What influences GPs' use of pelvic examination? A qualitative investigation in primary care.

BACKGROUND: Omission of pelvic examination (PE) has been associated with diagnostic delay in women diagnosed with gynaecological cancer. However, PEs are often not carried out by GPs. AIM: To determine the perceptions of GPs about the role of PEs, the barriers to and facilitators of PEs, and GPs' experience of PEs in practice. DESIGN AND SETTING: Qualitative semi-structured interview study conducted in one health board in Scotland (mixed urban and rural) with an approximate population of 500 000. METHOD: Interviews were conducted face-to-face or by telephone between March and June 2019. Framework analysis used the COM-B behaviour change model concepts of capability, opportunity, and motivation. RESULTS: Data was compatible with all three domains of the COM-B framework. Capability related to training in and maintenance of skills. These went beyond carrying out the examination to interpreting it reliably. Opportunity related to the clinical environment and the provision of chaperones for intimate examination. Interviewees described a range of motivations towards or against PEs that were unrelated to either capability or opportunity. These all related to providing high-quality care, but this was defined in different ways: 'doing what is best for the individual', 'doctors examine', and 'GPs as pragmatists'. CONCLUSION: GPs' reasons for carrying out, or not carrying out, PEs in women with symptoms potentially indicating cancer are complex. The COM-B framework provides a way of understanding this complexity. Interventions to increase the use of PEs, and critics of its non-use, need to consider these multiple factors.

Help-seeking behaviour in women diagnosed with gynaecological cancer: a systematic review.

BACKGROUND: Identifying what prompts or hinders women's help-seeking behaviour is essential to ensure timely diagnosis and management of gynaecological cancers. AIM: To understand the factors that influence the help- seeking behaviour of women diagnosed with gynaecological cancer. DESIGN AND SETTING: Systematic review and narrative synthesis of studies from high-income settings worldwide. METHOD: Five databases were searched for studies, of any design, that presented factors related to the help-seeking behaviour of women diagnosed with a gynaecological cancer. Data from the articles were extracted and presented using narrative synthesis, which was both inductive and deductive. The COM-B (capability, opportunity, motivation, behaviour) model of behaviour change was used as a framework. RESULTS: In total, 21 studies were included in the review. Inductive synthesis presented three main themes of factors related to the help-seeking behaviour of women diagnosed with gynaecological cancer: patient factors, such as knowledge of symptoms; emotional factors, including previous healthcare experience, embarrassment, and trust; and practical factors, including time and resources. Deductive synthesis demonstrated that capability (namely, symptom knowledge), opportunity (having the required time and overcoming the cultural taboos surrounding gynaecological symptoms), and motivation (believing that seeking help is beneficial) are all required to initiate help-seeking behaviour. CONCLUSION: Although it is a journey of defined steps, the help- seeking behaviour of women with symptoms diagnosed with gynaecological cancer is influenced by personal and societal factors. Interventions to improve help seeking will need to address the specific identified factors, as well as capability, opportunity, and motivation.

A process evaluation of 'We Can Quit': a community-based smoking cessation intervention targeting women from areas of socio-disadvantage in Ireland.

BACKGROUND: Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme, 'We Can Quit', was developed in Ireland tailored to SED women. This includes group-based support delivered by trained lay local community facilitators (CFs) and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, 'We Can Quit 2'. This paper reports on the WCQ2 process evaluation which assessed feasibility and acceptability of the programme and trial processes. METHODS: Embedded qualitative design using the UK Medical Research Council's process evaluation framework. Semi-structured interviews with trial participants (N = 21) and CFs (N = 8). Thematic analysis was utilised. RESULTS: Peer-modelling, a non-judgemental environment, CFs facilitation of group support were viewed as acceptable programme related factors. Some participants expressed concerns about NRT side effects. Provision of free NRT was welcomed and accepted by participants, although structural barriers made access challenging. Pharmacists took on a role that became larger than originally envisaged - and the majority provided additional support to women in their quit attempts between group meetings which augmented and supplemented the intervention sessions provided by the CFs. Participants reported good acceptance of repeated measures for data collection, but mixed acceptability of provision of saliva samples. Low literacy affected the feasibility of some women to fully engage with programme and trial-related materials. This was despite efforts made by intervention developers and the trial team to make materials (e.g., participant intervention booklet; consent forms and participant information leaflets) accessible while also meeting requirements under 2018 European General Data Protection Regulation legislation. Hypothetical scenarios of direct (e.g., researcher present during programme delivery) and indirect (e.g., audio recordings of programme sessions) observational fidelity assessments for a future definitive trial (DT) were acceptable. CONCLUSIONS: Intervention and trial-related processes were generally feasible and acceptable to participants and CFs. Any future DT will need to take further steps to mitigate structural barriers to accessing free NRT; and the established problem of low literacy and low educational attainment in SED areas, while continuing to comply within the contemporary legislative research environment. TRIAL REGISTRATION: WCQ2 pilot trial ( ISRCTN74721694 ).

