Search

ObjectiveMethodResultsConclusionsWe conducted a longitudinal observational study over 11 years to identify the risk factors for developing shoulder pain, stiffness, or both.The study population (n = 1645) was identified from Health 2000 Survey, a nationally representative sample of Finns aged ≥ 44 years, without shoulder pain and stiffness at the start of the study based on a questionnaire. The independent variables included age, sex, body mass index (BMI), education level, diabetes, physical work exposures, and Beck’s depression score. We used multinomial logistic regression models to estimate relative risk ratios and 95% confidence intervals for three outcomes: shoulder pain, shoulder stiffness, and both combined.We found that excess body mass and depressive symptoms were shared statistically significant risk factors for all three outcomes. However, we also observed distinct risk factor profiles: older age was associated with lower risk of shoulder pain but higher risk for shoulder stiffness with or without pain, while females had a lower risk of shoulder stiffness with or without pain. Participants with diabetes had higher risk of shoulder stiffness only. Physical workload factors predicted an increased risk of the combination of shoulder pain and stiffness.Our study identified increased BMI and depressive symptoms as consistent risk factors for shoulder pain, stiffness, or both. Older age increased the risk of shoulder stiffness but lowered the risk of pain alone, while females had a lower risk of stiffness. Diabetes was specifically linked to shoulder stiffness, and physical workload increased the risk of combined pain and stiffness. [ABSTRACT FROM AUTHOR]

Abstract Background Lack of physical activity (PA) is a known risk factor for many health conditions. The workplace is a setting often used to promote activity and health. We investigated the effectiveness of an intervention on PA and productivity-related outcomes in an occupational setting. Methods We conducted a randomized controlled trial of 12 months duration with two 1:1 allocated parallel groups of insurance company employees. Eligibility criteria included permanent employment and absence of any condition that risked the participant’s health during PA. Subjects in the intervention group monitored their daily PA with an accelerometer, set goals, had access to an online service to help them track their activity levels, and received counseling via telephone or web messages for 12 months. The control group received the results of a fitness test and an information leaflet on PA at the beginning of the study. The intervention’s aim was to increase PA, improve work productivity, and decrease sickness absence. Primary outcomes were PA (measured as MET minutes per week), work productivity (quantity and quality of work; QQ index), and sickness absence (SA) days at 12 months. Participants were assigned to groups using block randomization with a computer-generated scheme. The study was not blinded. Results There were 544 randomized participants, of which 521 were included in the analysis (64% female, mean age 43 years). At 12 months, there was no significant difference in physical activity levels between the intervention group (n = 264) and the control group (n = 257). The adjusted mean difference was −206 MET min/week [95% Bayesian credible interval −540 to 128; negative values favor control group]. There was also no significant difference in the QQ index (−0.5 [−4.4 to 3.3]) or SA days (0.0 [−1.2 to 0.9]). Of secondary outcomes, body weight (0.5 kg [0.0 to 1.0]) and percentage of body fat (0.6% [0.2% to 1.1%]) were slightly higher in the intervention group. An exploratory subgroup analysis revealed no subgroups in which the intervention affected physical activity. No adverse events were reported. Conclusions The intervention was not found effective, and this study does not provide support for the effectiveness of the workplace PA intervention used here. Trial registration ClinicalTrials.gov identifier: NCT00994565

Abstract Background The CoAct (Cocreating Activity) study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counselling via telephone and secure web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle counselling on the level of physical activity in an occupational health setting. The purposes include also analysing the potential effects of changes in physical activity on productivity at work and sickness absence, and healthcare costs. This article describes the design of the study and the participant flow until and including randomization. Methods/Design CoAct is a randomised controlled trial with two arms: a control group and intervention group with daily activity monitoring and distance counselling. The intervention focuses on lifestyle modification and takes 12 months. The study population consists of volunteers from 1100 eligible employees of a Finnish insurance company. The primary outcomes of this study are change in physical activity measured in MET minutes per week, work productivity and sickness absence, and healthcare utilisation. Secondary outcomes include various physiological measures. Cost-effectiveness analysis will also be performed. The outcomes will be measured by questionnaires at baseline, after 6, 12, and 24 months, and sickness absence will be obtained from the employer's registers. Discussion No trials are yet available that have evaluated the effectiveness of daily physical activity monitoring and distance counselling in an occupational health setting over a 12 month period and no data on cost-effectiveness of such intervention are available. Trial Registration ClinicalTrials.gov identifier: NCT00994565

