The association between exposure to antibiotics in the first week of life and later otitis media: The INCA study.

Otitis media (OM) is one of the most common diagnoses in preschool-age children. Its pathophysiology is poorly understood, but is associated with changes in the nasopharyngeal microbiome, immune system, and presence of allergies. These, in turn, can be affected by early-life antibiotic exposure. Therefore, this study aimed to determine if antibiotic treatment in the first week of life in children born at term was associated with acute otitis media (AOM) and otitis media with effusion (OME) in the first 4-6 years of life. METHODS: A prospective birth cohort of 436 term-born infants was followed up at 4-6 years of age. Parents reported (recurrent) AOM and OME through online questionnaires, sent to parents of 418 eligible children. Doctors' diagnoses of AOM and OME were collected after additional informed consent. Multivariate logistic regression analyses were used to study the association between antibiotic exposure and AOM and OME. RESULTS: Of the 436 infants, 151 infants received antibiotics in the first week of life. In total, 341 (82%) questionnaires were collected. The parental-reported prevalence was 45% (155/341) for AOM. Of these 155 children, 33 children also had OME (10% of the total cohort). Doctor's diagnoses were obtained from 308 (74%) children, of which 30% (91/308) had AOM. Of these 91 children, 12 children also had OME and 8 children had OME without a diagnosis of AOM (6% of the total obtained diagnoses). Antibiotic treatment in the first week of life was not significantly associated with parent-reported nor doctor-diagnosed (recurrent) AOM and OME in the first 4-6 years of life in the regression models. CONCLUSION: Antibiotic treatment in the first week of life was not associated with AOM and OME in the first 4-6 years of life in this prospective cohort of Dutch infants. More insight into the pathophysiology of OM is warranted to determine whether antibiotic-induced microbiome changes play a role in the susceptibility to OM.

The performance of COBRA, a decision rule to predict the need for intensive care interventions in intentional drug overdose.

BACKGROUND: COBRA was developed as a decision rule to predict which patients visiting the emergency department (ED) following intentional drug overdose will not require intensive care unit (ICU) interventions. COBRA uses parameters from five vital systems (cardiac conduction, oxygenation, blood pressure, respiration, and awareness) that are readily available in the ED. COBRA recommends against ICU admission when all these parameters are normal. OBJECTIVE: The primary aim of this study was to determine the negative predictive value (NPV) of COBRA in predicting ICU interventions. Secondary outcomes were the sensitivity, specificity and positive predictive value (PPV), and the observation time required for a reliable prediction. DESIGN: Observational cohort study. SETTINGS AND PARTICIPANTS: Patients with a reported intentional overdose with drugs having potential acute effects on neurological, circulatory or ventilatory function were included, and data necessary to complete the decision rule was collected. The attending physician in the ED made the actual admission decision, on the basis of clinical judgement. COBRA was measured 0, 3 and 6 h after arrival at the ED. OUTCOME MEASURES: Need for ICU interventions (treatment of convulsion; defibrillation; mechanical or noninvasive ventilation; intravenous administration of vasopressive agents, antiarrhythmics, atropine, calcium, magnesium or sedation; continuous hemofiltration or administration of antagonist/antidote and fluid resuscitation). MAIN RESULTS: Of 230 new cases (144 unique patients), 59 were immediately referred to the psychiatric services and/or sent home by the attending physician, 27 went to a regular ward, and 144 were admitted to the ICU. Of these 144 cases, 40 required one or more ICU interventions. By the time the first parameters were collected, the NPV of COBRA was 95.6%. After 3 h of observation, NPV was 100%, while sensitivity, specificity and PPV were 100, 61.1 and 35.1%, respectively. None of these values improved by prolonging the observation time to 6 h. CONCLUSION: In patients with a reported intentional overdose with drugs having potential acute effects on neurological, circulatory or ventilatory function, the COBRA decision rule showed good performances in predicting the need for intensive care interventions, with a NPV of 100% after 3 h of observation.

