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1.
Addiction ; 2019 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-31597207

RESUMO

AIM: To evaluate the cost-effectiveness of e-cigarettes as a smoking cessation aid used in routine stop smoking services in England. DESIGN: Cost-effectiveness analysis was performed from the National Health Service (NHS) and Personal Social Services (PSS) perspective for 12 months period and lifetime. Costs, including that of both treatments, other smoking cessation help and healthcare services, and health benefits, estimated from EQ-5D-5L and measured in quality-adjusted life years (QALYs), for the 12-month analysis, came from a randomised controlled trial. Lifetime analysis was model-based with input from both trial data and published secondary data sources. Cost-effectiveness was measured by an incremental cost-effectiveness ratio (ICER). SETTING: Three Stop-Smoking Service sites in England PARTICIPANTS: Adult smokers (n=886) who sought help to quit in the participating sites INTERVENTION AND COMPARATOR: An e-cigarette (EC) starter kit versus provision of nicotine replacement therapy (NRT) for up to three months, both with standard behavioural support. A total of 886 participants were randomised (439 in EC arm, 447 in NRT arm). Excluding one death in each arm, the one-year quit rate was 18.0% and 9.9%, respectively. MEASUREMENTS: Cost of treatments was estimated from treatment log. Costs of other smoking cessation help and healthcare services, and EQ-5D-5L were collected at baseline, six- and 12-month follow-ups. Incremental costs and incremental QALYs were estimated using regression adjusting for baseline covariates and their respective baseline values. FINDINGS: The ICER was £1,100 per QALY gained at the 12 months after quit date (87% probability below £20,000/QALY). Markov model estimated the lifetime ICER of EC to be £65 per QALY (85% probability below £20,000/QALY). CONCLUSION: Using e-cigarettes as a smoking cessation aid with standard behavioural support in stop-smoking services in England is likely to be more cost-effective than using nicotine replacement therapy in the same setting.

2.
Health Technol Assess ; 23(43): 1-82, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31434605

RESUMO

BACKGROUND: Over the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking. OBJECTIVE: The objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support. DESIGN: A randomised controlled trial comparing e-cigarettes and NRT. SETTING: Three sites that provide local SSSs. PARTICIPANTS: The participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis. INTERVENTIONS: The NRT arm (n = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm (n = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention. MAIN OUTCOME MEASURES: The primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted. RESULTS: The 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58; p < 0.001). The e-cigarette arm had significantly higher validated quit rates at all time points. Participants in the e-cigarette arm showed significantly better adherence and experienced fewer urges to smoke throughout the initial 4 weeks of their quit attempt than those in the NRT arm, and gave their allocated product more favourable ratings. They were also more likely to be still using their allocated product at 1 year (39.5% vs. 4.3%, χ2 = 161.4; p < 0.001). Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status). A detailed economic analysis confirmed that, because e-cigarettes incur lower NHS costs than NRT and generate a higher quit rate, e-cigarette use is more cost-effective. LIMITATIONS: The results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes. CONCLUSIONS: Within the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy. FUTURE WORK: The efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60477608. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).

