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BMJ (Clinical Research Ed.) Feb 2021To establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.
DESIGN
Series of randomised, placebo controlled n-of-1 trials.
SETTING
Primary care across 50 sites in the United Kingdom, December 2016 to April 2018.
PARTICIPANTS
200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.
INTERVENTIONS
Participants were randomised to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo.
MAIN OUTCOME MEASURES
At the end of each treatment period, participants rated their muscle symptoms on a visual analogue scale (0-10). The primary analysis compared symptom scores in the statin and placebo periods.
RESULTS
151 participants provided symptoms scores for at least one statin period and one placebo period and were included in the primary analysis. Overall, no difference in muscle symptom scores was found between the statin and placebo periods (mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; P=0.40)). Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period. Two thirds of those completing the trial reported restarting long term treatment with statins.
CONCLUSIONS
No overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins. Most people completing the trial intended to restart treatment with statins. N-of-1 trials can assess drug effects at the group level and guide individual treatment.
TRIAL REGISTRATION
ISRCTN30952488, EUDRACT 2016-000141-31, NCT02781064.
Topics: Adult; Aged; Aged, 80 and over; Atorvastatin; Double-Blind Method; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Muscular Diseases; Primary Health Care; Symptom Assessment; United Kingdom
PubMed: 33627334
DOI: 10.1136/bmj.n135 -
JAMA Network Open May 2023The American Institute for Cancer Research and American Cancer Society regularly publish modifiable lifestyle recommendations for cancer prevention. Whether these... (Observational Study)
Observational Study
IMPORTANCE
The American Institute for Cancer Research and American Cancer Society regularly publish modifiable lifestyle recommendations for cancer prevention. Whether these recommendations have an impact on high-risk breast cancer survival remains unknown.
OBJECTIVE
To investigate whether adherence to cancer prevention recommendations before, during, and 1 and 2 years after breast cancer treatment was associated with disease recurrence or mortality.
DESIGN, SETTING, AND PARTICIPANTS
The Diet, Exercise, Lifestyles, and Cancer Prognosis Study (DELCaP) was a prospective, observational cohort study designed to assess lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment completion, implemented ancillary to the Southwest Oncology Group (SWOG) S0221 trial, a multicenter trial that compared chemotherapy regimens in breast cancer. Participants were chemotherapy-naive patients with pathologic stage I to III high-risk breast cancer, defined as node-positive disease with hormone receptor-negative tumors larger than 1 cm or any tumor larger than 2 cm. Patients with poor performance status and comorbidities were excluded from S0221. The study was conducted from January 1, 2005, to December 31, 2010; mean (SD) follow-up time for those not experiencing an event was 7.7 (2.1) years through December 31, 2018. The analyses reported herein were performed from March 2022 to January 2023.
EXPOSURE
An aggregated lifestyle index score comprising data from 4 time points and 7 lifestyles, including (1) physical activity, (2) body mass index, (3) fruit and vegetable consumption, (4) red and processed meat intake, (5) sugar-sweetened beverage consumption, (6) alcohol consumption, and (7) smoking. Higher scores indicated healthier lifestyle.
MAIN OUTCOMES AND MEASURES
Disease recurrence and all-cause mortality.
RESULTS
A total of 1340 women (mean [SD] age, 51.3 [9.9] years) completed the baseline questionnaire. Most patients were diagnosed with hormone-receptor positive breast cancer (873 [65.3%]) and completed some education beyond high school (954 [71.2%]). In time-dependent multivariable analyses, patients with highest vs lowest lifestyle index scores experienced a 37.0% reduction in disease recurrence (hazard ratio, 0.63; 95% CI, 0.48-0.82) and a 58.0% reduction in mortality (hazard ratio, 0.42; 95% CI, 0.30-0.59).
CONCLUSIONS AND RELEVANCE
In this observational study of patients with high-risk breast cancer, strongest collective adherence to cancer prevention lifestyle recommendations was associated with significant reductions in disease recurrence and mortality. Education and implementation strategies to help patients adhere to cancer prevention recommendations throughout the cancer care continuum may be warranted in breast cancer.
