Reflecting on the methodological challenge of recruiting older care home residents to podiatry research

IntroductionSuccessful randomisd controlled trials (RCTs) require successful participant recruitment; poor recruitment leads to poor, under-powered studies, and may waste grant funds. Recruitment of older care home residents to RCTs is challenging. This is problematic for podiatry, because older people within care home settings are high users of podiatry services; therefore it is essential that strategies are employed to maximise recruitment to RCTs.We describe the experience of recruiting to a feasibility study of a podiatry intervention to reduce falls in care home residents in the East of Scotland. This was the first phase of a two phase project consisting of the feasibility study to acquire data (recruitment strategy, selection of suitable outcome measures) to inform the conduct of the second phase, an exploratory RCT. Recruitment difficulties became apparent early in the study. Difficulties arose when it came to assessing whether or not potential participants fulfilled certain inclusion criteria:(1) Presence of foot pain (defined as foot pain lasting for at least a day in the last month and a positive response of “some days” or “most/every days” to at least one item on the Manchester Foot Pain and Disability Index (MFPDI))(2) Ability to provide informed consent. The reasons for these difficulties are that (1) we discovered that in the area in which our study was conducted, the majority of care home residents receive basic NHS podiatry care to treat any superficial lesions (i.e. pathological nails and skin callus) thus the prevalence of foot pain resulting from these lesions was lower than we had originally anticipated, and (2) the care homes that we engaged for this phase of the study had residents who were far more dependent and with much higher levels cognitive impairment than we anticipated, making obtaining informed consent difficult. Based on the existing inclusion criteria, it was deemed unlikely that we would meet our recruitment target for the subsequent exploratory randomised controlled trial (n=40).MethodsFollowing discussion with co-applicants we proposed to make two changes in order to improve recruitment, whilst maintaining the scientific integrity of the protocol:(1) We engaged with care homes that cater for less dependent residents in order to improve the likelihood of obtaining informed consent. (2) Since evidence shows that there are several foot and ankle characteristics (toe muscle weakness, hallux valgus, decreased ankle flexibility and strength) that are associated with falls but which do not necessarily cause pain, we widened the inclusion criteria by removing foot pain as a criterion. The recruitment difficulties required a 3 month prolongation of the study duration.ResultsAs a result of tailoring the recruitment strategy early in the feasibility study, we recruited rapidly to the exploratory RCT. We have exceeded our target (n=48).ConclusionsCare home residents represent a convenient population for data collection, but frailty and multiple co-morbidities may make successful recruitment to intervention studies challenging. Whilst the adaptations used in this study may have implications for external validity, this work underlines the importance of testing recruitment strategies at an early stage.Journal supplement-The College of Podiatry Annual Conference 2014: meeting abstract

Determinants of motivation to quit in smokers screened for the early detection of lung cancer:a qualitative study

BACKGROUND: The promotion of smoking cessation within lung cancer screening could lead to benefits for smoking-related disease and improve cost-effectiveness of screening. Little is known about how smokers respond to lung cancer screening and how this impacts smoking behaviour. We aimed to understand how lung cancer screening influences individual motivations about smoking, including in those who have stopped smoking since screening.METHODS: Thirty one long-term smokers aged 51-74 took part in semi-structured interviews about smoking. They had been screened with the EarlyCDT-Lung Test (13 positive result; 18 negative) as part of the Early Cancer Detection Test Lung Cancer Scotland Study. They were purposively sampled for interview based on their self-reported post-screening smoking behaviour. Eleven participants had stopped smoking since screening. Verbatim interview transcripts were analysed using thematic analysis.RESULTS: Two key overarching themes were interpretations of screening test results and emotional responses to those interpretations. Participants' understanding of the risk implied by their test result was often inaccurate, for example a negative result interpreted as an 'all-clear' from lung cancer and a positive result as meaning lung cancer would definitely develop. Those interpretations led to emotional responses (fear, shock, worry, relief, indifferSaveence) influencing motivations about smoking. Other themes included a wake-up call causing changes in perceived risk of smoking-related disease, a feeling that now is the time to stop smoking and family influences. There was no clear pattern in smoking motivations in those who received positive or negative test results. Of those who had stopped smoking, some cited screening experiences as the sole motivation, some cited screening along with other coinciding factors, and others cited non-screening reasons. Cues to change were experienced at different stages of the screening process. Some participants indicated they underwent screening to try and stop smoking, while others expressed little or no desire to stop.CONCLUSIONS: We observed complex and individualised motivations about smoking following lung cancer screening. To be most effective, smoking cessation support in this context should explore understanding of screening test results and may need to be highly tailored to individual emotional responses to screening.</p

