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Article ; Online: Periodontal health and patient-reported outcomes: A longitudinal analysis of data from non-specialist practice settings.

Sharma, Praveen / Kristunas, Caroline / Chapple, Iain L / Dietrich, Thomas

2023 Volume 50, Issue 5, Page(s) 582–590

Abstract: Aim: To explore the associations between periodontal health and patient-reported outcomes (PROs), accounting for changes over time, in a large, non-specialist dental practice patient cohort.: Materials and methods: This longitudinal study used data ... ...

Abstract	Aim: To explore the associations between periodontal health and patient-reported outcomes (PROs), accounting for changes over time, in a large, non-specialist dental practice patient cohort. Materials and methods: This longitudinal study used data from 13,162 dentate patients, collected by 162 dentists at routine appointments between May 2013 and April 2020, in 238 non-specialist dental practices across the United Kingdom. Dentists collected data, as part of routine clinical care, on periodontal probing pocket depths, alveolar bone loss, bleeding on probing, as well as a range of covariates. Patients inputted data on outcomes (oral pain/discomfort, dietary restrictions, and dental appearance). Mixed-effects logistic regression analysis was used to investigate the associations between periodontal health and PROs. Models accounted for clustering at the patient and dentist level and were adjusted for time and variables which were thought to confound these associations. Results: The odds of all PROs tended to increase with worsening periodontal parameters. For example, the odds of reporting pain in the worst periodontal health category were 1.99 (95% confidence interval: 1.57-2.53) times higher than in the best periodontal health category. Conclusions: This study confirms, using a large longitudinal dataset from a unique non-specialist setting, the associations between poorer periodontal health and poorer PROs.
MeSH term(s)	Humans ; Longitudinal Studies ; Periodontal Pocket ; Patient Reported Outcome Measures ; United Kingdom
Language	English
Publishing date	2023-01-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	188647-2
ISSN	1600-051X ; 0303-6979
ISSN (online)	1600-051X
ISSN	0303-6979
DOI	10.1111/jcpe.13776
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Article ; Online: A novel method for the remote measurement of trismus in clinical trials using mobile phone cameras.

Li, Xiang / Kristunas, Caroline / Landini, Gabriel / Kroeger, Annika / Dietrich, Thomas

Clinical oral investigations

2023 Volume 27, Issue 12, Page(s) 7231–7236

Abstract: Objective: To evaluate the reliability and validity of a novel method for remotely measuring trismus.: Materials and methods: We recruited 60 volunteers who took three types of photographs at a fixed restricted jaw position mimicking limited mouth ... ...

Abstract	Objective: To evaluate the reliability and validity of a novel method for remotely measuring trismus. Materials and methods: We recruited 60 volunteers who took three types of photographs at a fixed restricted jaw position mimicking limited mouth opening, including one selfie and one portrait with or without a reference frame. Additionally, the interincisal distance and the width of the upper central incisors were measured with a ruler, as per common practice. Measurements of trismus were made using image analysis software comparing different types of photos and calibration methods. Intraclass correlation coefficient (ICC) and 95% limits of agreement (LoA) with 95% confidence interval were calculated to evaluate reliability and validity. Results: The proposed method demonstrated high reliability (ICC 0.998; 95% CI 0.997, 0.999). Calibration of photographs using at least a baseline photograph with an external reference frame yielded unbiased measurements and minimised variability. The use of selfies compared to portrait photos also increased variability. Conclusion: The measurement of trismus can be performed using images taken remotely by patients using their mobile phone cameras. The proposed method is highly accurate, with best results obtained by using a reference frame for calibration of portrait photographs. Clinical relevance: We propose an easy, cheap, and accurate method that allows for remote and frequent monitoring of trismus in clinical studies using patients' mobile phones.
MeSH term(s)	Humans ; Cell Phone ; Image Processing, Computer-Assisted ; Reproducibility of Results ; Software ; Trismus/diagnosis ; Clinical Trials as Topic
Language	English
Publishing date	2023-11-10
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1364490-7
ISSN	1436-3771 ; 1432-6981
ISSN (online)	1436-3771
ISSN	1432-6981
DOI	10.1007/s00784-023-05272-z
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Article ; Online: Mind the gap: covariate constrained randomisation can protect against substantial power loss in parallel cluster randomised trials.

Kristunas, Caroline / Grayling, Michael / Gray, Laura J / Hemming, Karla

BMC medical research methodology

2022 Volume 22, Issue 1, Page(s) 111

Abstract: Background: Cluster randomised trials often randomise a small number of units, putting them at risk of poor balance of covariates across treatment arms. Covariate constrained randomisation aims to reduce this risk by removing the worst balanced ... ...

