improve clinical Abstract

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1 low back pain. CG88. London: National Institute for Health and Clinical Excellence 25. Parsons T On the concept of influence, The Public Opinions Quarterly, 27(1), Poiraudeau S, Rannou F, Baron G, LeHenanff A, Coudeyre E, Rozenberg S. Huas D, Martineau C, Jolivet-Landreau I, Garcia-Macé J, Revel M and Ravaud, P 2006 Fear-Avoidence beliefs about back pain in patients with subacute low back pain Pain 124(3), Polgar S and Thomas AS Introduction to research in health sciences 5th ed., London: Churchill- Livingstone. 28. Rainville J, Bagnall D and Phalen L Healthcare providers attitudes and beliefs about functional impairments and chronic back pain The Clinical Journal of Pain, 11(4), Rainville J, Carlson N, Polatin P, Gatchel RL, Indahl A A Exploration of physicans recommendations for activities in chronic low back pain Spine, 25(17), Pallant J SPSS: Survival Manual, New York: McGraw Hill. 31. Ryan C, Murphy D, Clark M and Lee A The effect of a physiotherapy education compared with a non-healthcare education on the attitudes and beliefs of students towards functioning in individuals with back pain: An observational, cross-sectional study, Physiotherapy,96(2), Silcock J, Klaber Moffett J, Edmondson H, Waddell G and Burton AK Do community pharmacists have the attitudes and knowledge to support evidence-based self-management of low back pain? BMC Musculoskeletal Disorders, 8(10)1-8, 33. Sinel MS, William MD and Deardorff, W 1999 Back Pain Remedies For Dummies Hoboken: Wiley & Sons 34. Strohschein J, Hagler P and May L Assessing the need for change in clinical education practices Physical Therapy, 82(2), Symonds T, Burton A, Tilotson K, Main C Absence resulting from low back trouble can be reduced by psychosocial intervention at the work place, Spine, 20(24), Symonds TL, Burton AK, Tillotson KM, and Main CJ 1996 Do attitudes and beliefs influence work loss due to low back trouble? Occupational Medicine, 46(1),25 32, 37. Tarasuk V and Eakin JM Back problems are for life: perceived vulnerability and its implications for chronic disability Journal of Occupational Rehabilitation, 4, Tarasuk V and Eakin JM The problem of legitimacy in the experience of work-related back injury Qualitative health research 5(2), Urquhart DM, Bell RJ, Cicuttini FM, Cui1 J, Forbes A and Davis SR Negative beliefs about low back pain are associated with high pain intensity and high level disability in community-based women BMC Musculoskeletal Disorders, 9,148, 40. Van Tulder M. Ostelo R, Vlaeyen J, Linton S, Morley S and Assendelf W Behavioural treatment for chronic low back pain Spine, 25, Waddell G The Back Pain Revolution 2nd ed., London: Elsevier Limited. 42. Williamson E Fear-avoidance Beliefs Questionnaire (FABQ) Australian Journal of Physiotherapy 52, 152 Does specific training of Physiotherapists improve clinical outcomes: feasibility study considerations and results, a brief report. Author: Dr. Nick Harland Ph.D Affiliation: Extended Scope Practitioner Physiotherapist Research Fellow Teesside University Physiotherapy Dept, Friarage Hospital Northallerton, DL6 1JG. Telephone (01609) nick.harland@nhs.net Abstract Introduction - Methodological design of translational clinical studies is challenging and it is often impossible to control for all confounding variables. Feasibility studies are often used to investigate the effect of known or potential study confounders to establish their impact on larger planned studies. Feasibility study results are also used to provide evidence to funding panels to justify bids for larger studies. This brief report describes a Physiotherapist training feasibility study undertaken to establish if lack of training contamination would allow for a non-cluster randomisation to be used and how confounding the Hawthorne effect might be. This brief report describes the study s methodology and the specific results gained from the Hawthorne and contamination parts of the study only. Page 10 Issue No. 36 Winter 2014

2 Method - 18 therapists from 3 centres were randomised to receive a training intervention or not. The clinical outcomes of the therapists were measured in a group of patients before the training intervention and in a group of patients after the training intervention. A training contamination questionnaire was used to establish evidence regarding a non-cluster design and retrospective recruitment of patients seen by participating therapists was used to establish Hawthorne effect. Results - The results of the feasibility study confirm no significant Hawthorne effect is likely to skew results of a larger study and that no significant training contamination appeared to have taken place, justifying a non-cluster design. Conclusion The findings of the feasibility study justify planning of a larger non-cluster study design. The clinical outcomes of the feasibility study will be reported elsewhere. Introduction Designing methodologically sound medical research is a challenge and often compromises have to be made, particularly in translational research which aims to produce findings directly applicable to normal clinical situations. Without compromising the relevance of research to clinical situations it is difficult or impossible to account for all the variables that my skew or confound results. This paper briefly discusses some of the methodological problems inherent