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Article ; Online: Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov

Shelley Vanderhout / Dean A. Fergusson / Jonathan A. Cook / Monica Taljaard

PLoS Medicine, Vol 19, Iss

A cross-sectional analysis

2022 Volume 2

Abstract: Background Use of patient-reported outcomes (PROs) and patient and public engagement are critical ingredients of pragmatic trials, which are intended to be patient centered. Engagement of patients and members of the public in selecting the primary trial ... ...

Abstract	Background Use of patient-reported outcomes (PROs) and patient and public engagement are critical ingredients of pragmatic trials, which are intended to be patient centered. Engagement of patients and members of the public in selecting the primary trial outcome and determining the target difference can better ensure that the trial is designed to inform the decisions of those who ultimately stand to benefit. However, to the best of our knowledge, the use and reporting of PROs and patient and public engagement in pragmatic trials have not been described. The objectives of this study were to review a sample of pragmatic trials to describe (1) the prevalence of reporting patient and public engagement; (2) the prevalence and types of PROs used; (3) how its use varies across trial characteristics; and (4) how sample sizes and target differences are determined for trials with primary PROs. Methods and findings This was a methodological review of primary reports of pragmatic trials. We used a published electronic search filter in MEDLINE to identify pragmatic trials, published in English between January 1, 2014 and April 3, 2019; we identified the subset that were registered in ClinicalTrials.gov and explicitly labeled as pragmatic. Trial descriptors were downloaded from ClinicalTrials.gov; information about PROs and sample size calculations were extracted from the manuscript. Chi-squared, Cochran–Armitage, and Wilcoxon rank sum tests were used to examine associations between trial characteristics and use of PROs. Among 4,337 identified primary trial reports, 1,988 were registered in CT.gov, of which 415 were explicitly labeled as pragmatic. Use of patient and public engagement was identified in 39 (9.4%). PROs were measured in 235 (56.6%): 144 (34.7%) used PROs as primary outcomes and 91 (21.9%) as only secondary outcomes. Primary PROs were symptoms (64; 44%), health behaviors (36; 25.0%), quality of life (17; 11.8%), functional status (16; 11.1%), and patient experience (10; 6.9%). Trial characteristics with lower ...
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov

Shelley Vanderhout / Dean A Fergusson / Jonathan A Cook / Monica Taljaard

PLoS Medicine, Vol 19, Iss 2, p e

A cross-sectional analysis.

2022 Volume 1003896

Abstract	Background Use of patient-reported outcomes (PROs) and patient and public engagement are critical ingredients of pragmatic trials, which are intended to be patient centered. Engagement of patients and members of the public in selecting the primary trial outcome and determining the target difference can better ensure that the trial is designed to inform the decisions of those who ultimately stand to benefit. However, to the best of our knowledge, the use and reporting of PROs and patient and public engagement in pragmatic trials have not been described. The objectives of this study were to review a sample of pragmatic trials to describe (1) the prevalence of reporting patient and public engagement; (2) the prevalence and types of PROs used; (3) how its use varies across trial characteristics; and (4) how sample sizes and target differences are determined for trials with primary PROs. Methods and findings This was a methodological review of primary reports of pragmatic trials. We used a published electronic search filter in MEDLINE to identify pragmatic trials, published in English between January 1, 2014 and April 3, 2019; we identified the subset that were registered in ClinicalTrials.gov and explicitly labeled as pragmatic. Trial descriptors were downloaded from ClinicalTrials.gov; information about PROs and sample size calculations were extracted from the manuscript. Chi-squared, Cochran-Armitage, and Wilcoxon rank sum tests were used to examine associations between trial characteristics and use of PROs. Among 4,337 identified primary trial reports, 1,988 were registered in CT.gov, of which 415 were explicitly labeled as pragmatic. Use of patient and public engagement was identified in 39 (9.4%). PROs were measured in 235 (56.6%): 144 (34.7%) used PROs as primary outcomes and 91 (21.9%) as only secondary outcomes. Primary PROs were symptoms (64; 44%), health behaviors (36; 25.0%), quality of life (17; 11.8%), functional status (16; 11.1%), and patient experience (10; 6.9%). Trial characteristics with lower ...
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Heterogeneity in pragmatic randomised trials

Bruno Giraudeau / Agnès Caille / Sandra M. Eldridge / Charles Weijer / Merrick Zwarenstein / Monica Taljaard

BMC Medicine, Vol 20, Iss 1, Pp 1-

sources and management

2022 Volume 16

Abstract: Abstract Background Pragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions. Heterogeneity in patient characteristics contributes to heterogeneity in their response to the ... ...

