Corrigendum to "Study protocol for the follow-up examination of the Nor-Hand study: A hospital-based observational cohort study exploring pain and biomarkers in people with hand osteoarthritis" [Osteoarthr. Cartil. Open 3 (2021) 100198].

[This corrects the article DOI: 10.1016/j.ocarto.2021.100198.].

Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR.

Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments.

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Associations of pain sensitisation with tender and painful joint counts in people with hand osteoarthritis: results from the Nor-Hand study.

OBJECTIVE: To examine associations of pain sensitisation with tender and painful joint counts and presence of widespread pain in people with hand osteoarthritis (OA). METHODS: Pressure pain thresholds (PPT) at a painful finger joint and the tibialis anterior muscle, and temporal summation (TS) were measured in 291 persons with hand OA. We examined whether sex-standardised PPT and TS values were associated with assessor-reported tender hand joint count, self-reported painful hand and total body joint counts and presence of widespread pain using linear and logistic regression analyses adjusted for age, sex, body mass index, education and OA severity. RESULTS: People with lower PPTs at the painful finger joint (measure of peripheral and/or central sensitisation) had more tender and painful hand joints than people with higher PPTs. PPT at tibialis anterior (measure of central sensitisation) was associated with painful total body joint count (beta=-0.82, 95% CI -1.28 to -0.35) and presence of widespread pain (OR=0.57, 95% CI 0.43 to 0.77). The associations between TS (measure of central sensitisation) and joint counts in the hands and the total body were statistically non-significant. CONCLUSION: This cross-sectional study suggested that pain sensitisation (ie, lower PPTs) was associated with joint counts and widespread pain in hand OA. This knowledge may be used for improved pain phenotyping of people with hand OA, which may contribute to better pain management through more personalised medicine. Further studies are needed to assess whether a reduction of pain sensitisation leads to a decrease in tender and painful joint counts.

Transcatheter Mitral Valve Therapy in the United States: A Report from the STS/ACC TVT Registry.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

Associations between fluorescence optical imaging and magnetic resonance imaging and symptoms in hand osteoarthritis.

OBJECTIVES: To investigate whether Fluorescence Optical Imaging (FOI) enhancement and MRI-defined synovitis are associated with pain and physical function in hand OA patients. METHODS: Bilateral FOI scans and MRI of the dominant hand were available for 221 patients. Finger joints were examined for tenderness on palpation. Pain in individual finger joints during the last 24 h and last 6 weeks and hand pain intensity by the Australian/Canadian hand index and Numeric Rating Scale were self-reported. On joint level, we applied logistic regression with generalized estimating equations to examine whether FOI enhancement and MRI-defined synovitis were associated with pain in the same joint. On subject level, we applied linear regression to assess whether FOI and MRI sum scores were associated with pain intensity and physical function. RESULTS: Metacarpophalangeal and thumb base joints were excluded from analyses due to little/no FOI enhancement. Finger joints with FOI enhancement on the composite image had higher odds (95% CI) of pain during the last 6 weeks [grade 1: 1.4 (1.2-1.6); grade 2-3: 2.1 (1.7-2.6)]. Similar results were found for joint pain during the last 24 h and joint tenderness in fingers. Numerically stronger associations were found between MRI-defined synovitis and finger joint pain/tenderness. FOI and MRI sum scores demonstrated no/weak associations with hand pain and physical function. CONCLUSION: FOI enhancement and MRI-defined synovitis were associated with pain in the same finger joint. None of the imaging modalities demonstrated consistent associations with pain, stiffness and physical function on subject level.

Transcatheter Mitral Valve Therapy in the United States: A Report From the STS-ACC TVT Registry.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial.

