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1.  Measuring the psychosocial burden in women with low-grade abnormal cervical cytology in the TOMBOLA trial: psychometric properties of the Process and Outcome Specific Measure (POSM) 
There is a need for an instrument to measure the psychosocial burden of receiving an abnormal cervical cytology result which can be used regardless of the clinical management women receive.
3331 women completed the POSM as part of baseline psychosocial assessment in a trial of management of low grade cervical cytological abnormalities. Factor analysis and reliability assessment of the POSM were conducted.
Two factors were extracted from the POSM: Factor 1, containing items related to worry; and Factor 2 containing items relating to satisfaction with information and support received and change in the way women felt about themselves. Factor 1 had good reliability (Cronbach’s alpha 0.769), however reliability of the Factor 2 was poorer (0.482). Data collected at four subsequent time points demonstrated that the factor structure was stable over time.
This study demonstrates the presence and reliability of a scale measuring worries within the POSM. This analysis will inform its future use in this population and in other related contexts.
Electronic supplementary material
The online version of this article (doi:10.1186/s12955-014-0154-8) contains supplementary material, which is available to authorized users.
PMCID: PMC4252018
Cervical intraepithelial neoplasia; Questionnaires; Factor analysis; Psychosocial distress
2.  Smoking in young women in Scotland and future burden of hospital admission and death: a nested cohort study 
The British Journal of General Practice  2013;63(613):e523-e533.
Many women smoke, yet few longitudinal studies have examined the non-fatal burden of smoking in women.
To investigate smoking in young women, and hospital admission and death in Scotland; and to compare mortality risk with elsewhere in the UK.
Design and setting
Nested cohort study: Royal College of General Practitioners’ Oral Contraception Study, UK.
A total of 4121 women categorised by smoking habits and living in Scotland at recruitment (1968–1969) were followed until March 2009. Cox regression was used to investigate smoking and survival time; mortality from cancer, circulatory, or respiratory disease, and all other causes; and hospitalisation for any reason, and for specific reasons. The number and type of hospital admissions and bed-days were examined by smoking status. Life tables and Cox regression were used to compare the mortality risk of women living in Scotland with that of women living elsewhere.
All-cause mortality was increased in women who smoked <15 cigarettes daily (adjusted hazard ratio = 1.99, 95% confidence interval [CI] = 1.74 to 2.27) and those who smoked ≥15 cigarettes daily (adjusted HR = 2.81, 95% CI = 2.47 to 3.20). Smoking any amount increased death from cancer, circulatory, respiratory, and other causes. Increased risk estimates were seen in one or both smoking groups for hospitalisation for any cause, and for several specific causes. More smokers than non-smokers were admitted to hospital, for four or more reasons, and had a longer total stay. The median survival age among smokers was lower in Scotland than elsewhere. Higher adjusted hazard ratios for mortality were found among smokers in Scotland.
This study provides a powerful reminder of the burden of smoking in young women. In the UK, harmful effects appear to be worse in smokers in Scotland.
PMCID: PMC3722829  PMID: 23972193
cohort studies; general practice; hospitalisation; mortality; smoking; women
3.  Do health behaviours change after colonoscopy? A prospective cohort study on diet, alcohol, physical activity and smoking among patients and their partners 
BMJ Open  2014;4(1):e003706.
To describe diet, alcohol, physical activity and tobacco use prospectively, that is, before and 10 months after colonoscopy for patients and their partners.
Prospective cohort study of health behaviour change in patients and partners. Comparison groups are patients receiving a normal result notification (NRN) versus patients receiving an abnormal result notification (ARN). Patients and partners (controls) are also compared.
5 Scottish hospitals.
Of 5798 colonoscopy registrations, 2577 (44%) patients met the eligibility criteria of whom 565 (22%) were recruited; 460 partners were also recruited.
International Physical Activity Questionnaire, Scottish Collaborative Group Food Frequency Questionnaire (includes alcohol), smoking status, sociodemographic characteristics, body mass index, medical conditions, colonoscopy result, Multidimensional Health Locus of Control Scale, behaviour-specific self-efficacy scales.
