Non-speculum sampling approaches for cervical screening in older women: randomised controlled trial

Background: Cervical cancer disproportionately affects women aged 65 years and older, especially those with inadequate previous screening. Speculum use is a key deterrent to screening attendance in older women. Aim: To assess whether offering non-speculum clinician-taken sampling and self-sampling increase uptake among lapsed attenders aged 50-64. Design and setting: Pragmatic randomised control trial conducted between August 2018 and November 2019 at 10 general practices in East London, UK. Method: Participants were 784 women aged 50-64 last screened 6-15years before randomisation. Intervention women received a letter offering the choice of a self-sampling kit or a clinician-taken non-speculum sample. Control women received usual care. Main outcome measure: uptake within 4 months. Results: Screening uptake 4 months after randomisation was significantly higher in the intervention arm: 20.4% (N=80/393) vs 4.9% (N=19/391, absolute difference=15.5%, 95%CI: 11.0%-20.0%, p<0.001). This was maintained at 12 months; 30.5% (N=120/393) vs 13.6% (N=53/391), respectively (absolute difference=17.0%, 95%CI: 11.3%-22.7%, p<0.001). Conventional screening attendance within 12 months was very similar for both arms (intervention: 12.7% (N=50/393) vs control: 13.6% (N=53/391)). Ethnic differences were observed in screening modality preference. More white women opted for self-sampling (50.7%, N=38/75) while most Asian and Black women opted for conventional screening. Conclusions: Offering non-speculum clinician-sampling and self-sampling substantially increases uptake in older women with lapsed screening attendance. Non-speculum clinician sampling appeals to women who dislike the speculum but prefer a clinician to take their sample and who lack confidence in self-sampling. Providing a choice of screening modality may be important for optimising cervical screening uptake.

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Incentives in Diabetic Eye Assessment by Screening (IDEAS) trial: a three-armed randomised controlled trial of financial incentives

Health Services and Delivery Research ◽

10.3310/hsdr05150 ◽

2017 ◽

Vol 5 (15) ◽

pp. 1-60 ◽

Cited By ~ 4

Author(s):

Gaby Judah ◽

Ara Darzi ◽

Ivo Vlaev ◽

Laura Gunn ◽

Derek King ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Health Services ◽

Financial Incentives ◽

Financial Incentive ◽

Controlled Trial ◽

Fixed Group ◽

Screening Uptake ◽

Invitation Letter ◽

Screening Attendance ◽

Randomised Controlled

BackgroundThe UK national diabetic eye screening (DES) programme invites diabetic patients aged > 12 years annually. Simple and cost-effective methods are needed to increase screening uptake. This trial tests the impact on uptake of two financial incentive schemes, based on behavioural economic principles.ObjectivesTo test whether or not financial incentives encourage screening attendance. Secondarily to understand if the type of financial incentive scheme used affects screening uptake or attracts patients with a different sociodemographic status to regular attenders. If financial incentives were found to improve attendance, then a final objective was to test cost-effectiveness.DesignThree-armed randomised controlled trial.SettingDES clinic within St Mary’s Hospital, London, covering patients from the areas of Kensington, Chelsea and Westminster.ParticipantsPatients aged ≥ 16 years, who had not attended their DES appointment for ≥ 2 years.Interventions(1) Fixed incentive – invitation letter and £10 for attending screening; (2) probabilistic (lottery) incentive – invitation letter and 1% chance of winning £1000 for attending screening; and (3) control – invitation letter only.Main outcome measuresThe primary outcome was screening attendance. Rates for control versus fixed and lottery incentive groups were compared using relative risk (RR) and risk difference with corresponding 95% confidence intervals (CIs).ResultsA total of 1274 patients were eligible and randomised; 223 patients became ineligible before invite and 1051 participants were invited (control,n = 435; fixed group,n = 312; lottery group,n = 304). Thirty-four (7.8%, 95% CI 5.29% to 10.34%) control, 17 (5.5%, 95% CI 2.93% to 7.97%) fixed group and 10 (3.3%, 95% CI 1.28% to 5.29%) lottery group participants attended. Participants offered incentives were 44% less likely to attend screening than controls (RR 0.56, 95% CI 0.34 to 0.92). Examining incentive groups separately, the lottery group were 58% less likely to attend screening than controls (RR 0.42, 95% CI 0.18 to 0.98). No significant differences were found between fixed incentive and control groups (RR 0.70, 95% CI 0.35 to 1.39) or between fixed and lottery incentive groups (RR 1.66, 95% CI 0.65 to 4.21). Subgroup analyses showed no significant associations between attendance and sociodemographic factors, including gender (female vs. male, RR 1.25, 95% CI 0.77 to 2.03), age (≤ 65 years vs. > 65 years, RR 1.26, 95% CI 0.77 to 2.08), deprivation [0–20 Index of Multiple Deprivation (IMD) decile vs. 30–100 IMD decile, RR 1.12, 95% CI 0.69 to 1.83], years registered [mean difference (MD) –0.13, 95% CI –0.69 to 0.43], and distance from screening location (MD –0.18, 95% CI –0.65 to 0.29).LimitationsDespite verification, some address details may have been outdated, and high ethnic diversity may have resulted in language barriers for participants.ConclusionsThose receiving incentives were not more likely to attend a DES than those receiving a usual invitation letter in patients who are regular non-attenders. Both fixed and lottery incentives appeared to reduce attendance. Overall, there is no evidence to support the use of financial incentives to promote diabetic retinopathy screening. Testing interventions in context, even if they appear to be supported by theory, is important.Future workFuture research, specifically in this area, should focus on identifying barriers to screening and other non-financial methods to overcome them.Trial registrationCurrent Controlled Trials ISRCTN14896403.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 5, No. 15. See the NIHR Journals Library website for further project information.

