BACKGROUND: Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology.

METHODS/DESIGN: This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology.

DISCUSSION: Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.

Background: Biomechanical studies show varying results regarding the elongation of adjustable fixation devices. This has led to growing concern over the stability of the ToggleLoc with ZipLoop used in anterior cruciate ligament (ACL) reconstruction (ACLR) in vivo.

Purpose/Hypothesis: The purpose of this study was to compare passive knee stability 1 year after ACLR in patients in whom the Endobutton or ToggleLoc with ZipLoop was used for femoral graft fixation. The hypothesis was that the ToggleLoc with ZipLoop would be inferior in knee stability to the Endobutton 1 year after primary ACLR.

Study Design: Cohort study; Level of evidence, 2.

Methods: Data from 3175 patients (Endobutton: n = 2807; ToggleLoc with ZipLoop: n = 368) were included from the Danish Knee Ligament Reconstruction Registry (DKRR) between June 2010 and September 2013. Data were retrieved from standardized ACL forms filled out by the operating surgeon preoperatively, during surgery, and at a clinical examination 1 year after surgery. Passive knee stability was evaluated using 1 of 2 arthrometers (Rolimeter or KT-1000 arthrometer) and the pivot-shift test. Using the same database, the number of reoperations performed up to 4 years after primary surgery was examined.

Results: Full data were available for 1654 patients (Endobutton: n = 1538; ToggleLoc with ZipLoop: n = 116). ACLR with both devices resulted in increased passive knee stability (P < .001). Patients who received the ToggleLoc with ZipLoop were found to have a better preoperative (P = .005 ) and postoperative (P < .001) pivot-shift test result. No statistically significant difference regarding the number of reoperations (P = .086) or the time to reoperation (P = .295) was found.

Conclusion: Patients who underwent fixation with the ToggleLoc with ZipLoop had improved passive knee stability 1 year after surgery, measured by anterior tibial translation and pivot-shift test results, similar to patients who underwent fixation with the Endobutton. No difference was seen in knee stability or reoperation rates between the 2 devices.

BACKGROUND: Risky consumption of alcohol is a global problem. More than 3.3 million deaths annually are associated with risky use of alcohol, and global alcohol consumption continues to increase. People who have high alcohol consumption often require planned and emergency surgical procedures.Risky drinking is associated with increased postoperative complications such as infections, cardiopulmonary complications, and bleeding episodes. Alcohol causes disorders of the liver, pancreas, and nervous system. Stopping consumption of alcohol can normalize these organ systems to some degree and may reduce the occurrence of complications after surgery.This review was first published in 2012 and was updated in 2018.

OBJECTIVES: To assess the effects of perioperative alcohol cessation interventions on rates of postoperative complications and alcohol consumption.

SEARCH METHODS: We searched the following databases up until 21 September 2018: Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; CINAHL via EBSCOhost; and two trials registers. We scanned the reference lists and citations of included trials and any identified relevant systematic reviews for further references to additional trials. When necessary, we contacted trial authors to ask for additional information.

SELECTION CRITERIA: We included all randomized controlled trials (RCTs) that evaluated the effects of perioperative alcohol cessation interventions on postoperative complications and alcohol consumption. We included participants with risky consumption of alcohol who were undergoing all types of elective or acute surgical procedures under general or regional anaesthesia or sedation, who were offered a perioperative alcohol cessation intervention or no intervention.We defined 'risky drinking' as alcohol consumption equivalent to more than 3 alcoholic units (AU)/d or 21 AU/week (with 1 AU containing 12 grams of ethanol) with or without symptoms of alcohol abuse or dependency. This corresponds to the amount of alcohol associated with increased postoperative complication rates in most clinical studies.

