Category: Nevin Manimala

Lancet Oncol. 2023 May;24(5):e197-e206. doi: 10.1016/S1470-2045(23)00110-9.

ABSTRACT

Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 papers published between 2018 and 2021 of single-arm studies of cancer treatment with PRO data for current practice on design, analysis, reporting, and interpretation. We further examined the studies’ handling of potential bias and how they informed decision making. Most studies (58; 97%) analysed PROs without stating a predefined research hypothesis. 13 (22%) of the 60 studies used a PRO as a primary or co-primary endpoint. Definitions of PRO objectives, study population, endpoints, and missing data strategies varied widely. 23 studies (38%) compared the PRO data with external information, most often by using a clinically important difference value; one study used a historical control group. Appropriateness of methods to handle missing data and intercurrent events (including death) were seldom discussed. Most studies (51; 85%) concluded that PRO results supported treatment. Conducting and reporting of PROs in cancer single-arm studies need standards and a critical discussion of statistical methods and possible biases. These findings will guide the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Data in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) in developing recommendations for the use of PRO-measures in single-arm studies.

PMID:37142381 | DOI:10.1016/S1470-2045(23)00110-9

Am J Orthod Dentofacial Orthop. 2023 May;163(5):732-734. doi: 10.1016/j.ajodo.2023.02.005.

NO ABSTRACT

PMID:37142356 | DOI:10.1016/j.ajodo.2023.02.005

BMJ Open. 2023 May 4;13(5):e071059. doi: 10.1136/bmjopen-2022-071059.

ABSTRACT

INTRODUCTION: Digital game-based training interventions are scalable solutions that may improve cognitive function for many populations. This protocol for a two-part review aims to synthesise the effectiveness and key features of digital game-based interventions for cognitive training in healthy adults across the life span and adults with cognitive impairment, to update current knowledge and impact the development of future interventions for different adult subpopulations.

METHODS AND ANALYSIS: This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. A systematic search was performed in PubMed, Embase, CINAHL, Cochrane Library, Web of Science, PsycINFO and IEEE Explore on 31 July 2022 for relevant literature published in English from the previous 5 years. Experimental, observational, exploratory, correlational, qualitative and mixed methods studies will be eligible if they report at least one cognitive function outcome and include a digital game-based intervention intended to improve cognitive function. Reviews will be excluded but retained to search their reference lists for other relevant studies. All screening will be done by at least two independent reviewers. The appropriate Joanna Briggs Institute Critical Appraisal Tool, according to the study design, will be applied to perform the risk of bias assessment. Outcomes related to cognitive function and digital game-based intervention features will be extracted. Results will be categorised by adult life span stages in the healthy adult population for part 1 and by neurological disorder in part 2. Extracted data will be analysed quantitatively and qualitatively, according to study type. If a group of sufficiently comparable studies is identified, we will perform a meta-analysis applying the random effects model with consideration of the I² statistic.

ETHICS AND DISSEMINATION: Ethics approval is not applicable for this study since no original data will be collected. The results will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO REGISTRATION NUMBER: CRD42022351265.

PMID:37142320 | DOI:10.1136/bmjopen-2022-071059

BMJ Open. 2023 May 4;13(5):e066829. doi: 10.1136/bmjopen-2022-066829.

ABSTRACT

DESIGN: Analyst blinded, parallel, multi-centre, randomised controlled trial (RCT).

PARTICIPANTS: People with confirmed diagnoses of cancer (head and neck, skin or colorectal) attending follow-up consultation 3 months post-treatment between 2015 and 2020.

INTERVENTION: Holistic needs assessment (HNA) or care as usual during consultation.

OBJECTIVE: To establish whether incorporating HNA into consultations would increase patient participation, shared decision making and postconsultation self-efficacy.

OUTCOME MEASURES: Patient participation in the consultations examined was measured using (a) dialogue ratio (DR) and (b) the proportion of consultation initiated by patient. Shared decision making was measured with CollaboRATE and self-efficacy with Lorig Scale. Consultations were audio recorded and timed.

RANDOMISATION: Block randomisation.

