheduling system were related to risk assessment, patient profiling, and resources. The highest ranked functionalities for the user interface were related to the explainability of machine learning models. CONCLUSION: This study provided a comprehensive list of functionalities that can be used to design future AI-enhanced solutions and evaluate the designed solutions against requirements. The relevance of statements concerning the AI functionalities were considered somewhat relevant, which might be due to the low level or organizational readiness for AI in healthcare.

Randomised controlled trials in hand surgery: a scoping review.

OBJECTIVES: To identify the evidence gaps that exist regarding the efficacy or effectiveness of hand surgery. SETTING: A scoping review. We systematically searched MEDLINE, Embase and CENTRAL databases to identify all hand surgical randomised controlled trials from inception to 7 November 2020. RESULTS: Of the 220 identified randomised controlled trials, none were fundamental efficacy trials, that is, compared surgery with placebo surgery. 172 (78%) trials compared the outcomes of different surgical techniques, and 143 (65%) trials were trauma related. We identified only 47 (21%) trials comparing surgery with non-operative care or injection. CONCLUSION: The evidence supporting use of surgery especially for chronic hand conditions is scarce. To determine optimal care for people with hand conditions, more resources should be aimed at placebo-controlled trials and pragmatic effectiveness trials comparing hand surgery with non-operative care. PROSPERO REGISTRATION NUMBER: CRD42019122710.

Use of Placebo and Nonoperative Control Groups in Surgical Trials: A Systematic Review and Meta-analysis.

Importance: Nonspecific effects, particularly placebo effects, are thought to contribute significantly to the observed effect in surgical trials. Objective: To estimate the proportion of the observed effect of surgical treatment that is due to nonspecific effects (including the placebo effect). Data Sources: Published Cochrane reviews and updated, extended search of MEDLINE, Embase, and CENTRAL until March 2019. Study Selection: Published randomized placebo-controlled surgical trials and trials comparing the effect of the same surgical interventions with nonoperative controls (ie, no treatment, usual care, or exercise program). Data Extraction and Synthesis: Pairs of authors independently screened the search results, assessed full texts to identify eligible studies and the risk of bias of included studies, and extracted data. The proportion of all nonspecific effects was calculated as the change in the placebo control divided by the change in the active surgery and pooled in a random-effect meta-analysis. To estimate the magnitude of the placebo effect, we pooled the difference in outcome between placebo and nonoperative controls and used metaregression to estimate the association between the type of control group and the treatment effect (difference between the groups), adjusting for risk of bias, sample size, and type of outcome. Main Outcomes and Measures: Between- and within-group effect sizes expressed as Hedges g. Results: In this review, 100 trials were included comprising data from 62 trials with placebo controls (3 also included nonoperative controls), and 38 trials with nonoperative controls (32 interventions; 10 699 participants). Risk of bias across trials was comparable except for performance and detection bias, which was high in trials with nonoperative controls. The mean nonspecific effects accounted for 67% (95% CI, 61% to 73%) of the observed change after surgery; however, this varied widely between different procedures. The estimated surgical placebo effect had a standardized mean difference (SMD) of 0.13 (95% CI, -0.26 to 0.51). Trials with placebo and nonoperative controls found comparable treatment effects (SMD, -0.09 [95% CI, -0.35 to 0.18]; 15 interventions; 73 between-group effects; adjusted analysis: SMD, -0.11 [95% CI, -0.37 to 0.15]). Conclusions and Relevance: In this review, the change in health state after surgery was composed largely of nonspecific effects, but no evidence supported a large placebo effect. Placebo-controlled surgical trials may be redundant when trials with nonoperative controls consistently report no substantial association from surgery compared with nonoperative treatment.

Bias in Hand Surgical Randomized Controlled Trials: Systematic Review and Meta-Epidemiological Study.

