No description available.

No description available.

The aim of this thesis was to develop and evaluate a complex intervention for major depression in patients with lung cancer. Major depression is a leading cause of disease burden worldwide and is particularly important in patients with lung cancer, not only because it is common in this poor prognosis cancer group but also because it substantially reduces the quality of the often short period of time that patients have left to live. The thesis describes a systematic review of the relevant research literature, the development of a complex intervention and a multi-centre randomised controlled trial. I found no trials, in my systematic review, that had evaluated the effectiveness of treatments for depression in patients with lung cancer. I did, however, find six trials of interventions intended to improve symptoms or quality of life in this patient group, the findings of which suggested that enhanced care approaches were more effective in reducing depressive symptoms than standard medical care. I developed the complex intervention ‘Depression Care for People with Lung Cancer’ (DCPLC) with 12 patients who had major depression and lung cancer. DCPLC was delivered by a team of cancer nurses and psychiatrists in collaboration with the patient’s GP. It included education about depression, antidepressant medication, psychological treatments (behavioural activation and problem solving therapy) and systematic progress monitoring. The trial comparing DCPLC with usual care included 142 patients. Patients who received DCPLC reported significantly lower average depression severity during their time in the trial, and better self-rated depression improvement, anxiety, quality of life, role functioning and perceived quality of depression care. The methodological limitations, relevant literature and implications of these findings for future research and for clinical practice are discussed.

No description available.

PhD / Abstract Low back pain is a significant public health problem in many countries of the world being one of the major causes of work absence and disability. Although the outlook for evidence-based management of low back pain has greatly improved over the past decades, many questions remain. Questions related to treatment options, underlying mechanisms of treatment effects and optimal assessment of low back pain have yet to be fully addressed by researchers. The broad aim of this thesis therefore was to contribute to a better understanding of the contemporary management of low back pain by performing studies in these key research areas. Most clinical practice guidelines recommend exercise as an effective treatment option for chronic low back pain. However the evidence for this recommendation comes from trials that are not placebo-controlled and so this may potentially provide biased estimates of the effects of exercise. Therefore a randomised controlled trial testing the effect of motor control exercise versus placebo in patients with chronic low back pain was conducted. Chapters 2 and 3 describe the trial protocol and the report of the trial respectively. A total of 154 patients with chronic low back pain were randomised to receive a motor control exercise program, or placebo (i.e. detuned short-wave therapy and detuned ultrasound therapy). Primary outcomes were pain, function, and the patient’s global impression of recovery measured at 2 months. The exercise intervention improved function and patient’s global impression of recovery, but not pain, at 2 months. The mean effect of exercise on function was 1.1 points (95%CI, 0.3 to 1.8), the mean effect on global impression of recovery was 1.5 points (95%CI, 0.4 to 2.5) and the mean effect on pain was 0.9 points (95%CI, - 0.01 to 1.8), all measured on 11 point scales. Secondary outcomes also favoured motor control exercise. This is the first study ever to demonstrate that motor control exercise is better than placebo for patients with chronic low back pain. Most of the treatment effects were maintained at 6 and 12 months follow-up. These results suggest that this intervention should be considered for patients with chronic low back pain in order to improve disability, function, and global impression of recovery, and to improve pain intensity in the long term, but not in the short term. Rehabilitative ultrasound imaging (RUSI) has been increasingly used by physiotherapists in order to identify impairments in motor control as well as to monitor progress of patients with low back pain. As with any other clinical measure it is important to know how reproducible the RUSI measures are, and although there are some reproducibility studies in the literature, no systematic review on this topic has been conducted. Therefore a systematic review was performed with the objective of assessing the reproducibility studies of RUSI for abdominal wall muscles (Chapter 4). Eligible studies were indentified via searches in CINAHL, EMBASE and MEDLINE with citation tracking via the Web of Science Index. A total of 21 studies were included. Due to heterogeneity of the studies’ designs, pooling the data for a meta-analysis was not possible. RUSI measures of thickness of abdominal wall muscles were found to be