BACKGROUND: Current health policy states that patients with osteoarthritis (OA) should mainly be managed in primary health care. Still, research shows that patients with hand OA have poor access to recommended treatment in primary care, and in Norway, they are increasingly referred to rheumatologist consultations in specialist care. In this randomized controlled non-inferiority trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy (OT) specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist. More specifically, we will answer the following questions: 1. What are the characteristics of patients with hand OA referred to specialist health care with regards to joint affection, disease activity, symptoms and function? 2. Is OT-led hand OA care as effective and safe as rheumatologist-led care with respect to treatment response, disease activity, symptoms, function and patient satisfaction? 3. Is OT-led hand OA care equal to, or more cost effective than rheumatologist-led care? 4. Which factors, regardless of hand OA care, predict improvement 6 and 12 months after baseline? METHODS: Participants will be patients with hand OA diagnosed by a general practitioner and referred for consultation at one of two Norwegian departments of rheumatology. Those who agree will attend a clinical assessment and report their symptoms and function in validated outcome measures, before they are randomly selected to receive their first consultation by an OT specialist (n = 200) or by a rheumatologist (n = 200). OTs may refer patients to a rheumatologist consultation and vice versa. The primary outcome will be the number of patients classified as OMERACT/OARSI-responders after six months. Secondary outcomes are pain, function and satisfaction with care over the twelve-month trial period. The analysis of the primary outcome will be done by logistic regression. A two-sided 95% confidence interval for the difference in response probability will be formed, and non-inferiority of OT-led care will be claimed if the upper endpoint of this interval does not exceed 15%. DISCUSSION: The findings will improve access to evidence-based management of people with hand OA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03102788. Registered April 6th, 2017, https://clinicaltrials.gov/ct2/show/NCT03102788?term=Kjeken&draw=2&rank=1 Date and version identifier: December 17th, 2020. First version.

Study protocol for the follow-up examination of the Nor-Hand study: A hospital-based observational cohort study exploring pain and biomarkers in people with hand osteoarthritis.

Objective: This study aims to increase the understanding of pain mechanisms in hand OA and explore potential risk factors for pain development or worsening in a biopsychosocial framework. Another important aim is to validate potential soluble and imaging OA biomarkers. Design: The follow-up examination of the Nor-Hand hospital-based observational cohort study started in October 2019 and was completed in May 2021. In total, 212 of the 300 participants with hand OA who were examined at baseline attended the follow-up study. The participants underwent clinical joint examinations, medical and functional assessments, quantitative sensory testing, fluorescence optical imaging, ultrasound of the hands, acromioclavicular joints, feet, knees and hips, conventional radiographs of the hands and feet and magnetic resonance imaging of the dominant hand. Blood and urine samples were collected, and all participants answered questions about demographic factors and OA-related questionnaires. Associations between disease variables and symptoms will be examined in cross-sectional and longitudinal analyses. Longitudinal analyses will be performed to assess the predictive value of baseline variables on hand OA outcomes. Conclusion: Current knowledge about predictors for disease progression in hand OA is limited, but with longitudinal data we will be able to explore the predictive value of baseline variables on hand OA outcomes, such as changes in patient-reported outcomes or changes in soluble and imaging biomarkers. This provides a unique opportunity to gain more knowledge about the natural disease course of hand OA.

Improving Adherence to Adjuvant Hormonal Therapy Among Disadvantaged Women Diagnosed with Breast Cancer in South Carolina: Proposal for a Multimethod Study.

BACKGROUND: Current clinical guidelines recommend that hormone receptor-positive breast cancer survivors take adjuvant hormonal therapy (AHT) for 5 to 10 years, following the end of definitive treatment. However, fewer than half of patients adhere to the guidelines, and suboptimal adherence to AHT is associated with an increased risk of breast cancer mortality. Research has extensively documented sociodemographic and disease-specific factors associated with adherence to AHT, but very little evidence exists on behavioral factors (eg, knowledge, patient-provider communication) that can be modified and targeted by interventions. OBJECTIVE: The goal of this study is to develop and test a theory-based, multilevel intervention to improve adherence to AHT among breast cancer survivors from racially and socioeconomically disadvantaged backgrounds (eg, Medicaid-insured). The specific aims are to (1) explore multilevel (eg, patient, health care system) factors that influence adherence to AHT; (2) develop a theory-based, multilevel intervention to improve adherence to AHT; and (3) pilot test and evaluate the intervention developed in Aim 2. METHODS: For Aim 1, we will recruit breast cancer survivors and health care professionals to participate in semistructured interviews to gain their perspectives about barriers and facilitators to AHT use. We will conduct a directed content analysis of the Aim 1 qualitative interview data. For Aim 2, we will integrate Aim 1 findings and current literature into the design of a multilevel intervention using an Intervention Mapping approach. For Aim 3, we will recruit Medicaid-insured breast cancer survivors to assess the feasibility of the pilot intervention. RESULTS: From May 2016 to July 2018, we completed interviews with 19 breast cancer survivors and 23 health care professionals in South Carolina. We will conduct a directed content analysis of the qualitative interview data. Results from this analysis will be used, in combination with current literature, to design (Aim 2) and pilot test a theory-based multilevel intervention (Aim 3) in Summer 2021. Results of the pilot are expected for Fall 2021. CONCLUSIONS: This study will provide a deeper understanding of how to improve adherence to AHT, using a novel and multilevel approach, among socioeconomically disadvantaged breast cancer survivors who often experience disproportionate breast cancer mortality. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17742.

