Patient Strategies for Managing the Vicious Cycle of Fatigue, Pain and Urgency in Inflammatory Bowel Disease: Impact, Planning and Support.

BACKGROUND: Inflammatory bowel disease (IBD) causes inter-related symptoms of fatigue, pain and urgency which can persist in remission. AIM: To understand how people with IBD experience and self-manage these symptoms and to inform the future development of an online self-management programme. METHODS: Using exploratory qualitative methods, we recruited participants from clinic and community settings. Focus groups, conducted across the UK, were audio-recorded and professionally transcribed. Transcripts were analysed over four rounds using framework analysis. Eight patients were consulted to agree the final structure of data and themes. RESULTS: Seven focus groups were held; five gave useable data. Twenty-six participants (15 female; ages 21-60 years; disease duration 2-40 years) with Crohn's disease (n = 10), ulcerative colitis (n = 14) and IBD-unclassified (n = 2) attended one of these five focus groups. Three core themes emerged: The Negative Impact of Symptoms, Positively Taking Control and Seeking and Receiving Support. The persistent, often stark impact of multiple co-existing symptoms on physical and emotional wellbeing can force unwanted adjustments and limitations in working, social and intimate arenas of life. Unpredictable symptoms are challenging and impact each other in negative vicious cycles. Managing diet, pacing, accepting background levels of fatigue, pain and urgency, seeking support, exercising and attending to mental wellbeing, are all perceived as helpful in self-managing symptoms. CONCLUSION: Fatigue, pain and urgency are troublesome for patients, especially in combination, suggesting that these should be addressed simultaneously by clinicians. Participants reported several strategies for self-management, providing patient-focused evidence to inform future development of a self-management intervention programme.

Engagement with advice to reduce cardiovascular risk following a health check programme: A qualitative study.

BACKGROUND: The success of a cardiovascular health check programme depends not only on the identification of individuals at high risk of cardiovascular disease (CVD) but also on reducing CVD risk. We examined factors that might influence engagement and adherence to lifestyle change interventions and medication amongst people recently assessed at medium or high risk of CVD (>10% in the next 10 years). METHOD: Qualitative study using individual semi-structured interviews. Data were analysed using the Framework method. RESULTS: Twenty-two participants (12 men, 10 women) were included in the study. Four broad themes are described: (a) the meaning of 'risk', (b) experiences with medication, (c) attempts at lifestyle change, and (d) perceived enablers to longer-term change. The experience of having a health check was mostly positive and reassuring. Although participants may not have understood precisely what their CVD risk meant, many reported efforts to make lifestyle changes and take medications to reduce their risk. Individual's experience with medications was influenced by family, friends and the media. Lifestyle change services and family and friends support facilitated longer-term behaviour change. CONCLUSIONS: People generally appear to respond positively to having a CVD health check and report being motivated towards behaviour change. Some individuals at higher risk may need clearer information about the health check and the implications of being at risk of CVD. Concerns over medication use may need to be addressed in order to improve adherence. Strategies are required to facilitate engagement and promote longer-term maintenance with lifestyle changes amongst high-risk individuals.

Enhanced Invitations Using the Question-Behavior Effect and Financial Incentives to Promote Health Check Uptake in Primary Care.

Background: Uptake of health checks for cardiovascular risk assessment in primary care in England is lower than anticipated. The question-behavior effect (QBE) may offer a simple, scalable intervention to increase health check uptake. Purpose: The present study aimed to evaluate the effectiveness of enhanced invitation methods employing the QBE, with or without a financial incentive to return the questionnaire, at increasing uptake of health checks. Methods: We conducted a three-arm randomized trial including all patients at 18 general practices in two London boroughs, who were invited for health checks from July 2013 to December 2014. Participants were randomized to three trial arms: (i) Standard health check invitation letter only; (ii) QBE questionnaire followed by standard invitation letter; or (iii) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by standard invitation letter. In intention to treat analysis, the primary outcome of completion of health check within 6 months of invitation, was evaluated using a p value of .0167 for significance. Results: 12,459 participants were randomized. Health check uptake was evaluated for 12,052 (97%) with outcome data collected. Health check uptake within 6 months of invitation was: standard invitation, 590 / 4,095 (14.41%); QBE questionnaire, 630 / 3,988 (15.80%); QBE questionnaire and financial incentive, 629 / 3,969 (15.85%). Difference following QBE questionnaire, 1.43% (95% confidence interval -0.12 to 2.97%, p = .070); following QBE questionnaire and financial incentive, 1.52% (-0.03 to 3.07%, p = .054). Conclusions: Uptake of health checks following a standard invitation was low and not significantly increased through enhanced invitation methods using the QBE.

