Rozprawy doktorskie na temat „Outcome assessment (medical care)”

Background: Glaucoma is a chronic, progressive eye disease and the second cause of blindness in the world. To measure the patients’ perspective in randomised controlled trials (RCTs), patient-reported outcome measures (PROMs) are increasingly being used. However, the use of PROMs in glaucoma trials is low suggesting there may be a reluctance to use PROMs. Objectives: To explore three methodological challenges of using PROMs in RCTs in glaucoma: 1) PROM selection; 2) characterising glaucoma severity; and 3) interpreting PROM scores in terms of minimal important difference (MID). Methods: Vision PROMs used in glaucoma studies were identified and content validated using a systematic review approach and categorised by a new PROM taxonomy. Existing visual field staging systems (VFSSs) based on standard automated perimetry were systematically identified and quality assessed with a new tool developed for this review using a consensus method. The performance of four high quality visual field staging systems were evaluated and referenced against an experienced ophthalmologist in a diagnostic test accuracy study. A pilot study using the social comparison approach was undertaken to test the feasibility of an anchor-based approach in determining the MID of a vision PROM in a glaucoma population. Results: Thirty-three vision PROMs were identified and categorised, according to content into impairment, disability, status and satisfaction measures. Twenty-three VFSSs were identified but evaluation of quality assessment, particularly performance, was affected by poor VFSS reporting. The diagnostic accuracy study demonstrated suboptimal performance of the four highest quality staging systems. The pilot study to determine the MID for a vision PROM found the social comparison method to be a feasible approach in a glaucoma population. Conclusion: This thesis demonstrated how to select a PROM and identified difficulties with characterising glaucoma severity. Future research needs include development of robust methods for characterising glaucoma severity and full scale evaluation of MIDs in PROMs in glaucoma.

Thesis (Ph. D.)--Conservatory of Music and Dept. of Psychology. University of Missouri--Kansas City, 2006.
"A dissertation in music education and health psychology." Advisor: Robert Groene. Typescript. Vita. Title from "catalog record" of the print edition Description based on contents viewed Nov. 1, 2007 Includes bibliographical references (leaves 119-141). Online version of the print edition.

Royal Perth Hospital is the largest hospital in Western Australia and also has the largest intensive care unit (ICU) in the State. It was the first public hospital to provide intensive care services in Western Australia. This thesis examines the intermediateand long-term outcomes of patients admitted to the Royal Perth Hospital ICU between 1987 and 2002. Intermediate-term survival, defined as survival after discharge from hospital to one year and long-term survival, that exceeding one year after discharge, are important outcomes. Information on outcomes can be used by ICU staff in discussions with patients and their families and to inform policy decision-making and future research. The aim of this research was to examine one-year and long-term outcomes of patients admitted to the ICU between 1987 and 2002 and explore the factors that might be associated with the outcomes for 22,298 patients admitted to the ICU. A clinical ICU database was linked to morbidity and mortality databases by Data Linkage WA. A wide range of demographic and clinical factors were examined for their effect on outcome. These included age, sex, comorbidity, severity of illness, organ failure, ICU diagnostic groups, type of admission (medical, elective surgical and non-elective surgical), length of stay in ICU and era of admission (1987-1990, 1991-1994, 1995-1998, 1999-2002). Patients were followed-up to study end, 31st December 2003 or death if it occurred before study end, that is, up to 17 years after the index ICU admission. Kaplan Meier survival curves and Cox regression models were used to examine intermediate and long-term survival for patients who survived to hospital discharge. A comparison of admissions to hospital before and after the index ICU admission was made using descriptive statistics and logistic regression. Throughout the study period survival for the ICU cohort was shorter when compared to the Australian population. This was consistent throughout the follow-up period. The most important determinants of long-term survival were age, comorbidity, severity of illness and diagnostic group but the strength of association varied with the duration of follow-up. Although age, comorbidity and severity of illness increased among the critically ill survival improved over time. Hospital admissions were more frequent after a discharge from hospital that required an admission to ICU than before the index admission, even after adjusting for the ageing of the cohort. This study provides unique information about the survival and other outcomes of patients discharged from a hospital admission that included an ICU stay. The strength of this study lies in the follow-up to 17 years and the more comprehensive range of explanatory factors than in previous studies. This thesis demonstrates that follow-up studies after intensive care should be of sufficient duration to account for the changes that occur in survival over time and indicates the range of factors that should be taken into account when making comparisons of long-term survival.

To identify those with kidney disease early and thus facilitate earlier instigation of disease-progression slowing treatments, new definitions of chronic kidney disease (CKD) were introduced in 2002 (KDOQI). After this, the worldwide introduction of estimated glomerular filtration rate (eGFR) reporting (2006 onwards), also facilitated more widespread identification of those with CKD. Prognosis in those with CKD identified in this way was not known and the numbers with CKD appeared higher than originally expected. This thesis aimed to improve understanding of outcomes in those who met the definition of chronic kidney disease and facilitate better directed care. Data-linkage of several healthcare datasets including to laboratory, morbidity and mortality healthcare data for individuals in the Grampian region with measures of renal function in 2003 allowed those aims to be addressed. Patterns in the testing of kidney function over time were also described. Mortality and RRT initiation during the GLOMMS-I cohort's 6.5 years of follow-up were described, as were variables that were associated with these outcomes. Other measures of decline of kidney function over time (progression), were explored and compared to the ultimate measure of progression - the initiation of RRT. Various models to predict outcomes (RRT initiation, mortality and survival) were explored. Measures of model performance including discrimination, calibration, goodness of model fit and predictive performance were described. Overall the aim of this thesis was met - to improve the understanding of the prognosis of those currently labelled with chronic kidney disease. The work in this thesis has also provided the necessary information to plan and start a much wider population based study of outcome in those both with and without CKD (GLOMMS-II).

Antalet anhörigvårdare i Sverige är många. För att de anhöriga ska orka vårda sina närstående 24 timmar om dygnet, sju dagar i veckan behöver det finnas ett stöd. De anhörigstöd som finns varierar från kommun till kommun. Ett anhörigstöd som har utarbetats för att underlätta insatsbehovet är COAT- Carers Outcome Agreement Tool som syftar till att kartlägga anhörigas behov, planera och följa upp anhörigstöd. COAT har en grund i partnerskapsmodellen och i modellen ses den anhörige som experten på situationen runt den närstående. De studier som är gjorda med anhöriga har mycket positiva resultat. Det är få studier gjorda utifrån personalperspektivet därför avsåg vi att undersöka deras individuella erfarenheter utav att använda COAT. Tio stycken kvalitativa intervjuer med personal är utförda i studien och analyserades med hjälp av en innehållsanalys. Fem kategorier trädde fram i analysen och presenteras i resultatet. I kategorierna beskriver vi det som personalen berättat i intervjuerna. Personalen är uteslutande positiva till instrumentet och de anser att det bör användas i större utsträckning. Diskussionen är formad utifrån våra forskningsfrågor och diskuteras med stöd av tidigare forskning. Vi diskuterar olika begrepp och relaterar dem ur personalens synvinkel gentemot den anhörige och dennes familj.
Program: Specialistsjuksköterskeutbildning med inriktning mot distriktssköterska

