The use of PROMIS measures in clinical studies in patients with inflammatory arthritis: a systematic review.

PURPOSE: Although the use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures is widely advocated, little is known on their use in patients with inflammatory arthritis. We systematically describe the use and outcomes of PROMIS measures in clinical studies involving people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). METHODS: A systematic review was conducted according to the PRISMA guidelines. Through a systematic search of nine electronic databases, clinical studies including patients with RA or axSpA and reporting the use of PROMIS measure were selected. Study characteristics, details of PROMIS measures and their outcomes, if available, were extracted. RESULTS: In total, 29 studies described in 40 articles met the inclusion criteria, of which 25 studies included RA patients, three studies included axSpA patients and one study included both RA and axSpA patients. The use of two general PROMIS measures (PROMIS Global Health, PROMIS-29) and 13 different domain-specific PROMIS measures was reported, of which the PROMIS Pain Interference (n = 17), Physical Function (n = 14), Fatigue (n = 13), and Depression (n = 12) measures were most frequently used. Twenty-one studies reported their results in terms of T-scores. Most T-scores were worse than the general population mean, indicating impairments of health status. Eight studies did not report actual data but rather measurement properties of the PROMIS measures. CONCLUSION: There was considerable variety regarding the different PROMIS measures used, with the PROMIS Pain interference, Physical function, Fatigue, and Depression measures being the most frequently used. In order to facilitate the comparisons across studies, more standardization of the selection of PROMIS measures is needed.

Reporting quality of interventions using a wearable activity tracker to improve physical activity in patients with inflammatory arthritis or osteoarthritis: a systematic review.

To assess the reporting quality of interventions aiming at promoting physical activity (PA) using a wearable activity tracker (WAT) in patients with inflammatory arthritis (IA) or hip/knee osteoarthritis (OA). A systematic search was performed in eight databases (including PubMed, Embase and Cochrane Library) for studies published between 2000 and 2022. Two reviewers independently selected studies and extracted data on study characteristics and the reporting of the PA intervention using a WAT using the Consensus on Exercise Reporting Template (CERT) (12 items) and Consolidated Standards of Reporting Trials (CONSORT) E-Health checklist (16 items). The reporting quality of each study was expressed as a percentage of reported items of the total CERT and CONSORT E-Health (50% or less = poor; 51-79% = moderate; and 80-100% = good reporting quality). Sixteen studies were included; three involved patients with IA and 13 with OA. Reporting quality was poor in 6/16 studies and moderate in 10/16 studies, according to the CERT and poor in 8/16 and moderate in 8/16 studies following the CONSORT E-Health checklist. Poorly reported checklist items included: the description of decision rule(s) for determining progression and the starting level, the number of adverse events and how adherence or fidelity was assessed. In clinical trials on PA interventions using a WAT in patients with IA or OA, the reporting quality of delivery process is moderate to poor. The poor reporting quality of the progression and tailoring of the PA programs makes replication difficult. Improvements in reporting quality are necessary.

Acute pain after total hip and knee arthroplasty does not affect chronic pain during the first postoperative year: observational cohort study of 389 patients.

Chronic pain is frequently reported after total hip and knee arthroplasties (THA/TKA) in osteoarthritis (OA) patients. We investigated if severity of acute postoperative pain following THA/TKA in OA patients was associated with pain during the first postoperative year. From an observational study, OA patients scheduled for primary THA/TKA (June 2012-December 2017) were included from two hospitals in the Netherlands. Acute postoperative pain scores were collected within 72 h postoperatively and categorized as no/mild (NRS ≤ 4) or moderate/severe (NRS > 4). Pain was assessed preoperatively, 3, 6 and 12 months postoperatively using the HOOS/KOOS subscale pain. With Multilevel Mixed-effects-analyses, we estimated associations between acute and chronic pain until one year postoperative, adjusted for confounders and including an interaction term (Time*Acute pain). 193 THA and 196 TKA patients were included, 29% of THA and 51% of TKA patients reported moderate/severe pain acutely after surgery. In the THA group, the difference in pain at 3 months between the no/mild and moderate/severe groups, was approximately six points, in favor of the no/mild group (95% CI [-12.4 to 0.9]) this difference became smaller over time. In the TKA group we found similar differences, with approximately four points (95% CI [-9.6 to 1.3]) difference between the no/mild and moderate/severe group at 6 months, this difference attenuated at 12 months. No association between severity of acute postoperative pain and pain during the first postoperative year was found. These findings suggest that measures to limit acute postoperative pain will likely not impact development of chronic pain.