Targets for interventions for faecal incontinence in inflammatory bowel disease: a systematic review.

OBJECTIVE: Prevalence of faecal incontinence is greater in patients with inflammatory bowel disease than in the general population. It is a major concern for patients with inflammatory bowel disease, even when disease is in remission. It is underreported and negatively affects quality of life. We explored the evidence on the associations of faecal incontinence in inflammatory bowel disease and the effectiveness of interventions. MATERIAL AND METHODS: Databases searched in October 2017: Web of Science, MEDLINE, EMBASE, CINAHL, PsycINFO, British Nursing Index and Scopus. Manual search of reference lists was also conducted. Four researchers independently screened references and extracted data. RESULTS: Eighteen studies were included in the review (14 on associations, four on interventions). The presence of faecal incontinence was reported as 12.7-76% among 5924 participants, varying in definitions adopted and populations studied. Factors associated with faecal incontinence included disease activity, loose stool, female gender, childbirth, previous surgery, anal sphincter weakness or fatigability, anxiety and depression. The cross-sectional design of studies means causation cannot be inferred. Interventions included surgery (sphincter repair and sacral nerve stimulation) and tibial nerve stimulation which each improved faecal incontinence. However, the four intervention studies were small (34 participants in total) and uncontrolled. CONCLUSION: There is a high prevalence of faecal incontinence in inflammatory bowel disease associated with various sociodemographic, clinical and psychosocial factors which could be targeted in future interventions. Future intervention studies with control groups, targeting likely underlying causes such as disease activity, loose stool, psychological factors and anal sphincter function, are needed.

Cardiovascular risk at health checks performed opportunistically or following an invitation letter. Cohort study.

Background: A population-based programme of health checks has been established in England. Participants receive postal invitations through a population-based call-recall system but health check providers may also offer health checks opportunistically. We compared cardiovascular risk scores for 'invited' and 'opportunistic' health checks. Methods: Cohort study of all health checks completed at 18 general practices from July 2013 to June 2015. For each general practice, cardiovascular (CVD) risk scores were compared by source of check and pooled using meta-analysis. Effect estimates were compared by gender, age-group, ethnicity and fifths of deprivation. Results: There were 6184 health checks recorded (2280 invited and 3904 opportunistic) with CVD risk scores recorded for 5359 (87%) participants. There were 17.0% of invited checks and 22.2% of opportunistic health checks with CVD risk score ≥10%; a relative increment of 28% (95% confidence interval: 14-44%, P < 0.001). In the most deprived quintile, 15.3% of invited checks and 22.4% of opportunistic checks were associated with elevated CVD risk (adjusted odds ratio: 1.94, 1.37-2.74, P  < 0.001). Conclusions: Respondents at health checks performed opportunistically are at higher risk of cardiovascular disease than those participating in response to a standard invitation letter, potentially reducing the effect of uptake inequalities.

Innovations in medical care and mortality trends from four circulatory diseases between 1970 and 2005.