Abstract Background Modic changes are bone marrow lesions visible in magnetic resonance imaging (MRI), and they are assumed to be associated with symptomatic intervertebral disc disease, especially changes located at L5-S1. Only limited information exists about the determinants of Modic changes. The objective of this study was to evaluate the determinants of vertebral endplate (Modic) changes, and whether they are similar for Modic changes and severe disc degeneration focusing on L5-S1 level. Methods 228 middle-aged male workers (159 train engineers and 69 sedentary factory workers) from northern Finland underwent sagittal T1- and T2-weighted MRI. Modic changes and disc degeneration were analyzed from the scans. The participants responded to a questionnaire including items of occupational history and lifestyle factors. Logistic regression analysis was used to evaluate the associations between selected determinants (age, lifetime exercise, weight-related factors, fat percentage, smoking, alcohol use, lifetime whole-body vibration) and Modic type I and II changes, and severe disc degeneration (= grade V on Pfirrmann's classification). Results The prevalences of the Modic changes and severe disc degeneration were similar in the occupational groups. Age was significantly associated with all degenerative changes. In the age-adjusted analyses, only weight-related determinants (BMI, waist circumference) were associated with type II changes. Exposure to whole-body vibration, besides age, was the only significant determinant for severe disc degeneration. In the multivariate model, BMI was associated with type II changes at L5-S1 (OR 2.75 per one SD = 3 unit increment in BMI), and vibration exposure with severe disc degeneration at L5-S1 (OR 1.08 per one SD = 11-year increment in vibration exposure). Conclusion Besides age, weight-related factors seem important in the pathogenesis of Modic changes, whereas whole-body vibration was the only significant determinant of severe disc degeneration.

Background: The CoAct (Cocreating Activity) study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counselling via telephone and secure web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle counselling on the level of physical activity in an occupational health setting. The purposes include also analysing the potential effects of changes in physical activity on productivity at work and sickness absence, and healthcare costs. This article describes the design of the study and the participant flow until and including randomization.Methods/design: CoAct is a randomised controlled trial with two arms: a control group and intervention group with daily activity monitoring and distance counselling. The intervention focuses on lifestyle modification and takes 12 months. The study population consists of volunteers from 1100 eligible employees of a Finnish insurance company. The primary outcomes of this study are change in physical activity measured in MET minutes per week, work productivity and sickness absence, and healthcare utilisation. Secondary outcomes include various physiological measures. Cost-effectiveness analysis will also be performed. The outcomes will be measured by questionnaires at baseline, after 6, 12, and 24 months, and sickness absence will be obtained from the employer's registers.Discussion: No trials are yet available that have evaluated the effectiveness of daily physical activity monitoring and distance counselling in an occupational health setting over a 12 month period and no data on cost-effectiveness of such intervention are available.Trial Registration: ClinicalTrials.gov identifier: NCT00994565. [ABSTRACT FROM AUTHOR]

Background: Modic changes are bone marrow lesions visible in magnetic resonance imaging (MRI), and they are assumed to be associated with symptomatic intervertebral disc disease, especially changes located at L5-S1. Only limited information exists about the determinants of Modic changes. The objective of this study was to evaluate the determinants of vertebral endplate (Modic) changes, and whether they are similar for Modic changes and severe disc degeneration focusing on L5-S1 level.Methods: 228 middle-aged male workers (159 train engineers and 69 sedentary factory workers) from northern Finland underwent sagittal T1- and T2-weighted MRI. Modic changes and disc degeneration were analyzed from the scans. The participants responded to a questionnaire including items of occupational history and lifestyle factors. Logistic regression analysis was used to evaluate the associations between selected determinants (age, lifetime exercise, weight-related factors, fat percentage, smoking, alcohol use, lifetime whole-body vibration) and Modic type I and II changes, and severe disc degeneration (= grade V on Pfirrmann's classification).Results: The prevalences of the Modic changes and severe disc degeneration were similar in the occupational groups. Age was significantly associated with all degenerative changes. In the age-adjusted analyses, only weight-related determinants (BMI, waist circumference) were associated with type II changes. Exposure to whole-body vibration, besides age, was the only significant determinant for severe disc degeneration. In the multivariate model, BMI was associated with type II changes at L5-S1 (OR 2.75 per one SD = 3 unit increment in BMI), and vibration exposure with severe disc degeneration at L5-S1 (OR 1.08 per one SD = 11-year increment in vibration exposure).Conclusion: Besides age, weight-related factors seem important in the pathogenesis of Modic changes, whereas whole-body vibration was the only significant determinant of severe disc degeneration. [ABSTRACT FROM AUTHOR]