BLINDING: Audio recording analyst was blinded to study group.

RESULTS: 147 patients were randomised: 74 control versus 73 intervention.

OUTCOME: No statistically significant differences were found between groups for DR, patient initiative, self-efficacy or shared decision making. Consultations were on average 1 min 46 s longer in the HNA group (respectively, 17 m 25 s vs 15 min 39 s).

CONCLUSION: HNA did not change the amount of conversation initiated by the patient or the level of dialogue within the consultation. HNA did not change patient sense of collaboration or feelings of self-efficacy afterwards. HNA group raised more concerns and proportionally more emotional concerns, although their consultations took longer than treatment as usual.

IMPLICATIONS FOR PRACTICE: This is the first RCT to test HNA in medically led outpatient settings. Results showed no difference in the way the consultations were structured or received. There is wider evidence to support the roll out of HNA as part of a proactive, multidisciplinary process, but this study did not support medical colleagues facilitating it.

TRIAL REGISTRATION NUMBER: NCT02274701.

PMID:37142317 | DOI:10.1136/bmjopen-2022-066829

BMJ Open. 2023 May 4;13(5):e069768. doi: 10.1136/bmjopen-2022-069768.

ABSTRACT

OBJECTIVE: This study aimed to assess the incidence and identify predictors of perioperative mortality among the adult age group at Tibebe Ghion Specialised Hospital.

DESIGN: A single-centre prospective follow-up study.

SETTING: A tertiary hospital in North West Ethiopia.

PARTICIPANTS: We enrolled 2530 participants who underwent surgery in the current study. All adults aged 18 and above were included except those with no telephone.

PRIMARY OUTCOME MEASURES: The primary outcome was time to death measured in days from immediate postoperative time up to the 28th day following surgery.

RESULT: A total of 2530 surgical cases were followed for 67 145 person-days. There were 92 deaths, with an incidence rate of 1.37 (95% CI 1.11 to 1.68) deaths per 1000 person-day observations. Regional anaesthesia was significantly associated with lower postoperative mortality (adjusted hazard ratio (AHR) 0.18, 95% CI 0.05 to 0.62). Patients aged ≥65 years (AHR 3.04, 95% CI 1.65 to 5.75), American Society of Anesthesiologist (ASA) physical status III (AHR 2.41, 95% CI 1.1.13 to 5.16) and IV (AHR 2.74, 95% CI 1.08 to 6.92), emergency surgery (AHR 1.85, 95% CI 1.02 to 3.36) and preoperative oxygen saturation <95% (AHR 3.14, 95% CI 1.85 to 5.33) were significantly associated with a higher risk of postoperative mortality.

CONCLUSION: The postoperative mortality rate at Tibebe Ghion Specialised Hospital was high. Age ≥65, ASA physical status III and IV, emergency surgery, and preoperative oxygen saturation <95% were significant predictors of postoperative mortality. Patients with the identified predictors should be offered targeted treatment.

PMID:37142313 | DOI:10.1136/bmjopen-2022-069768

BMJ Open. 2023 May 4;13(5):e069664. doi: 10.1136/bmjopen-2022-069664.

ABSTRACT

PURPOSE: The Swedish Tattoo and Body Modifications Cohort (TABOO) cohort was established to provide an infrastructure for epidemiological studies researching the role of tattoos and other body modifications as risk factors for adverse health outcomes. It is the first population-based cohort with detailed exposure assessment of decorative, cosmetic, and medical tattoos, piercing, scarification, henna tattoos, cosmetic laser treatments, hair dyeing, and sun habits. The level of detail in the exposure assessment of tattoos allows for investigation of crude dose-response relationships.

PARTICIPANTS: The TABOO cohort includes 13 049 individuals that participated in a questionnaire survey conducted in 2021 (response rate 49%). Outcome data are retrieved from the National Patient Register, the National Prescribed Drug Register and the National Cause of Death Register. Participation in the registers is regulated by Swedish law, which eliminates the risk of loss to follow-up and associated selection bias.