BACKGROUND: Governments have identified innovation in pharmaceuticals and medical technology as a priority for health policy. Although the contribution of medical care to health has been studied extensively in clinical settings, much less is known about its contribution to population health. We examine how innovations in the management of four circulatory disorders have influenced trends in cause-specific mortality at the population level. METHODS: Based on literature reviews, we selected six medical innovations with proven effectiveness against hypertension, ischaemic heart disease, heart failure and cerebrovascular disease. We combined data on the timing of these innovations and cause-specific mortality trends (1970-2005) from seven European countries. We sought to identify associations between the introduction of innovations and favourable changes in mortality, using Joinpoint-models based on linear spline regression. RESULTS: For both ischaemic heart disease and cerebrovascular disease, the timing of medical innovations was associated with improved mortality in four out of five countries and five out of seven countries, respectively, depending on the innovation. This suggests that innovation has impacted positively on mortality at the population level. For hypertension and heart failure, such associations could not be identified. CONCLUSION: Although improvements in cause-specific mortality coincide with the introduction of some innovations, this is not invariably true. This is likely to reflect the incremental effects of many interventions, the time taken for them to be adopted fully and the presence of contemporaneous changes in disease incidence. Research on the impact of medical innovations on population health is limited by unreliable data on their introduction.

Implications of long-term conditions for both mental and physical health: comparison of rheumatoid arthritis and schizophrenia.

PURPOSE: To investigate whether people with long term conditions, whatever their specific nature, need to be assessed and treated for the full range of mental, physical and social problems. Main question investigated: that rheumatoid arthritis and schizophrenia will be associated with significantly greater impairment across the subscores of the SF36 scale than in reference general population samples. Specific hypothesis tested: while rheumatoid arthritis and schizophrenia will impair both physical and mental functioning, when comparing the two groups there will be a greater difference between the physical component scores than there will be between the mental/emotional component scores of the short form health survey (SF-36). METHODS: Cross sectional comparison of SF-36 subscore profiles of cohorts of: (1) people with rheumatoid arthritis attending specialist Rheumatology outpatient clinics in five London hospitals (n = 446), and (2) people with schizophrenia treated by community psychiatric teams in four sites in Europe (n = 409). RESULTS: Both groups had greater impairments across the whole spectrum of mental and physical problems assessed by the SF-36 than age specific normative data for the general population. The results also support our hypothesis that, comparing the people with rheumatoid arthritis and schizophrenia, we did find that there is a greater discrepancy between the physical scales than there is between the mental/emotional scales of the SF-36. CONCLUSIONS: These findings show that whether the primary long-term condition is presenting as physical or as mental disorder, the practitioner should ensure that the full range of physical, mental and social problems is assessed and treated.

Enhanced invitation methods and uptake of health checks in primary care: randomised controlled trial and cohort study using electronic health records.

BACKGROUND: A national programme of health checks to identify risk of cardiovascular disease (CVD) is being rolled out but is encountering difficulties because of low uptake. OBJECTIVE: To evaluate the effectiveness of an enhanced invitation method using the question-behaviour effect (QBE), with or without the offer of a financial incentive to return the QBE questionnaire, at increasing the uptake of health checks. The research went on to evaluate the reasons for the low uptake of invitations and compare the case mix for invited and opportunistic health checks. DESIGN: Three-arm randomised trial and cohort study. PARTICIPANTS: All participants invited for a health check from 18 general practices. Individual participants were randomised. INTERVENTIONS: (1) Standard health check invitation only; (2) QBE questionnaire followed by a standard invitation; and (3) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by a standard invitation. MAIN OUTCOME MEASURES: The primary outcome was completion of the health check within 6 months of invitation. A p-value of 0.0167 was used for significance. In the cohort study of all health checks completed during the study period, the case mix was compared for participants responding to invitations and those receiving 'opportunistic' health checks. Participants were not aware that several types of invitation were in use. The research team were blind to trial arm allocation at outcome data extraction. RESULTS: In total, 12,459 participants were included in the trial and health check uptake was evaluated for 12,052 participants for whom outcome data were collected. Health check uptake was as follows: standard invitation, 590 out of 4095 (14.41%); QBE questionnaire, 630 out of 3988 (15.80%); QBE questionnaire and financial incentive, 629 out of 3969 (15.85%). The increase in uptake associated with the QBE questionnaire was 1.43% [95% confidence interval (CI) -0.12% to 2.97%; p = 0.070] and the increase in uptake associated with the QBE questionnaire and offer of financial incentive was 1.52% (95% CI -0.03% to 3.07%; p = 0.054). The difference in uptake associated with the offer of an incentive to return the QBE questionnaire was -0.01% (95% CI -1.59% to 1.58%; p = 0.995). During the study period, 58% of health check cardiovascular risk assessments did not follow a trial invitation. People who received an 'opportunistic' health check had greater odds of a ≥ 10% CVD risk than those who received an invited health check (adjusted odds ratio 1.70, 95% CI 1.45 to 1.99; p < 0.001). CONCLUSIONS: Uptake of a health check following an invitation letter is low and is not increased through an enhanced invitation method using the QBE. The offer of a £5 incentive did not increase the rate of return of the QBE questionnaire. A high proportion of all health checks are performed opportunistically and not in response to a standard invitation letter. Participants receiving opportunistic checks are at higher risk of CVD than those responding to standard invitations. Future research should aim to increase the accessibility of preventative medical interventions to increase uptake. Research should also explore the wider use of electronic health records in delivering efficient trials. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42856343. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 84. See the NIHR Journals Library website for further project information.