57% of patients were men, with a mean age of 60.8 years (SE 0.5) and 43% were from more affluent areas. 72% (n=387) of patients received an ARN and 28% (n=149) received an NRN. Response rate of the second questionnaire was 68.9%. Overall, 27% of patients consumed <5 measures of fruit and vegetables/day, 20% exceeded alcohol limits, 50% had low levels of physical activity and 21% were obese. At 10-month follow-up, a 5% reduction in excessive alcohol consumption and an 8% increase in low levels of physical activity were observed among patients; no significant changes occurred in partners. Baseline high alcohol consumption and low physical activity were the strongest predictors of these behaviours at follow-up. Low alcohol self-efficacy and increasing age were associated with poorer health-related behaviours at follow-up for alcohol consumption and physical activity, respectively.
Colonoscopy is associated with marginal beneficial changes in some behaviours but not others. Further work is needed to explore how services can optimise increases in beneficial behaviours and mitigate increases in harmful ones.
REC REF 10/S0709/24, UKCRN 9911.
PMCID: PMC3902309  PMID: 24430875
Epidemiology; Public Health
4.  Prevalence and Causes of Prescribing Errors: The PRescribing Outcomes for Trainee Doctors Engaged in Clinical Training (PROTECT) Study 
PLoS ONE  2014;9(1):e79802.
Study objectives were to investigate the prevalence and causes of prescribing errors amongst foundation doctors (i.e. junior doctors in their first (F1) or second (F2) year of post-graduate training), describe their knowledge and experience of prescribing errors, and explore their self-efficacy (i.e. confidence) in prescribing.
A three-part mixed-methods design was used, comprising: prospective observational study; semi-structured interviews and cross-sectional survey. All doctors prescribing in eight purposively selected hospitals in Scotland participated. All foundation doctors throughout Scotland participated in the survey. The number of prescribing errors per patient, doctor, ward and hospital, perceived causes of errors and a measure of doctors' self-efficacy were established.
4710 patient charts and 44,726 prescribed medicines were reviewed. There were 3364 errors, affecting 1700 (36.1%) charts (overall error rate: 7.5%; F1:7.4%; F2:8.6%; consultants:6.3%). Higher error rates were associated with : teaching hospitals (p<0.001), surgical (p = <0.001) or mixed wards (0.008) rather thanmedical ward, higher patient turnover wards (p<0.001), a greater number of prescribed medicines (p<0.001) and the months December and June (p<0.001). One hundred errors were discussed in 40 interviews. Error causation was multi-factorial; work environment and team factors were particularly noted. Of 548 completed questionnaires (national response rate of 35.4%), 508 (92.7% of respondents) reported errors, most of which (328 (64.6%) did not reach the patient. Pressure from other staff, workload and interruptions were cited as the main causes of errors. Foundation year 2 doctors reported greater confidence than year 1 doctors in deciding the most appropriate medication regimen.
Prescribing errors are frequent and of complex causation. Foundation doctors made more errors than other doctors, but undertook the majority of prescribing, making them a key target for intervention. Contributing causes included work environment, team, task, individual and patient factors. Further work is needed to develop and assess interventions that address these.
PMCID: PMC3880263  PMID: 24404122
5.  Reducing the time before consulting with symptoms of lung cancer: a randomised controlled trial in primary care 
Most individuals with lung cancer have symptoms for several months before presenting to their GP. Earlier consulting may improve survival.
To evaluate whether a theory-based primary care intervention increased timely consulting of individuals with symptoms of lung cancer.
Design and setting
Open randomised controlled trial comparing intervention with usual care in two general practices in north-east Scotland.
Smokers and ex-smokers aged ≥55 years were randomised to receive a behavioural intervention or usual care. The intervention comprised a single nurse consultation at participants’ general practice and a self-help manual. The main outcomes were consultations within target times for individuals with new chest symptoms (≤3 days haemoptysis, ≤3 weeks other symptoms) in the year after the intervention commenced, and intentions about consulting with chest symptoms at 1 and 6 months.
Two hundred and twelve participants were randomised and 206 completed the trial. The consultation rate for new chest symptoms in the intervention group was 1.19 (95% confidence interval [CI] = 0.92 to 1.53; P = 0.18) times higher than in the usual-care group and the proportion of consultations within the target time was 1.11 (95% CI = 0.41 to 3.03; P = 0.83) times higher. One month after the intervention commenced, the intervention group reported intending to consult with chest symptoms 31 days (95% CI = 7 to 54; P = 0.012) earlier than the usual care group, and at 6 months this was 25 days (95% CI = 1.5 to 48; P = 0.037) earlier.