in designing a study to answer the question, Does personal development training of Physiotherapists affect their clinical outcomes? The results of the parts of the study aimed to address the methodological considerations highlighted below are then outlined. Cluster Randomisation In some circumstances, such as public health research and some primary care research, interventions cannot be isolated to individuals and intact social units, or clusters of individuals, rather than individuals themselves, are randomised (Giraudeau & Ravaud, 2009). In a screening program with a publicity campaign as part of the intervention for instance individual towns have to be randomised as intact social units as individuals within the town have all potentially been exposed to the publicity intervention. In this way members of a cluster will be more like one another than they are like members of other clusters e.g. members of a town targeted with publicity will be more like each other than members of town that had no additional publicity (Bland, 2004). In other circumstances, such as in training studies, the main reason for considering a cluster design is contamination. This describes the process by which again, members of a cluster may be more like each other. For instance if some GP s in a practice receive a training intervention and others do not it is possible other GP s in the practice could be contaminated by that training. The control group GP s could overhear a conversation about the training between intervention group colleagues or be told by a patient the new way in which one of the other partners they had seen had treated them. Control group GP s could potentially learn indirectly from the training of intervention group partners in a way which could affect their clinical practice and skew study results. This process is referred to as contamination. Other factors relevant to cluster designs are that due to potential similarities between participants a greater total number of participants is required to achieve the same statistical power as a non-cluster RCT (Campbell et al 2004). There are also potentially ethical issues with randomisation procedures where the gate keeper of a cluster, the senior individual within a cluster who decides the clusters participation, makes this decision prior to the individual consenting of members of the practice. These and related ethical issues are complex and described well by Hutton (2001). Hawthorne Effect Briefly the Hawthorne effect describes the various processes by which studying something may change it. The effect was first described after a series of studies was undertaken to try and improve productivity in the Western Electrical Company s Hawthorne Works in Chicago during the 1920s and 30s (McCarney, 2007). The outcome was that any intervention such as increasing or reducing the lighting had the same effect, to improve productivity. The conclusion was that the productivity improvement was secondary to workers knowing they were being monitored and was independent of the interventions themselves. In a training study where therapist outcomes are examined, therapists could consciously or unconsciously try to perform better as a result of being in a study. In this way even control group therapists not undertaking any training could perform better and skew results. Method Therapist Participant s 18 therapists from 3 hospital trusts were recruited to the study. Randomisation occurred within each centre, with 3 therapists from each centre being randomised to the intervention group and 3 to the control group. Pragmatically true randomisation of the group as a whole, or by centre, was not possible due to service constraints, with managers unable to commit to releasing an unknown number of staff to undertake the training at one time. Pre-intervention Data Collection Before the training intervention both the control group and intervention group had their clinical effectiveness and personal impact on patients measured. Patients due to see therapists were sent a standard questionnaire battery before their treatment started measuring pain using a visual analogue scale, (Korff et al, 2000), disability using the Pain Disability Journal of the Physiotherapy Pain Association Page 11

3 Questionnaire (Anagnostis et al, 2004), and psychosocial status using the Coping Strategies Questionnaire 24 (Harland & Georgieff, 2003). These patients were sent the same questionnaire three months later when the majority had completed treatment. Details of number of treatments and discharge date, if applicable, were taken. In addition to the normal clinical measures at three months patients were also sent a patient experience measure, the Personal Impact Factors Questionnaire (PIFQ), submitted for publication, measuring constructs including communication, empathy, trust and honesty. Patients returned questionnaires by post and were instructed not to discuss their participation with their therapist so therapists were blinded to which patients were involved in the study. Hawthorne Effects Study To measure any possible Hawthorne effect the Personal Impact Factors Questionnaire was sent to patients discharged by therapists within the last three months, before they were approached about the study. These PIFQ results were then compared to PIFQ results from patients seen by therapists after they had been consented and randomised, but before the intervention. In