Big data study using health insurance claims to predict multidisciplinary low vision service uptake.

SIGNIFICANCE: There is a lack of research from high-income countries with various health care and funding systems regarding barriers and facilitators in low vision services (LVS) access. Furthermore, very few studies on LVS provision have used claims data. PURPOSE: This study aimed to investigate which patient characteristics predict receiving multidisciplinary LVS (MLVS) in the Netherlands, a high-income country, based on health care claims data. METHODS: Data from a Dutch national health insurance claims database (2015 to 2018) of patients with eye diseases causing potentially severe visual impairment were retrieved. Patients received MLVS (n = 8766) and/or ophthalmic treatment in 2018 (reference, n = 565,496). MLVS is provided by professionals from various clinical backgrounds, including nonprofit low vision optometry. Patient characteristics (sociodemographic, clinical, contextual, general health care utilization) were assessed as potential predictors using a multivariable logistic regression model, which was internally validated with bootstrapping. RESULTS: Predictors for receiving MLVS included prescription of low vision aids (odds ratio [OR], 8.76; 95% confidence interval [CI], 7.99 to 9.61), having multiple ophthalmic diagnoses (OR, 3.49; 95% CI, 3.30 to 3.70), receiving occupational therapy (OR, 2.32; 95% CI, 2.15 to 2.51), mental comorbidity (OR, 1.17; 95% CI, 1.10 to 1.23), comorbid hearing disorder (OR, 1.98; 95% CI, 1.86 to 2.11), and receiving treatment in both a general hospital and a specialized ophthalmic center (OR, 1.23; 95% CI, 1.10 to 1.37), or by a general practitioner (OR, 1.23; 95% CI, 1.18 to 1.29). Characteristics associated with lower odds included older age (OR, 0.30; 95% CI, 0.28 to 0.32), having a low social economic status (OR, 0.91; 95% CI, 0.86 to 0.97), physical comorbidity (OR, 0.87; 95% CI, 0.82 to 0.92), and greater distance to an MLVS (OR, 0.95; 95% CI, 0.92 to 0.98). The area under the curve of the model was 0.75 (95% CI, 0.75 to 0.76; optimism = 0.0008). CONCLUSIONS: Various sociodemographic, clinical, and contextual patient characteristics, as well as factors related to patients' general health care utilization, were found to influence MLVS receipt as barriers or facilitators. Eye care practitioners should have attention for socioeconomically disadvantaged older patients when considering MLVS referral.

Posterolateral or Direct Lateral Surgical Approach for Hemiarthroplasty After a Hip Fracture: A Randomized Clinical Trial Alongside a Natural Experiment.

Importance: Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence to improve hip fracture care regarding the surgical approach of hemiarthroplasty is lacking. Objective: To compare 6-month outcomes of the posterolateral approach (PLA) and direct lateral approach (DLA) for hemiarthroplasty in patients with acute femoral neck fracture. Design, Setting, and Participants: This multicenter, randomized clinical trial (RCT) comparing DLA and PLA was performed alongside a natural experiment (NE) at 14 centers in the Netherlands. Patients aged 18 years or older with an acute femoral neck fracture were included, with or without dementia. Secondary surgery of the hip, pathological fractures, or patients with multitrauma were excluded. Recruitment took place between February 2018 and January 2022. Treatment allocation was random or pseudorandom based on geographical location and surgeon preference. Statistical analysis was performed from July 2022 to September 2022. Exposure: Hemiarthroplasty using PLA or DLA. Main Outcome and Measures: The primary outcome was health-related quality of life 6 months after surgery, quantified with the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L). Secondary outcomes included dislocations, fear of falling and falls, activities of daily living, pain, and reoperations. To improve generalizability, a novel technique was used for data fusion of the RCT and NE. Results: A total of 843 patients (542 [64.3%] female; mean [SD] age, 82.2 [7.5] years) participated, with 555 patients in the RCT (283 patients in the DLA group; 272 patients in the PLA group) and 288 patients in the NE (172 patients in the DLA group; 116 patients in the PLA group). In the RCT, mean EQ-5D-5L utility scores at 6 months were 0.50 (95% CI, 0.45-0.55) after DLA and 0.49 (95% CI, 0.44-0.54) after PLA, with 77% completeness. The between-group difference (-0.04 [95% CI, -0.11 to 0.04]) was not statistically significant nor clinically meaningful. Most secondary outcomes were comparable between groups, but PLA was associated with more dislocations than DLA (RCT: 15 of 272 patients [5.5%] in PLA vs 1 of 283 patients [0.4%] in DLA; NE: 6 of 113 patients [5.3%]) in PLA vs 2 of 175 patients [1.1%] in DLA). Data fusion resulted in an effect size of 0.00 (95% CI, -0.04 to 0.05) for the EQ-5D-5L and an odds ratio of 12.31 (95% CI, 2.77 to 54.70) for experiencing a dislocation after PLA. Conclusions and Relevance: This combined RCT and NE found that among patients treated with a cemented hemiarthroplasty after an acute femoral neck fracture, PLA was not associated with a better quality of life than DLA. Rates of dislocation and reoperation were higher after PLA. Randomized and pseudorandomized data yielded similar outcomes, which suggests a strengthening of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT04438226.