Behavioural intervention in primary care shortened the time individuals at high risk of lung disease intended to take before consulting with new chest symptoms (the secondary outcome of the study), but increases in consultation rates and the proportions of consultations within target times were not statistically significant.
PMCID: PMC3529292  PMID: 23336469
early detection of cancer; general practice; illness behaviour; lung neoplasms; randomised controlled trial
6.  Anticipatory care planning and integration: a primary care pilot study aimed at reducing unplanned hospitalisation 
The British Journal of General Practice  2012;62(595):e113-e120.
Anticipatory care for older patients who are frail involves both case identification and proactive intervention to reduce hospitalisation.
To identify a population who were at risk of admission to hospital and to provide an anticipatory care plan (ACP) for them and to ascertain whether using primary and secondary care data to identify this population and then applying an ACP can help to reduce hospital admission rates.
Design and setting
Cohort study of a service intervention in a general practice and a primary care team in Scotland.
The ACP sets out patients’ wishes in the event of a sudden deterioration in health. If admitted, a proactive approach was taken to transfer and discharge patients into the community. Cohorts were selected using the Nairn Case Finder, which matched patients in two practices for age, sex, multiple morbidity indexes, and secondary care outpatient and inpatient activity; 96 patients in each practice were studied for admission rate, occupied bed days and survival.
Survivors from the ACP cohort (n = 80) had 510 fewer days in hospital than in the 12 months pre-intervention: a significant reduction of 52.0% (P = 0.020). There were 37 fewer admissions of the survivors from that cohort post-intervention than in the preceding 12 months, with a significant reduction of 42.5% (P = 0.002). Mortality rates in the two cohorts were similar, but the number of patients who died in hospital and the hospital bed days used in the last 3 months of life were significantly lower for the decedents with an ACP than for the controls who had died (P = 0.007 and P = 0.045 respectively).
This approach produced statistically significant reductions in unplanned hospitalisation for a cohort of patients with multiple morbidities. It demonstrates the potential for providing better care for patients as well as better value for health and social care services. It is of particular benefit in managing end-of-life care.
PMCID: PMC3268490  PMID: 22520788
admission; advance care planning; end-of-life care; general practice; patient readmission
7.  Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study 
BMJ Open  2011;1(2):e000206.
To determine the lifetime risk of undergoing pelvic floor surgery in a cohort of UK parous women and the re-operation rates for pelvic floor surgery, time intervals for repeat surgery and independent risk factors for undergoing primary and repeat pelvic floor surgery.
Study design
A register linkage study.
Main outcome measures
The primary outcome was lifetime risk of parous women in the UK undergoing pelvic floor surgery for pelvic organ prolapse (POP), urinary incontinence (UI), and rectal prolapse or faecal incontinence (RP-FI). Secondary outcomes were re-operation rates and time interval of repeat surgery for POP/UI, and independent risk factors for undergoing primary and repeat pelvic floor surgery.
34 631 women identified from the Aberdeen Maternity and Neonatal Database were linked with the Scottish Morbidity Records databases of NHS Scotland to assess relevant outcomes. The lifetime risk for women by age 80 years of undergoing any form of pelvic floor surgery was 12.2%. 2130 (6.2%) women had at least one pelvic floor surgery, of whom 407 (19%) had repeat operations. The median time intervals (IQR) between index and repeat UI and POP surgery were 2.80 (0.94–8.07) years and 3 (1.00–8.25) years, respectively. There is a reduced lifetime risk of pelvic floor surgery in women who had all deliveries by caesarean section (p<0.001) and those aged <20 years at first delivery (p=0.021). Women who sustained at least one perineal laceration (in the absence of a classified perineal tear) during delivery or who had at least one instrumental delivery with forceps use were at increased risk (p<0.001 and p=0.015, respectively).
Our study shows that in the UK more than one in 10 parous women will require at least one surgical procedure for pelvic floor disorders over their lifetime. The study also identifies independent risk and protective factors for pelvic floor surgery in parous women.
Article summary
Article focus
Lifetime risk of undergoing various types of pelvic floor surgery in a cohort of UK women.
Re-operation rates for various types of pelvic floor surgery and time intervals for repeat surgery.