Referral decisions based on a pre-hospital HEART score in suspected non-ST-elevation acute coronary syndrome: final results of the FamouS Triage study.

AIMS: Although pre-hospital risk stratification of patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) by ambulance paramedics is feasible, it has not been investigated in daily practice whether referral decisions based on this risk stratification is safe and does not increase major adverse cardiac events (MACE). In Phase III of the FamouS Triage study, it was investigated whether referral decisions by ambulance paramedics based on a pre-hospital HEART score, is non-inferior to routine management. METHODS AND RESULTS: FamouS Triage Phase III is a non-inferiority study, comparing the occurrence of MACE before (Phase II) and after (Phase III) implementation of referral decisions based on a pre-hospital HEART score. In Phase II, all patients were risk-stratified and referred to the hospital; in Phase III, low-risk patients (HEART score ≤ 3) were not referred. Primary endpoint was MACE (acute coronary syndrome, revascularization, or death) within 45 days. A total of 1236 patients were included. Mean age was 63 years, 43% were female, 700 patients were included in the second phase and 536 in the third phase in which 149 low-risk patients (28%) were not transferred to the hospital. Occurrence of 45 days MACE was 16.6% in Phase II and 15.7% in Phase III (P = 0.67). Percentage MACE in low-risk patients was 2.9% in Phase II and 1.3% in Phase III. After adjustments for differences in baseline variables, the hazard ratio of 45 days MACE in Phase III was 0.88 (95% confidence interval 0.63-1.25) as compared to Phase II. CONCLUSION: Pre-hospital risk stratification of patients with suspected NSTE-ACS, avoiding hospitalization of a substantial number of low-risk patients, seems feasible and non-inferior to transferring all patients to the hospital.

Prevalence and follow-up of potentially inappropriate medication and potentially omitted medication in older patients with cancer - The PIM POM study.

OBJECTIVES: To determine the prevalence of Potentially Inappropriate Medication (PIMs) and Potentially Omitted Medication (POMs) in older patients with cancer. MATERIALS AND METHODS: In this prospective observational study (hospital) pharmacists conducted comprehensive medication reviews in older patients with cancer (aged ≥65 years) receiving parenteral chemotherapy and/or immunotherapy at the Deventer Hospital. PIMs and POMs were identified using the Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP), the Screening Tool to Alert doctors to the Right Treatment (START), and pharmacists' expert opinion. Recommendations regarding PIMs and POMs were communicated to the patient's oncologist/haematologist and follow-up was measured. Associations between covariates and the prevalence of PIMs and POMs were statistically analysed. RESULTS: For the 150 patients included, 180 PIMs and 86 POMs were identified with a prevalence of 78%. Using pharmacists' expert opinion in addition to only STOPP/START criteria contributed to 49% of the PIMs and 23% of the POMs. A follow-up action was required in 73% of the 266 PIMs and POMs. Number of medicines and Charlson Comorbidity Index score were both associated with having at least one PIM and/or POM (p = .031 and p = .016, respectively). CONCLUSION: The prevalence of PIMs and POMs and subsequent follow-up in older patients with cancer is high. A pharmacist-led comprehensive medication review is a good instrument to identify these PIMs and POMs and to optimize patients' treatment. A complete approach, including pharmacists' expert opinion, is recommended to identify all PIMs and POMs in clinical practice.

Referral decisions based on a prehospital HEART score in suspected non-ST-elevation acute coronary syndrome: design of the FamouS Triage 3 study.