DATA COLLECTION AND ANALYSIS: We used guidance provided in the Cochrane Handbook for Systematic Reviews of Interventions. We presented main outcomes as dichotomous variables in a meta-analysis. When data were available, we conducted subgroup and sensitivity analyses to explore the risk of bias. Primary outcome measures were postoperative complications and in-hospital and 30-day mortality. Secondary outcomes were successful quitting at the end of the programme, postoperative alcohol use, and length of hospital stay. We assessed the quality of evidence using the GRADE approach.

MAIN RESULTS: We included in this updated review one new study (70 participants), resulting in a total of three RCTs (140 participants who drank 3 to 40 AU/d). All three studies were of moderate to good quality. All studies evaluated the effects of intensive alcohol cessation interventions, including pharmacological strategies for alcohol withdrawal symptoms, patient education, and relapse prophylaxis. We identified one ongoing study.Overall, 53 of the 122 participants from three studies who underwent surgery developed any type of postoperative complication that required treatment. Of 61 participants in the intervention groups, 20 had complications, compared with 33 of 61 participants in the control groups (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.40 to 0.96). Results show differences between the three clinical studies regarding outcome measurement and intensity of the interventions. However, all alcohol cessation programmes were intensive and included pharmacological therapy. The overall quality of evidence for this outcome is moderate.In-hospital and 30-day postoperative mortality rates were low in the three studies. Researchers reported one death among 61 participants in the intervention groups, and three deaths among 61 participants in the control groups (RR 0.47, 95% CI 0.07 to 2.96). The quality of evidence for this outcome is low.Investigators describe more successful quitters at the end of the intervention programme than among controls. Forty-one out of 70 participants in the intervention groups successfully quit drinking compared with only five out of 70 participants in the control groups (RR 8.22, 95% CI 1.67 to 40.44). The quality of evidence for this outcome is moderate.All three studies reported postoperative alcohol consumption (grams of alcohol/week) at the end of the programme as median and range values; therefore it was not possible to estimate the mean and the standard deviation (SD). We performed no meta-analysis. All three studies reported length of stay, and none of these studies described a significant difference in length of stay. Data were insufficient for review authors to perform a meta-analysis. No studies reported on the prevalence of participants without risky drinking in the longer term.

AUTHORS' CONCLUSIONS: This systematic review assessed the efficacy of perioperative alcohol cessation interventions for postoperative complications and alcohol consumption. All three studies showed a significant reduction in the number of participants who quit drinking alcohol during the intervention period. Intensive alcohol cessation interventions offered for four to eight weeks to participants undergoing all types of surgical procedures to achieve complete alcohol cessation before surgery probably reduced the number of postoperative complications. Data were insufficient for review authors to assess their effects on postoperative mortality. No studies reported an effect on length of stay, and no studies addressed the prevalence of risky drinking in the longer term.Included studies were few and reported small sample sizes; therefore one should be careful about drawing firm conclusions based on these study results. All three studies were conducted in Denmark, and most participants were men. The included participants may represent a selective group, as they could have been more motivated and/or more interested in participating in clinical research or otherwise different, and effects may have been overestimated for both intervention and control groups in these studies. Trial results indicate that these studies are difficult to perform, that strong research competencies are necessary for future studies, and that further evaluation of perioperative alcohol cessation interventions in high-quality randomized controlled trials is needed. Once published and assessed, the one 'ongoing' study identified may alter the conclusions of this review.

BACKGROUND: To evaluate the trends in treatment of patellar dislocation in the Danish population as a whole from 1996 to 2014 and evaluate the incidence of persistent morbidity after Medial Patellofemoral Ligament Reconstruction (MPFL-R).

METHODS: This epidemiological study was performed by retrospectively searching the Danish National Patients Registry from 1996 to 2014. The study investigated the trends in surgery performed on patients with patellar dislocations and the risk of persistent patellar morbidity (PPM) with an eight-year follow-up. PPM was defined as a new patella-related contact to the healthcare system more than a year after surgery.

