To assess the clinical relevance of trials, facilitate comparisons across studies, and enable a priori power calculations for future trials, concepts coined ‘minimal important difference’ (MID) and ‘patient acceptable symptom state’ (PASS) have been advocated. In this study, we present MID and PASS values for three patient-reported knee outcomes: the Lysholm knee score, the Western Meniscal Evaluation Tool (WOMET), and knee pain after exercise measured on a numerical rating scale (pain-NRS), among patients who underwent arthroscopy for a degenerative meniscus tear of the knee. The outcome scores were prospectively collected from two patient populations: a cohort of 900 consecutive patients undergoing arthroscopic partial meniscectomy (APM) and a trial involving 146 patients with an arthroscopically-verified tear of the medial meniscus who were randomised to either APM or placebo surgery. The anchor question for calculating MID was the Patients’ Global Impression of Change, assessed using a 5-point Likert scale. Data on outcomes were collected at the time of knee arthroscopy (baseline) and at 2, 6, and 12 months postoperatively. PASS was determined at 12 months postoperatively. MID was determined using four methods: predictive, mean difference of change, mean change, and receiver operating characteristic (ROC) methods, by pooling data from all time points in the cohort and trial. PASS values were calculated using the ROC and the 75th percentile methods. All instruments demonstrated strong correlation with the anchor question (Spearman’s rho from 0.55 to 0.63). Depending on the method used, MID values varied from 13.8 to 19.2 points for Lysholm, 12.8 to 22.2 points for WOMET, and 1.3 to 2.3 for pain-NRS. The calculated PASS thresholds ranged from 87.5 to 89 points for Lysholm, 89.9 to 91.1 points for WOMET, and 1 to 1.5 for pain-NRS. Our study offers credible MID and PASS estimates for Lysholm, WOMET, and pain-NRS scores in patients undergoing arthroscopy for a degenerative meniscus tear. These thresholds can assist in the design and interpretation of future research and in evaluating treatment outcomes in this patient population. ClinicalTrials.gov NCT00549172 (first registered October 25, 2007).
Background: Humeral shaft fractures commonly affect working-age adults and can lead to prolonged work absence and substantial economic burden. Although surgical fixation and functional bracing offer comparable functional outcomes, their relative cost-effectiveness remains unclear.Methods: We conducted a prespecified economic evaluation alongside a multicenter, superiority, randomized clinical trial at 2 Finnish university hospitals between 2012 and 2018. Eighty-two adults (mean age, 48.9 years; 38 women) with displaced, closed humeral shaft fractures were randomly assigned to surgical fixation (n = 38) or functional bracing (n = 44) and followed for 2 years. The primary outcome was the incremental net monetary benefit (INMB) based on quality-adjusted life years (QALYs) measured with the 15-dimensional (15D) instrument, analyzed from both societal and health-care perspectives.Results: From a societal perspective, surgical treatment was both more effective and less costly than bracing. The mean total cost per patient was & euro;23,680 for surgery and & euro;30,389 for bracing, yielding an INMB of & euro;9,423 (95% confidence interval [CI], & euro;4,139 to & euro;14,609). Cost-effectiveness acceptability curves showed that surgery was highly likely to be cost-effective across all willingness-to-pay thresholds up to & euro;120,000 per QALY. The cumulative QALYs from 6 weeks to 2 years post-injury were 1.776 (95% CI, 1.725 to 1.827) for surgery and 1.705 (95% CI, 1.641 to 1.769) for bracing, corresponding to a QALY difference of 0.071 (95% CI, 0.012 to 0.130) in favor of surgery. From the health-care perspective, functional bracing was less costly (& euro;4,904 versus & euro;10,967) and therefore more cost-effective, with an INMB of -& euro;4,087 (95% CI, -& euro;5,215 to -& euro;3,054). When considering only direct medical costs, surgery was unlikely to be cost-effective at thresholds below & euro;80,000 per QALY, reaching a 75% probability of cost-effectiveness only at & euro;120,000 per QALY.Conclusions: Surgery is cost-effective when societal costs are considered. Functional bracing remains a reasonable option, particularly for patients less affected by time away from work. Shared decision-making should incorporate both economic and individual patient factors.Level of Evidence: Economic Level I. See Instructions for Authors for a complete description of levels of evidence.