addition to the PIFQ given to patients a question was included in the contamination questionnaire for therapists, described later, using a Visual Analogue Scale reply; As a result of knowing you are part of a study looking at factors like communication skills, and having the outcome of some of your patients measured, including aspects of their satisfaction, it is likely you may have paid more attention to your interaction with patients. This is to some degree inevitable and from a treatment perspective is a positive thing. Please mark on the scale below if you think just being involved in this study has changed the way you treat patients. Intervention The intervention training consisted of a three part package involving two, two day workshops and an online training package called OATEC; online awareness training for empathy and communication. The purpose of the training package was to personally develop therapists, increase their self-reflection skills and raise their awareness of the importance of factors such as empathy and communication. The training was undertaken over approximately 8 weeks. Post-Intervention Data Collection Clinical data was collected from patients seeing participating therapists after the training intervention was complete in an identical way to the pre-intervention data collection phase. Contamination Effects Study To measure the potential contamination effects a short questionnaire was designed to give to the control group colleagues of intervention group therapists at each centre. This questionnaire asked six questions with yes and no answer options. There was also one final question using a Visual Analogue Scale, as described earlier in the Hawthorne effects section, asking overall if the therapist felt they had been in any way affected by the training of their colleagues. See Appendix one for the contamination questionnaire. Results Full study results will be published elsewhere. Results shown below regard only the contamination and Hawthorne effects parts of the study. Contamination All nine control group therapists completed all parts of the contamination questionnaire. One therapist answered Yes to the question; have you spoken to a training group colleague in general terms about the training. This therapist scored 10 out of 100 on the global contamination VAS question regarding if they thought they had been affected by the training of their colleagues. This score of 10/100 was the highest single recorded score on this VAS scale. One different therapist answered Yes to the question; have you overheard colleagues who have had the training, talking about it but scored zero out of 100 on the global contamination VAS question. Three therapists other than the individual who scored 10 out of 100 scored more than zero on the global contamination VAS question scoring 8, 4 and 3 respectively. The overall mean score for the contamination VAS scale question was 2.8 (sd=3.9). Hawthorn Effect Post randomisation n=46 PIFQ s were collected from patients seen by therapists after their consent to the study but before the intervention training and n=109 were collected from patients discharged by therapists before joining the study e.g. pre-consent. The mean total PIFQ score out of 90 was 79.2 (sd=16.0) post consent and 81.1 (sd=11.8) before knowledge of the study. The lowest mean score post consent for an individual question was 8.5/10 (sd=2.5) regarding the question How friendly did you feel that the therapist who delivered your treatment was? The mean score for this question pre-consent was 9.1/10 (sd=1.6). The highest mean score post consent was 9.0/10 (sd=1.8) regarding the question How well did the therapist who delivered your treatment listen to you? The mean score for this question for the group before knowledge of the study was also 9.0 (sd=1.5). Upon t-testing no statistically significant differences were found between any scores pre and post consent. The mean score for the VAS global Hawthorne effect was 8.7/100 (sd=10.8). The nine therapists scored; 0,0,0,3,6,6,12,19,32 out of 100 respectively. Table 1 below shows the pre and post consent scored for each question. Page 12 Issue No. 36 Winter 2014

4 Table 1 PIFQ Question Post-consent (n=46) Pre-consent (n=109) 1. Therapist confident 8.8 (1.7) 9.2 (1.2) 2. Confident in therapist 8.8 (1.9) 9.0 (1.4) 3. Empathy 8.5 (1.9) 8.8 (1.5) 4. Communication 8.9 (1.9) 9.1 (1.4) Explaining 5. Communication 9.0 (1.8) 9.0 (1.4) Listening 6. Partnership 8.6 (1.9) 8.8 (1.7) 7. Honesty 8.7 (2.0) 9.0 (1.4) 8. Trust 8.8 (2.1) 9.0 (1.5) 9. Friendliness 8.5 (2.5) 9.1 (1.6) Total score 79.2 (15.8) 81.1 (11.8) Individual questions are scored from 0-10 standard deviations are shown in brackets. Discussion Overall the results of the contamination and Hawthorne tests confirm that it is likely to be valid to individually rather than cluster randomise therapists in a larger study of the same type, and that it is unlikely any significant Hawthorne effect would skew results of a future trial. There is a trend towards therapists being scored marginally higher preconsent compared to post-consent that is counter intuitive. The difference is small and not statistically significant. This may be due to memory effect bias with patients discharged by participating therapists before consent to the study receiving the questionnaires up to three months from having completed treatment. Figures collected from