RESUMEN
BACKGROUND: In the USA, more than 7200 new cases of anal cancer were diagnosed in 2014 with incidence rising. Concurrent chemoradiotherapy improves cancer-related outcomes but has led to an increase in acute and late adverse events. Patient-reported outcomes (PRO) are increasingly included in trials as a surrogate measure for reporting of late adverse events. This study aimed to select the most effective PRO to use in clinical research and practice for anal cancer since no questionnaire specific for anal cancer has been developed. METHODS: A mixed methods approached was used. A systematic review estimated the frequency of use of PROs and clinician reporting instruments used in anal cancer trials including radiation treatment. Health professional semi-structured interviews explored preferred questionnaires and revealed missing items; analysis was done using the framework approach. Two symptom-based, validated questionnaires were selected and assessed by means of inductive content analysis to highlight discrepancies relevant to anal cancer. FINDINGS: 34 relevant studies reported on radiotherapy adverse events. For PROs, EORTC QLQ-C30 (n=5) and EORTC QLQ-CR38 (n=3) were used most frequently. RTOG/EORTC (n=17) and CTCAE (n=15) criteria were most commonly used for clinician reporting. EORTC QLQ-C30 and EORTC QLQ-CR38, and National Cancer Institute's (NCI) PRO-CTCAE were selected for further analysis. No consensus for questionnaire content or design was found through health professional interviews (n=8). Domains and codes relevant to anal cancer treatment were selected from interviews to inform questionnaire analysis. 27 domains and 60 codes were found in EORTC questionnaires, and 21 domains and 44 codes in NCI PRO-CTCAE. Four domains and 16 codes were not covered by EORTC systems including radiation skin reaction. Six domains and 45 codes were not covered by NCI PRO-CTCAE including vaginal stenosis and bowel urgency. INTERPRETATION: This study shows that there are gaps in the questionnaires commonly used to record adverse events using PROs for anal cancer. Expert opinion is valuable in highlighting relevant missing items but provides no consensus on design and wording preferences. For use in longitudinal follow-up of patients with anal cancer treated with (chemo)radiation, the EORTC-QLQ system has the fewest missing symptom items for use as a validated PRO in clinical research and practice. FUNDING: This abstract presents independent research funded by the National Institute for Health Research (NIHR).
RESUMEN
BACKGROUND: Chlamydia trachomatis remains a significant public health problem. We used a complex intervention, with general practice staff, consisting of practice based workshops, posters, computer prompts and testing feedback and feedback to increase routine chlamydia screening tests in under 25 year olds in South West England. We aimed to evaluate how intervention components were received by staff and to understand what determined their implementation into ongoing practice. METHODS: We used face-to-face and telephone individual interviews with 29 general practice staff analysed thematically within a Normalisation Process Theory Framework which explores: 1. Coherence (if participants understand the purpose of the intervention); 2. Cognitive participation (engagement with and implementation of the intervention); 3. Collective action (work actually undertaken that drives the intervention forwards); 4. Reflexive monitoring (assessment of the impact of the intervention). RESULTS: Our results showed coherence as all staff including receptionists understood the purpose of the training was to make them aware of the value of chlamydia screening tests and how to increase this in their general practice. The training was described by nearly all staff as being of high quality and responsible for creating a shared understanding between staff of how to undertake routine chlamydia screening. Cognitive participation in many general practice staff teams was demonstrated through their engagement by meeting after the training to discuss implementation, which confirmed the role of each staff member and the use of materials. However several participants still felt unable to discuss chlamydia in many consultations or described sexual health as low priority among colleagues. National targets were considered so high for some general practice staff that they didn't engage with the screening intervention. Collective action work undertaken to drive the intervention included use of computer prompts which helped staff remember to make the offer, testing rate feedback and having a designated lead. Ensuring patients collected samples when still in the general practice was not attained in most general practices. Reflexive monitoring showed positive feedback from patients and other staff about the value of screening, and feedback about the general practices testing rates helped sustain activity. CONCLUSIONS: A complex intervention including interactive workshops, materials to help implementation and feedback can help chlamydia screening testing increase in general practices.