3.
Lung Cancer ; 130: 208-215, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30885346

RESUMO

OBJECTIVES: To estimate the number of past and future lung cancer deaths that have already been averted by tobacco control initiatives in Australia, and to estimate the number of additional deaths averted under various smoking scenarios. METHODS: We predicted lung cancer mortality rates and case numbers to 2100 using a previously validated generalized linear model based on age, birth cohort and population cigarette smoking exposure. We estimated the impact of various tobacco control scenarios: 'actual tobacco control' (incorporating the aggregate effect of past and current taxation, plain packaging, mass media campaigns and other initiatives) and scenarios where 10%, 5% and 0% smoking prevalence was achieved by 2025, all of which were compared to a counterfactual scenario with the highest historical smoking consumption level continuing into the future as if no tobacco control initiatives had been implemented. RESULTS: Without tobacco control, there would have been an estimated 392,116 lung cancer deaths over the period 1956-2015; of these 20% (78,925 deaths; 75,839 males, 3086 females) have been averted due to tobacco control. However, if past and current measures continue to have the expected effect, an estimated 1.9 million deaths (1,579,515 males, 320,856 females; 67% of future lung cancer deaths) will be averted in 2016-2100. If smoking prevalence is reduced to 10%, 5% or 0% by 2025, an additional 97,432, 208,714 or 360,557 deaths could be averted from 2016 to 2100, respectively. CONCLUSION: Tobacco control in Australia has had a dramatic impact on the number of people dying from lung cancer. Several hundred thousand more lung cancer deaths could be averted over the course of the century if close-to-zero smoking prevalence could be achieved in the next decade.

5.
BMJ Open ; 9(1): e026292, 2019 01 24.
Artigo em Inglês | MEDLINE | ID: mdl-30679300

RESUMO

OBJECTIVES: To better model underlying trends in cervical cancer incidence so as to model past trends, to estimate the impact of cervical screening on cervical cancer rates at different ages and to obtain a counterfactual baseline under a no-screening scenario. DESIGN: Trend analysis of cancer registry data recorded between 1971 and 2013. SETTING: England. PARTICIPANTS: 132 493 women aged 20-84 with a diagnosis of cervical cancer. OUTCOME MEASURE: Cervical cancer incidence data were modelled using a modified age period cohort model able to capture both increased exposure to human papillomavirus (HPV) as well as changes in the age of exposure to HPV in young cohorts. Observed rates were compared with counterfactual baseline rates under a no-screening scenario to estimate the protective effect of screening. RESULTS: Rates of cervical cancer incidence have been decreasing since the introduction of screening but are projected to increase in the future under the current scenario. Between 1988 and 2013, it was estimated that screening had prevented approximately 65 000 cancers. Moreover, in 2013, the age-standardised rate (ASR) estimated under the no-screening scenario (37.9, 95% CI 37.4 to 38.3) was threefold higher among women aged 20-84 than the observed ASR (12.8, 95% CI 12.3 to 13.3). We estimate that the age of first HPV exposure has decreased by about 1 year every decade since the early 1970s (women born in 1955 onwards). CONCLUSIONS: Our results corroborated the importance of screening in preventing cervical cancer and indicated future rates are dependent on age at HPV exposure. Estimated future rates can be used for healthcare planning while the counterfactual baseline to quantify the impact of HPV vaccination in microsimulations.

6.
N Engl J Med ; 380(7): 629-637, 2019 02 14.
Artigo em Inglês | MEDLINE | ID: mdl-30699054

RESUMO

BACKGROUND: E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments. METHODS: We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms. RESULTS: A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath. CONCLUSIONS: E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608 .).


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar/métodos , Dispositivos para o Abandono do Uso de Tabaco , Tabagismo/terapia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nicotina/administração & dosagem , Dispositivos para o Abandono do Uso de Tabaco/efeitos adversos , Resultado do Tratamento , Vaping/efeitos adversos
7.
Lung Cancer ; 125: 68-76, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30429040