Background: Dialysis is an intervention that involves the use of fairly advanced technology and is fairly expensive. Patients and health care funders are increasingly demanding evidence for the effectiveness for such high technology high cost interventions. While dialysis therapy has improved immediate prognosis in patients with kidney failure, the long-term survival of patients on chronic renal replacement therapy (dialysis or renal transplantation) is much lower than that of the general population and the mortality rates remain high for patients with acute renal failure needing dialysis. There are considerable variations between different countries and even between the dialysis centres within the same country with regards to the selection of the primary type of dialysis (haemodialysis or peritoneal dialysis) and in the different methods or equipment used to perform the various components of these various modalities. It is possible that variations in clinical practice are associated with variations in clinical outcomes such as mortality and morbidity. It is then important to identify the best practices from the various variations in current use and implementing these best practices may reduce morbidity and mortality of these patients. Methods: Systematic reviews, identifying and including only randomised trials, focusing on key clinical policy decision points in the dialysis process were undertaken. The review of literature was done in a systematic way according to a detailed scientific methodology. For all of the systematic reviews, a detailed protocol was written and agreed to by the authors of the review. The protocol detailed the clinical question, the types of studies, participants, interventions and outcomes to be included, search strategy and the statistical methods to be employed. Relevant randomised studies were then identified by systematically searching the electronic medical databases and reference lists of published studies; data relevant to predetermined outcome measures were extracted and where appropriate summary statistics were derived from meta-analysis. Recommendations and implications for clinical practice and future research studies were made following each review. The areas of dialysis policy reviewed were (1) Comparison of high-flux versus low-flux haemodialysis (HD) membranes for patients with end-stage renal disease (ESRD), (2) Comparison of extracorporeal renal replacement therapy technologies for patients with ESRD, (3) Comparison of intermittent (IRRT) and continuous renal replacement therapy (CRRT) for acute renal failure (ARF) in adults, (4) Comparison of antimicrobial interventions for the prevention of HD catheter related infections, (5) Comparison of continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) for patients with ESRD, and (6) Comparison of treatment measures for depression in dialysis patients. Conclusions: As the currently available evidence has not demonstrated superiority with high-flux membranes with respect to important clinical outcomes such as mortality, quality of life and hospitalisation, it is not possible to recommend the use of these membranes in preference to low-flux membranes. It has not been possible at present to demonstrate with the current evidence available that convective modalities (HF, HDF or AFB) have significant advantages over HD with regard to clinically important outcomes of mortality, dialysis-related hypotension and hospitalisation. It is not therefore possible to recommend the use of one modality in preference to the other. In ARF patients who are haemodynamically stable, the RRT modality does not appear to influence important patient outcomes, and therefore the preference for CRRT over IRRT in such patients does not appear justified in the light of available evidence. CRRT was shown to achieve better haemodynamic parameters such as MAP. APD appears to be more beneficial than CAPD, in terms of reducing peritonitis rates and with respect to certain social issues that impact on patients' quality of life. Further, adequately powered trials are required to confirm the benefits for APD found in this review and detect differences with respect to other clinically important outcomes that may have been missed by the trials included in this review due to their small size and short follow-up periods. APD may however be considered advantageous in select group of patients such as in the younger PD population and those in employment or education due to its psychosocial advantages. Firm conclusions on the efficacy of treatment measures for depression in chronic dialysis patients cannot be made as we identified only one small RCT that was of short duration. Current screening tools for depression are recognised to have poor specificity in the medically ill due to overlap of somatic symptoms of the medical illness. The development of a valid diagnostic tool would be helpful. The systematic reviews in general highlighted the paucity of large-scale randomised trials in nephrology even on topics of great practical relevance such as depression in dialysis. In many of the areas assessed adequate conclusions could not be reached as there was a lack of large-scale well designed randomised controlled trials raising the possibility that important clinical differences between the interventions assessed may have been missed due to Type 2 statistical error. We identified numerous RCTs which were small in size looking at surrogate end-points such as molecular markers of inflammation, especially in the areas of membrane flux and extracorporeal RRT technologies. Unfortunately benefits with surrogate end-points do not necessarily translate to better clinical outcomes. The urgent need of the hour is to conduct well-designed large scale RCTs in major areas of clinical importance such as the use of extracorporeal renal replacement therapy technologies looking at hard clinical end-points such as mortality, hospitalisation and quality of life.