BACKGROUND:Humeral shaft fractures commonly affect working-age adults and can lead to prolonged work absence and substantial economic burden. Although surgical fixation and functional bracing offer comparable functional outcomes, their relative cost-effectiveness remains unclear. METHODS:We conducted a prespecified economic evaluation alongside a multicenter, superiority, randomized clinical trial at 2 Finnish university hospitals between 2012 and 2018. Eighty-two adults (mean age, 48.9 years; 38 women) with displaced, closed humeral shaft fractures were randomly assigned to surgical fixation (n = 38) or functional bracing (n = 44) and followed for 2 years. The primary outcome was the incremental net monetary benefit (INMB) based on quality-adjusted life years (QALYs) measured with the 15-dimensional (15D) instrument, analyzed from both societal and health-care perspectives. RESULTS:From a societal perspective, surgical treatment was both more effective and less costly than bracing. The mean total cost per patient was €23,680 for surgery and €30,389 for bracing, yielding an INMB of €9,423 (95% confidence interval [CI], €4,139 to €14,609). Cost-effectiveness acceptability curves showed that surgery was highly likely to be cost-effective across all willingness-to-pay thresholds up to €120,000 per QALY. The cumulative QALYs from 6 weeks to 2 years post-injury were 1.776 (95% CI, 1.725 to 1.827) for surgery and 1.705 (95% CI, 1.641 to 1.769) for bracing, corresponding to a QALY difference of 0.071 (95% CI, 0.012 to 0.130) in favor of surgery. From the health-care perspective, functional bracing was less costly (€4,904 versus €10,967) and therefore more cost-effective, with an INMB of -€4,087 (95% CI, -€5,215 to -€3,054). When considering only direct medical costs, surgery was unlikely to be cost-effective at thresholds below €80,000 per QALY, reaching a 75% probability of cost-effectiveness only at €120,000 per QALY. CONCLUSIONS:Surgery is cost-effective when societal costs are considered. Functional bracing remains a reasonable option, particularly for patients less affected by time away from work. Shared decision-making should incorporate both economic and individual patient factors. LEVEL OF EVIDENCE:Economic Level I . See Instructions for Authors for a complete description of levels of evidence.
Importance:Shoulder pain is a common musculoskeletal complaint often attributed to rotator cuff (RC) abnormalities. Diagnostic imaging is frequently used, but the association between RC abnormalities and shoulder symptoms remains uncertain. Objective:To determine the prevalence of RC abnormalities in a general population sample and their association with shoulder symptoms. Design, Setting, and Participants:Population-based cross-sectional study in a nationally representative random sample of adults aged 41 to 76 years who underwent standardized clinical assessment and bilateral 3-Tesla magnetic resonance imaging (MRI) of the shoulders conducted from February 2023 to April 2024 in Finland. Eligibility criteria included ability to undergo MRI and absence of previous shoulder replacement surgery. Exposures:Structured interviews, standardized questionnaires, clinical shoulder tests, and shoulder MRI. Main Outcomes and Measures:RC tendon status was classified on MRI as normal, tendinopathic, partial-thickness tear (PTT), or full-thickness tear (FTT). Shoulder symptoms were defined as pain or dysfunction in the preceding week. The prevalence of RC abnormalities was compared across age groups and between symptomatic and asymptomatic shoulders, adjusting for demographic factors, concurrent MRI findings, and clinical examination. Results:Among 602 participants (median age, 58 [range, 41-76] years; 52% female), RC abnormalities on MRI were found in 595 (98.7%; 95% CI, 97.5%-99.5%): 25% tendinopathy, 62% PTT, and 11% FTT. The prevalence and severity of abnormalities increased with age but did not differ between sexes. RC abnormalities were present in 96% of asymptomatic shoulders (1039 of 1076) and 98% of symptomatic shoulders (126 of 128). Only FTTs were more prevalent in symptomatic shoulders (14.6%) than in asymptomatic shoulders (6.5%), but this difference diminished after adjustment (absolute difference, 0.8%; 95% CI, -3.4% to 6.0%). Conclusions and Relevance:In this population-based study, RC abnormalities were nearly universal after age 40 years and showed poor concordance with shoulder symptoms. These findings suggest that RC abnormalities often represent normal age-related changes rather than disease and call into question the clinical value of routine imaging for atraumatic shoulder pain.