RESUMO

OBJECTIVES: The aim was to develop and validate a statistical model which uses past trends for lung cancer mortality and historical and current data on tobacco consumption to project lung cancer mortality rates into the future for Australia. METHODS: We used generalized linear models (GLMs) with Poisson distribution including either age, birth cohort or period, and/or various measures of population tobacco exposure (considering cross-sectional smoking prevalence, cigarettes smoked and tar exposure per capita). Sex-specific models were fitted to data for 1956-2015 and age-standardized lung cancer mortality rates were projected forward to 2040. Possible lags of 20-30 years between tobacco exposure and lung cancer mortality were examined. The best model was selected using analysis of deviance. To validate the selected model, we temporarily re-fitted it to data for 1956-1990 and compared the projected rates to 2015 with the observed rates for 1991-2015. RESULTS: The best fitting model used information on age, birth cohort and tar exposure per capita; close concordance with the observed data was achieved in the validation. The forward projections for lung cancer mortality using this model indicate that male and female age-standardized rates will decline over the period 2011-2015 to 2036-2040 from 27.2 to 15.1 per 100,000, and 15.8 to 11.8 per 100,000, respectively. However, due to population growth and ageing the number of deaths will increase by 7.9% for males and 57.9% for females; from 41,040 (24,831 males, 16,209 females) in 2011-2015 to 52,403 (26,805 males, 25,598 females) in 2036-2040. CONCLUSION: In the context of the mature tobacco epidemic with past peaks in tobacco consumption for both males and females, lung cancer mortality rates are expected to continually decline over the next 25 years. However, the number of lung cancer deaths will continue to be substantial, and to increase, in Australia's ageing population.

8.
BMC Cancer ; 18(1): 784, 2018 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-30075763

RESUMO

BACKGROUND: Early detection of oesophageal cancer improves outcomes; however, the optimal strategy for identifying patients at increased risk from the pre-cancerous lesion Barrett's oesophagus (BE) is not clear. The Cytosponge, a novel non-endoscopic sponge device, combined with the biomarker Trefoil Factor 3 (TFF3) has been tested in four clinical studies. It was found to be safe, accurate and acceptable to patients. The aim of the BEST3 trial is to evaluate if the offer of a Cytosponge-TFF3 test in primary care for patients on long term acid suppressants leads to an increase in the number of patients diagnosed with BE. METHODS: The BEST3 trial is a pragmatic multi-site cluster-randomised controlled trial set in primary care in England. Approximately 120 practices will be randomised 1:1 to either the intervention arm, invitation to a Cytosponge-TFF3 test, or the control arm usual care. Inclusion criteria are men and women aged 50 or over with records of at least 6 months of prescriptions for acid-suppressants in the last year. Patients in the intervention arm will receive an invitation to have a Cytosponge-TFF3 test in their general practice. Patients with a positive TFF3 test will receive an invitation for an upper gastro-intestinal endoscopy at their local hospital-based endoscopy clinic to test for BE. The primary objective is to compare histologically confirmed BE diagnosis between the intervention and control arms to determine whether the offer of the Cytosponge-TFF3 test in primary care results in an increase in BE diagnosis within 12 months of study entry. DISCUSSION: The BEST3 trial is a well-powered pragmatic trial testing the use of the Cytosponge-TFF3 test in the same population that we envisage it being used in clinical practice. The data generated from this trial will enable NICE and other clinical bodies to decide whether this test is suitable for routine clinical use. TRIAL REGISTRATION: This trial was prospectively registered with the ISRCTN Registry on 19/01/2017, trial number ISRCTN68382401 .