Topics: Humans; Female; United States; Middle Aged; Breast Neoplasms; Prospective Studies; Neoplasm Recurrence, Local; Life Style; Hormones
PubMed: 37140922
DOI: 10.1001/jamanetworkopen.2023.11673 -
JAMA Psychiatry Sep 2017Transdiagnostic interventions have been developed to address barriers to the dissemination of evidence-based psychological treatments, but only a few preliminary studies... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Transdiagnostic interventions have been developed to address barriers to the dissemination of evidence-based psychological treatments, but only a few preliminary studies have compared these approaches with existing evidence-based psychological treatments.
OBJECTIVE
To determine whether the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is at least as efficacious as single-disorder protocols (SDPs) in the treatment of anxiety disorders.
DESIGN, SETTING, AND PARTICIPANTS
From June 23, 2011, to March 5, 2015, a total of 223 patients at an outpatient treatment center with a principal diagnosis of panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, or social anxiety disorder were randomly assigned by principal diagnosis to the UP, an SDP, or a waitlist control condition. Patients received up to 16 sessions of the UP or an SDP for 16 to 21 weeks. Outcomes were assessed at baseline, after treatment, and at 6-month follow-up. Analysis in this equivalence trial was based on intention to treat.
INTERVENTIONS
The UP or SDPs.
MAIN OUTCOMES AND MEASURES
Blinded evaluations of principal diagnosis clinical severity rating were used to evaluate an a priori hypothesis of equivalence between the UP and SDPs.
RESULTS
Among the 223 patients (124 women and 99 men; mean [SD] age, 31.1 [11.0] years), 88 were randomized to receive the UP, 91 to receive an SDP, and 44 to the waitlist control condition. Patients were more likely to complete treatment with the UP than with SDPs (odds ratio, 3.11; 95% CI, 1.44-6.74). Both the UP (Cohen d, -0.93; 95% CI, -1.29 to -0.57) and SDPs (Cohen d, -1.08; 95% CI, -1.43 to -0.73) were superior to the waitlist control condition at acute outcome. Reductions in clinical severity rating from baseline to the end of treatment (β, 0.25; 95% CI, -0.26 to 0.75) and from baseline to the 6-month follow-up (β, 0.16; 95% CI, -0.39 to 0.70) indicated statistical equivalence between the UP and SDPs.
CONCLUSIONS AND RELEVANCE
The UP produces symptom reduction equivalent to criterion standard evidence-based psychological treatments for anxiety disorders with less attrition. Thus, it may be possible to use 1 protocol instead of multiple SDPs to more efficiently treat the most commonly occurring anxiety and depressive disorders.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT01243606.
Topics: Adult; Agoraphobia; Anxiety Disorders; Cognitive Behavioral Therapy; Female; Humans; Male; Obsessive-Compulsive Disorder; Panic Disorder; Phobia, Social; Single-Blind Method; Treatment Outcome; Young Adult
PubMed: 28768327
DOI: 10.1001/jamapsychiatry.2017.2164 -
Lancet (London, England) Mar 2015The bile acid derivative 6-ethylchenodeoxycholic acid (obeticholic acid) is a potent activator of the farnesoid X nuclear receptor that reduces liver fat and fibrosis in... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The bile acid derivative 6-ethylchenodeoxycholic acid (obeticholic acid) is a potent activator of the farnesoid X nuclear receptor that reduces liver fat and fibrosis in animal models of fatty liver disease. We assessed the efficacy of obeticholic acid in adult patients with non-alcoholic steatohepatitis.
METHODS
We did a multicentre, double-blind, placebo-controlled, parallel group, randomised clinical trial at medical centres in the USA in patients with non-cirrhotic, non-alcoholic steatohepatitis to assess treatment with obeticholic acid given orally (25 mg daily) or placebo for 72 weeks. Patients were randomly assigned 1:1 using a computer-generated, centrally administered procedure, stratified by clinical centre and diabetes status. The primary outcome measure was improvement in centrally scored liver histology defined as a decrease in non-alcoholic fatty liver disease activity score by at least 2 points without worsening of fibrosis from baseline to the end of treatment. A planned interim analysis of change in alanine aminotransferase at 24 weeks undertaken before end-of-treatment (72 weeks) biopsies supported the decision to continue the trial (relative change in alanine aminotransferase -24%, 95% CI -45 to -3). A planned interim analysis of the primary outcome showed improved efficacy of obeticholic acid (p=0·0024) and supported a decision not to do end-of-treatment biopsies and end treatment early in 64 patients, but to continue the trial to obtain the 24-week post-treatment measures. Analyses were done by intention-to-treat. This trial was registered with ClinicalTrials.gov, number NCT01265498.