Associations Between Ultrasound-Detected Synovitis, Pain, and Function in Interphalangeal and Thumb Base Osteoarthritis: Data From the Nor-Hand Cohort.

OBJECTIVE: To explore whether ultrasound-detected gray-scale synovitis and power Doppler activity in the interphalangeal and first carpometacarpal (CMC1) joints are associated with pain and physical function in patients with hand osteoarthritis (OA). METHODS: A total of 290 patients with hand OA underwent an ultrasound examination of the bilateral interphalangeal and CMC1 joints. Using logistic regression analyses with generalized estimating equations, we examined whether grade 0-3 gray-scale synovitis and power Doppler activity were associated with pain in the same joint. Using linear regression analyses, we examined whether the degree of inflammation was associated with numeric rating scale and Australian/Canadian (AUSCAN) Osteoarthritis Hand Index hand pain, AUSCAN physical function, and grip strength scores. Analyses were made separately for interphalangeal and CMC1 joints, and adjusted for age, sex, body mass index, psychosocial factors, use of analgesics, and presence of osteophytes. RESULTS: At joint level, increasing gray-scale synovitis severity was associated with higher odds of pain upon palpation in both the interphalangeal (grade 2-3; odds ratio [OR] 3.17 [95% confidence interval (95% CI) 2.35, 4.28]) and CMC1 joints (grade 2-3; OR 4.40 [95% CI 2.10, 9.24]). Similar associations were found for power Doppler activity and joint pain in the previous 24 hours and 6 weeks. Power Doppler activity in CMC1 was also related to overall hand pain/physical function and lower grip strength. CONCLUSION: Inflammation in both the interphalangeal and CMC1 joints was associated with pain in the same joint. However, associations with hand pain, reduced physical function, and lower grip strength were only present for inflammation in the CMC1 joints, suggesting that lowering CMC1 inflammation is an important treatment target.

The Maternal and Paternal Effects on Clinically and Surgically Defined Osteoarthritis.

OBJECTIVE: It is currently unknown whether osteoarthritis (OA) is inherited mainly from the mother, father, or both. This study was undertaken to explore the effect of maternal and paternal factors on hip, knee, and hand OA in offspring. METHODS: Participants from the Musculoskeletal Pain in Ullensaker Study (MUST) (69% female; mean ± SD age 64 ± 9 years) and a Norwegian OA twin study (Nor-Twin) (56% female; 49 ± 11 years) reported whether their mother and/or father had OA. Using a recurrence risk estimation approach, we calculated whether maternal and paternal OA increased the risk of 1) surgically defined hip and knee OA (i.e., total joint replacement) and 2) clinically defined hip, knee, and hand OA (i.e., the American College of Rheumatology criteria) using logistic regression. Relative risks (RRs) with 95% confidence intervals (95% CIs) were calculated. RESULTS: Maternal OA consistently increased the risk of offspring OA across different OA locations and severities. Having a mother with OA increased the risk of any OA in daughters (RR 1.13 [95% CI 1.02-1.25] in the MUST cohort; RR 1.44 [95% CI 1.05-1.97] in the Nor-Twin cohort) but not (or with less certainty) in sons (RR 1.16 [95% CI 0.95-1.43] in the MUST cohort; RR 1.31 [95% CI 0.71-2.41] in the Nor-Twin cohort). Having a father with OA was less likely to increase the risk of any OA in daughters (RR 1.00 [95% CI 0.85-1.16] in the MUST cohort; RR 1.52 [95% CI 0.94-2.46] in the Nor-Twin cohort) and sons (RR 1.08 [95% CI 0.83-1.41] in the MUST cohort; RR 0.93 [95% CI 0.35-2.48] in the Nor-Twin cohort). CONCLUSION: OA in the mother increased the risk of surgically and clinically defined hip, knee, and hand OA in offspring, particularly in daughters. Our findings imply that heredity of OA may be linked to maternal genes and/or maternal-specific factors such as the fetal environment.

