2.2.1 The use of thermal imaging in the medical diagnosis of fractures As the technology has improved and become more reliable the research methodology and rigor demonstrated has been enhanced, ensuring more accurate data capture and reproducibility of results (Ring & Ammer, 2012, p. 33). The most relevant paper to this study was conducted by Silvia et al. (2012, p. 1007-­‐1015). They used digital infrared thermal imaging in paediatric extremity trauma to investigate whether thermal imaging would be useful in the diagnosis of fractures and in locating areas of pain. Their study examined 51 children presenting to a Children’s Emergency Department in the United States of America. Silvia et al. (2012) hypothesised that fractures would be associated with local hyperthermia, detectable with Digital infrared imaging (DITI) which could then direct focused radiographs. Their study was carried out over 2 months in which they used thermal images to detect “hot spots” which correlated to 73% of injuries and detected 7 out of 11 fractures. Rather than recording temperature of the injury site they relied on the visualisation of localised “hot spots”, taking the hottest point as the injury site/fracture. This study had a limited sample size with only 11 fractures recorded. All fractures occurred in the distal limb segment so the researchers were unable to comment on the use of DITI to detect proximal limb fractures. This study made no attempt to follow standard DITI preparation protocol, which may have resulted in the suboptimal results recorded. The major concern regarding the 29 methodology carried out for this study was the lack of strict standardisation regarding the digital infrared thermography preparation preceding the imaging. The researchers (Silvia et al. 2012) were concerned that this standardisation would take too long to set up and, given the time constraints placed upon them within a busy emergency department, this protocol was impractical. This is a major flaw within this research study because this standardisation of preparation is essential in order to produce results that are both reliable and reproducible (Plassmann, Ring & Jones, 2006, p. 10; Ring & Ammer, 2000, p. 7; Ring & Ammer, 2012, p. 34). This study made no attempt to analyse or record the individual temperatures of the effected limb and thus relied solely on detecting hot-­‐spot visualisation, which could affect the sensitivity of the study hugely as this only records temperature differences of 1-­‐2°C. However, this is difficult to quantify as no sensitivity rating for the camera is mentioned within this paper. Another relevant study was carried by Hosie et al. (1987, pp. 117-­‐20) who used liquid crystal thermography (LCT) to examine whether thermal images could be used to detect fractures in the wrist specific to the scaphoid bone. Fifty patients were enrolled into the study with suspected scaphoid fractures, all of the patients were brought back after 10 days and had their wrists X-­‐rayed a second time and thermal images taken of both the injured and uninjured wrist. The researchers noted the temperatures of both the injured and uninjured limbs and deduced that a temperature difference would signify a fracture; this was in association with the then gold standard scaphoid series of X-­‐rays. The researcher found when comparing the LCT with conventional X-­‐rays there were three false 30 negatives giving a sensitivity of 77% with seven false positives giving a specificity of 82%. The overall accuracy was 80 %; if the scan was negative then the negative predictive value was over 90%, suggesting that the thermal image was more useful in ruling out fractures rather than ruling them in. The authors deduced that it would be a useful test to be carried out on patients with suspected scaphoid fracture as it was non-­‐invasive, cheap and required limited technical ability. However this does highlight the problems associated with LCT; in the 1980s the technology was very user dependent (Ring & Ammer, 2000, p. 12) and could only measure temperature differences of 1°C or more. One could also argue that the reference standard for this paper, in terms of X-­‐rays being used as the gold standard for the detection of scaphoid fracture, is out of date as small limb MRE would be used as the gold standard in current practice (Memarsadeghi et al., 2006, pp. 169-­‐176; Beeres & Hogervorst, 2008, pp. 950-­‐
54). Another study, which examined the use of thermography in distal radius fractures, was carried out by Birklein, Schmelz, Schifter and Weber (2001, pp. 2179–2184). The researchers used thermography in order to analyse the pathophysiology behind the clinical similarity of limb trauma and acute stages of complex regional pain syndrome (CRPS). Birklein et al. examined 20 patients with external fixation after distal radius fracture (3.5 days after surgery) without signs of CRPS and 24 patients suffering from acute CRPS I (without nerve lesion; duration, 5 weeks). Hyperalgesia to heat was tested by a feedback-­‐controlled thermode and tested against a mechanical stimulus by an impact stimulator. They used infrared thermography to measure skin temperature to examine the 31 sympathetic nervous system. They also used laser–Doppler flowmetry to test different sympathetic vasoconstrictor reflexes and quantitative sudometry after thermal load (thermoregulatory sweat test). They found hyperalgesia to heat after trauma (P<0.001), but not in CRPS, whereas mechanical hyperalgesia was present in both patient groups (trauma: P<0.001; CRPS: P<0.005). Skin temperature was significantly increased on the affected side in both patient groups (acute trauma: P<0.001; CRPS: P<0.005). This study’s results suggest that thermography can be used to detect abnormalities in injured limbs, however the author highlighted that the temperature difference between a normal healing fracture and that of a patient with CRPS was limited. Gradl, Stenborn, Wizgall, Mittlemeir and Schurmann (2003, pp. 1020 – 6) carried out a follow up study to the one described above. In this study the focus was on the early diagnosis of CRPS in patients with distal radial fractures. For the study 158 consecutive patients with distal radial fractures were followed-­‐up for 16 weeks after trauma. Apart from a detailed clinical examination 8 and 16 weeks after trauma, thermography and bilateral radiographs of both hands were performed. At the end of the observation period 18 patients (11%) were clinically identified as CRPS. The severity of the preceding trauma and the chosen therapy did not influence the process of the disease. 16 weeks after trauma easy differentiation between normal fracture patients and CRPS patients was possible. 8 weeks after distal radial fracture clinical evaluation showed a sensitivity of 78% and a specificity of 94%. However, thermography (58%) and bilateral radiography (33%) revealed poor sensitivity respectively. The specificity was high for radiography (91%) and again poor for thermography 32 (66%), respectively. Gradl et al. concluded that plain radiography was better to determine diagnosis of CRPS and radial fractures due to the problems associated with sensitivity and specificity noted above. A study carried out by Niehof, Beerthuizen, Huygen and Zijlstra (2008, pp. 270-­‐
7) examined the use of thermography again in the field of detecting complex regional pain syndrome (CRPS). In this study, they assessed the validity of skin surface temperature recordings, based on various calculation methods applied to the thermographic data, to diagnose acute complex regional pain syndrome type 1 (CRPS1) in fracture patients. They used thermographic recordings of the palmar/plantar side and dorsal side of both hands and feet on CRPS1 patients and in control fracture patients with and without complaints similar to CRPS1 just after removal of plaster. Various calculation methods were used to examine the thermographic data. They found that the injured side in CRPS1 patients was often warmer compared with the uninjured extremity. The difference in temperature between the injured site and the uninjured extremity in CRPS1 patients significantly differed from the difference in temperature between the contra-­‐lateral extremities of the two control groups. Exact numbers within this study group were not published so the true significance of this research cannot be fully examined. However,, the largest temperature difference between extremities was found in CRPS1 patients. The difference in temperature recordings comparing the palmar/plantar and dorsal recording was not significant in any group. The sensitivity and specificity varied considerably between the various methods used to calculate temperature 33 difference between extremities. The highest level of sensitivity was 71% and the highest specificity was 64%; the highest positive predictive value reached a value of 35% and the highest negative predictive 84%. They concluded by suggesting that the use of thermography to discriminate between acute CRPS1 fracture patients and fracture patients without the complaint is limited and only useful as a supplementary diagnostic tool. Hosie et al. (1989) found that thermal imaging was useful in detecting some scaphoid injuries, suggesting a sensitivity of 88% and overall accuracy of 80%. However, this was using equipment that was out dated and very complicated to use. Hosie et al. (1989) used Liquid Chrystal Thermograph technology that is unreliable when detecting temperature differences below 1˚C, meaning that the more subtle temperature differences between soft tissue and bony injury would not have been detected (Sarbina, 2010; Jung and Zuber, 1998). Hosie et al. (1989) and Silvia et al. (2012, pp. 1007-­‐1015.) both conclude that thermal imaging should be used as a pre-­‐screening tool to decide whether further diagnostics were required. However, neither study suggested that thermal imaging could be used exclusively to detect fractures when tested against the gold standard of X-­‐rays. The papers reviewed here do suggest that thermography can detect temperature changes in injured limbs when compared to the uninjured limb (Hosie et al. 1989) and Silvia et al. (2012, pp. 1007-­‐1015.). However, the evidence highlights the inability of thermography to determine the severity of inflammation 34 surrounding the fracture site and the determination of whether the image results will highlight the difference between a fracture and that of a soft tissue injury. Devereaux, Parr, Lachman, Page-­‐Thoma and Hazleman (1984, pp. 531-­‐3) used thermography to investigate eighteen patients with shin pain, caused by a stress fracture of the tibia or fibula. All the patients in this study underwent radiological, thermographic, and scintigraphic studies and a test of ultrasound-­‐
induced pain. When they were initially assessed, 15 (83%) had stress fractures confirmed by scintigraphy. Of these, 12 (80%) had abnormal thermograms, 8 (53%) had positive test results for ultrasound-­‐induced pain and 7 (46%) had abnormal radiographs. Thermography used alone seemed to be a safe, rapid means of diagnosis for stress fractures in the tibia or fibula with no relationship to symptom duration. In the radiologically normal group of stress fractures, four (50%) had positive test results for ultrasound stress tests and normal thermograms. Although this was a small study (N=18), the results suggest that thermology can be used to rule out the presence of fractures. Conversely, given the relatively high false positives, one can deduce that it has relatively limited use in positively identifying fractures. Posinkovic, & Pavlovic (1989, pp. 166-­‐173) followed up this research by endeavoring to determine the major causes of stress fracture and determine whether early detection could result in improved clinical management. His research carried out over a period of five years examined how stress fractures were formed and how they could be diagnosed early on following injury. He found that X-­‐ray was a poor diagnostic indicator for the early detection of stress 35 fractures, instead finding that CT, ultra sound and thermography were much better at detecting early pathology. Having determined that thermography could be useful in detecting stress fractures in lower limbs, DiBenedetto et al. (2002, p.390) investigated whether thermography could be used to assess the severity of foot injury during basic military training. With the use of thermographs they determined normal foot parameters (from 30 soldiers before training), thermographic findings in different foot stress fractures (from 30 soldiers so diagnosed), and normal responses to abnormal stresses in 30 trainees who underwent the same training as the previous group but did not have musculoskeletal complaints. DiBenedetto et al. (2002, p. 390) found that thermograms of injured feet show areas of increased heat, but excessive weight-­‐bearing pressures on feet, new shoes, or boots also cause increased infrared emission even without discomfort. They concluded that the differentiation between normal foot pathology and abnormality detection using thermology was challenging. However, by continuously monitoring the soldiers feet and identifying the soldiers normal foot pathology in terms of heat signatures, thermography could detect signs of early injury and that the increased heat signature could be used to detect stress fractures. Although specific injury diagnoses remained difficult, its greatest benefit was established as its ease of use in follow-­‐up in order to monitor severity and healing. A similar study examining the use of thermography to monitor bone healing and predict complications post-­‐orthopaedic surgery was carried out by Merkulov, Dorokhin, Sokolov and Mininkov (2008, pp. 116 -­‐123) which studied over 3500 36 cases of long bone fractures in children and adolescents, analyzing the bone healing process using objective methods including ultra sound, Computerised Tomography (CT), osteodensitometry, thermography, polarography, and radionuclide studies. A group of patients with delayed consolidation of bone fragments was distinguished based on the results of clinical and instrumental investigations. He used the result of this research to develop diagnostic criteria for the early recognition of delayed healing. Thermal imaging was used to detect temperature difference in the affected limbs, which managed to map the degree of healing associated with limb warmth, however, thermography was not used in isolation but as a conduit to other diagnostic tests. This study was similar to one carried out on children with Perthe’s disease by Bajtay & Györ (1988, p. 1). By means of thermography the researcher carried out examinations on seven children suffering from the disease, finding hypothermia of the entire lower limb on the affected side. Although not obviously useful in isolation as a test for Perthe’s disease, thermal imaging may be useful in the identification and classification of the disease process and where conservative management is decided upon it would be a non-­‐invasive way of monitoring progress rather than the invasive harmful effects of serial radiographs. Sherman & Bruna (1987, pp. 1395-­‐402) used thermographic recordings of body temperature on 30 consecutive amputees who reported stump and/or phantom limb pain. Each subject participated in between two and four recording sessions. Whenever possible, subjects came for recording sessions when their pain intensity was different from that of previous sessions. He found that a consistent 37 inverse relationship occurred between intensity of pain and stump temperature relative to that of the intact limb for burning, throbbing and tingling descriptions of both phantom and stump pain. Heat emanating from the limbs is an accurate reflection of near-­‐surface blood flow. For the subjects giving these descriptions of pain, tensing the limb was followed by a decrease in blood flow and an increase in pain. Thermography was used effectively to monitor the management of the patient’s pain management and stump wound healing process (Sherman & Bruna, 1987 p. 1400). Although this study is not directly useful to the author’s study, it does highlight that thermography may be an excellent diagnostic tool to measure the inflammatory process and the acuity and the severity of the traumatic event. Another such paper, which can inform the methodology chosen for this paper and the use of thermography as a diagnostic tool in the inflammatory process, was carried out by Siegel, Siqueland and Noyes (1987, pp. 825-­‐30). They used thermography to evaluate eight patients with the complaint of non-­‐traumatic anterior knee pain. Thermograms were recorded before and after subjects performed a specific rehabilitation program. The thermographic imaging was then repeated 4 to 8 weeks after the initial thermogram. Among the subject group, thermal asymmetries were noted in the involved knees, though a specific abnormal thermal pattern could not be recognised. Changes in temperature and thermal patterns after exercise and over time were consistent within each subject, although not consistent between subjects. Thermal asymmetries did not appear to resolve over time. It was felt by Siegel et al. that the pathology investigated by this study might involve many an etiologies, therefore making it 38 difficult to establish a single abnormal thermal pattern with regard to non-­‐
