The Achieving Self-directed Integrated Cancer Aftercare Intervention for Detection of Recurrent and Second Primary Melanoma in Survivors of Melanoma: Pilot Randomized Controlled Trial.

BACKGROUND: Melanoma is common with increasing incidence. Guidelines recommend monthly total skin self-examinations (TSSEs) by survivors to detect recurrent and new primary melanomas. TSSE is underperformed despite evidence of benefit. OBJECTIVE: This study compares the effect on psychological well-being and TSSE practice of a self-directed digital intervention with treatment as usual in patients treated for a first stage 0 to IIC primary cutaneous melanoma within the preceding 60 months. METHODS: This randomized clinical trial was conducted at 2 UK National Health Service hospitals (Aberdeen Royal Infirmary, Grampian, and Addenbrooke's, Cambridge). Adults (≥18 years) diagnosed with a first 0 to IIC primary cutaneous melanoma were randomized to receive Achieving Self-directed Integrated Cancer Aftercare (ASICA), a tablet-based intervention prompting and supporting TSSE in survivors of melanoma, or to usual care. The hypothesis was that ASICA would increase TSSE practice in users affected by melanoma and compared with controls without affecting psychological well-being. The main primary outcomes were melanoma worry (Melanoma Worry Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and quality of life (EQ-5D-5L) as well as secondary outcomes collected using postal questionnaires 3, 6, and 12 months following randomization. RESULTS: A total of 240 recruits were randomized (1:1) into the ASICA (n=121, 50.4%) or control (n=119, 49.6%) groups. There were no significant differences between groups for melanoma worry at 12 months (mean difference: 0.12, 95% CI -0.6 to 0.84; P=.74), 3 months (0.23, 95% CI -0.31 to 0.78; P=.40), or 6 months (-0.1, 95% CI -0.7 to 0.51; P=.76). The ASICA group had lower anxiety scores at 12 months (-0.54, 95% CI -1.31 to 0.230; P=.17), 3 months (-0.13, 95% CI -0.79 to 0.54; P=.71), and significantly at 6 months (-1.00, 95% CI -1.74 to -0.26; P=.009). Depression scores were similar, being lower at 12 months (-0.44, 95% CI -1.11 to 0.23; P=.20) and 3 months (-0.24, 95% CI -0.84 to 0.35; P=.42) but only significantly lower at 6 months (-0.77, 95% CI -1.41 to -0.12; P=.02). The ASICA group had significantly higher quality of life scores at 12 months (0.044, 95% CI 0.003-0.085; P=.04) and 6 months (0.070, 95% CI 0.032-0.107; P<.001) and nonsignificantly at 3 months (0.024, 95% CI -0.006 to 0.054; P=.11). ASICA users reported significantly more regular (>5) TSSEs during the study year and significantly higher levels of self-efficacy in conducting TSSE. They also reported significantly higher levels of planning and intention to perform TSSE in the future. CONCLUSIONS: Using ASICA for 12 months does not increase melanoma worry, can reduce anxiety and depression, and may improve quality of life. ASICA has the potential to improve the well-being and vigilance of survivors of melanoma and enable the benefits of regular TSSE. TRIAL REGISTRATION: ClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3453-x.

Urban-rural and socioeconomic status: Impact on multimorbidity prevalence in hospitalized patients.

OBJECTIVE: The aim of this study was to describe multimorbidity prevalence in hospitalized adults, by urban-rural area of residence and socioeconomic status (SES). METHODS: Linked hospital episode data were used. Adults (≥18 years) admitted to hospital as an inpatient during 2014 in Grampian, Scotland, were included. Conditions were identified from admissions during the 5 years prior to the first admission in 2014. Multimorbidity was defined as ≥2 conditions and measured using Tonelli et al. based on International Classification of Diseases-10 coding (preselected list of 30 conditions). We used proportions and 95% confidence intervals (CIs) to summarize the prevalence of multimorbidity by age group, sex, urban-rural category and deprivation. The association between multimorbidity and patient characteristics was assessed using the χ 2 test. RESULTS: Forty one thousand five hundred and forty-five patients were included (median age 62, 52.6% female). Overall, 27.4% (95% CI 27.0, 27.8) of patients were multimorbid. Multimorbidity prevalence was 28.8% (95% CI 28.1, 29.5) in large urban versus 22.0% (95% CI 20.9, 23.3) in remote rural areas and 28.7% (95% CI 27.2, 30.3) in the most deprived versus 26.0% (95% CI 25.2, 26.9) in the least deprived areas. This effect was consistent in all age groups, but not statistically significant in the age group 18-29 years. Multimorbidity increased with age but was similar for males and females. CONCLUSION: Given the scarcity of research into the effect of urban-rural area and SES on multimorbidity prevalence among hospitalized patients, these findings should inform future research into new models of care, including the consideration of urban-rural area and SES.