Shoulder pain is a leading cause of disability, often resulting in functional limitations and reduced quality of life. Valid, culturally adapted patient-reported outcome measures (PROMs) are essential for assessing symptoms and treatment outcomes across populations. The Shoulder Pain and Disability Index (SPADI) is widely used internationally, but no validated Finnish version has been available. This study aimed to translate, culturally adapt, and psychometrically validate a Finnish version of the SPADI for use in Finnish-speaking patients with shoulder pain. Translation followed International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines, including forward and back translation, expert review, and cognitive debriefing with 10 patients. Psychometric validation was conducted in 179 patients at Helsinki University Hospital; 137 also completed retest assessments after 12–21 days. We evaluated internal consistency, test–retest reliability, factor structure, floor and ceiling effects, and convergent validity using Cronbach’s alpha, intraclass correlation coefficients (ICC), exploratory factor analysis, and predefined hypothesis testing based on Pearson correlations with other PROMs: QuickDASH, Oxford Shoulder Score (OSS), Constant-Murley Score, American Shoulder and Elbow Surgeons score (ASES), and Simple Shoulder Test (SST). The Finnish SPADI demonstrated excellent internal consistency (α = 0.96) and test–retest reliability (ICC = 0.91). Pain (α = 0.93; ICC = 0.89) and disability (α = 0.94; ICC = 0.89) subscales were similarly robust. No floor or ceiling effects were observed for total scores, although several disability items showed ceiling effects. Convergent validity was strong, with high correlations between SPADI and QuickDASH (r = 0.85), OSS (r = 0.88), Constant-Murley (r = 0.83), ASES (r = 0.80), and SST (r = 0.81) scores, confirming all predefined hypotheses. Factor analysis supported a two-dimensional structure separating pain and disability. The Finnish SPADI exhibits strong linguistic validity and excellent psychometric properties, providing a reliable tool for assessing shoulder pain and disability in Finnish-speaking populations. Study registration: 26 October 2022 at Clinical trials (NCT05598541).
The relationship between specific occupational health care (OHC) pathways and subsequent work disability following an initial mental health-related sickness absence (SA) is poorly understood. This study aimed to predict long-term SA outcomes by modeling the timing and composition of OHC pathways among employees absent due to mood disorders or anxiety. We conducted a register‑based observational cohort study using structured occupational health records from a major Finnish OHC provider (2015–2023, N = 35 385). Following a 12‑month washout period, the first mental health-related SA (ICD‑10 F30–F48) occurring in 2016–2021 was defined as the index episode. The OHC pathways were characterized within a 3-month window. XGBoost was employed to predict 24‑month recurrence of mental health-related SA and cumulative SA days using care pathway features and socio‑demographic variables. Model interpretability was assessed using Shapley Additive Explanations (SHAP) values. SA patterns emerged as the most potent predictors of long‑term outcomes. The accumulation of absence days, particularly between days 61 and 90, and internal recurrence within the index period markedly increased the predicted risk of future mental health-related SA. In contrast, specific OHC pathway elements and the timing of clinical contacts contributed less to overall model performance. Our findings suggest that long‑term work disability risk is most strongly predicted by indicators of condition severity rather than the specific composition of early OHC interventions. To improve outcomes, timely identification of workers whose recovery trajectories deviate from expected norms may allow more targeted and sustained support for work ability.