Abstract	Abstract Background Pragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions. Heterogeneity in patient characteristics contributes to heterogeneity in their response to the intervention. However, there are many other sources of heterogeneity in outcomes. Based on the expertise and judgements of the authors, we identify different sources of clinical and methodological heterogeneity, which translate into heterogeneity in patient responses—some we consider as desirable and some as undesirable. For each of them, we discuss and, using real-world trial examples, illustrate how heterogeneity should be managed over the whole course of the trial. Main text Heterogeneity in centres and patients should be welcomed rather than limited. Interventions can be flexible or tailored and control interventions are expected to reflect usual care, avoiding use of a placebo. Co-interventions should be allowed; adherence should not be enforced. All these elements introduce heterogeneity in interventions (experimental or control), which has to be welcomed because it mimics reality. Outcomes should be objective and possibly routinely collected; standardised assessment, blinding and adjudication should be avoided as much as possible because this is not how assessment would be done outside a trial setting. The statistical analysis strategy must be guided by the objective to inform decision-making, thus favouring the intention-to-treat principle. Pragmatic trials should consider including process analyses to inform an understanding of the trial results. Needed data to conduct these analyses should be collected unobtrusively. Finally, ethical principles must be respected, even though this may seem to conflict with goals of pragmatism; consent procedures could be incorporated in the flow of care.
Keywords	Pragmatic randomised trials ; Heterogeneity ; Cluster randomised trials ; Medicine ; R
Subject code	170 ; 332
Language	English
Publishing date	2022-10-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Effect of hand versus electronic signatures on response rates in postal surveys

Monica Taljaard / Jeffrey J Perry / Michael Hickey / Krishan Yadav / Dilan Patel

BMJ Open, Vol 12, Iss

a randomised controlled trial among emergency physicians in Canada

2022 Volume 8

Abstract: Objectives Hand signatures offer a more authentic personalisation, which carries over to a sense of trust, although are costly and time-consuming when considering large postal surveys. The objective of this study was to compare response rates when using ... ...

Abstract	Objectives Hand signatures offer a more authentic personalisation, which carries over to a sense of trust, although are costly and time-consuming when considering large postal surveys. The objective of this study was to compare response rates when using either hand-signed or electronic-signed letters in a postal survey.Design and setting We embedded this randomised controlled trial within a national cross-sectional postal survey of emergency physicians in Canada. The survey aimed to describe current practice patterns with respect to primary headache disorders.Participants We randomly sampled 500 emergency physicians listed in the Scott’s Canadian Medical Directory, 2019 edition.Interventions Using computer-generated random numbers, physicians were allocated to receiving either hand-signed (n=250) or electronic signed (n=250) letters. The initial mailout contained a US$5 Tim Hortons coffee card with the invitation letter. Four reminders were sent to non-responders every 3 weeks. The same type of signature was used for the initial invitation and subsequent reminders.Outcome The primary outcome was the survey response rate.Results Among 500 physicians invited, 32 invitations were undeliverable. Among the remaining 468 physicians, 231 had been allocated to the hand-signed group and 237 to the electronic signed group. The response rate in the hand-signed group was 87 (37.7%) vs 97 (40.9%) in the electronic-signed group (absolute difference in proportions −3.3%, 95% CI −12.1% to 5.6%).Conclusion There was no significant difference in physician response rate between hand-signed and e-signed cover letter and reminder letters. Electronic signatures should be used in future postal surveys among physicians to save on time and labour without impacting response rates.
Keywords	Medicine ; R
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Associations between dimensions of empowerment and nutritional status among married adolescent girls in East Africa

Alison Y. Riddle / Wenshan Li / Zulfiqar A. Bhutta / Carol Vlassoff / Monica Taljaard / Elizabeth Kristjansson / Vivian Welch / George A. Wells

BMC Public Health, Vol 23, Iss 1, Pp 1-

a structural equation modelling study

2023 Volume 14

Abstract: Abstract Background Empowering adolescent girls is an important component of combating malnutrition in this age group. Because empowerment is multidimensional and context specific, it can be difficult for policymakers and practitioners to target the ... ...

