Cumulative costs of severe traffic injuries in Finland: a 2-year retrospective observational study of 252 patients.

Road traffic injuries cause considerable financial strain on health care systems worldwide. We retrospectively analyzed injury-related costs of 252 severely injured (New Injury Severity Score, NISS ≥ 16) patients treated at Tampere University Hospital (TAUH) between 2013 and 2017, with 2-year follow-up. The costs were divided into direct treatment, indirect costs, and other costs. We analyzed various injury- and patient-related factors with costs. The total costs during the 2-year study period were 20 million euros. Median cost was 41,202 euros (Q1 23,409 euros, Q3 97,726 euros), ranging from 2,753 euros to 549,787 euros. The majority of costs (69.1%) were direct treatment costs, followed by indirect costs (28.4%). Other costs were small (5.4%). Treatment costs increased with the severity of the injury or when the injury affected the lower extremities or the face. Indirect costs were higher in working age patients and in patients with a higher level of education. The relative proportions of direct and indirect costs were constant regardless of the amount of the total costs. The largest share of costs was caused by a relatively small proportion of high-cost patients during the 1st year after injury. Combined, this makes planning of resource use challenging and calls for further studies to further identify factors for highest costs.

Prevalence, infant outcomes and gestational risk factors for transverse reduction deficiencies at or above the wrist: a population-based study.

We identified individuals born in Norway between 1970 and 2019 with transverse reduction deficiency at or above the wrist (TRDAW) from the Medical Birth Registry of Norway and from the CULA (congenital upper limb anomaly) North Oslo Registry. Infant outcomes and parental factors were compared for 202 individuals with TRDAW to 2,741,013 living individuals without TRDAW born during the same period. We found an overall TRDAW prevalence of 0.74/10,000. Infants with TRDAW had a higher risk for being small for gestational age, an Apgar score <7 and transfer to neonatal intensive care units after delivery. Nine of the infants with TRDAW had associated anomalies, most commonly in the lower limb, and at a higher proportion than the reference population. Other than twin pregnancies, we are unable to identify with certainty any other risk factors for TRDAW.Level of evidence: I.

Health-Related Quality of Life in severely injured patients in Finland: an observational cohort study of 325 patients with 1-year follow-up.

BACKGROUND: Major trauma has a significant effect on Health-Related Quality of Life (HR-QoL). It is unclear, however, which factors most affect HR-QoL. This study aims to evaluate HR-QoL after severe injury in Finland and determine how different injury patterns and patient-related factors, such as level of education and socioeconomic group, are associated with HR-QoL. We also assess how well different injury scoring systems associate with HR-QoL. METHODS: We retrospectively analyzed 325 severely injured trauma patients (aged ≥ 18 years, New Injury Severity Score, (NISS) ≥ 16, and alive at 1 year after injury) treated in the Intensive Care Unit (ICU) or High Dependence Unit (HDU) of Tampere University Hospital (TAUH) from 2013 through 2016. HR-QoL was assessed with the EQ-5D-3L questionnaire completed during ICU stay and 1 year after injury. HR-QOL index values and reported problems were further compared with Finnish population norms. RESULTS: The severity of the injury (measured by ISS and NISS) had no significant association with the decrease in HR-QoL. Length of ICU stay had a weak negative correlation with post-injury HR-QoL and a weak positive correlation with the change in HR-QoL. The largest mean decrease in HR-QoL occurred in patients with spinal cord injury (Spine AIS ≥ 4) (-0.338 (SD 0.136)), spine injury in general (Spine AIS ≥ 2 (-0.201 (SD 0.279)), and a lower level of education (-0.157 (SD 0.231)). Patient's age, sex, or socioeconomic status did not seem to associate with smaller or greater changes in HR-QoL. CONCLUSIONS: After serious injury, many patients have permanent disabilities which reduce HR-QoL. Injury scoring systems intended for assessing the risk for death did not seem to associate with HR-QoL and are not, therefore, a meaningful way to predict the future HR-QoL of a severely injured patient. Recovery from the injury seems to be weaker in poorer educated patients and patients with spinal cord injury, and these patients may benefit from targeted additional measures. Although there were significant differences in baseline HR-QoL levels between different socioeconomic groups, recovery from injury appears to be similar, which is likely due to equal access to high-quality trauma care.