RESULTS: From 1996 to 2014, a total of 1956 MPFL-R were performed in Denmark. In 2014, MPFL-R constituted 75% of all patella-stabilizing surgery and was performed on almost 10% of patients with patellar dislocation. The mean risk of PPM eight years after surgery was 20.9% (18.3-23.4%), and young patients aged 10-17 showed the highest risk of 28.9% (23.7-33.7%). The risk of PPM over time was significantly higher for other patella-stabilizing surgery (33.8%) and patients receiving conservative treatment (29.4%) compared to MPFL-R.

CONCLUSIONS: A rapid rise in the use of MPFL-R was found from 2005 to 2014, constituting 75% of all patella-stabilizing surgery in 2014. The overall risk of persistent patellar morbidity within eight years after MPFL-R was 21%. MPFL-R was found to give a significantly lower risk of PPM over time as compared to other patella-stabilizing surgery and conservative treatment.

Background It has been demonstrated that weight loss improves symptoms in obese subjects with knee osteoarthritis (KOA). A parallel change in cartilage morphology remains to be demonstrated. Purpose To demonstrate a parallel change in cartilage morphology. Material and Methods Obese patients with KOA were examined before and after weight loss over 16 weeks. Target knee joints were radiographically assessed by the Kellgren/Lawrence grading (KLG) system. Patients with KLG-1 and 2 changes in the lateral compartment were included. Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) was performed using intra-articular contrast. Results Nine patients with lateral KLG-1 and ten patients with lateral KLG-2 were studied. There were no group differences regarding the lateral compartment baseline dGEMRIC T1 values: median = 497 ms (KLG-1) and 533 ms (KLG-2) ( P = 0.12), or regarding reduction in body mass index (BMI) after 16 weeks: 12.8% versus 11.4% ( P = 0.74). In the KLG-1 group, several cases of increased dGEMRIC T1 values were seen and median value decreased significantly less than in KLG-2 group (15 ms versus 41 ms, P = 0.03) after weight loss. Conclusion Improvement of cartilage quality, assessed with dGEMRIC, after weight loss might be possible in early stage KOA (KLG-1), but not in later stage KOA (KLG-2). The results may suggest a point of no return for improvement of cartilage quality that should be tested in larger trials.

OBJECTIVES: The objective of this study was to estimate the prevalence of undiagnosed diabetes mellitus in patients with newly diagnosed frozen shoulder (FS) and study whether diabetes mellitus increases the severity of FS disease.

METHODS: Patients with newly diagnosed FS were consecutively included in this case-control study. Patients who were not already diagnosed as having diabetes mellitus were invited to be tested with the hemoglobin A1c blood sample test. The study population was compared with a control group, consisting of five individuals from the general population matched on age and sex. The passive range of motion, Oxford Shoulder Score, and visual analog scale (VAS) for average and maximum daily pain was recorded for all of the patients in the study group.

RESULTS: A total of 235 patients were included, 34 (14%) of whom were diagnosed as having diabetes mellitus before the examination. Of the remaining 201 patients, 122 (61%) agreed to be tested for diabetes mellitus. None of the tested patients had undiagnosed diabetes mellitus. This was not significantly different from the prevalence in the matched control population (P = 0.09). There was no difference between patients with and without diabetes mellitus in average daily VAS (P = 0.46) nor maximum daily VAS (P = 0.44). The Oxford Shoulder Score was similar in the two groups (P = 0.23) as was the range of motion.

CONCLUSIONS: The prevalence of undiagnosed diabetes mellitus is low in patients with FS and does not differ from the general population. Diabetes mellitus does not seem to affect patients' perceived severity of an FS.