Steeper memory decline after COVID-19 lockdown measures.

BACKGROUND: During COVID-19 lockdown measures, memory clinic patients reported worries for faster cognitive decline, due to loss of structure and feelings of loneliness and depression. We aimed to investigate the impact of the COVID-19 lockdown on rate of cognitive decline in a mixed memory clinic population, compared to matched historical controls. METHODS: We included patients who visited Alzheimer Center Amsterdam 6 months to 1 week before the first Dutch COVID-19 lockdown, and had a second visit 1 year later, after this lockdown period (n = 113; 66 ± 7 years old; 30% female; n = 55 dementia, n = 31 mild cognitive impairment (MCI), n = 18 subjective cognitive decline (SCD), n = 9 postponed diagnosis). Historical controls (visit in 2016/2017 and second visit 1 year later (n = 640)) were matched 1:1 to lockdown patients by optimal Mahalanobis distance matching (both groups n = 113). Groups were well matched. Differences between lockdown patients and historical controls over time in Mini-Mental State Examination, Trail Making Test part A and B, Rey-Auditory Verbal Learning Test (RAVLT) immediate and delayed recall, and category fluency scores were analyzed using linear mixed effect models with random intercepts. We examined differences in rate of cognitive decline between whole groups, and after stratification in SCD, MCI, and dementia separately. RESULTS: Lockdown patients had a faster rate of memory decline compared to controls on both RAVLT immediate [B(SE) = - 2.62 (1.07), p = 0.015] and delayed recall [B(SE) = - 1.07 (0.34), p = 0.002]. Stratification by syndrome diagnosis showed that this effect was largely attributable to non-demented participants, as we observed faster memory decline during lockdown in SCD and MCI (RAVLT immediate [SCD: B(SE) = - 6.85 (2.97), p = 0.027; MCI: B(SE) = - 6.14 (1.78), p = 0.001] and delayed recall [SCD: B(SE) = - 2.45 (1.11), p = 0.035; MCI: B(SE) = - 1.50 (0.51), p = 0.005]), but not in dementia. CONCLUSION: Memory clinic patients, specifically in pre-dementia stages, showed faster memory decline during COVID-19 lockdown, providing evidence that lockdown regulations had a deleterious effect on brain health. In individuals that may have been able to deal with accumulating, subclinical neuropathology under normal and structured circumstances, the additional stress of lockdown regulations may have acted as a "second hit," resulting in less beneficial disease trajectory.

Posterolateral or direct lateral approach for cemented hemiarthroplasty after femoral neck fracture (APOLLO): protocol for a multicenter randomized controlled trial with economic evaluation and natural experiment alongside.