Recovery and the use of postoperative physical therapy after total hip or knee replacement.

BACKGROUND: Total hip or knee arthroplasties (THA/TKA) show favorable long-term effects, yet the recovery process may take weeks to months. Physical therapy (PT) following discharge from hospital is an effective intervention to enhance this recovery process. To investigate the relation between recovery and postoperative PT usage, including the presence of comorbidities, 6 months after THA/TKA. METHODS: Multicenter, observational study in primary THA/TKA patients who completed preoperative and 6 months postoperative assessments. The assessments included questions on PT use (yes/no and duration; long term use defined as ≥ 12 weeks), comorbidities (musculoskeletal, non-musculoskeletal, sensory comorbidities and frequency of comorbidities). Recovery was assessed with the HOOS/KOOS on all 5 subdomains. Logistic regression with long term PT as outcome was performed adjusted for confounding including an interaction term (comorbidity*HOOS/KOOS-subdomain). RESULTS: In total, 1289 THA and 1333 TKA patients were included, of whom 95% received postoperative PT, 56% and 67% received postoperative PT ≥ 12 weeks respectively. In both THA and TKA group, less improvement on all HOOS/KOOS domain scores was associated with ≥ 12 weeks of postoperative PT (range Odds Ratios 0.97-0.99). In the THA group the impact of recovery was smaller in patient with comorbidities as non- musculoskeletal comorbidities modified all associations between recovery and postoperative PT duration (Odds Ratios range 1.01-1.05). Musculoskeletal comorbidities modified the associations between Function-in-Daily-Living-and Sport-and-recreation recovery and postoperative PT. Sensory comorbidities only had an effect on Sport-and-recreation recovery and postoperative PT. Also the frequency of comorbidities modified the relation between Function-in-Daily-Living, pain and symptoms recovery and postoperative PT. In the TKA group comorbidity did not modify the associations. CONCLUSION: Worse recovery was associated with longer duration of postoperative PT suggesting that PT provision is in line with patients' needs. The impact of physical recovery on the use of long-term postoperative PT was smaller in THA patients with comorbidities. TRIAL REGISTRATION: Registered in the Dutch Trial Registry on March 13, 2012. TRIAL ID NTR3348; registration number: P12.047. https://www.trialregister.nl/trial/3197 .

The reason why orthopaedic surgeons perform total knee replacement: results of a randomised study using case vignettes.

PURPOSE: End-stage knee osteoarthritis (OA) results in total knee arthroplasty (TKA) surgery. The decision to perform TKA is not well defined, resulting in variation of indications among orthopaedic surgeons. Non-operative treatment measures are often not extensively used. Aim of this study was to investigate factors influencing the decision to perform TKA by Dutch orthopaedic surgeons. METHODS: Three case vignettes, each case divided into two versions, being identical except for information on age (younger and older age), pain (mild and severe pain) or radiological OA (low and high grade) were developed. A questionnaire including these three case vignettes was sent to 599 Dutch orthopaedic surgeons, who were randomised to either one of the two versions. The orthopaedic surgeons were asked whether TKA would be the next step in treatment. Furthermore, from a list of patient factors they were asked how strong these factors would influence the decision to perform TKA. RESULTS: 54 % of the orthopaedic surgeons completed the questionnaire (n = 326). Orthopaedic surgeons indicated to perform TKA significantly more often at higher age (73.3 vs. 45.5 %, p < 0.001). In the presence of mild pain, orthopaedic surgeons were slightly more reluctant to perform a TKA compared to severe pain (57.0 vs. 64.0 %, n.s.). Mild radiological OA made surgeons more reluctant to perform TKA compared to severe OA (9.7 vs. 96.9 %, p < 0.001). CONCLUSION: Old age and severe radiological OA are variables which are considered to be important in the decision to perform a TKA. Pain symptoms of moderate or severe pain are unequivocal when considering a TKA. LEVEL OF EVIDENCE: Economic/decision analysis, Level III.

Deviant early pregnancy maternal triglyceride levels and increased risk of congenital anomalies: a prospective community-based cohort study.