Independent risk factors for undergoing primary and repeat pelvic floor surgery.
Key messages
The lifetime risk for women by age 80 years undergoing any form of pelvic floor surgery was 12.2%.
The re-operation rate for pelvic floor surgery was 19%.
There was a reduced lifetime risk of pelvic floor surgery in women who had all deliveries by caesarean section only and those aged <20 years at first delivery, while women who sustained at least one perineal laceration during delivery or who had at least one instrumental delivery with the use of forceps were at increased risk.
Strengths and limitations of this study
To our knowledge, this is the first study to report the lifetime risk for women in the UK of undergoing surgical treatment for pelvic floor dysfunction.
As the study represents the general population rather than a selected population, we are confident that our findings are generalisable to the UK or indeed any European population.
The Aberdeen Maternity and Neonatal Database and Scottish Morbidity Records (SMR) databases used in this study are subjected to quality control measures at regular intervals and there are numerous consistency checks in place to ensure the validity of data entry.
We were unable to link 27% of women with the SMR databases.
PMCID: PMC3221293  PMID: 22102637
8.  Impact of lifestyle in middle-aged women on mortality: evidence from the Royal College of General Practitioners' Oral Contraception Study 
Although many individuals have multiple lifestyle risk factors, few studies have investigated the impact of lifestyle risk factor combinations among women.
To investigate the relationship between individual and combinations of lifestyle risk factors in middle-aged women with subsequent mortality, and to estimate the associated population attributable risks.
Design of study
Prospective cohort study.
Royal College of General Practitioners' (RCGP) Oral Contraception Study, UK.
In 1994–1995, women remaining under follow-up in the RCGP Oral Contraception Study were sent a lifestyle survey, from which modifiable risk factors were identified: pack-years smoked, physical inactivity, never drinking versus consuming at least 7 units of alcohol weekly, and being underweight, overweight, or obese. The cohort was followed to December 2006 or death. Population attributable risks were calculated.
Of 10 059 women studied, 896 died. Pack-years smoked (11–20 years: adjusted hazard ratio [HR] = 1.82, 95% confidence interval [CI] = 1.46 to 2.27; >20 years: adjusted HR = 2.34, 95% CI = 2.00 to 2.74); never drinking alcohol (adjusted HR = 1.66, 95% CI = 1.34 to 2.05); being underweight (adjusted = HR 1.66, 95% CI = 1.03 to 2.68); and physical inactivity (<15 hours/week: adjusted HR = 1.73, 95% CI = 1.46 to 2.04) were significantly associated with mortality compared with their respective reference group. Women with multiple lifestyle risk factors had higher mortality risks than those reporting one factor. The population attributable risk of the combination of smoking, physical inactivity, body mass index outside normal range, and alcohol (never drinking or excess intake) was 59% (95% CI = 31% to 78%).
Assuming a causal relationship between lifestyle and mortality, avoidance of four lifestyle risk factors would have prevented 60% of the deaths. The importance of avoiding smoking and undertaking physical inactivity during midlife should continue to be emphasised.
PMCID: PMC2913736  PMID: 20822689
epidemiology; follow-up studies; lifestyle; mortality; women
9.  Investigating the missing data mechanism in quality of life outcomes: a comparison of approaches 
Missing data is classified as missing completely at random (MCAR), missing at random (MAR) or missing not at random (MNAR). Knowing the mechanism is useful in identifying the most appropriate analysis. The first aim was to compare different methods for identifying this missing data mechanism to determine if they gave consistent conclusions. Secondly, to investigate whether the reminder-response data can be utilised to help identify the missing data mechanism.
Five clinical trial datasets that employed a reminder system at follow-up were used. Some quality of life questionnaires were initially missing, but later recovered through reminders. Four methods of determining the missing data mechanism were applied. Two response data scenarios were considered. Firstly, immediate data only; secondly, all observed responses (including reminder-response).
In three of five trials the hypothesis tests found evidence against the MCAR assumption. Logistic regression suggested MAR, but was able to use the reminder-collected data to highlight potential MNAR data in two trials.
The four methods were consistent in determining the missingness mechanism. One hypothesis test was preferred as it is applicable with intermittent missingness. Some inconsistencies between the two data scenarios were found. Ignoring the reminder data could potentially give a distorted view of the missingness mechanism. Utilising reminder data allowed the possibility of MNAR to be considered.