traumatic anterior knee pain. Although limited in numbers and with variable scientific rigor, these papers do support the hypothesis presented within the title of this paper that thermal imaging may be useful in detecting fractures in children’s wrists following trauma. However, what these papers do not demonstrate is the quantifiable temperature difference between an uninjured limb, a fracture and a soft tissue injury. Despite this the research does demonstrate some attempt to distinguish between temperature and injury. Birklein et al. (2001, p. 2180) suggest a significance between the temperature gradient of a soft tissue injury when measured against a healing fracture. Hosie et al. (1987, p. 119) suggested that a temperature gradient greater than 1°C could signify a fracture, however this was using very primitive and out dated diagnostic equipment, unlike modern thermal imaging equipment which are capable of detecting differences of 0.01°C. The studies do highlight and justify the need for further research in this area as all of the studies presented have produced positive results. However, the need for a strict methodological approach, along with the need of a controlled imaging environment, is vital and supported in every paper reviewed for this thesis. 2.2.3 Further alternatives to X-­‐ray. Another alternative to X-­‐rays for the detection of distal radius fractures within the paediatric population has been carried out exploring the use of ultra sound as a diagnostic tool. Four papers have been published into the use of ultra sound versus X-­‐ray with very promising results (Tej et al., 2011, p. 443; Hubner et al., 39 2000, p. 1117; Williamson, Watura, & Cobby, 2000, p. 22). Each of the papers published reported a sensitivity of over 97% with a specificity of 91%. The four papers have similarites in design in the fact that they are all prospective cohorts comparing a new diagnostic test against the gold standard of X-­‐ray, similar to all of the thermal imaging studies carried out in the literature review above. All except one of the studies recruited small numbers which would clearly effect the sensitivity and specifity obtained (Guiffre, 1994, p. 334). The largest study was carried out in Germany by Hubner et al. (2000, p. 1117) where 163 patients were enrolled into the study with over 224 suspected fractures (some patients had more than one supsected fracture). Three paediatric surgeons carried out the scans, scanning all four planes of the suspected fracture sites; all of the patients recieved X-­‐rays of the fracture sites and the results analysed. Each of the studies used a convenience sample for their study group, this is often unavoidable when carrying out real world research when using the clinical setting for the research environment, though it can lead to the introduction of selection bias . The studies did have a variation in the degree of ultrasound experienced doctors, which could affect the published results. However, these papers did suggest that ultra-­‐
sound could detect fractures in children and couild be used as an alternative to X-­‐rays, but children did complain that the procedure was painful. These papers, although focussing on ultrasound, are extremely useful for informing the development of the methodology used for this study as they clearly have great similarities. Nonetheless there is an exception to this as thermal imaging is totally non-­‐invasive whereas ultrasound, although not being harmful, does require contact with the limb and may produce a degree of discomfort when a fracture or soft tissue injury is present. 40 2.2.5 Limitations associated with thermal imaging Much of the research surrounding the use of thermal imaging suggests that it can be used very successfully as a diagnostic adjunct in clinical practice. However , the papers reviewed also highlight the clinical vulnerability of the technology. The use of thermal imaging equipment appears to be very user dependent and often not reliable or results generalisable, as highlighted in the contradictory results reported in much of the published research reviewed. An example of this can be seen in the early detection of breast cancers where the use of thermal imaging has fallen in to disrepute (Ammer, 2006, p. 16). This observation has dominated the research carried out at the University of Glamorgan medical imaging research unit, led by Professor Ring. Ring and Ammer (2000, pp. 7 -­‐14) have set out standards that should always be followed when conducting research into thermal imaging as part of medical research. Much of this paper and the department’s findings will be discussed in the methodology chapters of this thesis as all of the recommendations were followed in the research design. Plassmann et al. (2006, p. 11) highlighted the need for frequent servicing and maintenance on the equipment used as, without this maintenance, considerable drift in the temperature variable can occur with a drift of up to 4˚C reported, which is significant given that most research studies report temperature changes of 0.1˚C – 1˚C as clinically significant (Jung and Zuber 1998, p. 19). Thermal imaging is a non-­‐contact, non-­‐invasive diagnostic method for the study of human body temperature. Therefore, as highlighted in this literature review, infrared thermal imaging may have increasing applications in clinical medicine as the technology becomes more sensitive and refined. 41 Since the 1970's thermography has been used across many areas in medicine. Early problems such as low detector sensitivity and, most significantly, poor training of the mammography technicians was the source of error in thermography and retarded the acceptance of this technique until 1990. Since that time, thermographic equipment has evolved significantly. Modern thermal imaging systems comprise of technically advanced thermal cameras coupled to computers with sophisticated software solutions. The recorded images are now of good quality and may be further manipulated to obtain reliable information. Thermography can be applied as a diagnostic tool in oncology, allergic diseases, angiology, plastic surgery, rheumatology and specific childhood conditions (Ammer, 2006, p. 17). This review has highlighted that contemporary thermal imaging must be performed according to certain principles aimed at reliability and reproducibility of results. Ignoring any of the principles described by European Association of Thermology leaves the research study open to criticism and error, thus reducing acceptance of this technique in medical diagnostics. This literature review has demonstrated evidence that thermal imaging can detect changes in body temperature due to the exothermic reaction of the inflammatory response caused by a fracture to a bone. However, it has highlighted the failings of the technology and the inconsistent nature of technology to date. None of the studies reviewed commented on expense when compared to X-­‐rays or the time taken to carry out the diagnostic procedure. This study will explore these issues within the discussion. The key points raised by this review are to ensure that the research methodology used for this study is rigorous and reproducible. All of the 42 studies reviewed above have demonstrated the difficulty in carrying out this type of research in regards to managing the control group, controlling the circulating air and temperature around the test subject in order to get reliable and meaningful readings and the need for a consistent and reproducible image which will encompass all of the above. The methodology for this study has been adapted accordingly, using the lessons learnt from the reviewed literature and advice given by Professor Ring and his colleagues at Mid Glamorgan University. 43 Chapter 3 44 Chapter 3: Research design and Sampling
This chapter will describe the research methodology used to investigate the research question posed and the design strategy used to achieve the primary and secondary objectives set for this study. The chapter will describe the conceptual framework used to determine the methodology and its influence on the pilot study design. The rationale for the pilot study design will be presented along with the description of the quasi-­‐experimental design used. The patient population and methods of data analysis will be discussed along with the inclusion and exclusion criteria described. Ethical implications of the study will be presented and discussed within this chapter. 3.1 Conceptual framework The researcher has used a conceptual framework to organise and focus the study toward the area of thermal imaging and the detection of wrist fractures in children. The conceptual framework ensures that all of the main themes and concepts are explored within the literature review. These themes and concepts are stated and organised within a conceptual map and therefore used to determine the research design (Burns, 1997). This ensures that the study is focused, linking the concepts of previous studies and their published theories to the present study. This avoids replication and enhances the previously gained knowledge rather than covering old ground (Newman, 1979). The researcher has used the conceptual framework to formulate his research question and organise his study. The conceptual framework used for this study is illustrated on page 47, figure 4. Crooke and Davies (1998, p. 106) state that this is essential, suggesting “no research study should be commenced without a full enquiry into the concept surrounding it they define the conceptual framework as an organisation or matrix of concepts that provides focus for the enquiry”. 45 Figure 5: Conceptual framework 46 3.2 Research question The research question has been devised using Knottnerus and Muris’s (2002) guidance on designing research questions for diagnostic tests. They suggest that the question must have a contrast to evaluate, the clinical problem must be defined and it should be placed in the context of the clinical setting. The research question has been formulated using the evidence from previous studies described in chapter two and the aims and objectives for the study presented in chapter 1, using Sackett & Haynes (2002, p. 20) guidance as a template. 3.2.1Research questions: 1. Do children with a fracture have a different temperature recording to those who do not have a fracture? 2. Are children with a higher temperature recording in their injured wrist more likely to have a fracture when compared to the control (Uninjured limb)? 3. Among patients who it is clinically sensible to suspect a fracture in their wrist, does thermal imaging distinguish those patients with or without a fracture? Previous literature suggests that there is superficial evidence that thermal imaging can be used to detect fractures in children. Thus this pilot study will explore whether children with a temperature recording greater than 1°C when compared to the unaffected limb are statistically significantly more likely to have a fracture than those with within the control group. A case study carried out by Cook et al. (2005, pp. 395-­‐397) highlighted that detection of a child’s fractured distal radius by thermography could prove useful as a new way to diagnose fractures in children. 47 Only once the reliability and accuracy of thermography in detecting fracture in children’s wrists is ascertained, can the researcher progress onto a full Phase III trial involving larger sample sizes and multi-­‐centred research (Lancaster, Dodd, & Williamson, 2004, p. 308; Bowling, 2009; Craig et al., 2008, p. 1655). The hypothesis posed for this research is that thermal imaging can be used as a diagnostic tool to detect fractures in children’s wrists (distal ulna and radius); this hypothesis has been derived from the literature and current supporting research surrounding thermography. The null hypothesis is therefore that thermal imaging offers no benefit or is not specific or sensitive enough to detect fracture in children’s wrists (Distal ulna and radius) when used in the clinical setting. As the pilot study is hypothesis driven there is a danger that the researcher can make a type one or type two errors. A type one error is when the researcher concludes that the null hypothesis is wrong when it is actually correct (Polit et al., 2001, p. 348). This can occur when the results of the study demonstrate a large degree of false positives. In this study the researcher has endeavored to reduce the chance of causing a type one error by producing a control group and by conducting a likelihood ratios test (Straus, Richardson, Glasziou, & Haynes, 2005; Cambell and Stanley, 1963). The use of a control group within the study considerably strengthens the interpretation of the results (Maas and Buckwalter, 1998). The researcher has also attempted to minimise the risk of making a type one error by only accepting significance of P< 0.05 (Polit et al., 2001, p. 351). This reduces the fears that the change in the experimental group occurred by chance rather than by the study’s 48 manipulation of the experimental group. A type two error is where the researcher accepts the null hypothesis when it is false (Beya and Nicoll, 1997). However one of the major reasons for conducting this study initially as a pilot is to explore the challenges surrounding sample sizes and data collection to inform the subsequent larger phase III study (Thabane et al., 2010; Lancaster , Dodd, & Williamson, 2004, p. 309). 3.3 Standard approach to infrared imaging As highlighted within the literature review in chapter two, some of the early studies involving thermal imaging for example Ring (2000) and Plassman (2005) failed to gain credibility due to the lack of a standard approach to the imaging applied. Poor technique and knowledge about these standard procedures have led to thermal imaging as a diagnostic tool being discredited and ignored within the main stream of medical diagnostic imaging (Ring, 2004). In view of these earlier criticisms and the growing popularity of thermal imaging research, the then European Thermography Association developed standards for carrying out diagnostic studies using infra imaging (Clark & DeCalcina-­‐Goff, 1997). Ring and Ammer (2000) carried out a meta-­‐
analysis concentrating on all of the previous studies conducted and, from the evidence gained from this study, established standards that must be followed when conducting thermal imaging studies. These standards concentrated on the location of thermal imaging equipment when imaging was taking place, the accuracy of the imaging equipment, how the patient was positioned/manipulated and how the data from the images was captured and subsequently reported. 3.3.1 Location of thermal imaging The investigation room should be at least 2x3 metres, preferably 3x4 metres, 49 with room for the patient and equipment to be comfortably positioned. Mabuchi (1997) suggests that the room should have an ambient temperature ranging between 18-­‐25°C and should be kept at this temperature for at least an hour before the imaging commences. The room should have the facility for additional cooling if required and a large digital thermometer displayed to ensure conformity (Mabuchi, Genno, Matsumoto, Chinzie, & Fujimasa, 1995). For this study the thermal imaging took place in the X-­‐ray room, which is kept at a constant temperature between 20-­‐25°C controlled by air-­‐conditioning and monitored constantly by electronic digital thermometry. The rooms were large enough to accommodate all the staff involved and the patient and their family without alteration in the ambient temperature of the examination room. The room is lead lined which meant that noise interference was minimalised as this could alter the reference temperature recorded (Vardasca & Bajwa, 1995). 3.3.2. The imaging system The imaging system must be specially adapted towards medical imaging self-­‐
cooling, able to process the image independently of any other system and provide basic quantification of the image produced. The camera must be able to self-­‐regulate its temperature referencing system or the researcher must have an external source of temperature referencing. The camera should be tested for optimal performance on an annual basis and calibrated to ensure accuracy (Plassmann, Ring, & Jones, 2006) A thermal imaging camera (FLIR SC640) was sourced for the months of April and May 2008 from the Engineering and Physical Sciences Research Council (EPSRC) instrument pool. The camera had been validated and calibrated by the National 50 Physiological Laboratory thus ensuring the reliability and accuracy of the thermal image analysis. The camera was mounted on a standard camera tripod stand with vertical height adjustment. The camera was turned on at least 10 minutes before the image was taken to allow for stabilisation of the image. A specialist image processing software package was used for the medical imaging camera, ensuring the reliability and accuracy of the image taken and the data captured. In this study the researcher used a specialist research-­‐imaging package, THERMACAM RESEARCHER produced by Flir systems specifically designed for medical imaging processing, with accuracy within +/-­‐ 0.1° C recorded. 3.3.3 Patient manipulation Patient information regarding the imaging procedure must be provided, ideally before the patient is called for imaging (Ammer & Ring, 2004). The patient’s skin must be devoid of cosmetics or any topical applications as this may cause a barrier between the skin and the image taken which would affect the thermal image taken (Engal, 1984). Those patients who have just had a large meal or hot drink should be excluded from the study as it has been suggested that these factors affect the thermal image recorded, however there appears to be little evidence to support this (Ring & Ammer, 2000). There is some evidence to suggest that certain food types can either raise or reduce ones core temperature temporarily (Mabuchi et al., 1995) however, due to the emergent nature of the attendance to the emergency department, nothing could be done to control this perceived complication. 51 On arrival to the department or imaging centre it is important that the patient should be asked to sit comfortably for a set period of time. Ring et al. (1976) and Mabuchi et al. (1995) suggest that 15 minutes is optimal for the patient’s blood pressure and skin temperature to stabilise, and suggest that if this is not achieved then this is likely to skew the results. During this preparation time the patient must avoid folding or crossing his /her arms and legs or placing their feet on cold floor if the lower extremities are to be examined (Ring and Ammer, 2000, p. 10). Standard views should be taken of the patient as per radiology standards and in some cases a template may be used to position the limb in the same position consecutively (Plassmann, Ring, & Jones, 2006). The position of the patient for scanning and in preparation must be constant. Standing, sitting or lying down will affect the surface area of the body exposed to the ambient temperature, therefore an image recorded with a patient in a sitting position may not be comparable with one on a separate occasion in a standing position (Ring and Ammer, 2000, p. 10). 3.3.4 Report generation and data capture Most software packages built into modern thermal imaging equipment have a standard approach to data capture. This should include the image itself, the demographic data and measuring tool for measuring the image. The colour scale must be standardised. The default colour scale is often to show white as hot, then yellow, then red (see figure 5 below). The background temperature should be avoided if at all possible, by placing the patients limb to be imaged on a cool or neutral surface i.e. hardboard template or cool towels. The researcher for this 52 study used the X-­‐ray plate for this purpose as it reduced the movement of the patients limb and was observed to be a neutral temperature. This procedure ensured picture clarity and reduced image deprecation making it much more accurate and reproducible (Ring and Ammer, 2000, p. 11). Figure 6: Example of thermal image. 3.4 The research design The research design used for this study is that of a quasi-­‐experimental approach, although the study does contain all of the characteristics of a true experimental design (Maas & Buckwalter, 1998). It could be argued that there is no true randomisation and that the control is not free of external influences, by the fact that the unaffected limb of the study group is to be used as the control and not random attendees of the Emergency Department. Although some compromise within experiments is acceptable (Brewin and Bradley, 1989), the researcher feels that this research fits more readily with the quasi-­‐experimental design approach than that of a randomised control trial in the true sense. Within the literature reviewed previously, the majority of these studies evaluated followed the criteria set by Campbell and Stanley (1963) for quasi-­‐experimental design. This correlates well with a similar study carried out by Moody et al. (1988) in a review of 720 nursing 53 research articles. They found that the majority of these studies used a quasi-­‐