Work-related injuries and road traffic injuries are common causes of morbidity and are major contributors to the burden of disease worldwide. In developed countries, these injuries are often covered under compensation schemes, and the costs of administering these schemes is high. The compensation systems have been put in place to improve the health outcomes, both physical and mental, of those injured under such systems; yet there is a widespread belief, and some evidence, that patients treated under these schemes may have worse outcomes than if they were treated outside the compensation system. Chapter One of this thesis explores the literature pertaining to any effect that compensation may have on patient outcomes. It is noted that the concept of “compensation neurosis” dates from the nineteenth century, with such injuries as “railway spine”, in which passengers involved in even minor train accidents at the time, would often have chronic and widespread symptoms, usually with little physical pathology. Other illnesses have been similarly labelled over time, and similarities are also seen in currently diagnosed conditions such as repetition strain injury, back pain and whiplash. There are also similarities in a condition that has been labelled “shell shock”, “battle fatigue”, and “post-traumatic stress disorder”; the latter diagnosis originating in veterans of the Vietnam War. While there is evidence of compensation status contributing to the diagnosis of some of these conditions, and to poor outcomes in patients diagnosed with these conditions, there is little understanding of the mechanism of this association. In contrast to popular stereotypes, the literature review shows that malingering does not contribute significantly to the effect of compensation on health outcomes. Secondary gain is likely to play an important role, but secondary gain is not simply confined to financial gain, it also includes gains made from avoidance of workplace stress and home and family duties. Other psychosocial factors, such as who is blamed for an injury (which may lead to retribution as a secondary gain) or the injured person’s educational and occupational status, may also influence this compensation effect. The literature review concludes that while the association between compensation and health after injury has been widely reported, the effect is inconsistent. These inconsistencies are due, at least in part, to differences in definitions of compensation (for example, claiming compensation versus using a lawyer), the use of different and poorly defined diagnoses (for example, back pain), a lack of control groups (many studies did not include uncompensated patients), and the lack of accounting for the many possible confounding factors (such as measures of injury severity or disease severity, and socio-economic and psychological factors). The literature review also highlighted the variety of different outcomes that had been used in previous studies, and the paucity of literature regarding the effect of compensation on general health outcomes. This thesis aims to explore the association between compensation status and health outcome after injury. It addresses many of the methodological issues of the previously published literature by, i selecting study populations of patients with measurable injuries, ii clearly defining and separating aspects of compensation status, iii including control groups of non-compensated patients with similar injuries iv allowing for a wide variety of possible confounders, and v using clearly defined outcome measures, concentrating on general health outcomes. Before commencing the clinical studies reported in Chapters Three and Four, a systematic review and meta-analysis was performed to quantify and analyse the effect of compensation on outcome after surgery. This allowed a clearly defined population of studies to be included, and was relevant to the thesis as the surgeries were performed as treatment of patients who had sustained injuries. The study, which is reported in Chapter Two, hypothesised that outcomes after surgery would be significantly worse for patients treated under compensation schemes. The study used the following data sources: Medline (1966 to 2003), Embase (1980 to 2003), CINAHL, Cochrane Controlled Trials Register, reference lists of retrieved articles and textbooks, and contact with experts in the field. The review included any trial of surgical intervention where compensation status was reported and results were compared according to that status, and no restrictions were placed on study design, language or publication date. Data extracted were study type, study quality, surgical procedure, outcome, country of origin, length and completeness of follow-up, and compensation type. Studies were selected by two unblinded independent reviewers, and data were extracted by two reviewers independently. Data were analysed using Cochrane Review Manager (version 4.2). Two hundred and eleven papers satisfied the inclusion criteria. Of these, 175 stated that the presence of compensation (worker's compensation with or without litigation) was associated with a worse outcome, 35 found no difference or did not describe a difference, and one paper described a benefit associated with compensation. A meta-analysis of 129 papers with available data (20,498 patients) revealed the summary odds ratio for an unsatisfactory outcome in compensated patients to be 3.79 (95% confidence interval 3.28 to 4.37, random effects model). Grouping studies by country, procedure, length of follow-up, completeness of follow-up, study type, and type of compensation showed the association to be consistent for all sub-groups. This study concludes that compensation status is associated with poor outcome after surgery, and that this effect is significant, clinically important and consistent. Therefore, the study hypothesis is accepted. However, as data were obtained from observational studies and were not homogeneous, the summary effect should be interpreted with caution. Determination of the mechanism for the association between compensation status and poor outcome, shown in the literature review (Chapter One) and the systematic review (Chapter Two) required further study. Two studies were designed to further explore this association and these are reported in Chapters Three and Four. The retrospective study reported in Chapter Three, the Major Trauma Outcome Study (MTOS), aimed to explore the association between physical, psychosocial, and compensation-related factors and general health after major physical trauma. The primary hypothesis predicted significantly poorer health outcomes in patients involved in pursuing compensation, allowing for possible confounders and interactions. The study also examined other health outcomes that are commonly associated with compensation, and examined patient satisfaction. Consecutive patients presenting to a regional trauma centre with major trauma (defined as an Injury Severity Score greater than 15) were surveyed between one and six years after their injury. The possible predictive factors measured were: general patient factors (age, gender, the presence of chronic illnesses, and the time since the injury), injury severity factors (injury severity score, admission to intensive care, and presence of a significant head injury), socio-economic factors (education level, household income, and employment status at the time of injury and at follow-up), and claim-related factors (whether a claim was pursued, the type of claim, whether the claim had settled, the time to settlement, the time since settlement, whether a lawyer was used, and who the patient blamed for the injury). Multiple linear regression was used to develop a model with general health (as measured by the physical and mental component summaries of the SF-36 General Health Survey) as the primary outcome. The secondary outcomes analysed were: neck pain, back pain, post-traumatic stress disorder, and patient satisfaction. On multivariate analysis, better physical health was significantly associated with increasing time since the injury, and with lower Injury Severity Scores. Regarding psychosocial factors, the education level and household income at the time of injury were not significantly associated with physical health, but pursuit of compensation, having an unsettled claim, and the use of a lawyer were strongly associated with poor physical health. Measures of injury severity or socio-economic status were not associated with mental health. However, the presence of chronic illnesses and having an unsettled compensation claim were strongly associated with poor mental health. Regarding the secondary outcomes, increasing neck pain and back pain were both significantly associated with lower education levels and the use of a lawyer, but not significantly associated with claiming compensation. The severity of symptoms related to post-traumatic stress disorder was not associated with measures of injury severity, but was significantly and independently associated with the use of a lawyer, having an unsettled compensation claim, and blaming others (not themselves) for the injury. The strongest predictor of patients’ dissatisfaction with their progress since the injury was having an unsettled compensation claim, and as with the other secondary outcomes, patient satisfaction was not significantly associated with injury severity factors. Factors relating to the compensation process were among the strongest predictors of poor health after major trauma, and were stronger predictors than measures of injury severity. The hypothesis that general physical and mental health would be poorer in patients involved in seeking compensation for their injury was accepted. This study concludes that the processes involved with claiming compensation after major trauma may contribute to poor health outcomes. The prospective study reported in Chapter Four, the Motor Vehicle Accident Outcome Study (MVAOS), aimed to explore the effect of compensation related factors on general health in patients suffering major fractures after motor vehicle accidents (MVAs). The study hypothesized that general health would be poorer in patients claiming compensation for their injuries. Patients presenting to 15 hospitals with one or more major fractures (any long bone fracture, or fracture of the pelvis, patella, calcaneus or talus) after a motor vehicle accident were invited to participate in this prospective study. Initial data was obtained from the patient and the treating doctors. Both the patients and treating surgeons were followed up with a final questionnaire at six months post injury. General factors (age, gender, treating hospital, country of birth, presence of chronic illnesses and job satisfaction), injury factors (mechanism of injury, number of fractures, and the presence of any non-orthopaedic injuries), socioeconomic factors (education level, income, and employment status), and compensation-related factors (whether a claim was made, the type of claim, whether a lawyer was used, and who was blamed for the injury) were used as explanatory variables. The primary outcome was general health as measured by the physical and mental component summaries of the SF-36 General Health Survey. The secondary outcomes were neck pain, back pain, and patients’ ratings of satisfaction with progress and of recovery. Multiple linear regression was used to develop predictive models for each outcome. Completed questionnaires were received from 232 (77.1%) of the 301 patients included in the study. Poor physical health at six months was strongly associated with increasing age, having more than one fracture, and using a lawyer, but not with pursuit of a compensation claim. Poor mental health was associated with using a lawyer and decreasing household income. Increasing neck pain and back pain were both associated with the use of a lawyer and with lower education levels. Higher patient satisfaction and patient-rated recovery were both strongly associated with blaming oneself for the injury, and neither were associated with pursuit of compensation. Although the use of a lawyer was a strong predictor of the primary outcomes, the pursuit of a compensation claim was not remotely associated with these outcomes, and therefore the study hypothesis was rejected. The studies reported in this thesis are compared in the final chapter, which concludes that poor health outcomes after injury are consistently and strongly associated with aspects of the compensation process, particularly the pursuit of a compensation claim, involvement of a lawyer, and having an unsettled claim. Compensation systems may be harmful to the patients that these systems were designed to benefit. Identification of the harmful features present in compensation systems my allow modification of these systems to improve patient outcomes.