FINDINGS
Between March 16, 2011, and Dec 3, 2012, 141 patients were randomly assigned to receive obeticholic acid and 142 to placebo. 50 (45%) of 110 patients in the obeticholic acid group who were meant to have biopsies at baseline and 72 weeks had improved liver histology compared with 23 (21%) of 109 such patients in the placebo group (relative risk 1·9, 95% CI 1·3 to 2·8; p=0·0002). 33 (23%) of 141 patients in the obeticholic acid developed pruritus compared with nine (6%) of 142 in the placebo group.
INTERPRETATION
Obeticholic acid improved the histological features of non-alcoholic steatohepatitis, but its long-term benefits and safety need further clarification.
FUNDING
National Institute of Diabetes and Digestive and Kidney Diseases, Intercept Pharmaceuticals.
Topics: Administration, Oral; Chenodeoxycholic Acid; Cholesterol, HDL; Cholesterol, LDL; Double-Blind Method; Female; Humans; Liver; Liver Cirrhosis; Male; Middle Aged; Non-alcoholic Fatty Liver Disease; Receptors, Cytoplasmic and Nuclear; Treatment Outcome; Weight Loss
PubMed: 25468160
DOI: 10.1016/S0140-6736(14)61933-4 -
The Lancet. Oncology Jan 2010The 21-gene recurrence score assay is prognostic for women with node-negative, oestrogen-receptor-positive breast cancer treated with tamoxifen. A low recurrence score...
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
BACKGROUND
The 21-gene recurrence score assay is prognostic for women with node-negative, oestrogen-receptor-positive breast cancer treated with tamoxifen. A low recurrence score predicts little benefit of chemotherapy. For node-positive breast cancer, we investigated whether the recurrence score was prognostic in women treated with tamoxifen alone and whether it identified those who might not benefit from anthracycline-based chemotherapy, despite higher risks of recurrence.
METHODS
The phase 3 trial SWOG-8814 for postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer showed that chemotherapy with cyclophosphamide, doxorubicin, and fluorouracil (CAF) before tamoxifen (CAF-T) added survival benefit to treatment with tamoxifen alone. Optional tumour banking yielded specimens for determination of recurrence score by RT-PCR. In this retrospective analysis, we assessed the effect of recurrence score on disease-free survival by treatment group (tamoxifen vs CAF-T) using Cox regression, adjusting for number of positive nodes.
FINDINGS
There were 367 specimens (40% of the 927 patients in the tamoxifen and CAF-T groups) with sufficient RNA for analysis (tamoxifen, n=148; CAF-T, n=219). The recurrence score was prognostic in the tamoxifen-alone group (p=0.006; hazard ratio [HR] 2.64, 95% CI 1.33-5.27, for a 50-point difference in recurrence score). There was no benefit of CAF in patients with a low recurrence score (score <18; log-rank p=0.97; HR 1.02, 0.54-1.93), but an improvement in disease-free survival for those with a high recurrence score (score > or =31; log-rank p=0.033; HR 0.59, 0.35-1.01), after adjustment for number of positive nodes. The recurrence score by treatment interaction was significant in the first 5 years (p=0.029), with no additional prediction beyond 5 years (p=0.58), although the cumulative benefit remained at 10 years. Results were similar for overall survival and breast-cancer-specific survival.
INTERPRETATION
The recurrence score is prognostic for tamoxifen-treated patients with positive nodes and predicts significant benefit of CAF in tumours with a high recurrence score. A low recurrence score identifies women who might not benefit from anthracycline-based chemotherapy, despite positive nodes.