Abstract	Background: Cluster randomised trials often randomise a small number of units, putting them at risk of poor balance of covariates across treatment arms. Covariate constrained randomisation aims to reduce this risk by removing the worst balanced allocations from consideration. This is known to provide only a small gain in power over that averaged under simple randomisation and is likely influenced by the number and prognostic effect of the covariates. We investigated the performance of covariate constrained randomisation in comparison to the worst balanced allocations, and considered the impact on the power of the prognostic effect and number of covariates adjusted for in the analysis. Methods: Using simulation, we examined the Monte Carlo type I error rate and power of cross-sectional, two-arm parallel cluster-randomised trials with a continuous outcome and four binary cluster-level covariates, using either simple or covariate constrained randomisation. Data were analysed using a small sample corrected linear mixed-effects model, adjusted for some or all of the binary covariates. We varied the number of clusters, intra-cluster correlation, number and prognostic effect of covariates balanced in the randomisation and adjusted in the analysis, and the size of the candidate set from which the allocation was selected. For each scenario, 20,000 simulations were conducted. Results: When compared to the worst balanced allocations, covariate constrained randomisation with an adjusted analysis provided gains in power of up to 20 percentage points. Even with analysis-based adjustment for those covariates balanced in the randomisation, the type I error rate was not maintained when the intracluster correlation is very small (0.001). Generally, greater power was achieved when more prognostic covariates are restricted in the randomisation and as the size of the candidate set decreases. However, adjustment for weakly prognostic covariates lead to a loss in power of up to 20 percentage points. Conclusions: When compared to the worst balanced allocations, covariate constrained randomisation provides moderate to substantial improvements in power. However, the prognostic effect of the covariates should be carefully considered when selecting them for inclusion in the randomisation.
MeSH term(s)	Cluster Analysis ; Computer Simulation ; Cross-Sectional Studies ; Humans ; Linear Models ; Random Allocation ; Randomized Controlled Trials as Topic ; Research Design
Language	English
Publishing date	2022-04-13
Publishing country	England
Document type	Journal Article
ZDB-ID	2041362-2
ISSN	1471-2288 ; 1471-2288
ISSN (online)	1471-2288
ISSN	1471-2288
DOI	10.1186/s12874-022-01588-8
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Article ; Online: Risk of Bias in Cluster Randomised Controlled Trials of Individual-Level Interventions

Christina Easter / Caroline Kristunas / Karla Hemming / Sheila Greenfield

International Journal of Qualitative Methods, Vol

Protocol for a Semi-Structured Interview Study

2022 Volume 21

Abstract: Background Many cluster randomised trials of individual-level interventions are at risk of bias, mostly due to identification and recruitment biases, which would not feature under individual randomisation. This bias arises when participants are recruited ...

Abstract	Background Many cluster randomised trials of individual-level interventions are at risk of bias, mostly due to identification and recruitment biases, which would not feature under individual randomisation. This bias arises when participants are recruited into the trial with knowledge of the treatment arm they’ve been allocated to. These trials are also at risk of other biases including lack of clear documentation of primary outcome and apparent unconcealed randomisation. Many of these other risks are easily surmountable, and might reflect poor reporting rather than poor practice, or signal lack of knowledge. Objectives To determine whether investigators are aware of the common sources of risks of bias in cluster trials, and methods to mitigate these risks. We will explore why these biases occur in light of what is known about preventing them and what enables these risks to be mitigated. We will also explore the reasons for adopting cluster randomisation. Setting Principal investigators, statisticians and trialists with experience in conducting cluster randomised trials identified via an existing sampling frame of 104 contemporary cluster trials of individual-level interventions. Methods A realist approach will be used to underpin this study. We will conduct semi-structured interviews over Zoom to identify the rationale behind using a cluster trial when the intervention is at the level of the individual, and knowledge of the importance of blinding for those identifying and recruiting participants. Data collected from the interviews will be analysed using thematic analysis. Themes within the data will be mainly captured with the research question in mind but will remain flexible. Anticipated results We aim to understand the reasons why cluster trials are being conducted when they are at risk of bias. It is hoped that understanding these reasons will provide useful information so future cluster trialists are aware of these risks, and provided with practical solutions.
Keywords	Social sciences (General) ; H1-99
Subject code	310
Language	English
Publishing date	2022-06-01T00:00:00Z
Publisher	SAGE Publishing
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Investigating harms of testing for ovarian cancer - psychological outcomes and cancer conversion rates in women with symptoms of ovarian cancer: A cohort study embedded in the multicentre ROCkeTS prospective diagnostic study.