Doctor of Philosophy
Work-related injuries and road traffic injuries are common causes of morbidity and are major contributors to the burden of disease worldwide. In developed countries, these injuries are often covered under compensation schemes, and the costs of administering these schemes is high. The compensation systems have been put in place to improve the health outcomes, both physical and mental, of those injured under such systems; yet there is a widespread belief, and some evidence, that patients treated under these schemes may have worse outcomes than if they were treated outside the compensation system. Chapter One of this thesis explores the literature pertaining to any effect that compensation may have on patient outcomes. It is noted that the concept of “compensation neurosis” dates from the nineteenth century, with such injuries as “railway spine”, in which passengers involved in even minor train accidents at the time, would often have chronic and widespread symptoms, usually with little physical pathology. Other illnesses have been similarly labelled over time, and similarities are also seen in currently diagnosed conditions such as repetition strain injury, back pain and whiplash. There are also similarities in a condition that has been labelled “shell shock”, “battle fatigue”, and “post-traumatic stress disorder”; the latter diagnosis originating in veterans of the Vietnam War. While there is evidence of compensation status contributing to the diagnosis of some of these conditions, and to poor outcomes in patients diagnosed with these conditions, there is little understanding of the mechanism of this association. In contrast to popular stereotypes, the literature review shows that malingering does not contribute significantly to the effect of compensation on health outcomes. Secondary gain is likely to play an important role, but secondary gain is not simply confined to financial gain, it also includes gains made from avoidance of workplace stress and home and family duties. Other psychosocial factors, such as who is blamed for an injury (which may lead to retribution as a secondary gain) or the injured person’s educational and occupational status, may also influence this compensation effect. The literature review concludes that while the association between compensation and health after injury has been widely reported, the effect is inconsistent. These inconsistencies are due, at least in part, to differences in definitions of compensation (for example, claiming compensation versus using a lawyer), the use of different and poorly defined diagnoses (for example, back pain), a lack of control groups (many studies did not include uncompensated patients), and the lack of accounting for the many possible confounding factors (such as measures of injury severity or disease severity, and socio-economic and psychological factors). The literature review also highlighted the variety of different outcomes that had been used in previous studies, and the paucity of literature regarding the effect of compensation on general health outcomes. This thesis aims to explore the association between compensation status and health outcome after injury. It addresses many of the methodological issues of the previously published literature by, i selecting study populations of patients with measurable injuries, ii clearly defining and separating aspects of compensation status, iii including control groups of non-compensated patients with similar injuries iv allowing for a wide variety of possible confounders, and v using clearly defined outcome measures, concentrating on general health outcomes. Before commencing the clinical studies reported in Chapters Three and Four, a systematic review and meta-analysis was performed to quantify and analyse the effect of compensation on outcome after surgery. This allowed a clearly defined population of studies to be included, and was relevant to the thesis as the surgeries were performed as treatment of patients who had sustained injuries. The study, which is reported in Chapter Two, hypothesised that outcomes after surgery would be significantly worse for patients treated under compensation schemes. The study used the following data sources: Medline (1966 to 2003), Embase (1980 to 2003), CINAHL, Cochrane Controlled Trials Register, reference lists of retrieved articles and textbooks, and contact with experts in the field. The review included any trial of surgical intervention where compensation status was reported and results were compared according to that status, and no restrictions were placed on study design, language or publication date. Data extracted were study type, study quality, surgical procedure, outcome, country of origin, length and completeness of follow-up, and compensation type. Studies were selected by two unblinded independent reviewers, and data were extracted by two reviewers independently. Data were analysed using Cochrane Review Manager (version 4.2). Two hundred and eleven papers satisfied the inclusion criteria. Of these, 175 stated that the presence of compensation (worker's compensation with or without litigation) was associated with a worse outcome, 35 found no difference or did not describe a difference, and one paper described a benefit associated with compensation. A meta-analysis of 129 papers with available data (20,498 patients) revealed the summary odds ratio for an unsatisfactory outcome in compensated patients to be 3.79 (95% confidence interval 3.28 to 4.37, random effects model). Grouping studies by country, procedure, length of follow-up, completeness of follow-up, study type, and type of compensation showed the association to be consistent for all sub-groups. This study concludes that compensation status is associated with poor outcome after surgery, and that this effect is significant, clinically important and consistent. Therefore, the study hypothesis is accepted. However, as data were obtained from observational studies and were not homogeneous, the summary effect should be interpreted with caution. Determination of the mechanism for the association between compensation status and poor outcome, shown in the literature review (Chapter One) and the systematic review (Chapter Two) required further study. Two studies were designed to further explore this association and these are reported in Chapters Three and Four. The retrospective study reported in Chapter Three, the Major Trauma Outcome Study (MTOS), aimed to explore the association between physical, psychosocial, and compensation-related factors and general health after major physical trauma. The primary hypothesis predicted significantly poorer health outcomes in patients involved in pursuing compensation, allowing for possible confounders and interactions. The study also examined other health outcomes that are commonly associated with compensation, and examined patient satisfaction. Consecutive patients presenting to a regional trauma centre with major trauma (defined as an Injury Severity Score greater than 15) were surveyed between one and six years after their injury. The possible predictive factors measured were: general patient factors (age, gender, the presence of chronic illnesses, and the time since the injury), injury severity factors (injury severity score, admission to intensive care, and presence of a significant head injury), socio-economic factors (education level, household income, and employment status at the time of injury and at follow-up), and claim-related factors (whether a claim was pursued, the type of claim, whether the claim had settled, the time to settlement, the time since settlement, whether a lawyer was used, and who the patient blamed for the injury). Multiple linear regression was used to develop a model with general health (as measured by the physical and mental component summaries of the SF-36 General Health Survey) as the primary outcome. The secondary outcomes analysed were: neck pain, back pain, post-traumatic stress disorder, and patient satisfaction. On multivariate analysis, better physical health was significantly associated with increasing time since the injury, and with lower Injury Severity Scores. Regarding psychosocial factors, the education level and household income at the time of injury were not significantly associated with physical health, but pursuit of compensation, having an unsettled claim, and the use of a lawyer were strongly associated with poor physical health. Measures of injury severity or socio-economic status were not associated with mental health. However, the presence of chronic illnesses and having an unsettled compensation claim were strongly associated with poor mental health. Regarding the secondary outcomes, increasing neck pain and back pain were both significantly associated with lower education levels and the use of a lawyer, but not significantly associated with claiming compensation. The severity of symptoms related to post-traumatic stress disorder was not associated with measures of injury severity, but was significantly and independently associated with the use of a lawyer, having an unsettled compensation claim, and blaming others (not themselves) for the injury. The strongest predictor of patients’ dissatisfaction with their progress since the injury was having an unsettled compensation claim, and as with the other secondary outcomes, patient satisfaction was not significantly associated with injury severity factors. Factors relating to the compensation process were among the strongest predictors of poor health after major trauma, and were stronger predictors than measures of injury severity. The hypothesis that general physical and mental health would be poorer in patients involved in seeking compensation for their injury was accepted. This study concludes that the processes involved with claiming compensation after major trauma may contribute to poor health outcomes. The prospective study reported in Chapter Four, the Motor Vehicle Accident Outcome Study (MVAOS), aimed to explore the effect of compensation related factors on general health in patients suffering major fractures after motor vehicle accidents (MVAs). The study hypothesized that general health would be poorer in patients claiming compensation for their injuries. Patients presenting to 15 hospitals with one or more major fractures (any long bone fracture, or fracture of the pelvis, patella, calcaneus or talus) after a motor vehicle accident were invited to participate in this prospective study. Initial data was obtained from the patient and the treating doctors. Both the patients and treating surgeons were followed up with a final questionnaire at six months post injury. General factors (age, gender, treating hospital, country of birth, presence of chronic illnesses and job satisfaction), injury factors (mechanism of injury, number of fractures, and the presence of any non-orthopaedic injuries), socioeconomic factors (education level, income, and employment status), and compensation-related factors (whether a claim was made, the type of claim, whether a lawyer was used, and who was blamed for the injury) were used as explanatory variables. The primary outcome was general health as measured by the physical and mental component summaries of the SF-36 General Health Survey. The secondary outcomes were neck pain, back pain, and patients’ ratings of satisfaction with progress and of recovery. Multiple linear regression was used to develop predictive models for each outcome. Completed questionnaires were received from 232 (77.1%) of the 301 patients included in the study. Poor physical health at six months was strongly associated with increasing age, having more than one fracture, and using a lawyer, but not with pursuit of a compensation claim. Poor mental health was associated with using a lawyer and decreasing household income. Increasing neck pain and back pain were both associated with the use of a lawyer and with lower education levels. Higher patient satisfaction and patient-rated recovery were both strongly associated with blaming oneself for the injury, and neither were associated with pursuit of compensation. Although the use of a lawyer was a strong predictor of the primary outcomes, the pursuit of a compensation claim was not remotely associated with these outcomes, and therefore the study hypothesis was rejected. The studies reported in this thesis are compared in the final chapter, which concludes that poor health outcomes after injury are consistently and strongly associated with aspects of the compensation process, particularly the pursuit of a compensation claim, involvement of a lawyer, and having an unsettled claim. Compensation systems may be harmful to the patients that these systems were designed to benefit. Identification of the harmful features present in compensation systems my allow modification of these systems to improve patient outcomes.