reliable. Few studies analysed the reliability for the measurement of thickness changes (reflecting the muscle activity) finding good to poor results. Evidence for the reproducibility of the difference in thickness changes over time (necessary to evaluate improvements in muscle activity with treatment) was not available. A limitation of the existing literature is that studies typically had suboptimal designs and analysis. The current evidence for the reproducibility of RUSI for measuring abdominal muscle activity is mainly based upon studies with suboptimal designs that included mostly healthy subjects, making generalisability to clinical settings uncertain. Some questions about the reproducibility of RUSI measures of abdominal wall muscles are still unanswered; this is mainly due to design issues, such as inadequate statistics, inadequate sampling and lack of control of sources of bias (e.g. blinding and absence of controlling for ordering effects). In addition the clinically important questions about the reproducibility of thickness changes (reflecting the muscle activity) and differences in thickness changes over time (reflecting the improvement or deterioration of muscle activity) have not been adequately investigated. Therefore a reproducibility study that aimed to answer these questions was performed (Chapter 5). Thirty-five patients seeking care for chronic low back pain participated in this study. RUSI measures were taken at baseline and eight weeks post-baseline. Replicate measures of thickness, thickness changes and differences in thickness changes over time were analysed. The reproducibility of static images (thickness) was excellent (ICC2,1 = 0.97, 95%CI = 0.96-0.97, Standard Error of the Measurement (SEM) = 0.04cm, Smallest Detectable Change (SDC) = 0.11cm), the reproducibility of thickness changes was moderate (ICC2,1 = 0.72, 95%CI 0.65-0.76 SEM = 15%, SDC 41%), while the reproducibility of differences in thickness changes over time was poor. Improvements in the test protocol should be undertaken in order to enhance the reproducibility of RUSI measures, especially for differences in thickness chang over time. Self-report outcome measures (questionnaires) are widely used by health care providers for measuring patient’s health status or treatment outcomes. Most of the questionnaires related to low back pain were developed in English and therefore their usefulness in non-English speaking countries is considerably limited. Cross-cultural adaptation and clinimetric testing are possibly the most efficient methods for solving this problem. Although there are many publications on the topic, a simple guide on how to perform a cross-cultural adaptation and clinimetric testing was not available. Therefore a “clinician-friendly” narrative review for Brazilian physical therapists (Chapter 6) was written. This review aimed firstly to explain the concepts and the relevance of cross-cultural adaptation and clinimetrics testing, secondly to summarise the current guidelines on the topic, thirdly to provide advice on how to choose a relevant questionnaire and finally how to evaluate the quality of an adapted questionnaire. Some examples of cross-cultural adaptations and clinimetrics testing of relevant low back pain questionnaires in the Brazilian-Portuguese language were also provided. Although the number of international versions of low back questionnaires is growing, to date it is unclear which questionnaires have been cross-culturally adapted and into which specific language. To answer these questions a systematic review was conducted in order to describe the available cross-cultural adaptations of low back pain self-report outcome measures and the clinimetric testing that has occurred for each adaptation (Chapter 7). Searches were performed in MEDLINE, EMBASE, CINALH and LILACS; these searches were supplemented with information from experts in the field of low back pain from 27 different countries to ensure that the results were comprehensive. Sixty-one adaptations were identified. While there are a large number of low back pain questionnaires available, very few have been adapted into other languages, particularly commonly spoken languages such as Mandarin, Hindi and Portuguese. The quality and comprehensiveness of clinimetric testing varied considerably, with the evaluation of reliability and construct validity most common. Further cross-cultural adaptation and clinimetric studies are clearly needed and special consideration must be given to study designs for clinimetric testing. The final aim of this thesis was to cross-culturally adapt self-report instruments relevant to the management of low back pain in Brazil. This was achieved by two independent studies. The first study (Chapter 8) aimed to cross-culturally adapt the Functional Rating Index (FRI) into Brazilian-Portuguese and to test the clinimetric properties of the FRI and also of an existing Brazilian-Portuguese version of the Roland Morris Disability Questionnaire (RMDQ) which was not fully evaluated in the original study. Both instruments were tested for internal consistency, reliability, construct validity, ceiling and floor effects and internal responsiveness in 140 chronic low back patients presenting for physiotherapy