Background: Rotator cuff tear is a common cause of shoulder disability and results in patients predominantly complaining of pain and loss of motion and strength. Traumatic rotator cuff tears are typically managed surgically followed by ~ 20 weeks of rehabilitation. However, the timing and intensity of the postoperative rehabilitation strategy required to reach an optimal clinical outcome is unknown. Early controlled and gradually increased tendon loading has been suggested to positively influence tendon healing and recovery. The aim of this trial is therefore to examine the effect of a progressive rehabilitation strategy on pain, physical function and quality of life compared to usual care (that limits tendon loading in the early postoperative phase) in patients who have a rotator cuff repair of a traumatic tear. Methods: The current study is a randomized, controlled, outcome-assessor blinded, multicenter, superiority trial with a two-group paralleled design. A total of 100 patients with surgically repaired traumatic rotator cuff tears will be recruited from up to three orthopedic departments in Denmark, and randomized to either a progressive early passive and active movement program or a limited early passive movement program (usual care). The primary outcome measure will be the change from pre-surgery to 12 weeks post-surgery in the Western Ontario Rotator Cuff Index questionnaire. Secondary outcomes include the Disabilities Arm, Shoulder and Hand questionnaire (DASH), range of motion, strength and tendon healing characteristics from ultrasound measurements at 12 months follow up. Discussion: We hypothesized that patients who receive the progressive rehabilitation strategy will benefit more with respect to pain reduction, physical function and quality of life than those who receive care as usual. If this is confirmed our study can be used clinically to enhance the recovery of patients with traumatic rotator cuff tear.

OBJECTIVE: To assess the effect of quadriceps strengthening on quadriceps muscle force, power, and work and tibio-femoral compressive loads during walking in adults with knee osteoarthritis.

METHODS: Study design: Two-center, randomized, controlled trial.

INTERVENTION: Patients with knee osteoarthritis were randomly allocated to quadriceps strengthening program (3 times weekly) or no attention control group.

MAIN OUTCOME MEASURES: Primary outcome was change from baseline in peak quadriceps force during walking at 12 weeks. Secondary outcomes included quadriceps power and work, knee compression forces during walking estimated with musculoskeletal modeling, muscle strength and pain and function. Outcomes were measured at baseline and 12 weeks.

RESULTS: 30 patients were randomized to receive either training (n = 15) or no attention (n = 15). At follow-up, there were no statistical differences between groups for maximum quadriceps force, quadriceps positive power, negative work, and positive work, and knee compressive force. Maximum negative quadriceps power in early stance was statistically significantly increased 36% in the training group compared to the control group which was most likely partially a response to faster walking velocity at follow-up. Muscle strength and patient reported pain and function were improved in the training group compared to the control group.

CONCLUSIONS: Quadriceps strength training leads to increased muscle strength and improved symptomatic and functional outcomes but does not change quadriceps or knee joint biomechanics during walking. The biomechanical mechanism of improved health with strength training in knee osteoarthritis patients remains unknown. ClinicalTrials.gov Identifier: NCT01538407.

Clinical practice guidelines can assist rheumatologists in the proper prescription of newer treatment for rheumatoid arthritis (RA). The objective of this paper is to report on the recommendations for the management of patients with RA in the Eastern Mediterranean region. We adapted the 2015 American College of Rheumatology guidelines in two separate waves. We used the adolopment methodology, and followed the 18 steps of the "Guidelines 2.0" comprehensive checklist for guideline development. For each question, we updated the original guidelines' evidence synthesis, and we developed an Evidence Profile (EP) and an Evidence to Decision (EtD) table. In the first wave, we adoloped eight out of the 15 original questions on early RA. The strength changed for five of these recommendations from strong to conditional, due to one or more of the following factors: cost, impact on health equities, the balance of benefits, and harms and acceptability. In the second wave, we adoloped eight out of the original 44 questions on established RA. The strength changed for two of these recommendations from strong to conditional, in both cases due to cost, impact on health equities, balance of benefits and harms, and acceptability. The panel also developed a good practice recommendation. We successfully adoloped 16 recommendations for the management of early and established RA in the Eastern Mediterranean region. The process proved feasible and sensitive to contextual factors.