experimental approach rather than that of a true experimental approach. Maas et al. (1988) argue that the quasi-­‐experimental approach has developed far beyond the narrow, passive approaches first described by Campbell and Stanley (1963). They suggest that the quasi-­‐experimental approach evolved into a more comprehensive and active process, which is more suited to clinical practice. Campbell and Stanley (1963) suggest that quasi-­‐experimental designs are sufficiently probing and well worth employing. Brink and Wood (1994) support this view, suggesting that these approaches are appropriate for answering phase III questions (Bowling, 2009), thus defending the validity of the quasi-­‐experimental approach and enhancing its value as a research approach. 3.5 The Quasi-­‐experimental design The study has adopted a quasi-­‐ experimental approach, involving the manipulation of an independent variable but without any randomisation (Polit and Hungler, 1995). The chosen design involves a non-­‐equivalent control group as described by Campbell and Stanley (1974) and other researchers: Non-­‐equivalent design is defined as those in which dependant variable measures are obtained for an experimental and comparison group (non-­‐
randomly assigned) before and after the introduction of the independent variable to the experiment group (Maas & Buckwalter, 1998). The advantages of using this approach is that it reflects and is directly relevant to the ‘True’ world of nursing/clinical practice (Maas & Buckwalter, 1998; Robson, 2002) and is not just an experiment carried out within the artificial surrounding, using predetermined experimental samples. However, it is important that the 54 environment is manipulated to ensure optimum effectiveness for the equipment used. This design allows the researcher to examine the true diversity of the hypothesis posed and reflects a more valid picture of the population and the clinical setting chosen (Knottnerus & Muris, 2002). Methodologically the design has its advantages as it tests the casual hypothesis often witnessed within the clinical setting. Maas and Buckwalter state: ‘Quasi experimental designs provide a systematic framework for answering the questions that might otherwise be left to subjective analysis, trial and error or conclusion drawn from compromised experiments in which rival casual hypothesis have not been explicitly evaluated (1998, p. 59).’ Owens, Slade and Fielding (1996) suggest that the sheer nature of the quasi-­‐
experimental design adds to its weaknesses. The fact that the design encourages the researcher to examine the casual hypothesis and to interpret differing variables means alternatives to interpretation will always be found. This suggests that the positive results gained from this pilot study cannot produce unequivocal evidence to support or refute the hypothesis. Nonetheless it can provide the researcher with a clearer and more accurate view in order to initiate a phase III study, which will clarify remaining questions (Owens et al., 1996). The design has been focused toward the guidance afforded to researchers by Straus et al. (2005, pp. 67-­‐99). 3.6 Methodology The methodology selected for this study follows the three major principles as 55 dictated by Straus et al. (2005) for diagnostic studies as outlined below. 3.6.1 Measurement: the reference (Gold) standard measured independently, i.e. blind to the test group. The thermal imaging was conducted totally independently of the X-­‐ray (Gold Standard) by the researcher. The thermal image was interpreted post-­‐test after the research phase was completed and independent of the X-­‐ray results. The researcher was blinded to the X-­‐ray result and thus reduced the chances of interpreter bias. Both tests were performed independently i.e. the thermal image was not taken by the radiographer who obtained the X-­‐ray (Engal, 1984). The standard against which thermal imaging will be compared is the formal X-­‐ray reporting by a Consultant Radiologist or Reporting Radiographer (Meininger, 1998, p. 218). This approach is supported by Knottnerus & Muris who state: The results of the test should be interpreted without knowledge of the reference group standard results. Similarly the reference standard result should be established without knowing the outcome of the test under study (2002). This greatly reduced the chance of test review bias and ensured blinding of the study. It also reduced the diagnosis review bias, which often occurs when there is non-­‐independent assessment of test results, resulting in overestimation of the test (Knottnerus & Muris, 2002). 3.6.2 Representative: was the diagnostic test evaluated in an appropriate spectrum of patients. The diagnostic test was carried out on children attending the Emergency Departments with suspected fractures in their wrist. The inclusion criteria for this 56 study was created using a validated study conducted in Sheffield Children’s Hospital by Webster et al. (2006), who devised guidelines for when children should receive an X-­‐ray of their wrist for a suspected fracture. 3.7 Population and sample Over the period of the study, 71 children presented to the emergency department with painful wrists that met the inclusion criteria. Over the trial period the researcher remained in the department from 0800 to 2200 hours every day. A review of all the notes of the children attending the emergency department during the study period revealed that no cases were missed, however this number does not include patients attending with hand, scaphoid and proximal/mid shaft of radius/ulna injuries. Although this study has been designed as a pilot, therefore there is no requirement for a power calculation to be performed (Lancaster, Dodd, Williamson, 2004, p. 308), a power calculation was carried out based on an audit of children presenting to the emergency department in August 2007. This audit recorded 76 children presenting to the emergency department with painful wrists, of which 39 children were reported to have fractures of their distal radius and ulna. Based on this audit a pre-­‐study sample size was calculated, a sample size of 216 children was required to ensure a confidence level of 95% was achieved. The pilot study was designed to be conducted over a four-­‐month period within a two-­‐year time frame, commencing in April 2008 and finishing in August 2009. This was due to the limited two months in one-­‐year loan period of the camera. However, the study was only conducted over a one-­‐month period between the months of May and June 2008 due to a breakage with the camera and the closure of the research equipment loan facility. 57 3.7.1 Inclusion criteria: 1) Children between the ages of 0-­‐ 15 years (up to the child’s 16th birthday) and one of the following: 2) Are complaining of or indicating pain in their wrist. 3) Have obvious swelling and deformity of the wrist on clinical examination. 4) The child is unable to supinate or pronate their wrist or has severe loss of function. 3.7.2 Exclusion criteria: The following exclusion criteria have been noted in adult studies and are therefore included here, however it is not anticipated they will account for large numbers within the study population (children under the age of 16). 1) Patients that have had topical cream or cosmetics applied to their arm such as fake tan etc. This can artificially affect the skin temperature and therefore skew the test results (Engel, 1984, pp. 177 -­‐184). 2) Patients who on questioning report that they have smoked. External environmental factors such as smoking have been shown to affect skin temperature and therefore skew results (Usuki et al., 1998, pp. 173-­‐81). 3.7.3 Ascertainment; was the reference standard ascertained regardless of the diagnostic test result. The reference standard was maintained throughout this trial since all patients presenting fitting the above inclusion criteria had their wrist X-­‐rayed regardless of the thermal imaging results. The methodology used provided the researcher with enough data to evaluate the usefulness of thermography in the speciality of paediatric emergency medicine. By determining whether thermography can be used 58 to rule out the possibility of a fracture in a child’s limb certainly extends its usefulness as a diagnostic tool in a clinical setting, such as primary care, and remote access clinics. 3.8 The Clinical trial Children who attended the Emergency Department in the months of April and May 2008 with a painful wrist were invited to take part in this pilot study. The streaming nurse examined the child’s wrist and calculated their pain score using the standard pain-­‐scoring tool readily available in the department; appropriate analgesia was given to the child and the child was then made comfortable. Information was given to the parents and child concerning the trial; if they decided to take part in the study they were given the option to withdraw their consent at any time (please refer to appendix 1 for patient information leaflet, appendix 2 for consent form). The complete flow diagram of the clinical trial is shown in figure 7 on page 62. A signed informed consent/assent was obtained from the parent and the child. The child and his family were then asked to sit in the playroom, which has a controlled temperature of 20 –25 ˚C (Ring and Ammer, 2000, p. 8). The child was kept in the playroom for 15 minutes so that they became acclimatised to the ambient room temperature and for their blood pressure and skin temperature to stabilise (Mabuchi et al., 1995). If the temperature is colder than 20 ˚C, the child will generate heat by shivering, if the room is warmer than 25˚ C, the child will sweat. Both of these states will produce spurious findings and could impact on the clinical findings. The child was then escorted to the x-­‐ray facility, were they underwent the imaging( both x-­‐ray and thermal imaging ) . All measures were taken to ensure that the imaging room was a stable 22°C, with diffuse airflow to avoid 59 adverse temperature fluctuation (Ring, Jones, Ammer, Plassmann, & Bola, 2004). The children were positioned in either the prone position or the sitting position with their arm supported on the X-­‐ray plate. A FLIR SC640 thermal imaging camera that has been specifically manufactured for medical researchers was positioned over the subject to image each wrist separately; the wrists were positioned by the radiographer to ensure a standard approach was used for the positioning and image capture. The thermal image was taken before the X-­‐ray to try to avoid excessive heat exchange between the thermal imaging operator and the patient. A thermal image was taken of both the child’s affected wrist and unaffected wrist (the unaffected wrist provided the researcher with a reference point/further control). An anterior/posterior and lateral view by thermal imaging will be taken in exactly the same way as a radiograph, to ensure that the views are taken in a standard way (Ammer & Ring, 2004). If careful attention is not paid to the positioning of the wrist, individual measurement errors due to variations of placement can take place (Ammer & Ring, 2004). These variations can be as be as large as 2˚C if not taken into account, which can alter the results exponentially. The image was taken using a standard approach described by Ring and Ammer (2000). The camera was mounted on a stand and adjusted according to the size and position of the patient. Standard views were taken at a distance of 50cm, which was measured using a standard measuring stick before each image was taken. The X-­‐ray was then taken of the affected wrist. The interpretation of the thermal image was carried out after the trial period to ensure blinding of the results. The X-­‐rays were interpreted independently of the thermal image by the clinician caring for the child. To ensure rigor and reliability of the X-­‐ray results an independent reviewer examined the X-­‐rays the next 60 day independently of the study (Strauss et al., 2005). The child was managed appropriately according to whether a fracture was present or not. The thermal image and the X-­‐ray were marked with the patient’s name and district number for identification. The details of the child’s attendance were held on the patient’s notes and a copy was kept in a secure patient’s records facility for the duration of the study and for up to five years post study. Figure 7: Patient journey through department preceding trial Child attends the Emergency Dept with injury to wrist
Triaged in the PED Pain score and Analgesia given Asessed by clinician Clinical critieria for X-­‐ray met Patient sent to xray X -­‐ Ray Interpreted Appropriate treatment given Follow up arranged if necessary 61 Figure 8: Flow chart of clinical trial FLOW CHART OF CLINICAL TRIAL Child attends the emergency department
With a painful wrist
Assessed by streaming nurse in Paediatric Emergency
department
The child meets the entry requirement for the research study
Informed consent obtained from parent and child Child given analgesia and made comfortable. Sat in examination room for 15 minutes. Room is kept at 20 –25 °C Thermal image taken of both wrists Image examined for evidence of exothermic reaction in affected wrist X-­‐ray taken in X-­‐ ray department Independently reported the next day Child receives the appropriate treatment and follow up dependent on X-­‐ray findings 62 3.9 Data Collection A data collection tool captured both the epidemiological and clinical data of the child presenting with a painful wrist (refer to appendix 3). The ambient temperature of the imaging room was recorded along with the clinical data regarding the temperature recording for both the injured and the uninjured wrist as recorded by the thermal imaging camera. A copy of the data collection tool was inserted into the patient’s notes and a copy used for data collection by the principal researcher. Inclusion criteria were included on the tool as well as presenting complaint, history, and examination findings. The ethics committee stipulated that the results of the X-­‐