PURPOSE: Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to evaluate how often hand surgical randomized controlled trials (RCTs) use and report adequate methods to ensure internal validity, and whether inadequate reporting or methods are associated with the magnitude of treatment effect estimates. METHODS: Data Sources were the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase databases until November 2020. We included published RCTs investigating the effects of any surgical intervention in the hand and wrist region. We assessed internal validity using the Cochrane Risk of Bias (RoB) tool for 6 domains: selection, performance, detection, attrition, selective reporting, and "other" bias. We extracted the primary outcome and calculated the effect size for each study. We used mixed-effect meta-regression to assess whether the RoB modified the magnitude of the effects. RESULTS: For 207 assessed trials, the RoB was unclear or high for 72% in selection, 93% in performance, 88% in detection, 25% in attrition, 22% in selective reporting, and 34% in the "other" bias domain. Trials with a high or unclear risk of selection bias yielded 0.28 standardized mean difference (95% confidence interval, 0.02-0.55) larger effect sizes compared to studies with a low risk. Risks of bias for other domains did not modify the intervention effects. The risk for selection bias declined over time: the odds ratio for a high or unclear RoB was 0.90 (95% confidence interval, 0.85-0.95) per additional year of publication CONCLUSIONS: The internal validity and credibility of hand surgical RCTs can be improved by using established methods to achieve true randomization, blinding of the participants and study personnel, publishing the trial protocol and avoiding selective reporting of the outcomes, and reporting the trial as recommended in the Consolidated Standards of Reporting Trials statement. CLINICAL RELEVANCE: Clinicians should be aware that RCTs that do not use or report proper randomization and allocation concealment may overestimate the treatment effects.

Surgery for rotator cuff tears.

BACKGROUND: This review is one in a series of Cochrane Reviews of interventions for shoulder disorders. OBJECTIVES: To synthesise the available evidence regarding the benefits and harms of rotator cuff repair with or without subacromial decompression in the treatment of rotator cuff tears of the shoulder. SEARCH METHODS: We searched the CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry unrestricted by date or language until 8 January 2019. SELECTION CRITERIA: Randomised controlled trials (RCTs) including adults with full-thickness rotator cuff tears and assessing the effect of rotator cuff repair compared to placebo, no treatment, or any other treatment were included. As there were no trials comparing surgery with placebo, the primary comparison was rotator cuff repair with or without subacromial decompression versus non-operative treatment (exercises with or without glucocorticoid injection). Other comparisons were rotator cuff repair and acromioplasty versus rotator cuff repair alone, and rotator cuff repair and subacromial decompression versus subacromial decompression alone. Major outcomes were mean pain, shoulder function, quality of life, participant-rated global assessment of treatment success, adverse events and serious adverse events. The primary endpoint for this review was one year. DATA COLLECTION AND ANALYSIS: We used standard methodologic procedures expected by Cochrane. MAIN RESULTS: We included nine trials with 1007 participants. Three trials compared rotator cuff repair with subacromial decompression followed by exercises with exercise alone. These trials included 339 participants with full-thickness rotator cuff tears diagnosed with magnetic resonance imaging (MRI) or ultrasound examination. One of the three trials also provided up to three glucocorticoid injections in the exercise group. All surgery groups received tendon repair with subacromial decompression and the postoperative exercises were similar to the exercises provided for the non-operative groups. Five trials (526 participants) compared repair with acromioplasty versus repair alone; and one trial (142 participants) compared repair with subacromial decompression versus subacromial decompression alone. The mean age of trial participants ranged between 56 and 68 years, and females comprised 29% to 56% of the participants. Symptom duration varied from a mean of 10 months up to 28 months. Two trials excluded tears with traumatic onset of symptoms. One trial defined a minimum duration of symptoms of six months and required a trial of conservative therapy before inclusion. The trials included mainly repairable full-thickness supraspinatus tears, six trials specifically excluded tears involving the subscapularis tendon. All trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding, but also for other reasons such as unclearly reported methods of random sequence generation or allocation concealment (six trials), incomplete outcome data (three trials), selective reporting (six trials), and other biases (six trials). Our main comparison was subacromial decompression versus non-operative treatment and results are reported for the 12 month follow up. At one year, moderate-certainty evidence (downgraded for bias) from 3 trials with 258 participants indicates that surgery probably provides little or no improvement in pain; mean pain (range 0 to 10, higher scores indicate more pain) was 1.6 points with non-operative treatment and 0.87 points better (0.43 better to 1.30 better) with surgery.. Mean function (zero to 100, higher score indicating better outcome) was 72 points with non-operative treatment and 6 points better (2.43 better to 9.54 better) with surgery (3 trials; 269 participants), low-certainty evidence (downgraded for bias and imprecision). Participant-rated global success rate was 873/1000 after non-operative treatment and 943/1000 after surgery corresponding to (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.96 to 1.22; low-certainty evidence (downgraded for bias and imprecision). Health-related quality of life was 57.5 points (SF-36 mental component score, 0 to 100, higher score indicating better quality of life) with non-operative treatment and 1.3 points worse (4.5 worse to 1.9 better) with surgery (1 trial; 103 participants), low-certainty evidence (downgraded for bias and imprecision). We were unable to estimate the risk of adverse events and serious adverse events as only one event was reported across the trials (very low-certainty evidence; downgraded once due to bias and twice due to very serious imprecision). AUTHORS' CONCLUSIONS: At the moment, we are uncertain whether rotator cuff repair surgery provides clinically meaningful benefits to people with symptomatic tears; it may provide little or no clinically important benefits with respect to pain, function, overall quality of life or participant-rated global assessment of treatment success when compared with non-operative treatment. Surgery may not improve shoulder pain or function compared with exercises, with or without glucocorticoid injections. The trials included have methodology concerns and none included a placebo control. They included participants with mostly small degenerative tears involving the supraspinatus tendon and the conclusions of this review may not be applicable to traumatic tears, large tears involving the subscapularis tendon or young people. Furthermore, the trials did not assess if surgery could prevent arthritic changes in long-term follow-up. Further well-designed trials in this area that include a placebo-surgery control group and long follow-up are needed to further increase certainty about the effects of surgery for rotator cuff tears.