Assesses the clinical management of chronic low back pain (CLBP) in the U.S. Statistical details on the incidence of CLBP; Etiological analysis of CLBP; Assessment of quality of life conditions in the treatment of CLBP patients.

Objective: To assess the 5-year effects of arthroscopic partial meniscectomy (APM) vs. placebo surgery on the development of the structural changes of the knee by magnetic resonance imaging (MRI)., Design: This multicentre, randomized, participant- and outcome-assessor-blinded, placebo-surgery-controlled trial was carried out in Finland. We randomized 146 adults, mean age 52 years (range 35 to 65) to undergo either APM or placebo surgery. The subjects had symptoms of degenerative medial meniscus tear, a tear verified in MRI and arthroscopy, and no advanced osteoarthritis at baseline. We compared the baseline and 5-year follow-up MRIs using MRI Osteoarthritis Knee Score scoring to derive subregional data on cartilage damage, osteophytes and bone marrow lesions (BMLs). Progression of structural cartilage changes analyzed per subregion was the main outcome, that of osteophytes and BMLs secondary outcomes. We analyzed the progression with multilevel logistic regression model on subregion-level data, adjusted for randomization stratification factors, and using robust standard errors., Results: Sixty-three (90%) subjects in the APM and 73 (96%) in the placebo-surgery group had MRI at both time points. The adjusted odds ratio (APM vs. placebo-surgery) was 1.31 (95% confidence interval 0.81, 1.94) for progression of cartilage damage, 2.86 (1.16, 6.21) for osteophytes, and 1.43 (0.84, 2.43) for BMLs., Conclusions: We found a slightly greater risk for progression of osteophytes in the APM group compared to the placebo-surgery group at 5 years after surgery., Trial Registration: ClinicalTrials.gov (NCT01052233 and NCT00549172)., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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., Competing Interests: Declarations. Ethical approval: Ethics approval was not sought for this study. This study is a systematic review of study level data. The review does not directly involve human participants. The studies included in the review include human participants for which the individual study investigators would have sought approval from an Ethics Committee or Institutional Board. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

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., Competing Interests: Disclosure: No external funding was received for this work. The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJSOA/A708)., (Copyright © 2024 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved.)

Background: Most current studies on COVID-19 have focused on the first weeks or months of the pandemic or have addressed specific diseases. The long-term effects of the COVID-19 pandemic on healthcare services are insufficiently understood. We analysed the long-term effects of the COVID-19 pandemic on outpatient healthcare utilisation in the full spectrum of diseases in Uusimaa, the capital region of Finland., Methods: Our data included 632 466 individual patients between the ages of 18 and 65 and 6 521 394 visits to healthcare personnel from electronic health records. We fitted an autoregressive integrated moving average (ARIMA) model to pre-2020 data to predict the expected quantity of diagnoses for the period between 1 January 2020 and 16 June 2022. Expected and observed quantities of diagnoses were compared., Results: The overall quantity of diagnoses declined by one-fourth immediately following the onset of the pandemic and remained around 15% below predicted values for most of the pandemic. After the pandemic-related restrictions were lifted, the total diagnostic activity started to recover to pre-pandemic projection levels. However, this recovery has been mainly driven by upper respiratory system-related activity. The number of diagnoses for many diagnosis groups has remained below the predicted levels, even after the concurrent removal of mobility restrictions and increased coverage of vaccinations in this population., Conclusions: The pandemic resulted in an overall reduction in outpatient healthcare utilisation which persisted for 30 months. While the overall diagnostic activity has eventually recovered to predicted levels, many classes of diagnoses display reduced levels in the study population over the follow-up period. Some diseases that may have long-lasting effects when left untreated seem to remain underdiagnosed, potentially increasing pressure on the healthcare system in the future., (© 2024. The Author(s).)

