Category: Nevin Manimala

Neurology. 2021 Apr 7:10.1212/WNL.0000000000011933. doi: 10.1212/WNL.0000000000011933. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the effects of rituximab on retinal atrophy in patients with relapsing-remitting multiple sclerosis (RRMS), we performed serial optical coherence tomography (OCT) scans among a cohort of RRMS patients on rituximab, and compared rates of ganglion cell+inner plexiform layer (GCIPL) atrophy to those observed among age- and sex-matched glatiramer acetate (GA)- and natalizumab-treated RRMS patients, and healthy controls (HCs).

METHODS: In this observational study, patients with RRMS treated with a single disease-modifying therapy, and HCs, were followed with serial OCT for a median duration of 2.8 years. Participants with uncontrolled hypertension, diabetes mellitus, or glaucoma, and eyes with optic neuritis ≤6 months prior to baseline OCT, or during follow-up, were excluded. Statistical analyses were performed using linear mixed-effects regression.

RESULTS: During the overall follow-up period, rates of GCIPL atrophy were -0.28±0.11µm/yr among rituximab-treated RRMS patients (n=35). This was similar to GA-treated (n=49; -0.33±0.05µm/yr; p=0.69) and natalizumab-treated patients (n=88; -0.17±0.10µm/yr; p=0.13), and faster than HCs (n=78; -0.15±0.03µm/yr; p=0.006). Rituximab-treated patients exhibited 0.55±0.23µm/yr faster rates of GCIPL atrophy during the first 12 months of treatment, relative to afterwards (n=25; p=0.02), during which period GCIPL atrophy rates were -0.14±0.13µm/yr.

CONCLUSIONS: Retinal atrophy in RRMS is modulated by rituximab. Greater attenuation of retinal atrophy may occur after 12 months of rituximab treatment, following which time GCIPL atrophy rates are similar to those observed among natalizumab-treated RRMS patients and HCs. Our findings raise the possibility that the neuroprotective therapeutic response with rituximab in RRMS may take up to 12 months, though should be confirmed by larger studies.

CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence on the difference in rate of change of the ganglion cell+inner plexiform layer thickness in patients with RRMS, comparing rituximab to other DMTs.

PMID:33827962 | DOI:10.1212/WNL.0000000000011933

BMJ Open. 2021 Apr 7;11(4):e046226. doi: 10.1136/bmjopen-2020-046226.

ABSTRACT

OBJECTIVE: This study aims to advance understanding of globally valid versus country-specific quality dimensions and indicators, as perceived by relevant stakeholders. It specifically addresses patient-level indicators for cataract surgery.

DESIGN: A mixed-methods case study comparing Singapore and The Netherlands SETTING: Singapore (2017-2019) and The Netherlands (2014-2015).

PARTICIPANTS: Stakeholder representatives of cataract care in Singapore and The Netherlands.

INTERVENTION: Based on the previously identified complete set of stakeholders in The Netherlands, we identified stakeholders of cataract care in Singapore. Stakeholder representatives then established a multi-stakeholder perspective on the quality of cataract care using a concept mapping approach. This yielded a multidimensional cluster map based on multivariate statistical analyses. Consensus-based quality dimensions were subsequently defined during a plenary session. Thereafter, Singaporean dimensions were matched with dimensions obtained in The Netherlands to identify commonalities and differences.

MAIN OUTCOME MEASURE: Health-services quality dimensions of cataract care.

RESULTS: 19 Singaporean stakeholders representing patients, general practitioners, ophthalmologists, nurses, care providers, researchers and clinical auditors defined health-services quality of cataract care using the following eight dimensions: clinical outcome, patient outcomes, surgical process, surgical safety, patient experience, access, cost and standards of care. Compared with the Dutch results, 61% of the indicators were allocated to dimensions of comparable names and compositions. Considerable differences also existed in the composition of some dimensions and the importance attached to indicators.

CONCLUSIONS AND RELEVANCE: This study on cataract care in Singapore and The Netherlands shows that cataract care quality measurement instruments can share a common international core. At the same time, it emphasises the importance of taking a country-specific multi-stakeholder approach to quality definition and measurement. Complementing an international core set with country-specific measures is required to ensure that the included dimensions and indicators adequately capture the country-specific quality views.

PMID:33827846 | DOI:10.1136/bmjopen-2020-046226

BMJ Open. 2021 Apr 7;11(4):e047121. doi: 10.1136/bmjopen-2020-047121.