BACKGROUND:Persisting symptoms after an attempt of nonoperative treatment represents one of the most common indications for surgery in many musculoskeletal conditions, such as tennis elbow. The rationale behind the practice of resorting to surgery in individuals with long-standing symptoms is that resolution of symptoms is believed to be unlikely without surgery after a certain period, and surgeons can identify a subgroup to benefit from surgery. For this approach to be sound, surgeons must be able to reliably distinguish between patients unlikely to improve without surgery and those who are likely to benefit from it. QUESTIONS/PURPOSES:(1) Do patients with persistent tennis elbow symptoms (lasting > 10 months) who are referred to a surgeon improve without surgery over a 24-month follow-up period? (2) Are surgeons' or patients' predictions about improvement associated with actual improvement? (3) What patient characteristics, if any, are associated with predictions of improvement made by either surgeons or patients? METHODS:Between 2016 and 2018, we prospectively recruited 97 patients with persistent tennis elbow symptoms (> 10 months) who were dissatisfied with nonsurgical treatment and referred for surgical consultation at five secondary or tertiary public hospitals. Of these, 89% (86 of 97) agreed to continued nonoperative treatment and were included in this observational cohort study. To evaluate the outcomes of continued nonoperative treatment, we measured the Oxford Elbow Score (OES) and global improvement at 6 weeks and at 3, 6, 12, and 24 months. To assess whether either the surgeons or the patients could predict the likelihood of symptom improvement, we asked both parties at baseline to predict whether each patient would be satisfied with their symptom state without surgery within the next 6 months. We then evaluated the prognostic value of these predictions by comparing the OES and global improvement scores between (1) patients who believed that they would improve versus patients who did not and (2) patients whom the surgeons predicted would improve versus those whom the surgeons predicted would not. To explore factors that might explain the predictions, we assessed the correlation between the predictions and baseline characteristics, including age, sex, affected side, smoking status, duration of symptoms, disability (OES score), Pain Catastrophizing Scale score, prior corticosteroid injections, and any planned injection treatments. Data from patients who underwent surgery during the follow-up period were included only up to the time of surgery. The mean ± SD age of the patients was 49 ± 5.4 years, and prior to the initial consultation, they had had symptoms for a mean ± SD of 20 ± 12 months. One-half of the patients were female. RESULTS:Nine percent (8 of 86) of patients eventually underwent operation during the 2-year follow-up period. The mean total OES of the cohort (range 0 to 100, with higher scores indicating better outcomes) increased from approximately 50 points at baseline to 80 points at the final 24-month follow-up visit. Surgeons' predictions about likelihood of improvement were not associated with the observed improvement, while patients who were more pessimistic about their likelihood of recovery at baseline had slightly inferior outcomes compared with patients who were more optimistic about their likelihood of recovery. As for factors associated with patients' predictions of recovery, both patients who had previously received corticosteroid injections (relative risk [RR] 1.4 [95% confidence interval (CI) 1.1 to 1.7]; p = 0.03) and those scheduled to receive botulinum toxin or platelet-rich plasma injections (RR 3.8 [95% CI 2.0 to 7.3]; p < 0.001) were more likely to predict improvement compared with those who opted to wait and see. Surgeons' predictions about the recovery were not associated with any of the measured patient characteristics, indicating that the predictions were based on heuristics, that is, mental shortcuts or rules of thumb that clinicians commonly use in clinical decision-making. CONCLUSION:Our findings suggest that persistent tennis elbow symptoms are a poor indication for surgery, as the majority of patients experience symptom resolution without it, and surgeons are unable to reliably predict who will or will not improve with nonoperative treatment. Therefore, treatment decisions should not be based on the clinician's perception of the disease course. Patients' predictions, especially more pessimistic views, were found to more accurately reflect the likely recovery trajectory. Finally, despite evidence demonstrating the ineffectiveness of injections, they elevated patients' expectations for improvement. LEVEL OF EVIDENCE:Level II, therapeutic study.
Abstract Objectives To determine the prevalence of acromioclavicular (AC) joint and subacromial space imaging abnormalities in asymptomatic adults, with a secondary objective of comparing findings between asymptomatic and symptomatic shoulders within the same study populations. Methods We conducted a systematic review of studies examining shoulder imaging abnormalities detected by X-ray, ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) in asymptomatic adults (PROSPERO registration CRD42018090041). This report focuses on AC joint and subacromial space abnormalities. Databases searched included Ovid MEDLINE, Embase, CINAHL and Web of Science from inception to June 2023. Our primary analysis used data from population-based studies, and risk of bias and certainty of evidence were evaluated with tools for prognostic studies. Results Thirty-one studies (4 X-ray, 11 US, 15 MRI, 1 both X-ray and MRI) provided useable prevalence data. One study was population-based (20 shoulders), 16 included miscellaneous study populations (2436 shoulders) and 14 focused on athletes (708 shoulders). The certainty of evidence was very low mainly due to high risk of bias, imprecision, and indirectness across studies. Clinical diversity precluded pooling. Population-based prevalence of acromioclavicular osteoarthritis (AC OA) ranged from 85% on MRI to 95% on X-ray. In other study populations, AC OA prevalence in asymptomatic shoulders varied from 6 to 47% on X-ray, 1 to 65% on US, and 0 to 82% on MRI. Among eight studies that included both asymptomatic and symptomatic shoulders, AC OA prevalence ranged from 13 to 95% in asymptomatic shoulders and from 20 to 100% in symptomatic shoulders. Conclusion The prevalence of AC joint and subacromial space abnormalities in asymptomatic shoulders is highly variable, and often comparable to that in symptomatic shoulders. Due to the low certainty of evidence and significant variation among study populations, further research is needed to clarify these prevalence estimates and to guide evidence-based management of shoulder abnormalities.