Background: It is not yet investigated whether referral decisions based on prehospital risk stratification of non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) by the complete History, ECG, Age, Risk factors and initial Troponin (HEART) score are feasible and safe. Hypothesis: Implementation of referral decisions based on the prehospital acquired HEART score in patients with suspected NSTE-ACS is feasible and not inferior to routine management in the occurrence of major adverse cardiac events within 45 days. Study design & methods: FamouS Triage 3 is a feasibility study with a before-after sequential design. The aim is to assess whether prehospital HEART-score management including point-of-care troponin measurement is feasible and noninferior to routine management. Primary end point is the occurrence of major adverse cardiac events within 45 days. Conclusion: If referral decisions based on prehospital acquired risk stratification are feasible and noninferior this can become the new prehospital management in suspected NSTE-ACS.

The value of radiographic markers in the diagnostic work-up of rotator cuff tears, an arthroscopic correlated study.

OBJECTIVE: To evaluate the value of radiographs during the diagnostic work-up of rotator cuff tears, using arthroscopy as reference standard. MATERIALS AND METHODS: This retrospective study included 236 shoulders of 236 patients. All radiographs were evaluated for inferior cortical acromial sclerosis, lateral acromial spur, superior migration of the humeral head, greater tubercle cysts, and subacromial space calcifications. Predictive value of these radiographic signs in predicting rotator cuff tears was determined with arthroscopy as reference standard. RESULTS: According to arthroscopy, 131 shoulders were diagnosed with rotator cuff tears. Seventy-two out of 131 shoulders (55%) had inferior cortical acromial sclerosis, 37 (28%) lateral acromial spur, 21 (16%) superior migration of the humeral head, 7 (5%) greater tubercle cysts and 15 subacromial space calcifications (11%). Inferior cortical acromial sclerosis (P = 0.001), lateral spur (P = 0.001), superior migration (P = 0.002), and cysts (P = 0.03) were significantly and independently associated with rotator cuff tears, whereas subacromial calcifications (p = 0.21) was not. Inferior cortical acromial sclerosis, superior migration, lateral acromial spur, and cysts combined have a positive predictive value of 78%. CONCLUSIONS: The combination of inferior cortical acromial sclerosis, lateral acromial spur, superior migration of the humeral head, and greater tubercle cysts has a high positive predictive value for the presence of full-thickness rotator cuff tears. In patients with a high suspicion for having a rotator cuff tear based on radiographic findings, MRI can be performed directly without the delay and costs caused by an additional ultrasound exam.

Minimally Invasive versus Open Approach for Right-Sided Colectomy: A Study in 12,006 Patients from the Dutch Surgical Colorectal Audit.

BACKGROUND: There is ongoing debate whether laparoscopic right colectomy is superior to open surgery. The purpose of this study was to address this issue and arrive at a consensus using data from a national database. METHODS: Patients who underwent elective open or laparoscopic right colectomy for colorectal cancer during the period 2009-2013 were identified from the Dutch Surgical Colorectal Audit. Complications that occurred within 30 days after surgery and 30-day mortality rates were calculated and compared between open and laparoscopic resection. RESULTS: In total, 12,006 patients underwent elective open or laparoscopic surgery for right-sided colorectal cancer. Of these, 6,683 (55.7%) underwent open resection and 5,323 (44.3%) underwent laparoscopic resection. Complications occurred within 30 days after surgery in the laparoscopic group in 26.1% of patients and in 32.1% of patients in the open group (p < 0.001). Thirty-day mortality was also significantly lower in the laparoscopic group (2.2 vs. 3.6% p < 0.001). CONCLUSION: In this non-randomized, descriptive study conducted in the Netherlands, open right colectomy seems to have a higher risk for complications and mortality as compared to laparoscopic right colectomy, even after correction for confounding factors.

Psychological symptoms and the MCID of the DASH score in shoulder surgery.

