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CHAPTER THREE METHODS
3.1 This chapter outlines the methods of collecting data on i) the number of occupational exposure incidents reported, ii) the circumstances and the management of each case, iii) experts' evaluations of the post-incident management, and iv) the views of exposed individuals. The chapter notes the study timetable and some methodological limitations.
Study design
3.2 The evaluation of incidents of occupational exposure to blood/body fluids was carried out through police and prison OH departments, and employed a prospective approach. The method was based on previous work carried out by the research team (Gordon et al, 2003; Cullen et al, 2006).
3.3 Anonymised data was collected by OH staff on each case of occupational exposure to blood and/or body fluids reported by police or prison service staff to their OH unit over the study period (initially 6 months but extended to 12 months, see below), using a standardised Incident Report Form ( IRF) ( Annex 1) and supplementary sheet ( Annex 2). The design of the IRF was based on that used in a previous study of needle-stick injuries among health care workers (Gordon et al, 2003), but modified to reflect the circumstances of police and prison staff work exposures and their management, and the forms used in OH units. During the consultation (face-to-face or by telephone) OH staff recorded details of the circumstances of each incident, any factors affecting risk and the clinical management of the case. Information was collected from the exposed person and from OH staff (and if necessary from other medical services with the exposed person's consent).
3.4 The proposed data collection process and the draft IRF were discussed with OH staff in each police force and with OHSAS and SALUS managers and clinicians. Because of time constraints it was not possible to pilot the use of the IRF.
3.5 The appropriateness and adequacy of the management of each case was evaluated by a panel of experts, with reference to current guidelines and their knowledge and expertise. Twelve clinicians in the fields of OH, ID, and GUM, whose jobs normally involved risk assessment of BBV exposures, agreed to act as members of an expert panel. They reviewed the information from the IRFs to assess the risk of BBV transmission in each case and evaluated the appropriateness and adequacy of the clinical management reportedly provided, recording their views on an Incident Review Form ( Annex 3).
3.6 Cases of occupational exposure to blood or body fluids can be complex, and the risk of BBV infection difficult to assess. Research has shown that assessments of risk and views about post-incident management can differ (van Wijk et al, 2008). To ensure that the assessment was valid and reliable, 6 members of one of 2 sub-panels reviewed each incident, independently. This method was based on previous work carried out by members of the research team (Cullen et al, 2006). Some differences between reviewers were anticipated and it was, therefore, decided that no expert would be excluded from the analysis unless his/her ratings differed significantly from those of others. Prior to reviewing incidents, panel members received written guidance and training on the review process to ensure a consistent approach and agreement on the policies being utilised, and had the opportunity to comment on a draft Incident Review Form. The review process was piloted with 3 early cases.
3.7 In addition, exposed individuals were asked to complete a Staff Evaluation Questionnaire ( SEQ) ( Annex 4), giving their views and experiences of the services they received, their reasons for reporting the incident to OH, any non-reporting in the past and any training they had received about BBVs and occupational exposure. Staff were also asked to rate their anxiety i) immediately after the incident, ii) following consultations with medical services, and iii) at the time of completing the questionnaire. The questionnaire was designed to be completed 4 weeks after the incident, when anxiety might have reduced over time, but when any blood test results would not have been received. It drew on recognised ways of measuring anxiety, and studies investigating patient satisfaction (Balfour et al, 2004) and non-reporting (Gershon et al, 2007). It used both quantitative and qualitative approaches, the latter having been useful in understanding individuals' experiences of post-exposure (Gershon et al, 2000). Attempts were made to pilot the use of the SEQ but these were unsuccessful.
3.8 The final versions of the 3 data collection forms were approved by the funders.
3.9 It was initially estimated that 200 incidents of occupational exposure would be reported by police and prison service staff over a 6 month period, if the evaluation was publicised and staff were encouraged to report any incidents. This figure was based on advice from the SPF to the Scottish Executive that during 2003-2004 there had been 229 incidents with a possible risk of BBV infection ( SPF, 2005). From SPSOH&W records, 31 incidents of occupational exposure were reported in the SPS between 1 st January 2005 and 31 st May 2007, of which 11 were referred to A&E services (personal communication, J. McKay, 17 th July 2007). Thus the number of incidents reported within the SPS over 6 months was thought likely to be about 10.
3.10 To allow for the possibility that not all incidents of occupational exposure reported to police and prison H&S departments were also reported to OH, H&S departments agreed to collect the number of incidents reported to them over the study period.
Steering group
3.11 A steering group was recruited by the Scottish Government Directorate-General for Justice and Communities. Its remit was to scrutinise the research methods, instruments, progress and findings. Members included representatives of Scottish police and prison service staff, including trade union representatives and OH staff, clinicians in OH and ID, and others with knowledge of the topic.
Ethical approval
3.12 The University of the West of Scotland 1 Research Ethics Advisory Group granted ethical approval for the evaluation. No ethical approval was needed to carry out the evaluation within prisons but a governance form was signed by the principal grant-holder.
Permission and support
3.13 The Scottish Police committees, staff organisations and trade unions who were consulted expressed support for the evaluation. Written permission to carry out and publicise the evaluation, and for OH nurse advisers to assist with data collection, was obtained from the Chief Constable in each force, and from OH line managers.
3.14 In the prison service it was agreed that the evaluation would be carried out in the 15 prisons in Scotland in which staff were employed by the SPS. The permission of prison governors was not required. SPSHR managers and trade union and staff association representatives were supportive of the evaluation. OH&W staff agreed to distribute information about the study to SPS staff, including H&S and HR staff. OHSAS and SALUS managers agreed that their staff would collect data.