BACKGROUND AND PURPOSE: The posterolateral and direct lateral surgical approach are the 2 most common surgical approaches for performing a hemiarthroplasty in patients with a hip fracture. It is unknown which surgical approach is preferable in terms of (cost-)effectiveness and quality of life. METHODS AND ANALYSIS: We designed a multicenter randomized controlled trial (RCT) with an economic evaluation and a natural experiment (NE) alongside. We will include 555 patients ≥ 18 years with an acute femoral neck fracture. The primary outcome is patient-reported health-related quality of life assessed with the EQ-5D-5L. Secondary outcomes include healthcare costs, complications, mortality, and balance (including fear of falling, actual falls, and injuries due to falling). An economic evaluation will be performed for quality adjusted life years (QALYs). We will use variable block randomization stratified for hospital. For continuous outcomes, we will use linear mixed-model analysis. Dichotomous secondary outcome measures will be analyzed using chi-square statistics and logistic regression models. Primary analyses are based on the intention-to-treat principle. Additional as treated analyses will be performed to evaluate the effect of protocol deviations. Study summary: (i) Largest RCT addressing the health-related patient outcome of the main surgical approaches of hemiarthroplasty. (ii) Focus on outcomes that are important for the patient. (iii) Pragmatic and inclusive RCT with few exclusion criteria, e.g., patients with dementia can participate. (iv) Natural experiment alongside to amplify the generalizability. (v) The first study conducting a costutility analysis comparing both surgical approaches.

CGR-CUSUM: a continuous time generalized rapid response cumulative sum chart.

Rapidly detecting problems in the quality of care is of utmost importance for the well-being of patients. Without proper inspection schemes, such problems can go undetected for years. Cumulative sum (CUSUM) charts have proven to be useful for quality control, yet available methodology for survival outcomes is limited. The few available continuous time inspection charts usually require the researcher to specify an expected increase in the failure rate in advance, thereby requiring prior knowledge about the problem at hand. Misspecifying parameters can lead to false positive alerts and large detection delays. To solve this problem, we take a more general approach to derive the new Continuous time Generalized Rapid response CUSUM (CGR-CUSUM) chart. We find an expression for the approximate average run length (average time to detection) and illustrate the possible gain in detection speed by using the CGR-CUSUM over other commonly used monitoring schemes on a real-life data set from the Dutch Arthroplasty Register as well as in simulation studies. Besides the inspection of medical procedures, the CGR-CUSUM can also be used for other real-time inspection schemes such as industrial production lines and quality control of services.

Prevalence and Hospital Admissions in Patients With Osteogenesis Imperfecta in The Netherlands: A Nationwide Registry Study.

Osteogenesis Imperfecta (OI) is a complex disease caused by genetic alterations in production of collagen type I, and collagen-related proteins. Bone fragility is the most common patient issue, but extraskeletal complications also present an adverse factor in the quality of life and prognosis of patients with OI. However, still little is known about the morbidity and mortality of these patients. The objective of this paper is to determine and describe to what extent OI impacts patients' life in terms of hospitalization and complications describing the incidence and prevalence of the Dutch cohort of OI patients and the characteristics of their hospital admissions. Information regarding OI patients and their hospital admission was extracted from the Statistics Netherlands Database and matched to the OI Genetics Database of Amsterdam UMC. Hospital admission data was available for 674 OI patients. This OI nationwide registry study shows that the life expectancy of OI patients is adversely affected by the disease. The median annual incidence risk of OI between 1992 and 2019 was 6.5 per 100,000 live births. Furthermore, patients with OI had a 2.9 times higher hospitalization rate compared to the general Dutch population. The highest hospitalization rate ratio of 8.4 was reported in the patient group between 0 and 19 years old. OI type and severity had impact on extraskeletal manifestations, which play a key role in the numerous hospital admissions. More awareness about the impact of OI on patients' life is needed to improve and implement prevention and follow-up guidelines.

The course of depressive symptoms in the first 12 months post-stroke and its association with unmet needs.