OBJECTIVE:The primary objective was to determine the population prevalence of glenohumeral joint imaging abnormalities in asymptomatic adults. METHOD:We systematically reviewed studies reporting the prevalence of X-ray, ultrasound (US), computed tomography, and magnetic resonance imaging (MRI) abnormalities in adults without shoulder symptoms (PROSPERO registration number CRD42018090041). This report presents the glenohumeral joint imaging findings. We searched Ovid MEDLINE, Embase, CINAHL and Web of Science from inception to June 2023 and assessed risk of bias using a tool designed for prevalence studies. The primary analysis was planned for the general population. The certainty of evidence was assessed using a modified Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) for prognostic studies. RESULTS:Thirty-five studies (4 X-ray, 10 US, 20 MRI, 1 X-ray and MRI) reported useable prevalence data. Two studies were population-based (846 shoulders), 15 studies included miscellaneous study populations (1715 shoulders) and 18 included athletes (727 shoulders). All were judged to be at high risk of bias. Clinical diversity precluded pooling. Population prevalence of glenohumeral osteoarthritis ranged from 15% to 75% (2 studies, 846 shoulders, 1 X-ray, 1 X-ray and MRI; low certainty evidence). Prevalence of labral abnormalities, humeral head cysts and long head of biceps tendon abnormalities were 20%, 5%, 30% respectively (1 study, 20 shoulders, X-ray and MRI; very low certainty evidence). CONCLUSION:The population-based prevalence of glenohumeral joint imaging abnormalities in asymptomatic individuals remains uncertain, but may range between 30% and 75%. Better estimates are needed to inform best evidence-based management of people with shoulder pain.
Background:The Finnish Shaft of the Humerus (FISH) trial compared open reduction and internal plate fixation (ORIF) with functional bracing in adult patients with displaced, closed humeral shaft fractures. Here, we compare the results of the patients in the randomized clinical trial (RCT [the randomized cohort]) with those of the cohort of patients who were also eligible but declined randomization (the nonrandomized cohort) to investigate if patients' treatment preference was associated with the outcomes during a 2-year follow-up. Methods:A total of 321 patients were treated at 2 university hospitals in Finland between November 2012 and January 2018. Of the 140 eligible patients, 82 were randomized to ORIF or functional bracing. Of the 58 patients declining randomization, 42 consented to participate in a nonrandomized cohort in which the patients were able to choose the treatment method. The primary outcome of this study was the Disabilities of the Arm, Shoulder and Hand (DASH) score. Patients in the randomized cohort and the nonrandomized cohort were analyzed separately in 3 groups: those who had (1) initial surgery, (2) successful functional bracing, and (3) late surgery due to failed functional bracing. We used mixed-model, repeated-measures analysis of variance to compare the treatment effect among the 3 groups. Results:In the randomized cohort, 38 patients had an initial surgical procedure. Of the 44 patients randomized to functional bracing, 30 (68%) healed successfully and 14 (32%) underwent a late surgical procedure. In the nonrandomized cohort, 9 patients preferred an initial surgical procedure. Of the 33 patients preferring functional bracing, 26 (79%) healed successfully and 7 (21%) underwent late surgery. The DASH scores in the randomized cohort and the nonrandomized cohort were 6.8 (95% confidence interval [CI], 2.3 to 11.4) and 12.3 (95% CI, 0.3 to 24.3) for the initial surgery groups, 6.0 (95% CI, 1.0 to 11.0) and 3.4 (95% CI, 0 to 9.3) for the bracing groups, and 17.5 (95% CI, 10.5 to 24.5) and 20.5 (95% CI, 9.4 to 31.6) for the late surgery groups at 2 years. Conclusions:The results of the randomized cohort and the nonrandomized cohort were comparable and suggest that patients' treatment preferences are not associated with the treatment outcomes of these injuries. Level of Evidence:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
ObjectivesTo assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up.DesignMulticentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial.SettingOrthopaedic departments in five public hospitals in Finland.Participants146 adults, mean age 52 years (range 35–65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised.InterventionsAPM or placebo surgery (diagnostic knee arthroscopy).Main outcome measuresWe used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale).ResultsThere was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI −2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), −1.7 (95% CI −7.7 to 4.3) in WOMET, −2.1 (95% CI −6.8 to 2.6) in Lysholm knee score, and −0.04 (95% CI −0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar.ConclusionsAPM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery.Trial registrationClinicalTrials.gov (NCT01052233andNCT00549172).