3.15 Since prison service staff sustaining an exposure while on duty might not necessarily attend the OH provider, a procedure was put in place for the duration of the evaluation so that data could be collected. Prison service staff who reported an exposure to blood and body fluids to their H&S department would be referred to HR. The HR manager would outline the study and ask the member of staff to attend the OH provider for the purpose of the evaluation. Since this procedure was not normal practice, publicity ahead of the evaluation was used to raise awareness of the evaluation and the procedure.
Publicity
3.16 The study was publicised within the Scottish police and prison services in various ways, both ahead of data collection, and over the evaluation period. The publicity materials outlined the purpose of the evaluation, what was involved, the potential benefits to staff and the fact that the research was supported by employers. Staff were encouraged to report all incidents of occupational exposure and participate in the evaluation.
3.17 The publicity materials sent to the police included newsletter articles and information for general circulation, material (posters) for intranet sites and the text of a letter to be sent to each force. In the SPS, posters and a 'Notice to Staff' were circulated ahead of data collection and leaflets were sent out with pay advice after 2 months.
Data collection and timescale
3.18 Full details of the data collection process are given in Annex 5.
3.19 Data collection began in the police on 7 th August 2007 and in the SPS on 8 th October 2007. The later start date in the prison service reflected unavoidable postponements to meetings with stakeholders, and the need to circulate publicity ahead of data collection.
3.20 A 6-month evaluation had been proposed initially; however, after 3 months only 25 cases had been received from police forces (2 per week on average) and one from the prison service. The Scottish Government Directorate-General for Justice and Communities asked that data be collected for 12 months to increase the size of the sample.
3.21 Data collection by OH staff of new cases of occupational exposure ended on 31 st August 2008. Details of 106 cases were sent to the expert panel. (In the other 2 cases, the IRFs were received after the deadline for delivery to the panel.) Follow-up questionnaires were sent out for all 108 cases.
Data entry and analysis
3.22 The quantitative and qualitative data from the IRFs and SEQs were entered into SPSS and data cleaned. Quantitative data analysis was carried out using descriptive statistics. The qualitative responses of exposed individuals were analysed for themes.
3.23 Quantitative and qualitative data from the expert panel (Incident Review Forms) were entered into a Microsoft EXCELTM spreadsheet and data cleaned. This data cleaning was carried out by 2 researchers independently. In the few instances where a reviewer's comments indicated some misunderstanding, the comment and corresponding evaluation were removed from the analysis. A qualitative analysis identified the issues highlighted in panel members' comments on specific cases, and their general recommendations. A quantitative analysis was carried out using Microsoft EXCELTM.
3.24 The expert panel methodology was considered to be valid after checking for intra-observer variation (the consistency of each expert's scoring over time), inter-observer variation (the consistency of experts' scoring within each panel) and inter-panel variation (the consistency of the scoring of the 2 sub-panels). Details of the checks carried out are given in Annex 6. Each expert was found to be scoring consistently over time and compared with other panel members. The 2 sub-panels were found to be scoring to the same standard. Therefore, no expert was excluded from the analysis, and the data for the sub-panels has been presented together.
Methodological limitations
3.25 This study had some methodological limitations, and some other problems were experienced. The main methodological difficulties, with possible limitations on the data and hence on the findings, are outlined below.
3.26 The study had the potential to change behaviour. Since OH staff knew that their actions and their judgements were being evaluated, they might have been expected to act as 'correctly' as possible during the evaluation, even though this might not necessarily have been their normal behaviour. However, perceptions of 'correct' behaviour may differ, and the evaluation had the potential to reveal interesting differences ( e.g. between units) in protocols, knowledge, ways of perceiving risk, or language. The existence of the study might also have changed the behaviour of police and prison service staff - indeed it was hoped that they would be encouraged to report incidents of occupational exposure - but this could not be known. Although the potential for behaviour change might have limited the ability of the evaluation to ascertain the adequacy and appropriateness of 'normal' actions by OH and other medical services, this possible limitation could have resulted in other outcomes that were beneficial, such as raising awareness and improving practice.
3.27 The evaluation did not include the direct collection of data on the management provided by any medical service other than OH. Any details on the IRF about care provided by any other first point of contact, such as A&E, could only be that reported by the exposed person to OH, unless OH had received first-hand information from the service(s). Panel members did not, therefore, feel able to evaluate the post-incident management provided by any service other than OH (see Chapter Four).
3.28 At the time of the study, the post-incident management for prison service staff occupationally exposed to blood or body fluids was normally organised through A&E. Not only would any details of management by A&E inevitably be second-hand (as above), but also questions about measures provided by OH, reasons for non-reporting to OH in the past, or OH nurses' ability to assess the risk of BBV infection, might not be relevant in the prison service. However, the study afforded the SPS an opportunity to pilot a new approach, which involved referral to OH.
3.29 There was scope for differences in procedures between the police forces (and between the police and prison services) to affect the data collected. If the normal first point of medical contact for staff in a given police force or the SPS was A&E, not all the incidents of occupational exposure sustained in that organisation might be notified to OH, especially low-risk cases.
3.30 Finally, the evaluation depended on OH staff collecting data on the incidents of occupational exposure reported to them, and forwarding follow-up questionnaires. This method was used i) because OH staff had the relevant expertise, and ii) for reasons of confidentiality. There was scope, however, for the response rates to be affected by the availability of OH nurse advisers. One police OH unit was unable to participate in the evaluation for 3½ months because of staff shortages.
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