Cash transfer during the COVID-19 pandemic: a multicentre, randomised controlled trial.

OBJECTIVE: To evaluate the effect of a one-time cash transfer of $C1000 in people who are unable to physically distance due to insufficient income. DESIGN: Open-label, multi-centre, randomised superiority trial. SETTING: Seven primary care sites in Ontario, Canada; six urban sites associated with St. Michael's Hospital in Toronto and one in Manitoulin Island. PARTICIPANTS: 392 individuals who reported trouble affording basic necessities due to disruptions related to COVID-19. INTERVENTION: After random allocation, participants either received the cash transfer of $C1000 (n=196) or physical distancing guidelines alone (n=196). MAIN OUTCOME MEASURES: The primary outcome was the maximum number of symptoms consistent with COVID-19 over 14 days. Secondary outcomes were meeting clinical criteria for COVID-19, SARS-CoV-2 presence, number of close contacts, general health and ability to afford basic necessities. RESULTS: The primary outcome of number of symptoms reported by participants did not differ between groups after 2 weeks (cash transfer, mean 1.6 vs 1.9, ratio of means 0.83; 95% CI 0.56 to 1.24). There were no statistically significant effects on secondary outcomes of the meeting COVID-19 clinical criteria (7.9% vs 12.8%; risk difference -0.05; 95% CI -0.11 to 0.01), SARS-CoV-2 presence (0.5% vs 0.6%; risk difference 0.00 95% CI -0.02 to 0.02), mean number of close contacts (3.5 vs 3.7; rate ratio 1.10; 95% CI 0.83 to 1.46), general health very good or excellent (60% vs 63%; risk difference -0.03 95% CI -0.14 to 0.08) and ability to make ends meet (52% vs 51%; risk difference 0.01 95% CI -0.10 to 0.12). CONCLUSIONS: A single cash transfer did not reduce the COVID-19 symptoms or improve the ability to afford necessities. Further studies are needed to determine whether some groups may benefit from financial supports and to determine if a higher level of support is beneficial. TRIAL REGISTRATION NUMBER: NCT04359264.

Does Type of Sponsorship of Randomized Controlled Trials Influence Treatment Effect Size Estimates in Rehabilitation: A Meta-Epidemiological Study.

BACKGROUND: Sponsorship bias could affect research results to inform decision makers when using the results of these trials. The extent to which sponsorship bias affect results in the field of physical therapy has been unexplored in the literature. Therefore, the main aim of this study was to evaluate the influence of sponsorship bias on the treatment effects of randomized controlled trials in physical therapy area. METHODS: This was a meta-epidemiological study. A random sample of randomized controlled trials included in meta-analyses of physical therapy area were identified. Data extraction including assessments of appropriate influence of funders was conducted independently by two reviewers. To determine the association between biases related to sponsorship biases and effect sizes, a two-level analysis was conducted using a meta-meta-analytic approach. RESULTS: We analyzed 393 trials included in 43 meta-analyses. The most common sources of sponsorship for this sample of physical therapy trials were government (n = 205, 52%), followed by academic (n = 44, 11%) and industry (n = 39, 10%). The funding was not declared in a high percentage of the trials (n = 85, 22%). The influence of the trial sponsor was assessed as being appropriate in 246 trials (63%) and considered inappropriate/unclear in 147 (37%) of them. We have moderate evidence to say that trials with inappropriate/unclear influence of funders tended to have on average a larger effect size than those with appropriate influence of funding (effect size = 0.15; 95% confidence interval = -0.03 to 0.33). CONCLUSIONS: Based on our sample of physical therapy trials, it seems that most of the trials are funded by either government and academia and a small percentage are funded by the industry. Treatment effect size estimates were on average 0.15 larger in trials with lack of appropriate influence of funders as compared with trials with appropriate influence of funding. Contrarily to other fields, industry funding was relatively small and their influence perhaps less marked. All these results could be explained by the relative youth of the field and/or the absence of clear industry interests. In front of the call for action by the World Health Organization to strengthen rehabilitation in health systems, these results raise the issue of the need of public funding in the field.

Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial.

OBJECTIVES: This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management. BACKGROUND: There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding. RESULTS: Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (pint = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (pint = 0.79), myocardial infarction (pint = 0.25), stroke (pint = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (pint = 0.45). CONCLUSIONS: Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.

Caesarean sections and private insurance: systematic review and meta-analysis.