Spironolactone for People Age 70 Years and Older With Osteoarthritic Knee Pain:A Proof‐of‐Concept Trial

Objective: To determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life. Methods: This parallel-group, randomized, placebo-controlled, double-blind trial randomized community-dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between-group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5-domain (EQ-5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed-model regression, adjusting for baseline values of test variables. Results: A total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62%) were women. Adherence to study medication was 99%, and all participants completed the 12-week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95% confidence interval (95% CI) - 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95% CI -0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95% CI -0.7, 0.8]; P = 0.98), or EQ-5D 3L score (0.04 points [95% CI -0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C-telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident. Conclusion: Spironolactone did not improve symptoms, physical function, or health-related quality of life in older people with knee OA

Associations between frailty, physical performance, and renal biomarkers in older people with advanced chronic kidney disease

Acknowledgments With thanks to the recruiting teams and participants who took part in the BiCARB trial. GS and MDW acknowledge support from the NIHR Newcastle Biomedical Research CentrePeer reviewedPublisher PD

Unconditional and conditional monetary incentives to increase response to mailed questionnaire : a randomised controlled study within a trial (SWAT)

Rationale, aims, and objectives: High response rates to research questionnaires can help to ensure results are more representative of the population studied and provide increased statistical power, on which the study may have been predicated. Improving speed and quality of response can reduce costs.Method: We conducted a randomised Study Within A Trial (SWAT) to assess questionnaire response rates, reminders sent and data completeness with unconditional compared to conditional monetary incentives. Eligible individuals were mailed a series of psychological questionnaires as a follow-up to a baseline host trial questionnaire. Half received a £5 gift voucher with questionnaires (unconditional) and half were promised the voucher after returning questionnaires (conditional).Results: Of 1079 individuals, response rates to the first follow-up questionnaire were 94.2% and91.7% in the unconditional and conditional monetary incentive groups respectively (OR 1.78, 95% CI0.85 to 3.72). There were significantly greater odds of returning repeat questionnaires in the unconditional group at six months (OR 2.97, 95% CI 1.01 to 8.71; p = 0.047) but not at 12 months(OR 1.12, 95% CI 0.44 to 2.85). Incentive condition had no impact at any time point on the proportion of sent questionnaires that needed reminders. Odds of incomplete questionnaires were significantly greater at three months in the unconditional compared to the conditional incentive group (OR 2.45, 95% CI 1.32 to 4.55; p = 0.004).Conclusions: Unconditional monetary incentives can produce a transitory greater likelihood of mailed questionnaire response in a clinical trial participant group, consistent with the direction of effect in other settings. However, this could have been a chance finding. The use of multiple strategies to promote response may have created a ceiling effect. This strategy has potential to reduce administrative and postage costs, weighed against the cost of incentives used, but could risk compromising the completeness of data

Finding your feet: The development of a podiatry intervention to reduce falls in care home residents.