9.
BMC Cancer ; 18(1): 554, 2018 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-29747610

RESUMO

BACKGROUND: High resolution anoscopy (HRA) examination is regarded as the best method for the management of anal high grade squamous intraepithelial lesions to prevent anal squamous carcinoma. However, little is known about the acceptability of this procedure. This analysis looks at patient experience of HRA examination and ablative treatment under local anaesthetic. METHODS: Patients took part in anonymised feedback of their experience immediately after their HRA examinations and/or treatments. A standard questionnaire was used that included assessment of pain and overall satisfaction scores as well as willingness to undergo future HRA examinations. RESULTS: Four hundred four (89.4%) responses were received and all responses were analysed. The group consisted of 119 females (29.4%) and 261 males (64.6%) with median age of 45 years (IQR = 19) and 45 years (IQR = 21) respectively, and included 58 new cases, 53 treatment cases and 202 surveillance cases. 158 patients (39.1%) had at least one biopsy during their visits. The median pain score was 2 [Inter Quartile Range (IQR) 3] on a visual analogue scale of 0 to 10, where 0 indicated no pain / discomfort and 10 indicated severe pain. The median pain score was 2 (IQR 2) in men and 4 (IQR = 3) in women [Dunn's Test = 4.3, p < 0.0001] and 3 (IQR 4.5) in treatment cases. Problematic pain defined as a pain score of ≥7 occurred more frequently in women (14%) than in men (6%), [Chi square test (chi2) = 5.6, p = 0.02]. Patient satisfaction with the care they received, measured on a scale of 0 (not happy) to 10 (very happy) found the median score to be 10 with 76% reporting a score of 10. Out of 360 responses, 98% of women and 99% of men said that they would be willing to have a future HRA examination. CONCLUSIONS: In this cohort, the overall pain scores were low and similar across appointment types. However, women had a higher pain score, including troublesome pain levels. Despite this, both women and men were equally satisfied with their care and were willing to have a future examination. The results of the analysis show that the procedure is acceptable to patient groups. A small number of women may need general anaesthesia for their examinations/treatment.

11.
Br J Cancer ; 118(10): 1391-1398, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29563637

RESUMO

BACKGROUND: The aim of this study was to assess the incidence and trends of oesophageal adenocarcinomas (OACs) and squamous cell carcinomas (OSCCs) in England from 1971 to 2037. METHODS: Data on 220,026 oesophageal cancers diagnosed in England between 1971 and 2013 were extracted. Multiple imputation was used to predict morphology data were missing. Incidence rates were modelled and extrapolated to 2037 using age-period-cohort models. RESULTS: The OAC age-standardised incidence rate (ASRs) increase was greatest from 1972 to 1992 (from 4.8 to 12.3 for men and 1.1 to 3 per 100,000 for women) and slowed from 1992 to 2012 (with an increase to 17 for men and 3.8 per 100,000 for women). OSCCs rates decreased from 7.5 to 4.9 from 1972 to 2012 for men. For women, ASRs increased from 5.5 to 5.9 between 1972 and 1992 and then decreased to 4.7 per 100,000 until 2012. Rates until 2032 are predicted to stay stable for OACs and further decrease for OSCCs. CONCLUSIONS: Imputing missing morphology allowed accurate and up-to-date estimates of trends and projections. We observed a slowing down of the increase in OAC ASRs and an overall decrease in OSCC ASRs.