Exercise for Hand Osteoarthritis: A Cochrane Systematic Review.

OBJECTIVE: To assess the benefits and harms of exercise compared with other interventions, including placebo or no intervention, in people with hand osteoarthritis (OA). METHODS: Systematic review using Cochrane Collaboration methodology. Six electronic databases were searched up until September 2015. INCLUSION CRITERIA: randomized or controlled clinical trials comparing therapeutic exercise versus no exercise, or comparing different exercise programs. MAIN OUTCOMES: hand pain, hand function, finger joint stiffness, quality of life, adverse events, and withdrawals because of adverse effects. Risk of bias and quality of the evidence were assessed. RESULTS: Seven trials were included in the review, and up to 5 trials (n = 381) were included in the pooled analyses with data from postintervention. Compared to no exercise, low-quality evidence indicated that exercise may improve hand pain [5 trials, standardized mean difference (SMD) -0.27, 95% CI -0.47 to -0.07], hand function (4 trials, SMD -0.28, 95% CI -0.58 to 0.02), and finger joint stiffness (4 trials, SMD -0.36, 95% CI -0.58 to -0.15) in people with hand OA. Quality of life was evaluated by 1 study (113 participants) showing very low-quality evidence for no difference. Three studies reported on adverse events, which were very few and not severe. CONCLUSION: Pooled results from 5 studies with low risk of bias showed low-quality evidence for small to moderate beneficial effects of exercise on hand pain, function, and finger joint stiffness postintervention. Estimated effect sizes were small, and whether they represent a clinically important change may be debated.

A hospital-based observational cohort study exploring pain and biomarkers in patients with hand osteoarthritis in Norway: The Nor-Hand protocol.

INTRODUCTION: We have limited knowledge about the underlying disease mechanisms and causes of pain in hand osteoarthritis (OA). Consequently, no disease-modifying drug exists, and more knowledge about the pathogenesis of hand OA is needed, as well as a validation of different outcome measures. Our first aim of this study is to explore the validity of various imaging modalities for the assessment of hand OA. Second, we want to gain a better understanding of the disease processes, with a special focus on pain mechanisms. METHODS AND ANALYSIS: The Nor-Hand study is a hospital-based observational study including 300 patients with evidence of hand OA by ultrasound and/or clinical examination. The baseline examination consists of functional tests and joint assessment of the hands, medical assessment, pain sensitisation tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet), CT and MRI of the dominant hand, conventional radiographs of the hands and feet, fluorescence optical imaging of the hands, collection of blood and urine samples as well as self-reported demographic factors and OA-related questionnaires. Two follow-up examinations are planned. Cross-sectional analyses will be used to investigate agreements and associations between different relevant measures at the baseline examination, whereas the longitudinal data will be used for evaluation of predictors for clinical outcomes. ETHICS AND DISSEMINATION: The protocol is approved by the Norwegian Regional Committee for Medical and Health Research Ethics (Ref. no: 2014/2057). The participants receive oral and written information about the project and sign a consent form before participation. They can, whenever they want, withdraw from the study, and all de-identified data will be safely stored on the research server at Diakonhjemmet Hospital. Results will be presented at international and national congresses and in peer-reviewed rheumatology journals. TRIAL REGISTRATION NUMBER: NCT03083548; Pre-results.

Ultrasound-detected osteophytes predict the development of radiographic and clinical features of hand osteoarthritis in the same finger joints 5 years later.