Objective: The aim of the study was to evaluate the clinical outcomes of oral implant treatment provided at the School of Dentistry, University of Otago from 1989 to 2005. Methods: Oral implant patients (n=320) with 586 implants were identified and invited to attend for a clinical examination. Implant demographics of all the patients were extracted from the files. Implant demographics of the examined and unexamined patients were compared to assess if the examined patients were representative of the total group. One hundred and three patients with 214 implants agreed to attend for an examination. In the clinical examination full mouth plaque scores, probing depths, bleeding on probing and suppuration were measured. In addition, around implants recession and width of keratinized gingiva were also recorded. For the radiographic examination, baseline radiographs and radiographs taken at the time of examination were digitized and compared to measure the amount of bone lost or gained around implants using NIH Image J software. Results: There were equal numbers of males and females with a mean age of 46.3 � 15 years at the time of implant placement. The smoking history at the time of examination was recorded, 56% of the patients were non-smokers, 37% former smokers, and 7% were current smokers. More than half of the implants (56%) were placed in the anterior region. Based on the type of implant system, 79% were Branemark implants, 10% Straumann, 6% Southern implants and 4% were unknown. Most of the patients (64%) had implant-supported crowns, 19% had fixed denture prostheses, and 17% had implant-supported overdentures. The overall implant survival rate was 97.7% with five implants lost (2.3%) and 8 implants treated for peri-implantitis (3.8%). The mean PD around implants was 2.3mm (SD 0.6mm), mean recession was 0.5mm (SD 0.8mm) and mean attachment level of 2.8mm (SD 0.9mm). Probing depths [greater than or equal to] 4mm with BOP were recorded around implants in 8.9% of patients. The mean full mouth plaque score was 30% while mean plaque score around implants was 15.9%. The average bone loss around implants was 0.3mm (SD 0.8). Maximum bone loss observed was 2.9 mm. Conclusion: The prevalence of peri-implant inflammation and implant survival rates in this group of patients appeared comparable to that reported in the literature. The prevalence of peri-implant lesions was low in the group of patients examined.

Thesis (M.S.)--West Virginia University, 2005.
Title from document title page. Document formatted into pages; contains xiii, 177 p. : ill. (some col.). Vita. Includes abstract. Includes bibliographical references (p. 147-154).

Thematic Paper (M.C.T.M. (Clinical Tropical Medicine))--Mahidol University, 2007.
LICL has E-Thesis 0024 ; please contact computer services. LIRV has E-Thesis 0024 ; please contact circulation services.

Thesis (Ph. D.)--University of Sydney, 2009.
Title from title screen (viewed Nov. 3, 2009) Includes tables and questionnaires. Submitted in fulfilment of the requirements for the degree of Doctor of Philosophy to the School of Public Health, Faculty of Medicine. Includes bibliography. Also available in print form.

Thesis (Ph.D. in Nursing) -- University of Colorado Denver, 2008.
Typescript. Includes bibliographical references (leaves 100-107). Free to UCD Anschutz Medical Campus. Online version available via ProQuest Digital Dissertations;

Thesis (Ph.D. in Nursing) -- University of Colorado Denver, 2007.
Typescript. Includes bibliographical references (leaves 176-188). Free to UCD affiliates. Online version available via ProQuest Digital Dissertations;