12.
Lancet Public Health ; 3(1): e34-e43, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29307386

RESUMO

BACKGROUND: In the next 25 years, the epidemiology of cervical cancer in England, UK, will change: human papillomavirus (HPV) screening will be the primary test for cervical cancer. Additionally, the proportion of women screened regularly is decreasing and women who received the HPV vaccine are due to attend screening for the first time. Therefore, we aimed to estimate how vaccination against HPV, changes to the screening test, and falling screening coverage will affect cervical cancer incidence in England up to 2040. METHODS: We did a data modelling study that combined results from population modelling of incidence trends, observable data from the individual level with use of a generalised linear model, and microsimulation of unobservable disease states. We estimated age-specific absolute risks of cervical cancer in the absence of screening (derived from individual level data). We used an age period cohort model to estimate birth cohort effects. We multiplied the absolute risks by the age cohort effects to provide absolute risks of cervical cancer for unscreened women in different birth cohorts. We obtained relative risks (RRs) of cervical cancer by screening history (never screened, regularly screened, or lapsed attender) using data from a population-based case-control study for unvaccinated women, and using a microsimulation model for vaccinated women. RRs of primary HPV screening were relative to cytology. We used the proportion of women in each 5-year age group (25-29 years to 75-79 years) and 5-year period (2016-20 to 2036-40) who have a combination of screening and vaccination history, and weighted to estimate the population incidence. The primary outcome was the number of cases and rates per 100 000 women under four scenarios: no changes to current screening coverage or vaccine uptake and HPV primary testing from 2019 (status quo), changing the year in which HPV primary testing is introduced, introduction of the nine-valent vaccine, and changes to cervical screening coverage. FINDINGS: The status quo scenario estimated that the peak age of cancer diagnosis will shift from the ages of 25-29 years in 2011-15 to 55-59 years in 2036-40. Unvaccinated women born between 1975 and 1990 were predicted to have a relatively high risk of cervical cancer throughout their lives. Introduction of primary HPV screening from 2019 could reduce age-standardised rates of cervical cancer at ages 25-64 years by 19%, from 15·1 in 2016 to 12·2 per 100 000 women as soon as 2028. Vaccination against HPV types 16 and 18 (HPV 16/18) could see cervical cancer rates in women aged 25-29 years decrease by 55% (from 20·9 in 2011-15 to 9·5 per 100 000 women by 2036-40), and introduction of nine-valent vaccination from 2019 compared with continuing vaccination against HPV 16/18 will reduce rates by a further 36% (from 9·5 to 6·1 per 100 000 women) by 2036-40. Women born before 1991 will not benefit directly from vaccination; therefore, despite vaccination and primary HPV screening with current screening coverage, European age-standardised rates of cervical cancer at ages 25-79 years will decrease by only 10% (from 12·8 in 2011-15 to 11·5 per 100 000 women in 2036-40). If screening coverage fell to 50%, European age-standardised rates could increase by 27% (from 12·8 to 16·3 per 100 000 by 2036-40). INTERPRETATION: Going forward, focus should be placed on scenarios that offer less intensive screening for vaccinated women and more on increasing coverage and incorporation of new technologies to enhance current cervical screening among unvaccinated women. FUNDING: Jo's Cervical Cancer Trust and Cancer Research UK.


Assuntos
Neoplasias do Colo do Útero/epidemiologia , Adulto , Idoso , Detecção Precoce de Câncer/métodos , Inglaterra/epidemiologia , Feminino , Humanos , Incidência , Programas de Rastreamento/estatística & dados numéricos , Pessoa de Meia-Idade , Modelos Estatísticos , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Reino Unido/epidemiologia
13.
Br J Cancer ; 117(12): 1865-1873, 2017 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-29096400

RESUMO

BACKGROUND: Estimating the future incidence of cancer is important to establish sufficient service provision, however, work in this area is limited for cancer in children, adolescents, and young adults (aged 0-24). METHODS: Age-period-cohort models were applied to cancer incidence rates for the period 1971-2013 in England. This allowed us to extrapolate past trends to 2030. We used the appropriate cancer classification developed for cancers in children and young adults, which are analysed as two separate groups to capture inherent differences. RESULTS: The data set consisted of 119 485 records (55% among 15+ years group). Overall, cancer rates have increased over time and are expected to continue to rise into the future. Of particular interest is the increase in rates of germ cell tumours (in males) and carcinomas (in females) in young adults, since their rates are projected to further increase over time. CONCLUSIONS: The estimated future incidence rates provide a baseline for different cancer subtypes, which will allow policymakers to develop a contingency plan to deal with future demands.


Assuntos
Neoplasias/epidemiologia , Adolescente , Fatores Etários , Criança , Pré-Escolar , Inglaterra/epidemiologia , Feminino , Previsões , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Fatores Sexuais , Adulto Jovem
14.
Lancet ; 390(10092): 363-373, 2017 07 22.
Artigo em Inglês | MEDLINE | ID: mdl-28648402