FINDINGS TO DATE: The tattoo prevalence in TABOO is 21%. The cohort is currently used to clarify the incidence of acute and long-lasting health complaints after tattooing based on self-reported data. Using register-based outcome data, we are investigating the role of tattoos as a risk factor for immune-mediated disease, including hypersensitisation, foreign body reactions and autoimmune conditions.

FUTURE PLANS: The register linkage will be renewed every third year to update the outcome data, and we have ethical approval to reapproach the responders with additional questionnaires.

PMID:37142309 | DOI:10.1136/bmjopen-2022-069664

BMJ Open Gastroenterol. 2023 May;10(1):e001037. doi: 10.1136/bmjgast-2022-001037.

ABSTRACT

OBJECTIVE: To estimate the risk of non-Hodgkin’s lymphoma (NHL) and Hodgkin’s lymphoma (HL) in patients with inflammatory bowel disease (IBD).

DESIGN: We undertook a two-country population cohort study with all patients diagnosed with IBD in Norway and Sweden from 1987 and 1993 through 2015 and 2016, respectively, and analysed the risk of NHL and HL. In Sweden, we also analysed prescriptions of thiopurines and anti-tumour necrosis factor (TNF)-α therapy from 2005. We calculated standardised incidence ratios (SIRs) with 95% CIs using the general populations as reference.

RESULTS: Among 131 492 patients with IBD with a medium follow-up of 9.6 years, we identified 369 cases of NHL and 44 cases of HL. The SIR of NHL was 1.3 (95% CI 1.1 to 1.5) in ulcerative colitis and 1.4 (95% CI 1.2 to 1.7) in Crohn’s disease. We found no compelling heterogeneity in analyses stratified by patient characteristics. We found a similar pattern and magnitude of excess risks for HL. At 10 years, cumulative incidence was 0.26% (95% CI 0.23% to 0.30%) and 0.06% (95% CI 0.04% to 0.08%) for NHL and HL, respectively. Higher excess risks were found among patients with NHL with concomitant primary sclerosing cholangitis (SIR 3.4; 95% CI 2.1 to 5.2) and in those prescribed thiopurines alone (SIR 2.8; 95% CI 1.4 to 5.7) or with anti-TNF-α agents (SIR 5.7; 95% CI 2.7 to 11.9).

CONCLUSION: Patients with IBD have a statistically significant increased risk of malignant lymphomas compared with the general population, but the absolute risk remains low.

PMID:37142293 | DOI:10.1136/bmjgast-2022-001037

Biol Rev Camb Philos Soc. 2023 May 4. doi: 10.1111/brv.12966. Online ahead of print.

ABSTRACT

Despite discussions extending back almost 160 years, the means by which Madagascar’s iconic land vertebrates arrived on the island remains the focus of active debate. Three options have been considered: vicariance, range expansion across land bridges, and dispersal over water. The first assumes that a group (clade/lineage) occupied the island when it was connected with the other Gondwana landmasses in the Mesozoic. Causeways to Africa do not exist today, but have been proposed by some researchers for various times in the Cenozoic. Over-water dispersal could be from rafting on floating vegetation (flotsam) or by swimming/drifting. A recent appraisal of the geological data supported the idea of vicariance, but found nothing to justify the notion of past causeways. Here we review the biological evidence for the mechanisms that explain the origins of 28 of Madagascar’s land vertebrate clades [two other lineages (the geckos Geckolepis and Paragehyra) could not be included in the analysis due to phylogenetic uncertainties]. The podocnemid turtles and typhlopoid snakes are conspicuous for they appear to have arisen through a deep-time vicariance event. The two options for the remaining 26 (16 reptile, five land-bound-mammal, and five amphibian), which arrived between the latest Cretaceous and the present, are dispersal across land bridges or over water. As these would produce very different temporal influx patterns, we assembled and analysed published arrival times for each of the groups. For all, a ‘colonisation interval’ was generated that was bracketed by its ‘stem-old’ and ‘crown-young’ tree-node ages; in two instances, the ranges were refined using palaeontological data. The synthesis of these intervals for all clades, which we term a colonisation profile, has a distinctive shape that can be compared, statistically, to various models, including those that assume the arrivals were focused in time. The analysis leads us to reject the various land bridge models (which would show temporal concentrations) and instead supports the idea of dispersal over water (temporally random). Therefore, the biological evidence is now in agreement with the geological evidence, as well as the filtered taxonomic composition of the fauna, in supporting over-water dispersal as the mechanism that explains all but two of Madagascar’s land-vertebrate groups.