AIM: To describe the course of depressive symptoms during the first 12 months post-stroke and its association with unmet needs. METHODS: A prospective cohort study among stroke patients admitted to inpatient rehabilitation. Depressive symptoms were assessed 3, 6, and 12 months post-stroke using the Hospital Anxiety and Depression Scale, and categorized into three trajectories: no (all times <8), non-consistent (one or two times ≥8), or persistent (all times ≥8) depressive symptoms. Unmet needs were assessed using the Longer-Term Unmet Needs questionnaire. Multivariable logistic regression analyses were used to investigate the association between depressive symptoms and unmet needs. RESULTS: One hundred and fifty-one patients were included, of whom 95 (62.9%), 38 (25.2%), and 18 (11.9%) had no, non-consistent, or persistent depressive symptoms, respectively. Depressive symptoms three months post-stroke persisted in 43.9% and recurred in 19.5% of patients during the first 12 months post-stroke. Depressive symptoms were significantly associated with the occurrence and number of unmet needs (odds ratio 6.49; p = 0.003 and odds ratio 1.28; p = 0.005, respectively). CONCLUSIONS: Depressive symptoms three months post-stroke were likely to persist or recur during the first 12 months post-stroke. Depressive symptoms are associated with unmet needs. These results suggest that routine monitoring of depressive symptoms and unmet needs should be considered post-stroke.Implications for rehabilitationPatients with depressive symptoms three months post-stroke have a high risk of developing persistent or recurrent depressive symptoms during the first 12 months post-stroke.Unmet needs are associated with both non-consistent and persistent depressive symptoms post-stroke.These results suggest that health professionals should routinely screen for depressive symptoms and health care needs around three months post-stroke.In patients with depressive symptoms at three months post-stroke early treatment of depressive symptoms and addressing unmet needs should be considered and depressive symptoms should be routinely monitored during the first 12 months post-stroke.

Evolution from mitral annular dysfunction to severe mitral regurgitation in Barlow's disease.

OBJECTIVES: Barlow's disease (BD) is characterized by thick, redundant mitral valve (MV) leaflets, which can lead to prolapse and significant mitral regurgitation (MR). MV annular abnormalities are also commonly observed and increasingly recognized as possible primary pathology, with leaflet thickening being secondary to increased stress on the MV apparatus. To provide more insights into this hypothesis, the evolution of MV abnormalities over time in patients with BD was assessed. METHODS: A total of 64 patients (54 ± 12 years, 72% male) with BD who underwent MV surgery and had multiple transthoracic echocardiograms (TTE) before surgery were included. In total, 186 TTE were analysed (median time interval 4.2, interquartile range 2.2-6.5 years) including specific MV characteristics. RESULTS: At baseline, MV leaflet length, thickness, billowing height and annular diameter were larger in patients with BD compared to 59 healthy subjects. Systolic outward motion (curling) of the annulus was observed in 77% and severe mitral annular disjunction (≥5 mm) in 38% of patients with BD. Forty (63%) patients had MR grade I-II and 24 (37%) MR grade III-IV; at baseline, the 2 groups only differed in left atrial volume and in thickness and billowing height of the posterior leaflet, showing comparable MV annular abnormalities and dilatation despite different grades of MR. Over time, MV annulus diameter, leaflet length and billowing height increased significantly along with MR grade. CONCLUSIONS: In patients with BD, MV annulus abnormalities are present at an early stage and precede the development of significant MR, suggesting their substantial role in the pathophysiology of this disease and as an important target for surgical treatment.

Physical activity, fatigue and sleep quality at least 6 months after mild traumatic brain injury in adolescents and young adults: A comparison with orthopedic injury controls.

OBJECTIVES: To compare physical activity (PA), fatigue and sleep quality in adolescents and young adults (AYAs) after mild TBI (mTBI) to persons of similar age after orthopedic injury (OI) on the longer term. SETTING: Follow-up at least 6 months after visiting the emergency department of one of 2 general hospitals. PARTICIPANTS: Forty-nine patients aged 12-25 years (mean 18.4 years), diagnosed with mTBI and 54 patients aged 12-25 years (mean 15.8 years) with OI. DESIGN: Cross-sectional electronic survey study. MAIN OUTCOME MEASURES: The Activity Questionnaire for Adults and Adolescents with results dichotomized for meeting/not meeting Dutch Health Enhancing PA recommendations (D-HEPA), the Checklist Individual Strength (range 20-140, low-high) measuring fatigue, and the Pittsburgh Sleep Quality Index (range 0-21, high-low) measuring sleep quality were administered. RESULTS: Patients with mTBI less frequently met D-HEPA recommendations than patients with OI (49% vs. 70%; OR 2.87, 95%CI 1.07, 7.72) and reported more concentration-related fatigue problems (mean 19.1 (SD 8.0), mean 13.9 (SD 7.8), respectively; ß 3.98, 95%CI 0.39, 7.56), after adjusting for potential confounders, sex, BMI, age and time since injury. No differences were found in sleep quality. CONCLUSIONS: Identifying symptoms and limitations in activities is important after mTBI so that rehabiliation treatment can be initiated. Whether physical activity or fatigue is the best target for treatment remains to be established.