Kwong, Fong Lien / Kristunas, Caroline / Davenport, Clare / Aggarwal, Ridhi / Deeks, Jon / Mallett, Sue / Kehoe, Sean / Timmerman, Dirk / Bourne, Tom / Stobart, Hilary / Neal, Richard / Menon, Usha / Gentry-Maharaj, Alex / Sturdy, Lauren / Ottridge, Ryan / Sundar, Sudha

BJOG : an international journal of obstetrics and gynaecology

2024

Abstract: Objective: To investigate psychological correlates in women referred with suspected ovarian cancer via the fast-track pathway, explore how anxiety and distress levels change at 12 months post-testing, and report cancer conversion rates by age and ... ...

Abstract	Objective: To investigate psychological correlates in women referred with suspected ovarian cancer via the fast-track pathway, explore how anxiety and distress levels change at 12 months post-testing, and report cancer conversion rates by age and referral pathway. Design: Single-arm prospective cohort study. Setting: Multicentre. Secondary care including outpatient clinics and emergency admissions. Population: A cohort of 2596 newly presenting symptomatic women with a raised CA125 level, abnormal imaging or both. Methods: Women completed anxiety and distress questionnaires at recruitment and at 12 months for those who had not undergone surgery or a biopsy within 3 months of recruitment. Main outcome measures: Anxiety and distress levels measured using a six-item short form of the State-Trait Anxiety Inventory (STAI-6) and the Impact of Event Scale - Revised (IES-r) questionnaire. Ovarian cancer (OC) conversion rates by age, menopausal status and referral pathway. Results: Overall, 1355/2596 (52.1%) and 1781/2596 (68.6%) experienced moderate-to-severe distress and anxiety, respectively, at recruitment. Younger age and emergency presentations had higher distress levels. The clinical category for anxiety and distress remained unchanged/worsened in 76% of respondents at 12 months, despite a non-cancer diagnosis. The OC rates by age were 1.6% (95% CI 0.5%-5.9%) for age <40 years and 10.9% (95% CI 8.7%-13.6%) for age ≥40 years. In women referred through fast-track pathways, 3.3% (95% CI 1.9%-5.7%) of pre- and 18.5% (95% CI 16.1%-21.0%) of postmenopausal women were diagnosed with OC. Conclusions: Women undergoing diagnostic testing display severe anxiety and distress. Younger women are especially vulnerable and should be targeted for support. Women under the age of 40 years have low conversion rates and we advocate reducing testing in this group to reduce the harms of testing.
Language	English
Publishing date	2024-03-31
Publishing country	England
Document type	Journal Article
ZDB-ID	2000931-8
ISSN	1471-0528 ; 0306-5456 ; 1470-0328
ISSN (online)	1471-0528
ISSN	0306-5456 ; 1470-0328
DOI	10.1111/1471-0528.17813
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Article ; Online: Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review.

Kristunas, Caroline / Morris, Tom / Gray, Laura

BMJ open

2017 Volume 7, Issue 11, Page(s) e017151

Abstract: Objectives: To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials.: Setting: Any, not ... ...

Abstract	Objectives: To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials. Setting: Any, not limited to healthcare settings. Participants: Any taking part in an SW-CRT published up to March 2016. Primary and secondary outcome measures: The primary outcome is the variability in cluster sizes, measured by the coefficient of variation (CV) in cluster size. Secondary outcomes include the difference between the cluster sizes assumed during the sample size calculation and those observed during the trial, any reported variability in cluster sizes and whether the methods of sample size calculation and methods of analysis accounted for any variability in cluster sizes. Results: Of the 101 included SW-CRTs, 48% mentioned that the included clusters were known to vary in size, yet only 13% of these accounted for this during the calculation of the sample size. However, 69% of the trials did use a method of analysis appropriate for when clusters vary in size. Full trial reports were available for 53 trials. The CV was calculated for 23 of these: the median CV was 0.41 (IQR: 0.22-0.52). Actual cluster sizes could be compared with those assumed during the sample size calculation for 14 (26%) of the trial reports; the cluster sizes were between 29% and 480% of that which had been assumed. Conclusions: Cluster sizes often vary in SW-CRTs. Reporting of SW-CRTs also remains suboptimal. The effect of unequal cluster sizes on the statistical power of SW-CRTs needs further exploration and methods appropriate to studies with unequal cluster sizes need to be employed.
MeSH term(s)	Cluster Analysis ; Humans ; Randomized Controlled Trials as Topic/methods ; Sample Size
Language	English
Publishing date	2017-11-15
Publishing country	England
Document type	Journal Article ; Review ; Systematic Review
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2017-017151
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: An imbalance in cluster sizes does not lead to notable loss of power in cross-sectional, stepped-wedge cluster randomised trials with a continuous outcome.