treatment in Brazil. Both instruments were considered reliable and valid for the measurement of disability in Brazilian-Portuguese speakers with low back pain, no ceiling or floor effects were detected, but the internal responsiveness of both instruments was considered small. The second study (Chapter 9) aimed to cross-culturally adapt the Patient-Specific Functional Scale (PSFS) and to perform a head-to-head comparison of the clinimetric properties of the PSFS, RMDQ and FRI. All instruments were tested for internal consistency, reliability, construct validity, ceiling and floor effects, internal and external responsiveness in 99 acute low back patients presenting for physiotherapy treatment in Brazil. In order to fully test the construct validity and external responsiveness, it was necessary to cross-culturally adapt the Pain Numerical Rating Scale and the Global Perceived Effect Scale. The results of this study demonstrate that the Brazilian-Portuguese versions of the RMDQ, FRI and PSFS have similar clinimetric properties to each other and to the original English versions; however the PSFS was the most responsive instrument. The results from the studies in Chapters 8 and 9 will benefit the understanding of low back pain by enabling international comparisons between studies conducted in Brazil and English speaking countries. In addition it will encourage researchers to include Brazilian- Portuguese speakers in their future clinical trials. Overall, the studies included in this thesis have provided an important contribution to the contemporary management of low back pain. Firstly the use of motor control exercise could be considered for patients with chronic low back pain as it produces improvements in global impression of recovery, function, disability and pain. Secondly RUSI measures of abdominal wall muscles in patients with low back pain were considered reproducible for the measurement of muscle activity, but not as an outcome measure to detect improvement/deterioration of muscle activity over the course of treatment. Thirdly just a few high-quality cross-cultural adaptations and clinimetrics testing for self-report outcome measures relevant to the management of low back pain are available, and clearly more studies in this area are needed. Finally the Brazilian-Portuguese versions of the Functional Rating Index, the Roland Morris Disability Questionnaire and the Patient-Specific Functional Scale have acceptable clinimetric properties and could be used in clinical practice as well as in research studies in Brazil.

Background: Acupuncture involves puncturing the skin with thin sterile needles at defined acupuncture points. Previous studies are inconclusive regarding the effect of acupuncture on labour pain, but some studies have found a reduction in the use of pharmacological pain relief when acupuncture is administered. The appropriate dose of acupuncture treatment required to elicit a potential effect on labour pain has not been fully explored. The dose is determined by many different factors, including the number of needles used and the intensity of the stimulation. In Sweden, manual stimulation of the needles is common practice when acupuncture is used for labour pain, but electrical stimulation of the needles, which gives a higher dose, could possibly be more effective. The overall aim of this thesis was to evaluate the effectiveness of acupuncture with manual stimulation (MA) of the needles as well as acupuncture with a combination of manual and electrical stimulation (EA) in reducing labour pain, compared with standard care without any form of acupuncture (SC). Methods: The study was designed as a three-armed randomised controlled trial in which 303 nulliparous women with normal pregnancies were randomised to MA, EA, or SC. The primary outcome was labour pain, assessed using the Visual Analogue Scale (VAS). Secondary outcomes were relaxation during labour, use of obstetric pain relief, and associations between maternal characteristics and labour pain and use of epidural analgesia respectively. Also, labour and infant outcomes, recollection of labour pain, and maternal experiences, such as birth experience and experience of the midwife, were investigated two months after the birth. The sample size calculation was based on the potential to discover a difference of 15 mm on the VAS. Data were collected during labour before the interventions, the day after birth, and two months later. Besides using the VAS, information was collected by means of study specific protocol, questionnaires and medical records. Results: The mean VAS scores were 66.4 in the MA group, 68.5 in the EA group, and 69.0 in the SC group (mean differences: MA vs. SC 2.6 95% CI -1.7 to 6.9, and EA vs. SC 0.6 95% CI -3.6 to 4.8). Other methods of pain relief were used less frequently in the EA group, including epidural analgesia, MA 61.4%, EA 46%, and SC 69.9%. (EA vs. SC OR 0.4 95% CI 0.2 to 0.7). No statistically significant differences were found in the recollection of labour pain between the three groups two months after birth (mean VAS score: MA 69.3, EA 68.7 and SC 70.1). A few maternal characteristics were associated with labour pain (age, dysmenorrhea, and cervix dilatation), but none of the investigated