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., Trial Registration: ClinicalTrials.gov Identifier: NCT03979443.

Customer satisfaction and enablement are key facets of healthcare quality. We examined their interplay within a large sample of predominantly working-age primary care patients. Our dataset encompasses 140 055 customer satisfaction reports, with concurrently gathered measures of patient enablement, delivered after doctor appointments. We used the customer satisfaction (CSAT) score and the patient enablement instrument (PEI). Additionally, we assessed 3 dimensions of customer satisfaction in conjunction with the CSAT score and calculated a sum score. Age and gender were included as covariates. Our findings from linear regression analyses are twofold: (1) customer satisfaction and enablement are interconnected, yet they maintain a degree of distinctiveness, as indicated by a beta coefficient of 0.45 on a 5-point scale, and (2) within the customer experience on a dichotomous scale, negative experiences exert a more substantial impact (betas between -0.77 and -0.97) on enablement than positive experiences (betas between 0.24 and 0.40). In addition, a dose-response relationship was observed between the sum of customer experiences and PEI. Ensuring that patients' voices are acknowledged, their queries are addressed, and they have comprehensible guidance regarding the progression of their treatment, are fundamental aspects of interactions with patients., (© The Author(s) 2024.)

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., Competing Interests: Declaration of Competing Interest The authors have nothing to disclose., (Copyright © 2024. Published by Elsevier Ltd.)

Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

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., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research ® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Association of Bone and Joint Surgeons.)