ABSTRACT

OBJECTIVES: To develop a prognostic model to identify and quantify risk factors for mortality among patients admitted to the hospital with COVID-19.

DESIGN: Retrospective cohort study. Patients were randomly assigned to either training (80%) or test (20%) sets. The training set was used to fit a multivariable logistic regression. Predictors were ranked using variable importance metrics. Models were assessed by C-indices, Brier scores and calibration plots in the test set.

SETTING: Optum de-identified COVID-19 Electronic Health Record dataset including over 700 hospitals and 7000 clinics in the USA.

PARTICIPANTS: 17 086 patients hospitalised with COVID-19 between 20 February 2020 and 5 June 2020.

MAIN OUTCOME MEASURE: All-cause mortality while hospitalised.

RESULTS: The full model that included information on demographics, comorbidities, laboratory results, and vital signs had good discrimination (C-index=0.87) and was well calibrated, with some overpredictions for the most at-risk patients. Results were similar on the training and test sets, suggesting that there was little overfitting. Age was the most important risk factor. The performance of models that included all demographics and comorbidities (C-index=0.79) was only slightly better than a model that only included age (C-index=0.76). Across the study period, predicted mortality was 1.3% for patients aged 18 years old, 8.9% for 55 years old and 28.7% for 85 years old. Predicted mortality across all ages declined over the study period from 22.4% by March to 14.0% by May.

CONCLUSION: Age was the most important predictor of all-cause mortality, although vital signs and laboratory results added considerable prognostic information, with oxygen saturation, temperature, respiratory rate, lactate dehydrogenase and white cell count being among the most important predictors. Demographic and comorbidity factors did not improve model performance appreciably. The full model had good discrimination and was reasonably well calibrated, suggesting that it may be useful for assessment of prognosis.

PMID:33827848 | DOI:10.1136/bmjopen-2020-047121

BMJ Open. 2021 Apr 7;11(4):e044669. doi: 10.1136/bmjopen-2020-044669.

ABSTRACT

INTRODUCTION: Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas.

METHODS AND ANALYSIS: This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18-36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect.

ETHICS AND DISSEMINATION: This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT04244721.

PMID:33827837 | DOI:10.1136/bmjopen-2020-044669

BMJ Open. 2021 Apr 7;11(4):e044854. doi: 10.1136/bmjopen-2020-044854.

ABSTRACT

OBJECTIVE: Survival gains in teenagers and young adults (TYA) are reported to be lower than children and adults for some cancers. Place of care is implicated, influencing access to specialist TYA professionals and research.Consequently, age-appropriate specialist cancer care is advocated for TYA although systematic investigation of associated outcomes is lacking. In England, age-appropriate care is delivered through 13 Principal Treatment Centres (TYA-PTC). BRIGHTLIGHT is the national evaluation of TYA cancer services to examine outcomes associated with differing places and levels of care. We aimed to examine the association between exposure to TYA-PTC care, survival and documentation of clinical processes of care.

DESIGN: Prospective cohort study.

SETTING: 109 National Health Service (NHS) hospitals across England.

PARTICIPANTS: 1114 TYA, aged 13-24, newly diagnosed with cancer between 2012 and 2014.

INTERVENTION: Participants were assigned a TYA-PTC category dependent on the proportion of care delivered in a TYA-PTC in the first year after diagnosis: all care in a TYA-PTC (ALL-TYA-PTC, n=270), no care in a TYA-PTC (NO-TYA-PTC, n=359), and some care in a TYA-PTC with additional care in a children’s/adult unit (SOME-TYA-PTC, n=419).

PRIMARY OUTCOME: Data were collected on documented processes indicative of age-appropriate care using clinical report forms, and survival through linkage to NHS databases.

RESULTS: TYA receiving NO-TYA-PTC care were less likely to have documentation of molecular diagnosis, be reviewed by a children’s or TYA multidisciplinary team, be assessed by supportive care services or have a fertility discussion. There was no significant difference in survival according to category of care. There was weak evidence that the association between care category and survival differed by age (p=0.08) with higher HRs for those over 19 receiving ALL or SOME-TYA-PTC compared with NO-TYA-PTC.

CONCLUSION: TYA-PTC care was associated with better documentation of clinical processes associated with age-appropriate care but not improved survival.