What to do when presented with a prescription from another European country: insight from a qualitative study of pharmacists in England.

OBJECTIVES: Prescriptions for medicines issued by healthcare professionals in other parts of the European Union are legally valid in the UK. However, it is not known whether this is fully understood by British community pharmacists. In this study we aimed to understand the implementation of UK pharmacy policy on dispensing prescriptions from other parts of the European Union and to investigate pharmacists' knowledge and interpretation of the relevant provisions in a mystery shopping exercise in English pharmacies. METHODS: We reviewed the policy literature on regulations and practices pertaining to the prescribing and dispensation of prescription-only medicines in the UK. We interviewed key English informants in pharmacy. We then conducted a 'mystery shopping' exercise in 60 randomly selected pharmacies in urban, peri-urban and rural areas of England to investigate how community pharmacists manage four different types of prescriptions from another EU country. KEY FINDINGS: From the eight interviews conducted there was broad consensus that existing processes for verifying the authenticity of foreign prescriptions could be improved. Of the 60 pharmacies visited, only 27% (16 out of 60) were willing to dispense the medication. Pharmacists unwilling to dispense were invited to explain their reasons for refusal. The most common were that they believed that English pharmacists are unauthorised to dispense foreign prescriptions, and that prescriptions must be in the English language or issued by a UK-recognised prescriber. CONCLUSION: Existing processes available to English pharmacists for verifying the authenticity of foreign prescriptions seem to be insufficient. Strategies to overcome these problems were proposed by pharmacists and key informants, and include the creation of a database or registry of all authorised European Economic Area/Swiss prescribers, development of EU standards on prescription content and on dosage of medications, consistent international non-proprietary name (INN) prescribing and the use of an agreed common language for key information on prescriptions.

Innovations in health care and mortality trends from five cancers in seven European countries between 1970 and 2005.

OBJECTIVES: Although the contribution of health care to survival from cancer has been studied extensively, much less is known about its contribution to population health. We examine how medical innovations have influenced trends in cause-specific mortality at the national level. METHODS: Based on literature reviews, we selected six innovations with proven effectiveness against cervical cancer, Hodgkin's disease, breast cancer, testicular cancer, and leukaemia. With data on the timing of innovations and cause-specific mortality (1970-2005) from seven European countries we identified associations between innovations and favourable changes in mortality. RESULTS: For none of the five specific cancers, sufficient evidence for an association between introduction of innovations and a positive change in mortality could be found. The highest association was found between the introduction of Tamoxifen and breast cancer mortality. CONCLUSIONS: The lack of evidence of health care effectiveness may be due to gradual improvements in treatment, to effects limited to certain age groups or cancer subtypes, and to contemporaneous changes in cancer incidence. Research on the impact of health care innovations on population health is limited by unreliable data on their introduction.

Amenable mortality revisited: the AMIEHS study.