PMCID: PMC2711047  PMID: 19545408
10.  A review of RCTs in four medical journals to assess the use of imputation to overcome missing data in quality of life outcomes 
Trials  2008;9:51.
Randomised controlled trials (RCTs) are perceived as the gold-standard method for evaluating healthcare interventions, and increasingly include quality of life (QoL) measures. The observed results are susceptible to bias if a substantial proportion of outcome data are missing. The review aimed to determine whether imputation was used to deal with missing QoL outcomes.
A random selection of 285 RCTs published during 2005/6 in the British Medical Journal, Lancet, New England Journal of Medicine and Journal of American Medical Association were identified.
QoL outcomes were reported in 61 (21%) trials. Six (10%) reported having no missing data, 20 (33%) reported ≤ 10% missing, eleven (18%) 11%–20% missing, and eleven (18%) reported >20% missing. Missingness was unclear in 13 (21%). Missing data were imputed in 19 (31%) of the 61 trials. Imputation was part of the primary analysis in 13 trials, but a sensitivity analysis in six. Last value carried forward was used in 12 trials and multiple imputation in two. Following imputation, the most common analysis method was analysis of covariance (10 trials).
The majority of studies did not impute missing data and carried out a complete-case analysis. For those studies that did impute missing data, researchers tended to prefer simpler methods of imputation, despite more sophisticated methods being available.
PMCID: PMC3225816  PMID: 18694492
11.  Simple imputation methods were inadequate for missing not at random (MNAR) quality of life data 
QoL data were routinely collected in a randomised controlled trial (RCT), which employed a reminder system, retrieving about 50% of data originally missing. The objective was to use this unique feature to evaluate possible missingness mechanisms and to assess the accuracy of simple imputation methods.
Those patients responding after reminder were regarded as providing missing responses. A hypothesis test and a logistic regression approach were used to evaluate the missingness mechanism. Simple imputation procedures were carried out on these missing scores and the results compared to the actual observed scores.
The hypothesis test and logistic regression approaches suggested the reminder data were missing not at random (MNAR). Reminder-response data showed that simple imputation procedures utilising information collected close to the point of imputation (last value carried forward, next value carried backward and last-and-next), were the best methods in this setting. However, although these methods were the best of the simple imputation procedures considered, they were not sufficiently accurate to be confident of obtaining unbiased results under imputation.
The use of the reminder data enabled the conclusion of possible MNAR data. Evaluating this mechanism was important in determining if imputation was useful. Simple imputation was shown to be inadequate if MNAR are likely and alternative strategies should be considered.
PMCID: PMC2531086  PMID: 18680574
12.  Using ‘dead or dependent’ as an outcome measure in clinical trials in Parkinson's disease 
Simple, robust, sensitive and clinically meaningful outcome measures are required for neuroprotective trials in Parkinson's disease (PD). We explored the feasibility of a composite binary outcome measure, ‘dead or dependent’, in such trials using data from a prospective follow-up study of an incident cohort of PD patients.
Two hundred incident patients had an annual follow-up, including assessment of the Hoehn-Yahr stage (H-Y) and Schwab and England Activities of Daily Living Scale (S&E). Annual scores were converted into binary variables (H-Y <3 vs H-Y ≥3, and S&E ≥80% vs S&E <80%). A new outcome of ‘dead or dependent’ was also created, with dependence in activities of daily living defined as S&E <80%. Using these data, sample sizes were calculated for a hypothetical three-year randomised trial in which the trial outcome was defined by a binary clinical variable, all-cause mortality, or PD-related mortality.
At 3 years, 18.0% of patients were dead and 38.4% were dead or dependent. At 80% power, large sample sizes were required if PD-related mortality (n=1938 per study arm) or all-cause mortality (n=734) were used as the outcome, even for large treatment effects (30% reduction in relative risk). The new outcome of ‘death or dependency’ required the smallest sample sizes of all the outcome measures (n=277 for 30% reduction in relative risk, 627 for a 20% reduction).
‘Death or dependency’ is a feasible and potentially useful outcome measure in PD trials of neuroprotective agents, but further work is required to validate its use and define dependency.
PMCID: PMC4316847  PMID: 24854405

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