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A Randomised Controlled Trial of Strategies to Prompt Attendance for a Pap Smear

Journal of Medical Screening ◽

10.1177/096914139500200408 ◽

1995 ◽

Vol 2 (4) ◽

pp. 211-218 ◽

Cited By ~ 23

Author(s):

Jenny Bowman ◽

Rob Sanson-Fisher ◽

Catherine Boyle ◽

Stephanie Pope ◽

Sally Redman

Keyword(s):

At Risk ◽

Randomised Controlled Trial ◽

Pap Smear ◽

Controlled Trial ◽

Self Report ◽

Health Clinic ◽

Control Group ◽

Screening Attendance ◽

Randomised Controlled

Objective – To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage “at risk” women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. Methods – Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. Results – A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P =0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. Conclusions – The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

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Recruitment And Retention Of Participants From Socioeconomically Deprived Communities: Lessons From The Awareness And Beliefs About Cancer (ABACus3) Randomised Controlled Trial

10.21203/rs.3.rs-33953/v1 ◽

2020 ◽

Author(s):

Vasiliki Kolovou ◽

Yvonne Moriarty ◽

Stephanie Gilbert ◽

Harriet Quinn-Scoggins ◽

Julia Townson ◽

...

Keyword(s):

Financial Incentives ◽

Controlled Trial ◽

Qualitative Interviews ◽

Randomised Control Trial ◽

Trial Participant ◽

Community Settings ◽

Research Strategies ◽

Healthcare Settings ◽

Randomised Controlled ◽

Deprived Areas

Abstract Background Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample. Methods Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections. Results The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n = 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n = 212) retention at 2-weeks and 85% (n = 199) at 6-months. Community settings yielded 75% (n = 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n = 148) were female, with 66% (n = 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings. Conclusions The ABACus3 trial achieved recruitment and high retention with a population that is often “hard to reach” or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement.

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Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-041121 ◽

2020 ◽

Vol 10 (12) ◽

pp. e041121

Author(s):

Yago Tavares Pinheiro ◽

Germanna Medeiros Barbosa ◽

Hilmaynne Renaly Fonseca Fialho ◽

César Augusto Medeiros Silva ◽

Jaciara de Oliveira Anunciação ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Knee Osteoarthritis ◽

Older Women ◽

Controlled Trial ◽

Secondary Outcome ◽

Group Differences ◽

Control Group ◽

Kinesio Taping ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

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Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033586 ◽

2019 ◽

Vol 9 (12) ◽

pp. e033586 ◽

Cited By ~ 1

Author(s):

Irene Jaén ◽

Carlos Suso-Ribera ◽

Diana Castilla ◽

Irene Zaragoza ◽

Azucena García-Palacios ◽

...