FUNDING
National Cancer Institute and Genomic Health.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Breast Neoplasms; Clinical Trials, Phase III as Topic; Cyclophosphamide; Disease-Free Survival; Doxorubicin; Female; Fluorouracil; Gene Expression Profiling; Gene Expression Regulation, Neoplastic; Genetic Testing; Humans; Kaplan-Meier Estimate; Lymphatic Metastasis; Middle Aged; Patient Selection; Postmenopause; Predictive Value of Tests; Proportional Hazards Models; Randomized Controlled Trials as Topic; Receptors, Estrogen; Recurrence; Retrospective Studies; Reverse Transcriptase Polymerase Chain Reaction; Risk Assessment; Tamoxifen; Time Factors; Treatment Outcome; United States
PubMed: 20005174
DOI: 10.1016/S1470-2045(09)70314-6 -
BMJ (Clinical Research Ed.) Sep 2022To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75... (Randomized Controlled Trial)
Randomized Controlled Trial
Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT).
OBJECTIVE
To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19.
DESIGN
Phase 3 open label randomised controlled trial.
SETTING
United Kingdom.
PARTICIPANTS
6200 people aged ≥16 years who were not taking vitamin D supplements at baseline.
INTERVENTIONS
Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months.
MAIN OUTCOME MEASURES
The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat.
RESULTS
Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH)D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63).
CONCLUSIONS
Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04579640.
Topics: COVID-19; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Respiratory Tract Infections; Vitamin D; Vitamin D Deficiency; Vitamins
PubMed: 36215226
DOI: 10.1136/bmj-2022-071230 -
The Lancet. Oncology Feb 2023Poly(ADP-ribose) polymerase (PARP) inhibitors are effective in germline BRCA1 or BRCA2 (BRCA1/2) mutation-associated metastatic breast cancer. However, studies... (Randomized Controlled Trial)
Randomized Controlled Trial
Cisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial.
BACKGROUND
Poly(ADP-ribose) polymerase (PARP) inhibitors are effective in germline BRCA1 or BRCA2 (BRCA1/2) mutation-associated metastatic breast cancer. However, studies evaluating PARP inhibitors plus platinum-based chemotherapy in germline BRCA1/2-wildtype triple-negative breast cancer are scarce. A large proportion of germline BRCA1/2-wildtype triple-negative breast cancer shows homologous recombination deficiency (HRD), resulting in a BRCA-like phenotype that might render sensitivity to PARP inhibitors. The S1416 trial assessed the efficacy of cisplatin combined with the PARP inhibitor veliparib in three predefined groups of metastatic breast cancer: germline BRCA1/2-mutated, BRCA-like, and non-BRCA-like.
METHODS
S1416 was a randomised, double-blind, placebo-controlled, phase 2 trial conducted at 154 community and academic clinical sites across the USA. Eligible patients aged 18 years or older had metastatic or recurrent triple-negative breast cancer or germline BRCA1/2-associated metastatic or recurrent breast cancer, an Eastern Cooperative Oncology Group performance status of 0-2, and had received up to one line of chemotherapy for metastatic disease. Patients were randomly assigned (1:1) via the National Clinical Trials Network open interactive system with dynamic balancing on number of previous cytotoxic regimens for metastatic disease to receive intravenous cisplatin (75 mg/m, day 1) combined with either veliparib or matching placebo (300 mg orally twice a day, days 1-14) on a 21-day cycle. Investigators, patients, and the sponsors were masked to treatment assignment; the study statisticians were unmasked. Central testing after ran domisation classified patients as having mutated or wildtype germline BRCA1/2. A biomarker panel established a priori was used to classify patients with wildtype germline BRCA1/2 into BRCA-like and non-BRCA-like phenotype groups, with BRCA-like status based on at least one of the biomarkers: genomic instability score (≥42), somatic BRCA1/2 mutations, BRCA1 promoter methylation, or non-BRCA1/2 homologous recombination repair germline mutations. The primary endpoint was investigator-assessed progression-free survival, analysed separately for the three predefined biomarker groups with a prespecified α value for each analysis. Efficacy analyses were done by intention to treat and included all eligible patients. Safety analyses of toxicities attributed to treatment included all patients who received at least one dose of veliparib or placebo. The study is ongoing and registered with ClinicalTrials.gov, NCT02595905.