OBJECTIVES: There is a renewed interest in health system indicators. In 1976 a measure of quality of healthcare, amenable mortality, was introduced by Rutstein. This indicator is based on the concept that deaths from certain causes should not occur in the presence of timely and effective healthcare. In the project "Amenable mortality in the European Union: toward better indicators for the effectiveness of health systems" (AMIEHS), we introduce a new approach to the selection of indicators of amenable mortality. METHODS: Based on predefined selection criteria and a broad review of the literature on the effectiveness of medical interventions, a first set of potential indicators of amenable mortality (causes of death) was selected. The timing of the introduction of medical innovations was established through reviews and questionnaires sent to national experts from seven participating European countries. The preselected indicators were then validated by a trend analysis that identified associations between the timing of innovations and cause-specific mortality trends and by a Delphi-procedure. RESULTS: After a short review of previous lists of amenable mortality indicators and a detailed description of the innovative procedure in the AMIEHS project we present a list of 14 causes of death that passed our selection criteria. We illustrate our empirical validation of these indicators using the examples of peptic ulcer and renal failure. CONCLUSIONS: The innovation developed in the AMIEHS study is a rigorous new approach to the concept of amenable mortality that includes empirical validation. Only validated indicators can be successfully used to assess the quality of healthcare systems in international comparisons.

Using 'amenable mortality' as indicator of healthcare effectiveness in international comparisons: results of a validation study.

BACKGROUND AND STUDY AIMS: There is widespread consensus on the need for better indicators of the effectiveness of healthcare. We carried out an analysis of the validity of amenable mortality as an indicator of the effectiveness of healthcare, focusing on the potential use in routine surveillance systems of between-country variations in rates of mortality. We assessed whether the introduction of specific healthcare innovations coincided with declines in mortality from potentially amenable causes in seven European countries. In this paper, we summarise the main results of this study and illustrate them for four conditions. DATA AND METHODS: We identified 14 conditions for which considerable declines in mortality have been observed and for which there is reasonable evidence in the literature of the effectiveness of healthcare interventions to lower mortality. We determined the time at which these interventions were introduced and assessed whether the innovations coincided with favourable changes in the mortality trends from these conditions, measured using Poisson linear spline regression. All the evidence was then presented to a Delphi panel. MAIN RESULTS: The timing of innovation and favourable change in mortality trends coincided for only a few conditions. Other reasons for mortality decline are likely to include diffusion and improved quality of interventions and in incidence of diseases and their risk factors, but there is insufficient evidence to differentiate these at present. For most conditions, a Delphi panel could not reach consensus on the role of current mortality levels as measures of effectiveness of healthcare. DISCUSSION AND CONCLUSIONS: Improvements in healthcare probably lowered mortality from many of the conditions that we studied but occurred in a much more diffuse way than we assumed in the study design. Quantification of the contribution of healthcare to mortality requires adequate data on timing of innovation and trends in diffusion and quality and in incidence of disease, none of which are currently available. Given these gaps in knowledge, between-country differences in levels of mortality from amenable conditions should not be used for routine surveillance of healthcare performance. The timing and pace of mortality decline from amenable conditions may provide better indicators of healthcare performance.

Measuring NHS performance 1990-2009 using amenable mortality: interpret with care.

OBJECTIVES: The new performance framework for the NHS in England will assess how well health services are preventing people from dying prematurely, based on the concept of mortality amenable to healthcare. We ask how the different parts of the UK would be assessed had this measure been in use over the past two decades, a period that began with somewhat lower levels of health expenditure in England and Wales than in Scotland and Northern Ireland but which, after 1999, saw the gap closing. DESIGN: We assessed the change in age-standardized death rates in England and Wales, Northern Ireland and Scotland in two time periods: 1990-1999 and 1999-2009. Mortality data by five-year age group, sex and cause of death for the years 1990 to 2009 were analysed using age-standardized death rates from causes considered amenable to healthcare. The absolute change was assessed by fitting linear regression and the relative change was estimated as the average annual percent decline for the two periods. SETTING: United Kingdom. PARTICIPANTS: Not applicable. MAIN OUTCOME MEASURES: Mortality from causes amenable to healthcare. RESULTS: Between 1990 and 1999 deaths amenable to medical care had been falling more slowly in England and Wales than in Scotland and Northern Ireland. However the rate of decline in England and Wales increased after 1999 when funding of the NHS there increased. Examination of individual causes of death reveals a complex picture, with some improvements, such as in breast cancer deaths, occurring simultaneously across the UK, reflecting changes in diagnosis and treatment that took place in each nation at the same time, while others varied. CONCLUSIONS: Amenable mortality is a useful indicator of health system performance but there are many methodological issues that must be taken into account when interpreting it once it is adopted for routine use in England.