Background: Chronic subdural haematoma is a common surgically treated intracranial emergency. Burr-hole drainage surgery, to evacuate chronic subdural haematoma, involves three elements: creation of a burr hole for access, irrigation of the subdural space, and insertion of a subdural drain. Although the subdural drain has been established as beneficial, the therapeutic effect of subdural irrigation has not been addressed., Methods: The FINISH trial was an investigator-initiated, pragmatic, multicentre, nationwide, randomised, controlled, parallel-group, non-inferiority trial in five neurosurgical units in Finland that enrolled adults aged 18 years or older with a chronic subdural haematoma requiring burr-hole drainage. Patients were randomly assigned (1:1) by computer-generated block randomisation with block sizes of four, six, or eight, stratified by site, to burr-hole drainage either with or without subdural irrigation. All patients and staff were masked to treatment assignment apart from the neurosurgeon and operating room staff. A burr hole was drilled at the site of maximum haematoma thickness in both groups, and the subdural space was either irrigated or not irrigated before inserting a subdural drain, which remained in place for 48 h. Reoperations, functional outcome, mortality, and adverse events were recorded for 6 months after surgery. The primary outcome was the reoperation rate within 6 months. The non-inferiority margin was set at 7·5%. Key secondary outcomes that were also required to conclude non-inferiority were the proportion of participants with unfavourable functional outcomes (ie, modified Rankin Scale score of 4-6, where 0 indicates no symptoms and 6 indicates death) and mortality rate at 6 months. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT04203550) and is completed., Findings: From Jan 1, 2020, to Aug 17, 2022, we assessed 1644 patients for eligibility and 589 (36%) patients were randomly assigned to a treatment group and treated (294 assigned to drainage with irrigation and 295 assigned to drainage without irrigation; 165 [28%] women and 424 [72%] men). The 6-month follow-up period extended until Feb 14, 2023. In the intention-to-treat analysis, 54 (18·3%) of 295 participants required reoperation in the group assigned to receive no irrigation versus 37 (12·6%) of 294 in the group assigned to receive irrigation (difference of 6·0 percentage points, 95% CI 0·2-11·7; p=0·30; adjusted for study site). There were no significant between-group differences in the proportion of people with modified Rankin Scale score of 4-6 (37 [13·1%] of 283 in the no-irrigation group vs 36 [12·6%] of 285 in the irrigation group; p=0·89) or mortality rate (18 [6·1%] of 295 in the no-irrigation group vs 21 [7·1%] of 294 in the irrigation group; p=0·58). The findings of the primary intention-to-treat analysis were not materially altered in the per-protocol analysis. There were no significant between-group differences in the number of adverse events, and the most frequent severe adverse events were systemic infections (26 [8·8%] of 295 participants who did not receive irrigation vs 22 [7·5%] of 294 participants who received irrigation), intracranial haemorrhage (13 [4·4%] vs seven [2·4%]), and epileptic seizures (five [1·7%] vs nine [3·1%])., Interpretation: We could not conclude non-inferiority of burr-hole drainage without irrigation. The reoperation rate was 6·0 percentage points higher after burr-hole drainage without subdural irrigation than with subdural irrigation. Considering that there were no differences in functional outcome or mortality between the groups, the trial favours the use of subdural irrigation., Funding: State Fund for University Level Health Research (Helsinki University Hospital), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv och Hälsa, and Svenska Kulturfonden., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: COVID-19 has had wide-reaching effects on healthcare services beyond the direct treatment of the pandemic. Most current studies have reported changes in realised service usage, but the dynamics of how patients engage with healthcare services are less well understood. We analysed the effects of COVID-19 on healthcare bookings and cancellations for various service channels between January 2020 and July 2021., Methods: Our data includes 7.3 million bookings, 11.0 million available appointments, and 405.1 thousand cancellations by 900.6 thousand individual patients between the ages of 18 and 65 years. The data were collected from electronic health record data, including laboratory and imaging services as well as inpatient stays, between January 2017 and July 2021. The patients were Finnish private and occupational healthcare customers in the capital region of Finland. We fitted an autoregressive moving average (ARIMA) model on data between 2017 and 2019 to predict the expected numbers of bookings, available appointments, and cancellations, which were compared to observed time series data between 2020 and 2021., Results: Utilisation of physical, in-person primary care physician appointments decreased by up to 50% during the first 18 months of the pandemic. At the same time, digital care channels experienced a rapid, multi-fold increase in service usage. Simultaneously, the number of bookings for laboratory and imaging services decreased by 50% below the pre-pandemic projections. The number of specialist and hospital service bookings remained at the predicted level during the study period. Cancellations for most health services increased sharply by up to three times the pre-COVID levels during the first weeks of the pandemic but returned to the pre-pandemic levels for the rest of the study period., Conclusions: The reduction in in-person appointments and the increase in the utilisation of digital services was likely a contributing factor in the decrease of the utilisation of diagnostic and imaging services throughout the study period. Utilisation of specialist care and hospital services were not affected. Cancellations contributed to the changes in service utilisation only during the first weeks of the pandemic., (© 2024. The Author(s).)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: 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., Methods: 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., Results: 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., Conclusion: 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., Trial Registration: ClinicalTrials.gov NCT02425982 (first registered April 24, 2015)., (© 2023. The Author(s).)

Background: Two common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well., Methods: We recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale., Results: The change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively., Conclusion: Our study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture., Trial Registration: ClinicalTrials.gov NCT01719887, first registration 01/11/2012., (© 2022. The Author(s).)

Background: 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., Methods: 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 75 th 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., Results: 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., Conclusion: 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., Trial Registration: This clinimetrics study was approved by the Helsinki University ethical review board (HUS1525/2017)., (© 2022. The Author(s).)