IntroductionPeople who live in care homes often fall. Foot and ankle muscle weakness, sub-optimal footwear, and common foot problems such as corns and hallux valgus are known and potentially modifiable contributory factors to falls in older people. Conducting a randomised controlled trial in a care home setting to address these issues is challenging and presents a number of uncertainties that need to be addressed prior to undertaking a phase III trial. Therefore, this study used a qualitative approach to assess the feasibility and acceptability of a podiatry falls intervention to care home residents and staff. The data acquired during this qualitative preparatory phase will inform the conduct of a subsequent exploratory randomised controlled trial of a podiatry intervention to reduce falls in care homes.Methods ParticipantsPermanent care home residents with a history of falls, mini mental state examination (MMSE) >9, ability to provide informed consent (n=8); staff (n=5).InterventionResidents, supported by care home staff, participated in a 3-month feasibility-testing phase of an intervention (footwear and orthoses provision, toe and ankle muscle strengthening programme).EvaluationExercise frequency was recorded in logbooks by staff. To assess acceptability and perceptions of feasibility at the conclusion of the 3-month testing period, face to face semi-structured interviews were conducted.Data analysisDescriptive data of exercise frequency were calculated. Analysis of the qualitative data employed a constant-comparative process embedded within the wider framework method to identify emerging themes and concepts to inform the intervention remodelling and development.ResultsFidelity30/57(52.6%) logbooks returned; 11(19.3%) completed in full. Adherence ranged between exercises not having been completed at all in some weeks, to three times per week (optimal) in others.FacilitatorsParticipation in the programme was well received and fitted into care home routines. The exercise component of the intervention was easily carried out and took no longer then 10 minutes to complete. Participants reported that explanation of the aims of the programme at each exercise session was beneficial to adherence. Some residents saw peer support as important; however other residents preferred one-to-one sessions. Footwear and orthoses were well received by the participants.BarriersDiscomfort during exercises, cognitive impairment and illness were barriers reported by residents and staff. A major barrier to adherence was limited access for all staff to training resulting in exercises not being performed when trained staff were not available.ConclusionsA podiatry intervention to reduce falls in care homes is feasible and acceptable. Delivery to residents should be tailored to individual preferences (taking into account goals, targets, and information). Accessing training via DVD or an online resource may improve the reach of the training, facilitating adherence and fidelity. These findings have informed intervention development and modes of delivery for an exploratory randomised controlled trial that is currently underway.Journal supplement - The College of Podiatry Annual Conference 2014: meeting abstract

Genetic determinants of disease severity in the myotonic dystrophy type 1 OPTIMISTIC cohort

To evaluate the role of genetic variation at the locus on symptomatic diversity in 250 adult, ambulant patients with myotonic dystrophy type 1 (DM1) recruited to the Observational Prolonged Trial in Myotonic Dystrophy Type 1 to Improve Quality of Life-Standards, a Target Identification Collaboration (OPTIMISTIC) clinical trial.We used small pool PCR to correct age at sampling biases and estimate the progenitor allele CTG repeat length and somatic mutational dynamics, and AciI digests and repeat primed PCR to test for the presence of variant repeats.We confirmed disease severity is driven by progenitor allele length, is further modified by age, and, in some cases, sex, and that patients in whom the CTG repeat expands more rapidly in the soma develop symptoms earlier than predicted. We revealed a key role for variant repeats in reducing disease severity and quantified their role in delaying age at onset by approximately 13.2 years (95% confidence interval 5.7-20.7, 2-tailed test = -3.7, = 0.0019).Careful characterization of the CTG repeat to define progenitor allele length and presence of variant repeats has increased utility in understanding clinical variability in a trial cohort and provides a genetic route for defining disease-specific outcome measures, and the basis of treatment response and stratification in DM1 trials

Whole body cardiovascular MRI for the comparison of atherosclerotic burden and cardiac remodelling in healthy South Asian and European adults

Objective: To determine the feasibility of using wholebody cardiovascular MRI (WB-CVMR) to compare South Asians (SAs)-a population known to have a higher risk of cardiovascular disease (CVD) but paradoxically lower prevalence of peripheral arterial disease-and Western Europeans (WEs). Methods: 19 SAs and 38 age-, gender- and body mass index-matched WEs were recruited. All were aged 40 years and over, free from CVD and with a 10-year risk of CV

Vitamin K supplementation to improve vascular stiffness in CKD:The K4Kidneys randomized controlled trial