Tendon Length, Calf Muscle Atrophy, and Strength Deficit After Acute Achilles Tendon Rupture: Long-Term Follow-up of Patients in a Previous Study.

BACKGROUND: In this prospective study, we used magnetic resonance imaging (MRI) to assess long-term Achilles tendon length, calf muscle volume, and muscle fatty degeneration after surgery for acute Achilles tendon rupture. METHODS: From 1998 to 2001, 60 patients at our center underwent surgery for acute Achilles tendon rupture followed by early functional postoperative rehabilitation. Fifty-five patients were reexamined after a minimum duration of follow-up of 13 years (mean, 14 years), and 52 of them were included in the present study. Outcome measures included Achilles tendon length, calf muscle volume, and fatty degeneration measured with MRI of both the affected and the uninjured leg. The isokinetic plantar flexion strength of both calves was measured and was correlated with the structural findings. RESULTS: The Achilles tendon was, on average, 12 mm (95% confidence interval [CI] = 8.6 to 15.6 mm; p < 0.001) longer (6% longer) in the affected leg than in the uninjured leg. The mean volumes of the soleus and medial and lateral gastrocnemius muscles were 63 cm (13%; p < 0.001), 30 cm (13%; p < 0.001), and 16 cm (11%; p < 0.001) lower in the affected leg than in the uninjured leg, whereas the mean volume of the flexor hallucis longus (FHL) was 5 cm (5%; p = 0.002) greater in the affected leg, indicating FHL compensatory hypertrophy. The median plantar flexion strength for the whole range of motion ranged from 12% to 18% less than that on the uninjured side. Finally, the side-to-side difference in Achilles tendon length correlated substantially with the strength deficit (ρ = 0.51, p < 0.001) and with medial gastrocnemius (ρ = 0.46, p = 0.001) and soleus (ρ = 0.42, p = 0.002) muscle atrophy. CONCLUSIONS: Increased Achilles tendon length is associated with smaller calf muscle volumes and persistent plantar flexion strength deficits after surgical repair of Achilles tendon rupture. Strength deficits and muscle volume deficits are partly compensated for by FHL hypertrophy, but 11% to 13% deficits in soleus and gastrocnemius muscle volumes and 12% to 18% deficits in plantar flexion strength persist even after long-term follow-up. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Soleus Atrophy Is Common After the Nonsurgical Treatment of Acute Achilles Tendon Ruptures: A Randomized Clinical Trial Comparing Surgical and Nonsurgical Functional Treatments.