characteristics predicted the outcome of the acupuncture treatment in MA or EA. Women in the EA group experienced acupuncture as being effective for labour pain to a higher extent than women who received MA, MA 44.4%, EA 67.1% (EA vs. MA OR 2.4 95% CI 1.2 to 4.8). Women in the EA group also spent less time in labour (mean 500 min) than those who received MA (mean 619 min) and SC (mean 615 min) (EA vs. MA HR 1.4 95% CI 1.0 to1.9, EA vs. SC HR 1.4, 95% CI 1.1 to 2.0), and had less blood loss than women receiving SC, (EA vs. SC OR 0.1 95% CI 0.3 to 0.7). The women’s assessment of the midwife as being supportive during labour (MA 77.2%, EA 83.5%, SC 80%), overall satisfaction with midwife care (MA 100%, EA 97.5%, SC 98.7%), and having an overall positive childbirth experience (MA 64.6%, EA 61.0%, SC 54.3%) did not differ statistically. No serious side effects of the acupuncture treatment were reported. Conclusion: Acupuncture, regardless of type of stimulation, did not differ from standard care without acupuncture in terms of reducing women’s experience of pain during labour, or their memory of pain and childbirth overall two months after the birth. However, other forms of obstetric pain relief were less frequent in women receiving a combination of manual and electrical stimulation, suggesting that this method could facilitate coping with labour pain.

PhD / Abstract Low back pain is a significant public health problem in many countries of the world being one of the major causes of work absence and disability. Although the outlook for evidence-based management of low back pain has greatly improved over the past decades, many questions remain. Questions related to treatment options, underlying mechanisms of treatment effects and optimal assessment of low back pain have yet to be fully addressed by researchers. The broad aim of this thesis therefore was to contribute to a better understanding of the contemporary management of low back pain by performing studies in these key research areas. Most clinical practice guidelines recommend exercise as an effective treatment option for chronic low back pain. However the evidence for this recommendation comes from trials that are not placebo-controlled and so this may potentially provide biased estimates of the effects of exercise. Therefore a randomised controlled trial testing the effect of motor control exercise versus placebo in patients with chronic low back pain was conducted. Chapters 2 and 3 describe the trial protocol and the report of the trial respectively. A total of 154 patients with chronic low back pain were randomised to receive a motor control exercise program, or placebo (i.e. detuned short-wave therapy and detuned ultrasound therapy). Primary outcomes were pain, function, and the patient’s global impression of recovery measured at 2 months. The exercise intervention improved function and patient’s global impression of recovery, but not pain, at 2 months. The mean effect of exercise on function was 1.1 points (95%CI, 0.3 to 1.8), the mean effect on global impression of recovery was 1.5 points (95%CI, 0.4 to 2.5) and the mean effect on pain was 0.9 points (95%CI, - 0.01 to 1.8), all measured on 11 point scales. Secondary outcomes also favoured motor control exercise. This is the first study ever to demonstrate that motor control exercise is better than placebo for patients with chronic low back pain. Most of the treatment effects were maintained at 6 and 12 months follow-up. These results suggest that this intervention should be considered for patients with chronic low back pain in order to improve disability, function, and global impression of recovery, and to improve pain intensity in the long term, but not in the short term. Rehabilitative ultrasound imaging (RUSI) has been increasingly used by physiotherapists in order to identify impairments in motor control as well as to monitor progress of patients with low back pain. As with any other clinical measure it is important to know how reproducible the RUSI measures are, and although there are some reproducibility studies in the literature, no systematic review on this topic has been conducted. Therefore a systematic review was performed with the objective of assessing the reproducibility studies of RUSI for abdominal wall muscles (Chapter 4). Eligible studies were indentified via searches in CINAHL, EMBASE and MEDLINE with citation tracking via the Web of Science Index. A total of 21 studies were included. Due to heterogeneity of the studies’ designs, pooling the data for a meta-analysis was not possible. RUSI measures of thickness of abdominal wall muscles were found to be reliable. Few studies analysed the reliability for the measurement of thickness changes (reflecting the muscle activity) finding good to poor results. Evidence for the reproducibility of the difference in thickness changes over time (necessary to evaluate improvements in muscle activity with treatment) was not available. A limitation of the existing literature is that studies typically had suboptimal designs and analysis. The current evidence for the reproducibility of RUSI for measuring abdominal muscle activity is mainly based upon studies with suboptimal designs that included mostly healthy subjects, making