[Truncated abstract] Physical healthcare uses a suite of tools for measuring response to treatment. However, reliable systems of regular patient monitoring are rare in mental healthcare. Mental health services often measure a treatment response from pre- to post- therapy, yet measurement between those occasions is less common. This omission is problematic since arguably there is a need for an alarm system in psychotherapy (Andrews & Page, 2005). A substantial minority of patients do not experience reliable change following treatment, and a small proportion deteriorates (Hansen, Lambert, & Forman, 2002; Newnham, Harwood, & Page, 2007). Without monitoring, it is not always possible to know which patients are progressing poorly. Since the publication of Howard and colleagues' (1996) proposal that patient progress be monitored routinely during therapy and the results fed back to clinicians to direct treatment, this monitoring regime has garnered attention in the United States and Europe (Lambert, 2007; Lutz, et al., 2006). Findings in outpatient psychotherapy have demonstrated that providing real-time feedback on patient progress to clinicians and patients significantly improves clinical outcomes for those patients demonstrating a negative response to treatment (Harmon et al., 2007; Lambert et al., 2001; Lambert et al., 2002). What is not yet apparent is how these processes would generalize to inpatient and day patient (i.e. patients attending hospital for a whole day of treatment) psychiatric care. Inpatients often present with greater severity and are treated in an intensive setting. ... Deviations from this expected pattern would highlight possible differences between inpatient and outpatient care. To develop an appropriate system for monitoring patient progress, it was important to first define clinically significant recovery in inpatient psychiatric care, and provide criteria for clinicians to judge outcome in routine practice (Newnham, Harwood, & Page, 2007). Second, a quick and easy-to-administer system of progress monitoring and real-time feedback was developed to enhance treatment decision making (Newnham, Hooke, & Page, 2009). Third, the system was evaluated to determine clinical effectiveness. Using the World Health Organization’s Wellbeing Index, a program for monitoring patient progress and providing feedback to clinicians and patients was established at Western Australia's largest private psychiatric service. The sample consisted of 1308 consecutive inpatients and day patients whose primary diagnoses were predominantly depressive (67.7%) and anxiety (25.9%) disorders. Feedback to patients and clinicians was effective in reducing depressive symptoms (F (1,649) = 6.29, p<.05) for those patients at risk of poor outcome, but not effective in improving wellbeing (F (1,569) = 1.14, p>.05). The findings support the use of progress monitoring and feedback in psychiatric care to improve symptom outcomes, but raise questions about changes in wellbeing during psychotherapy. The effectiveness study was conducted as a historical cohort trial, consistent with quality improvement efforts, and replication with a randomized controlled design is warranted. Feedback of progress information appears to be an important process within psychotherapy, and further investigation of the means by which clinicians and patients use that information is necessary.

Thesis (Ph. D.)--University of California, San Diego and San Diego State University, 2008.
Title from first page of PDF file (viewed July 11, 2008). Available via ProQuest Digital Dissertations. Vita. Includes bibliographical references (p. 67-76).

[Tuncated abstract] This research thesis consists of five sections. Section one provides the background information (chapter 1) and a description of characteristics of the cohort and the methods of analysis (chapter 2). The Acute Physiology and Chronic Health Evaluation (APACHE) II scoring system is one of commonly used severity of illness scoring systems in many intensive care units (ICUs). Section two of this thesis includes an assessment of the performance of the APACHE II scoring system in an Australian context. First, the performance of the APACHE II scoring system in predicting hospital mortality of critically ill patients in an ICU of a tertiary university teaching hospital in Western Australia was assessed (Chapter 3). Second, a simple modification of the traditional APACHE II scoring system, the 'admission APACHE II scoring system', generated by replacing the worst first 24-hour data by the ICU admission physiological and laboratory data was assessed (Chapter 3). Indigenous and Aboriginal Australians constitute a significant proportion of the population in Western Australia (3.2%) and have marked social disadvantage when compared to other Australians. The difference in the pattern of critical illness between indigenous and non-indigenous Australians and also whether the performance of the APACHE II scoring system was comparable between these two groups of critically ill patients in Western Australia was assessed (Chapter 4). Both discrimination and calibration are important indicators of the performance of a prognostic scoring system. ... The use of the APACHE II scoring system in patients readmitted to ICU during the same hospitalisation was evaluated and also whether incorporating events prior to the ICU readmission to the APACHE II scoring system would improve its ability to predict hospital mortality of ICU readmission was assessed in chapter 10. Whilst there have been a number of studies investigating predictors of post-ICU in-hospital mortality none have investigated whether unresolved or latent inflammation and sepsis may be an important predictor. Section four examines the role of inflammatory markers measured at ICU discharge on predicting ICU re- 4 admission (Chapter 11) and in-hospital mortality during the same hospitalisation (Chapter 12) and whether some of these inflammatory markers were more important than organ failure score and the APACHE II scoring system in predicting these outcomes. Section five describes the development of a new prognostic scoring system that can estimate median survival time and long term survival probabilities for critically ill patients (Chapter 13). An assessment of the effects of other factors such as socioeconomic status and Aboriginality on the long term survival of critically ill patients in an Australian ICU was assessed (Chapter 14). Section six provides the conclusions. Chapter 15 includes a summary and discussion of the findings of this thesis and outlines possible future directions for further research in this important aspect of intensive care medicine.

The ability to monitor client change in psychotherapy over time is vital to quality assurance in service delivery as well as the continuing improvement of psychotherapy research. Unfortunately, there is not currently a comprehensive, affordable, and easily utilized outcome measure for psychotherapy specifically normed and standardized for use in psychology training clinics. The current study took the first steps in creating such an outcome measure. Following development of an item bank, factor analysis and item-response theory analyses were applied to data gathered from a stratified sample of university (n = 101) and community (n = 261) participants. The factor structure did not support a phase model conceptualization, but did reveal a structure consistent with the theoretical framework of the research domain criteria (RDoC). Suggestions for next steps in the measure development process are provided and implications discussed.

Thesis (Ph. D.)--Ohio State University, 2005.
Title from first page of PDF file. Document formatted into pages; contains xii, 134 p.; also includes graphics. Includes bibliographical references (p. 105-115). Available online via OhioLINK's ETD Center

The Institute for Healthcare Improvement (IHI) has promoted implementing a RRS to provide safer care for hospitalized patients. Additionally, the Joint Commission made implementing a RRS a 2008 National Patient Safety Goal. Although mandated, the evidence to support the effectiveness of a RRS to reduce cardiac arrests on hospital medical or surgical floors and un-anticipated ICU transfers remains inconclusive, partly because of weak study designs and partly due to a failure of published studies to report all critical aspects of their intervention. This study attempted to evaluate the effectiveness and the implementation of a RRS on the two campuses of the UMass Memorial Medical Center (UMMMC). The first study presented was an attempt to identify the preventability and timeliness of floor to ICU transfers. This was done using 3 chief residents who reviewed 100 randomly selected medical records. Using Cohen’s kappa to assess the inter-rater reliability it was determined that 13% of the cases could have possibly been preventable with earlier intervention. The second study was an evaluation of the effectiveness of the Rapid Response System. Outcomes were cardiac arrests, code calls and floor to ICU admissions. There were two study periods 24 months before the intervention and 24 months after. A Spline regression model was used to compare the two time periods. Though there was a consistent downward trend over all 4 years there were no statistically significant changes in the cardiac arrests and ICU transfers when comparing the before and after periods. There was a significant reduction in code calls to the floors on the University campus. The third study was a modified process evaluation of the Rapid Response intervention that will assess fidelity of RRS implementation, the proportion of the intended patient population that is reached by the RRS, the overall number of RRS calls implemented (dose delivered) and the perceptions of the hospital staff affected by the RRS with respect to acceptability and satisfaction with the RRS and barriers to utilization. The process evaluation showed that that the Rapid Response System was for the most part being used as it was designed, though the nurses were not using the specific triggers as a deciding factor in making the call. Staff satisfaction with the intervention was very high. Overall these studies demonstrated the difficulty in clearly defining outcomes and data collection in a large hospital system. Additionally the importance of different study designs and analysis methods are discussed.