BACKGROUND: Psychological symptoms are frequently present in patients scheduled for shoulder surgery. The perception of functional disability, activity level and pain in the shoulder is negatively influenced by psychological symptoms, which leads to higher scores of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The aim of this study was to determine the influence of psychological symptoms on the minimal clinically important difference (MCID) of the DASH score in patients after shoulder surgery. METHODS: In this prospective longitudinal cohort study, 176 patients were included. Group 1 (32 patients) had symptoms of psychological disorders before and after surgery; group 2 had no symptoms of psychological disorders (110 patients). In the remaining patients (34 patients), psychological disorders changed after surgery. Clinical outcome was measured with the change of DASH score and anchor questions for perceived improvement of pain and function after surgery. Symptoms of psychological disorders were identified with the Four-Dimensional Symptom Questionnaire. An anchor-based mean change score technique was used to determine the MCID of the DASH score. RESULTS: DASH scores before and 12 months after shoulder surgery were significantly higher in patients with symptoms of psychological disorders; change of DASH score was not different between the two groups. The MCID of the DASH score was 13.0 [SD 20.7] in the group with symptoms of psychological disorders and 12.7 [SD 17.6] in the group with no symptoms of psychological disorders. We observed no difference (p = 0.559) in the MCID between the group with and the group without symptoms of psychological disorders. CONCLUSION: Symptoms of psychological disorders had a negative effect on the DASH score but no influence on the MCID of the DASH score. The DASH score could be used in future studies to assess the influence of psychological factors on the clinical outcome of treatment.

Comparison of Outcomes and Intervention Among Patients With Non-ST-Segment Elevation Acute Myocardial Infarction of Those With a Left Circumflex Versus Those With a Non-Left Circumflex-Related Coronary Artery (From the ELISA-3 Trial).

Previous studies found that patients with an acute coronary syndrome (ACS) due to occlusion of the left circumflex (LC) coronary artery often present without ST-elevation, leading to a delay in diagnosis and revascularization, a larger infarct size, and a worse prognosis. In this subgroup analysis of the ELISA-3 study (early or late intervention in high-risk non-ST-segment elevation acute coronary syndromes [NSTE-ACS]) incidence, characteristics and prognosis of LC-related NSTE-ACS was investigated, and the outcome of early versus late invasive strategy was compared. In 383 of 542 patients the culprit vessel could be identified, with the LC artery in 112 (29%) of them. Patients with LC-related ACS had more often single vessel disease and underwent percutaneous coronary intervention more and CABG less frequently. The primary end point of the combined incidences of death, myocardial infarction, and recurrent ischemia at 30-day follow-up occurred in 9.0% of LC versus 16.5% of non-LC-related ACS (p = 0.057). Enzymatic infarct size and incidence of bleeding were comparable. Of patients with LC-related ACS, 62 were assigned to an early and 50 to a late invasive treatment with a median time from admission to angiography of 5.5 and 65.7 hours, respectively. The primary end point occurred in 9.7% and 8.0%, respectively (p = 1.00) with comparable enzymatic infarct size and bleeding. In conclusion, no significant differences in outcome were found between patients with an LC- and a non-LC-related NSTE-ACS. In LC-related NSTE-ACS, angiography within 12 hours of admission is feasible but not superior to angiography after more than 48 hours.

The development of the Patient Expectations of Shoulder Surgery survey.

BACKGROUND: Patient satisfaction after a surgical procedure is dependent on meeting preoperative expectations. There is currently no patient expectations survey available for patients undergoing shoulder surgery that is validated, reliable, and easy to use in daily practice. The aim of this study was to develop a Patient Expectations of Shoulder Surgery (PESS) survey. METHODS: In 315 patients, answers to an open-ended question about patient expectations were collected before shoulder surgery to develop the PESS survey. Patients' expectations of the PESS survey were associated with clinical outcome (change of Disabilities of the Arm, Shoulder, and Hand score). Content validity was assessed by a panel of 10 patients scheduled for shoulder surgery, and test-retest reliability was evaluated. RESULTS: Six items were included in the PESS survey: pain relief, improved range of motion, improved ability to perform daily activities, improved ability to perform work, improved ability to participate in recreational activities and sports, and stop shoulder from dislocating. Three of the 6 expectations were significantly associated with clinical outcome after shoulder surgery. Test-retest reliability was high with an intraclass correlation coefficient of 0.52-0.92. DISCUSSION: The PESS survey is a valid and reliable survey that can be used in future clinical research and in daily orthopedic practice. We believe that the preoperative evaluation of patient expectations should be a standard procedure before shoulder surgery.