Abstract	Abstract Background Empowering adolescent girls is an important component of combating malnutrition in this age group. Because empowerment is multidimensional and context specific, it can be difficult for policymakers and practitioners to target the dimensions of empowerment associated with adolescent girls’ nutrition in a particular setting. This study sought to identify the empowerment dimensions significantly associated with married adolescent girls' nutritional status in East Africa; a region where malnutrition and gender inequality stubbornly persist. Methods We used cross-sectional Demographic and Health Survey (DHS) data from Ethiopia (2016), Kenya (2014), Tanzania (2015–16) and Uganda (2016) to construct and test theoretically informed structural equation models of the relationship between six dimensions of empowerment and BMI-for-age and haemoglobin levels for married adolescent girls aged 15–19 years. Results Our models were found to be a good fit for the data. Married adolescent girls’ access to information, measured by their education level and mass media use, was directly and positively associated with their BMI-for-age (p < 0.05). Asset ownership, measured by owning a house or land alone or jointly, was directly and positively associated with haemoglobin (p < 0.05) and reduced odds of being moderately to severely anemic. Rejecting justifications for intimate partner violence, a measure of respondents’ intrinsic agency, was directly and positively associated with the odds of being overweight or obese. Adolescent girls’ level of empowerment across all dimensions had a direct relationship with their country of residence and household wealth. Conclusions Our findings suggest that investment in girls’ access to information through education and mass/social media and their economic empowerment may be important contributors to their overall empowerment and nutritional status. However, caution is needed as greater autonomy may contribute to increased consumption of unhealthy foods that can contribute ...
Keywords	Adolescent Girls ; Adolescent Nutrition ; Adolescent Empowerment ; East Africa ; Structural Equation Models ; Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Introducing the new CONSORT extension for stepped-wedge cluster randomised trials

Karla Hemming / Monica Taljaard / Jeremy Grimshaw

Trials, Vol 20, Iss 1, Pp 1-

2019 Volume 4

Abstract: Abstract The use of the stepped-wedge cluster randomised trial (SW-CRT) is on the increase, and although there are still relatively few SW-CRTs currently published its use is bound to show an increase in the near future. An extension of the CONSORT ... ...

Abstract	Abstract The use of the stepped-wedge cluster randomised trial (SW-CRT) is on the increase, and although there are still relatively few SW-CRTs currently published its use is bound to show an increase in the near future. An extension of the CONSORT reporting guideline for SW-CRTs has recently been developed. By making reporting guidelines for this innovative design available relatively early in its development, it is possible that the methodological conduct and reporting of future SW-CRTs will not be at the same risk of low-quality of reporting as is the case with many other study designs. We provide a brief overview of this reporting guideline and encourage authors to use it appropriately; and for journal editors to endorse its use.
Keywords	Medicine (General) ; R5-920
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Spatial variability in factors influencing maternal health service use in Jimma Zone, Ethiopia

Jaameeta Kurji / Charles Thickstun / Gebeyehu Bulcha / Monica Taljaard / Ziqi Li / Manisha A. Kulkarni

BMC Health Services Research, Vol 21, Iss 1, Pp 1-

a geographically-weighted regression analysis

2021 Volume 14

Abstract: Abstract Background Persisting within-country disparities in maternal health service access are significant barriers to attaining the Sustainable Development Goals aimed at reducing inequalities and ensuring good health for all. Sub-national decision- ... ...