Background: Basal thumb joint osteoarthritis (OA) is a common painful condition of the hand often treated surgically if non-operative care does not provide sufficient pain relief. Many instruments are available to measure pain for this condition including single item and multidimensional measures. To inform our choice of instrument for the purpose of evaluating the value of surgery for people with thumb OA, the aim of this study was to compare the longitudinal validity and signal to noise ratio of a single item numeric rating scale (NRS) for pain and the Patient-rated Wrist and Hand Evaluation (PRWHE) pain subscale, and to assess if recall period affects longitudinal validity of the NRS pain and reported pain levels., Methods: We invited 52 patients referred for surgical treatment of basal thumb joint OA to participate in this study. All wore a splint for six weeks followed by surgery. Pain during the past day, week, and month and the PRWHE were collected at baseline, operation day, and 3, 6, 9 and 12 months after surgery. Responsiveness was assessed with two methods: 1) using participant-reported global improvement and PRWHE function subscale as external anchors (longitudinal validity) and 2) comparing Standardized Response Means (SRM)., Results: The Spearman's ρ between PRWHE pain and participant-reported global improvement was better (0.71) compared with NRS past day (0.55), past week (0.62), or past month (0.59). Similar findings were found with PRWHE function as anchor (Pearson's r for PRWHE pain 0.78; NRS past day 0.68; past week 0.73; past month 0.69). The SRM of PRWHE pain subscale (2.8) and NRS past week (2.9) outperformed pain past day (2.3) and month (2.4). Mean pain was 0.3 points (on a 0 to 10 scale) worse during past week when compared with past day and 0.3 worse during past month than during past week., Conclusions: All studied pain measures captured the change in pain over time. For clinical trials, we recommend PRWHE pain subscale or NRS past week due to their better signal noise ratio., Trial Registration: Retrospectively registered., (© 2022. The Author(s).)

Objective: To evaluate the trajectories of acute upper respiratory tract infections (URTIs), COVID-19, and the use of antibiotics in Finland during the COVID-19 epidemic., Design: Population-based cohort study., Setting: Electronic medical records from a nationwide healthcare chain in Finland., Participants: 833 444 patients from a cohort of 1 970 013 Finns who had used medical services between 2017 and 2020., Main Outcome Measures: Number 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., Results: There 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., Conclusions: At 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., Competing Interests: Competing interests: ON, AT, ST, PB and SR were employed by Terveystalo during the conduct of the study. PB reports personal fees outside the submitted work during the last 36 months from Faron Pharmaceuticals, Oncorena and TILT Biotherapeutics. ST reports personal fees from DBC group of companies and grants from the Academy of Finland, Social Security Institution of Finland, and University of Helsinki, Finland, all outside the submitted work during the last 36 months. ON, PB and SR own Terveystalo stocks. Additional Stock ownerships: PB: TILT Biotherapeutics. An immediate family member of PB has Stock ownership Faron Pharmaceuticals. ST has stock ownership in DBC group of companies., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Arthroscopic subacromial decompression is one of the most commonly performed shoulder surgeries in the world. It is performed to treat patients with suspected shoulder impingement syndrome, i.e., subacromial pain syndrome. Only few studies have specifically assessed return-to-work rates after subacromial decompression surgery. All existing evidence comes from open, unblinded study designs and this lack of blinding introduces the potential for bias. We assessed return to work and its predictors in patients with shoulder impingement syndrome in a secondary analysis of a placebo-surgery controlled trial., Methods: One hundred eighty-four patients in a randomised trial had undergone arthroscopic subacromial decompression (n = 57), diagnostic arthroscopy, a placebo surgical intervention, (n = 59), or exercise therapy (n = 68). We assessed return to work, defined as having returned to work for at least two follow-up visits by the primary 24-month time point, work status at 24 and 60 months, and trajectories of return to work per follow-up time point. Patients and outcome assessors were blinded to the assignment regarding the arthroscopic subacromial decompression vs. diagnostic arthroscopy comparison. We assessed the treatment effect on the full analysis set as the difference between the groups in return-to-work rates and work status at 24 months and at 60 months using Chi-square test and the predictors of return to work with logistic regression analysis., Results: There was no difference in the trajectories of return to work between the study groups. By 24 months, 50 of 57 patients (88%) had returned to work in the arthroscopic subacromial decompression group, while the respective figures were 52 of 59 (88%) in the diagnostic arthroscopy group and 61 of 68 (90%) in the exercise therapy group. No clinically relevant predictors of return to work were found. The proportion of patients at work was 80% (147/184) at 24 months and 73% (124/184) at 60 months, with no difference between the treatment groups (p-values 0.842 and 0.943, respectively)., Conclusions: Arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy or exercise therapy on return to work in patients with shoulder impingement syndrome. We did not find clinically relevant predictors of return to work either., Trial Registration: ClinicalTrials.gov identifier NCT00428870 ., (© 2021. The Author(s).)