RESUMO

BACKGROUND: Graded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help. METHODS: In this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in the UK. Patients were randomly assigned to receive specialist medical care (SMC) alone (control group) or SMC with additional guided graded exercise self-help (GES). Block randomisation (randomly varying block sizes) was done at the level of the individual with a computer-generated sequence and was stratified by centre, depression score, and severity of physical disability. Patients and physiotherapists were necessarily unmasked from intervention assignment; the statistician was masked from intervention assignment. SMC was delivered by specialist doctors but was not standardised; GES consisted of a self-help booklet describing a six-step graded exercise programme that would take roughly 12 weeks to complete, and up to four guidance sessions with a physiotherapist over 8 weeks (maximum 90 min in total). Primary outcomes were fatigue (measured by the Chalder Fatigue Questionnaire) and physical function (assessed by the Short Form-36 physical function subscale); both were self-rated by patients at 12 weeks after randomisation and analysed in all randomised patients with outcome data at follow-up (ie, by modified intention to treat). We recorded adverse events, including serious adverse reactions to trial interventions. We used multiple linear regression analysis to compare SMC with GES, adjusting for baseline and stratification factors. This trial is registered at ISRCTN, number ISRCTN22975026. FINDINGS: Between May 15, 2012, and Dec 24, 2014, we recruited 211 eligible patients, of whom 107 were assigned to the GES group and 104 to the control group. At 12 weeks, compared with the control group, mean fatigue score was 19·1 (SD 7·6) in the GES group and 22·9 (6·9) in the control group (adjusted difference -4·2 points, 95% CI -6·1 to -2·3, p<0·0001; effect size 0·53) and mean physical function score was 55·7 (23·3) in the GES group and 50·8 (25·3) in the control group (adjusted difference 6·3 points, 1·8 to 10·8, p=0·006; 0·20). No serious adverse reactions were recorded and other safety measures did not differ between the groups, after allowing for missing data. INTERPRETATION: GES is a safe intervention that might reduce fatigue and, to a lesser extent, physical disability for patients with chronic fatigue syndrome. These findings need confirmation and extension to other health-care settings. FUNDING: UK National Institute for Health Research Research for Patient Benefit Programme and the Sue Estermann Fund.


Assuntos
Terapia por Exercício/métodos , Síndrome de Fadiga Crônica/terapia , Autogestão/métodos , Adulto , Terapia Cognitivo-Comportamental/métodos , Terapia Combinada , Avaliação da Deficiência , Exercício , Terapia por Exercício/efeitos adversos , Síndrome de Fadiga Crônica/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Resultado do Tratamento
15.
Br J Cancer ; 115(9): 1140-1146, 2016 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-27632376

RESUMO

BACKGROUND: It is well established that screening can prevent cervical cancer, but the magnitude of the impact of regular screening on cervical cancer mortality is unknown. METHODS: Population-based case-control study using prospectively recorded cervical screening data, England 1988-2013. Case women had cervical cancer diagnosed during April 2007-March 2013 aged 25-79 years (N=11 619). Two cancer-free controls were individually age matched to each case. We used conditional logistic regression to estimate the odds ratio (OR) of developing stage-specific cancer for women regularly screened or irregularly screened compared with women not screened in the preceding 15 years. Mortality was estimated from excess deaths within 5 years of diagnosis using stage-specific 5-year relative survival from England with adjustment for age within stage based on SEER (Surveillance, Epidemiology and End Results, USA) data. RESULTS: In women aged 35-64 years, regular screening is associated with a 67% (95% confidence interval (CI): 62-73%) reduction in stage 1A cancer and a 95% (95% CI: 94-97%) reduction in stage 3 or worse cervical cancer: the estimated OR comparing regular (⩽5.5yearly) screening to no (or minimal) screening are 0.18 (95% CI: 0.16-0.19) for cancer incidence and 0.08 (95% CI: 0.07-0.09) for mortality. It is estimated that in England screening currently prevents 70% (95% CI: 66-73%) of cervical cancer deaths (all ages); however, if everyone attended screening regularly, 83% (95% CI: 82-84%) could be prevented. CONCLUSIONS: The association between cervical cancer screening and incidence is stronger in more advanced stage cancers, and screening is more effective at preventing death from cancer than preventing cancer itself.