generalisability to clinical settings uncertain. Some questions about the reproducibility of RUSI measures of abdominal wall muscles are still unanswered; this is mainly due to design issues, such as inadequate statistics, inadequate sampling and lack of control of sources of bias (e.g. blinding and absence of controlling for ordering effects). In addition the clinically important questions about the reproducibility of thickness changes (reflecting the muscle activity) and differences in thickness changes over time (reflecting the improvement or deterioration of muscle activity) have not been adequately investigated. Therefore a reproducibility study that aimed to answer these questions was performed (Chapter 5). Thirty-five patients seeking care for chronic low back pain participated in this study. RUSI measures were taken at baseline and eight weeks post-baseline. Replicate measures of thickness, thickness changes and differences in thickness changes over time were analysed. The reproducibility of static images (thickness) was excellent (ICC2,1 = 0.97, 95%CI = 0.96-0.97, Standard Error of the Measurement (SEM) = 0.04cm, Smallest Detectable Change (SDC) = 0.11cm), the reproducibility of thickness changes was moderate (ICC2,1 = 0.72, 95%CI 0.65-0.76 SEM = 15%, SDC 41%), while the reproducibility of differences in thickness changes over time was poor. Improvements in the test protocol should be undertaken in order to enhance the reproducibility of RUSI measures, especially for differences in thickness chang over time. Self-report outcome measures (questionnaires) are widely used by health care providers for measuring patient’s health status or treatment outcomes. Most of the questionnaires related to low back pain were developed in English and therefore their usefulness in non-English speaking countries is considerably limited. Cross-cultural adaptation and clinimetric testing are possibly the most efficient methods for solving this problem. Although there are many publications on the topic, a simple guide on how to perform a cross-cultural adaptation and clinimetric testing was not available. Therefore a “clinician-friendly” narrative review for Brazilian physical therapists (Chapter 6) was written. This review aimed firstly to explain the concepts and the relevance of cross-cultural adaptation and clinimetrics testing, secondly to summarise the current guidelines on the topic, thirdly to provide advice on how to choose a relevant questionnaire and finally how to evaluate the quality of an adapted questionnaire. Some examples of cross-cultural adaptations and clinimetrics testing of relevant low back pain questionnaires in the Brazilian-Portuguese language were also provided. Although the number of international versions of low back questionnaires is growing, to date it is unclear which questionnaires have been cross-culturally adapted and into which specific language. To answer these questions a systematic review was conducted in order to describe the available cross-cultural adaptations of low back pain self-report outcome measures and the clinimetric testing that has occurred for each adaptation (Chapter 7). Searches were performed in MEDLINE, EMBASE, CINALH and LILACS; these searches were supplemented with information from experts in the field of low back pain from 27 different countries to ensure that the results were comprehensive. Sixty-one adaptations were identified. While there are a large number of low back pain questionnaires available, very few have been adapted into other languages, particularly commonly spoken languages such as Mandarin, Hindi and Portuguese. The quality and comprehensiveness of clinimetric testing varied considerably, with the evaluation of reliability and construct validity most common. Further cross-cultural adaptation and clinimetric studies are clearly needed and special consideration must be given to study designs for clinimetric testing. The final aim of this thesis was to cross-culturally adapt self-report instruments relevant to the management of low back pain in Brazil. This was achieved by two independent studies. The first study (Chapter 8) aimed to cross-culturally adapt the Functional Rating Index (FRI) into Brazilian-Portuguese and to test the clinimetric properties of the FRI and also of an existing Brazilian-Portuguese version of the Roland Morris Disability Questionnaire (RMDQ) which was not fully evaluated in the original study. Both instruments were tested for internal consistency, reliability, construct validity, ceiling and floor effects and internal responsiveness in 140 chronic low back patients presenting for physiotherapy treatment in Brazil. Both instruments were considered reliable and valid for the measurement of disability in Brazilian-Portuguese speakers with low back pain, no ceiling or floor effects were detected, but the internal responsiveness of both instruments was considered small. The second study (Chapter 9) aimed to cross-culturally adapt the Patient-Specific Functional Scale (PSFS) and to perform a head-to-head comparison of the clinimetric properties of the PSFS, RMDQ and FRI. All instruments were tested for internal consistency, reliability, construct validity, ceiling and floor effects, internal and