BACKGROUND: It remains controversial whether nonsurgical or surgical treatment provides better calf muscle strength recovery after an acute Achilles tendon rupture (ATR). Recent evidence has suggested that surgery might surpass nonsurgical treatment in restoring strength after an ATR. PURPOSE: To assess whether magnetic resonance imaging (MRI) findings could explain calf muscle strength deficits and the difference between nonsurgical and surgical treatments in restoring calf muscle strength. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: From 2009 to 2013, 60 patients with acute ATRs were randomized to surgery or nonsurgical treatment with an identical rehabilitation protocol. The primary outcome measure was the volume of calf muscles assessed using MRI at 3 and 18 months. The secondary outcome measures included fatty degeneration of the calf muscles and length of the affected Achilles tendon. Additionally, isokinetic plantarflexion strength was measured in both legs. RESULTS: At 3 months, the study groups showed no differences in muscle volumes or fatty degeneration. However, at 18 months, the mean differences between affected and healthy soleus muscle volumes were 83.2 cm3 (17.7%) after surgery and 115.5 cm3 (24.8%) after nonsurgical treatment (difference between means, 33.1 cm3; 95% CI, 1.3-65.0; P = .042). The study groups were not substantially different in the volumes or fatty degeneration of other muscles. From 3 to 18 months, compensatory hypertrophy was detected in the flexor hallucis longus (FHL) and deep flexors in both groups. In the nonsurgical treatment group, the mean difference between affected and healthy FHL muscle volumes was -9.3 cm3 (12%) and in the surgical treatment group was -8.4 cm3 (10%) ( P ≤ .001). At 18 months, Achilles tendons were, on average, 19 mm longer in patients treated nonsurgically compared with patients treated surgically ( P < .001). At 18 months, surgically treated patients demonstrated 10% to 18% greater strength results ( P = .037). Calf muscle isokinetic strength deficits for the entire range of ankle motion correlated with soleus atrophy (ρ = 0.449-0.611; P < .001). CONCLUSION: Treating ATRs nonsurgically with a functional rehabilitation protocol resulted in greater soleus muscle atrophy compared with surgical treatment. The mean Achilles tendon length was 19 mm longer after nonsurgical treatment than after the surgical treatment of ATRs. These structural changes partly explained the 10% to 18% greater calf muscle strength observed in patients treated with surgery compared with those treated nonsurgically. Registration: NCT02012803 ( ClinicalTrials.gov identifier).

A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures.

BACKGROUND: The optimal treatment of acute Achilles tendon ruptures for active patients is under debate. PURPOSE: To compare clinical outcomes and calf muscle strength recovery after the nonsurgical treatment and open surgical repair of acute Achilles tendon ruptures with identical accelerated rehabilitation programs. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: From 2009 to 2013, a total of 60 patients with an acute Achilles tendon rupture were randomized to surgery or nonsurgical treatment. Nonsurgical treatment included first a week of cast immobilization, followed by a functional orthosis for 6 weeks, allowing full weightbearing after week 1 and active plantar flexion after week 5. Surgery was simple end-to-end open repair, and postoperative treatment was identical to nonsurgical treatment. Outcome measures included the Leppilahti Achilles tendon performance score, isokinetic calf muscle strength, and RAND 36-Item Health Survey at 18-month follow-up. RESULTS: At 18-month follow-up, the mean Leppilahti score was 79.5 and 75.7 for the surgically and nonsurgically treated groups, respectively (mean difference, 3.8; 95% CI, -1.9 to 9.5; P = .19). Angle-specific peak torque results of affected legs showed that surgery resulted in faster and better recovery of calf muscle strength over the entire range of motion of the ankle joint: at 6 months, the difference varied from 16% to 24% (P = .016), favoring the surgically treated group, whereas at 18 months, surgically treated patients had 10% to 18% greater strength results (P = .037). At 18 months, a 14% difference in the peak torque of the affected leg favored the surgical group versus the nonsurgical group (mean peak torque, 110.3 vs 96.5 N·m, respectively; mean difference, 13.6 N·m; 95% CI, 2.0-25.1 N·m; P = .022). The RAND 36-Item Health Survey indicated better results in the domains of physical functioning (P = .006) and bodily pain (P = .037) for surgically treated patients. CONCLUSION: Surgical and nonsurgical treatments of acute Achilles tendon ruptures have similar results in terms of the Achilles tendon performance score, but surgery restores calf muscle strength earlier over the entire range of motion of the ankle joint, with a 10% to 18% strength difference favoring surgery at 18 months. Surgery may also result in better health-related quality of life in the domains of physical functioning and bodily pain compared with nonsurgical treatment. REGISTRATION: NCT02012803 (ClinicalTrials.gov).