Kristunas, Caroline A / Smith, Karen L / Gray, Laura J

Trials

2017 Volume 18, Issue 1, Page(s) 109

Abstract: Background: The current methodology for sample size calculations for stepped-wedge cluster randomised trials (SW-CRTs) is based on the assumption of equal cluster sizes. However, as is often the case in cluster randomised trials (CRTs), the clusters in ... ...

Abstract	Background: The current methodology for sample size calculations for stepped-wedge cluster randomised trials (SW-CRTs) is based on the assumption of equal cluster sizes. However, as is often the case in cluster randomised trials (CRTs), the clusters in SW-CRTs are likely to vary in size, which in other designs of CRT leads to a reduction in power. The effect of an imbalance in cluster size on the power of SW-CRTs has not previously been reported, nor what an appropriate adjustment to the sample size calculation should be to allow for any imbalance. We aimed to assess the impact of an imbalance in cluster size on the power of a cross-sectional SW-CRT and recommend a method for calculating the sample size of a SW-CRT when there is an imbalance in cluster size. Methods: The effect of varying degrees of imbalance in cluster size on the power of SW-CRTs was investigated using simulations. The sample size was calculated using both the standard method and two proposed adjusted design effects (DEs), based on those suggested for CRTs with unequal cluster sizes. The data were analysed using generalised estimating equations with an exchangeable correlation matrix and robust standard errors. Results: An imbalance in cluster size was not found to have a notable effect on the power of SW-CRTs. The two proposed adjusted DEs resulted in trials that were generally considerably over-powered. Conclusions: We recommend that the standard method of sample size calculation for SW-CRTs be used, provided that the assumptions of the method hold. However, it would be beneficial to investigate, through simulation, what effect the maximum likely amount of inequality in cluster sizes would be on the power of the trial and whether any inflation of the sample size would be required.
MeSH term(s)	Cluster Analysis ; Computer Simulation ; Data Interpretation, Statistical ; Humans ; Models, Statistical ; Monte Carlo Method ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/statistics & numerical data ; Research Design/statistics & numerical data ; Sample Size
Language	English
Publishing date	2017-03-07
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-017-1832-8
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Article ; Online: The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials: a systematic review.

Kristunas, Caroline A / Hemming, Karla / Eborall, Helen / Eldridge, Sandra / Gray, Laura J

BMC medical research methodology

2019 Volume 19, Issue 1, Page(s) 12

Abstract: Background: Stepped-wedge cluster randomised trials (SW-CRTs) are a pragmatic trial design, providing an unprecedented opportunity to increase the robustness of evidence underpinning implementation and quality improvement interventions. Given the ... ...

Abstract	Background: Stepped-wedge cluster randomised trials (SW-CRTs) are a pragmatic trial design, providing an unprecedented opportunity to increase the robustness of evidence underpinning implementation and quality improvement interventions. Given the complexity of the SW-CRT, the likelihood of trials not delivering on their objectives will be mitigated if a feasibility study precedes the definitive trial. It is not currently known if feasibility studies are being conducted for SW-CRTs nor what the objectives of these studies are. Methods: Searches were conducted of several databases to identify published feasibility studies which were designed to inform a future SW-CRT. For each eligible study, data were extracted on the characteristics of and rationale for the feasibility study; the process for determining progression to the main trial; how the feasibility study informed the main trial; and whether the main trial went ahead. A narrative synthesis and descriptive analysis are presented. Results: Eleven feasibility studies were identified, which included eight completed study reports and three protocols. Three studies used a stepped-wedge design and these were the only studies to be randomised. Studies were predominantly of a mixed-methods design. Only one study assessed specific features related to the feasibility of using a SW-CRT and one investigated the time taken to complete the study procedures. The other studies were mostly assessing the feasibility and acceptability of the intervention. Conclusion: Published feasibility studies for SW-CRTs are scarce and those that are being reported do not investigate issues specific to the complexities of the trial design. When conducting feasibility studies in advance of a definitive SW-CRT, researchers should consider assessing the feasibility of study procedures, particularly those specific to the SW-CRT design, and ensure that the findings are published for the benefit of other researchers.
MeSH term(s)	Cluster Analysis ; Feasibility Studies ; Humans ; Randomized Controlled Trials as Topic ; Research Design
Language	English
Publishing date	2019-01-10
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ISSN	1471-2288
ISSN (online)	1471-2288
DOI	10.1186/s12874-019-0658-3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: The use of feasibility studies for stepped-wedge cluster randomised trials: protocol for a review of impact and scope.