Importance: During the past decade, spinal surgical procedures have been increasingly performed on an ambulatory basis, a change in clinical practice supported only by observational evidence thus far. There have been no randomized clinical trials (RCTs) comparing ambulatory care with inpatient care after any spinal surgery. Objective: To assess whether ambulatory care is noninferior to overnight hospital surveillance in functional outcome, as measured by Neck Disability Index (NDI), in adults after anterior cervical decompression and fusion (ACDF) for cervical radiculopathy. Design, setting, and participants: This parallel group, noninferiority RCT enrolled patients at 3 tertiary neurosurgical centers in Finland (University Hospitals of Helsinki, Turku, and Oulu) between June 2019 and February 2021, with a final follow-up in October 2021. Patients aged 18 to 62 years who underwent 1-level or 2-level ACDF due to cervical radiculopathy were assessed for eligibility. After surgery, participants were randomly assigned to either ambulatory care or overnight hospital surveillance. Intention-to-treat data analyses were conducted in August 2022. Interventions: Patients randomly assigned to ambulatory care were kept under surveillance for 6 to 8 hours after surgery and then discharged. Patients assigned to overnight hospital surveillance were kept in the ward for 24 hours or longer. Main outcomes and measures: The primary outcome was NDI at 6 months. A minimal important difference of 17.3 percentage points for NDI was set as the margin of noninferiority. Results: Among the 105 patients (mean [SD] age, 47.0 [7.9] years; 54 women [50%]) randomly assigned to ambulatory care (n = 52) or overnight hospital surveillance (n = 53), 94 (90%) completed the trial. Four (8%) patients who received ambulatory care crossed over to overnight hospital surveillance. Seventy-nine patients (75%) had a 1-level ACDF and 26 (25%) had a 2-level ACDF. At 6 months after surgery, the mean NDI was 13.3% (95% CI, 9.3%-17.3%) in the ambulatory care group and 12.2% (95% CI, 8.2%-16.2%) in the overnight hospital surveillance group (between-group mean difference, 1.1 [95% CI, -4.6 to 6.8] percentage points). Conclusions and relevance: In this RCT comparing functional outcomes of ambulatory care vs overnight hospital surveillance after ACDF, ambulatory care resulted in noninferior functional outcomes.
Background In patients with a degenerative tear of the medial meniscus, recent meta-analyses and systematic reviews have shown no treatment benefit of arthroscopic partial meniscectomy (APM) over conservative treatment or placebo surgery. Yet, advocates of APM still argue that APM is cost effective. Giving advocates of APM their due, we note that there is evidence from the treatment of other musculoskeletal complaints to suggest that a treatment may prove cost effective even in the absence of improvements in efficacy outcomes, as it may lead to other benefits, such as diminished productivity loss and reduced costs, and so the question of cost effectiveness needs to be answered for APM. Questions/purposes (1) Does APM result in lower postoperative costs compared with placebo surgery? (2) Is APM cost-effective compared with placebo surgery? Methods One hundred forty-six adults aged 35 to 65 years with knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis according to the American College of Rheumatology clinical criteria were randomized to APM (n = 70) or placebo surgery (n = 76). In the APM and placebo surgery groups, mean age was 52 ± 7 years and 52 ± 7 years, and 60% (42 of 70) and 62% (47 of 76) of participants were men, respectively. There were no between-group differences in baseline characteristics. In both groups, a standard diagnostic arthroscopy was first performed. Thereafter, in the APM group, the torn meniscus was trimmed to solid meniscus tissue, whereas in the placebo surgery group, APM was carefully mimicked but no resection of meniscal tissue was performed; as such, surgical costs were the same in both arms and were not included in the analyses. All patients received identical postoperative care including a graduated home-based exercise program. At the 2-year follow-up, two patients were lost to follow-up, both in the placebo surgery group. Cost effectiveness over the 2-year trial period was computed as incremental net monetary benefit (INMB) for improvements in quality-adjusted life years (QALY), using both the societal (primary) and healthcare system (secondary) perspectives. To be able to consider APM cost effective, the CEA analysis should yield a positive INMB value. Nonparametric bootstrapping was used to assess uncertainty. Several one-way sensitivity analyses were also performed. Results APM did not deliver lower postoperative costs, nor did it convincingly improve quality of life scores when compared with placebo surgery. From a societal perspective, APM was associated with € 971 (95% CI -2013 to 4017) higher costs and 0.015 (95% CI -0.011 to 0.041) improved QALYs over 2-year follow-up compared with placebo surgery. Both differences were