Patient Engagement in Physiotherapy - Research Proposal Example

MASTER OF SCIENCE (PUBLIC HEALTH) EXPERIMENTAL EVIDENCE AND EVALUATION (PUB002-6) A RESEARCH PROPOSAL FOR THE MODULE: --------------------------------- By: Samantha ------, RN Student #: ---- [Name of the Supervisor] April 05, 2009 Introduction Roberts and Torgerson (1998) stated that randomization is primarily intended to avoid biases by distributing the patient’s characteristics such as age, prognostic factors, clinical history, and severity of diseases that influences randomly the outcome between the groups being treated so that any outcome difference can be explained solely by treatment. To obtain statistical estimates in differences of treatment, patients are randomized between two or possibly more treatments (Wathen and Cook, 2006). Moreover, patients have equal chances of receiving treatment using the standard randomization schemes. A randomized control trial or RCT consists of two groups where the subjects are assigned randomly to the following: (1) experimental group, a group who receives intervention being tested, and (2) comparison or control group, the group who receives alternative or conventional treatment (Kendall, 2003). Any differences between the outcomes will be followed up by the researcher, and the trials’ results and subsequent analysis are used in assessing the efficacy of the intervention (Kendall, 2003). Kendall added that the most stringent way of determining the existence of cause and effect between the intervention and outcome are the RCTs. Figure 1: Schematic Representation of Randomized Control Trial (Source: Kendall, 2003) Kendall (2003) noted that the following are the characteristic features of a well – designed RCT, these are: (1) In order to achieve appropriate generalisable results, the sample being studied must be appropriate to the tested hypothesis. Sufficient patients will be recruited in the study to allow it to have probability of clinically detecting important clinical differences between treatments if a difference exists truly. (2) In order to eliminate bias selection and minimise confounding variables, an effective (concealed) randomisation of the subjects must be considered to the intervention or control groups. (3) In all respects, both groups will be identically treated for the tested intervention and to this end, patients and investigators will be blinded ideally to which group an individual is assigned. (4) The treatment allocation will be blinded from the investigator who assesses the outcome of the study. (5) Within the group, these patients are analysed to which they were allocated; irrespective of the intended intervention (the intention to treat analysis) experienced by the patient. (6) The focus of analysis is on testing the research questions that lead initially to the trial rather than “trawling” to find the difference that is significant. First Part of the Assignment Instruction: Assume that your recommendation is that the application should not be funded, and explain carefully any faults that you feel the proposal may have. I suggest you concentrate on the methodology for the study and whether it will achieve its aims and answer the research question, and whether the proposed study would be ethical, in terms of what would be done to the participants. If you feel the study will not achieve its aims, state why; if you feel that it is ethically flawed, explain your opinion. After reading the grant application concerning the treatment of back pain by physiotherapists, it is hereby decided that the proposal will not be funded by the regional committee for the following reasons: The researcher did not discuss the basis of doing randomised controlled trial method in the clinical research study. The advantages of using this type of sampling over other types of clinical trials must be clearly indicated in the proposal. It was noted in the study that the main purpose of this paper is to measure the clinical impact of encouraging patient’s choice in the setting of physiotherapy department; however, the types of treatment that has to be chosen by the experimental group were not clearly indicated in the research proposal. Hence, it is highly suggested that the treatments that has to be employed must be clearly enumerated in the proposal. In a randomised control trial (RCT), subjects are assigned randomly to either: experimental group where the tested intervention will be received, and the control group who will receive the conventional type of treatment. However, in this proposal, the objective of the study is for the experimental group to decide which type of physiotherapy he prefers to have. This contradicts the primary objective of the RCT where an intervention has to be proven effective. In this proposal, no intervention was specified by the researcher. It is also noted in the study that the range of proposed age group of patients, 18 – 65 years of age, is too wide and the criteria of choosing the patients, such as the age group, sex, hospital identification, pre – existing conditions, clinical history, prognostic factors, and severity of diseases are not best presented in the proposed methodology. It must be noted that older people suffers from back pain as a result of work – related injury coupled with deterioration or from aging process such as osteoporosis. Factors such as age and pre – existing diseases that may have caused back pain must be considered in the criteria as this may affect the result and interpretation of data. The aforementioned factors must be presented in the inclusion and exclusion criterion on the target population. The inclusion and exclusion criteria are important since this would define population being targeted in the hypothesis. The inclusion criteria must note the specific characteristic