Assuntos
Programas de Rastreamento , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/mortalidade , Esfregaço Vaginal/estatística & dados numéricos , Adulto , Idoso , Estudos de Casos e Controles , Detecção Precoce de Câncer/métodos , Detecção Precoce de Câncer/estatística & dados numéricos , Inglaterra/epidemiologia , Feminino , Humanos , Incidência , Programas de Rastreamento/métodos , Programas de Rastreamento/estatística & dados numéricos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Teste de Papanicolaou
16.
Med Educ ; 50(7): 738-45, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27295478

RESUMO

CONTEXT: Developed by Jacobson and Truax, the reliable change index (RCI) provides a measure of whether the change in an individual's score over time is within or beyond that which might be accounted for by measurement variability. In combination with measures of whether an individual's final score is closer to those of one population or another, this provides useful individual-level information that can be used to supplement traditional analyses. OBJECTIVES: This article aims to highlight the potential of the RCI for use within medical education, particularly as a novel means of monitoring progress at the student level across successive test occasions or academic years. METHODS: We provide an example of how the RCI can be applied informatively to assessment evaluation, and discuss its wider usage. CONCLUSIONS: The RCI approach can be used to identify and support failing students, as well as to determine best teaching and learning practices by identifying high-performing students. Furthermore, the individual-level nature of the RCI makes it well suited for educational research with small cohorts, as well as for tracking individual profiles within a larger cohort or addressing questions about individual performance that may be unanswerable at group level.


Assuntos
Educação Médica/métodos , Avaliação Educacional/métodos , Aprendizagem , Estudantes de Medicina/psicologia , Competência Clínica/normas , Humanos , Reprodutibilidade dos Testes , Pesquisa
17.
JMIR Res Protoc ; 5(2): e70, 2016 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-27278762

RESUMO

BACKGROUND: Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is characterized by chronic disabling fatigue and other symptoms, which are not explained by an alternative diagnosis. Previous trials have suggested that graded exercise therapy (GET) is an effective and safe treatment. GET itself is therapist-intensive with limited availability. OBJECTIVE: While guided self-help based on cognitive behavior therapy appears helpful to patients, Guided graded Exercise Self-help (GES) is yet to be tested. METHODS: This pragmatic randomized controlled trial is set within 2 specialist CFS/ME services in the South of England. Adults attending secondary care clinics with National Institute for Health and Clinical Excellence (NICE)-defined CFS/ME (N=218) will be randomly allocated to specialist medical care (SMC) or SMC plus GES while on a waiting list for therapist-delivered rehabilitation. GES will consist of a structured booklet describing a 6-step graded exercise program, supported by up to 4 face-to-face/telephone/Skype™ consultations with a GES-trained physiotherapist (no more than 90 minutes in total) over 8 weeks. The primary outcomes at 12-weeks after randomization will be physical function (SF-36 physical functioning subscale) and fatigue (Chalder Fatigue Questionnaire). Secondary outcomes will include healthcare costs, adverse outcomes, and self-rated global impression change scores. We will follow up all participants until 1 year after randomization. We will also undertake qualitative interviews of a sample of participants who received GES, looking at perceptions and experiences of those who improved and worsened. RESULTS: The project was funded in 2011 and enrolment was completed in December 2014, with follow-up completed in March 2016. Data analysis is currently underway and the first results are expected to be submitted soon. CONCLUSIONS: This study will indicate whether adding GES to SMC will benefit patients who often spend many months waiting for rehabilitative therapy with little or no improvement being made during that time. The study will indicate whether this type of guided self-management is cost-effective and safe. If this trial shows GES to be acceptable, safe, and comparatively effective, the GES booklet could be made available on the Internet as a practitioner and therapist resource for clinics to recommend, with the caveat that patients also be supported with guidance from a trained physiotherapist. The pragmatic approach in this trial means that GES findings will be generalizable to usual National Health Service (NHS) practice. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRTCTN): 22975026; http://www.isrctn.com/ISRCTN22975026 (Archived by WebCite at http://www.webcitation.org/6gBK00CUX).