Abstract	Abstract Background Persisting within-country disparities in maternal health service access are significant barriers to attaining the Sustainable Development Goals aimed at reducing inequalities and ensuring good health for all. Sub-national decision-makers mandated to deliver health services play a central role in advancing equity but require appropriate evidence to craft effective responses. We use spatial analyses to identify locally-relevant barriers to access using sub-national data from rural areas in Jimma Zone, Ethiopia. Methods Cross-sectional data from 3727 households, in three districts, collected at baseline in a cluster randomized controlled trial were analysed using geographically-weighted regressions. These models help to quantify associations within women’s proximal contexts by generating local parameter estimates. Data subsets, representing an empirically-identified scale for neighbourhood, were used. Local associations between outcomes (antenatal, delivery, and postnatal care use) and potential explanatory factors at individual-level (ex: health information source), interpersonal-level (ex: companion support availability) and health service-levels (ex: nearby health facility type) were modelled. Statistically significant local odds ratios were mapped to demonstrate how relevance and magnitude of associations between various explanatory factors and service outcomes change depending on locality. Results Significant spatial variability in relationships between all services and their explanatory factors (p < 0.001) was detected, apart from the association between delivery care and women’s decision-making involvement (p = 0.124). Local models helped to pinpoint factors, such as danger sign awareness, that were relevant for some localities but not others. Among factors with more widespread influence, such as that of prior service use, variation in estimate magnitudes between localities was uncovered. Prominence of factors also differed between services; companion support, for example, had wider ...
Keywords	Geographically weighted regressions ; Spatial heterogeneity ; Ethiopia ; Maternal health services ; Responsive health systems ; Sub-national data ; Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2021-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Evaluation of statistical methods used in the analysis of interrupted time series studies

Simon L. Turner / Andrew B. Forbes / Amalia Karahalios / Monica Taljaard / Joanne E. McKenzie

BMC Medical Research Methodology, Vol 21, Iss 1, Pp 1-

a simulation study

2021 Volume 18

Abstract: Abstract Background Interrupted time series (ITS) studies are frequently used to evaluate the effects of population-level interventions or exposures. However, examination of the performance of statistical methods for this design has received relatively ... ...

Abstract	Abstract Background Interrupted time series (ITS) studies are frequently used to evaluate the effects of population-level interventions or exposures. However, examination of the performance of statistical methods for this design has received relatively little attention. Methods We simulated continuous data to compare the performance of a set of statistical methods under a range of scenarios which included different level and slope changes, varying lengths of series and magnitudes of lag-1 autocorrelation. We also examined the performance of the Durbin-Watson (DW) test for detecting autocorrelation. Results All methods yielded unbiased estimates of the level and slope changes over all scenarios. The magnitude of autocorrelation was underestimated by all methods, however, restricted maximum likelihood (REML) yielded the least biased estimates. Underestimation of autocorrelation led to standard errors that were too small and coverage less than the nominal 95%. All methods performed better with longer time series, except for ordinary least squares (OLS) in the presence of autocorrelation and Newey-West for high values of autocorrelation. The DW test for the presence of autocorrelation performed poorly except for long series and large autocorrelation. Conclusions From the methods evaluated, OLS was the preferred method in series with fewer than 12 points, while in longer series, REML was preferred. The DW test should not be relied upon to detect autocorrelation, except when the series is long. Care is needed when interpreting results from all methods, given confidence intervals will generally be too narrow. Further research is required to develop better performing methods for ITS, especially for short series.
Keywords	Autocorrelation ; Interrupted time series ; Public health ; Segmented regression ; Statistical methods ; Statistical simulation ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2021-08-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Quality and transparency of reporting derivation and validation prognostic studies of recurrent stroke in patients with TIA and minor stroke

Kasim E. Abdulaziz / Jeffrey J. Perry / Krishan Yadav / Dar Dowlatshahi / Ian G. Stiell / George A. Wells / Monica Taljaard

Diagnostic and Prognostic Research, Vol 6, Iss 1, Pp 1-

a systematic review

2022 Volume 13

Abstract: Abstract Background Clinical prediction models/scores help clinicians make optimal evidence-based decisions when caring for their patients. To critically appraise such prediction models for use in a clinical setting, essential information on the ... ...