An application of PRECIS-2 to evaluate trial design in a pilot cluster randomised controlled trial of a community-based smoking cessation intervention for women living in disadvantaged areas of Ireland.

BACKGROUND: "We Can Quit2" (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of 'We Can Quit' (WCQ, a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised 'enhanced usual care' offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under 'real-world' conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT). METHODS: The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: eligibility, recruitment, setting, organisation, flexibility-delivery, flexibility-adherence, follow-up and primary outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop. RESULTS: Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Trial recruitment was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT. CONCLUSIONS: PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry ( No. 74721694 ).

Patient and primary care delays in the diagnostic pathway of gynaecological cancers: a systematic review of influencing factors.

BACKGROUND: Gynaecological cancers are the second most common female cancer type, with survival rates in the UK lower than in many comparable countries. A potentially important factor in the UK's poorer cancer outcomes is diagnostic delay; gynaecological cancers are the cancer type most likely to be affected by less timely diagnosis. AIM: To examine current evidence for factors that contribute to patient and primary care delays in the diagnostic pathway of gynaecological cancer. DESIGN AND SETTING: A systematic review of the available literature. METHOD: PRISMA guidelines were followed. MEDLINE and Embase databases and the Cochrane Library were searched using three terms: primary care; gynaecological cancer; and delay. Citation lists of all identified articles were searched. Two authors independently screened the titles, abstracts, and full texts of publications. Data extraction was performed by one author and quality assured by a second reviewer in a 20% sample of selected articles. Synthesis was narrative. RESULTS: A total of 1253 references was identified, of which 37 met the inclusion criteria. Factors associated with delayed diagnosis were categorised as either patient factors (patient demographics, symptoms or knowledge, and presentation to the GP) or primary care factors (doctor factors: patient demographics, symptoms or knowledge, and referral process); and system factors (such as limited access to investigations). CONCLUSION: Delayed diagnosis in the patient and primary care intervals of the diagnostic journey of gynaecological cancer is complex and multifactorial. This review identifies areas of future research that could lead to interventions to enable prompter diagnosis of gynaecological cancers.

The use, quality and effectiveness of pelvic examination in primary care for the detection of gynaecological cancer: a systematic review.

BACKGROUND: Urgent suspected cancer referral guidelines recommend that women with gynaecological cancer symptoms should have a pelvic examination (PE) prior to referral. We do not know to what extent GPs comply, their competency at PE, or if PE shortens the diagnostic interval. OBJECTIVES: We conducted a systematic review of the use, quality and effectiveness of PE in primary care for women with suspected gynaecological cancer. METHOD: PRISMA guidelines were followed. Three databases were searched using four terms: PE, primary care, competency and gynaecological cancer. Citation lists of all identified papers were screened independently for eligibility by two reviewers. Data extraction was performed in duplicate and independently. Paper quality was assessed using the relevant Critical Appraisal Skills Programme checklist. Emergent themes and contrasting issues were explored in a narrative ecological synthesis. MAIN FINDINGS: Twenty papers met the inclusion criteria. 52% or less of women with suspicious symptoms had a PE. No papers directly explored GPs' competence at performing PE. Pre-referral PE was associated with reduced diagnostic delay and earlier stage diagnosis. Ecological synthesis demonstrated a complex interplay between patient and practitioner factors and the environment in which examination is performed. Presenting symptoms are commonly misattributed by patients and practitioners resulting in misdiagnosis and lack of PE. CONCLUSION: We do not know if pre-referral PE leads to better outcomes for patients. PE is often not performed for women with gynaecological cancer symptoms, and evidence that it may result in earlier stage of diagnosis is weak. More research is needed.