A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions.

BACKGROUND: Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants' behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development. METHODS: We undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT. RESULTS: We reached data saturation and found five main themes; Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings. Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty-Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable. Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that these trial designs should go through at least a proportionate ethical review. GP staff were happy for the PCT leads to give consent on their behalf. GP research capacity and trial participation: GP staff considered the design increased generalisability, as staff who would not normally volunteer to participate in research due to perceived time constraints and paperwork might do so. Design 'worth it': All interviewees agreed that the advantages of the "more accurate" or "truer" results and information gained about uptake of workshops within Primary Care Trusts (PCTs) outweighed any disadvantages of the consent procedure. DISCUSSION: Our RCT was evaluating the effect of an educational intervention to increase chlamydia screening tests in general practices where there was routine monitoring of testing rates; our participants may have been less enthusiastic about the design if it had been evaluating a more controversial educational area, or if data monitoring was not routine. IMPLICATIONS: The McNulty-Zelen design should be considered for the evaluation of educational interventions, but these designs should have clear consent protocols and proportionate ethical review. TRIAL REGISTRATION: The trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN9722 .

Provision of chlamydia testing, and training of primary health care staff about chlamydia testing, across four European countries.

BACKGROUND: The objectives of this study were to describe and compare chlamydia testing provided by general practitioners (GPs) in four selected European countries with well-developed primary health care systems and high reported chlamydia rates; we aimed to compare contrasting countries where chlamydia testing is provided by GPs (England, Sweden) with countries where primary care chlamydia testing is absent or very limited (France, Estonia). METHODS: For data generation a structured questionnaire was developed and secondary data sources were searched. The questionnaire developed by the research team allowed a systematic approach to analysing chlamydia care (including testing in general practice) and the gathering of relevant data. RESULTS: There were no significant differences in the burden of the disease or the type of general practice care provision in the study countries. In all four countries, testing for chlamydia (with nucleic acid amplification test, NAAT) is available in the public sector, a substantial proportion (>60%) of young people aged 16-25 years visit their general practitioner (GP) annually, and reimbursement for chlamydia testing costs to the relevant parties (GPs in England, Sweden and Estonia; and patients in France) by the national health insurance system or its equivalent.In countries where chlamydia testing is provided by GPs (England, Sweden) a national strategy or plan on STI control that specifically mentions chlamydia was in force, chlamydia care guidelines for GPs were in place and STI management was more firmly established in the GP residency training curriculum, either formally (England) or informally (Sweden), than in the other countries. CONCLUSION: Future research on the effectiveness of chlamydia screening (also in the context of general practice care) and program provision should reflect national needs and the prevention of complications.

Qualitative impact assessment of an educational workshop on primary care practitioner attitudes to NICE HIV testing guidelines.

BACKGROUND: In 2013, Public Health England piloted the '3Cs (chlamydia, contraception, condoms) and HIV (human immunodeficiency virus)' educational intervention in 460 GP surgeries. The educational HIV workshop aimed to improve the ability and confidence of staff to offer HIV testing in line with national guidelines. AIM: To qualitatively assess the impact of an educational workshop on GP staff's attitudes to NICE HIV testing guidelines. DESIGN & SETTING: Qualitative interviews with GP staff across England before and after an educational HIV workshop. METHOD: Thirty-two GP staff (15 before and 17 after educational HIV workshop) participated in interviews exploring their views and current practice of HIV testing. Interview transcripts were thematically analysed and examined, using the components of the theory of planned behaviour (TPB) and normalisation process theory (NPT) as a framework. RESULTS: GPs reported that the educational HIV workshop resulted in increased knowledge of, and confidence to offer, HIV tests based on indicator conditions. However, overall participants felt they needed additional HIV training around clinical care pathways for offering tests, giving positive HIV results, and current treatments and outcomes. Participants did not see a place for point-of-care testing in general practice. CONCLUSION: Implementation of national HIV guidelines will require multiple educational sessions, especially to implement testing guidelines for indicator conditions in areas of low HIV prevalence. Additional role-play or discussions around scripts suggesting how to offer an HIV test may improve participants' confidence and facilitate increased testing. Healthcare assistants (HCAs) may need specific training to ensure that they are skilled in offering HIV testing within new patient checks.

Chlamydia and HIV testing, contraception advice, and free condoms offered in general practice: a qualitative interview study of young adults' perceptions of this initiative.

BACKGROUND: Opportunistic chlamydia screening is actively encouraged in English general practices. Based on recent policy changes, Public Health England piloted 3Cs and HIV in 2013-2014, integrating the offer of chlamydia testing with providing condoms, contraceptive information, and HIV testing (referred to as 3Cs and HIV) according to national guidelines. AIM: To determine young adults' opinions of receiving a broader sexual health offer of 3Cs and HIV at their GP practice. DESIGN AND SETTING: Qualitative interviews were conducted in a general practice setting in England between March and June 2013. METHOD: Thirty interviews were conducted with nine male and 21 female patients aged 16-24 years, immediately before or after a routine practice attendance. Data were transcribed verbatim and analysed using a thematic framework. RESULTS: Participants indicated that the method of testing, timing, and the way the staff member approached the topic were important aspects to patients being offered 3Cs and HIV. Participants displayed a clear preference for 3Cs and HIV to be offered at the GP practice over other sexual health service providers. Participants highlighted convenience of the practice, assurance of confidentiality, and that the sexual health discussion was appropriate and routine. Barriers identified for patients were embarrassment, unease, lack of time, religion, and patients believing that certain patients could take offence. Suggested facilitators include raising awareness, reassuring confidentiality, and ensuring the offer is made in a professional and non-judgemental way at the end of the consultation. CONCLUSION: General practice staff should facilitate patients' preferences by ensuring that 3Cs and HIV testing services are made available at their surgery and offered to appropriate patients in a non-judgemental way.

Qualitative interviews with healthcare staff in four European countries to inform adaptation of an intervention to increase chlamydia testing.

OBJECTIVE: To determine the needs of primary healthcare general practice (GP) staff, stakeholders and trainers to inform the adaptation of a locally successful complex intervention (Chlamydia Intervention Randomised Trial (CIRT)) aimed at increasing chlamydia testing within primary healthcare within South West England to three EU countries (Estonia, France and Sweden) and throughout England. DESIGN: Qualitative interviews. SETTING: European primary healthcare in England, France, Sweden and Estonia with a range of chlamydia screening provision in 2013. PARTICIPANTS: 45 GP staff, 13 trainers and 18 stakeholders. INTERVIEWS: The iterative interview schedule explored participants' personal attitudes, subjective norms and perceived behavioural controls around provision of chlamydia testing, sexual health services and training in general practice. Researchers used a common thematic analysis. RESULTS: Findings were similar across all countries. Most participants agreed that chlamydia testing and sexual health services should be offered in general practice. There was no culture of GP staff routinely offering opportunistic chlamydia testing or sexual health advice, and due to other priorities, participants reported this would be challenging. All participants indicated that the CIRT workshop covering chlamydia testing and sexual health would be useful if practice based, included all practice staff and action planning, and was adequately resourced. Participants suggested minor adaptations to CIRT to suit their country's health services. CONCLUSIONS: A common complex intervention can be adapted for use across Europe, despite varied sexual health provision. The intervention (ChlamydiA Testing Training in Europe (CATTE)) should comprise: a staff workshop covering sexual health and chlamydia testing rates and procedures, action planning and patient materials and staff reminders via computer prompts, emails or newsletters, with testing feedback through practice champions. CATTE materials are available at: www.STItraining.eu.