PMID:33827838 | DOI:10.1136/bmjopen-2020-044854

BMJ Open. 2021 Apr 7;11(4):e043364. doi: 10.1136/bmjopen-2020-043364.

ABSTRACT

OBJECTIVE: To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.

DESIGN: Randomised controlled, open feasibility trial with embedded economic and process evaluations.

SETTING: Audiology departments in two hospitals in two UK cities.

PARTICIPANTS: Twelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.

INTERVENTIONS: Consenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group).

PRIMARY OUTCOME MEASURES: The primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.

SECONDARY OUTCOME MEASURES: International Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible.

RESULTS: Twelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size.

CONCLUSIONS: While ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point.

TRIAL REGISTRATION NUMBER: ISRCTN28090877.

PMID:33827834 | DOI:10.1136/bmjopen-2020-043364

BMJ Open. 2021 Apr 7;11(4):e041742. doi: 10.1136/bmjopen-2020-041742.

ABSTRACT

INTRODUCTION: This double-blind, randomised controlled trial (RCT) aims to estimate the effect of a physiotherapist-led intervention with targeted strengthening compared with a physiotherapist-led intervention with standardised stretching, on hip-related quality of life (QOL) or perceived improvement at 6 months in people with femoroacetabular impingement (FAI) syndrome. We hypothesise that at 6 months, targeted strengthening physiotherapist-led treatment will be associated with greater improvements in hip-related QOL or greater patient-perceived global improvement when compared with standardised stretching physiotherapist-led treatment.

METHODS AND ANALYSIS: We will recruit 164 participants with FAI syndrome who will be randomised into one of the two intervention groups, both receiving one-on-one treatment with the physiotherapist over 6 months. The targeted strengthening physiotherapist-led treatment group will receive a personalised exercise therapy and education programme. The standardised stretching physiotherapist-led treatment group will receive standardised stretching and personalised education programme. Primary outcomes are change in hip-related QOL using International Hip Outcome Tool-33 and patient-perceived global improvement. Secondary outcomes include cost-effectiveness, muscle strength, range of motion, functional task performance, biomechanics, hip cartilage structure and physical activity levels. Statistical analyses will make comparisons between both treatment groups by intention to treat, with all randomised participants included in analyses, regardless of protocol adherence. Linear mixed models (with baseline value as a covariate and treatment condition as a fixed factor) will be used to evaluate the treatment effect and 95% CI at primary end-point (6 months).

ETHICS AND DISSEMINATION: The study protocol was approved (La Trobe University Human Ethics Committee (HEC17-080)) and prospectively registered with the Australian New Zealand Clinical Trials Registry. The findings of this RCT will be disseminated through peer reviewed scientific journals and conferences. Patients were involved in study development and will receive a short summary following the completion of the RCT.

TRIAL REGISTRATION NUMBER: ACTRN12617001350314.

PMID:33827828 | DOI:10.1136/bmjopen-2020-041742

BMJ Open. 2021 Apr 7;11(4):e041917. doi: 10.1136/bmjopen-2020-041917.

ABSTRACT

OBJECTIVE: The purpose of this study was to assess the trends in outcomes of out-of-hospital cardiac arrest (OHCA) in Beijing over 5 years.

DESIGN: Cross-sectional study.

METHODS: Adult patients with OHCA of all aetiologies who were treated by the Beijing emergency medical service (EMS) between January 2013 and December 2017 were analysed. Data were collected using the Utstein Style. Cases were followed up for 1 year. Descriptive statistics were used to characterise the sample and logistic regression was performed.

RESULTS: Overall, 5016 patients with OHCA underwent attempted resuscitation by the EMS in urban areas of Beijing during the study period. Survival to hospital discharge was 1.2% in 2013 and 1.6% in 2017 (adjusted rate ratio=1.0, p for trend=0.60). Survival to admission and neurological outcome at discharge did not significantly improve from 2013 to 2017. Patient characteristics and the aetiology and location of cardiac arrest were consistent, but there was a decrease in the initial shockable rhythm (from 6.5% to 5.6%) over the 5 years. The rate of bystander cardiopulmonary resuscitation (CPR) increased steadily over the years (from 10.4% to 19.4%).

CONCLUSION: Survival after OHCA in urban areas of Beijing did not improve significantly over 5 years, with long-term survival being unchanged, although the rate of bystander CPR increased steadily, which enhanced the outcomes of patients who underwent bystander CPR.