Abstract	Abstract Background Clinical prediction models/scores help clinicians make optimal evidence-based decisions when caring for their patients. To critically appraise such prediction models for use in a clinical setting, essential information on the derivation and validation of the models needs to be transparently reported. In this systematic review, we assessed the quality of reporting of derivation and validation studies of prediction models for the prognosis of recurrent stroke in patients with transient ischemic attack or minor stroke. Methods MEDLINE and EMBASE databases were searched up to February 04, 2020. Studies reporting development or validation of multivariable prognostic models predicting recurrent stroke within 90 days in patients with TIA or minor stroke were included. Included studies were appraised for reporting quality and conduct using a select list of items from the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) Statement. Results After screening 7026 articles, 60 eligible articles were retained, consisting of 100 derivation and validation studies of 27 unique prediction models. Four models were newly derived while 23 were developed by validating and updating existing models. Of the 60 articles, 15 (25%) reported an informative title. Among the 100 derivation and validation studies, few reported whether assessment of the outcome (24%) and predictors (12%) was blinded. Similarly, sample size justifications (49%), description of methods for handling missing data (16.1%), and model calibration (5%) were seldom reported. Among the 96 validation studies, 17 (17.7%) clearly reported on similarity (in terms of setting, eligibility criteria, predictors, and outcomes) between the validation and the derivation datasets. Items with the highest prevalence of adherence were the source of data (99%), eligibility criteria (93%), measures of discrimination (81%) and study setting (65%). Conclusions The majority of derivation and validation studies for ...
Keywords	Prediction models ; Prediction rules ; Clinical decision rules ; Risk scores ; Recurrent stroke ; Transient ischemic attack ; Medicine (General) ; R5-920
Subject code	690
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: PREPARE trial

Dean A Fergusson / Monica Taljaard / John Muscedere / Daniel I McIsaac / Emily Hladkowicz / Chelsia Gillis / Rachel Khadaroo / Amanda Meliambro

BMJ Open, Vol 12, Iss

a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores

2022 Volume 8

Abstract: Introduction Frailty is a strong predictor of adverse postoperative outcomes. Prehabilitation may improve outcomes after surgery for older people with frailty by addressing physical and physiologic deficits. The objective of this trial is to evaluate the ...

Abstract	Introduction Frailty is a strong predictor of adverse postoperative outcomes. Prehabilitation may improve outcomes after surgery for older people with frailty by addressing physical and physiologic deficits. The objective of this trial is to evaluate the efficacy of home-based multimodal prehabilitation in decreasing patient-reported disability and postoperative complications in older people with frailty having major surgery.Methods and analysis We will conduct a multicentre, randomised controlled trial of home-based prehabilitation versus standard care among consenting patients >60 years with frailty (Clinical Frailty Scale>4) having elective inpatient major non-cardiac, non-neurologic or non-orthopaedic surgery. Patients will be partially blinded; clinicians and outcome assessors will be fully blinded. The intervention consists of >3 weeks of prehabilitation (exercise (strength, aerobic and stretching) and nutrition (advice and protein supplementation)). The study has two primary outcomes: in-hospital complications and patient-reported disability 30 days after surgery. Secondary outcomes include survival, lower limb function, quality of life and resource utilisation. A sample size of 750 participants (375 per arm) provides >90% power to detect a minimally important absolute difference of 8 on the 100-point patient-reported disability scale and a 25% relative risk reduction in complications, using a two-sided alpha value of 0.025 to account for the two primary outcomes. Analyses will follow intention to treat principles for all randomised participants. All participants will be followed to either death or up to 1 year.Ethics and dissemination Ethical approval has been granted by Clinical Trials Ontario (Project ID: 1785) and our ethics review board (Protocol Approval #20190409-01T). Results will be disseminated through presentation at scientific conferences, through peer-reviewed publication, stakeholder organisations and engagement of social and traditional media.Trial registration number ...
Keywords	Medicine ; R
Subject code	170
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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