Concurrent validity study of QuickDASH with respect to DASH in patients with traumatic upper extremity amputation.

BACKGROUND: The Disability of the Arm, Shoulder and Hand Outcome Measure (DASH) is a validated patient-reported outcome measure (PROM) for many upper extremity musculoskeletal disorders. In patients with severe traumatic conditions, limited evidence exists regarding the equivalence between DASH and its shortened version, QuickDASH, which is more feasible in clinical practice. The rationale of this study was to analyze the concurrent validity of QuickDASH with respect to DASH in patients with traumatic upper extremity amputation. METHODS: This study is based on a consecutive cohort of traumatic upper extremity amputation patients treated with replantation or revision (completion) amputation at Tampere University Hospital between 2009 and 2019. We estimated the concurrent validity of QuickDASH with respect to DASH by correlation coefficients, mean score differences, Bland-Altman plots, and distribution density. Additionally, we assessed internal reliability with Cronbach's alpha coefficients and item-total correlations. RESULTS: We found a very strong linear correlation between DASH and QuickDASH scores (r = 0.97 [CI 95% 0.97-0.98], p < 0.001). The mean difference between DASH and QuickDASH was minor (MD = -1, SD 4 [CI95% from -1 to 0] p = 0.02). The mean sub-score for the activity domain was higher for QuickDASH than DASH (MD = -3 [CI95% from -4 to -3] p < 0.000) and lower for the symptom domain (MD = 7 [CI95% from 6 to 9] p < 0.000). The Bland and Altman plot showed good agreement between DASH and QuickDASH scores, but there was measurement error in QuickDASH with high scores (r = -0.20, [CI95% from -0.31 to -0.09], p = 0.001). CONCLUSION: QuickDASH demonstrates higher total scores than the full DASH and emphasizes rating of activity over symptoms. Still, on average the differences in total scores are likely less than the MCID of DASH, and consequently, this study shows that QuickDASH can be recommended instead of the full DASH when assessing a traumatic condition. TRIAL REGISTRATION: Retrospectively registered.

Patient-reported function, quality of life and prosthesis wear in adults born with one hand: a national cohort study.

We invited individuals aged above 16 years with a congenital transverse reduction deficiency at and above the wrist born in Norway between 1970 and 2006 to complete the short version of the Disabilities of the Arm, Shoulder and Hand Outcome Measure, the 5-Level EuroQoL-5-Dimension instrument, the RAND 36-Item Short Form Health Survey and a single-item questionnaire on arm function, appearance, pain and prosthesis wear. Of 154 eligible participants, 58 (38%) responded. Their scores were not different from the general population. All had been offered prostheses, and 56 (97%) had been fitted at a median age of 1 year (interquartile range 0-2.8). Of the participants, 37 (64%) were still prosthesis wearers, while 21 (36%) were non-wearers or using gripping devices only. Prosthesis wearers had higher levels of 'vitality' as assessed by the RAND-36 and rated their arm appearance higher, but there were no other score differences, indicating that prosthesis rejection is not associated with worse functional outcomes.Level of evidence: III.

Long-term donor site outcome after second toe transfer for congenital hand differences.

This study evaluates the long-term donor site outcomes after second toe transfers for congenital hand differences performed during childhood. In total, 25 toe transfers in 18 patients were followed up for a mean period of 17.4 years. We examined the patients clinically, radiologically and with a gait analysis system. Patient-reported outcome measures were collected. The patients were asymptomatic and there were no problematic clinical or radiological findings. Patients expressed high levels of satisfaction. The results were consistent, regardless of the resection level in the toe transfer or whether the operation was unilateral or bilateral. No postoperative complications or late reoperations on the foot were observed.Level of evidence IV.

Is Replantation Associated With Better Hand Function After Traumatic Hand Amputation Than After Revision Amputation?