BACKGROUND: Structural pathology may be present in joints without radiographic evidence of osteoarthritis (OA). Ultrasound is a sensitive tool for early detection of osteophytes. Our aim was to explore whether ultrasound-detected osteophytes (in radiographically and clinically normal finger joints) predicted the development of radiographic and clinical hand OA 5 years later. METHODS: We included finger joints without radiographic OA (Kellgren-Lawrence grade (KLG)=0; n=301) or no clinical bony enlargements (n=717) at baseline and examined whether ultrasound-detected osteophytes predicted incident radiographic OA (KLG ≥1, osteophytes or joint space narrowing (JSN)) or incident clinical bony enlargement (dependent variables) in the same joints 5 years later. We applied logistic regression with generalised estimating equations adjusted for age, sex, body mass index and follow-up time. RESULTS: Ultrasound demonstrated osteophytes in 86/301 (28.6%) joints without radiographic OA and 392/717 (54.7%) joints without clinical bony enlargement. These osteophytes were confirmed in the majority of joints where MRI assessment was available. Significant associations were found between ultrasound-detected osteophytes and development of both radiographic OA (OR=4.1, 95% CI 2.0 to 8.1) and clinical bony enlargement (OR=3.5, 95% CI 2.4 to 5.1) and also incident radiographic osteophytes (OR=4.2, 95% CI 2.1 to 8.5) and JSN (OR=5.3, 95% CI 2.1 to 13.4). CONCLUSION: Ultrasound-detected osteophytes predicted incident radiographic and clinical hand OA 5 years later. These results support the use of ultrasound for early detection of OA.

Exercise for hand osteoarthritis.

BACKGROUND: Hand osteoarthritis (OA) is a prevalent joint disease that may lead to pain, stiffness and problems in performing hand-related activities of daily living. Currently, no cure for OA is known, and non-pharmacological modalities are recommended as first-line care. A positive effect of exercise in hip and knee OA has been documented, but the effect of exercise on hand OA remains uncertain. OBJECTIVES: To assess the benefits and harms of exercise compared with other interventions, including placebo or no intervention, in people with hand OA. Main outcomes are hand pain and hand function. SEARCH METHODS: We searched six electronic databases up until September 2015. SELECTION CRITERIA: All randomised and controlled clinical trials comparing therapeutic exercise versus no exercise or comparing different exercise programmes. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data, assessed risk of bias and assessed the quality of the body of evidence using the GRADE approach. Outcomes consisted of both continuous (hand pain, physical function, finger joint stiffness and quality of life) and dichotomous outcomes (proportions of adverse events and withdrawals). MAIN RESULTS: We included seven studies in the review. Most studies were free from selection and reporting bias, but one study was available only as a congress abstract. It was not possible to blind participants to treatment allocation, and although most studies reported blinded outcome assessors, some outcomes (pain, function, stiffness and quality of life) were self-reported. The results may be vulnerable to performance and detection bias owing to unblinded participants and self-reported outcomes. Two studies with high drop-out rates may be vulnerable to attrition bias. We downgraded the overall quality of the body of evidence to low owing to potential detection bias (lack of blinding of participants on self-reported outcomes) and imprecision (studies were few, the number of participants was limited and confidence intervals were wide for the outcomes pain, function and joint stiffness). For quality of life, adverse events and withdrawals due to adverse events, we further downgraded the overall quality of the body of evidence to very low because studies were very few and confidence intervals were very wide.Low-quality evidence from five trials (381 participants) indicated that exercise reduced hand pain (standardised mean difference (SMD) -0.27, 95% confidence interval (CI) -0.47 to -0.07) post intervention. The absolute reduction in pain for the exercise group, compared with the control group, was 5% (1% to 9%) on a 0 to 10 point scale. Pain was estimated to be 3.9 points on this scale (0 = no pain) in the control group, and exercise reduced pain by 0.5 points (95% CI 0.1 to 0.9; number needed to treat for an additional beneficial outcome (NNTB) 9).Four studies (369 participants) indicated that exercise improved hand function (SMD -0.28, 95% CI -0.58 to 0.02) post intervention. The absolute improvement in function noted in the exercise group, compared with the control group, was 6% (0.4% worsening to 13% improvement). Function was estimated at 14.5 points on a 0 to 36 point scale (0 = no physical disability) in the control group, and exercise improved function by 2.2 points (95% CI -0.2 to 4.6; NNTB 9).One study (113 participants) evaluated quality of life, and the effect of exercise on quality of life is currently uncertain (mean difference (MD) 0.30, 95% CI -3.72 to 4.32). The absolute improvement in quality of life for the exercise group, compared with the control group, was 0.3% (4% worsening to 4% improvement). Quality of life was 50.4 points on a 0 to 100 point scale (100 = maximum quality of life) in the control group, and the mean score in the exercise group was 0.3 points higher (3.5 points lower to 4.1 points higher).Four studies (369 participants) indicated that exercise reduced finger joint stiffness (SMD -0.36, 95% CI -0.58 to -0.15) post intervention. The absolute reduction in finger joint stiffness for the exercise group, compared with the control group, was 7% (3% to 10%). Finger joint stiffness was estimated at 4.5 points on a 0 to 10 point scale (0 = no stiffness) in the control group, and exercise improved stiffness by 0.7 points (95% CI 0.3 to 1.0; NNTB 7).Three studies reported intervention-related adverse events and withdrawals due to adverse events. The few reported adverse events consisted of increased finger joint inflammation and hand pain. Low-quality evidence from the three studies showed an increased likelihood of adverse events (risk ratio (RR) 4.55, 95% CI 0.53 to 39.31) and of withdrawals due to adverse events in the exercise group compared with the control group (RR 2.88, 95% CI 0.30 to 27.18), but the effect is uncertain and further research may change the estimates.Included studies did not measure radiographic joint structure changes. Two studies provided six-month follow-up data (220 participants), and one (102 participants) provided 12-month follow-up data. The positive effect of exercise on pain, function and joint stiffness was not sustained at medium- and long-term follow-up.The exercise intervention varied largely in terms of dosage, content and number of supervised sessions. Participants were instructed to exercise two to three times a week in four studies, daily in two studies and three to four times daily in another study. Exercise interventions in all seven studies aimed to improve muscle strength and joint stability or function, but the numbers and types of exercises varied largely across studies. Four studies reported adherence to the exercise programme; in three studies, this was self-reported. Self-reported adherence to the recommended frequency of exercise sessions ranged between 78% and 94%. In the fourth study, 67% fulfilled at least 16 of the 18 scheduled exercise sessions. AUTHORS' CONCLUSIONS: When we pooled results from five studies, we found low-quality evidence showing small beneficial effects of exercise on hand pain, function and finger joint stiffness. Estimated effect sizes were small, and whether they represent a clinically important change may be debated. One study reported quality of life, and the effect is uncertain. Three studies reported on adverse events, which were very few and were not severe.