ray were not to be recorded on the data collection tool for six months post initial presentation to reduce interpreter bias. This meant that no data comparison was made for six months post study. The patient data has been stored securely in the patient’s records storage facility in the usual manner. 3.10 Analysis of the data The statistician from the University of Portsmouth advised the researcher on the appropriate statistical tools and parametric tests to be used for this study. SPSS 21 and Graph pad, Prism 6 (2013) advanced research analysis software were used to analyse the data for this study, as advised by the medical statisticians from the University of Portsmouth and the University of Southampton. The initial analysis of the data was to determine whether there was a significant temperature difference between the injured wrists (test group) versus the uninjured wrist (control group). Once this was determined further data analysis was carried out by dividing the test groups into two groups. Those with a 63 fracture determined by X-­‐ray were measured against the control (uninjured limb), while those with proven soft tissue injury were also measured against the control (uninjured limb). Once the data was analysed and calculated for these groups, the two groups’ means were compared using an independent t-­‐test to determine the difference between the control and the test group means (Polit et al., 2001, p. 473). The reference standard to determine the difference between a fracture and a soft tissue injury was set at a difference of greater than 1˚ C (Hosie et al., 1987, pp. 117-­‐20). This was to ensure that the thermal image could differentiate between a fracture and a soft tissue injury. The results have been presented in table, bar graph and text for the main study group (fracture group), whereas for group two the comparison group has been presented in a table comparing the two arms of the study, examining the difference between the control group against the soft tissue/no fracture noted group. An independent t-­‐test has been used to compare the two test groups with their control. This is a parametric test designed to compare the two means of a test group in this study, comparing the injured arm versus the uninjured arm (control), and then the soft tissue injured limb against the fractured limb. The standard approach to determine the accuracy of a diagnostic tool is to investigate their sensitivity or specificity (Dawes et al., 2005, p. 155). The sensitivity examines whether the diagnostic test can detect subjects with a particular disease, in the case of this study whether the thermal imaging is sufficiently sensitive and specific to detect the exothermic reaction that may signify a break in the cortex of the ulna or radius. Thus a high sensitivity suggests that if an exothermic reaction is present then the patient does have a fracture. The specificity examines whether a certain test can rule out a disorder, therefore 64 if no exothermic reaction is detected, can this test positively rule out a fracture. As yet no body temperature atlas or reference data is available to formulate the normal range, therefore the reference intervals was taken from the unaffected limb. No study determining whether thermal images could be used to detect fractures in children have been conducted previously, which meant that the researcher was unable to determine the standard deviation of the mean temperature of a normal, unaffected limb. Therefore for this pilot study the standard deviation was calculated by the data produced from the control arm, to determine what would constitute an abnormal rise in temperature thus suggesting an exothermic reaction, which could signify a fracture. The investigator examined the incidence of false positives and false negatives amongst the gold standard, thus determining the reliability of either diagnostic tool. Frequency tables were used to report the results and determine the positive and negative predictive values for each of the diagnostic tools used. Given this data likelihood ratios were calculated to determine whether the positive result occurred by chance. A high likelihood ratio for a positive result suggests that the test provides useful information, as does a likelihood ratio close to zero for a negative result (Petrie & Sabin, 2005, p. 103). 3.11 Ethical issues This research protocol has been devised using the four ethical principles described by Beauchamp and Childress (1989): •
Respect for autonomy •
Beneficence •
Non Maleficence 65 •
Justice 3.11.1 Respect for autonomy Full consent was obtained from the subjects invited to take part in this research project. The information regarding this research was discussed in full and the participants were able to withdraw consent at any time. Where children were judged to be too young to understand and give full assent, the parents were asked to provide consent for their child in accordance to the safeguarding children’s report (2005). The consent form (refer to appendix II) and patient information leaflet had been devised in liaison with the Patient, Advice Liaison Service (PALS) within the hospital where the trial was conducted. The consent form has been adapted for this project from MREC 2007 guidance document. At all times the patient’s rights were taken into consideration and the Human Rights Act adhered to at all times. Although Pence (1990, p. 26) recommends that patients should be given 24 hours to reflect on the information given and then decided to enroll or not, this was not possible for this research project. However, the parent and child were given adequate time to reflect and ask relevant questions, parent and the child could withdraw from this study at any point and, in this case, any pictures and data collected would be destroyed. 3.11.2 Beneficence and Non-­‐maleficence Following the literature search described above the principal researcher could find no evidence of any sequelae or harmful effects observed after having a thermal image taken. No child received a radiograph unless they met the inclusion criteria as described above. There is an obligation to maximise the benefits to the patient and minimise the harm (Crooke & Davies, 1998, p. 214). At no time was the child’s treatment or investigations delayed by this research project, the project improved 66 the care given to children with fractures to their forearm as it ensured that the strict timelines prescribed within this project were adhered to. If the child got distressed at any stage of the research procedure they were immediately withdrawn from the research project. A play specialist was available to comfort the child and care for the child’s psychological needs. The principal researcher was available at all times throughout this research project to answer any questions or queries that the patient or parent had. No image of the child was kept on a public database at any time; it has been stored on hospital password protected computer file. No identifying images were taken of the child and the parent and child were shown every picture taken. All possible measures were taken to protect the child and their families’ identity. All pictures used in subsequent publications regarding this research project will be made anonymous and the child’s identity withheld. 3.11.3 Justice Crookes and Davies (1998) suggest this refers to the researcher ensuring that the benefits and burdens of participation are equally distributed across the sample group. The principal researcher ensured that throughout the research project all children enrolled into this trial were managed and cared for in accordance to the research protocol outlined above. No child received care outside the parameters of the research project. All the children enrolled into this project were managed according to best practice. To ensure that sample bias is reduced the ethics committee stipulated that the results from the thermal imaging should be kept separate from the results of the X-­‐rays and that the analysis should take place at least six month post study. Ethics approval was granted by the National Research and Ethics Service Southampton & South West Hampshire Research Ethics committee in full on 18th 67 March 2008, without any amendments or conditions imposed. The study was granted permission to proceed by the Portsmouth NHS R&D consortium on 28th March 2008 (refer to Appendix 4). 68 Chapter 4 69 Chapter 4 Data analysis and results 4.1 Introduction This chapter will present the findings of the study using the data collected over the study period. The data was collected in a quantitative form over a one-­‐month period. However,to reduce test review bias, or the Hawthorne effect (Knottnerus, 2002), the data was not analysed until six months post study period, as directed by the ethics committee. The data has been presented from both the control group (uninjured wrist) and the test group (injured limb) of the overall study participants. This chapter will compare the results of the control group and test group as well as subdividing the findings into a fracture positive group (confirmed by X-­‐ray) and soft tissue injury group. The data from the fracture group has been presented on individual test sheets describing the individual thermal imaging results from each subject and in spread sheets describing the whole test series (Appendix 3). The data was collated and stored using advanced spreadsheet in Microsoft office 2008©. Once the data had been collected it was cleaned, checked for accuracy of translation and any missing data identified (Bowling, 2009). The data was analysed using statistical packages SPSS 21 and graph pad prism 6, (2013) as advised by the University of Portsmouth and the University of Southampton medical statisticians. 4.2 Demographic data Overall 71 children were entered into this study. Two patients were withdrawn from the trial due to the distress caused by the significance of their fracture and two patients were excluded in the initial stages of the pilot due to set up 70 complications and loss of data, meaning that 67 children were included in this studies results. Fig 9: Flow Diagram: Patients enrolled into the pilot study Assessed for eligibility (n= 71)
Excluded (n= 4)
♦ Declined to participate (n= 2)
♦ Other reasons (n= 2)
Randomised (n= 0)
Allocated to intervention (n= 69)
♦ Received allocated intervention underwent
thermal imaging and X-rays (n= 67) Discontinued intervention (n=2) due to lost
data on camera thus excluded from trial
Analysis Fracture group compared with
control Analysed (n= 34)
♦ fractures diagnosed on x ray Injured group (non – fractured)
compared with control: Analysed
(n= 33)
♦ no fracture found on x-­‐ray Injured wrist compared with
control: Analysed (n=67) 71 Age subjects of Mean Range: Age (yrs.) 1-­‐5 (yrs.) 6-­‐10 (yrs) No 67 9.4 7 Gender 11-­‐15 M F (yrs.) (yrs.) 24 36 44 23 Table 4.1 Demographic data The mean age of the children enrolled onto the study was 9.5 years of age with the majority of the children being boys. The youngest child was 18 months old with the oldest being 15 yrs. Overall 44 male subjects and 23 female subjects were enrolled in the study. 4.2.1 Results from the Data collection forms The interrogation of the data collection forms shows that, out of the 67 children enrolled onto this study, 34 patients had fractures confirmed by X-­‐ray. Of these fractures: 11 were buckle fractures, 18 were green stick fractures with ulna and radius involvement and 5 were reported as transverse fractures with a Salter Harris deformity reported. There were three fractures not detected by thermal imaging (not recording a temperature rise greater than 1°C when compared with the control). Two of these fractures were reported to have gross deformity with very obvious clinical signs and one was reported to have minimal deformity with reasonable range of movement. This fracture would have been missed if solely dependent on thermal imaging recordings. A breakdown of the individual results can be seen in Tables 4.2 and 4.3, which summarises the clinical, and demographic data collated this study. 72 Table 4.2 Summary of the clinical and demographic data from study data collection forms: Children with fractures. Age Gender Fracture Type of fracture Clinical deformity 10 7 M M Yes Yes Buckle Buckle Minimal None Pain score 8 6 8 F Yes Green stick None 2 12 11 6 7 11 M M F F M Yes Yes Yes Yes Yes None None Minimal Gross Gross 7 3 2 4 10 11 13 8 14 M M M M Yes Yes Yes Yes Minimal Minimal Minimal Minimal / SH1 6 8 6 2 14 5 6 11 15 8 15 6 7 11 13 14 12 10 13 10 F F M M F M F M F M M M M M M F Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Minimal Gross Minimal Minimal Minimal Minimal Gross Gross Minimal Minimal Gross Gross Minimal None None Minimal 3 9 6 2 6 6 3 2 2 7 3 10 6 6 6 6 13 11 4 7 14 10 M M M M M M Yes Yes Yes Yes Yes Yes Buckle Buckle Green stick Green stick Fracture Transverse Green stick Green stick Green stick Buckle / greenstick Buckle Off ended /SH2 Green stick Green stick Green stick Green stick Salter Harris 4 Off ended Green stick Green stick Green stick Green stick Green stick Buckle Buckle Buckle / greenstick Green stick Buckle Buckle Green stick Green stick Buckle Minimal None None Minimal Gross Minimal 6 7 5 6 6 7 73 Table 4.3 Summary of the clinical and demographic data from study data collection forms: Children without fractures. (Soft tissue injury) Age Gender Fracture Type of fracture Clinical deformity 6 9 14 M F F NO NO NO NO NO NO Minimal Minimal Minimal Pain score 6 6 8 10 M NO NO Minimal 10 11 11 14 11 13 13 10 8 13 6 13 14 9 12 11 8 4 8 3 1 9 15 15 4 8 6 14 13 1 F M M F M F M M F M F M F M F M M F M M F M F M F M M F M NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO ? But reported NBI NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO Minimal Minimal Minimal Minimal Minimal None Minimal None Minimal Minimal None None None None None None None None None None None None Minimal Minimal None None Minimal None None 2 2 1 2 2 2 2 2 6 6 6 2 2 2 3 2 1 2 3 2 8 8 6 2 2 5 2 2 2 74 4.2.2: Inclusion criteria met Table 4.4 inclusion criteria Children the age of 0-­‐15years (up to their 16th birthday) Total 67 Complaining of or indicating pain in their wrist 67 Obvious swelling or deformity of the wrist on clinical examination 44 Child is unable to supinate or pronate their wrist 57 Have severe loss of function on clinical examination 46 The above table (Table 4.4) shows the inclusion criteria for the children presenting to the emergency department with an injury to their wrist. Each of the children presenting to the department complained of pain in their wrist and the pain score recorded on the data sheet at nurse streaming confirmed this. Forty-­‐four children had obvious deformity or swelling reported to their wrists, on examination of the child’s clinical records 57 were unable to pronate/supinate their wrist and 46 children reported some degree of loss of function on clinical examination. 4.3 Results from thermal imaging data Table 4.5 shows the data collected from all of the participants enrolled onto the study. The table below details the mean temperature recorded from the thermal image using the temperature analysis software FLIR researcher Pro 2.10 (Flir, 2008) for thermal imaging research. The table shows the differences in the mean temperatures taken from the anterior posterior view and lateral view of 75 the thermal imaging camera. The table below also shows the temperature recorded using the thermal imaging camera for both the injured limb (study group) when compared to the opposite uninjured limb (control). The third column of the table shows the variance of temperatures recorded between the injured limb (study group) and the uninjured limb (control). Table 4.5 Study group versus control (uninjured limb) Thermal imaging data : Control (°C) Study group (°C) 34.5 35.5 Variance (°C) 1 34.9 36.05 1.15 33.1 34.5 1.45 34.8 35.9 1.1 34.8 35.8 1 34.6 36.1 1.5 34.2 35.3 1.2 33.1 34.5 1.4 33.1 35 1.8 33.6 35.7 2.1 34.4 35.1 1.1 34.9 36.1 1.2 33.2 34.5 1.3 36.4 37.1 0.65 34.4 35.4 1 34.6 35.6 1.15 34.8 36.4 1.5 34.8 36 1.2 33.5 33.5 0 32.8 36 3.1 33.2 35.2 2 34.4 34.5 0.1 34.5 35.5 1 33 34.4 1.3 35.5 36.5 1 34.6 35.4 1 34.7 36.5 1.3 34.6 35.7 1.1 76 Control (°C) 35 Study group (°C) Variance (°C) 36.3 1.3 33.1 34.2 1 34.3 35.9 1.6 34.8 36.4 1.5 34.8 36 1.2 33.7 35.5 1.8 34.75 34.7 0.05 34.35 34.2 0.2 34.9 35.35 0.6 34.1 35 0.9 34.9 35.2 0.3 35 35 0.4 34.45 35.15 0.7 31.25 33.25 2 35 35.6 0.6 35.05 35.5 0.4 35.35 35.95 0.6 35.35 36 0.65 33.85 34.25 0.4 35.7 35.25 0.25 34.2 34.4 0.2 34.5 34.5 0 35.45 35.9 0.45 34.4 34.4 0 33.55 33.55 0 33.5 33.7 0.2 32.75 32.75 0 33.45 34.65 1.2 32.8 33.1 0.3 33.5 33.55 0.05 32.55 33.15 0.6 33.7 33.85 0.15 31.8 33.9 2.1 33.4 34.35 0.9 29.8 31.45 1.6 31.5 32.8 1.3 35.25 35.5 0.25 35.3 35.35 0.05 34.4 35.3 0.95 77 Table 4.6: Summary of results; Study Group vs. Control (uninjured limb) Condition Number Mean Std deviation Std Error of Mean Significance Fractures 67 34.99°C 1.084 0.132 Control 67 34.09°C 1.149 0.1404 P<0.0001 Higher mean temperatures were recorded in the study group (mean = 34.99°C) when compared to those of the control group (34.09°C). A paired sample T-­‐test showed that the difference between the two groups were statistically significant (T =10.14,df=66,p <0.0001), two tailed). The magnitude of the difference in the means (mean difference 0.90°C, 95% CI: 0.72 to 1.079) was significant enough to suggest that a pathological change had taken place (SD of difference = 0.72: SEM of difference = 0.088). The results in table 4.5 suggest that thermal imaging may demonstrate the ability to detect changes in temperature due to traumatic injury in children’s wrists. 78 4.4 Study Group : fractured wrist compared with injured non-­‐fractured group. Table 4.7 Comparison of the fracture group with the injured non fractured group. Children with Fractures compared injured non fracture Fractured (°C) Non – fractured (°C) (Study group, n=34) (Study group, n=33) 35.5 34.7 36 34.2 36.4 35.35 35.4 35 35.95 35.2 34.1 35.0 36.3 35.15 35.7 33.25 36.05 35.6 36.49 35.5 34.4 35.95 35.5 36 34.5 34.25 35.2 35.25 36 34.4 33.5 34.5 36.05 35.9 36.4 34.4 35.7 33.55 35.49 33.7 37.1 32.75 34.4 34.65 36.1 33.1 35.1 33.55 35.75 33.15 35 33.85 34.56 33.9 35.3 34.35 36.1 31.45 35.8 32.8 35.9 35.5 34.55 35.35 36.05 35.4 35.5 79 Table 4.8: Summary of independent T-­‐test results: fractured wrist study group compared with injured non-­‐fractured study group Condition Number Mean Std deviation Std Error of Significance Mean Fractures Non Fractured Study group 34 33 35.52°C 34.44°C 0.793 1.086 0.1361 0.1891 P < 0.0001 Table 4.7 demonstrates the difference in degrees centigrade between the injury groups. The table shows the results from the wrists that were fractured according to their X-­‐ray results (N= 34) compared with those who had no fracture reported on X-­‐ray (N = 33). The fracture group records a higher mean temperature (Mean = 35.52˚C) when compared to the non-­‐fractured group (injury group) (Mean = 34.44˚C). An independent T-­‐test showed that the difference between fracture and the soft tissue injury group was statistically significantly different (t = 4.704,df = 65, p <0.0001two tailed). The difference in the means between the two groups (mean difference 1.084 95% CI = 0.62 to 1.54) was large. The sample mean for the fracture group is 35.52 and the sample shows that we can be 95% confident that the population falls between 35.25˚C and 35.80˚C. The sample mean for the non-­‐fracture group was 34.44˚C and the sample shows that we can be 95% confident that the population falls between 34.06˚C and 34.83˚C. This suggests that the difference between the fracture group and the non-­‐fractured injury group is quantifiable and therefore suggests that thermal imaging may be useful in determining the difference between a fracture and a non-­‐fracture when comparing recorded mean temperatures. 