Merged block randomisation: A novel randomisation procedure for small clinical trials.

BACKGROUND/AIMS: Randomisation in small clinical trials is a delicate matter, due to the tension between the conflicting aims of balanced groups and unpredictable allocations. The commonly used method of permuted block randomisation has been heavily criticised for its high predictability. This article introduces merged block randomisation, a novel and conceptually simple restricted randomisation design for small clinical trials (less than 100 patients per stratum). Merged block randomisation is a simple procedure that can be carried out without need for a computer. Merged block randomisation is not restricted to 1:1 randomisation, but is readily applied to unequal target allocations and to more than two treatment groups. METHODS: The position of merged block randomisation on the spectrum of balance and predictability is investigated in a simulation study, in two common situations: a single-centre study and a multicentre study (with sampling stratified per centre). Methods included for comparison were permuted block randomisation, Efron's biased coin design, the maximal procedure, the block urn design and the big stick design. RESULTS: Compared to permuted block randomisation with blocks of size 4, merged block randomisation has the same maximum tolerated imbalance and is thus as impervious to chronological bias, with the added benefit of being less predictable. Each method in the study takes a different position on the balance/determinism spectrum, and none was uniformly best. Merged block randomisation was either less predictable or more balanced than the other methods, in all simulation settings. CONCLUSION: Merged block randomisation is a versatile restricted randomisation method that outperforms permuted block randomisation and is a good choice for small clinical trials where imbalance is a main concern, especially in multicentre trials where the number of patients per centre may be small.

Patients' outcome expectations and their fulfilment in multidisciplinary stroke rehabilitation.

BACKGROUND: Patients' expectations of the outcomes of rehabilitation may influence the outcomes and satisfaction with treatment. OBJECTIVES: For stroke patients in multidisciplinary rehabilitation, we aimed to explore patients' outcome expectations and their fulfilment as well as determinants. METHODS: The Stroke Cohort Outcomes of REhabilitation (SCORE) study included consecutive stroke patients admitted to an inpatient rehabilitation facility after hospitalisation. Outcome expectations were assessed at the start of rehabilitation (admission) by using the three-item Expectancy scale (sum score range 3-27) of the Credibility/Expectancy Questionnaire (CEQ). After rehabilitation, patients answered the same questions formulated in the past tense to assess fulfilment of expectations. Baseline patient characteristics were recorded and health-related quality of life (EQ-5D) was measured at baseline and after rehabilitation. The number of patients with expectations unfulfilled or fulfilled or exceeded was computed by subtracting the admission and discharge CEQ Expectancy scores. Multivariable regression analysis was used to determine the factors associated with outcome expectations and their fulfilment, estimating odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: We included 165 patients (96 males [58.2%], mean (SD) age 60.2 years [12.7]) who completed the CEQ Expectancy instrument at admission (median score 21.6, interquartile range [IQR] 17.0-24.0); 79 completed it both at admission (median score 20.6, IQR 16.6-24.4) and follow-up (median score 20.0, IQR 16.4-22.8). For 40 (50.6%) patients, expectations of therapy were fulfilled or exceeded. No patient characteristic at admission was associated with baseline CEQ Expectancy score. Odds of expectation fulfilment were associated with low expectations at admission (OR 0.70, 95% CI 0.60-0.83) and improved EQ-5D score (OR 1.35, 95% CI 1.04-0.75). CONCLUSIONS: In half of the stroke patients in multidisciplinary rehabilitation, expectations were fulfilled or exceeded, most likely in patients with low expectations at admission and with improved health-related quality of life. More research into the role of health professionals regarding the measurement, shaping and management of outcome expectations is needed.

Different competing risks models for different questions may give similar results in arthroplasty registers in the presence of few events.