BACKGROUND: Replantation is an established treatment for traumatic upper extremity amputation. Only a few studies, however, have assessed the patient-reported outcomes of replantation, and the findings of these studies have been conflicting. QUESTIONS/PURPOSES: (1) Is replantation associated with better hand function than revision amputation? (2) Is replantation associated with better health-related quality of life, less painful cold intolerance, and more pleasing hand esthetics than revision amputation after a traumatic hand amputation? METHODS: In this retrospective, comparative study, we collected the details of all patients who sustained a traumatic upper extremity amputation and were treated at the study hospital. Between 2009 and 2019, we treated 2250 patients, and we considered all patients who sustained a traumatic amputation of two or more digital rays or a thumb as potentially eligible. Based on that, 15% (334 of 2250) were eligible; a further 2% (8 of 334) were excluded because of a subsequent new traumatic amputation or bilateral amputation, and another 22% (72 of 334) refused participation, leaving 76% (254 of 334) for analysis here. The primary outcome was the DASH score. Secondary outcomes included health-related quality of life (EuroQOL-5D [EQ-5D-5L] Index), painful cold intolerance (the Cold Intolerance Symptom Severity score), and hand esthetics (the Michigan Hand Questionnaire aesthetic domain score). The minimum follow-up time for inclusion was 18 months. Patients were classified into two treatment groups: replantation (67% [171 of 254], including successful replantation in 84% [144 of 171] and partially successful replantation in 16% [27 of 171], in which some but not all of the replanted tissue survived), and revision (complete) amputation (33% [83 of 254], including primary revision amputation in 70% [58 of 83] and unsuccessful replantation followed by secondary amputation in 30% [25 of 83]). In this cohort, replantation was performed if possible, and the reason for choosing primary revision amputation over replantation was usually an amputated part that was too severely damaged (15% [39 of 254]) or was unattainable (2% [4 of 254]). Some patients (3% [8 of 254]) refused to undergo replantation, or their health status did not allow replantation surgery and postoperative rehabilitation (3% [7 of 254]). Gender, age (mean 48 ± 17 years in the replantation group versus 50 ± 23 years in the revision amputation group; p = 0.41), follow-up time (8 ± 4 years in the replantation group versus 7 ± 4 years in the revision amputation group; p = 0.18), amputation of the dominant hand, smoking, extent of tissue loss, or presence of arterial hypertension did not differ between the groups. Patients in the replantation group less frequently had diabetes mellitus (5% [8 of 171] versus 12% [10 of 83]; p = 0.03) and dyslipidemia (4% [7 of 171] versus 11% [9 of 83]; p = 0.04) than those in the revision group and more often had cut-type injuries (75% [129 of 171] versus 60% [50 of 83]; p = 0.02). RESULTS: After controlling for potential confounding variables such as age, injury type, extent of tissue loss before treatment, and accident of the dominant hand, replantation was not associated with better DASH scores than revision amputation (OR 0.82 [95% confidence interval (CI) 0.50 to 1.33]; p = 0.42). After controlling for potential cofounding variables, replantation was not associated with better EQ-5D-5L Index scores (OR 0.93 [95% CI 0.56 to 1.55]; p = 0.55), differences in Cold Intolerance Symptom Severity scores (OR 0.85 [95% CI 0.51 to 1.44]; p = 0.79), or superior Michigan Hand Questionnaire esthetic domain scores (OR 0.73 [95% CI 0.43 to 1.26]; p = 0.26) compared with revision amputation. CONCLUSION: Replantation surgery was conducted, if feasible, in a homogenous cohort of patients who underwent amputation. If the amputated tissue was too severely damaged or replantation surgery was unsuccessful, the treatment resulted in revision (complete) amputation, which was not associated with worse patient-reported outcomes than successful replantation. These results contradict the assumed benefits of replantation surgery and indicate the need for credible evidence to better guide the care of these patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

Patient-reported significant disability after major traumatic upper extremity amputation.