The Association between Social Jetlag, the Metabolic Syndrome, and Type 2 Diabetes Mellitus in the General Population: The New Hoorn Study.

Only a few studies have investigated the metabolic consequences of social jetlag. Therefore, we examined the association of social jetlag with the metabolic syndrome and type 2 diabetes mellitus in a population-based cohort. We used cross-sectional data from the New Hoorn Study cohort ( n = 1585, 47% men, age 60.8 ± 6 years). Social jetlag was calculated as the difference in midpoint sleep (in hours) between weekdays and weekend days. Poisson and linear regression models were used to study the associations, and age was regarded as a possible effect modifier. We adjusted for sex, employment status, education, smoking, physical activity, sleep duration, and body mass index. In the total population, we only observed an association between social jetlag and the metabolic syndrome, with prevalence ratios adjusted for sex, employment status, and educational levels of 1.64 (95% CI 1.1-2.4), for participants with >2 h social jetlag, compared with participants with <1 h social jetlag. However, we observed an interaction effect of median age (<61 years). In older participants (≥61 years), no significant associations were observed between social jetlag status, the metabolic syndrome, and diabetes or prediabetes. In the younger group (<61 years), the adjusted prevalence ratios were 1.29 (95% CI 0.9-1.9) and 2.13 (95% CI 1.3-3.4) for the metabolic syndrome and 1.39 (95% CI 1.1-1.9) and 1.75 (95% CI 1.2-2.5) for diabetes/prediabetes, for participants with 1-2 h and >2 h social jetlag, compared with participants with <1 h social jetlag. In conclusion, in our population-based cohort, social jetlag was associated with a 2-fold increased risk of the metabolic syndrome and diabetes/prediabetes, especially in younger (<61 years) participants.

Vitamin D and mortality: Individual participant data meta-analysis of standardized 25-hydroxyvitamin D in 26916 individuals from a European consortium.

BACKGROUND: Vitamin D deficiency may be a risk factor for mortality but previous meta-analyses lacked standardization of laboratory methods for 25-hydroxyvitamin D (25[OH]D) concentrations and used aggregate data instead of individual participant data (IPD). We therefore performed an IPD meta-analysis on the association between standardized serum 25(OH)D and mortality. METHODS: In a European consortium of eight prospective studies, including seven general population cohorts, we used the Vitamin D Standardization Program (VDSP) protocols to standardize 25(OH)D data. Meta-analyses using a one step procedure on IPD were performed to study associations of 25(OH)D with all-cause mortality as the primary outcome, and with cardiovascular and cancer mortality as secondary outcomes. This meta-analysis is registered at ClinicalTrials.gov, number NCT02438488. FINDINGS: We analysed 26916 study participants (median age 61.6 years, 58% females) with a median 25(OH)D concentration of 53.8 nmol/L. During a median follow-up time of 10.5 years, 6802 persons died. Compared to participants with 25(OH)D concentrations of 75 to 99.99 nmol/L, the adjusted hazard ratios (with 95% confidence interval) for mortality in the 25(OH)D groups with 40 to 49.99, 30 to 39.99, and <30 nmol/L were 1.15 (1.00-1.29), 1.33 (1.16-1.51), and 1.67 (1.44-1.89), respectively. We observed similar results for cardiovascular mortality, but there was no significant linear association between 25(OH)D and cancer mortality. There was also no significantly increased mortality risk at high 25(OH)D levels up to 125 nmol/L. INTERPRETATION: In the first IPD meta-analysis using standardized measurements of 25(OH)D we observed an association between low 25(OH)D and increased risk of all-cause mortality. It is of public health interest to evaluate whether treatment of vitamin D deficiency prevents premature deaths.