Augmented Compared with Nonaugmented Surgical Repair After Total Achilles Rupture: Results of a Prospective Randomized Trial with Thirteen or More Years of Follow-up.

BACKGROUND: This prospective randomized trial with a mean fourteen-year follow-up compared simple end-to-end repair with fascial flap-augmented repair for acute Achilles tendon ruptures. METHODS: From 1998 to 2001, sixty patients with acute Achilles tendon rupture were randomized to receive simple end-to-end repair or augmented repair; both groups were treated with postoperative bracing allowing free active plantar flexion. After a follow-up of thirteen years or more, fifty-five patients (twenty-eight in the nonaugmented-repair group and twenty-seven in the augmented-repair group) were reexamined. Outcome measures included the Leppilahti Achilles tendon score, isokinetic plantar flexion strength (peak torque and the work-displacement deficit at 10° intervals over the ankle range of motion), tendon elongation, and the RAND 36-item health survey. RESULTS: After a mean of fourteen years of follow-up, the mean Leppilahti score was 87.1 points for the nonaugmented repairs and 91.5 points for the augmented repairs, with a mean difference of 4.3 points (95% confidence interval [CI], -0.1 to 8.8 points). The surgical technique did not have an impact on strength parameters, with a mean peak torque of 112.6 Nm after the nonaugmented repairs and 107.3 Nm after the augmented repairs (mean difference, 5.3 Nm [95% CI, -22.2 to 11.6 Nm]) and a median work-displacement deficit of 6.7% to 20.3% after the nonaugmented repairs and 12.8% to 18.0% after the augmented repairs (p = 0.9). Strength did not significantly change between the twelve-month and fourteen-year follow-up examinations. At a mean of fourteen years, the injured side showed a 12.2% to 18.0% median work-displacement deficit compared with the unaffected side (p < 0.001). RAND-36 scores indicated no between-group difference in health domains. CONCLUSIONS: Augmented repair of total Achilles tendon ruptures provided no advantage over simple end-to-end repair. Achilles tendon ruptures result in a permanent calf muscle strength deficit, but its clinical relevance remains unclear. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Early functional treatment versus cast immobilization in tension after achilles rupture repair: results of a prospective randomized trial with 10 or more years of follow-up.

BACKGROUND: There are no long-term prospective controlled trials comparing postoperative regimens after Achilles tendon rupture repair. PURPOSE: To compare ≥10-year outcomes of 2 postoperative regimens after Achilles tendon rupture repair: early weightbearing with early mobilization versus early weightbearing with early immobilization in tension. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 50 patients with acute Achilles tendon ruptures were randomized postoperatively to receive either early movement of the ankle between neutral and plantar flexion in a brace for 6 weeks (group 1) or Achilles tendon immobilization in tension using a below-knee cast with the ankle in a neutral position for 6 weeks (group 2). Patients were assessed at 3, 6, and 14 months and 11 years postoperatively. RESULTS: There were 37 patients (74%) evaluated at a mean (±SD) of 11.0 ± 0.9 years. The mean Leppilahti score was 92.9 ± 5.6 in group 1 and 93.6 ± 7.2 in group 2 (P = .68). The mean isokinetic plantar flexion peak torque deficits or average work deficits in plantar flexion showed no differences between the groups with any angular velocity. Isokinetic strength changed minimally between 1 and 11 years compared with the unaffected ankle, but a mean deficit of 5% in peak torque and mean deficit of 8% in average work were still present after 11 years. On the contrary, isometric plantar flexion strength recovered significantly, with only a 2.4% difference at 11-year follow-up. CONCLUSION: After the 11-year follow-up, early mobilization and immobilization in tension after Achilles rupture repair resulted in similar clinical outcomes and isokinetic strengths. Regardless of patient satisfaction with the operative treatment, calf muscle strength did not recover normally even at 11-year follow-up.

A 1.33 µm picosecond pulse generator based on semiconductor disk mode-locked laser and bismuth fiber amplifier.

We demonstrate that a combination of ultrafast wafer bonded semiconductor disk laser and a bismuth-doped fiber amplifier provides an attractive design for high power 1.33 µm tandem hybrid systems. Over 0.5 W of average output power was achieved at a repetition rate of 827 MHz that corresponds to a pulse energy of 0.62 nJ.