The aims of this study were to record patient-reported outcomes of treatment of proximal upper extremity amputation injuries and subsequent return to work. A consecutive cohort of 38 patients with a traumatic amputation at or proximal to the carpus had been treated with a replantation or revision (completion) amputation in Tampere University Hospital between 2009 and 2019, and 31 of them participated in this study. The primary outcome was the Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH). Patients reported significant disability indicated by DASH score after replantation (median 30; interquartile range [IQR] 21-47) and revision (completion) amputation (median 33; IQR 16-52). Most patients had cold intolerance and reported low hand function and aesthetics scores. Out of 17 working patients, 10 did not return to their previous work. Our study demonstrates the influence of major upper extremity amputation on daily life activities, even after a successful replantation.Level of evidence: IV.

A Prospective Follow-up Study of Fingertip Amputation Treatment With Semi-occlusive Dressing.

Background: The aim of this prospective cohort was to evaluate the conservative treatment of fingertip amputation with exposed bone, with a semi-occlusive dressing. Methods: Ten patients with an amputation distal to the distal interphalangeal joint were treated via secondary healing under a semi-occlusive film dressing. We followed up the patients weekly until the fingertip had healed, then a final clinical visit at 6 months, and a patient-reported outcome assessment at 2 years after the injury. Results: All 10 patients completed the 6-month clinical follow-up, and seven patients completed the final patient-rated outcome assessments at 2 years. There were no complications during the study period, all the patients were satisfied with the results, and all answered "fully agree" on choosing the same treatment method again in a similar injury. Conclusion: Our results show that conservative treatment of fingertip amputation is feasible and can provide good results.

Satisfactory thumb metacarpophalangeal joint stability after ligament reconstruction with flexor digitorum superficialis in children with radial longitudinal deficiency.

We investigated thumb joint stability and patient-reported and functional outcomes a minimum of 1 year after flexor digitorum superficialis opponensplasty and ligament reconstruction in 23 thumbs of 20 consecutive children with radial longitudinal deficiency. In total, 15 thumbs had preoperative multidirectional instability in the metacarpophalangeal joint. We reconstructed 22 ulnar and 16 radial collateral ligaments. At follow-up, all the metacarpophalangeal joints were stable ulnarly. Seven metacarpophalangeal joints were unstable radially despite ligament reconstruction but had no related complaints. We recommend the flexor digitorum superficialis opponensplasty as a safe and reliable procedure in hypoplastic thumbs to create stability and augment thumb strength.Level of evidence: IV.

Incidence of Peripheral Nerve Decompression Surgery During Pregnancy and the First Year After Delivery in Finland From 1999 to 2017: A Retrospective Register-Based Cohort Study.

PURPOSE: We aimed to report the incidence of peripheral nerve decompression surgery during pregnancy and 12 months after delivery in Finland from 1999 to 2017. METHODS: Using nationwide data from the Finnish Care Register for Health Care and the Finnish Medical Birth Register, all women of potentially childbearing age (15-49 years) who underwent peripheral nerve decompression surgery or had a pregnancy ending in delivery from January 1, 1999, to December 31, 2017, were included. Incidence rates and incidence rate ratios for operations were calculated for both childbearing women and the age-adjusted general female population. RESULTS: In total, 308 women underwent carpal tunnel release (CTR) during pregnancy, and an additional 675 women underwent CTR within 12 months after delivery. The incidence of CTR during pregnancy was 38 per 100,000 person-years, with an incidence rate ratio of 0.5 (95% CI, 0.4-0.6), when compared with that in the general population. Women who were active smokers before becoming pregnant were more likely to undergo CTR during pregnancy (odds ratio, 2.4; 95% CI, 1.8-3.0). The highest rates of CTR were observed during the first trimester. The incidence of CTR in the first postpartum year increased steadily during the first 4 months to 79 per 100,000 person-years. During the latter 8 months, incidences were similar to those in the general population (incidence rate ratio, 1.0; 95% CI, 0.9-1.2). Women who smoked were more likely to undergo CTR during the first postpartum year (odds ratio, 1.6; 95% CI, 1.3-1.9). CONCLUSIONS: Carpal tunnel release is performed more rarely during pregnancy than in the age-matched general population. Postpartum incidences increased toward the end of the first year, reaching those observed in the general population after the first 4 months. Smoking before pregnancy is associated with increased incidences of CTR both during pregnancy and the first year after delivery. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic II.