Incidence and prognostic factors for postoperative frozen shoulder after shoulder surgery: a prospective cohort study.

PURPOSE: Frozen shoulder is a potential complication after shoulder surgery. It is a clinical condition that is often associated with marked disability and can have a profound effect on the patient's quality of life. The incidence, etiology, pathology and prognostic factors of postoperative frozen shoulder after shoulder surgery are not known. The purpose of this explorative study was to determine the incidence of postoperative frozen shoulder after various operative shoulder procedures. A second aim was to identify prognostic factors for postoperative frozen shoulder after shoulder surgery. METHODS: 505 consecutive patients undergoing elective shoulder surgery were included in this prospective cohort study. Follow-up was 6 months after surgery. A prediction model was developed to identify prognostic factors for postoperative frozen shoulder after shoulder surgery using the TRIPOD guidelines. We nominated five potential predictors: gender, diabetes mellitus, type of physiotherapy, arthroscopic surgery and DASH score. RESULTS: Frozen shoulder was identified in 11% of the patients after shoulder surgery and was more common in females (15%) than in males (8%). Frozen shoulder was encountered after all types of operative procedures. A prediction model based on four variables (diabetes mellitus, specialized shoulder physiotherapy, arthroscopic surgery and DASH score) discriminated reasonably well with an AUC of 0.712. CONCLUSIONS: Postoperative frozen shoulder is a serious complication after shoulder surgery, with an incidence of 11%. Four prognostic factors were identified for postoperative frozen shoulder: diabetes mellitus, arthroscopic surgery, specialized shoulder physiotherapy and DASH score. The combination of these four variables provided a prediction rule for postoperative frozen shoulder with reasonable fit. LEVEL OF EVIDENCE: Level II, prospective cohort study.

Clinical parameters that predict the need for medium or intensive care admission in intentional drug overdose patients: A retrospective cohort study.

INTRODUCTION: Many patients with intentional drug overdose (IDO) are admitted to a medium (MC) or intensive care unit (IC) without ever requiring MC/IC related interventions. The objective of this study was to develop a decision tool, using parameters readily available in the emergency room (ER) for patients with an IDO, to identify patients requiring admission to a monitoring unit. METHODS: Retrospective cohort study among cases of IDO with drugs having potentially acute effects on neurological, circulatory or ventilatory function, admitted to the MC/IC unit between 2007 and 2013. A decision tool was developed, using 6 criteria, representing intubation, breathing, oxygenation, cardiac conduction, blood pressure, and consciousness. Cases were labeled as 'high acuity' if one or more criteria were present. RESULTS: Among 255 cases of IDO that met the inclusion criteria, 197 were identified as "high acuity". Only 70 of 255 cases underwent one or more MC/IC related interventions, of which 67 were identified as 'high acuity by the decision tool (sensitivity 95.7%). CONCLUSION: In a population of patients with intentional drug overdose with agents having potentially acute effect on vital functions, 95.7% of MC/IC interventions could be predicted by clinical assessment, supplemented with electrocardiogram and blood gas analysis, in the ER.

The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study.

BACKGROUND: Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. METHODS AND FINDINGS: A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression and somatisation were associated with worse perceived improvement of function. CONCLUSIONS: Preoperative symptoms of distress, depression, anxiety and somatisation were not associated with worse clinical outcome 12 months after shoulder surgery. Symptoms of psychological disorders before shoulder surgery persisted in 56% of patients after surgery. Postoperative symptoms of psychological disorders 12 months after shoulder surgery were strongly associated with worse clinical outcome.

Outcome of the Cementless Zweymüller BICON-PLUS Cup and SL-PLUS Stem in the Very Elderly Individuals.