Background and purpose - In arthroplasty registry studies, the analysis of time to revision is complicated by the competing risk of death. There are no clear guidelines for the choice between the 2 main adjusted analysis methods, cause-specific Cox and Fine-Gray regression, for orthopedic data. We investigated whether there are benefits, such as insight into different aspects of progression to revision, to using either 1 or both regression methods in arthroplasty registry studies in general, and specifically when the length of follow-up is short relative to the expected survival of the implants. Patients and methods - Cause-specific Cox regression and Fine-Gray regression were performed on total hip (138,234 hips, 124,560 patients) and knee (139,070 knees, 125,213 patients) replacement data from the Dutch Arthroplasty Register (median follow-up 3.1 years, maximum 8 years), with sex, age, ASA score, diagnosis, and type of fixation as explanatory variables. The similarity of the resulting hazard ratios and confidence intervals was assessed visually and by computing the relative differences of the resulting subdistribution and cause-specific hazard ratios. Results - The outcomes of the cause-specific Cox and Fine-Gray regressions were numerically very close. The largest relative difference between the hazard ratios was 3.5%. Interpretation - The most likely explanation for the similarity is that there are relatively few events (revisions and deaths), due to the short follow-up compared with the expected failure-free survival of the hip and knee prostheses. Despite the similarity, we recommend always performing both cause-specific Cox and Fine-Gray regression. In this way, both etiology and prediction can be investigated.

Early and long-term outcomes of mitral valve repair for Barlow's disease: a single-centre 16-year experience.

OBJECTIVES: Following mitral valve repair for Barlow's disease, recurrent mitral regurgitation (MR) is believed to occur frequently and is mainly attributed to disease progression. METHODS: Between January 2000 and December 2015, 180 patients (40% women, mean age 58.7 ± 13.5 years) with Barlow's disease underwent mitral valve repair. To provide a longitudinal assessment of mitral valve repair durability, a multistate model for interval-censored observations (4 states: 1, Grade 0/1+ MR; 2, Grade 2+ MR; 3, Grade 3+/4+ MR; 4, reintervention/death) was developed. The mechanism of recurrent MR was assessed echocardiographically. RESULTS: Early mortality was 1.7%. After hospital discharge, 6 late reinterventions were performed. With death as a competing risk, the 10-year overall reintervention-free survival and reintervention rates were 79.8% (95% confidence interval 72.7-87.6%) and 4.5% (95% confidence interval 2.0-10.2%), respectively. Echocardiographic follow-up was available for 165 (93%) of hospital survivors with a total of 480 examinations. The incidence of both recurrent Grade 2+ and Grade 3+/4+ MR was relatively low up to 10 years after surgery. Grade 2+ MR did not always progress to higher regurgitation grade during the follow-up period. Grade 3+/4+ regurgitation was highly associated with valve-related morbidity and mortality. Recurrent MR (≥Grade 2+) was predominantly related to the technical aspects of valve repair. CONCLUSIONS: Despite the complex valve abnormalities observed in patients with Barlow's disease, mitral valve repair can be performed with good early and late outcomes and low rates of recurrence of MR up to 10 years after surgery. Early and late valve repair durability is good and remains stable over time, suggesting that underlying disease progression has limited clinical significance.

Patients with Staged Bilateral Total Joint Arthroplasty in Registries: Immortal Time Bias and Methodological Options.

BACKGROUND: In arthroplasty data, patients with staged bilateral total joint arthroplasty (TJA) pose a problem in statistical analysis. Subgroup analysis, in which patients with unilateral and bilateral TJA are studied separately, is sometimes considered an appropriate solution to the problem; we aim to show that this is not true because of immortal time bias. METHODS: We reviewed patients who underwent staged (at any time) bilateral TJA. The logical fallacy leading to immortal time bias is explained through a simple artificial data example. The cumulative incidences of revision and death are computed by subgroup analysis and by landmark analysis based on hip replacement data from the Dutch Arthroplasty Register and on simulated data sets. RESULTS: For patients who underwent unilateral TJA, subgroup analysis can lead to an overestimate of the cumulative incidence of death and an underestimate of the cumulative incidence of revision. The reverse conclusion holds for patients who underwent staged bilateral TJA. Analysis of these patients can lead to an underestimate of the cumulative incidence of death and an overestimate of the cumulative incidence of revision. Immortal time bias can be prevented by using landmark analysis. CONCLUSIONS: When examining arthroplasty registry data, patients who underwent staged bilateral TJA should be analyzed with caution. An appropriate statistical method to address the research question should be selected.