patients post-consent were sent out three months after starting treatment so the average time gap between completing care and being asked to rate their therapist using the PIFQ will have been shorter and in fact 30% of this sample were still receiving care at the time. With the marginal difference and the relatively small numbers of participants in the post-consent group however the trend may also be chance. Conclusion Though not an insignificant undertaking itself this feasibility study has given answers to questions that a National Institute for Health Research Panellist commented would be likely to be asked regarding this type of study. Findings have supported the planned study methodology and feasible recruitment of NHS centres, their staff and patients. Work towards multiinstitutional Health Technology Assessment (HTA) funding application for a six centre revised version of the study is now underway. Appendix One Contamination Questionnaire 1. Have you spoken directly and specifically to a training group colleague about the training they received what it consisted of, and what they learnt from it? 2. Have you spoken to a training group colleague in very general terms about the kind of training they have received? 3. Have you spoken to a non-training group colleague about the training who has themselves spoken to one of the therapists who has had the training about what they have learnt. 4. Have you overheard colleagues who have had the training talking about it and what they learnt. 5. Have you seen or overheard a colleague who has had the training with a patient and noticed a difference in how they interact or treat them. 6. Have you noticed other colleagues not in the study interacting or treating patients differently and thought this might be as a result of speaking to a colleague who has had the training. Journal of the Physiotherapy Pain Association Page 13

5 7. Overall taking all factors into account, which might include things not listed above, please indicate with a single vertical line on the Visual analogue scale below how affected you think you may have been by the training of some of your colleagues in a way you think may have changed your thinking or how you act. Not Affected Very At All Affected 8. Lastly as a result of knowing you are part of a study looking at factors like communication skills, and having the outcome of some of your patients measured, including aspects of their satisfaction, it is likely you may have paid more attention to your interaction with patients. This is to some degree inevitable and from a treatment perspective a positive thing. Please mark on the scale below if you think just being involved in this study has changed the way you treat patients. No Change Very Significant At All Change References Anagnostis C, Gatchel RJ, Mayer T. The Pain Disability Questionnaire: Spine 2004;29: Bland JM. (2004) Cluster randomised trials in the medical literature: two bibliometric surveys. BMC Medical Research Methodology, 4, 21. Campbell MK, Elbourne DR, Altman DG, (2004). CONSORT statement: extension to cluster randomised trials. British Medical Journal, 328:702. doi: bmj Giraudeau B, Ravaud P. (2009) Preventing Bias in Cluster Randomised Trials. PLoS Med 6(5): e doi: / journal.pmed Harland, N. & Georgieff, K. (2003). Development of the Coping Strategies Questionnaire 24, a clinically utilitarian version of the Coping Strategies Questionnaire. Rehabilitation Psychology, 48, Hutton JL. (2001). Are distinctive ethical principles required for cluster randomised controlled trials?, Statistics in Medicine, 20: Korff, M.V., Jensen, M.P. & Karoly, P. (2000). Assessing global pain severity by self report in clinical and health services research. Spine, 25, McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, and Fisher P. (2007) The Hawthorne Effect: a randomised, controlled trial, BMC Medical Research Methodology, 7:30 doi: / A preliminary investigation into the diagnostic accuracy of clinical neurological examination in patients with lumbar radiating leg pain. Authors: Kate Thompson MSc, Senior Physiotherapy Lecturer Leeds Metropolitan University, School of Health & Social Sciences, PD620 Civic Quarter, Leeds Metropolitan University, LS1 3HE, United Kingdom k.a.thompson@leedsmet.ac.uk Tel +44 (0) University of Bradford, Division of Allied Health Professions, School of Health Studies, University of Bradford, BD71DP Osama Tashani, Pain Research Fellow Affiliations: School of Health & Social Sciences, Civic Quarter, Leeds Metropolitan University, LS1 3HE, United Kingdom. Gareth Jones MSc, Senior Physiotherapy Lecturer Affiliations: School of Health & Social Sciences, PD620, Civic Quarter, Leeds Metropolitan University, LS1 3HE, United Kingdom. Abstract Objectives The purpose of this preliminary study was to investigate the feasibility of carrying out research to determine the diagnostic accuracy of routine clinical neurological examination in patients with lumbar radiating leg pain. Design: A preliminary investigation Setting: Primary Care NHS Leeds spinal injection clinic. Participants: Fifteen patients were contacted. Ten patients attended spinal injection clinic, six of which consented to take part in the study. Interventions: Participants agreed to a clinical neurological examination consisting of dermatome, myotome and reflex testing by a Physiotherapist (Rater 1). The physiotherapist Page 14 Issue No. 36 Winter 2014