Thesis (M.A.)--Georgia State University, 2006.
Title from title screen. Lesley Reid, committee chair; Wendy Simonds, Dawn Baunach, committee members. Electronic text (80 p.) : digital, PDF file. Description based on contents viewed June 18, 2007. Includes bibliographical references (p. 66-74).

Thesis (MSc)--Stellenbosch University, 2014.
ENGLISH ABSTRACT: Pregnant women living in South African peri-urban settlements face many challenges for their health and the health of their infants. Current health care services face many constraints and are not able to meet all the needs of pregnant mothers. Home-visiting programmes implemented by community health workers can alleviate these constraints. The current RCT assessed the effectiveness of the Philani Plus Intervention Program that addressed HIV, alcohol, maternal and child nutrition and mental health. The effectiveness of the intervention was assessed by measuring infant social withdrawal behaviour using the modified Alarm Distress Baby Scale (m- ADBB). A total of 681 cases were randomised into control (N=330) and intervention groups (N=351) and assessed using the m-ADBB. A cut-off score of two and above was used to determined significant social withdrawal behaviour. Data was analysed using descriptive statistics and cross-tabulation initially, followed by analysis of variance and multilevel modelling. Results indicated a prevalence of 46.7% of social withdrawal behaviour; however, no significant differences between groups were found. The current prevalence was substantially higher in comparison to the only other published study using the m-ADBB. Furthermore, the prevalence rate was also significantly higher compared to the majority of other studies using the original Alarm distress Baby Scale (ADBB). The high prevalence of social withdrawal behaviour found in this study indicates an increased risk for suboptimal infant development. Further research regarding social withdrawal behaviour and the casual mechanisms associated with the development of such behaviour is needed. Furthermore, validation of the m-ADBB in different settings is needed.
AFRIKAANSE OPSOMMING: Swanger vroue wat in Suid-Afrikaanse buitestedelike nedersettings woon staar baie uitdagings in die gesig met betrekking tot hul gesondheid en die gesondheid van hul babas. Huidige gesondheidsdienste is baie beperk en is nie in staat om in al die behoeftes van swanger moeders te voorsien nie. Huis-besoek programme wat deur gemeenskaplike gesondheidswerkers geïmplementeer word, kan hierdie beperkings verlig. Die huidige RCT het die effektiwiteit van die Philani Plus Intervensie Program wat MIV, alkohol, voeding en geestelike gesondheid aanspreek, geassesseer. Die effektiwiteit van die intervensie is geassesseer deur sosiale onttrekkingsgedrag met behulp van die gewysigde Alarm Nood Baba Skaal (m-ADBB) te meet. ‘n Totaal van 681 gevalle is lukraak in kontrole (N = 330) en intervensie groepe (N = 351) verdeel en geëvalueer volgens die m-ADBB. 'n Afsnypunt van twee en hoër is gebruik om beduidende sosiale onttrekkingsgedrag te bepaal. Data is aanvanklik ontleed met behulp van beskrywende statistiek en kruis-tabulering, gevolg deur analise van variansie en multi-modelle. Resultate toon 'n 46,7%-voorkoms van sosiale onttrekkingsgedrag, maar het egter geen beduidende verskille tussen groepe getoon nie. Die huidige voorkoms was aansienlik hoër in vergelyking met die enigste ander gepubliseerde studie wat gebruik gemaak het van die m- ADBB. Verder was die voorkomssyfer ook aansienlik hoër in vergelyking met die meerderheid van die ander studies wat gebruik gemaak het van die oorspronklike Alarm Nood Baba Skaal (ADBB). Die hoë voorkoms van sosiale onttrekkingsgedrag dui op 'n verhoogde risiko vir suboptimale baba ontwikkeling. Verdere navorsing oor sosiale onttrekkingsgedrag en die meganismes wat verband hou met die ontwikkeling van sulke gedrag, is nodig. Verder word die bekragtiging van die m-ADBB in verskillende instellings benodig.

The purpose of this study was to investigate the survey as a method of assessing client satisfaction with clinical services and to then assess parental satisfaction of clinical services at Portland State University's language clinic using the survey method. The survey asked questions regarding the parents' perceived benefits from the clinic, their perception of the skills of the clinicians who served their children, and the parents' perception of the clinical atmosphere. Eighty-five Consumer Satisfaction Surveys were mailed to 81 parents of children receiving services at Portland State University Speech-Language Clinic between the years 1987 and 1994. Eleven surveys were returned, all containing a signed consent letter, representing a 13% rate. Determining the cause behind the poor response rate for this particular survey was not difficult. No surveys were returned from the years 1987 through 1989. The highest percentage of return was from the year 1994 (38% ), indicating that higher response rates were achieved if the client was polled within 1 year of using clinical services. To further substantiate this conclusion, two of the parents contacted by telephone refused to participate in the survey, and gave length of time as the reason behind their refusal. The overall response to the survey was positive, indicating a high rate of satisfaction among the survey respondents with the services provided at the Portland State University Speech-Language clinic.

Now more than ever, speech clinicians are being required to justify the effectiveness of their work by showing results. There are different ways to measure outcomes. For example, outcomes may be measured by testing to determine if change has occurred regarding clinical goals, or by comparing the cost of the treatment to the benefit of the treatment to determine if the treatment was economically sound. Another type of measure is subjective outcomes, such as client satisfaction. Subjective outcomes are difficult to define and measure and few studies of this type have been reported in the literature. Because clinical outcome is dependent, at least to some extent, on client satisfaction (Williams, 1994), and because few studies have been reported in the literature regarding client satisfaction with speech and language services, this area became the focus of the current study. This study sought to answer the following questions: (a) Did the parents think their child benefrtted from the articulation intervention services received at the clinic? and (b) What were parents' attitudes regarding the clinical atmosphere and staff? The Consumer Satisfaction Measure of the American SpeechLanguage- Hearing Association (ASHA) was used in this study because it is broad in scope and contains statements relating to the research questions of the current study. Answers to the research questions were derived from the responses to the survey that was mailed to the parents of 86 children who had received articulation services from the PSU Speech and Hearing Clinic. Ninety-five percent of the parental responses regarding whether parents felt that their children benefited from services obtained at the PSU Speech and Hearing Clinic were positive, indicating that parents were satisfied with the services received. Ninety-one percent of the parental responses regarding parent's attitudes toward the clinical atmosphere and staff were positive. It appears that parents hold favorable views regarding the clinical atmosphere and staff and that they were satisfied with the services their children received at the PSU Speech and Hearing Clinic.