statistically inconclusive (a wide 95% CI that crossed the line of no difference). Using the conventional willingness to pay (WTP) threshold of € 35,000 per QALY, APM resulted in a negative INMB of € -460 (95% CI -3757 to 2698). In our analysis, APM would result in a positive INMB only when the WTP threshold rises to about € 65,000 per QALY. The wide 95% CIs suggests uncertain cost effectiveness irrespective of chosen WTP threshold. Conclusion The results of this study lend further support to clinical practice guidelines recommending against the use of APM in patients with a degenerative meniscus tear. Given the robustness of existing evidence demonstrating no benefit or cost effectiveness of APM over nonsurgical treatment or placebo surgery, future research is unlikely to alter this conclusion. Level of Evidence Level III, economic analysis.
This study compares outcomes of surgery and functional bracing for closed humeral shaft fractures after 5 years of follow-up.
The Oxford Elbow Score (OES) and the short version of Disabilities of Arms, Shoulder and Hand (QuickDASH) are common patient-reported outcomes for people with elbow problems. Our primary objective was to define thresholds for the Minimal Important Difference (MID) and Patient-Acceptable Symptom State (PASS) for the OES and QuickDASH. The secondary aim was to compare the longitudinal validity of these outcome measures. We recruited 97 patients with clinically-diagnosed tennis elbow for a prospective observational cohort study in a pragmatic clinical setting. Fifty-five participants received no specific intervention, 14 underwent surgery (11 as primary treatment and 4 during follow-up), and 28 received either botulinum toxin injection or platelet rich plasma injection. We collected OES (0 to 100, higher is better) and QuickDASH (0 to 100, higher is worse), and global rating of change (as an external transition anchor question) at six weeks, three months, six months and 12 months. We defined MID and PASS values using three approaches. To assess the longitudinal validity of the measures, we calculated the Spearman’s correlation coefficient between the change in the outcome scores and external transition anchor question, and the Area Under the Curve (AUC) from a receiver operating characteristics (ROC) analysis. To assess signal-to-noise ratio, we calculated standardized response means. Depending on the method, MID values ranged from 16 to 21 for OES Pain; 10 to 17 for OES Function; 14 to 28 for OES Social-psychological; 14 to 20 for OES Total score, and − 7 to -9 for QuickDASH. Patient-Acceptable Symptom State (PASS) cut offs were 74 to 84 for OES Pain; 88 to 91 for OES Function; 75 to 78 with OES Social-psychological; 80 to 81 with OES Total score and 19 to 23 with Quick-DASH. OES had stronger correlations with the anchor items, and AUC values suggested superior discrimination (between improved and not improved) compared with QuickDASH. OES also had superior signal-to-noise ratio compared with QuickDASH. The study provides MID and PASS values for OES and QuickDASH. Due to better longitudinal validity, OES may be a better choice for clinical trials. ClinicalTrials.gov NCT02425982 (first registered April 24, 2015).
INTRODUCTION:Shoulder pain is a substantial medical and socioeconomic problem in most societies, affecting the ability to work or carry out leisure time activities as well as subsequently influencing physical and psychological well-being. According to a nationwide survey in Finland, 27% of the population reported shoulder pain within the last 30 days. In clinical practice, imaging findings of structural abnormalities are typically thought to explain symptoms, even though such findings are also prevalent in asymptomatic individuals, particularly with increasing age. Overall, there is a paucity of high-quality evidence on the prevalence, clinical relevance and prognosis of 'abnormal' imaging findings of the shoulder.The aim of the Finnish Imaging of Shoulder (FIMAGE) study is fourfold: to assess (1) the prevalence of shoulder symptoms and the most common anatomical variants and imaging abnormalities of the shoulder; (2) the concordance between shoulder symptoms, function and imaging abnormalities; (3) the most important determinants of symptoms, function and imaging abnormalities; and (4) the course of shoulder complaints over 5 years. METHODS:The FIMAGE target population of 600 participants, aged 40-75 years, will be randomly selected from a nationally representative general population sample of 9922 individuals originally recruited for the Finnish Health 2000 Survey. On giving informed consent, the participants will be invited to a clinical visit that includes assessment of general health, shoulder symptoms, bilateral shoulder examination and imaging of both shoulders with plain radiography and MRI. ETHICS AND DISSEMINATION:The study has been approved by the Institutional Review Board of the Helsinki and Uusimaa Hospital District. The findings will be published according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria. TRIAL REGISTRATION NUMBER:NCT05641415.