INTRODUCTION: There is current debate about which type of total hip prosthesis implants are best for the elderly patient. Implanting uncemented total hip arthroplasty (THA) in elderly people remains contested. The aim of present study was to evaluate the outcome of the uncemented Zweymüller BICON-PLUS THA in those with a minimum of 80 years of age. MATERIALS AND METHODS: A retrospective data collection was performed in a regional teaching hospital in the Netherlands. The primary outcome of interest was the operation-free period. Secondary outcomes included the revision rates of the femoral and acetabular components and postoperative complications of the procedure. After a follow-up of at least 7 years, the surviving patients were reviewed on functionality using validated scores (Hip Disability and Osteoarthritis Outcome Score, Timed Up and Go, and Harris Hip Score) and radiographic analysis. RESULTS: Between January 1999 and September 2004, 124 patients (128 THAs), aged 80 years and older, received an uncemented THA with a BICON-PLUS cup and SL-PLUS stem. The overall operation-free period was 6.5 years. One case of loosening of the cup was found among participants, with a survival rate of 99.2% of the BICON-PLUS cup in the analyzed group. In all, 28.8% of this group could be followed for a postoperative period of at least 7 years. The remainder of the patients died prior to the end of the 7-year period. Of these, 16.0% were eligible for clinical review. This group showed good function without evident signs of prosthetic loosening. CONCLUSION: The uncemented Zweymüller THA system, with threaded BICON-PLUS cup and SL-PLUS stem, showed good results, compared to outcome of other THA systems in elderly individuals. Therefore, it is a reliable option in older patients requiring THA.

Validation of the four-dimensional symptom questionnaire (4DSQ) and prevalence of psychological symptoms in orthopedic shoulder patients.

Psychological problems are common in shoulder patients. A validated psychological questionnaire measuring clinically relevant psychological symptoms (including distress, depression, anxiety, and somatization) in shoulder patients is lacking. The Four-Dimensional Symptom Questionnaire (4DSQ) is a self-report questionnaire to identify distress, depression, anxiety, and somatization which has been validated in primary care populations. The aim of this study was to validate the 4DSQ in orthopedic shoulder patients. We assessed whether the 4DSQ measures these four constructs the same way in an orthopedic population with shoulder problems compared to a general practice population. We also investigated the prevalence of psychological symptoms in shoulder patients. The shoulder group consisted of 200 consecutive patients and the general practice group comprised 368 patients, matched for gender and age. Differential item functioning analysis showed that the 4DSQ measures the different psychological symptoms in orthopedic shoulder patients the same way as in general practice patients. The shoulder patients tended to score higher on the somatization scale, resulting in a new cut-off point for somatization. The prevalence of distress, somatization, anxiety, and depression in the shoulder group was 23%, 14%, 10%, and 8%, respectively. It can be concluded from this study that the 4DSQ in orthopedic shoulder patients measures the same constructs as in general practice patients and can therefore be used in orthopedic practice to measure psychological symptoms in patients with shoulder complaints.

Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial.

BACKGROUND: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff tears. METHODS: We conducted a randomized controlled trial that included 56 patients with a degenerative full-thickness rotator cuff tear between January 2009 and December 2012; 31 patients were treated conservatively, and rotator cuff repair was performed in 25 patients. Outcome measures, including the Constant-Murley score (CMS), visual analog scale (VAS) pain and VAS disability scores, were assessed preoperatively and after 6 weeks and 3, 6, and 12 months. Magnetic resonance imaging was performed preoperatively and at 12 months postoperatively. RESULTS: At 12 months postoperatively, the mean CMS was 81.9 (standard deviation [SD], 15.6) in the surgery group vs 73.7 (SD, 18.4) in the conservative group (P = .08). VAS pain (P = .04) and VAS disability (P = .02) were significantly lower in the surgery group at the 12-month follow-up. A subgroup analysis showed postoperative CMS results were significantly better in surgically treated patients without a retear compared with conservatively treated patients (88.5 [SD, 6.2] vs 73.7 [SD, 18.4]). CONCLUSION: In our population of patients with degenerative rotator cuff tears who were randomly treated by surgery or conservative protocol, we did not observe differences in functional outcome as measured with the CMS 1 year after treatment. However, significant differences in pain and disabilities were observed in favor of surgical treatment. The best outcomes in function and pain were seen in patients with an intact rotator cuff postoperatively.