Validity and Reliability of the Thumb Grasp and Pinch Assessment for Children After Reconstruction of Congenital Hypoplastic Thumbs.

PURPOSE: The Thumb Grasp and Pinch Assessment (T-GAP) is a new instrument for evaluating thumb use in children with congenital hypoplastic thumbs. The assessors video-record the children while they perform nine specific activities and score their grasp types using T-GAP. A high T-GAP score indicates more mature grasp patterns. The developers reported the instrument's validity and reliability for index finger pollicization. This study investigated T-GAP's validity and reliability in children with reconstructed hypoplastic thumbs. METHODS: Four hand surgeons and two hand therapists from two hospitals rated video clips of 20 Manske type II and IIIa hands twice in 17 patients who performed the T-GAP at least 1 year after opposition transfer and thumb ligament reconstruction. To investigate the validity, we calculated correlation coefficients for T-GAP scores and clinical outcomes, including thumb ROM, grip and pinch strength, and visual analog assessments of thumb function and appearance. To estimate T-GAP's inter- and intrarater reliability, we calculated intraclass correlation coefficients and their 95% confidence intervals (CIs). RESULTS: Thumb Grasp and Pinch Assessment score showed a strong linear correlation (r = 0.815-0.944) and a moderate to strong nonlinear correlation (ρ = 0.527-0.744) with visual analog scale assessments of thumb function and appearance, respectively; a moderate nonlinear correlation (ρ = 0.464) with grip strength; and a moderate nonlinear correlation (ρ = 0.541) with thumb MCP joint range of motion. The intraclass correlation coefficient for the interrater reliability was 0.892 (95% CI, 0.768-0.954) in round 1 and 0.898 (95% CI, 0.754-0.959) in round 2, and for intrarater reliability, the mean was 0.882 (95% CI, 0.785-0.980). CONCLUSIONS: Thumb Grasp and Pinch Assessment score had a moderate to strong construct validity and a moderate concurrent validity. Both inter- and intrarater reliability was strong. CLINICAL RELEVANCE: This study supports the T-GAP instrument's validity and reliability for assessing functional outcomes in congenital hypoplastic thumb reconstruction.

Indications, anaesthesia and postoperative protocol for replantation and revascularization in the hand in Nordic countries.

In this survey, we compared the current postoperative practices in the largest replantation units of four Nordic countries. The topics included were indication for surgery, anaesthesia, postoperative monitoring, use of antibiotics, anticoagulation and postoperative intravenous fluids, change of dressings, duration of bed rest and hospital stay, hand therapy and follow-up after discharge. Although there were many similarities between the units in the postoperative protocols, we found a large variety of practices. There is no robust evidence to assess or support or reject most of the strategies in postoperative care. The differences in practice warrant prospective studies in order to establish an evidence-based postoperative protocol for replantation surgery.

Randomised controlled trials in hand surgery: a scoping review.

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

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

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

Inter- and intra-rater reliability of the Oberg-Manske-Tonkin classification of congenital upper limb anomalies.

On two occasions, five surgeons classified a cohort of 150 consecutive patients with congenital upper limb anomalies according to the Oberg-Manske-Tonkin classification (2020 update). We estimated reliability for the main anomaly code by means of Cohen's kappa (Κ) for ten rater pairs for five common and easily distinguishable anomalies (Group 1), and for all the other anomalies (Group 2). Inter-rater reliability for all patients (n = 150) was substantial, almost perfect for Group 1 (n = 64), but only moderate for Group 2 (n = 86). Intra-rater reliability was higher for all groups. We suggest simplifications to the Oberg-Manske-Tonkin classification and highlight specific requirements for instructions to increase its reliability.Level of evidence: I.

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).

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

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

Responsiveness of different pain measures and recall periods in people undergoing surgery after a period of splinting for basal thumb joint osteoarthritis.

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.