ObjectiveTo evaluate the trajectories of acute upper respiratory tract infections (URTIs), COVID-19, and the use of antibiotics in Finland during the COVID-19 epidemic.DesignPopulation-based cohort study.SettingElectronic medical records from a nationwide healthcare chain in Finland.Participants833 444 patients from a cohort of 1 970 013 Finns who had used medical services between 2017 and 2020.Main outcome measuresNumber of weekly patients of acute URTIs, COVID-19, and the prescribed number of antibiotics in Finland between 6 January 2020 and 21 June 2020. We estimated the respective expected numbers from 1 March 2020 onward using autoregressive integrated moving average model from 1 January 2017 to 1 March 2020. We assessed the public interest in COVID-19 by collecting Google search trend frequencies.ResultsThere was a rapid increase in COVID-related internet searches between weeks 10 and 12. At the same time, there was a 106% increase in diagnoses of acute URTIs, from 410 per 100 000 inhabitants to 845 per 100 000. The first COVID-19 cases were diagnosed on week 11. Prescriptions for URTI-related antibiotics declined by 71% (403 per 100 000 to 117 per 100 000) between weeks 11 and 15 while no relevant change took place in prescriptions of antibiotics for urinary tract infections.ConclusionsAt the beginning of the epidemic, many people contacted healthcare professionals with relatively mild symptoms, as indicated by the reduced rate of URTI-antibiotics prescriptions. Our findings indicate that health service providers should be prepared for rapid variations in service demand. Securing access of true COVID-19 patients to proper diagnostics, care and isolation measures may help in preventing the spread of the disease.
The Numerical Rating Scale (NRS) and Patient-rated wrist/hand evaluation (PRWHE) are patient-reported outcomes frequently used for evaluating pain and function of the wrist and hand. The aim of this study was to determine thresholds for minimal important difference (MID) and patient acceptable symptom state (PASS) for NRS pain and PRWHE instruments in patients with base of thumb osteoarthritis. Fifty-two patients with symptomatic base of thumb osteoarthritis wore a splint for six weeks before undergoing trapeziectomy. NRS pain (0 to 10) and PRWHE (0 to 100) were collected at the time of recruitment (baseline), after splint immobilization prior to surgery, and at 3, 6, 9 and 12 months after surgery. Four anchor-based methods were used to determine MID for NRS pain and PRWHE: the receiver operating characteristics (ROC) curve, the mean difference of change (MDC), the mean change (MC) and the predictive modelling methods. Two approaches were used to determine PASS for NRS pain and PRWHE: the 75th percentile and the ROC curve methods. The anchor question for MID was the change perceived by the patient compared with baseline; the anchor question for PASS was whether the patient would be satisfied if the condition were to stay similar. The correlation between the transition anchor at baseline and the outcome at all time points combined was calculated using the Spearman’s rho analysis. The MID for NRS pain was 2.5 using the ROC curve method, 2.0 using the MDC method, 2.8 using the MC method, and 2.5 using the predictive modelling method. The corresponding MIDs for PRWHE were 22, 24, 10, and 20. The PASS values for NRS pain and PRWHE were 2.5 and 30 using the ROC curve method, and 2.0 and 22 using the 75th percentile method, respectively. The area under curve (AUC) analyses showed excellent discrimination for all measures. We found credible MID estimates for NRS and PRWHE (including its subscales), although the MID estimates varied depending on the method used. The estimates were 20-30% of the range of scores of the instruments. The cut-offs for MID and PASS showed good or excellent discrimination, lending support for their use in future studies. This clinimetrics study was approved by the Helsinki University ethical review board (HUS1525/2017).