external responsiveness in 99 acute low back patients presenting for physiotherapy treatment in Brazil. In order to fully test the construct validity and external responsiveness, it was necessary to cross-culturally adapt the Pain Numerical Rating Scale and the Global Perceived Effect Scale. The results of this study demonstrate that the Brazilian-Portuguese versions of the RMDQ, FRI and PSFS have similar clinimetric properties to each other and to the original English versions; however the PSFS was the most responsive instrument. The results from the studies in Chapters 8 and 9 will benefit the understanding of low back pain by enabling international comparisons between studies conducted in Brazil and English speaking countries. In addition it will encourage researchers to include Brazilian- Portuguese speakers in their future clinical trials. Overall, the studies included in this thesis have provided an important contribution to the contemporary management of low back pain. Firstly the use of motor control exercise could be considered for patients with chronic low back pain as it produces improvements in global impression of recovery, function, disability and pain. Secondly RUSI measures of abdominal wall muscles in patients with low back pain were considered reproducible for the measurement of muscle activity, but not as an outcome measure to detect improvement/deterioration of muscle activity over the course of treatment. Thirdly just a few high-quality cross-cultural adaptations and clinimetrics testing for self-report outcome measures relevant to the management of low back pain are available, and clearly more studies in this area are needed. Finally the Brazilian-Portuguese versions of the Functional Rating Index, the Roland Morris Disability Questionnaire and the Patient-Specific Functional Scale have acceptable clinimetric properties and could be used in clinical practice as well as in research studies in Brazil.

Falls are a relatively frequent occurrence amongst older people. Rates of falls amongst patients in subacute care are substantially higher than amongst people living in the community. Falls have been reported to cause physical and psychological injury, increase the likelihood of being discharged to nursing home, and are associated with longer lengths of stay in hospital. Thus, minimisation of falls in the subacute hospital setting is of high public health importance. (For complete abstract open document)

PhD / Abstract Low back pain is a significant public health problem in many countries of the world being one of the major causes of work absence and disability. Although the outlook for evidence-based management of low back pain has greatly improved over the past decades, many questions remain. Questions related to treatment options, underlying mechanisms of treatment effects and optimal assessment of low back pain have yet to be fully addressed by researchers. The broad aim of this thesis therefore was to contribute to a better understanding of the contemporary management of low back pain by performing studies in these key research areas. Most clinical practice guidelines recommend exercise as an effective treatment option for chronic low back pain. However the evidence for this recommendation comes from trials that are not placebo-controlled and so this may potentially provide biased estimates of the effects of exercise. Therefore a randomised controlled trial testing the effect of motor control exercise versus placebo in patients with chronic low back pain was conducted. Chapters 2 and 3 describe the trial protocol and the report of the trial respectively. A total of 154 patients with chronic low back pain were randomised to receive a motor control exercise program, or placebo (i.e. detuned short-wave therapy and detuned ultrasound therapy). Primary outcomes were pain, function, and the patient’s global impression of recovery measured at 2 months. The exercise intervention improved function and patient’s global impression of recovery, but not pain, at 2 months. The mean effect of exercise on function was 1.1 points (95%CI, 0.3 to 1.8), the mean effect on global impression of recovery was 1.5 points (95%CI, 0.4 to 2.5) and the mean effect on pain was 0.9 points (95%CI, - 0.01 to 1.8), all measured on 11 point scales. Secondary outcomes also favoured motor control exercise. This is the first study ever to demonstrate that motor control exercise is better than placebo for patients with chronic low back pain. Most of the treatment effects were maintained at 6 and 12 months follow-up. These results suggest that this intervention should be considered for patients with chronic low back pain in order to improve disability, function, and global impression of recovery, and to improve pain intensity in the long term, but not in the short term. Rehabilitative ultrasound imaging (RUSI) has been increasingly used by physiotherapists in order to identify impairments in motor control as well as to monitor progress of patients with low back pain. As with any other clinical measure it is important to know how reproducible the RUSI measures are, and although there are some reproducibility studies in the literature, no systematic review on this topic has been conducted. Therefore