Stage 3 clinical data collection

3.3.3.1 The investigator file

The investigator file consisted of two folders; the first, a ‘set up file’ which had details regarding the set up of the research study, the second a ‘file in progress’ related and was for the documentation of minor changes which were recorded in a summary amendment log, the patient master log and field diary. In this study the minor changes that were documented and related to the presentation of the questionnaire not the content. These amendments were made for the following reasons; a) requests from participants with specific needs who were attending the hypermobility clinic; b) transcription of the paper based questionnaire to a survey monkey for the comparison group; c) to allow participants the flexibility of being able to ask the researcher questions in the clinic and to take the questionnaire home and forward it to the researcher at the university with the appropriate consent form. In addition within the ‘file in progress’ were details of the patient master log and field diary.

3.3.3.2 The hypermobility clinic

A security pass was issued to enable access to relevant areas in the hospital and the administration building where the consent forms were stored in a locked filing cabinet. After accessing the new email address training was received by clinic staff on how to access the patient record system.

The principal investigator introduced and supervised the researcher during the data collection phase in the hypermobility clinic. The hypermobility clinic ran from 08.30 – 12.30 and was attended by one or two consultants twice a week. The researcher attended from 08.00 in preparation for patients with JHS arriving for the early appointments. Administrative activities were carried out after 13.00, this included writing up data for the study diary, the participant log, sending out letters of invitation and participant information packs, GP letters and the filing of consent forms.

The clinic staff were made aware of the research project and the names of the consultants with whom the researcher was working alongside. They were proactive in alerting the researcher to the arrival of patients attending the hypermobility clinic. The location of the hypermobility clinic was in a busy out- patient clinic area in which patients were attending appointments to see a variety of consultants in different disciplines. At either end of the morning there was generally sufficient seating for patients and their accompanying visitors. For a couple of hours in the middle of the morning the clinic could be so busy that there was insufficient seating for all. These factors meant that more time was spent talking with patients with JHS who attended the clinic at either end of the morning. Most patients with JHS were given the opportunity to discuss the study with the researcher and ask questions. On the information sheet participants were given the phone number of the research administrator as a contact and the email of the researcher if there were any queries.

Registration details of patients attending the hypermobility clinic were entered on to a sheet designated as the patient master log. The aim of this log was to record the patients name, unique study code, date of birth, clinic appointment date, the date the patient information pack was sent, date of consent and the record of the letter sent to the GP. There was space to record comments. The unique codes were simple. The first eight participants started with a double P and a

subsequent number. After collecting data from the first eight participants the recruitment and consent process were discussed with the principal investigator and the research administrator from the hospital research and development unit. There were no changes made to the process and the data collection continued. Subsequently participants were allocated a single P and sequential number. Where participants were added to the clinic list, they were allocated a code PE and a corresponding number related to where they would appear on the clinic list. This made the locating of participants at relevant clinics easier to trace than if their details had been added to the end of the participant list which might be for a subsequent clinic.

3.3.3.3 Consent

Most consent forms were signed in the clinic by the participant and the researcher together. Consent forms were then photocopied, one copy was given to the participant, another copy filed in the participant’s notes and the original filed in the research study consent form folder and kept in a locker in the administration building. Occasionally participants wanted more time to think about the study and on these occasions they sent the consent form and completed questionnaire through to the researcher. Consent forms were then copied and a copy of the consent form was posted to the participant. On a few occasions where participants had only initialed the boxes instead of signing their full name the consent forms were sent out to the participant with a letter of explanation and a stamped addressed envelope for the return of the consent form.

3.3.3.4 Field diary

The aim of the field diary was to record; a) events during the time of the data collection in the hypermobility clinic; b) thoughts and ideas during the data collection and c) observations and significant interactions with participants and consultants. This field diary was accessed during the data analysis. The following extract was taken from the field diary and enables a broader

understanding about the patient population attending the hypermobility clinic.

