Ten-year mortality, disease progression, and treatment-related side effects in men with localised prostate cancer from the ProtecT randomised controlled trial according to treatment received

Background The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy. Objective To report outcomes according to treatment received in men in randomised and treatment choice cohorts. Design, setting, and participants This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy. Intervention Two cohorts included 1643 men who agreed to be randomised and 997 who declined randomisation and chose treatment. Outcome measurements and statistical analysis Analysis was carried out to assess mortality, metastasis and progression and health-related quality of life impacts on urinary, bowel, and sexual function using patient-reported outcome measures. Analysis was based on comparisons between groups defined by treatment received for both randomised and treatment choice cohorts in turn, with pooled estimates of intervention effect obtained using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores. Results and limitations According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p = 0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p = 0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6 mo) and urinary incontinence (55% at 6 mo) after surgery, and of sexual dysfunction (88% at 6 mo) and bowel dysfunction (5% at 6 mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and changes in the protocol for AM during the lengthy follow-up required in trials of screen-detected PCa. Conclusions Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group. Patient summary More than 95 out of every 100 men with low or intermediate risk localised prostate cancer do not die of prostate cancer within 10 yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are better after active monitoring, but the risks of spreading of prostate cancer are more common

Functional and quality of life outcomes of localised prostate cancer treatments (prostate testing for cancer and treatment [ProtecT] study)

Objective To investigate the functional and quality of life (QoL) outcomes of treatments for localised prostate cancer and inform treatment decision-making. Patients and Methods Men aged 50–69 years diagnosed with localised prostate cancer by prostate-specific antigen testing and biopsies at nine UK centres in the Prostate Testing for Cancer and Treatment (ProtecT) trial were randomised to, or chose one of, three treatments. Of 2565 participants, 1135 men received active monitoring (AM), 750 a radical prostatectomy (RP), 603 external-beam radiotherapy (EBRT) with concurrent androgen-deprivation therapy (ADT) and 77 low-dose-rate brachytherapy (BT, not a randomised treatment). Patient-reported outcome measures (PROMs) completed annually for 6 years were analysed by initial treatment and censored for subsequent treatments. Mixed effects models were adjusted for baseline characteristics using propensity scores. Results Treatment-received analyses revealed different impacts of treatments over 6 years. Men remaining on AM experienced gradual declines in sexual and urinary function with age (e.g., increases in erectile dysfunction from 35% of men at baseline to 53% at 6 years and nocturia similarly from 20% to 38%). Radical treatment impacts were immediate and continued over 6 years. After RP, 95% of men reported erectile dysfunction persisting for 85% at 6 years, and after EBRT this was reported by 69% and 74%, respectively (P < 0.001 compared with AM). After RP, 36% of men reported urinary leakage requiring at least 1 pad/day, persisting for 20% at 6 years, compared with no change in men receiving EBRT or AM (P < 0.001). Worse bowel function and bother (e.g., bloody stools 6% at 6 years and faecal incontinence 10%) was experienced by men after EBRT than after RP or AM (P < 0.001) with lesser effects after BT. No treatment affected mental or physical QoL. Conclusion Treatment decision-making for localised prostate cancer can be informed by these 6-year functional and QoL outcomes

Constructing Care in the Community Together: A Discourse Analysis of Care Planning Meetings

Objectives: The Care Programme Approach (CPA) is the official framework for care for adults with severe mental health problems in England. Research on interactions in health settings have explored key concepts of patient-centred care, shared decision-making and the biopsychosocial model. Discourse analysis has been used to examine interactions in both health and mental health care. However, research on the CPA has largely been based on service outcome measures and interviews with service providers. This study aimed to explore discursive constructions of service users' difficulties and therapeutic interventions in CPA meetings and documentation in community mental health settings; how potentially different viewpoints are negotiated; and the differences and similarities between the meetings and documentation. Method: Audiorecordings of six CPA meetings and their resultant CPA documents were collected from a Community Mental Health Team and an Early Intervention Service. A discourse analysis at the micro level, using a Discursive Psychology framework, and at the macro level, using a Foucauldian Discourse Analysis framework was conducted. Results: An account of constructions of services users' difficulties, causes and risk factors, care as medicine and care as managing the practicalities of everyday living was produced. Rhetorical devices were used to create consensual explanations of difficulties and decisions about medicine; tensions and disagreements were not recorded in CPA documents. Discourses of a medical model of difficulties were implicit and explicit in both teams, although discourses of a biopsychosocial model were also apparent in the Early Intervention Service. The complexity of participants negotiating discourses about the value of paid employment and discourses of illness were evidenced in all meetings. Conclusions: Discourse analysis provided a useful means to explore CPA meetings and documentation. The primacy of the medical model, even within biopsychosocial accounts, and the goals of shared decision making within a recovery framework are discussed and clinical, policy, and research implications are explored

Five-year predictive validity of DSM-IV conduct disorder research diagnosis in 4A1/2-5-year-old children

OBJECTIVE: This longitudinal study of a non-referred, population-based sample tested the 5-year predictive validity of the DSM-IV conduct disorder (CD) research diagnosis in children 4½–5 years of age. METHOD: In the E-Risk Study, a representative birth cohort of 2,232 children, mothers were interviewed and teachers completed mailed questionnaires to assess children’s past 6-month CD symptoms. A follow-up assessment was conducted when children were 10 years old. RESULTS: CD-diagnosed 5-year-olds were significantly more likely than controls to have behavioural and educational difficulties at age 10. Increased risk for age-10 educational difficulties persisted after controlling for age-5 IQ and ADHD diagnosis. Although the majority of CD-diagnosed 5-year-olds had no CD symptoms at age 10, findings suggest that these “remitted” children continued to experience behavioural and educational problems 5 years later despite their apparent remission from CD. CONCLUSIONS: DSM-IV CD symptoms validly identify preschool-aged children who continue to have behavioural and educational problems in middle-childhood