The impact of third- or fourth-degree perineal tears on the second pregnancy: A cohort study of 182,445 Scottish women.

This study aimed to investigate the reproductive impact of a third- or fourth-degree tear in primigravid women. A retrospective population-based cohort study was conducted using data from Scottish Morbidity Records (SMR02). Primigravid women with a vaginal birth in Scotland from 1997 until 2010 were included. Exposure was third- or fourth-degree tear in the first pregnancy. The second pregnancy rate, interpregnancy interval and third- or fourth-degree tear in a second pregnancy were the primary outcomes. A nested case-control study was used to determine factors associated with repeat third- or fourth-degree tears in a second vaginal birth. Cox regression analysis and logistic regression were used to look for associations. Initial third- or fourth-degree tear occurred in 2.8% women (5174/182445). The percentage of third- or fourth-degree tears in first vaginal births increased from 1% in 1997 to 4.9% in 2010. There was no difference in having a second pregnancy (adjusted Odds Ratio (aOR) 0.98 (99%CI 0.89-1.09)) or the median interpregnancy interval to second pregnancy (adjusted Hazard Ratio (aHR) 1.01 (99%CI 0.95-1.08)) after an initial third- or fourth-degree tear. Women were over four times more likely to have a repeat injury in a subsequent vaginal birth (n = 149/333, aOR 4.68 (99% 3.52-6.23)) and were significantly more likely to have an elective caesarean section in their second pregnancy (n = 887/3333, 26.6%; 12.75 (11.29-14.40)). Increased maternal age and birthweight ≥4500g were risk factors for repeat injury. Third- and fourth-degree tears are increasing in Scotland. Women do not delay or avoid childbirth after initial third- or fourth-degree tear. However, women are more likely to have a repeat third- or fourth-degree tear or an elective caesarean section in the second pregnancy. Strategies to prevent third- or fourth-degree tears are needed.

Measuring multimorbidity in hospitalised patients using linked hospital episode data: comparison of two measures.

INTRODUCTION: Multimorbidity is a complex and growing health challenge. There is no accepted "gold standard" multimorbidity measure for hospital resource planning, and few studies have compared measures in hospitalised patients. AIM: To evaluate operationalisation of two multimorbidity measures in routine hospital episode data in NHS Grampian, Scotland. METHODS: Linked hospital episode data (Scottish Morbidity Record (SMR)) for the years 2009-2016 were used. Adults admitted to hospital as a general/acute inpatient during 2014 were included. Conditions (ICD-10) were identified from general/acute (SMR01) and psychiatric (SMR04) admissions during the five years prior to first admission in 2014. Two count-based multimorbidity measures were used (Charlson Comorbidity Index and Tonelli et al.), and multimorbidity was defined as ≥2 conditions. Kappa statistics assessed agreement. The association between multimorbidity and length of stay, readmission and mortality was assessed using logistic and negative binomial regression as appropriate. RESULTS: In 41,545 adults (median age 62 years, 52.6% female), multimorbidity prevalence was 15.1% (95% CI 14.8%, 15.5%) using Charlson and 27.4% (27.0%, 27.8%) using Tonelli - agreement 85.1% (Kappa 0.57). Multimorbidity prevalence, using both measures, increased with age. Multimorbidity was higher in males (16.5%) than females (13.9%) using the Charlson measure, but similar across genders when measured with Tonelli. After adjusting for covariates, multimorbidity remained associated with longer length of stay (Charlson IRR 1.1 (1.0, 1.2); Tonelli IRR 1.1 (1.0, 1.2)) and readmission (Charlson OR 2.1 (1.9, 2.2); Tonelli OR 2.1 (2.0, 2.2)). Multimorbidity had a stronger association with mortality when measured using Charlson (OR 2.7 (2.5, 2.9)), than using Tonelli (OR 1.8 (1.7, 2.0)). CONCLUSIONS: Multimorbidity measures operationalised in hospital episode data identified those at risk of poor outcomes and such operationalised tools will be useful for future multimorbidity research and use in secondary care data systems. Multimorbidity measures are not interchangeable, and the choice of measure should depend on the purpose. HIGHLIGHTS: Operationalisation of two count-based multimorbidity measures using linked electronic hospital episode data was evaluated (Charlson and Tonelli).First study to compare the Tonelli measure with another measure for investigating multimorbidity in hospitalised patients.Multimorbidity prevalence differed depending on measure used, but both multimorbidity measures identified those at risk of poor outcomes.Operationalised multimorbidity tools have uses for future multimorbidity research and use in secondary care data systems.Multimorbidity measures are not interchangeable, and choice of measure should depend on purpose.