2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%. CONCLUSIONS: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.

The comparison of magnetic resonance imaging and radiographs to assess structural progression over 5 years in hand osteoarthritis.

Objective: . The aim was to explore the agreement between 1.0 T MRI and conventional radiography (CR) to detect progression of hand OA over 5 years and the associations between structural progression and incident joint tenderness. Methods: Paired radiographs and paired MRIs of the second-fifth IP joints of the dominant hand from 69 hand OA patients were read for osteophytes, joint space narrowing and erosions. Patients with two or more joints demonstrating progression of any structural feature(s) were classified as progressors per imaging modality. Agreement between methods to detect progressors was evaluated with κ and intraclass correlation coefficients. At the joint level, the associations between methods to detect progression were explored with generalized estimating equations. Likewise, we analysed the associations between progression per imaging modality and incident pain. Results: MRI (58.0%) and CR (62.3%) detected similar numbers of progressors. The agreement between methods to detect progressors was good (κ = 0.61). We found good agreement between methods regarding the number of progressive joints (intraclass correlation coefficient = 0.61, 95% CI: 0.43, 0.76). At the joint level, MRI progression was associated with radiographic progression (P < 0.001). Incident joint tenderness was more common in joints with progression by MRI and CR, but statistically significance was not reached. Conclusion: Both 1.0 T MRI and CR detect a similar amount of progression over 5 years in patients with hand OA, although not in exactly the same joints. As CR assesses more joints for a lower cost, CR should be the imaging modality of choice rather than 1.0 T MRI in observational studies with a long period of follow-up.