Integrating data to facilitate clinical research : a case study

The integration of routine clinical administrative activities into ongoing rigorous clinical research poses challenges for both clinicians and researchers. This case study describes the development of a responsive database system used to facilitate comprehensive longitudinal research into the outcomes of patients waiting for hip and knee replacement surgery in a large public teaching hospital. The initial research procedure was paper-based, with manual patient matching and data entry. This process was time-consuming and associated with substantial risk of error and omissions, necessitating the design of a better system. An integrated database system was designed to receive daily electronic updates of the orthopaedic waiting-list and scheduled clinic and surgery dates. Using readily available software (Microsoft Access), new patients were identified through specifying inclusion and exclusion criteria which allowed rapid and complete recruitment at time of entry to the waiting-list. The integrated system specified the appropriate timing of multiple follow-up assessments, provided prompt information on recruitment for reporting purposes and integrated multiple linked research projects within one database. Seamless exporting of data to statistical programs for analysis was also enabled. This simple integrated approach facilitated efficient execution of a longitudinal study from recruitment to statistical analysis while maximising confidentiality and minimising resources required. This case study describes the development and design of a simple system which could be easily adapted for database management in hospital or clinic-based settings according to local requirements.<br /

Can a disease-specific education program augment self-management skills and improve Health-Related Quality of Life in people with hip or knee osteoarthritis?

BACKGROUND: Patient education and self-management programs are offered in many countries to people with chronic conditions such as osteoarthritis (OA). The most well-known is the disease-specific Stanford Arthritis Self-Management Program (ASMP). While Australian and international clinical guidelines promote the concept of self-management for OA, there is currently little evidence to support the use of the ASMP. Several meta-analyses have reported that arthritis self-management programs had minimal or no effect on reducing pain and disability. However, previous studies have had methodological shortcomings including the use of outcome measures which do not accurately reflect program goals. Additionally, limited cost-effectiveness analyses have been undertaken and the cost-utility of the program has not been explored. METHODS/DESIGN: This study is a randomised controlled trial to determine the efficacy (in terms of Health-Related Quality of Life and self-management skills) and cost-utility of a 6-week group-based Stanford ASMP for people with hip or knee OA. Six hundred participants referred to an orthopaedic surgeon or rheumatologist for hip or knee OA will be recruited from outpatient clinics at 2 public hospitals and community-based private practices within 2 private hospital settings in Victoria, Australia. Participants must be 18 years or over, fluent in English and able to attend ASMP sessions. Exclusion criteria include cognitive dysfunction, previous participation in self-management programs and placement on a waiting list for joint replacement surgery or scheduled joint replacement. Eligible, consenting participants will be randomised to an intervention group (who receive the ASMP and an arthritis self-management book) or a control group (who receive the book only). Follow-up will be at 6 weeks, 3 months and 12 months using standardised self-report measures. The primary outcome is Health-Related Quality of Life at 12 months, measured using the Assessment of Quality of Life instrument. Secondary outcome measures include the Health Education Impact Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index (pain subscale and total scores), Kessler Psychological Distress Scale and the Hip and Knee Multi-Attribute Priority Tool. Cost-utility analyses will be undertaken using administrative records and self-report data. A subgroup of 100 participants will undergo qualitative interviews to explore the broader potential impacts of the ASMP. DISCUSSION: Using an innovative design combining both quantitative and qualitative components, this project will provide high quality data to facilitate evidence-based recommendations regarding the ASMP

The feasibility of implementing the ICHOM Standard Set for Hip and Knee Osteoarthritis: a mixed-methods evaluation in public and private hospital settings.

Background: There is growing international momentum for standardising patient outcome assessment and using patient-reported outcome measures (PROMs) to capture outcomes that matter to patients. The International Consortium for Health Outcomes Measurement (ICHOM) Standard Sets were developed to capture the outcomes of care for costly conditions including osteoarthritis. This study evaluated the feasibility of implementing the ICHOM Standard Set for Hip and Knee Osteoarthritis in \u27real world\u27 public and private hospital settings. Methods: A mixed-methods design was used to capture comprehensive data on patient outcomes, implementation costs, and the implementation experiences of patients, clinicians and administrative staff. The ICHOM Standard Set was implemented at two hospital sites (1 public, 1 private) in May 2016. Patients undergoing primary hip or knee replacement for osteoarthritis were recruited from pre-admission clinics and a private orthopaedic clinic. Baseline Standard Set data were collected before surgery and at pre-determined post-operative timepoints. Data on the costs of Standard Set implementation were also collected. Semi-structured interviews were conducted with key stakeholders ( Results: The cost of Standard Set implementation and ongoing data collection for 17 months totalled $AUD94,955. Preference data (collected prior to completing the Standard Set) revealed that most participants preferred paper-based (83%) or web-based questionnaire completion (14%), with only a small proportion preferring iPad-based completion (3%). Several PROMs within the Standard Set were responsive to change (effect size range 0.19-0.85), with significant improvements in important health outcomes identified 6 weeks after surgery. Patient interviews showed a variable understanding of why patient-reported data collection is undertaken; however, patients perceived that PROMs provided relevant information to treating clinicians, and that the burden of questionnaire completion was minimal. Staff interviews revealed that PROMs are considered valuable, dedicated personnel are required to support data collection, gaps in information technology resources must be addressed, and that the Standard Set offers benefits beyond what currently-used measures provide. Conclusion: The Standard Set can be feasibly implemented in hospital settings, but with important caveats around staffing and technical support, consideration of patient preferences, and promotion of active clinician engagement