A systematic review of chronic fatigue, its syndromes and ethnicity: prevalence, severity, co-morbidity and coping.

BACKGROUND: Chronic Fatigue Syndrome (CFS) is characterized by unexplained fatigue that lasts for at least 6 months alongside a constellation of other symptoms. CFS was historically thought to be most common among White women of higher socio-economic status. However, some recent studies in the USA suggest that the prevalence is actually higher in some minority ethnic groups. If there are convincing differences in prevalence and risk factors across all or some ethnic groups, investigating the causes of these can help unravel the pathophysiology of CFS. METHODS: A systematic review was conducted to explore the relationship between fatigue, chronic fatigue (CF--fatigue lasting for 6 months), CFS and ethnicity. Studies were population-based and health service-based. Meta-analysis was also conducted to examine the population prevalence of CF and CFS across ethnic groups. RESULTS: Meta-analysis showed that compared with the White American majority, African Americans and Native Americans have a higher risk of CFS [Odds Ratio (OR) 2.95, 95% confidence interval (CI): 0.69-10.4; OR = 11.5, CI: 1.1-56.4, respectively] and CF (OR = 1.56, CI: 1.03-2.24; OR = 3.28, CI: 1.63-5.88, respectively). Minority ethnic groups with CF and CFS experience more severe symptoms and may be more likely to use religion, denial and behavioural disengagement to cope with their condition compared with the White majority. CONCLUSIONS: Although available studies and data are limited, it does appear that some ethnic minority groups are more likely to suffer from CF and CFS compared with White people. Ethnic minority status alone is insufficient to explain ethnic variation of prevalence. Psychosocial risk factors found in high-risk groups and ethnicity warrant further investigation to improve our understanding of aetiology and the management of this complex condition.

Development and validation of a patient-based disease activity score in rheumatoid arthritis that can be used in clinical trials and routine practice.

OBJECTIVE: Assessor-based disease activity measures such as the Disease Activity Score in 28 joints (DAS28), although widely used in rheumatoid arthritis (RA), have high interobserver variability. We developed and validated a patient-based disease activity score (PDAS) as an alternative assessment. METHODS: Patients' assessments of swollen or tender joints, visual analog scales for pain and general health, the Health Assessment Questionnaire, and erythrocyte sedimentation rate (ESR) were used to develop the PDAS. In a developmental cohort (204 patients), regression analyses determined the best fit with the DAS28. A validation cohort (322 patients) subsequently evaluated criterion and construct validity against a range of outcome measures, including the Nottingham Health Profile (NHP) and Short Form 36 (SF-36). Sensitivity to change was assessed in 56 patients after 6 months of treatment with disease-modifying antirheumatic drugs or biologics. RESULTS: In the developmental cohort, the PDAS with ESR (PDAS1) and without ESR (PDAS2) achieved excellent fit with the DAS28 (r = 0.88 and 0.74, respectively). In the validation cohort, the PDAS showed high criterion validity by correlation with the DAS28 (PDAS1: r = 0.89, PDAS2: r = 0.76). Construct validity was demonstrated by high correlations with a range of disease activity measures (r > or = 0.45), whereas low correlations (r < 0.45) with mental and social components of the SF-36 and NHP indicated divergent validity. The PDAS and DAS28 had similar sensitivity to change, determined using effect sizes (DAS28 = 1.03, PDAS1 = 1.02, PDAS2 = 0.77) or standardized response means (DAS28 = 0.79, PDAS1 = 0.77, PDAS2 = 0.73). CONCLUSION: The PDAS1 and PDAS2 are valid and sensitive tools to assess disease activity in RA. They appear suitable for clinical decision making, epidemiologic research, and clinical trials.