Keyword(s):

Chronic Pain ◽

Web Application ◽

Controlled Trial ◽

Repeated Measure ◽

Health Concern ◽

Randomised Control Trial ◽

Treatment As Usual ◽

Use Of Technology ◽

Public Costs ◽

Randomised Controlled

IntroductionChronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This study describes a randomised control trial designed to test the utility of a technology-based solution for pain telemonitoring consisting of a smartphone app for patients and a web application for physicians. The goal of this study will be to explore whether this combination of eHealth and mHealth improves the effectiveness of existing pain treatments.Methods and analysisParticipants will be 250 patients randomly assigned to one of these two conditions: treatment-as-usual (TAU) and TAU +app+ web. All participants will receive the usual treatment for their pain. Only the TAU +app+ web group use Pain Monitor app, which generates alarms that are sent to the physicians in the face of previously established undesired events. Physicians will be able to monitor app reports using a web application, which might result in an adjustment of treatment. We anticipate that the use of Pain Monitor plus the therapist web will result in a reduction of pain intensity and side effects of the medication. Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected. Mixed repeated-measure multivariate analyses of variances will be conducted to investigate whether there are differences between preassessment and postassessment scores as a function of the experimental condition.Ethics and disseminationEthical approval from the Hospital General Universitari de Castellon was obtained. The findings will be published in peer-reviewed journals.Trial registration numberNCT03606265

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A randomised controlled trial of the effectiveness of pedometers plus systematic advice to increase physical activity levels in sedentary older women

http://isrctn.org/> ◽

10.1186/isrctn26786857 ◽

2013 ◽

Author(s):

Marion McMurdo

Keyword(s):

Physical Activity ◽

Randomised Controlled Trial ◽

Older Women ◽

Controlled Trial ◽

Activity Levels ◽

Physical Activity Levels ◽

Randomised Controlled

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Behavioural text message reminders to improve participation in cervical screening: a randomised controlled trial

The Lancet ◽

10.1016/s0140-6736(17)32981-1 ◽

2017 ◽

Vol 390 ◽

pp. S46 ◽

Cited By ~ 3

Author(s):

Sarah Huf ◽

Dominic King ◽

Robert Kerrison ◽

Tim Chadborn ◽

Adele Richmond ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Cervical Screening ◽

Text Message ◽

Randomised Controlled

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Effect of vitamin D3 supplementation on relapses, disease progression, and measures of function in persons with multiple sclerosis: exploratory outcomes from a double-blind randomised controlled trial

Multiple Sclerosis Journal ◽

10.1177/1352458511434607 ◽

2012 ◽

Vol 18 (8) ◽

pp. 1144-1151 ◽

Cited By ~ 127

Author(s):

Margitta T Kampman ◽

Linn H Steffensen ◽

Svein I Mellgren ◽

Lone Jørgensen

Keyword(s):

Multiple Sclerosis ◽

Vitamin D ◽

Randomised Controlled Trial ◽

Disease Progression ◽

Grip Strength ◽

Controlled Trial ◽

Absolute Difference ◽

Mineral Density ◽

Significant Difference ◽

Randomised Controlled

Background: High vitamin D levels may reduce the risk of relapses and disease progression in multiple sclerosis. Methods: This 96-week randomised controlled trial was designed to assess the effect of vitamin D3 supplementation on bone mineral density in persons with multiple sclerosis. Supplementation with 20,000 IU vitamin D3 weekly raised median serum 25-hydroxy vitamin D (25[OH]D) to 121 nmol/L. The modified intention to treat analysis included 35 persons in the vitamin D3 group and 33 in the placebo group. Participants were age 21 to 50 years and fully ambulatory (median Expanded Disability Status Scale (EDSS) 2.5). We studied the effect of supplementing vitamin D3 on the exploratory outcomes annualised relapse rate (ARR), EDSS, multiple sclerosis functional composite (MSFC) components, grip strength, and fatigue. Results: After 96 weeks, there was no significant difference between groups in ARR (absolute difference 0.10, 95% CI -0.07 to 0.27; p = 0.25), EDSS (absolute difference -0.01, 95% CI -0.35 to 0.35; p = 0.97), MSFC components, grip strength, or fatigue. Conclusion: Supplementation with 20,000 IU vitamin D3 weekly did not result in beneficial effects on the measured multiple sclerosis-related outcomes. This study was not powered to address clinical outcomes, but none of the results were suggestive of an effect in this unselected population of fully ambulatory persons with multiple sclerosis.

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