OBJECTIVE: Financial incentives associated with private insurance may encourage healthcare providers to perform more caesarean sections. We therefore sought to determine the association of private insurance and odds of caesarean section. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, Embase and The Cochrane Library from the first year of records through August 2016. ELIGIBILITY CRITERIA: We included studies that reported data to allow the calculation of OR of caesarean section of privately insured as compared with publicly insured women. OUTCOMES: The prespecified primary outcome was the adjusted OR of births delivered by caesarean section of women covered with private insurance as compared with women covered with public insurance. The prespecified secondary outcome was the crude OR of births delivered by caesarean section of women covered with private insurance as compared with women covered with public insurance. RESULTS: Eighteen articles describing 21 separate studies in 12.9 million women were included in this study. In a meta-analysis of 13 studies, the adjusted odds of delivery by caesarean section was 1.13 higher among privately insured women as compared with women with public insurance coverage (95% CI 1.07 to 1.18) with no relevant heterogeneity between studies (τ2=0.006). The meta-analysis of crude estimates from 12 studies revealed a somewhat more pronounced association (pooled OR 1.35, 95% CI 1.27 to 1.44) with no relevant heterogeneity between studies (τ2=0.011). CONCLUSIONS: Caesarean sections are more likely to be performed in privately insured women as compared with women using public health insurance coverage. Although this effect is small on average and variable in its magnitude, it is present in all analyses we performed.

Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool: a prospective study.

BACKGROUND: The Cochrane risk of bias tool is commonly criticized for having a low reliability. We aimed to investigate whether training of raters, with objective and standardized instructions on how to assess risk of bias, can improve the reliability of the Cochrane risk of bias tool. METHODS: In this pilot study, four raters inexperienced in risk of bias assessment were randomly allocated to minimal or intensive standardized training for risk of bias assessment of randomized trials of physical therapy treatments for patients with knee osteoarthritis pain. Two raters were experienced risk of bias assessors who served as reference. The primary outcome of our study was between-group reliability, defined as the agreement of the risk of bias assessments of inexperienced raters with the reference assessments of experienced raters. Consensus-based assessments were used for this purpose. The secondary outcome was within-group reliability, defined as the agreement of assessments within pairs of inexperienced raters. We calculated the chance-corrected weighted Kappa to quantify agreement within and between groups of raters for each of the domains of the risk of bias tool. RESULTS: A total of 56 trials were included in our analysis. The Kappa for the agreement of inexperienced raters with reference across items of the risk of bias tool ranged from 0.10 to 0.81 for the minimal training group and from 0.41 to 0.90 for the standardized training group. The Kappa values for the agreement within pairs of inexperienced raters across the items of the risk of bias tool ranged from 0 to 0.38 for the minimal training group and from 0.93 to 1 for the standardized training group. Between-group differences in Kappa for the agreement of inexperienced raters with reference always favored the standardized training group and was most pronounced for incomplete outcome data (difference in Kappa 0.52, p < 0.001) and allocation concealment (difference in Kappa 0.30, p = 0.004). CONCLUSIONS: Intensive, standardized training on risk of bias assessment may significantly improve the reliability of the Cochrane risk of bias tool.

Patient satisfaction is biased by renovations to the interior of a primary care office: a pretest-posttest assessment.

BACKGROUND: Measuring quality of care is essential to improve primary care. Quality of primary care for patients is usually assessed by patient satisfaction questionnaires. However, patients may not be able to judge quality of care without also reflecting their perception of the environment. We determined the effect that redesigning a primary care office had on patient satisfaction. We hypothesized that renovating the interior would make patients more satisfied with the quality of medical care. METHODS: We performed a Pretest-Posttest analysis in a recently renovated single-practice primary care office in Grenchen, Switzerland. Before and after renovation, we distributed a questionnaire to assess patient satisfaction in four domains. We chose a Likert scale (1 = very poor to 6 = very good), and 12 quality indicators, and included two consecutive samples of patients presenting at the primary care office before (n = 153) and after (n = 153) interior design renovation. RESULTS: Response rate was high (overall 85 %). The sample was similar to the enlisted patient collective, but the sample population was older (60 years) than the collective (52 years). Patient satisfaction was higher for all domains after the office was renovated (p < 0.01-0.001). Results did not change when we included potential confounders in the multivariable model (p < 0.01). CONCLUSIONS: Renovating the interior of a primary care office was associated with improved patient satisfaction, including satisfaction in domains otherwise unchanged. Physician skills and patient satisfaction sometimes depend on surrounding factors that may bias the ability of patients to assess the quality of medical care. These biases should be taken into account when quality assessment instruments are designed for patients.