Pointers to earlier diagnosis of endometriosis: a nested case-control study using primary care electronic health records.

BACKGROUND: Endometriosis is a condition with relatively non-specific symptoms, and in some cases a long time elapses from first-symptom presentation to diagnosis. AIM: To develop and test new composite pointers to a diagnosis of endometriosis in primary care electronic records. DESIGN AND SETTING: This is a nested case-control study of 366 cases using the Practice Team Information database of anonymised primary care electronic health records from Scotland. Data were analysed from 366 cases of endometriosis between 1994 and 2010, and two sets of age and GP practice matched controls: (a) 1453 randomly selected females and (b) 610 females whose records contained codes indicating consultation for gynaecological symptoms. METHOD: Composite pointers comprised patterns of symptoms, prescribing, or investigations, in combination or over time. Conditional logistic regression was used to examine the presence of both new and established pointers during the 3 years before diagnosis of endometriosis and to identify time of appearance. RESULTS: A number of composite pointers that were strongly predictive of endometriosis were observed. These included pain and menstrual symptoms occurring within the same year (odds ratio [OR] 6.5, 95% confidence interval [CI] = 3.9 to 10.6), and lower gastrointestinal symptoms occurring within 90 days of gynaecological pain (OR 6.1, 95% CI = 3.6 to 10.6). Although the association of infertility with endometriosis was only detectable in the year before diagnosis, several pain-related features were associated with endometriosis several years earlier. CONCLUSION: Useful composite pointers to a diagnosis of endometriosis in GP records were identified. Some of these were present several years before the diagnosis and may be valuable targets for diagnostic support systems.

Provision of hormonal and long-acting reversible contraceptive services by general practices in Scotland, UK (2004-2009).

BACKGROUND: In the UK, a large proportion of contraceptive services are provided from general practice. However, little is known about which contraceptive services are provided and to whom. STUDY DESIGN: Descriptive serial cross-sectional study of women aged 12-55 years, registered with 191 general practices in Scotland, UK between 2004 and 2009. RESULTS: Annual incidence of provision of hormonal and long-acting reversible contraceptives (LARCs) increased from 27.7% in 2004 to 30.1% in 2009. Amongst those women registered with a general practice for the full 5-year period the provision of LARCs increased from 8.8% to 12.5% (p<0.001). For the same group, the provision of emergency hormonal contraception (EHC) decreased from 5.2% to 2.6% (p<0.001). CONCLUSIONS: With the exception of EHC, there was an increase over time in the provision of hormonal contraceptives and LARCs from general practices. It is important that a full range of contraceptive options remains easily available to women.

Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial.

BACKGROUND: There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study. METHODS: Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue. RESULTS: Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval -15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable. CONCLUSIONS: Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans. TRIAL REGISTRATION: ISRCTN29666484.

Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial.