80 4.5 Fracture group compared with control (Unijured limb) Table 4.9 Children with Fractures compared with the control (Uninjured limb) Children with Fractures compared with the control (Uninjured limb) N=34 Fracture (°C) Control (°C) Variance 35.5 33.7 1.8 36 34.8 1.2 36.4 34.8 1.6 35.4 34.4 1 35.95 34.3 1.6 34.1 33.1 1 36.3 35 1.3 35.7 34.6 1.15 36.05 34.75 1.3 36.49 35.5 1 34.4 33.05 1.3 35.5 34.5 1.05 34.5 34.4 0.15 35.2 33.2 2 36 32.2 3.9 33.5 33.5 0 36.05 34.8 1.2 36.4 34.85 1.55 35.7 34.6 1.15 35.49 34.5 1 37.1 36.4 0.65 34.4 33.2 1.3 36.1 34.9 1.2 35.1 34.4 1.1 35.75 33.6 2.1 35 33.1 1.9 34.56 33.15 1.4 35.3 34. 1.2 36.1 34.6 1.5 35.8 34.8 1 35.9 34.8 1.1 34.55 33.1 1.45 36.05 34.9 1.15 35.5 34.5 1 81 Table 4.10: Summary of results from comparison of fracture group vs. control (Uninjured Limb) Condition Number Mean Std deviation of Std Error Mean differences of differences Fracture 34 35.52°C 0.7827 0.1342 Control 34 34.24°C 0.8653 0.1484 Significance P<0.0001 The comparison between the fracture group (diagnosed by X-­‐ray) and the control group (uninjured wrist) are shown in Table 4.9. A higher mean temperature was recorded in the fracture group (mean = 35.52, 95% CI 35.25 to 35.80) than in the non-­‐injured control arm (mean = 34.24 95% CI 33.93 to 34.54). A paired T-­‐test showed that the difference between the two groups were statistically significant (t = 6.44,df=66,p<. 0001, two tailed) the size of the difference in the means (mean difference = 1.28, 95%CI 0.889 to 1.689) is considered clinically and statistically significant (p<. 0001). The mean variance between the two groups was 1.28˚C which suggests that the hypothesis that a fracture has a greater than 1˚C temperature gradient, when compared to a control (uninjured arm), was accurate. Based on the temperature recordings taken from the individual subject groups, three fractures were missed by the thermal reading taken. Two of these fractures were clinically obvious on examination with gross deformity noted of the exterior anatomy of the wrist and an X-­‐ray would have been requested on clinical examination. A buckle fracture of a 14-­‐year-­‐old boy would have been missed both clinically and on thermal imaging, which was captured by X-­‐ray. 82 4.6 Non fractured injury group compared with control (Unijured limb) Table 4.11: Non-­‐fractured injury group vs. control (Uninjured limb) Non fractured study group Control (°C) n=33 n=33 Variance 34.7 34.2 35.35 35 35.2 35.0 35.15 33.25 35.6 35.5 35.95 36 34.25 35.25 34.4 34.5 35.9 34.4 33.55 33.7 32.75 34.65 33.1 33.55 33.15 33.85 33.9 34.35 31.45 32.8 35.5 35.35 35.4 34.75 34.3 34.9 34.1 34.9 35 34.45 31.25 35 35.05 35.35 35.35 33.85 35.7 34.2 34.5 35.45 34.4 33.55 33.5 32.75 33.45 32.8 33.5 32.55 33.7 31.8 33.4 29.8 31.5 35.25 35.3 34.45 0.05 0.1 0.6 0.9 0.3 0.4 0.7 2 0.6 0.4 0.6 0.65 0.4 0.25 0.2 0 0.45 0 0 0.2 0 1.2 0.3 0.05 0.6 0.15 2.1 0.9 1.6 1.3 0.25 0.05 0.45 83 Table: 4 12 Summary of paired T –test results: non fractured injury group vs. control (Uninjured limb) Condition Number of Mean patients Std deviation of Std Error Mean Significance difference of difference Injury group NF 33 34.44 1.83 0.1886 Control 33 33.93 1.379 0.2400 P<0.0001 Table 4.12 compares the results of the non-­‐fractured injury group with the control (uninjured arm). Higher mean temperatures were recorded in the non-­‐
fractured injury group (Mean=34.44˚C) than in the control group (mean=33.93˚C). A paired T-­‐test showed that the difference between the two groups was statistically significant (t =4.8396,df= 32, p <0.0001, two tailed). A mean temperature variance of 0.507 centigrade was recorded between the injured non-­‐fractured group and their control (95% CI: 0.2939to 0.7213). Four subjects with soft tissue injuries had temperatures differences recorded over 1.0˚C when compared to their control, which means that they would have received an X-­‐ray when no fracture was observed either by the initial clinician or consultant radiologist. 84 4.7 Sensitivity and specificity Table 4.13 Fractures compared with no fractures: Sensitivity and specificity of thermal imaging when compared with radiographs Fracture No Totals fracture Test positive 31 4 35 Positive 88.57% predictive value Test negative 3 29 32 Negative 90.32% predictive value Totals 34 33 67 Prevalence 50.75 Sensitivity 91.18% (76-­‐98) Specificity 87.88% (71-­‐96) Table 4.13 shows the sensitivity and specificity findings demonstrating the ability of thermal imaging to detect fractures in children when compared with the gold standard of X-­‐ray. When compared with radiographs, thermal imaging is 91.18 % likely to correctly diagnose a fracture in a child with injury to the wrist and is 87.85% accurate in ruling out a fracture; the sensitivity is increased to 96.7 % when the clinical examination is taken into account. During the study only one fracture would have been missed if the physical examination were used within the results findings instead of the thermal image being used in isolation. 4.8 Likelihood Ratio A likelihood calculation was carried out to determine whether the positive result has occurred due to chance rather than by the diagnostic tool itself. The likelihood ratio for a test result is defined as the ratio between the probability of observing that result in patients with the disease in question, and the probability of that result in patients without the disease (Akobeng, 2006, p. 487). Likelihood ratios are clinically, more useful than sensitivity and specificity and are becoming the most popular and accurate test when reporting diagnostic 85 research (Deeks, 2004, p. 169). A likelihood ratio greater than 1 indicates the test result is associated with the disease, a likelihood ratio less than 1 indicates that the result is associated with absence of the disease. Table 4 .14 Likelihood Ratios Likelihood ratio positive result Likelihood ratio negative result 7.52 (2.98-­‐
18.95) .10 (0.03-­‐0.31) In this study the likelihood ratio for the positive test was calculated to be 7.52. This means that a child with a temperature recording equal to or greater than 1°C in their injured wrist is 7.5 times more likely to have a fracture than not have a fracture. This suggests that it is highly probable that thermal imaging is able to detect a fracture in children rather than it just being by chance. The negative likelihood ratio was calculated to be 0.1, which means the probability of having a negative test for individuals with a fracture is 0.10 times of that of those without the fracture. This suggests that children without fractures are 10 times more likely to have a negative test result than those who have a fracture. Jaescheke, Guyatt and Limer (2002, p. 123) suggest that having a negative likelihood ratio below 0.1 virtually rules out the chance that a person has the disease. The likelihood ratio conducted for this study showed very positive results suggesting that thermographs can be used to detect fracture in children. 86 The results from this study suggest that there is a significant difference between the control and the test groups. The results described in this chapter suggest that thermal imaging may be useful in detecting differences in pathology following injury in children’s limbs. The results highlight a mean difference of 1.28˚C (t= 6.44,df =66,p=. 0001) when a fracture is present in a child’s wrist and mean difference of .50˚C when associated with a soft tissue injury when compared with the control. The likelihood ratio adds further weight to this argument as does the sensitivity and specificity related to this test. The fact that such highly significant results were found with a comparatively small sample size adds further weight to the study’s findings (Guiffre, 1994). Further discussion and analysis of these results and their implication to practice are discussed in detail in the following chapter. 4.9 Summary This chapter has highlighted the findings from this study, detailing the clinical variance and the data collected throughout the study time frame. The data from this study has been collated in tabular form and evaluated using statistical packages SPSS 21 and graph pad prism 6, (2013). The overall findings have concluded that thermal imaging can detect a temperature rise of greater than 1˚C in children with a fracture when compared with a non-­‐injured arm in the majority of cases. However, the thermal imaging camera was less useful in distinguishing a fracture from a soft tissue injury. The next chapter will discuss these findings in detail and debate the use of thermal imaging as a diagnostic tool for detecting fractures in children, revisiting the pilot studies’ primary and secondary objectives. 87 Chapter 5 88 Chapter 5 Discussion 5.1 Introduction The aim of this chapter is to discuss the findings of this pilot study in the context of the current literature and evidence surrounding the use of thermal imaging in the detection of fractures. The aim of this pilot study was to explore the effectiveness of thermal imaging in diagnosing wrist fractures in children using plain X-­‐rays as the gold standard and determine whether a full phase III study was viable. Haynes and Sackett (2002) suggest that the value of a diagnostic test is to distinguish between the normal and the abnormal within the clinical context. This chapter will discuss this theory, exploring the strengths and weaknesses of this research study by revisiting the research objective posed in chapter one to determine whether a full scale phase III study should be commenced into the use of thermal imaging for the detection of distal ulna and radius fractures using thermal imaging as a diagnostic tool on children. 5.2 Primary objectives for this study 1. To determine whether thermal imaging (thermography) can be used to detect fractures in children’s wrists. 2. To examine whether patients with a 1°C or greater difference in temperature on thermal imaging results are more likely to have a fracture to their wrist. 3. To determine in patients who it is clinically sensible to suspect a fracture, does the level of the test result distinguish those with or without a fracture. 89 5.2.1 To determine whether thermal imaging (thermography) can be used to detect the fractures in children’s wrists The main objective for this pilot study was to determine whether thermal imaging could be used as a diagnostic tool to detect fractures in children’s wrists. The obvious fundamental factor to this question is whether the fracture site does have a different temperature to that of a soft tissue injury or uninjured wrist? The evidence presented in this study suggests that fractures do show a different temperature recording (>1°C) in the majority of cases (31 out of 34) when compared to that of a child with an injury to their wrist with no fracture reported. When compared to the control group, five of the participants recorded no difference in temperature between the control group and the injury group. Four of these children had sustained soft tissue injuries of varying degrees and one had a fracture noted on X-­‐ray. This evidence suggests that thermal imaging does detect a difference in pathology at differing levels and, as this study results suggests, detected temperature differentials in 33 of the 34 children presenting with fractures. However, the results do demonstrate that the thermal imaging is not 100% accurate at determining significant temperature changes to determine the difference between a soft tissue injury and a fracture (31 out of 34 cases). Marsell and Einhorn (2011) and Niehof et al. (2008) in their respective research reported a similar concern that thermal imaging did have limited scope in determining the difference between a severe inflammatory response from a soft tissue injury and that caused by a fracture. On interrogation of the data there 90 appears to be an inconsistency in the level of exothermic reaction produced by a fracture in a child. There is good evidence to suggest that young children’s bones heal much faster than their older peers. This is due to the nature of the difference in bone make up and the response activated following injury, which may equate to a greater degree of heat produced by the inflammatory response. However, there has been no study conducted to evaluate how quickly this inflammatory response reacts to a fracture or whether there is a delay in this healing/inflammatory process. The children studied in this paper all presented to the emergency department having sustained an injury to their wrist/forearm with varying degrees of severity and mechanism, all within 6 hours of their injury. The data suggests that there is no correlation between the time of injury and time of data capture. However, one can hypothesise that in some circumstances the inflammatory response is delayed and therefore the thermal imaging was conducted too early to pick up the exothermic changes. There was a clinical suspicion pre-­‐test that a fracture was present in all children enrolled in this study as elicited by the inclusion criteria (Webster, 2006). The results from this study demonstrate that thermal imaging can detect temperature differences between wrists that have sustained a traumatic injury when compared to one that had no injury. This correlates well with the studies conducted by Merkulov et al. (2008) and Hosie et al. (1989). Merkulov et al. (2008) found that thermal imaging could be used to determine whether a fracture was present but published no sensitivity or specificity value in his study to determine its true value. The results from the main study, to determine whether the thermal 91 imaging camera could detect a difference in temperature between the injured wrist and the non-­‐injured arm, reported a mean variance of .90 ˚C (P = 0.0001) when compared with the control. This suggests a significant difference between the injured limbs when compared to one where no injury has been sustained. However, this study shows that even if the temperature level in which a fracture was diagnosed was reduced to >0.9° C none of the missed fractures would have been diagnosed. These results correlate well with research conducted by Gradl et al. (2003) who found that, although thermal imaging could be used to detect the presence of injury, they were less useful in determining whether a fracture was present. However, Gradl et al.’s (2003) study was conducted 16 weeks post injury and thus it be could argued that most of the exothermic reaction due to the healing process would have ceased by the time the imaging was carried out. All of the studies examined within the systematic review supported the above findings that thermal imaging could be used with varying degrees of accuracy to detect injury, though all of the papers reviewed demonstrated different degrees of accuracy in terms of specificity and sensitivity. Thermal imaging can be used to detect fractures in children, however its accuracy in determining the difference between a fracture and a soft tissue injury is variable and it has been proven not to be 100% accurate in detecting fractures in children’s wrists. 92 5.2.2: To examine whether patients with a 1°C or greater difference in temperature on thermal imaging results are more likely to have a fracture ot their wrist. Another fundamental questions stated for this research was to determine whether children with a higher temperature recording in their injured wrist were more likely to have a fracture when compared to the control. A higher mean temperature was recorded in children with fractures to their wrists when compared to the control (uninjured group) in 31 out of 34 cases. The mean temperature difference reported between the injured wrist and the uninjured wrist was 0.90°C which statically was shown to be significant. When the fracture group was compared with the soft tissue injury group a P value of .00001 was recorded, which suggests that there was a statistically significant difference between the two groups with a mean variance of 1.08 ˚C recorded overall. The fracture group recorded higher temperatures overall when compared with the soft tissue group. When the temperature of the fracture group (injured arm) was compared with the control (uninjured arm) group a mean variance of 1.28° C (p = 0.0001) was recorded. This result is highly significant for this study as it suggests that when a fracture is present a temperature difference of greater than 1˚C is recorded. However no other study has reported similar findings. Hosie et al. (1989) did not comment on the temperature gradient recorded in the affected limb, they simply suggested that a fracture was hotter than a non-­‐fracture. No other study has commented on the level of temperature rise required to differentiate between a fracture and a soft tissue injury. Using a greater than 1˚C target temperature would have meant that three fractures would have been missed. Two of the 93 fractures as noted previously were clinically obvious and would have been X-­‐