18.
Psychiatr Serv ; 67(6): 658-63, 2016 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-26876660

RESUMO

OBJECTIVE: Clinical decision making is an important aspect of mental health care. Predictors of how patients experience decision making and whether decisions are implemented are underresearched. This study investigated the relationship between decision topic and involvement in the decision, satisfaction with it, and its subsequent implementation from both staff and patient perspectives. METHODS: As part of the Clinical Decision Making and Outcome in Routine Care for People With Severe Mental Illness study, patients (N=588) and their providers (N=213) were recruited from community-based mental health services in six European countries. Both completed bimonthly assessments for one year using the Clinical Decision Making in Routine Care Scale to assess the decision topic and implementation; both also completed the Clinical Decision Making Involvement and Satisfaction Scale. RESULTS: Three categories of decision topics were determined: treatment (most frequently cited), social, and financial. The topic identified as most important remained stable over the follow-up. Patients were more likely to rate their involvement as active rather than passive for social decisions (odds ratio [OR]=5.7, p<.001) and financial decisions (OR=9.5, p<.001). They were more likely to report higher levels of satisfaction rather than lower levels for social decisions (OR=1.5, p=.01) and financial decisions (OR=1.7, p=.01). Social decisions were more likely to be partly implemented (OR=3.0, p<.001) or fully implemented (OR=1.7, p=.03) than not implemented. CONCLUSIONS: Patients reported poorer involvement, satisfaction, and implementation in regard to treatment-related decisions, compared with social and financial decisions. Clinicians may need to employ different interactional styles for different types of decisions to maximize satisfaction and decision implementation.


Assuntos
Tomada de Decisão Clínica , Transtornos Mentais/economia , Transtornos Mentais/terapia , Participação do Paciente , Satisfação do Paciente , Adolescente , Adulto , Europa (Continente) , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Relações Médico-Paciente , Adulto Jovem
19.
Schizophr Res ; 175(1-3): 142-147, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-26527245

RESUMO

BACKGROUND: Little is known about the empirical relationship between clinical and personal recovery. AIMS: To examine whether there are separate constructs of clinical recovery and personal recovery dimensions of outcome, how they change over time and how they can be assessed. METHOD: Standardised outcome measures were administered at baseline and one-year follow-up to participants in the REFOCUS Trial (ISRCTN02507940). An exploratory factor analysis was conducted and a confirmatory factor analysis assessed change across time. RESULTS: We identified three factors: patient-rated personal recovery, patient-rated clinical recovery and staff-rated clinical recovery. Only the personal recovery factor improved after one year. HHI, CANSAS-P and HoNOS were the best measures for research and practice. CONCLUSIONS: The identification of three rather than two factors was unexpected. Our findings support the value of concurrently assessing staff and patient perceptions of outcome. Only the personal recovery factor changed over time, this desynchrony between clinical and recovery outcomes providing empirical evidence that clinical recovery and personal recovery are not the same. We did not find evidence of a trade-off between clinical recovery and personal recovery outcomes. Optimal assessment based on our data would involve assessment of hope, social disability and patient-rated unmet need.


Assuntos
Transtornos Mentais/psicologia , Transtornos Mentais/terapia , Adulto , Análise Fatorial , Feminino , Seguimentos , Pessoal de Saúde , Humanos , Masculino , Saúde Mental , Medidas de Resultados Relatados pelo Paciente , Escalas de Graduação Psiquiátrica , Fatores de Tempo , Resultado do Tratamento
20.
Epidemiol Psychiatr Sci ; 25(3): 235-46, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25698298

RESUMO

AIMS: Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing. METHODS: WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes. RESULTS: The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4). CONCLUSIONS: This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.


Assuntos
Psicoterapia de Grupo , Psicoterapia , Transtornos Psicóticos/terapia , Depressão , Humanos , Projetos Piloto , Qualidade de Vida
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