Managing an extension of screening intervals: Avoiding boom and bust in health care workloads.

Extending screening intervals in ongoing cancer screening programmes can lead to challenging year-on-year variations in the number of screening tests. We explored how such variation could be diminished with a managed transition to the extended interval. We defined three extension scenarios: immediate extension for the entire target population; stepped transition by birth cohort; and gradual transition by reducing the number of available screening appointments. These were compared to a situation in which the interval remains unchanged in a demographic model covering a 15-year period. The model was populated with observed parameters from England, a real-world setting recommending cervical screening with 3-year intervals at age 25-49 and 5-year intervals at age 50-64. Informed by typical changes currently considered by several European programmes including the programme in England, we explored the effect on screening test numbers of an extension of the 3-year interval to 5 years for women younger than 50. All three extension scenarios resulted in similar cumulative numbers of screening tests, which were about 30% lower compared to a situation in which the interval would remain unchanged. However, the year-on-year variation in the number of screening tests varied between the scenarios. This variation was around 4-fold for the immediate scenario. In the stepped scenario, the yearly numbers could differ by around 20%, whereas in the gradual scenario they were virtually constant. A managed interval extension, transitioning different groups of the target population at different times, can substantially reduce the yearly variation in screening workload without increasing the total number of screening tests in the long term.

Acceleration of cervical cancer diagnosis with human papillomavirus testing below age 30: Observational study.

Several international cervical screening guidelines advise against using high-risk human papillomavirus (HR-HPV) testing in women younger than 30. The rationale for this in young women, lies in the potential for additional detection of both low-grade and high-grade cervical intraepithelial neoplasia (CIN) leading to unnecessary treatments without reducing the burden of cervical cancer. We studied 56 544 women screened at 24 to 29 with HR-HPV testing and 116 858 screened with liquid-based cytology (LBC) in the English HPV screening pilot. They were compared to 528 460 women screened at the age of 30 to 49. We studied the detection of cervical cancer and CIN2/3 across two consecutive screening rounds 3 years apart. At 24 to 29, a positive HR-HPV test detected more cases of cervical cancer in the prevalence round than did a positive LBC test (1.36/1000 screened vs 0.82/1000, ORadj : 1.61, 95% CI: 1.18-2.19). In women with a negative HR-HPV test, cervical cancer was diagnosed before or at the incidence round in 0.07/1000. After a negative LBC test, cancer detection reached 0.47/1000 and 40% of these cases were diagnosed at FIGO stage IB+. HR-HPV testing increased the detection of CIN2/3 diagnoses in two consecutive rounds combined by 30% (71.9/1000 vs 55.2/1000). The patterns of detection of cervical cancer and CIN2/3 were almost identical at older ages. These data support using HR-HPV testing for screening of women younger than 30, which not only accelerates the diagnosis of cervical cancer but leads to a similar relative increase in CIN2/3 diagnosis to that found in women aged 30 to 49.

The impact of catch-up bivalent human papillomavirus vaccination on cervical screening outcomes: an observational study from the English HPV primary screening pilot.

BACKGROUND: In England, bivalent vaccination (Cervarix) against high-risk human papillomavirus (HR-HPV) genotypes 16/18 was offered in a population-based catch-up campaign in 2008-2010 to girls aged 14-17 years. These women are now entering the national cervical screening programme. We determined the impact of catch-up bivalent vaccination on their screening outcomes. METHODS: We studied the overall and genotype-specific screening outcomes in 108,138 women aged 24-25 (offered vaccination) and 26-29 years (not offered vaccination) included in the English HPV screening pilot between 2013 and 2018. RESULTS: At 24-25 years, the detection of high-grade cervical intraepithelial neoplasia (CIN2+) associated with HPV16/18 decreased from 3 to 1% (p < 0.001), with estimated vaccine effectiveness of 87% (95% CI: 82-91%). The detection of any CIN2+ halved from 6 to 3% (p < 0.001), with an estimated vaccine effectiveness of 72% (95% CI: 66-77%). The positive predictive value of a colposcopy for CIN2+ decreased for both low-grade (p < 0.001) and high-grade (p = 0.02) abnormalities on triage cytology. The decreases in screen-detected abnormalities at age 26-29 were of a substantially smaller magnitude. CONCLUSIONS: These data confirm high effectiveness of bivalent HPV vaccination delivered through a population-based catch-up campaign in England. These findings add to the rationale for extending screening intervals for vaccinated cohorts.

A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy.

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 .).

Age-specific outcomes from the first round of HPV screening in unvaccinated women: Observational study from the English cervical screening pilot.