of patients that the researcher is looking for. This area is significant in a research study since poor sampling thins out the possibility of introducing bias. Kendall (2003) also noted that a relevant review of literature focused on the evidence that exists related to the studied condition or intervention must be included in the proposed study; however, this was not indicated in the research proposal. In this proposal, the researcher did not indicate the specific intervention allocated in the experimental group. Allowing the patient choose a particular treatment modality for back pain cannot be considered as intervention. Different patients may choose different modes of treatment which may cause discrepant result later on. The most effective way of doing an experiment must be to test a new type of therapy for back pain in the experimental group and the conventional type of treatment for back pain in the control group. Diagnostic studies must also be made before, during, and after the study in order to measure the efficacy of treatment modalities in both the experimental and control group In the hypothesis, it is also inconclusive to say that the patient will prefer to receive treatment they favour than they do not favour, unless they have gone through and tested different types of physiotherapies for chronic back pain. It is also noted in the trial objective that patients who have preference of physical therapy are compared from patients who are allocated by the physiotherapist in the “normal way.” However, in a research study, it is highly recommended that a researcher must be specific with the interventions proposed. In a research proposal, the researcher must be specific in the objective and methodology, and noting in the proposal the “preference” and “allocated treatment by the physiotherapy in the normal way” is not enough when presenting a research proposal. Moreover, it is noted in the trial objective “to identify personal characteristics.” The aforementioned statement is too broad and must be specified by the researcher in the proposal. It is noted in the study design that this study is a randomised controlled trial with modified consent. However, consent cannot be expressed as modified. Patients must know that they will be participating in a study and therefore, it is ethical to note that the design of the study must be made known to the patient as well. For that reason, the researcher must propose a design as randomised controlled trial with written consent. Moreover, a research proposal must also be supported by literature review to ensure that selection of patient, proposed interventions, controls, and desired outcomes are all appropriate (Gillard and Bentliff, 2009). Revised Draft Proposal I. Hypothesis: It is hypothesized that spinal stabilization training program is more efficacious in treating chronic back pain than the customary outpatient physiotherapy program (individual advice, exercises, and joint manipulation or mobilization). Whether or not one form of physiotherapy program is more effective than another is unknown. The following trial objectives are presented in order to test this hypothesis: (1) To compare the improvement of disability scores among patients who are randomly assigned to participate in spinal stabilization training program from patients who receives the aforementioned customary outpatient physiotherapy program. (2) To identify patient’s characteristics such as age, prognostic factors, clinical history, and severity of diseases that influences randomly the outcome between the groups being treated. II. Supporting Literature Critchley et al. (2007) in a pragmatic, randomised, assessor blinded, clinical trial with economic analysis aimed to compare the effectiveness and cost – effectiveness of three kinds of physiotherapy used commonly to reduce disability in chronic pain in the lower back. Critchley et al. (2007) concluded in their study that all three regimens of physiotherapy improved disability of chronic pain in the lower back as well as other health outcomes that are relevant despite of their content. III. Plan of Investigation (1) Study Design Following Bedfordshire University Research Ethics Committee approval, this study will be carried out as randomised controlled trial with written consent from all participants with age ranging from 40 to 65 years old. The study will be performed between January 2006 and June 2007. The research physiotherapist will collect the data using questionnaires and interviews that are structured (Critchley et al., 2007). (2) Population 125 in the experimental group 125 in the control group (3) Recruitment Recruitment of participants will be made from the referrals by back or spine specialists or from the primary care physician of the participants. (4) Inclusion/Exclusion Criteria a. Inclusion Criteria Patients who are 40 – 65 years old with low back pain of more than 6 months, with or without radiculopathy to lower extremities, with adequate English command, and with ability to render informed consent. b. Exclusion Criteria Patients who cannot understand written or oral English; received physiotherapy in the last six months for low back pain; those who had recent surgery in the spine; and those who had disabilities that renders them unfit to have physiotherapy for low back pain. (5) Intervention Treatments will be delivered in the physiotherapy departments of the chosen hospital, and all physiotherapists who will be treating the patients must have at least one year of clinical experience. These physiotherapists will be briefed about the treatment protocol and must give their consent in facilitating the research program. The patients will be ensured with equal expectation that each intervention is effective before starting the trial. Written consent