Purpose: Work disability (WD) is a medico-legal concept that refers to disability benefits (DB) granted due to diseases. We assessed whether subjective cognitive complaints (SCC)-presenting as self-rated difficulties of concentration, memory, clear thinking, and decision making-predict permanent WD in knowledge-intensive occupations., Methods: In this prospective cohort study with up to 7-year follow-up, we combined the SCC questionnaire results with reliable registry data on the DBs of 7161 professional/managerial employees (46% females). We excluded employees who were on long-term sickness absence (SA) or had received a DB at baseline. The exposure variable was the presence of SCC. Age and SA before the questionnaire as a proxy measure of general health were treated as confounders and the analyses were conducted by gender. The outcome variable was a granted DB. The cumulative incidence function illustrates the difference between SCC categories, and the Fine-Gray model estimates the predictors of WD during the 8-year follow-up., Results: The annual incidence of DB was 0.15% in the entire cohort: 0.18% among the females, and 0.12% among the males (p = 0.795). The most common primary reasons for permanent WD were mental (36%) and musculoskeletal (20%) disorders. SCC predicted DB in both genders when controlling for age and prior SA. Hazard ratios were 2.9 with a 95% confidence interval 1.4-6.0 for the females and 3.7 (1.8-7.9) for the males., Conclusion: Subjective cognitive complaints predict permanent WD in knowledge-intensive occupations. This finding has implications for supporting work ability and preventing work disability among employees with cognitively demanding tasks.

Importance: Existing evidence indicates that surgery fails to provide superior functional outcome over nonoperative care in patients with a closed humeral shaft fracture. However, up to one-third of patients treated nonoperatively may require secondary surgery., Objective: To compare the 2-year outcomes of patients who required secondary surgery with the outcomes of patients with successful initial treatment., Design, Setting, and Participants: This 2-year follow-up of the Finnish Shaft of the Humerus (FISH) randomized clinical trial comparing surgery with nonoperative treatment (functional brace) was completed in January 2020. Enrollment in the original trial was between November 2012 and January 2018 at 2 university hospital trauma centers in Finland. A total of 321 adult patients with closed, displaced humeral shaft fracture were assessed for eligibility. After excluding patients with cognitive disabilities, multimorbidity, or multiple trauma and those refusing randomization, 82 patients were randomized., Interventions: Interventions were surgery with plate fixation (n = 38; initial surgery group) or functional bracing (n = 44); the latter group was divided into the successful fracture healing group (n = 30; bracing group) and the secondary surgery group (n = 14) with fracture healing problems., Main Outcomes and Measures: The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 2 years (range, 0 to 100 points; 0 denotes no disability, 100 extreme disability; minimal clinically important difference, 10 points)., Results: Of 82 randomized patients, 38 (46%) were female. The mean (SD) age was 48.9 (17.1) years. A total of 74 patients (90%) completed the 2-year follow-up. At 2 years, the mean DASH score was 6.8 (95% CI, 2.3 to 11.4) in the initial surgery group, 6.0 (95% CI, 1.0 to 11.0) in the bracing group, and 17.5 (95% CI, 10.5 to 24.5) in the secondary surgery group. The between-group difference was -10.7 points (95% CI, -19.1 to -2.3; P = .01) between the initial and secondary surgery groups and -11.5 points (95% CI, -20.1 to -2.9; P = .009) between the bracing group and secondary surgery group., Conclusions and Relevance: Patients contemplating treatment for closed humeral shaft fracture should be informed that two-thirds of patients treated with functional bracing may heal successfully while one-third may experience fracture healing problems that require secondary surgery and lead to inferior functional outcomes 2 years after the injury., Trial Registration: ClinicalTrials.gov Identifier: NCT01719887.

Background: The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well., Objective: To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS)., Methods: We used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100 mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds., Results: Different MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2 mm for pain at rest, 9 mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83., Conclusion: We recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20 mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9 mm for pain on arm activity, 80 points for CS, and 11 points for SST., Trial Registration: ClinicalTrials.gov NCT00428870 (first registered January 29, 2007).

Objectives: To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison)., Methods: We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry., Results: In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (-5.6 to 7.6; p=0.77) at rest and -3.9 (-12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events., Conclusions: ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome., Competing Interests: Competing interests: ST reports personal fees from Evalua group of companies, personal fees from DBC group of companies, and personal fees from insurance companies, outside the submitted work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)