rayed on clinical grounds, one child (11 year old, male) with a clinically significant green stick fracture would have been missed as a temperature rise of 0.01 ˚C was recorded, however this rise in temperature would correlate with Jung and Zuber’s (1998, p. 15) findings that any rise in temperature could be considered pathological no matter how small. When the non-­‐fractured injury group was compared with their control a temperature recording of .5°C was recorded and when compared with the fractured injury group a mean temperature variance of 1.08° C was recorded. However these differences in temperature were not found consistently throughout the study. Neihof et al. (2008) found similar inconsistencies reporting a sensitivity (71%) and specificity (64%) within their study; they deduced that thermal imaging could not be used as a primary diagnostic test to determine the difference between a soft tissue injury and a fracture. Four subjects from the soft tissue group recorded temperatures greater than 1.0 centigrade in the affected limb when compared with their control; this would mean that four patients would have received needless X-­‐rays where no fracture was noted either by the examining clinician or consultant radiologist. However an argument could be posed that these represent more serious soft tissue damage and therefore the X-­‐ray examination of these subjects may have been warranted. A simple logistic regression analysis was performed examining the temperature data recorded in this study, using the correct diagnosis of a fracture as the 94 dependent variable and the differing temperature recordings as predictor variables. A total of 67 cases were analysed and the full model significantly predicted fracture detection rates (Chi-­‐square = 14.77, df=1p =0.0001). The values of the coefficient reveal that an increase in temperature by 3˚C increases the odds of a fracture detection from a factor of 0.67 at 34˚C to a factor of 8.23 at 37 ˚C, suggesting that the warmer the limb the greater likelihood in detecting a fracture using thermography as a diagnostic tool. The results from the study would suggest that thermal imaging could detect temperature rises associated with traumatic injury to a child's wrist when compared to the uninjured wrist. There also appears to be a correlation between the differentiation of a fracture and soft tissue injury when compared to the uninjured wrist. The results from this study do suggest that a temperature difference of 1°C or more is an indication that a fracture is present, however these results are inconsistent and, as this study has reported, the accuracy of the diagnostic test in determining temperature rise is variable. 5.2.3: To determine in patients who it is clinically sensible to suspect a fracture, does the level of the test result distinguish those with or without a fracture? In this study the sensitivity was calculated at 91.18% which suggests that out of 100 children 91 would have their fracture detected using thermal imaging, the sensitivity was further increased to 96.7% when combined with the clinical examination. Two of the three children where the thermal image did not detect a raise in heat signature, who had fractures of their wrist detected by X-­‐rays, had grossly 95 deformed limbs which can be seen directly on the thermal picture, thus these subjects would have been sent automatically for an X-­‐ray. One fracture would have been completely missed if thermal imaging alone were used to diagnose the presence of a fracture. According to Pountos et al. (2010) this compares very favourably when compared to the considered “gold standard” of X-­‐rays. Their study compared the effectiveness of ultra sound versus X-­‐rays in detecting green stick/torus fractures in children's wrists. Their results found that, out of 79 fractures detected, only 75 were seen on X-­‐ray giving a sensitivity of 95.1%. The use of thermal imaging to rule out fractures in children showed a specificity of 88% which suggests that 12 out of 100 children would have a needless investigation. Given that the reported sensitivity of X-­‐ray interpretation ranges between 93% to 98% (Mayhue et al., 1989; Freij et al., 1996; Benger, 2002; Tackara et al., 2002) there is a theoretical chance that the soft tissue injuries recording temperature rises greater than 1°C (4) could have been fractures that were missed on X-­‐ray interpretation. However, this is unlikely as none of the patients re-­‐attended the department following their injury and consultant radiologists reported all of the X-­‐rays, which heightens the sensitivity to 98.8% (Tackara et al., 2002). As discussed previously in the results chapter, Akobeng (2007, p. 490) argues that likelihood in association with pre-­‐test and post-­‐test probabilities are more clinically useful than sensitivity and specificity, especially when determining the value of a specific diagnostic test (Atta, 2003, p. 111). The likelihood ratio for a positive test was calculated at 7.52, which suggests that a child with a temperature recording greater than 1°C in their injured wrist is 7.5 times more 96 likely to have a fracture than not have a fracture. This result predicts that it is highly probable that thermal imaging is able to detect a fracture in children rather than it just being by chance. The negative likelihood ratio was calculated to be 0.1; this means that the probability of having a negative test for individuals with a fracture is 0.10 times of that of those without a fracture (Jaescheke, Guyatt & Limer, 2002, p. 123). To answer this question fully Mant (2005) and Akobeng (2007, p. 489) suggest the pre-­‐test and the post-­‐test probability must be examined. Heston and Thomas (2011) would argue that although sensitivity and specificity can be useful in interpretation of results they do not demonstrate the whole picture. They suggest that predictive values are much more relevant in demonstrating the accuracy of a diagnostic test. Fagan’s Nomagram (Sackett et al., 1991) for predicting post-­‐test probability calculated that the positive predictive value (PPV) for thermal imaging to detect a fracture as 89% (95%CI 75% to 95%) with 0.11% false positives and the negative predictive value (NPV) for thermal imaging to rule out a fracture was calculated to be 9% (95%CI: 3% to 24%). The fact that the number of patients in the non-­‐fractured group is very similar in number to the fractured group is very significant in regard to the accuracy of the NPV and PPV (Altman & Bland, 1994). The prevalence of fractures within this study correlates well with the pre-­‐study audit into the number of children presenting to the emergency department with painful wrists conducted in August 2007, which recorded 76 patients presenting to ED with painful wrists of which 39 had fractures detected on X-­‐ray. 97 Deeks (2004, p. 169) suggests that another useful way of determining the true value of a diagnostic test is to calculate the odds ratio of a specific test. Although the odds ratio is not a useful statistic for determining the overall accuracy of a test for an individual patient, it does have a value as a single measure that determines the overall accuracy of a test (Mant, 2005, p. 165). Figure 10: A Nomogram for applying likelihood ratios (Fagan 1975) (Reproduced from Sackett, Haynes, Guyatt & Tugwell, p 90) The odds ratio for this study has been calculated at 75%, which suggest that the predictive value for the accuracy of thermal imaging as a whole, in this study was poor. The discussion above suggests that although thermal imaging can 98 distinguish between those children presenting with or without a fracture, its accuracy in diagnosing a fracture cannot be guaranteed and does not reach the accuracy of X-­‐rays, which are considered to be the current diagnostic gold standard. 5.3 Secondary objective for this study •
To test the feasibility of a full-­‐scale study, including the process surrounding data collection, methodology, protocol adherence, and research question design. 5.3.1: To test the feasibility of a full-­‐scale study, including the process surrounding data collection, methodology, protocol adherence, and research question design. Thabane (2010) states the rationale for conducting a pilot study is to assess the process, resource management and specific scientific methodology of a study before conducting a full phase III trial. In effect testing the feasibility of conducting a larger scale study (Arnold et al., 2009). This study was conducted in busy children’s emergency departments and thus the process of obtaining the recruitment rates required for a fully powered study could be adequately achieved over a six-­‐month period. Even allowing for refusal rates and data capture complications this should produce over 400 hundred children presenting to the department with injuries to their wrists. The inclusion and exclusion process observed by the study meant that no child with an injury to their forearm was missed and that all the children attending the emergency department with an injury to their wrist were given analgesia in a timely fashion and correctly triaged (Webster et al. 2006). Two children meeting the inclusion 99 criteria for the study withdrew from the study due to pain and distress caused by their injuries. Both of these children had grossly deformed limbs and thus were too distressed to be involved despite analgesia and distraction methods. Although the numbers of patients opting out were low, there is a concern that this could skew the overall results and thus not fully test the hypothesis. The fact that the two patients who withdrew from the trial had very obvious fractures, and two of the three fractures which were not picked up by the thermal imaging camera also had very obvious fractures is extremely important to the studies overall results. Thus the principle that thermal imaging could detect all types of fractures was not tested or proven. A principle objective of the larger phase III study would be to ensure that this area would be investigated in depth, to investigate whether grossly deformed fractures could be detected and if not why not? However all of the parents of the patients enrolled onto this study stated that they thought the study was worthwhile and regarded the trial as a positive experience, this data was only collected anecdotally and thus could not form part of the results or data analysis. Should a phase III study be commenced the researcher should expand the methodology to include combined research methodological approach (Carter and Henderson, 2009, p 380). Qualitative data should be investigated in terms of patient and parent satisfaction, information regarding concept and process testing should be further investigated and a more naturalistic approach used for data collection (Bickman, L., & Rog, D., 2009, p 4). The resources available to this study were heavily limited by the loan period of the camera and the lack of funding associated within this research project. For a full phase III trial to take place, several camera systems would be needed and full funding achieved in order to fully train staff in the use of the camera and the 100 diagnostic package associated with the data capture. The need for more operators to be trained in the use of thermal imaging would be crucial to the success of any further larger study. As demonstrated in previous studies the use of thermal imaging can be inconsistent and very user dependent and thus consistent accurate training must be provided to the user group (Ring and Ammer, 2000, pp. 7 -­‐14) This could be easily achieved by sending personnel to the University of Glamorgan to complete the medical thermal imaging course, which is conducted over one week. The ethics committee expressed a concern that children would have to wait longer for their subsequent diagnosis and treatment. This concern was unfounded, due to the thermal imaging taking place alongside the x-­‐ray capture, this had three major advantages: firstly that the child’s care and subsequent treatment were not delayed in any way, secondly that the positioning of the child’s wrist was conducted by the same person, thus ensuring consistency in image capture and thirdly that the imaging was taking place in a temperature controlled room with restricted air flow. This approach complies to the guidance stipulated by the European Thermography Association standard for carrying out diagnostic studies using infra imaging (Clark & DeCalcina-­‐Goff, 1997) as discussed in chapter three. If a larger study was to be conducted the camera would need to be perminatley fixed in one room, this would reduce the chances of the camera being damaged in the process of moving it from room to room, and would ensure that the camera is always ready to use at any time. This was an exstremely important learing point for the reseracher as the damage to the camera caused huge delays to the research process and resulted in the reduced 101 sample size. However the pilot study did meet its secondary objective to test the feasibilty of the research design in the clinical area (Van Teijlingen, Rennine, Hundley, Graham, 2001,p 289) Overall the methodology appeared to be acheivable, requiring minimal change for a mulit centered phase III study. This pilot study has provided the researcher with an excellent grounding of how best to procede and conduct a larger study . This study answers the research questions posed within the limitations of the pilot study design. The study provides the researcher with a template to follow in order to produce a study design which is both valuable in terms of answering the research question and reliable in terms of acurately informing the hypotheis posed. The limitations of this study are discussed fully in the limitations section below and although the results from this study should be treated cautiously there is no doubt that they inform the overall sceintific question of whether thermal imaging is a usful diagnostic tool in detecting fracture of the ulna and raduis in children. 5.4Limitations A great deal of the limitations surrounding the use of thermal imaging in research studies described by Ring and Ammer (2000) were addressed within this studies design, however there have been some unavoidable limitations. One of the major concerns for the chief investigator of this study has been the limited sample size used. Despite this, through evidence gained within the literature review and from other similar papers, this study has one of the largest sample 102 sizes documented for thermal imaging research in this field (Ammer, 2006, p. 16). The limited sample size was due to the short loan time the researcher was allocated the camera and breakage of the camera equipment. A solution for this would have been to initially run this study on all patients presenting with known fractures in a fracture clinic, this would have greatly enhanced the population size and, as an initial phase II study, supported either the hypothesis or the null hypothesis (Ippokratis, 2010). The initial study was scheduled to be four months in duration. This would have provided the study with over three hundred subjects, which would have doubled the sample size required to fulfill the power calculated for this study. However, due to the need to repair the camera mid study the sample size was only taken over a month. Polit, Beck and Hungler (2001) suggest that one of the largest threats to the validity of a study is the lack of an adequate sample size. Brink and Wood (1998) suggest that this is often the case with clinical studies or real life world research where the population size is limited is due to location and clinical situation. Dawes (2005) suggests that the sampling size can be a major concern but if properly managed its effects can be limited. Having too few patients in the study can lead to two sorts of concerns. The first of these are type 1 errors where the intervention is shown to be effective when in reality it is not. To protect the study from making this type of error a P calculation was performed, this consistently showed a P value of less than 0.0001, which means that there is a less than 1% chance that an error has occurred within this sample. This suggests that there is a less than 1% chance 103 that these results occurred by chance. Gardner and Altman (1986) suggest that confidence intervals are more reliable in assessing the validity of a studies results and its effect on the population sample. This study showed a P value between the control and the test group is = 0.0001, which suggests there is a statistically significant difference between the injury group and their control with a mean variance of 0.90°C, showing 95% CI: 0.72 to 1.079. This would suggest that thermal imaging could be used to detect changes due to traumatic injury in children’s wrists; however, it does not demonstrate the ability of thermal imaging to differentiate between a fracture and a soft tissue injury. The second concern for this study is that a type II error may have occurred. Although the results of this study have been promising a larger, multi-­‐centred study must be conducted before any true results can be extrapolated from this study. Another limitation to this study is the clinical arena in which the study was carried out, as previously alluded to in chapter 4. Sackett and Haynes (2002) argue that one should be cautious in assuming that the sensitivity and specificity remains constant across all settings. Although the sample was taken from a group of children attending an emergency department with an injury to their wrist, this sample could be different to a group attending a walk-­‐in centre or general practitioners surgery with a similar complaint. Wagner (2000) suggests that patients may be self-­‐selecting, with children more likely to attend the emergency department with a broken limb while those who believed their injury was less severe would visit their general practitioner or walk-­‐in center. Although this does not affect this studies result per se it may alter the results found in a 104 similar Phase III study involving a remote primary care setting, as indicated as the eventual outcomes for this thermal imaging research. There is no doubt that if thermal imaging is to be used, as a diagnostic test to detect fractures in children, then its greatest use would be in a primary care setting with limited resources and budget. Therefore a phase III study would need to take place within the primary care setting and conducted using the eventual target group. One of the problems when designing this study was the lack of previous research into this specific subject. This led to difficulties in getting the design concept right. The limited research surrounding this area of study has made it difficult to calculate a true power, hence the requirement for a pilot study. However, this exploration into uncharted territory has added to the excitement of the study in the fact that the study results were unique and gained without any pre conception or bias. Field and Morse (1985) suggest that because there is little known about this domain and that the present knowledge and theories surrounding the use of thermal imaging could be biased, that a mixed methodological approach should have been used. They suggest that a qualitative approach may lead to an increased understanding of the subject matter. The need to assess the “real Life” behind this subject is paramount (Hutchinson, 1985, Bickman & Rog, 2009, p 11) for the researcher to fully understand