Increasing numbers of medicines are being used by pregnant South African women in the public sector during pregnancy, for the treatment of different biomedical and supernatural disease states and conditions. The motivation for the research is to support the development of more local pregnancy registries in order to strengthen evidence for the safety and efficacy of medicines used in pregnancy. A mixed methods approach was used. Women in their ninth month of pregnancy in a public sector setting, and four community pharmacists were identified. The women who met the inclusion criteria were recruited. One in-depth semi-structured interview was conducted with each woman before giving birth and data on their pregnancy outcomes were collected after labour. Coincidentally, the mother of one of the participants was found to be a traditional healer. She was also interviewed on the topic. A structured questionnaire was administered to the pharmacists. Ten pregnant women between the ages of 19 to 39 who had used or were using a traditional medicine during the pregnancy were recruited. All the participants had had at least one antenatal check up during their pregnancy with one having attended five times. No abnormal results were reported from any of the check ups or tests done during the visits. All of them had been to school and had at least Standard 8/Grade 10 education. Ten babies were seen between one and four days postpartum and no birth defects were obvious or were reported for any of them. The traditional healer did not provide additional information to what the women had said and confirmed that some of the practices the women reported were known to her as traditional medicine practices. All four pharmacists indicated that they considered complementary and alternative medicines (CAMs) to be “somewhat effective” and sold them at their pharmacies although none of them were aware of whether or not they were registered with the MCC. None of the pharmacists appeared to have an in-depth knowledge of traditional, complementary and alternative medicines (TCAMs). All four pharmacists said that it is important to have a basic understanding of TCAMs before using them, although they did not agree on the reasons for this. All of them felt that pharmacists have a professional responsibility to provide information on TCAMs (especially herbal preparations) and two felt that providing this information is part of a medical doctors’ responsibility. No harm from taking TCAMs could be shown. However herbal medicines have numerous ingredients some of which are unknown and taking these medicines is risky. The pharmacists in this sample were unsure whether they were accessing unreliable CAM information. Reliable sources of information and reference materials on CAMs to assist pharmacists and other healthcare professionals are needed. The apparent widespread use of TCAM in pregnancy indicates a need for documentation about its efficacy and safety. The establishing of TCAM pregnancy registries should seriously be considered. Due to the increase in CAM use, CAM education during pharmacists’ training as well as continuing professional development (CPD) in CAM for pharmacists in practice should be encouraged.

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution (Barros 2013) is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality (i.e. differences in effectiveness or efficiency). The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function (i.e. testimonial evidence and evidence of mechanisms) is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies.

QC 20150312

The purpose of this study was to compare and measure the long term effectiveness of the rehabilitative day treatment program at San Bernardino County's Department of Mental Health. This current study was completed in 2005 and is a follow up study tracking the long term effectiveness of the program.

INTRODUÇÃO: O câncer de pulmão é a terceira neoplasia maligna mais frequentemente diagnosticada em todo o mundo e a primeira em termos de mortalidade. O tratamento cirúrgico é a melhor abordagem nos estágios iniciais, contudo, está associado a morbimortalidade considerável. Para que o impacto do tratamento cirúrgico na diminuição global da mortalidade pelo câncer de pulmão no estado de São Paulo seja maior, precisamos conhecer os indicadores de qualidade das instituições envolvidas no tratamento desta neoplasia, através da criação de uma base de dados abrangente, confiável e transparente. Este estudo envolveu a implementação do Registro Paulista de Tratamento Cirúrgico do Câncer de Pulmão (RPCP). O desfecho principal foi a análise da qualidade dos dados capturados através de um sistema de auditoria direta e indireta, com o intuito de identificar as variáveis com menor padrão de qualidade. MÉTODOS: Estudo prospectivo, multicêntrico, com participação de 10 instituições no estado de São Paulo. A auditoria dos dados foi realizada de forma direta por revisão dos prontuários, para análise da taxa de discordância, Coeficiente Kappa e Intraclass correlation e de forma indireta para análise dos índices de completude, acurácia e consistência. RESULTADOS: Dos 536 casos disponíveis, 511 foram incluídos para a auditoria indireta. O índice total de completude por questionário variou de 0,82 a 1, sendo que as seguintes variáveis obtiveram valor individual abaixo da meta estabelecida de 0,8: ECOG, MRC, hematócrito, potássio, uréia, creatinina, DHL, albumina, cálcio e FA, tempo de cirurgia e data da recidiva. O índice total de acurácia e consistência foi 0,99 e 0,96, respectivamente. Para auditoria direta foram randomizados 100 casos entre os 511 iniciais, sendo 4 excluídos, restando 96 para análise. As variáveis com maiores taxas de discordância ( > 20%), estavam no questionário de avaliação pré-operatória (ECOG, MRC, carga tabágica, DPOC, PFP, peso, altura, IMC e exames laboratoriais). Variáveis relacionadas ao estadiamento (tamanho da neoplasia, invasão de estruturas adjacentes, status linfonodal não invasivo) e dados cirúrgicos (tempo de cirurgia) também apresentaram taxas > 20%. CONCLUSÕES: A auditoria indireta dos dados mostrou índices de completude, acurácia e consistência aceitáveis para o padrão estabelecido e comparáveis a bancos de dados internacionais. Por outro lado, a auditoria direta, revelou algumas variáveis com altos índices de discordância, dados que serão analisados futuramente para aprimoramento do RPCP e que poderão contribuir para o desenvolvimento de outras bases de dados semelhantes
BACKGROUND: Lung cancer is the third malignant neoplasm most frequently diagnosed worldwide and the first in terms of mortality. Surgical treatment is the best approach in the initial stages; however, it\'s associated with considerable morbidity and mortality. In order to improve the surgical treatment global impact on lung cancer mortality in the state of Sao Paulo, we need to know the quality indicators of the institutions involved in the treatment of this neoplasm through the creation of a extensive, reliable and transparent database. The study involved the implementation of the Paulista Lung Cancer Registry (PLCR). The main outcome was the quality analysis of the data captured through a direct and indirect audit system, in order to identify the variables with the lowest quality standard. METHODS: A prospective, multicenter study with the participation of 10 institutions in the state of São Paulo. The data audit was performed directly, through the revision of medical registries, with the intention to analyze the discordance rate; and indirectly, with the intention to analyze the completeness, accuracy and consistency indexes. RESULTS: Of the 536 cases available, 511 were included for the indirect audit. The total completeness index per questionnaire ranged from 0.82 to 1, and the following variables had a in individual value bellow the established target of 0,8: ECOG, MRC, hematocrit, potassium, urea, creatinine, LDH, albumin, calcium, AF, surgical time, date of recurrence. The total accuracy and consistency index was 0.99 and 0.96, respectively. For direct audit, 100 cases were randomized among the initial 511, of which 4 were excluded, remaining 96 for analysis. The variables with the highest discordance rates ( > 20%) were in the preoperative evaluation questionnaire (ECOG, MRC, smoking rate, COPD, PFT, weight, high, BMI and lab tests). Variables related to staging (size of neoplasm, invasion of adjacent structures, noninvasive lymph node status) and surgical data (time of surgery) also presented rates > 20%. CONCLUSIONS: Regarding the established standards, the Indirect audit showed acceptable completeness, accuracy and consistency indices, comparable to international databases. On the other hand, the direct audit revealed some variables with high discordance indices, data that will be analyzed in the future for the improvement of the PLCR and that may contribute to the development of other similar databases