Obesity and increased burden of hip and knee joint disease in Australia: results from a national survey

BACKGROUND: Research involving more representative samples is needed to extend our understanding of the broader impact of obesity in hip or knee joint disease (arthritis and OA) beyond clinical settings. Although population-based research has been conducted in the United States, how these findings translate to other countries is unclear. Using a national approach, this study explored associations between obesity and the burden of hip and knee joint disease in Australia (in terms of prevalence, pain, stiffness, function, Health-Related Quality of Life (HRQoL) and disease severity). METHODS: A random sample of 5000 Australians (&ge; 39 years) from the federal electoral roll was invited to complete a mailed questionnaire to identify doctor-diagnosed hip arthritis, hip OA, knee arthritis and knee OA and evaluate the burden of these conditions. Validated questionnaires included the WOMAC Index, Assessment of Quality of Life instrument and Multi-Attribute Prioritisation Tool. Body Mass Index (BMI) was classified into underweight/normal weight (&le; 24.99 kg/m2), overweight (25-29.99) or obese (&ge; 30). Multiple logistic regression was used to estimate odds of arthritis and OA, with demographic and socioeconomic variables included in the models. Associations between BMI and other variables were investigated using analysis of covariance, with adjustment for age and sex. RESULTS: Data were available from 1,157 participants (23%). Overweight participants had increased odds of knee arthritis (adjusted OR (AOR) 1.87, 95%CI 1.14-3.07) and knee OA (AOR 2.11, 95%CI 1.07-4.15). Obesity was associated with higher prevalence of hip arthritis (AOR 2.18, 95%CI 1.17-4.06), knee arthritis (AOR 5.47, 95%CI 3.35-8.95) and knee OA (AOR 7.35, 95%CI 3.85-14.02). Of those with arthritis or OA, obese individuals reported more pain (for hip arthritis, hip OA and knee OA), greater stiffness (for hip arthritis, knee arthritis and knee OA), worse function (all diagnoses), lower HRQoL (for hip arthritis and hip OA) and greater disease severity (all diagnoses). CONCLUSIONS: This national study has demonstrated that the odds of arthritis and OA was up to 7 times higher for obese individuals, compared with those classified as underweight/normal weight. Concurrent obesity and joint disease had a marked impact on several key aspects of wellbeing, highlighting the need for public health interventions

Investigating well-being, work limitations and preferences for self-management education and peer support among younger people with hip and knee osteoarthritis: protocol for a cross-sectional study

Introduction:&nbsp;Osteoarthritis (OA) has traditionally&nbsp;been considered a condition of older age. However,&nbsp;younger people are also affected by hip and knee OA,&nbsp;often as a result of sporting and work-related injuries.&nbsp;As OA studies have generally focused on older&nbsp;individuals, little is known about the experience of&nbsp;younger adults with hip or knee OA who can face a&nbsp;distinct set of pressures including work responsibilities&nbsp;and parenting roles. This study aims to investigate&nbsp;well-being and work participation among younger&nbsp;people with hip or knee OA, as well as preferences for&nbsp;OA education and support.Methods and analysis: 200 people aged 20&ndash;55 years with a diagnosis of hip and/or knee OA will be&nbsp;recruited for this cross-sectional study. Participants will&nbsp;be recruited from three major public hospitals in the&nbsp;state of Victoria, Australia following screening of&nbsp;orthopaedic outpatient clinic lists and referrals, and&nbsp;through community-based advertisements. A study&nbsp;questionnaire will be mailed to all participants and&nbsp;written informed consent obtained. Validated measures&nbsp;of Health-Related Quality of Life (HRQoL), health status,&nbsp;psychological distress and work limitations will be used. Information on health services use will be collected,&nbsp;in addition to information on the perceived utility and&nbsp;accessibility of a range of existing and proposed&nbsp;education and peer support models. HRQoL data will be&nbsp;compared with Australian population norms using&nbsp;independent t tests, and associations between HRQoL,&nbsp;health status, psychological distress, work limitations&nbsp;and demographic factors will be evaluated using&nbsp;univariate and multivariate analyses. Data on the&nbsp;perceived utility and accessibility of education and peer&nbsp;support models will be analysed descriptively.&nbsp;Ethics and dissemination: Ethics approval for the&nbsp;study has been obtained. The study findings will be&nbsp;submitted to peer-reviewed journals and arthritis&nbsp;consumer organisations for broader dissemination, and&nbsp;presented at national and international scientific meetings.</div