Rates and factors associated with falls in older European Americans, Afro-Caribbeans, African-Americans, and Hispanics.

PURPOSE: To evaluate rates and factors associated with older adult falls in different ethnic groups. PARTICIPANTS AND METHODS: Information on demographics, medical and falls history, and pain and physical activity levels was collected from 550 community-dwelling older adults (75±9 years old, 222 European Americans, 109 Afro-Caribbeans, 106 African-Americans, and 113 Hispanics). RESULTS: Taking medications for anxiety (risk ratio [RR] =1.4, 95% confidence interval [CI] =1.1-2.0), having incontinence (RR =1.4, 95% CI =1.1-1.8, P=0.013), back pain (RR =1.4, 95% CI =1.0-1.8), feet swelling (RR =1.3, 95% CI =1.1-1.7), and age ≥75 years (RR =1.3, 95% CI =1.0-1.6) were associated with falls. The associations were stronger for Afro-Caribbeans, but they presented approximately 40% lower prevalence of falls than the other groups. CONCLUSION: Taking anxiety medication, incontinence, back pain, feet swelling, and age ≥75 years were associated with falls, and Afro-Caribbeans presented lower prevalence of falls. These findings need to be taken into consideration in clinical interventions in aging.

Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool: a study protocol.

BACKGROUND: The Cochrane risk of bias (RoB) tool has been widely embraced by the systematic review community, but several studies have reported that its reliability is low. We aim to investigate whether training of raters, including objective and standardized instructions on how to assess risk of bias, can improve the reliability of this tool. We describe the methods that will be used in this investigation and present an intensive standardized training package for risk of bias assessment that could be used by contributors to the Cochrane Collaboration and other reviewers. METHODS/DESIGN: This is a pilot study. We will first perform a systematic literature review to identify randomized clinical trials (RCTs) that will be used for risk of bias assessment. Using the identified RCTs, we will then do a randomized experiment, where raters will be allocated to two different training schemes: minimal training and intensive standardized training. We will calculate the chance-corrected weighted Kappa with 95% confidence intervals to quantify within- and between-group Kappa agreement for each of the domains of the risk of bias tool. To calculate between-group Kappa agreement, we will use risk of bias assessments from pairs of raters after resolution of disagreements. Between-group Kappa agreement will quantify the agreement between the risk of bias assessment of raters in the training groups and the risk of bias assessment of experienced raters. To compare agreement of raters under different training conditions, we will calculate differences between Kappa values with 95% confidence intervals. DISCUSSION: This study will investigate whether the reliability of the risk of bias tool can be improved by training raters using standardized instructions for risk of bias assessment. One group of inexperienced raters will receive intensive training on risk of bias assessment and the other will receive minimal training. By including a control group with minimal training, we will attempt to mimic what many review authors commonly have to do, that is-conduct risk of bias assessment in RCTs without much formal training or standardized instructions. If our results indicate that an intense standardized training does improve the reliability of the RoB tool, our study is likely to help improve the quality of risk of bias assessments, which is a central component of evidence synthesis.

Patient-reported outcomes in meta-analyses-part 2: methods for improving interpretability for decision-makers.

Systematic reviews and meta-analyses of randomized trials that include patient-reported outcomes (PROs) often provide crucial information for patients, clinicians and policy-makers facing challenging health care decisions. Based on emerging methods, guidance on improving the interpretability of meta-analysis of patient-reported outcomes, typically continuous in nature, is likely to enhance decision-making. The objective of this paper is to summarize approaches to enhancing the interpretability of pooled estimates of PROs in meta-analyses. When differences in PROs between groups are statistically significant, decision-makers must be able to interpret the magnitude of effect. This is challenging when, as is often the case, clinical trial investigators use different measurement instruments for the same construct within and between individual randomized trials. For such cases, in addition to pooling results as a standardized mean difference, we recommend that systematic review authors use other methods to present results such as relative (relative risk, odds ratio) or absolute (risk difference) dichotomized treatment effects, complimented by presentation in either: natural units (e.g. overall depression reduced by 2.4 points when measured on a 50-point Hamilton Rating Scale for Depression); minimal important difference units (e.g. where 1.0 unit represents the smallest difference in depression that patients, on average, perceive as important the depression score was 0.38 (95% CI 0.30 to 0.47) units less than the control group); or a ratio of means (e.g. where the mean in the treatment group is divided by the mean in the control group, the ratio of means is 1.27, representing a 27% relative reduction in the mean depression score).