a systematic review was performed with the objective of assessing the reproducibility studies of RUSI for abdominal wall muscles (Chapter 4). Eligible studies were indentified via searches in CINAHL, EMBASE and MEDLINE with citation tracking via the Web of Science Index. A total of 21 studies were included. Due to heterogeneity of the studies’ designs, pooling the data for a meta-analysis was not possible. RUSI measures of thickness of abdominal wall muscles were found to be reliable. Few studies analysed the reliability for the measurement of thickness changes (reflecting the muscle activity) finding good to poor results. Evidence for the reproducibility of the difference in thickness changes over time (necessary to evaluate improvements in muscle activity with treatment) was not available. A limitation of the existing literature is that studies typically had suboptimal designs and analysis. The current evidence for the reproducibility of RUSI for measuring abdominal muscle activity is mainly based upon studies with suboptimal designs that included mostly healthy subjects, making generalisability to clinical settings uncertain. Some questions about the reproducibility of RUSI measures of abdominal wall muscles are still unanswered; this is mainly due to design issues, such as inadequate statistics, inadequate sampling and lack of control of sources of bias (e.g. blinding and absence of controlling for ordering effects). In addition the clinically important questions about the reproducibility of thickness changes (reflecting the muscle activity) and differences in thickness changes over time (reflecting the improvement or deterioration of muscle activity) have not been adequately investigated. Therefore a reproducibility study that aimed to answer these questions was performed (Chapter 5). Thirty-five patients seeking care for chronic low back pain participated in this study. RUSI measures were taken at baseline and eight weeks post-baseline. Replicate measures of thickness, thickness changes and differences in thickness changes over time were analysed. The reproducibility of static images (thickness) was excellent (ICC2,1 = 0.97, 95%CI = 0.96-0.97, Standard Error of the Measurement (SEM) = 0.04cm, Smallest Detectable Change (SDC) = 0.11cm), the reproducibility of thickness changes was moderate (ICC2,1 = 0.72, 95%CI 0.65-0.76 SEM = 15%, SDC 41%), while the reproducibility of differences in thickness changes over time was poor. Improvements in the test protocol should be undertaken in order to enhance the reproducibility of RUSI measures, especially for differences in thickness chang over time. Self-report outcome measures (questionnaires) are widely used by health care providers for measuring patient’s health status or treatment outcomes. Most of the questionnaires related to low back pain were developed in English and therefore their usefulness in non-English speaking countries is considerably limited. Cross-cultural adaptation and clinimetric testing are possibly the most efficient methods for solving this problem. Although there are many publications on the topic, a simple guide on how to perform a cross-cultural adaptation and clinimetric testing was not available. Therefore a “clinician-friendly” narrative review for Brazilian physical therapists (Chapter 6) was written. This review aimed firstly to explain the concepts and the relevance of cross-cultural adaptation and clinimetrics testing, secondly to summarise the current guidelines on the topic, thirdly to provide advice on how to choose a relevant questionnaire and finally how to evaluate the quality of an adapted questionnaire. Some examples of cross-cultural adaptations and clinimetrics testing of relevant low back pain questionnaires in the Brazilian-Portuguese language were also provided. Although the number of international versions of low back questionnaires is growing, to date it is unclear which questionnaires have been cross-culturally adapted and into which specific language. To answer these questions a systematic review was conducted in order to describe the available cross-cultural adaptations of low back pain self-report outcome measures and the clinimetric testing that has occurred for each adaptation (Chapter 7). Searches were performed in MEDLINE, EMBASE, CINALH and LILACS; these searches were supplemented with information from experts in the field of low back pain from 27 different countries to ensure that the results were comprehensive. Sixty-one adaptations were identified. While there are a large number of low back pain questionnaires available, very few have been adapted into other languages, particularly commonly spoken languages such as Mandarin, Hindi and Portuguese. The quality and comprehensiveness of clinimetric testing varied considerably, with the evaluation of reliability and construct validity most common. Further cross-cultural adaptation and clinimetric studies are clearly needed and special consideration must be given to study designs for clinimetric testing. The final aim of this thesis was to cross-culturally adapt self-report instruments relevant to the management of low back pain in Brazil. This was achieved by two independent studies. The first study (Chapter 8) aimed to cross-culturally