OBJECTIVE: To report detailed age-specific outcomes from the first round of an English pilot studying the implementation of high-risk human papillomavirus (HR-HPV) testing in primary cervical screening. DESIGN: Observational study with screening in 2013-2016, followed by two early recalls and/or colposcopy until the end of 2019. SETTING: Six NHS laboratory sites. POPULATION: A total of 1 341 584 women undergoing screening with HR-HPV testing or liquid-based cytology (LBC). METHODS: Early recall tests and colposcopies were recommended, depending on the nature of the screening-detected abnormality. MAIN OUTCOME MEASURES: We reported standard screening process indicators, e.g. proportions with an abnormality, including high-grade cervical intraepithelial neoplasia (CIN2+) or cancer, and the positive predictive value (PPV) of colposcopy for CIN2+, by screening test and age group. RESULTS: Among unvaccinated women screened with HR-HPV testing at age 24-29 years, 26.9% had a positive test and 10.4% were directly referred to colposcopy following cytology triage, with a PPV for CIN2+ of 47%. At 50-64 years of age, these proportions were much lower: 5.3%, 1.2% and 27%, respectively. The proportions of women testing positive for HR-HPV without cytological abnormalities, whose early recall HR-HPV tests returned negative results, were similar across the age spans: 54% at 24-29 years and 55% at 50-64 years. Two-thirds of infections at any age were linked to non-16/18 genotypes. Among women with CIN2, CIN3 or cervical cancer, however, the proportion of non-16/18 infections increased with age. As expected, the detection of abnormalities was lower following screening with LBC. CONCLUSIONS: These data provide a reliable reference for future epidemiological studies, including those concerning the effectiveness of HPV vaccination. TWEETABLE ABSTRACT: Data from the English pilot study provide a comprehensive overview of abnormalities detected through HPV screening.

Recovery strategies following COVID-19 disruption to cervical cancer screening and their impact on excess diagnoses.

BACKGROUND: The COVID-19 pandemic has disrupted cervical cancer screening services. Assuming increases to screening capacity are unrealistic, we propose two recovery strategies: one extends the screening interval by 6 months for all and the other extends the interval by 36/60 months, but only for women who have already missed being screened. METHODS: Using routine statistics from England we estimate the number of women affected by delays to screening. We used published research to estimate the proportion of screening age women with high-grade cervical intraepithelial neoplasia and progression rates to cancer. Under two recovery scenarios, we estimate the impact of COVID-19 on cervical cancer over one screening cycle (3 years at ages 25-49 and 5 years at ages 50-64 years). The duration of disruption in both scenarios is 6 months. In the first scenario, 10.7 million women have their screening interval extended by 6 months. In the second, 1.5 million women (those due to be screened during the disruption) miss one screening cycle, but most women have no delay. RESULTS: Both scenarios result in similar numbers of excess cervical cancers: 630 vs. 632 (both 4.3 per 100,000 women in the population). However, the scenario in which some women miss one screening cycle creates inequalities-they would have much higher rates of excess cancer: 41.5 per 100,000 delayed for screened women compared to those with a 6-month delay (5.9 per 100,000). CONCLUSION: To ensure equity for those affected by COVID-19 related screening delays additional screening capacity will need to be paired with prioritising the screening of overdue women.

Multizonal anogenital neoplasia in women: a cohort analysis.

BACKGROUND: There is currently a lack of information on full anogenital evaluation of women with a previous history of anogenital neoplasia. METHODS: Retrospective analysis of the Homerton Anogenital Neoplasia Service records from January 2012 to March 2017, to identify all new referrals of women with previous anogenital neoplasia, who had had at least one complete examination of all anogenital sites. Multizonal anogenital disease (MZD) was defined as the presence of high-grade squamous intraepithelial lesions (HSIL)/carcinoma concurrently at two or more of the following sites/zones: perianus, anal canal, vulva, vagina or cervix. RESULTS: 253 women were included, mean age was 47 (SD=15) years and median duration of follow-up was 12 (IQR=21) months. Fifty-six women (22%) were diagnosed with MZD at first assessment and/or during follow-up. Current smokers (RR=1.84, 95% CI 1.21-2.79, p=0.004) and women on immunodulators/immunosuppressive drugs (RR=2.57, 95% CI 1.72-3.86, p<0.001) had an increased risk for MZD. The risk was lower for women without a previous history of anogenital high-grade lesions/cancer compared to those with this history (RR=0.06, 95% CI 0.01-0.45, p=0.006). CONCLUSIONS: Multizonal assessment was important to diagnose occult areas of disease and should be especially considered in current smokers, pharmacologically immunocompromised and those with a previous history of anogenital HSIL/cancer.