the concept studied. This study should have included qualitative data from the patient and their parent regarding their understanding and expectations of the thermal imaging process. The study should have used a phenomenological approach to gain a better understanding of the “lived experience “of the patient and their families undergoing the diagnostic test in order to investigate the true 105 clinical value of this diagnostic approach (Guenther, Stiles & Champion, 2012, p 602). Guenther et al (2012) used a phenomenological approach to analyse the lived experience of the diagnostic process for women with ovarian cancer, they concluded that this approach gave then a much greater understanding of the diagnostic approach used and how the diagnostic process can be adapted to meet the need of the patients and their families. Another limitation to this study was the lack of research funding, due to the controls imposed at the time of the writing of the study proposal. The national research-­‐funding organisation would not fund PHD or Doctorate studies, which severely impeded the resources available for this study. The camera was loaned to the study by the national research equipment laboratory, which imposed a time frame on the loan period due to a long waiting list for the camera for other research studies. The chief investigator applied to loan the camera again the following year but funding was removed from the national laboratory and they were no longer able to provide loan equipment. The study would have achieved its sample size and run for a greater period of time if funding were provided for the provision of a camera and equipment. A major recommendation for a further, larger study of this type would be to gain funding in order to purchase its own research equipment for the study. Cooke et al.’s (2005) concept paper suggests that thermal imaging may be more accurate twenty-­‐four hours post injury due to the inflammatory response. A thermal image taken at the time of the fracture clinic review may answer this question and prove more clinically accurate. Further studies should include taking thermal images at the time of the fracture clinic follow up, this would be 106 useful in answering the question regarding the optimal time of thermal imaging. It could also act as a further validation of the hypothesis given that all of the patients returning to fracture clinic do have fractures (Silva, 2012; Lindaman, 2001). Another limitation to this study was that no formal follow up was arranged for patients to ascertain whether patients who undergo thermal imaging would fare better than similar patients who do not. Sackett and Haynes (2002) suggest that to fully investigate whether a diagnostic test has true advantages over an alternative is to determine whether patients who undergo that test fare better than similar patient who do not. The evidence produced within this study demonstrates no clinical advantage for the patients presenting to an emergency department to have thermal imaging for their diagnosis of their fracture when compared with an X-­‐ray. The evidence produced by this paper would suggest that due to the inconsistencies in its accuracy and its inability to produce images that assist with the exact location of the fracture and/or the severity of the fracture diagnosed, that the use of thermal imaging when compared with X-­‐rays could be detrimental to the child’s care. Previous studies (Silvia et al., 2012, pp. 1007-­‐1015) have suggested that by using thermal imaging to detect fractures the amount of needless exposure to ionizing radiation produced by X-­‐rays could be reduced. To counter this argument there is evidence to suggest that the levels of radiation used in X-­‐raying a child’s wrist is minimal and equate to 3 days worth of naturally occurring radiation (Belson, 2007, p. 138; Wakeford, 2008, p. 66; Hart, Hillier & Wall, 2003, p. 3). However, a recent study conducted by Bartley, Metayer, Selvin, Ducore and Buffler (2010, pp. 1-­‐10) has called this previous theory into question. Bartley et 107 al. (2010, p. 1) suggest that exposure to post natal diagnostic X-­‐ray’s is associated with an increased risk of childhood acute lymphoid leukemia (ALL). Their research has found that in children below the age of 15 who have had three or more X-­‐ray’s in their lifetime, show a greater risk of contracting acute lymphoid leukaemia. However they do state that these results must be used cautiously and further investigation into this subject carried out. This does suggest that reducing the risk (however small) to children from the exposure of ionizing radiation may warrant further investigation. Nevertheless it does not negate the evidence published within this paper regarding the accuracy of the thermal imaging for the detection of fractures. The evidence produced in this paper suggests that 87% of patients who had no fracture reported following their X-­‐ray could have avoided X-­‐rays if the thermal imaging results were used instead. This poses the question of whether thermal imaging has a role in ruling out a fracture, rather than ruling them in, the results from this study suggests that 30 patients would not have received an X-­‐ray when clinical examination and thermal imaging alone was used. This would have resulted in one clinically significant fracture being missed and four needless X-­‐rays being conducted. With this evidence, one could deduce that 29 patients could have fared better from not having an X-­‐ray in the first place. One of the major draw backs to using thermal imaging when compared to x-­‐rays is that the clinician is unable to identify which bone has been fractured and the severity of that fracture. However Noonan & Price (1998.p 149) ague that the majority of children’s fractures requires no specific clinical intervention other than a splint or plaster, unless clinically deformed, so it could be argued that not knowing the exact location / severity of fracture in a non clinically deformed wrist is clinically 108 irrelevant unless there is evidence of clinical deformity or the wrist is grossly swollen. Even in Salter Harris type fractures the level of deformity has to be greater than 15° of angulation to warrant any clinical intervention other than conservative plaster of Paris management. (Armstrong, Joughlin, Clarke, 1994 p 176) The limitations posed in the above section are significant, however they should not detract from the important results gained by this pilot study. All of the results gained from this limited study support the theory that thermal imaging can be used to detect heat changes in children's wrists following injury, this in itself is a major breakthrough and should pave the way for larger, more well resourced studies. 5.5 Could thermal imaging be used as a screening tool for children’s fractures : An area that has not been investigated within this research study is whether thermal imaging could be better utilized as a screening tool for fractures rather than as a purely diagnostic tool. The definition of screening is: “Screening is a process of identifying apparently healthy people who may be at increased risk of a disease or condition. They can then be offered information, further tests and appropriate treatment to reduce their risk and/or any complications arising from the disease or condition” UK National screening committee (2011p 8) The European World Health Organisation (Holland, Stewart, Masseria, 2006.p5) state that in order for a screening tool to be acceptable they must adhere to Cochrane & Holland (1971p3) seven criteria for the evaluation of a screening tool: The screening tool must be simple to use, acceptable to its client and user 109 group, the screening test should be accurate in order to give a true measurement of the condition or symptoms under investigation, the test results have to be repeatable, capable of giving a positive test when the individual is being screen (sensitivity) and the test should be able capable of giving a negative finding when the individual being screened does not have the condition. The expense of the test must be considered in relation to the benefits of early detection to the disease or condition. Silva et al (2012) in their paper examined this aspect of thermal imaging in greater depth (refer to chapter 2, p26), they used thermal imaging to detect hot spots on pre verbal children’s limbs post injury to determine where to focus their X-­‐rays. They found that the thermal imaging only detected 7 – 11 fractures present returning a sensitivity of 63% and a specificity of 57%. Hosie, Wardrope, Crosby & Ferguson (1987) concluded that thermal imaging may be an acceptable, reliable and cheap method of screening for scaphiod injuries in adults, however, they returned a sensitivity of 77% and a specificity of 82%. The results from this study would suggest that if thermal imaging was used in conjunction with the criteria established by Cochrane and Holland (1971) as a screening tool then 31 out of the 34 children presenting with fractures to the emergency department would have received further diagnostic testing (X-­‐rays), 29 (87%) children would have been sent home correctly without receiving further diagnostics. If clinical examination had not been carried out on these children prior to the screening 3 fractures would have been missed (sensitivity = 91%), five children would have received needless X-­‐rays, however, it could be argued that theses children would have received the X-­‐rays any way as they met the clinical criteria for receiving an X-­‐ray (Webster et al. 2006). One area that thermal imaging may be useful is to screen pre verbal 110 children prior to x-­‐rays. This could prevent “whole limb” x-­‐rays or “excludegrams” by using thermal images to detect injury sites and thus focus the x-­‐ray on specific sites rather than the whole limb. This could be the true role of thermal imaging in the future and should be pursued in future studies. The question of whether thermal imaging would be useful as a clinical screening tools remains unanswered, however this study has highlighted that maybe the clinical importance of thermal imaging lies within screening rather than in diagnostic testing. 5.6 Could Thermal imaging be used as a diagnostic tool in a remote setting? Another area that remains unanswered and not included within the methodology of this study, is whether thermal imaging could be usual as a diagnostic tool within the remote setting? Mant (2005, p. 159) suggests that to extrapolate these results and use them to prove whether thermal imaging may have a use outside the emergency department should be treated cautiously as the population group could be altered toward the setting of the test. Mant (2005) suggests that the population presenting to a walk-­‐in center or general practitioner may be different to those presenting to an Emergency Department, therefore altering the prevalence of the disease. The theories regarding prevalence of disease would suggest that patients may be self selecting, suggesting that children with a fracture would be more likely to preset to an Emergency Department when compared to those with a soft tissue injury, who would either go to a primary care setting or not attend at all. The question of whether a thermal imaging could be useful in the remote setting has not been answered, as the test results are not generalisable to a remote target population. However the controlled environment in which thermal 111 imaging must be taken would prove challenging within a setting of limited resources and could effect the results further (Ring, 2000; Plassman, 2005) An example of how results could be affected if the strict guidance for the use of thermal imaging were not adhered to was demonstrated in Silvia et al. (2012, p. 1014). This study made no attempt to follow standard DITI preparation protocol and as a result only detected seven out of the eleven fractures reported in this study. However this study has produced some promising results and a feasibility study could be developed using these results as a baseline. The study could examine whether thermal imaging does have a use within the pre hospital setting where no X-­‐ray facility exists and the need for a reliable, inexpensive and transportable diagnostic test is required. Further research into the use of thermal imaging must be conducted to examine this theory in more depth. The use of thermal imaging in the detection of fractures per se requires a large-­‐scale multi centred research project with adequate funding and resources made available to the research team. This limited pilot study has highlighted the potential of using thermal imaging for detecting fractures in a group of patients presenting to an emergency department, supporting Hosie et al.’s (1987) original research in this area. Thermal imaging may represent the future of inexpensive, non-­‐invasive and prove an effective diagnostic tool, however more research into this area need to be conducted before it could become part of a solution to the ever changing and beleaguered health care economy. 112 Chapter 6 113 Chapter 6: Conclusion This chapter will discuss the conclusions demonstrated within this study, summarising the key objectives for this study and whether they have been fully achieved. It will document the key findings and suggest ways in which thermal imaging could become part of a mainstream diagnostic imaging pathway for children attending either primary or secondary care services. This represents an exciting avenue for future research and could mark the way for a diagnostic approach, which is accurate, reliable and fit for a future health care programmes. The examination of human physiology and its relationship to the inflammatory process of healing has been studied since the Roman age (Ring & Ammer, 2000). However, only in the last decade has thermal imaging technology advanced enough to be accurate and produce consistent results that can be used with diagnostic certainty (Plassmann et al., 2006). There is evidence to suggest that infrared thermography is an excellent non-­‐invasive tool in the follow-­‐up of hemangiomas, vascular malformations and digit amputations related to re-­‐
implantation, burns as well as skin and vascular growth after biomaterial implants in newborns with gastroschisis and giant omphaloceles. In the emergency department, it has been shown to be a valuable tool for rapid diagnosis of extremity thrombosis, varicoceles, inflammation, abscesses, gangrene and wound infections (Jung & Zuber, 1998; Saxena & Willital, 2007). However, research into the use of digital infrared thermal imaging over the last thirty years to detect bony injury has been limited to only 14 other studies, with only one examining its use for children (Silva, 2012). 114 This pilot study has achieved it objectives by presenting data to demonstrate both clinical and statistical significance for the use of thermal imaging to detect the presence of a fracture in a child’s wrist post injury when compared to a non-­‐
injured wrist. The main finding of this research found that there was a statistical difference between a non-­‐injured limb and a fracture (mean difference = 1.28, 95%CI .889 to 1.689). The result’s from this study demonstrate that children presenting with fractures to there ulna and radius are more likely to have a temperature recording greater than 1˚C than that of a child without a fracture. The results found a difference of 1˚C or more in the fractured limb when compared to the non-­‐injured limb in 31 out of 34 cases, showing a sensitivity of 91.18 % and a specificity of 87.85% when compared to the gold standard. However, the sensitivity increased significantly when associated with a clinical examination to 96.7% which compares very favourably with the gold standard (radiographs), which in a recent study produces a sensitivity of 95.1% when applied to the interpretation of children’s X-­‐rays by the average clinician (Pountos et al., 2010). Although this study has demonstrated that thermal imaging can be used to detect fractures in children’s wrists when compared to a non-­‐injured wrist, its reliability and accuracy in detecting 100% of the fractures has been challenged. Thermal imaging has not consistently demonstrated that it can accurately detect the difference between a fracture and a soft tissue injury using a target temperature of greater than 1˚C. If thermal imaging had been used to determine whether a child received an X-­‐ray or not, 12 out of 100 children would receive needless X-­‐rays. These results do demonstrate a quantifiable difference between an uninjured limb, a fracture and a soft tissue injury, but the results have to be used cautiously as they do not show the differences on every 115 examination. However, this study has been conducted with a limited sample size and further studies would be needed to validate these findings. Sackett and Haynes (2002) suggest that for this study to test the methodology in order to move onto a full the phase III study it must be shown to be independent and blind when compared with the gold standard of diagnosis. This study meets the criteria fully with all of the patients undergoing the diagnostic test and the gold standard test with the reference standard applied, regardless of the test result. The study was blinded in that the reference standard test results were interpreted in total ignorance to the diagnostic test results and vise-­‐versa (Sackett & Haynes, 2002, p. 31). The pilot study represents a significant development into the use of thermal imaging within the field of diagnostics, though it highlights the need for a standardised approach to thermal imaging within the clinical environment. This is the first documented paper examining the use of thermal imaging to detect fractures in children's wrist and highlights its potential use within health care. One coincidental finding from this paper is that the inclusion criteria established from research carried out by Webster et al. (2005) confirms their finding that clinical decision rules used for the detection of fractures are not reliable in ruling out the presence of a fracture and therefore cannot be used to make a clinical diagnosis on their own. 6.1 Summary: This paper highlights the need for further research into developing new technology, which would enhance the care and experience of a certain client groups, which could be more cost effective and efficient in terms of care delivery. 