Distinct HbA1c trajectories in a type 2 diabetes cohort.

AIMS: The aim of this study was to identify subgroups of type 2 diabetes mellitus patients with distinct hemoglobin A1c (HbA1c) trajectories. Subgroup characteristics were determined and the prevalence of microvascular complications over time was investigated. STUDY DESIGN AND SETTING: Data from a cohort of 5,423 type 2 diabetes patients from a managed primary care system were used [mean follow-up 5.7 years (range 2-9 years)]. Latent class growth modeling was used to identify subgroups of patients with distinct HbA1c trajectories. Multinomial logistic regression analyses were conducted to determine which characteristics were associated with different classes. RESULTS: Four subgroups were identified. The first and largest subgroup (83 %) maintained good glycemic control over time (HbA1c ≤53 mmol/mol), the second subgroup (8 %) initially showed severe hyperglycemia, but reached the recommended HbA1c target within 2 years. Patients within this subgroup had significantly higher baseline HbA1c levels but were otherwise similar to the good glycemic control group. The third subgroup (5 %) showed hyperglycemia and a delayed response without reaching the recommended HbA1c target. The fourth subgroup (3.0 %) showed deteriorating hyperglycemia over time. Patients within the last two subgroups were significantly younger, had higher HbA1c levels and a longer diabetes duration at baseline. These subgroups also showed a higher prevalence of retinopathy and microalbuminuria. CONCLUSION: Four subgroups with distinct HbA1c trajectories were identified. More than 90 % reached and maintained good glycemic control (subgroup one and two). Patients within the two subgroups that showed a more unfavorable course of glycemic control were younger, had higher HbA1c levels and a longer diabetes duration at baseline.

Low-grade inflammation and endothelial dysfunction explain the association between retinopathy and left ventricular ejection fraction in men: an 8-year follow-up of the Hoorn Study.

PURPOSE: The aim of this study was to prospectively investigate the association of retinopathy with changes in left ventricular (LV) function. METHODS: Within the Hoorn Study, a population-based cohort study of diabetes in The Netherlands, retinal photography and echocardiography were performed in the year 2000 (baseline) and 2008 (follow-up). Retinopathy was graded according to the Eurodiab classification and further defined as absent or present retinopathy. LV systolic and diastolic functions were assessed by LV ejection fraction (%), LV mass (g/m(2.7)) and left atrial (LA) volume indices and the ratio of LV inflow (E) and early diastolic lengthening (e') velocities. Linear regression analyses stratified for sex were completed to investigate associations of retinopathy with changes in LV function in participants with impaired glucose metabolism and type 2 diabetes. RESULTS: One hundred forty-seven participants (58% men, mean age 66) were included in the study, of whom 13.6% were present with retinopathy at baseline. LV ejection fraction was similar among participants with and without retinopathy (60.2% versus 60.7%) at baseline. Eight years later, retinopathy was significantly associated with a lower LV ejection fraction (ß -8.0 95% CI -15.37 to -0.68) in men, independent of risk factors. Microvascular endothelial dysfunction ([ED] ß -4.87 95% CI -13.40 to 3.67) and low-grade inflammation ([LGI] ß -5.30 95% CI -13.72 to 3.12) both diminished the association. No significant associations between retinopathy and other LV function parameters were observed. CONCLUSION: Retinopathy was significantly associated with a lower LV ejection fraction in men but not in women. LGI and ED might explain the observed association.