adapt the Functional Rating Index (FRI) into Brazilian-Portuguese and to test the clinimetric properties of the FRI and also of an existing Brazilian-Portuguese version of the Roland Morris Disability Questionnaire (RMDQ) which was not fully evaluated in the original study. Both instruments were tested for internal consistency, reliability, construct validity, ceiling and floor effects and internal responsiveness in 140 chronic low back patients presenting for physiotherapy treatment in Brazil. Both instruments were considered reliable and valid for the measurement of disability in Brazilian-Portuguese speakers with low back pain, no ceiling or floor effects were detected, but the internal responsiveness of both instruments was considered small. The second study (Chapter 9) aimed to cross-culturally adapt the Patient-Specific Functional Scale (PSFS) and to perform a head-to-head comparison of the clinimetric properties of the PSFS, RMDQ and FRI. All instruments were tested for internal consistency, reliability, construct validity, ceiling and floor effects, internal and external responsiveness in 99 acute low back patients presenting for physiotherapy treatment in Brazil. In order to fully test the construct validity and external responsiveness, it was necessary to cross-culturally adapt the Pain Numerical Rating Scale and the Global Perceived Effect Scale. The results of this study demonstrate that the Brazilian-Portuguese versions of the RMDQ, FRI and PSFS have similar clinimetric properties to each other and to the original English versions; however the PSFS was the most responsive instrument. The results from the studies in Chapters 8 and 9 will benefit the understanding of low back pain by enabling international comparisons between studies conducted in Brazil and English speaking countries. In addition it will encourage researchers to include Brazilian- Portuguese speakers in their future clinical trials. Overall, the studies included in this thesis have provided an important contribution to the contemporary management of low back pain. Firstly the use of motor control exercise could be considered for patients with chronic low back pain as it produces improvements in global impression of recovery, function, disability and pain. Secondly RUSI measures of abdominal wall muscles in patients with low back pain were considered reproducible for the measurement of muscle activity, but not as an outcome measure to detect improvement/deterioration of muscle activity over the course of treatment. Thirdly just a few high-quality cross-cultural adaptations and clinimetrics testing for self-report outcome measures relevant to the management of low back pain are available, and clearly more studies in this area are needed. Finally the Brazilian-Portuguese versions of the Functional Rating Index, the Roland Morris Disability Questionnaire and the Patient-Specific Functional Scale have acceptable clinimetric properties and could be used in clinical practice as well as in research studies in Brazil.

Missing data is a potential source of bias in the results of randomised controlled trials (RCTs), which can have a negative impact on guidance derived from them, and ultimately patient care. This thesis aims to improve the understanding, handling, analysis and reporting of missing data in patient reported outcome measures (PROMs) for RCTs. A review of the literature provided evidence of discrepancies between recommended methodology and current practice in the handling and reporting of missing data. Particularly, missed opportunities to minimise missing data, the use of inappropriate analytical methods and lack of sensitivity analyses were noted. Missing data patterns were examined and found to vary between PROMs as well as across RCTs. Separate analyses illustrated difficulties in predicting missing data, resulting in uncertainty about assumed underlying missing data mechanisms. Simulation work was used to assess the comparative performance of statistical approaches for handling missing available in standard statistical software. Multiple imputation (MI) at either the item, subscale or composite score level was considered for missing PROMs data at a single follow-up time point. The choice of an MI approach depended on a multitude of factors, with MI at the item level being more beneficial than its alternatives for high proportions of item missingness. The approaches performed similarly for high proportions of unit-nonresponse; however, convergence issues were observed for MI at the item level. Maximum likelihood (ML), MI and inverse probability weighting (IPW) were evaluated for handling missing longitudinal PROMs data. MI was less biased than ML when additional post-randomisation data were available, while IPW introduced more bias compared to both ML and MI. A case study was used to explore approaches to sensitivity analyses to assess the impact of missing data. It was found that trial results could be susceptible to varying assumptions about missing data, and the importance of interpreting the results in this context was reiterated. This thesis provides researchers with guidance for the handling and reporting of missing PROMs data in order to decrease bias arising from missing data in RCTs.