Nicotine Delivery and User Ratings of IQOS Heated Tobacco System Compared With Cigarettes, Juul, and Refillable E-Cigarettes.

INTRODUCTION: Reduced-risk nicotine products are more likely to replace smoking if they match cigarettes in nicotine delivery and user satisfaction. AIMS AND METHODS: We examined the nicotine delivery profile and user ratings of IQOS heated tobacco system and compared it with own brand cigarettes (OBC), Juul, and refillable e-cigarettes (EC).Participants (N = 22) who were daily vapers smoking <1 cigarette per day on average, attended after overnight abstinence from smoking and vaping, to test at separate sessions OBC, IQOS, and Juul. Eight participants also tested two refillable EC using e-liquid with 20 mg/mL nicotine. At each session, a baseline blood sample was taken before participants used the product ad libitum for 5 minutes. Further samples were taken at 2, 4, 6, 8, 10, and 30 minutes. Maximum nicotine concentration (Cmax), time to Cmax (Tmax), and nicotine delivered over 30 minutes (AUC0->30) were calculated. Participants rated their urge to smoke and product characteristics. RESULTS: IQOS delivered less nicotine than OBC (AUC0->30: z = -2.73, p = .006), and than Juul (AUC0->30: z = -3.08, p = .002; Cmax: z = -2.65, p = .008), and received less favorable ratings than Juul (effect on urges to smoke: z = -3.23, p = .001; speed of urge relief: z = -2.75, p = .006; recommendation to friends: z = -2.45, p = .014). Compared with refillable EC, IQOS delivered nicotine faster (Tmax: z = -2.37, p = .018), but received less favorable overall ratings (recommended to friends: z = -2.32, p = .021). CONCLUSIONS: IQOS' pharmacokinetic profile suggests that it may be less effective than Juul for smoking cessation, but at least as effective as refillable EC; although participants, who were experienced vapers rather than IQOS users, preferred refillable EC. IMPLICATIONS: Because IQOS provided less efficient nicotine delivery than cigarettes and Juul in this sample, and also had a weaker effect on urges to smoke than Juul, it could be less helpful than Juul in assisting such dual users, and possibly smokers generally, to switch to an alternative product. IQOS, however, provided nicotine faster than refillable EC products, although participants preferred EC.

Trends and projections in adenocarcinoma and squamous cell carcinoma of the oesophagus in England from 1971 to 2037.

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.

Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial.

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.

The acceptability of high resolution anoscopy examination in patients attending a tertiary referral centre.

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.

Barrett's oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux.

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 .

Cancer incidence in English children, adolescents and young people: past trends and projections to 2030.

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.

Impact of cervical screening on cervical cancer mortality: estimation using stage-specific results from a nested case-control study.

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.

Accounting for test reliability in student progression: the reliable change index.

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.

Psychometric evaluation of the Questionnaire about the Process of Recovery (QPR).

BACKGROUND: Supporting recovery is the aim of national mental health policy in many countries. However, only one measure of recovery has been developed in England: the Questionnaire about the Process of Recovery (QPR), which measures recovery from the perspective of adult mental health service users with a psychosis diagnosis. AIMS: To independently evaluate the psychometric properties of the 15- and 22-item versions of the QPR. METHOD: Two samples were used: data-set 1 (n = 88) involved assessment of the QPR at baseline, 2 weeks and 3 months. Data-set 2 (n = 399; trial registration: ISRCTN02507940) involved assessment of the QPR at baseline and 1 year. RESULTS: For the 15-item version, internal consistency was 0.89, convergent validity was 0.73, test-retest reliability was 0.74 and sensitivity to change was 0.40. Confirmatory factor analysis showed the 15-item version offered a good fit. For the 22-item version, the interpersonal subscale was found to underperform and the intrapersonal subscale overlaps substantially with the 15-item version. CONCLUSIONS: Both the 15-item and the intrapersonal subscale of the 22-item versions of the QPR demonstrated satisfactory psychometric properties. The 15-item version is slightly more robust and also less burdensome, so it can be recommended for use in research and clinical practice.

Development and evaluation of the INSPIRE measure of staff support for personal recovery.

BACKGROUND: No individualised standardised measure of staff support for mental health recovery exists. AIMS: To develop and evaluate a measure of staff support for recovery. DEVELOPMENT: initial draft of measure based on systematic review of recovery processes; consultation (n = 61); and piloting (n = 20). Psychometric evaluation: three rounds of data collection from mental health service users (n = 92). RESULTS: INSPIRE has two sub-scales. The 20-item Support sub-scale has convergent validity (0.60) and adequate sensitivity to change. Exploratory factor analysis (variance 71.4-85.1 %, Kaiser-Meyer-Olkin 0.65-0.78) and internal consistency (range 0.82-0.85) indicate each recovery domain is adequately assessed. The 7-item Relationship sub-scale has convergent validity 0.69, test-retest reliability 0.75, internal consistency 0.89, a one-factor solution (variance 70.5 %, KMO 0.84) and adequate sensitivity to change. A 5-item Brief INSPIRE was also evaluated. CONCLUSIONS: INSPIRE and Brief INSPIRE demonstrate adequate psychometric properties, and can be recommended for research and clinical use.