must be obtained from the patient. It is essential that the patient must verbalise his understanding towards the research program, and the treatment protocol that has to be administered to him. In the individual protocol of physiotherapy, all patients must be assessed and treated according to the findings obtained from assessment. Following the assessment, the physiotherapist assessing the patient will be asked to suggest what each patients allocation will be. In the experimental group, treatment will consist of spinal stabilisation training program consisting of individual transverses abdominis and lumbar multifidus training of the muscle. This must be followed by group exercises that will challenge the stability of the spine. Spinal stabilisation physiotherapy is an exercise that is specific for deeper muscles of the trunk (Critchley et al., 2007). These muscles are dysfunction in the chronic pain of the lower back, and spinal stabilisation physiotherapy is proposed to stabilise actively the lumbar spine (Critchley et al., 2007). Hence, this type of intervention reduces lumbar instability caused by pain and disability. However, the efficacy of spinal stabilisation physiotherapy is not proven in non specific chronic pain of the back (Critchley et al., 2007). In the control group, patients will be treated with customary physiotherapy program that includes individual advice, exercises, massage, joint manipulation, and joint mobilization. These exercises are to be taught to the patients and will be performed individually. These exercises include specific retraining of trunk muscle, stretches, and general mobility of the spine. Both programs will consist of 8 sessions of 90 minutes in a week for 18 months supervised by a physiotherapist. Patients will be assessed right after giving their consent and before the commencement of the treatment program. Patients will be reassessed every three months until 18th month. The results will be compared with the improvement in Oswestry Disability Questionnaire (ODQ) scores in patients who receives the spinal stabilization training program with the improvement in ODQ scores for patients allocated with the customary physiotherapy program (Appendix A). (6) Outcome Measures Bone scan must be performed before the commencement of the study to determine other factors that may cause back pain. Electromyography and Nerve Conduction Velocity of the lower back must be performed also before and after the treatment program to assess the response of the patient to therapy. The primary outcome measure to be used for this trial is the Oswestry Back Pain Disability Questionnaire (ODQ). The Quebec back pain disability questionnaire is a relatively new instrument that shows promising psychometric properties. It will be used alongside the ODQ and comparisons of their performance made. As secondary outcomes, patients will be asked to rate their satisfaction with their care, and physiotherapists and patients will be asked to rate their judged degree of improvement every three months and at the end of therapy. Strength of belief in different therapies will be measured using a visual analogue or Likert scale. The Internal Control Index questionnaire (a health locus of control measure) will be used to explore if this personality trait modifies the effect of the intervention. All the outcomes are collected by self completed questionnaires sent and returned by post. Patients will be reminded by post and telephone or personal visit up until they state that they wish to withdraw from the study. (7) Data Collection Kindly refer to Appendix B. (8) Follow up The patients will be followed up every three months until the 18th month for assessment of efficacy of treatment programs. (9) Power Calculation Alpha error of 5% and Beta error of 20% IV. Ethical issues The patient will be informed that he will be participating in a research study. He will be asked to sign a consent form. The patient will also be informed that the kind of intervention to be applied will be unknown to him. V. Proposed timetable Proposed starting date will be on June 2009. The research study will lasts for 18 months. VI. Generalisability of results The methods and findings of this research will be presented for publication in a high impact peer review journal, and the findings will also be presented at relevant conferences and professional meetings and made known through local health service contacts. If it is shown that patient information and choice has a significant health impact then I will explore the possibilities of making this physiotherapy information more widely available through a commercial partnership with a publishing company. VII. Benefits to the NHS and emergency medicine On completion this trial will provide useful contributions in three areas: (1) It will provide precise evidence of the impact or lack of impact of one simple approach in one condition. It will also provide more general information about the likely impact of treatment of chronic back pain in the clinical outcomes. This will help care providers to plan how they provide information and care. (2) It will provide some understanding of the mechanisms by which effective treatment applied may impact on clinical outcomes. This may give pointers to future health services research. (3) It will provide an example of, and some lessons to be learned from, a novel use of traditional trial methods. VIII. Resources required Research staff: Research assistant (0.8 WTE): annual salary £10552; superannuation etc £2267; total annual cost £12819. Costs in year 1: £12819; in year 2 £6626; total = £19445. Travel and subsistence: Year 1 £800; year 2, £700; total = £1500. Consumables: Stationery and printing: year 1 £800; year 2 £400; total = £1200. Telephone: year 1 £300; year 2 £150; total = £450. Postage: year 1 £1000; year 2 £300; total = £1300. Information booklet writing and printing: year 1, £1500. Total = £1500. Copies of ‘the Back Book’ (HMSO) (125 copies): year 1 £157. Total = £157. IX. References Akobeng, A. (2005). ‘Evidence Based Child Health’, British Medical Journal, 90(2005), 840 – 844. Critchley, D., Ratcliffe, J., Noonan, S., Jones, R.., and Hurley, M. (2007). ‘Effectiveness and Cost-Effectiveness of Three Types of Physiotherapy Used to Reduce Chronic Low Back Pain Disability: A Pragmatic Randomized Trial With Economic Evaluation’, Spine, 32(14), 1474 – 1481. Dangour, A., Clemens, F., Elbourne, D., Fasey, N., Fletcher, A., Hardy, P., Holder, G., Huppert, F., Knight, R., Letley, L., Richards, M., Truesdale, A., Vickers, M., and Uauy, R. (2006) ‘A randomised controlled trial investigating the effect of n-3 long-chain polyunsaturated fatty acid supplementation on cognitive and retinal function in cognitively healthy older people: the Older People And n-3 Long-chain polyunsaturated fatty acids (OPAL) study protocol [ISRCTN72331636]’, Nutritional Journal, 5(20), 1475-2891 Gillard, P. and Bentliff, N. (2009). Writing a Research Proposal. Retrieved from http://www.collemergencymed.ac.uk/CEM/Research/Writing%20A%20Research%20Proposal/default.asp (Accessed: March 31, 2009). Kendall, J. (2003). ‘Designing a research project: randomised controlled trials and their principles’, Emergency Medicine Journal, 20(2003), 164 – 168. Roberts, C. and Torgerson, D. (1998). ‘Understanding controlled trials Randomisation methods in controlled trials’, British Medical Journal, 317(7168), 1301 - 1310. Rodgers, M. (2009). Physical Therapy and Rehabilitation Science. Retrieved from http://pt.umaryland.edu/clinical_education/docs/outcome_tools/Oswestry.pdf (Accessed April 1, 2009 Wathen, K. and Cook (2006). Power and Bias in Adaptively Randomized Clinical Trials Technical Report UTMDABTR-002-06. Retrieved March 31, 2009, from http://www.mdanderson.org/pdf/biostats_utmdabtr_002_06.pdf X. Appendices A. Oswestry Disability Questionnaire (Source: Rodgers, 2009) Section 1: Pain Intensity  I have no pain at the moment  The pain is very mild at the moment  The pain is moderate at the moment  The pain is fairly severe at the moment  The pain is very severe at the moment  The pain is the worst imaginable at the moment Section 2: Personal Care (eg. washing, dressing)  I can look after myself normally without causing extra pain  I can look after myself normally but it causes extra pain  It is painful to look after myself and I am slow and careful  I need some help but can manage most of my personal care  I need help every day in most aspects of self-care  I do not get dressed, wash with difficulty and stay in bed Section 3: Lifting  I can lift heavy weights without extra pain  I can lift heavy weights but it gives me extra pain  Pain prevents me lifting heavy weights off the floor but I can manage if they are conveniently placed eg. on a table  Pain prevents me lifting heavy weights but I can manage light to medium weights if they are conveniently positioned  I can only lift very light weights  I cannot lift or carry anything Section 4: Walking*  Pain does not prevent me walking any distance  Pain prevents me from walking more than 2 kilometres  Pain prevents me from walking more than 1 kilometre  Pain prevents me from walking more than 500 metres  I can only walk using a stick or crutches  I am in bed most of the time Section 5: Sitting  I can sit in any chair as long as I like  I can only sit in my favourite chair as long as I like  Pain prevents me sitting more than one hour  Pain prevents me from sitting more than 30 minutes  Pain prevents me from sitting more than 10 minutes  Pain prevents me from sitting at all Section 6: Standing  I can stand as long as I want without extra pain  I can stand as long as I want but it gives me extra pain  Pain prevents me from standing for more than 1 hour  Pain prevents me from standing for more than 30 minutes  Pain prevents me from standing for more than 10 minutes  Pain prevents me from standing at all Section 7: Sleeping  My sleep is never disturbed by pain  My sleep is occasionally disturbed by pain  Because of pain I have less than 6 hours sleep  Because of pain I have less than 4 hours sleep  Because of pain I have less than 2 hours sleep  Pain prevents me from sleeping at all Section 8: Sex Life (if applicable)  My sex life is normal and causes no extra pain  My sex life is normal but causes some extra pain  My sex life is nearly normal but is very painful  My sex life is severely restricted by pain  My sex life is nearly absent because of pain  Pain prevents any sex life at all Section 9: Social Life  My social life is normal and gives me no extra pain  My social life is normal but increases the degree of pain  Pain has no significant effect on my social life apart from limiting my more energetic interests e.g. sport  Pain has restricted my social life and I do not go out as often  Pain has restricted my social life to my home  I have no social life because of pain Section 10: Travelling  I can travel anywhere without pain  I can travel anywhere but it gives me extra pain  Pain is bad but I manage journeys over two hours  Pain restricts me to journeys of less than one hour  Pain restricts me to short necessary journeys under 30 minutes  Pain prevents me from traveling except to receive treatment Score: / x 100 = % Scoring: For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum Detectable Change (90% confidence): 10%points (Change of less than this may be attributable to error in the measurement) Appendix B: Data Collection Name: Age: Sex: Hospital Identification: Pre - existing conditions: Clinical History: Diagnostic results: Severity of Disease: Assessment of Physiotherapist: Read More