OBJECTIVE: To determine whether mobile phone based monitoring improves asthma control compared with standard paper based monitoring strategies. DESIGN: Multicentre randomised controlled trial with cost effectiveness analysis. SETTING: UK primary care. PARTICIPANTS: 288 adolescents and adults with poorly controlled asthma (asthma control questionnaire (ACQ) score ≥ 1.5) from 32 practices. INTERVENTION: Participants were centrally randomised to twice daily recording and mobile phone based transmission of symptoms, drug use, and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring. MAIN OUTCOME MEASURES: Changes in scores on asthma control questionnaire and self efficacy (knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)) at six months after randomisation. Assessment of outcomes was blinded. Analysis was on an intention to treat basis. RESULTS: There was no significant difference in the change in asthma control or self efficacy between the two groups (ACQ: mean change 0.75 in mobile group v 0.73 in paper group, mean difference in change -0.02 (95% confidence interval -0.23 to 0.19); KASE-AQ score: mean change -4.4 v -2.4, mean difference 2.0 (-0.3 to 4.2)). The numbers of patients who had acute exacerbations, steroid courses, and unscheduled consultations were similar in both groups, with similar healthcare costs. Overall, the mobile phone service was more expensive because of the expenses of telemonitoring. CONCLUSIONS: Mobile technology does not improve asthma control or increase self efficacy compared with paper based monitoring when both groups received clinical care to guidelines standards. The mobile technology was not cost effective. TRIAL REGISTRATION: Clinical Trials NCT00512837.

Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery.

BACKGROUND: Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR) services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer. METHODS: Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS) Boards for 6 months. Eligible patients are all women who are: (1) aged between 18 and 65 years; (2) in paid employment or self-employed; (3) living or working in Lothian or Tayside, Scotland, UK; (4) diagnosed with an invasive breast cancer tumour; (5) treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B), fatigue (FACIT-Fatigue) and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer. DISCUSSION: To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and feasibility of a larger future trial involving patients with breast, prostate or lung cancer and inform the development of appropriate VR services for people living with cancer.

Comparison of patient survival in non-diabetic transplant-listed patients initially treated with haemodialysis or peritoneal dialysis.

BACKGROUND: It is still not known whether patients survive longer on one modality of dialysis compared to the other. We have tried to answer this question using data from the Scottish Renal Registry. METHODS: To avoid the confounding effects of co-morbidity, we limited our survival analysis to those patients listed for a renal transplant and excluded patients with a primary renal diagnosis (PRD) of diabetic nephropathy. We studied patients starting dialysis between 01 January 1982 and 31 December 2006. RESULTS: Three thousand one hundred and ninety-seven patients fulfilled our criteria. A Kaplan-Meier plot showed no difference in survival between initial dialysis modality (log-rank P = 0.996). In the Cox regression model, initial dialysis modality was not a significant predictor of survival; hazard ratio = 0.97 (95% CI 0.80 to 1.18) after adjusting for age, sex and PRD. Age at the start of dialysis, hazard ratio = 1.05 (95% CI 1.04 to 1.06) and a PRD group of 'multi-system disease' or 'unknown' were found to significantly influence survival. When survival was also censored for change in modality, there was no difference in survival over the whole study period with the hazard of death for patients on haemodialysis compared to those on peritoneal dialysis being 1.04 (95% CI 0.78 to 1.38; P = 0.803). Age at the start of dialysis remained a significant predictor of death. CONCLUSIONS: This study shows that there was no survival advantage between initial dialysis modalities in non-diabetic patients who are deemed healthy enough for listing for a renal transplant.

Preoperative determinants for failure of transobturator tapes in the management of female urodynamic stress incontinence.

OBJECTIVES: To determine significant preoperative risk factors for failure of transobturator tapes. METHODS: Secondary analysis of data from the E-TOT (Evaluation of Transobturator Tapes) study. Patient-reported outcomes (n=310) and objective outcomes (n=297) were analyzed using univariate and multivariate analyses. RESULTS: On univariate analysis, body mass index (BMI) >or= 35, maximum urethral closure pressure (MUCP) or=35 (OR 6.37; 95% CI, 1.73-23.44; P=0.005), nocturia (OR 2.18; 95% CI, 1.04-4.58; P=0.039), urgency incontinence (OR 3.35; 95% CI, 1.07-10.51; P=0.039), and previous incontinence surgery (OR 2.33; 95%CI, 1.1-5.48; P=0.048) were independently associated with patient-reported failure. MUCP