‘The hypermobility clinic is run as part of the rheumatology specialism at a London teaching hospital. It is attended by two consultant rheumatologists. From January to June 2009 a total of 363 patients attended the clinic of which 207 were new patients. The patients were referred from all over the country, this included Wales and Cornwall in the west, Kent in the East, and Manchester in the north and ‘everywhere’ in between. The patient population was predominantly female 304/363 (83.7%), with the number of male patients during this time as 59 (16.3%). The average age of the 363 patients attending the clinic was 33 years. (Grahame 2009). Presentation to the Arthritis Research Council at University College London [21st July 2009]).’ (Field Diary CC 21/7/2009).

3.3.3.5 Recruitment for the pilot and continuation of the study in the hypermobility clinic Pilot studies are used in social science research to run small scale versions of the major study (Polit et al 2001) and to pre-test the research instruments (Baker 1994). The purpose of this pilot study was to test the logistics and feasibility of the main study in a hypermobility clinic.

Data collection for the pilot study in the hypermobility clinic was conducted between May and June 2009. Potential participants for the study were accessed using the patient record system. The initial screening confirmed that participants who were sent a participant information pack (PIP) were

between the ages of 18-65 years (this was part of the inclusion criteria). The attendance lists constantly changed therefore where possible clinic lists were accessed several times in order to keep up with the changes. Potential participants were sent a participant information pack by post 8- 14 days prior to their hospital appointment. Participants who had not received a participant

information pack when they attended the clinic were given the option of receiving an information pack. The information pack consisted of a letter of invitation to the study, an information sheet, consent form and questionnaire (See appendices 9, 11,12 and13). All participants who were sent or given a patient information pack were recorded in the patient master log.

The data from the questionnaires was loaded into SPSS within 48 hours of the researcher receiving the completed health and activities questionnaire. Qualitative data was initially entered on to SPSS and subsequently transcribed to a word document. The researcher was actively involved in

checking questionnaires in order to ascertain if there were any difficulties that required addressing. The number of completed questionnaires received from patients from the hypermobility clinic on the 16th June was 22. The hypermobility clinic was cancelled on the 18th June giving a week between clinics. The natural break in the data collection enabled the researcher a chance to analyse some of the data and to see if the questionnaire required any further revisions. After this analysis it was anticipated that the data being collected would enable the research questions and hypotheses to be answered. No further changes were required for the questionnaire. This information was conveyed to the principal investigator and supervisors. The data collection continued until the end of July which was when the participant number predicted by the sample size calculation had been met.

3.3.3.6 Calculating sample size

The end of the data collection phase in the hypermobility clinic was determined by meeting the sample size requirement. In order to calculate a sample size for this study, it was decided to use the SF-12. The requirement was to find the optimum number of patients with JHS and participants in a comparison group without JHS required to show a difference in the score of the SF-12. The score of the SF-12 is divided into the physical component summary (PCS) score and the mental component summary (MCS) score. It had previously been reported that a difference of 5 points on the SF-12 scoring system was the lowest score associated with a perceived clinical difference in clinical and population studies (Bjorner et al 2007). The minimum clinically important difference is based on the concept that this is the smallest difference in which patients would perceive a beneficial difference, in the absence of any side effects or excessive changes in health management (Jaeschke et al 1989). There were no previous studies in which the SF-12 had been reported in patients with JHS. It is suggested in this instance that data from a previous study may be employed (Petrie and Sabin 2005). The data for this calculation was therefore taken from a previous study in which participants reported chronic low back pain (Baldwin et al 2007) as this study was one that most closely

mirrored the current study. The PCS scores from the chronic low back pain study were employed for the sample size calculation.

In this instance Lehr’s formula for calculating sample size was employed (Lehr 1992). The assumed standard deviation of the observations in two groups was taken as 10.16. This was the average standard deviations taken from two groups in a chronic low back pain study one group who had no lasting pain and the other reported multiple episodes of pain (Baldwin et al ), a 5% 2−sided significance level, and a power of 90% the sample size was calculated at 88 per group. Assuming an 80% response rate for the questionnaires the aim was to send out 110 participant information packages to the patients with JHS attending a hypermobility clinic.

In practice the response rate to the questionnaire was less than had initially been anticipated, it was 60% instead of 80% and therefore the total number of patient information packs sent out were 154 of whom 114 recipients attended the hypermobility clinic and 97 patients with JHS completed the questionnaire. Patients with JHS who did not fulfill the inclusion criteria were 7 this left a sample of 90.