PMID:33827829 | DOI:10.1136/bmjopen-2020-041917

Fertil Steril. 2021 Apr 4:S0015-0282(21)00147-3. doi: 10.1016/j.fertnstert.2021.02.029. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the association between body mass index (BMI) and embryo aneuploidy and mosaicism in a cohort of patients undergoing in vitro fertilization (IVF) with trophectoderm biopsy for preimplantation genetic testing for aneuploidy (PGT-A) using next-generation sequencing technology.

DESIGN: Retrospective cohort study.

SETTING: Academic center.

PATIENTS: Patients undergoing their first IVF cycle with trophectoderm biopsy and PGT-A at our center between January 1, 2017, and August 31, 2020. Patients classified as underweight on the basis of BMI (BMI <18.5 kg/m²) and patients who underwent fresh embryo transfers were excluded.

INTERVENTION: None.

MAIN OUTCOME MEASURES: Number and proportion of aneuploid, mosaic, and euploid embryos.

RESULTS: The patients were stratified according to the World Health Organization’s BMI classification: normal weight (18.5-24.9 kg/m², n = 1,254), overweight (25-29.9 kg/m², n = 351), and obese (≥30 kg/m², n = 145). Age-adjusted regression models showed no relationship between BMI classification and the number or proportion of aneuploid embryos. There were no statistically significant associations between BMI classifications and the number or proportion of mosaic or euploid embryos. A subgroup analysis of patients classified into age groups of <35, 35-40, and >40 years similarly showed no relationships between BMI and embryo ploidy outcomes.

CONCLUSION: Body mass index was not associated with the number or proportion of aneuploid, mosaic, or euploid embryos in this large cohort of patients undergoing IVF with PGT-A, suggesting that the negative effect of excess weight on reproductive outcomes was independent of the ploidy status of the embryo cohort.

PMID:33827765 | DOI:10.1016/j.fertnstert.2021.02.029

Injury. 2021 Mar 26:S0020-1383(21)00267-9. doi: 10.1016/j.injury.2021.03.049. Online ahead of print.

ABSTRACT

INTRODUCTION: Amongst critically ill trauma patients admitted to ICU and still alive and in ICU after 24 hours, it is unclear which trauma scoring system offers the best performance in predicting in-hospital mortality.

METHODS: The Australia and New Zealand Intensive Care Society Adult Patient Database and Victorian State Trauma Registry were linked using a unique patient identification number. Six scoring systems were evaluated: the Australian and New Zealand Risk of Death (ANZROD), Acute Physiology and Chronic Health Evaluation III (APACHE III) score and associated APACHE III Risk of Death (ROD), Trauma and Injury Severity Score (TRISS), Injury Severity Score (ISS), New Injury Severity Score (NISS) and the Revised Trauma Score (RTS). Patients who were admitted to ICU for longer than 24 hours were analysed. Performance of each scoring system was assessed primarily by examining the area under the receiver operating characteristic curve (AUROC) and in addition using standardised mortality ratios, Brier score and Hosmer-Lemeshow C statistics where appropriate. Subgroup assessments were made for patients aged 65 years and older, patients between 18 and 40 years of age, major trauma centre and head injury.

RESULTS: Overall, 5,237 major trauma patients who were still alive and in ICU after 24 hours were studied from 25 ICUs in Victoria, Australia between July 2008 and January 2018. Hospital mortality was 10.7%. ANZROD (AUROC 0.91; 95% CI 0.90-0.92), APACHE III ROD (AUROC 0.88; 95% CI 0.87-0.90), and APACHE III (AUROC 0.88; 95% CI 0.87-0.89) were the best performing tools for predicting hospital mortality. TRISS had acceptable overall performance (AUROC 0.78; 95% CI 0.76-0.80) while ISS (AUROC 0.61; 95% CI 0.59-0.64), NISS (AUROC 0.68; 95% CI 0.65-0.70) and RTS (AUROC 0.69; 95% CI 0.67-0.72) performed poorly. The performance of each scoring system was highest in younger adults and poorest in older adults.

CONCLUSION: In ICU patients admitted with a trauma diagnosis and still alive and in ICU after 24 hours, ANZROD and APACHE III had a superior performance when compared with traditional trauma-specific scoring systems in predicting hospital mortality. This was observed both overall and in each of the subgroup analyses. The anatomical scoring systems all performed poorly in the ICU population of Victoria, Australia.

PMID:33827776 | DOI:10.1016/j.injury.2021.03.049