FINDINGS
Between July 7, 2016, and June 15, 2019, 335 patients were enrolled and randomly assigned. 320 patients (n=162 to cisplatin plus veliparib, all women; and n=158 to cisplatin plus placebo, 157 women and one man) were eligible for efficacy evaluation. 247 patients were classified into the three biomarker groups: germline BRCA1/2-mutated (n=37), BRCA-like (n=101), and non-BRCA-like (n=109). 73 patients could not be classified due to missing biomarker information. Median follow-up was 11·1 months (IQR 5·6-20·8). In the germline BRCA1/2-mutated group, median progression-free survival was 6·2 months (95% CI 2·3-9·2) in the cisplatin plus veliparib group and 6·4 months (4·3-8·2) in the cisplatin plus placebo group (HR 0·79 [95% CI 0·38-1·67]; log-rank p=0·54). In the BRCA-like group, median progression-free survival was 5·9 months (95% CI 4·3-7·8) in the cisplatin plus veliparib group versus 4·2 months (2·3-5·0) in the cisplatin plus placebo group (HR 0·57 [95% CI 0·37-0·88]; p=0·010). In the non-BRCA-like group, median progression-free survival was 4·0 months (95% CI 2·5-4·7) in the cisplatin plus veliparib group versus 3·0 months (2·2-4·4) in the cisplatin plus placebo group (HR 0·89 [95% CI 0·60-1·33]; p=0·57). The most common grade 3 or worse adverse events attributed to treatment were neutropenia (71 [46%] of 155 patients in the cisplatin plus veliparib group vs 29 [20%] of 147 in the cisplatin plus placebo group), leukopenia (42 [27%] vs 11 [7%]), anaemia (35 [23%] vs 12 [8%]), and thrombocytopenia (29 [19%] vs four [3%]). Serious adverse events attributed to treatment occurred in 48 (31%) patients in the cisplatin plus veliparib group and 53 (36%) patients in the cisplatin plus placebo group. Treatment-related adverse events led to death in one patient in the cisplatin plus veliparib group (sepsis) and one patient in the cisplatin plus placebo group (acute kidney injury due to cisplatin plus heart failure from previous doxorubicin exposure).
INTERPRETATION
The addition of veliparib to cisplatin significantly improved progression-free survival in patients with BRCA-like metastatic triple-negative breast cancer, but not in patients with non-BRCA-like metastatic breast cancer. PARP inhibitors combined with platinum-based chemotherapy should be explored further in BRCA-like triple-negative breast cancer.
FUNDING
National Cancer Institute and National Institute of General Medical Sciences (US National Institutes of Health); AbbVie; Myriad Genetics; the Biomarker, Imaging, and Quality of Life Studies Funding Program (awarded by the National Cancer Institute); and The University of Kansas Cancer Center.
Topics: Female; Humans; Cisplatin; Triple Negative Breast Neoplasms; Poly(ADP-ribose) Polymerase Inhibitors; Quality of Life; Neoplasm Recurrence, Local; Antineoplastic Agents; Mutation; Antineoplastic Combined Chemotherapy Protocols; Double-Blind Method
PubMed: 36623515
DOI: 10.1016/S1470-2045(22)00739-2 -
Health Expectations : An International... Dec 2015Patient and public involvement (PPI) is seen as a way of helping to shape health policy and ensure a patient-focused health-care system. While evidence indicates that... (Review)
Review
BACKGROUND AND OBJECTIVES
Patient and public involvement (PPI) is seen as a way of helping to shape health policy and ensure a patient-focused health-care system. While evidence indicates that PPI can improve health-care decision making, it also consumes monetary and non-monetary resources. Given the financial climate, it is important to start thinking about the costs and benefits of PPI and how to evaluate it in economic terms.
DESIGN
We conducted a literature review to assess the potential benefits and costs of involvement and the challenges in carrying out an economic evaluation of PPI.
RESULTS
The benefits of PPI include effects on the design of new projects or services, on NHS governance, on research design and implementation and on citizenship and equity. Economic evaluation of PPI activities is limited. The lack of an appropriate analytical framework, data recording and understanding of the potential costs and benefits of PPI, especially from participants' perspectives, represent serious constraints on the full evaluation of PPI.
CONCLUSIONS
By recognizing the value of PPI, health-care providers and commissioners can embed it more effectively within their organizations. Better knowledge of costs may prompt organizations to effectively plan, execute, evaluate and target resources. This should increase the likelihood of more meaningful activity, avoid tokenism and enhance organizational efficiency and reputation.