BACKGROUND:Vascular calcification, a risk factor for cardiovascular disease, is common among patients with CKD and is an independent contributor to increased vascular stiffness and vascular risk in this patient group. Vitamin K is a cofactor for proteins involved in prevention of vascular calcification. Whether or not vitamin K supplementation could improve arterial stiffness in patients with CKD is unknown. METHODS:To determine if vitamin K supplementation might improve arterial stiffness in patients in CKD, we conducted a parallel-group, double-blind, randomized trial in participants aged 18 or older with CKD stage 3b or 4 (eGFR 15-45 ml/min per 1.73 m2). We randomly assigned participants to receive 400 μg oral vitamin K2 or matching placebo once daily for a year. The primary outcome was the adjusted between-group difference in carotid-femoral pulse wave velocity at 12 months. Secondary outcomes included augmentation index, abdominal aortic calcification, BP, physical function, and blood markers of mineral metabolism and vascular health. We also updated a recently published meta-analysis of trials to include the findings of this study. RESULTS:We included 159 randomized participants in the modified intention-to-treat analysis, with 80 allocated to receive vitamin K and 79 to receive placebo. Mean age was 66 years, 62 (39%) were female, and 87 (55%) had CKD stage 4. We found no differences in pulse wave velocity at 12 months, augmentation index at 12 months, BP, B-type natriuretic peptide, or physical function. The updated meta-analysis showed no effect of vitamin K supplementation on vascular stiffness or vascular calcification measures. CONCLUSIONS:Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER:Vitamin K therapy to improve vascular health in patients with chronic kidney disease, ISRCTN21444964 (www.isrctn.com)

Prevalence of unrecognised myocardial infarction in a low-intermediate risk asymptomatic cohort and its relation to systemic atherosclerosis

The study was funded by the Souter Charitable Foundation and the Chest, Heart and Stroke Scotland Charity. J.R.W.M. is supported by the Wellcome Trust through the Scottish Translational Medicine and Therapeutics Initiative (grant no. WT 085664) in the form of a clinical research fellowship.Aims :  Unrecognized myocardial infarctions (UMIs) have been described in 19-30% of the general population using late gadolinium enhancement (LGE) on cardiac magnetic resonance. However, these studies have focused on an unselected cohort including those with known cardiovascular disease (CVD). The aim of the current study was to ascertain the prevalence of UMIs in a non-high-risk population using magnetic resonance imaging (MRI). Methods and Results :  A total of 5000 volunteers aged >40 years with no history of CVD and a 10-year risk of CVD of <20%, as assessed by the ATP-III risk score, were recruited to the Tayside Screening for Cardiac Events study. Those with a B-type natriuretic peptide (BNP) level greater than their gender-specific median were invited for a whole-body MR angiogram and cardiac MR including LGE assessment. LGE was classed as absent, UMI, or non-specific. A total of 1529 volunteers completed the imaging study; of these, 53 (3.6%) were excluded because of either missing data or inadequate LGE image quality. Ten of the remaining 1476 (0.67%) displayed LGE. Of these, three (0.2%) were consistent with UMI, whereas seven were non-specific occurring in the mid-myocardium (n = 4), epicardium (n = 1), or right ventricular insertion points (n = 2). Those with UMI had a significantly higher BNP [median 116 (range 31-133) vs. 22.6 (5-175) pg/mL, P = 0.015], lower ejection fraction [54.6 (36-62) vs. 68.9 (38-89)%, P = 0.007], and larger end-systolic volume [36.3 (27-61) vs. 21.7 (5-65) mL/m(2), P = 0.014]. Those with non-specific LGE had lower diastolic blood pressure [68 (54-70) vs. 72 (46-98) mmHg, P = 0.013] but no differences in their cardiac function. Conclusion :  Despite previous reports describing high prevalence of UMI in older populations, in a predominantly middle-aged cohort, those who are of intermediate or low cardiovascular risk have a very low risk of having an unrecognized myocardial infarct.Publisher PDFPeer reviewe