The Developmental Relationship Between Depressive Symptoms in Adolescence and Harmful Drinking in Emerging Adulthood: The Role of Peers and Parents.

Depressive symptoms have been linked to the development of harmful drinking in adolescence but it remains unclear to what extent this effect continues into emerging adulthood. Deviant peers represent a risk factor while parental monitoring is a protective factor for harmful drinking. The study explored the relationship between depressive symptoms and harmful drinking between early adolescence and emerging adulthood. We also assessed to what extent this relationship is mediated by the influence of deviant peers and whether parental monitoring weakens this process. The sample consisted of 2964 adolescents (64 % females) from the Avon Longitudinal Study of Parents and Children study assessed between the ages of 14 and 19. Using structural equation modelling, we found that affiliation with deviant peers mediated the association between depressive symptoms and harmful drinking after adjustment for socio-demographic variables, parental drinking and depression, teenager's sex, conduct problems as well as drinking and depressive symptoms in early adolescence. We also found that parental control and solicitation reduced the influence of deviant peers on harmful drinking. The results indicate that prevention programs should offer adolescents training for peer resistance training and monitoring skills training for parents may have a long-term effect at weakening peer influences on harmful drinking.

Efficacy of Electronic Cigarettes vs Varenicline and Nicotine Chewing Gum as an Aid to Stop Smoking: A Randomized Clinical Trial.

Importance: Electronic cigarettes (ECs) are often used by smokers as an aid to stopping smoking, but evidence is limited regarding their efficacy compared with nicotine replacement therapy (NRT), and no evidence is available on how their efficacy compares with that of varenicline. Objective: To evaluate whether ECs are superior to NRT and noninferior to varenicline in helping smokers quit. Design, Setting, and Participants: This was a randomized clinical trial conducted at 7 sites in China and including participants who were smoking at least 10 cigarettes per day and motivated to quit, not using stop-smoking medications or EC, and willing to use any of the study products. Participants were first recruited in May 2021, and data analysis was conducted in December 2022. Interventions: A cartridge-based EC (30 mg/mL nicotine salt for 2 weeks and 50 mg/mL after that), varenicline (0.5 mg, once a day for 3 days; 0.5 mg, twice a day for 4 days; and 1 mg, twice a day, after that), and 2 mg (for smokers of ≤20 cigarettes per day) or 4 mg (>20 cigarettes per day) nicotine chewing gum, all provided for 12 weeks and accompanied by minimal behavioral support (an invitation to join a self-help internet forum). Main Outcomes and Measures: The primary outcome was sustained abstinence from smoking at 6 months as validated by an expired-air carbon monoxide reading (<8 parts per million). Participants lost to follow-up were included as nonabstainers. Results: Of 1068 participants, 357 (33.5%) were female, and the mean (SD) age was 33.9 (3.1) years. A total of 409 (38.3%), 409 (38.3%), and 250 (23.4%) participants were randomized to the EC, varenicline, and NRT arms, respectively. The 6-month biochemically validated abstinence rates were 15.7% (n = 64), 14.2% (n = 58), and 8.8% (n = 22) in the EC, varenicline, and NRT study arms, respectively. The quit rate in the EC arm was noninferior to the varenicline arm (absolute risk reduction, 1.47%; 95% CI, -1.41% to 4.34%) and higher than in the NRT arm (odds ratio, 1.92; 95% CI, 1.15-3.21). Treatment adherence was similar in all study arms during the initial 3 months, but 257 participants (62.8%) in the EC arm were still using ECs at 6 months, with no further use in the 2 other study arms. The most common adverse reactions were throat irritation (32 [7.8%]) and mouth irritation (28 [6.9%]) in the EC arm, nausea (36 [8.8%]) in the varenicline arm, and throat irritation (20 [8.0%]) and mouth irritation (22 [8.8%]) in the NRT arm. No serious adverse events were recorded. Conclusions and Relevance: The results of this randomized clinical trial found that when all treatments were provided with minimal behavior support, the efficacy of EC was noninferior to varenicline and superior to nicotine chewing gum. Trial Registration: Chinese Clinical Trial Registry: ChiCTR2100048156.