Kristunas, Caroline A / Hemming, Karla / Eborall, Helen C / Gray, Laura J

BMJ open

2017 Volume 7, Issue 7, Page(s) e017290

Abstract: Introduction: The stepped-wedge cluster randomised trial (SW-CRT) is a complex design, for which many decisions about key design parameters must be made during the planning. These include the number of steps and the duration of time needed to embed the ... ...

Abstract	Introduction: The stepped-wedge cluster randomised trial (SW-CRT) is a complex design, for which many decisions about key design parameters must be made during the planning. These include the number of steps and the duration of time needed to embed the intervention. Feasibility studies are likely to be useful for informing these decisions and increasing the likelihood of the main trial's success. However, the number of feasibility studies being conducted for SW-CRTs is currently unknown. This review aims to establish the number of feasibility studies being conducted for SW-CRTs and determine which feasibility issues are commonly investigated. Methods and analysis: Fully published feasibility studies for SW-CRTs will be identified, according to predefined inclusion criteria, from searches conducted in Ovid MEDLINE, Scopus, Embase and PsycINFO. To also identify and gain information on unpublished feasibility studies the following will be contacted: authors of published SW-CRTs (identified from the most recent systematic reviews); contacts for registered SW-CRTs (identified from clinical trials registries); lead statisticians of UK registered clinical trials units and researchers known to work in the area of SW-CRTs.Data extraction will be conducted independently by two reviewers. For the fully published feasibility studies, data will be extracted on the study characteristics, the rationale for the study, the process for determining progression to a main trial, how the study informed the main trial and whether the main trial went ahead. The researchers involved in the unpublished feasibility studies will be contacted to elicit the same information.A narrative synthesis will be conducted and provided alongside a descriptive analysis of the study characteristics. Ethics and dissemination: This review does not require ethical approval, as no individual patient data will be used. The results of this review will be published in an open-access peer-reviewed journal.
MeSH term(s)	Feasibility Studies ; Humans ; Randomized Controlled Trials as Topic ; Research Design
Language	English
Publishing date	2017-08-01
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2017-017290
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Article ; Online: The current use of feasibility studies in the assessment of feasibility for stepped-wedge cluster randomised trials

Caroline A. Kristunas / Karla Hemming / Helen Eborall / Sandra Eldridge / Laura J. Gray

BMC Medical Research Methodology, Vol 19, Iss 1, Pp 1-

a systematic review

2019 Volume 9

Abstract: Abstract Background Stepped-wedge cluster randomised trials (SW-CRTs) are a pragmatic trial design, providing an unprecedented opportunity to increase the robustness of evidence underpinning implementation and quality improvement interventions. Given the ...

Abstract	Abstract Background Stepped-wedge cluster randomised trials (SW-CRTs) are a pragmatic trial design, providing an unprecedented opportunity to increase the robustness of evidence underpinning implementation and quality improvement interventions. Given the complexity of the SW-CRT, the likelihood of trials not delivering on their objectives will be mitigated if a feasibility study precedes the definitive trial. It is not currently known if feasibility studies are being conducted for SW-CRTs nor what the objectives of these studies are. Methods Searches were conducted of several databases to identify published feasibility studies which were designed to inform a future SW-CRT. For each eligible study, data were extracted on the characteristics of and rationale for the feasibility study; the process for determining progression to the main trial; how the feasibility study informed the main trial; and whether the main trial went ahead. A narrative synthesis and descriptive analysis are presented. Results Eleven feasibility studies were identified, which included eight completed study reports and three protocols. Three studies used a stepped-wedge design and these were the only studies to be randomised. Studies were predominantly of a mixed-methods design. Only one study assessed specific features related to the feasibility of using a SW-CRT and one investigated the time taken to complete the study procedures. The other studies were mostly assessing the feasibility and acceptability of the intervention. Conclusion Published feasibility studies for SW-CRTs are scarce and those that are being reported do not investigate issues specific to the complexities of the trial design. When conducting feasibility studies in advance of a definitive SW-CRT, researchers should consider assessing the feasibility of study procedures, particularly those specific to the SW-CRT design, and ensure that the findings are published for the benefit of other researchers.
Keywords	Stepped-wedge trial ; Cluster randomised trial ; Pilot trial ; Feasibility study ; Systematic review ; Medicine (General) ; R5-920
Subject code	420
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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