OBJECTIVE: The maternal lipid profile could be of importance in congenital anomaly development. This study therefore investigates whether the maternal lipid profile during early pregnancy is associated with major nonsyndromic congenital anomalies (MNCA). DESIGN: Prospective community-based cohort study. SETTING: Amsterdam Born Children and their Development (ABCD) study. POPULATION: A cohort of 3074 pregnant women recruited in 2003-2004 and their offspring. METHODS: Non-fasting blood samples from pregnant women participating in the ABCD-study (median 12.9 weeks of gestation) were analysed for triglycerides (TG), cholesterol (TC), free fatty acids (FFA), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA) (n = 3074). The perinatal outcome (MNCA) was obtained from the Youth Health Care Registration and two questionnaires. Adjustment was made for ethnicity. MAIN OUTCOME MEASURE: MNCA prevalence. RESULTS: The prevalence of MNCA was 2.2% (n = 68: 20 cardiovascular, 25 bone and muscle, and 23 other single anomalies). A nonlinear association was found between maternal TG levels and MNCA prevalence. With a lower or higher level of maternal TG, the estimated probability increased: a TG level of 0.73 mmol/l (5th percentile), of 1.28 mmol/l (50th percentile), and of 2.35 mmol/l (95th percentile) corresponded with an estimated probability of 3.6, 2.1, and 2.9%, respectively. Unadjusted subgroup analyses showed that the U-shaped association was most prominent for cardiovascular congenital anomalies. Other lipids were not associated with MNCA. CONCLUSIONS: Both low and high maternal TG levels during early pregnancy were associated with an increased risk of MNCA in offspring. This suggests that an attempt should be made to normalise TG levels before or during early pregnancy; however, replication of our results is necessary before clinical practice recommendations can be made.

Neurocardiological differences between musicians and control subjects.

BACKGROUND: Exercise training is beneficial in health and disease. Part of the training effect materialises in the brainstem due to the exercise-associated somatosensory nerve traffic. Because active music making also involves somatosensory nerve traffic, we hypothesised that this will have training effects resembling those of physical exercise. METHODS: We compared two groups of healthy, young subjects between 18 and 30 years: 25 music students (13/12 male/female, group M) and 28 controls (12/16 male/female, group C), peers, who were non-musicians. Measurement sessions to determine resting heart rate, resting blood pressure and baroreflex sensitivity (BRS) were held during morning hours. RESULTS: Groups M and C did not differ significantly in age (21.4 ± 3.0 vs 21.2 ± 3.1 years), height (1.79 ± 0.11 vs 1.77 ± 0.10 m), weight (68.0 ± 9.1 vs 66.8 ± 10.4 kg), body mass index (21.2 ± 2.5 vs 21.3 ± 2.4 kg∙m(-2)) and physical exercise volume (39.3 ± 38.8 vs 36.6 ± 23.6 metabolic equivalent hours/week). Group M practised music daily for 1.8 ± 0.7 h. In group M heart rate (65.1 ± 10.6 vs 68.8 ± 8.3 beats/min, trend P =0.08), systolic blood pressure (114.2 ± 8.7 vs 120.3 ± 10.0 mmHg, P = 0.01), diastolic blood pressure (65.0 ± 6.1 vs 71.0 ± 6.2 mmHg, P < 0.01) and mean blood pressure (83.7 ± 6.4 vs 89.4 ± 7.1, P < 0.01) were lower than in group C. BRS in groups M and C was 12.9 ± 6.7 and 11.3 ± 5.8 ms/mmHg, respectively (P = 0.17). CONCLUSIONS: The results of our study suggest that active music making has training effects resembling those of physical exercise training. Our study opens a new perspective, in which active music making, additionally to being an artistic activity, renders concrete health benefits for the musician.

Are pain, functional limitations and quality of life associated with objectively measured physical activity in patients with end-stage osteoarthritis of the hip or knee?