116 There is no doubt that this thesis marks the infancy of thermal imaging research in the area of fracture detection and its use within the clinical setting. The need for a larger phase III study is evident from the published finding, and does demonstrate a degree of success for thermal imaging to be used to detect fractures in children. The major floor in the use of thermal imaging in this way is its inconsistency in practice and the fact that it is not 100% reliable as a diagnostic tool. This paper has demonstrated concerns over its use within the mainstream health care system, however with further research and mechanical advances into the thermal imaging technology the reliability and sensitivity of the imaging equipment may be improved. Key Findings: • Thermal imaging is not consistently reliable in detecting fractures of the ulna and radius in children returning a sensitivity of only 91.8% when compared with x-­‐rays (96.8%) however when used along side clinical examination the results demonstrate a sensitivity of up to 96.7%. • Thermal imaging can detect quantifiable differences in temperature, between an uninjured wrist, a soft tissue injury and a fracture. • Further research needs to be conducted in this area, and funding established for the development of the theory surrounding the use of thermal imaging as a future low cost, non-­‐invasive diagnostic test. • A full phase III multi centered study must be developed to establish whether thermal imaging could be a useful adjunct to the diagnosis of fractures within the wider health care setting. 117 6.2 Implication for practice Over four million children attend Emergency Departments annually (RCPCH 2012p 9). Wrist fractures account for approximately 30% of all attendance's (Firmin & Crouch, 2009) to either walk in centres or emergency departments. A large number of these are diagnosed as simple green stick or torus fractures that could easily be managed conservatively within the primary care setting (Boyer, 2002). Although this study does not examine whether thermal imaging may be useful out side the emergency department boundaries it does provide the researcher with information surrounding the challenges of using thermal imaging outside the controlled environment of the emergency department setting. This pilot study has highlighted that thermal imaging may be useful in the diagnoses of fractures to the ulna/radius in children with reasonable efficacy. The results of this study and previous audits carried out within the clinical setting have shown that up to 79 children a month attend the emergency department due to a painful wrist. There is no doubt that a reduction in these numbers attending the emergency department could be beneficial both to the health economy and patients themselves (DOH, 2005; Cooke, 2005). All simple wrist fractures, unless clinically displaced, could be treated initially in the community/primary care setting without the major upheaval of attending the emergency department and carefully planned follow up (Ippokratis et al., 2010; Symons et al., 2001; Bosse et al., 2005; West et al., 2005). The advantages of a community based thermal imaging center rather than a fully equipped radiology 118 department is evident both in terms of cost and reduced ionizing radiation exposure to the client group involved (Williamson et al., 2000). If patients meeting the clinical inclusion criteria presented to a walk in centre equipped with a thermal imaging camera, then a thermal image could be taken and a decision made regarding the further treatment and care of that patient made. This would result in tangible cost saving to the health economy. If proven clinically effective the cost of a thermal imaging camera with up-­‐keep would be less than £60,000, no special facilities need to be built and it could be accommodated in a normal clinical space and used by the attending clinician. 6.3 Dissemination of findings: A paper is currently being written for publication on this thesis and its research findings the author wanted to complete the study and thesis before publishing the complete results of this research study. The study was presented at the Wessex Regional Emergency Care conference in Sept 2012 119 Chapter 7 120 Chapter 7: Reflections on the doctorate program Formal reflection in terms of models and set formulas has never sat comfortably with me, as I have found that they do not meet my individual learning style or needs. However, it would be naive of me to think that reflection does not play an important role in my professional development. Those who know me and work with me will know that I spend a great deal of time both internalising and externalising clinical scenarios to try to improve practice or do something different next time, one could argue that this is a form of ‘reflection in action’ as described by Schon (1983). Holm and Stephenson (1994) expressed support for this idea of reflection suggesting that there can be no definitive rules and no universally correct way in which to reflect and therefore reflection must be individually based and individually relevant. However, a model I found useful for evaluating and reflecting on educational programs during my Masters in Education is one devised by Gibbs (1988) as it was routed firmly within education with emphasis placed on learning. However, to reflect on this educational and professional program I have decided to use Borton’s (1970) reflective framework as the model has been developed around practice, and allows the practitioner to explore the journey they have embarked upon fully. From an early stage in my career it became apparent to me that life long learning was going to be an important part of my career development and progression. For nursing to evolve as a profession it has had to develop its own unique body of evidence and researched based practice (Jasper, 1999). Therefore it has become increasingly important for nurses and professionals allied to medicine to 121 become more professional and academically astute. This has become increasingly difficult, as the blurring of professional roles and boundaries has meant that the exclusivity of practice between the differing professions no longer exists (Eddy, 1996). The main reason for me to enroll on this professional doctorate was that I required an educational programme that would support my progression from an emergency nurse practitioner/senior nurse to a consultant nurse in Paediatric Emergency Medicine. The Professional doctorate appeared to enhance the symbiotic relationship between practice and academia. This educational program appeared to be ideally suited to the development of the consultant practitioner role. The four elements of the professional doctorate encompass all of the consultant practitioner role, research, education, expert practice, leadership and strategic service development (Skills for health, 2010). The educational program in my opinion is the only programme available to allow the clinician to develop their own practice at doctorate level. The need for me to develop my expertise in clinical practice and develop my post with recognisable and established competences was paramount to demonstrate my clinical expertise as a consultant in Paediatric Emergency Medicine and practice on equal terms with my medical colleagues (College of Emergency Medicine, 2007). The professional doctorate has been divided into two parts and is a development of the taught doctorate where the final research thesis is focused strictly on an element of clinical practice. The professional doctorate offered me the professional development that I required in a way that a traditional PHD could not. The taught equipped my with the tools required to take on the research element but as described above encouraged me to develop my clinical practice. The three key areas in which the taught program enhanced my practice, 122 Ø The clinical Portfolio of PEM competency, as part of my professional doctorate clinical portfolio, which took three years to complete and challenged my professional competence at every level. Ø Advanced diagnostic skills, the ability to perform ultra sound and thermal imaging investigations independently. Ø Clinical leadership, develop my skills to lead clinical scenarios as a consultant. This programme has developed my thinking and knowledge surrounding the specialty of emergency medicine encouraging me to think out side the box and develop my practice further. Since embarking on the clinical doctorate I have become part of an editorial team for four major texts in the field of emergency nursing and paediatric emergency medicine, the most exciting being the Oxford Handbook of Emergency Nursing, which has sold over 6000 copies and is now in development for its second edition. There is no doubt that the publications module assisted me with the development of this title and subsequent publication. The importance of the clinical element of the Professional Doctorate and it close links to advanced practice must not be underestimated or lost in the world of academia and is the key element of the course that makes it unique and more credible in terms of professional recognition. Whilst on the course I was called upon to practice independently in many differing clinical environments both with in this country and abroad, the clinical element of this program meant that I was professionally and clinically prepared for that challenge. I don't feel that any 123 other programme would have better prepared me for the clinical challenged that I faced. So what: what was good and what was bad about the experience On reflection the educational programme of the professional doctorate was exactly what I required to enhance my career and professional development both in terms of clinical and theoretical knowledge. There is no doubt that I have found the process extremely difficult with trying to juggle a full time job as the consultant lead in paediatric emergency medicine, an army nurse in the Army Reserve and my other national and international professional commitments. I thoroughly enjoyed my honorary consultant nurse position in St Mary’s Paddington and I am indebted to their commitment to develop my professional practice and clinical knowledge in the field of paediatric emergency medicine, I regret that due to my own clinical commitments I was unable to continue with this practice/ opportunity. This experience enabled me to advance my practice in a progressive but safe environment away from the challenging distracting environment of my own work place. One of the major challenges for completing this study was the conflicting time constraints imposed on me and the lack of education time allocated to me over the past 5 years. That said I should have been a lot more disciplined with my time and prioritised better. Another major challenge / threat to my research project has been the availability of a loan thermal imaging camera, although the National Research Loan Laboratory lent me the camera it was only for a very limited period and over this time the camera had to be returned to the manufacturer due to a breakage. This 124 became a real issue in that it meant that the study was only carried out over a month meaning that only 67 subjects where enrolled into the study. Attempts to secure the camera for a longer loan period were quashed due to the closure of the loan facility and the lack of funding. For future studies, funding must be gained to purchase a research camera through Flir and thus not rely on other outside agencies. At the time of developing the research model the national research funding institutes would not provide funding for PHD or doctoral students, this is currently not the case and funding streams have become available. To enhance the study I think I would have included a patient / parent qualitative questioner exploring the use acceptability towards thermal imaging versus X-­‐ray. Anecdotally, the end users expressed a real interest in the new technology and expressed very positive attitudes towards the use of thermal imaging within the clinical arena. Although the study results do not present compelling evidence that thermal imaging can be used equivocally to determine whether a child has a fracture in the wrist following injury, they do highlight the importance of further research into this area of diagnostics. The development of improved thermal imaging technology over the last decade has meant that the imaging is more reliable and reproducible. I remain committed to this technology, sincerely believing that the development of this cost effective, non-­‐invasive form of diagnostic imaging has a very promising future. Now what: Following a presentation given at the Wessex Emergency Care Committee conference in September 2012, an expression of interest in continuing the 125 research into this topic has been articulated by the chair of the South of England Children’s Trauma Network. Funding would be needed to carry out a phase III multi centered trial into the use of thermal imaging for the detection of wrist fractures in children. I remain convinced that this could be the tip of the iceberg in terms of diagnostic imaging and further research in to other areas of diagnostic imaging need to be explored within in the specialty of Children’s Emergency Care. For example, the detection of toddlers fractures in children’s lower limbs, detect hip effusions and aid the diagnosis of appendicitis in children remains unexplored, however, potential has been shown in these areas. My practice and clinical knowledge will continue to expand and I remain committed to life-­‐long learning and developing my knowledge and skills in paediatric emergency medicine. I feel that the professional doctorate is by no means the end stage in my professional learning but a new dawn in my clinical practice and education. 126 Bibliography Akobeng, A. (2007). Understanding diagnostic tests 2: likelihood ratio, pre-­‐ and post-­‐test probabilities and their use in clinical practice. Acta Paediatrica, 96(4): 487-­‐491. Altman, D. G. & Bland J.M. 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NHS Trust
Consent Form
Version 2 dated 11/03/08 Patient ID for this trial: Name of researcher: Alan Charters Detection of fractures in children using thermal imaging as a diagnostic screening tool • I confirm that I have read and understand the information sheet (version 2 Dated 12/03/08) for the above study and have had the opportunity to ask questions • I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. • I understand that sections of any of my medical notes may be looked at by responsible individuals from regulatory authorities where it is relevant to my taking part in research. .
I agree that the thermal images and x-­‐rays taken can be used in this research •
•
I agree to take part in the above study. Name of participant: ………………………………………………………….. Date:……………. Signature:……………………………………………………………………………………………… Name of person taking consent:………………………………………………….Date:…………… Signature:……………………………………………………………………………………………… Researchers signature:……………………………………………………………Date:………..….. 149 Portsmouth Hospitals NHS
NHS Trust
Patient ID for this trial: Parent & participant (aged 0-­‐15 years) Consent Form Name of researcher: Alan Charters Detection of fractures in children using thermal imaging as a diagnostic screening tool Please initial box Child Parent/carer I confirm that I (parent)………………………….have read and understand the information sheet (version 12/03/08) for the above study and that (child)…………………………has read the information sheet (version 1 12/03/08 ) and we both have had the opportunity to ask questions. • We understand that our participation is voluntary and that are free to withdraw at any time, without giving any reason, •
we without our medical care or legal rights being affected. • We understand that sections of the medical notes maybe looked at by responsible individuals from regulatory authorities where it is relevant to us taking part in research. I agree that the thermal images and x-­‐rays taken can be used in this research •
•
We give our permission for these individuals to access (child’s name) ………………………………… records 150 •
We agree to take part in the above study. Name of child:………………………………………………………… …………Date:……………. Signature:……………………………………………………………………………………………… Name of parent/carer……………………………………………………………..Date:……………. Signature:……………………………………………………………………………………………… Name of person taking consent:………………………………………………….Date:…………… Signature:……………………………………………………………………………………………… Researchers signature:……………………………………………………………Date:………..….. 4 copies of form required – 1 to chiAppendix 3: Version 2 12/03/08 151 Appendix 3: Data collection form 152 Version 2 12/03/08
Date …………………………. Patient No. ………………….. Pain Score …………………… Inclusion criteria: o Children under the age of 16
Age ………………………….. Analgesia given: Yes / No (and / or )
o Complaining of or indicating pain in their wrist
o Obvious swelling and deformity of the wrist
o Child is unable to supinate or pronate their wrist or has severe loss
of function
Consent gained by whom: please initial ……………………………………………………… Temperature of room in degrees Centigrade…………………………………………………... X-­‐ray: Initial report X-­‐ray: Radiology report Treatment given: Exclusion Criteria
•
Patients that have had topical cream or cosmetics applied to their arm
such as fake tan etc. This can artificially affect the skin temperature and
therefore skew the test results
•
Patients who smoke, external environmental factors such as smoking has
be shown to effect skin temperature and therefore skew results
Thermal image to be reviewed at the end of study not on day of x –ray Temperature gradient of uninjured wrist ………………………………………………….. Temperature gradient of injured wrist …………………………………………………….. Obvious hot spot in thermal picture of injured ……………………………………….. 153 Appendix 4: Ethics Committee acceptance letter 154 155 156 157