Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial.

BACKGROUND: Surgery, needle fasciotomy, and collagenase injection are used to treat Dupuytren contracture. The treatment decision requires balancing initial morbidity and costs of surgery against its potential long-term benefits over needle fasciotomy and collagenase. OBJECTIVE: To compare the effectiveness of surgery, needle fasciotomy, and collagenase injection at 3 months and 2 years (secondary time points of the trial). DESIGN: A multicenter, randomized, outcome assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT03192020). SETTING: 6 public hospitals in Finland. PARTICIPANTS: 302 persons with treatment-naive Dupuytren contracture (contracture angle <135°). INTERVENTION: Surgery (n = 101), needle fasciotomy (n = 101), or collagenase (n = 100). MEASUREMENTS: The primary outcome was the success rate, defined as greater than 50% contracture release and patients reaching the patient acceptable symptom state. Secondary outcomes included hand function, pain, quality of life, patient satisfaction, residual contracture angle, finger flexion, risk for retreatment, and serious adverse events. RESULTS: A total of 292 (97%) and 284 (94%) participants completed the 3-month and 2-year follow-ups. Success rates were similar at 3 months: 71% (95% CI, 62% to 80%) for surgery, 73% (CI, 64% to 82%) for needle fasciotomy, and 73% (CI, 64% to 82%) for collagenase. At 2 years, surgery had superior success rates compared with both needle fasciotomy (78% vs. 50%; adjusted risk difference [aRD], 0.30 [CI, 0.17 to 0.43]) and collagenase (78% vs. 65%; aRD, 0.13 [CI, 0.01 to 0.26]). Secondary analyses paralleled with the primary analysis. LIMITATION: Participants were not blinded. CONCLUSION: Initial outcomes are similar between the treatments, but at 2 years success rates were maintained in the surgery group but were lower with both needle fasciotomy and collagenase despite retreatments. PRIMARY FUNDING SOURCE: Research Council of Finland.

Minimal important difference, patient acceptable symptom state and longitudinal validity of oxford elbow score and the quickDASH in patients with tennis elbow.

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).

Minimal important difference and patient acceptable symptom state for the Numerical Rating Scale (NRS) for pain and the Patient-Rated Wrist/Hand Evaluation (PRWHE) for patients with osteoarthritis at the base of thumb.

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 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. 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).

Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data.

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.

Cardiorespiratory fitness is linked with heart rate variability during stress in "at-risk" adults.

BACKGROUND: Physiological mechanisms explaining why cardiorespiratory fitness (CRF) predicts cardiovascular morbidity and mortality are incompletely understood. We examined if CRF modifies vagally mediated heart rate variability (HRV) during acute physical or psychosocial stress or night-time sleep in adults with cardiovascular risk factors. METHODS: Seventy-eight adults (age 56 years [IQR 50-60], 74% female, body mass index 28 kg/m2 [IQR 25-31]) with frequent cardiovascular risk factors participated in this cross-sectional study. They went through physical (treadmill cardiopulmonary exercise test [CPET]) and psychosocial (Trier Social Stress Test for Groups [TSST-G]) stress tests and night-time sleep monitoring (polysomnography). Heart rate (HR) and vagally mediated HRV (root mean square of successive differences between normal R-R intervals [RMSSD]) were recorded during the experiments and analyzed by taking account of potential confounders. RESULTS: CRF (peak O2 uptake) averaged 99% (range 78-126) in relation to reference data. From pre-rest to moderate intensities during CPET and throughout TSST-G, HR did not differ between participants with CRF below median (CRFlower) and CRF equal to or above median (CRFhigher), whereas CRFhigher had higher HRV than CRFlower, and CRF correlated positively with HRV in all participants. Meanwhile, CRF had no independent associations with HR or HRV levels during slow-wave sleep, the presence of metabolic syndrome was not associated with recorded HR or HRV levels, and single factors predicted HRV responsiveness independently only to limited extents. CONCLUSIONS: CRF is positively associated with prevailing vagally mediated HRV at everyday levels of physical and psychosocial stress in adults with cardiovascular risk factors.

Measuring psychosocial stress with heart rate variability-based methods in different health and age groups.

Objective.Autonomic nervous system function and thereby bodily stress and recovery reactions may be assessed by wearable devices measuring heart rate (HR) and its variability (HRV). So far, the validity of HRV-based stress assessments has been mainly studied in healthy populations. In this study, we determined how psychosocial stress affects physiological and psychological stress responses in both young (18-30 years) and middle-aged (45-64 years) healthy individuals as well as in patients with arterial hypertension and/or either prior evidence of prediabetes or type 2 diabetes. We also studied how an HRV-based stress index (Relax-Stress Intensity, RSI) relates to perceived stress (PS) and cortisol (CRT) responses during psychosocial stress.Approach.A total of 197 participants were divided into three groups: (1) healthy young (HY,N = 63), (2) healthy middle-aged (HM,N = 61) and (3) patients with cardiometabolic risk factors (Pts,N = 73, 32-65 years). The participants underwent a group version of Trier Social Stress Test (TSST-G). HR, HRV (quantified as root mean square of successive differences of R-R intervals, RMSSD), RSI, PS, and salivary CRT were measured regularly during TSST-G and a subsequent recovery period.Main results.All groups showed significant stress reactions during TSST-G as indicated by significant responses of HR, RMSSD, RSI, PS, and salivary CRT. Between-group differences were also observed in all measures. Correlation and regression analyses implied RSI being the strongest predictor of CRT response, while HR was more closely associated with PS.Significance.The HRV-based stress index mirrors responses of CRT, which is an independent marker for physiological stress, around TSST-G. Thus, the HRV-based stress index may be used to quantify physiological responses to psychosocial stress across various health and age groups.