Topics: Cost-Benefit Analysis; Health Policy; Humans; Patient Participation; Patient-Centered Care
PubMed: 24813243
DOI: 10.1111/hex.12204 -
Developmental Medicine and Child... Dec 2022To describe the development of cognitive empathy across the lifespan from a very large cohort using a standardized measure of cognitive empathy ability.
AIM
To describe the development of cognitive empathy across the lifespan from a very large cohort using a standardized measure of cognitive empathy ability.
METHOD
Participants (n=4545, age bands <5y to >75y, 60% female) were a convenience sample recruited voluntarily from visitors to the Glasgow Science Centre in the UK, who completed the Reading the Mind in the Eyes Test.
RESULTS
When compared to preceding age groups, we found significant developmental gains in empathy ability in children aged 6 to 7 years (p=0.048, d=0.45) and again at 10 to 12 years (p=0.042, d=0.23), followed by a slight reduction in ability during adolescence (p=0.087, d=-0.18), and functional maturity in those aged 19 to 25 years (p=0.001, d=0.76). Cognitive empathy abilities remained relatively stable across adulthood but gradually declined in people over 65 years, with notable decline in males over 75 years (p=0.001, d=-0.98). Females performed better than males at all ages.
INTERPRETATION
Understanding developmental issues in cognitive empathy could influence approaches to moral and social education for children, and health and social care support for older people. Standardized cognitive empathy tests could also provide novel approaches in the early detection of developmental vulnerabilities in a range of neurological conditions, and within neuropsychiatric and neurodegenerative disorders in which cognitive empathy is known to be impaired.
WHAT THIS PAPER ADDS
Cognitive empathy is a late-developing ability and changes across the lifespan. Cognitive empathy increases during childhood but with potentially altered abilities during adolescence. Cognitive empathy matures during early adulthood and gradually declines in older age. There is a female advantage in cognitive empathy abilities.
Topics: Adolescent; Male; Child; Humans; Female; Aged; Adult; Empathy; Longevity; Cognition
PubMed: 35594529
DOI: 10.1111/dmcn.15263 -
Globalization and Health Jan 2022The COVID-19 pandemic has led to an avalanche of scientific studies, drawing on many different types of data. However, studies addressing the effectiveness of government... (Review)
Review
BACKGROUND
The COVID-19 pandemic has led to an avalanche of scientific studies, drawing on many different types of data. However, studies addressing the effectiveness of government actions against COVID-19, especially non-pharmaceutical interventions, often exhibit data problems that threaten the validity of their results. This review is thus intended to help epidemiologists and other researchers identify a set of data issues that, in our view, must be addressed in order for their work to be credible. We further intend to help journal editors and peer reviewers when evaluating studies, to apprise policy-makers, journalists, and other research consumers about the strengths and weaknesses of published studies, and to inform the wider debate about the scientific quality of COVID-19 research.
RESULTS
To this end, we describe common challenges in the collection, reporting, and use of epidemiologic, policy, and other data, including completeness and representativeness of outcomes data; their comparability over time and among jurisdictions; the adequacy of policy variables and data on intermediate outcomes such as mobility and mask use; and a mismatch between level of intervention and outcome variables. We urge researchers to think critically about potential problems with the COVID-19 data sources over the specific time periods and particular locations they have chosen to analyze, and to choose not only appropriate study designs but also to conduct appropriate checks and sensitivity analyses to investigate the impact(s) of potential threats on study findings.
CONCLUSIONS
In an effort to encourage high quality research, we provide recommendations on how to address the issues we identify. Our first recommendation is for researchers to choose an appropriate design (and the data it requires). This review describes considerations and issues in order to identify the strongest analytical designs and demonstrates how interrupted time-series and comparative longitudinal studies can be particularly useful. Furthermore, we recommend that researchers conduct checks or sensitivity analyses of the results to data source and design choices, which we illustrate. Regardless of the approaches taken, researchers should be explicit about the kind of data problems or other biases that the design choice and sensitivity analyses are addressing.
Topics: COVID-19; Humans; Pandemics; Research Design; Research Personnel; SARS-CoV-2
PubMed: 34991622
DOI: 10.1186/s12992-021-00795-0