PMID:37142264 | DOI:10.1111/brv.12966

Infect Dis Now. 2023 May 2:104716. doi: 10.1016/j.idnow.2023.104716. Online ahead of print.

ABSTRACT

OBJECTIVE: Fever contributes to the inflammatory response; in some infections, antipyretics could prolong the illness. The objective of our study was to evaluate the impact of antipyretic treatments on the evolution of acute upper and lower respiratory tract infections (RTI).

METHOD: A systematic literature review of randomized controlled trials (RCTs) with meta-analysis was conducted. Our primary endpoint was the time to recovery from illness. Our prespecified secondary endpoints were quality of life, duration and number of fever episodes, repeated medical visits, and adverse events.

RESULTS: Out of the 1466 references found, 25 RCTs were included. There were two studies assessing mean fever clearance time, and five studies examining the duration of symptoms associated with the illness studied. No statistically significant differences were found when pooling the results of the different studies. The assessment of adverse events showed a significant difference disadvantaging non-steroidal anti-inflammatory drugs. No meta-analysis could be performed for our other secondary endpoints. The quality of the evidence is limited by the small number of studies included for our primary endpoint and by heterogeneity between the studies.

CONCLUSION: Our results suggest that the use of antipyretics does not prolong or shorten illness duration in acute upper and lower RTI. The symptomatic efficacy of antipyretics must be weighed against their adverse effects, particularly when fever is well-tolerated.

PMID:37142229 | DOI:10.1016/j.idnow.2023.104716

J Neuroradiol. 2023 May 2:S0150-9861(23)00200-6. doi: 10.1016/j.neurad.2023.05.001. Online ahead of print.

ABSTRACT

PURPOSE: To explore the intrinsic alteration of cerebral 18F-FDG metabolism in acute/subacute seropositive autoimmune encephalitis (AE) and to propose a universal classification model based on 18F-FDG metabolic patterns to predict AE.

METHODS: Cerebral 18F-FDG PET images of 42 acute/subacute seropositive AE patients and 45 healthy controls (HCs) were compared using voxelwise and region of interest (ROI)-based schemes. The mean standardized uptake value ratios (SUVRs) of 59 subregions according to a modified Automated Anatomical Labeling (AAL) atlas were compared using a t-test. Subjects were randomly divided into a training set (70%) and a testing set (30%). Logistic regression models were built based on the SUVRs and the models were evaluated by determining their predictive value in the training and testing sets.

RESULTS: The 18F-FDG uptake pattern in the AE group was characterized by increased SUVRs in the brainstem, cerebellum, basal ganglia, and temporal lobe, and decreased SUVRs in the occipital, and frontal regions with voxelwise analysis (false discovery rate [FDR] p<0.05). Utilizing ROI-based analysis, we identified 15 subareas that exhibited statistically significant changes in SUVRs among AE patients compared to HC (FDR p<0.05). Further, a logistic regression model incorporating SUVRs from the calcarine cortex, putamen, supramarginal gyrus, cerebelum_10, and hippocampus successfully enhanced the positive predictive value from 0.76 to 0.86 when compared to visual assessments. This model also demonstrated potent predictive ability, with AUC values of 0.94 and 0.91 observed for the training and testing sets, respectively.

CONCLUSIONS: During the acute/subacute stages of seropositive AE, alterations in SUVRs appear to be concentrated within physiologically significant regions, ultimately defining the general cerebral metabolic pattern. By incorporating these key regions into a new classification model, we have improved the overall diagnostic efficiency of AE.

PMID:37142216 | DOI:10.1016/j.neurad.2023.05.001