OBJECTIVES: Physical activity is promoted in patients with hip or knee osteoarthritis (OA), yet little is known about its relationship with symptoms, functional limitations and Quality of Life (QoL). We investigated if OA-associated pain, functional limitations and QoL are associated with objectively measured physical activity in patients with end-stage hip/knee OA. METHODS: Cross-sectional study including patients scheduled for primary total hip/knee arthroplasty. Patients wore an accelerometer (Activ8) with physical activity assessed over waking hours, and expressed as number of activity daily counts (ADC) per hour, %time spent on physical activity i.e. walking, cycling or running (%PA), and %time spent sedentary (%SB). Pain, functional limitations and joint-specific and general QoL were assessed with the Hip disability/Knee Injury and Osteoarthritis Outcome Score (HOOS/KOOS) and the Short Form (SF)-12. Multivariate linear regression models with the three to Z-scores transformed parameters of physical activity as dependent variables and adjusted for confounding, were conducted. RESULTS: 49 hip and 48 knee OA patients were included. In hip and knee OA patients the mean number of ADC, %PA and %SB were 18.79 ± 7.25 and 21.19 ± 6.16, 14 ± 6.4 and 15 ± 5.0, and 66 ± 10.5 and 68 ± 8.7, respectively. In hip OA, better joint-specific and general QoL were associated with more ADC, (ß 0.028; 95%CI:0.007-0.048, ß0.041; 95%CI:0.010-0.071). Also, better general QoL was associated with the %PA (ß 0.040, 95%CI:0.007-0.073). No other associations were found. CONCLUSION: Whereas QoL was associated with physical activity in hip OA, pain and functional limitations were not related to objectively measured physical activity in patients with end-stage hip or knee OA.

Severity classification of Tenosynovial Giant Cell Tumours on MR imaging.

AIM: Current development of novel systemic agents requires identification and monitoring of extensive Tenosynovial Giant Cell Tumours (TGCT). This study defines TGCT extension on MR imaging to classify severity. METHODS: In part one, six MR parameters were defined by field-experts to assess disease extension on MR images: type of TGCT, articular involvement, cartilage-covered bone invasion, and involvement of muscular/tendinous tissue, ligaments or neurovascular structures. Inter- and intra-rater agreement were calculated using 118 TGCT MR scans. In part two, the previously defined MR parameters were evaluated in 174 consecutive, not previously used, MR-scans. TGCT severity classification was established based on highest to lowest Hazard Ratios (HR) on first recurrence. RESULTS: In part one, all MR parameters showed good inter- and intra-rater agreement (Kappa≥0.66). In part two, cartilage-covered bone invasion and neurovascular involvement were rarely appreciated (<13%) and therefore excluded for additional analyses. Univariate analyses for recurrent disease yielded positive associations for type of TGCT HR12.84(95%CI4.60-35.81), articular involvement HR6.00(95%CI2.14-16.80), muscular/tendinous tissue involvement HR3.50(95%CI1.75-7.01) and ligament-involvement HR4.59(95%CI2.23-9.46). With these, a TGCT severity classification was constructed with four distinct severity-stages. Recurrence free survival at 4 years (log rank p < 0.0001) was 94% in mild localized (n56, 1 recurrence), 88% in severe localized (n31, 3 recurrences), 59% in moderate diffuse (n32, 12 recurrences) and 36% in severe diffuse (n55, 33 recurrences). CONCLUSION: The proposed TGCT severity classification informs physicians and patients on disease extent and risk for recurrence after surgical treatment. Definition of the most severe subgroup attributes to a universal identification of eligible patients for systemic therapy or trials for novel agents.

Validation of the SQUASH Physical Activity Questionnaire in a Multi-Ethnic Population: The HELIUS Study.

PURPOSE: To investigate the reliability and validity of the SQUASH physical activity (PA) questionnaire in a multi-ethnic population living in the Netherlands. METHODS: We included participants from the HELIUS study, a population-based cohort study. In this study we included Dutch (n = 114), Turkish (n = 88), Moroccan (n = 74), South-Asian Surinamese (n = 98) and African Surinamese (n = 91) adults, aged 18-70 years. The SQUASH was self-administered twice to assess test-re-test reliability (mean interval 6-7 weeks) and participants wore an accelerometer and heart rate monitor (Actiheart) to enable assessment of construct validity. RESULTS: We observed low test-re-test reliability; Intra class correlation coefficients ranged from low (0.05 for moderate/high intensity PA in African Surinamese women) to acceptable (0.78 for light intensity PA in Moroccan women). The discrepancy between self-reported and measured PA differed on the basis of the intensity of activity: self-reported light intensity PA was lower than measured but self-reported moderate/high intensity PA was higher than measured, with wide limits of agreement. The discrepancy between questionnaire and Actiheart measures of moderate intensity PA did not differ between ethnic minority and Dutch participants with correction for relevant confounders. Additionally, the SQUASH overestimated the number of participants meeting the Dutch PA norm; Cohen's kappas for the agreement were poor, the highest being 0.30 in Dutch women. CONCLUSION: We found considerable variation in the test-re-test reliability and validity of self-reported PA with no consistency based on ethnic origin. Our findings imply that the SQUASH does not provide a valid basis for comparison of PA between ethnic groups.