Decline in Health-Related Quality of Life reported by more than half of those waiting for joint replacement surgery: a prospective cohort study

<p>Abstract</p> <p>Background</p> <p>In many healthcare systems, people with severe joint disease wait months to years for joint replacement surgery. There are little empirical data on the health consequences of this delay and it is unclear whether people with substantial morbidity at entry to the waiting list continue to deteriorate further while awaiting surgery. This study investigated changes in Health-Related Quality of Life (HRQoL), health status and psychological distress among people waiting for total hip (THR) and knee replacement (TKR) surgery at a major metropolitan Australian public hospital.</p> <p>Methods</p> <p>134 patients completed questionnaires including the Assessment of Quality of Life (AQoL) instrument, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Kessler Psychological Distress Scale after entering an orthopaedic waiting list (baseline) and before surgery (preadmission). To quantify potential decline in wellbeing, we calculated the proportion of people experiencing clinically important deterioration using published guidelines and compared HRQoL and psychological distress outcomes with population norms.</p> <p>Results</p> <p>Most participants (69%) waited ≥6 months for surgery (median 286 days, IQR 169-375 days). Despite poor physical and psychological wellbeing at baseline, there was an overall deterioration in HRQoL during the waiting period (mean AQoL change -0.04, 95%CI -0.08 to -0.01), with 53% of participants experiencing decline in HRQoL (≥0.04 AQoL units). HRQoL prior to surgery remained substantially lower than Australian population norms (mean sample AQoL 0.37, 95%CI 0.33 to 0.42 vs mean population AQoL 0.83, 95%CI 0.82 to 0.84). Twenty-five per cent of participants showed decline in health status (≥9.6 WOMAC units) over the waiting period and prevalence of high psychological distress remained high at preadmission (RR 3.5, 95%CI 2.8 to 4.5). Most participants considered their pain (84%), fatigue (76%), quality of life (73%) and confidence in managing their health (55%) had worsened while waiting for surgery.</p> <p>Conclusions</p> <p>Despite substantial initial morbidity, over half of the participants awaiting joint replacement experienced deterioration in HRQoL during the waiting period. These data provide much-needed evidence to guide health professionals and policymakers in the design of care pathways and resource allocation for people who require joint replacement surgery.</p

Understanding the information needs of women with rheumatoid arthritis concerning pregnancy, post-natal care and early parenting: A mixed-methods study

© 2015 Ackerman et al. Background: Although women with rheumatoid arthritis (RA) face a number of challenges in negotiating the journey to parenthood, no studies have explored the information needs of women with RA in relation to their childbearing years. This study aimed to determine the need for (and preferred mode/s of delivery of) information regarding pregnancy, post-natal care and early parenting among women with RA. Methods: Interviews and focus groups were conducted with 27 women with RA who were pregnant in the last 5 years, currently pregnant or planning pregnancy. Verbatim transcripts were analysed using both inductive and deductive approaches. Two validated instruments were used to quantify information needs and preferences: the Educational Needs Assessment Tool (ENAT, range 0-156, higher scores indicate higher educational needs) and the Autonomy Preference Index (API, range 0-100, higher scores indicate stronger preferences). Results: Lack of information about medication safety, access to physical/emotional support services and practical strategies for coping with daily challenges related to parenting were the most prominent of the six key themes identified. Rheumatologists were the primary source for information regarding treatment decisions while arthritis consumer organisations were perceived as critical 'resource hubs'. There was strong preference for information delivered electronically, especially among rural participants. Quantitative outcomes supported the qualitative findings; on average, participants reported high educational needs (mean ENAT score 97.2, SD 30.8) and API scores indicated that desire for information (mean 89.8, SD 5.6) was greater than the need for involvement in treatment decision-making (mean 68.4, SD 8.2). Conclusions: Many women with RA struggle to find adequate information on pregnancy planning, pregnancy and early parenting in relation to their chronic condition, and there is a clear need to develop accessible information that is consumer-focused and evidence-based. Although most participants trusted their rheumatologist as their primary information source, there was consistent demand for more information, particularly regarding the safety of RA medications during pregnancy and breastfeeding, and the importance of learning from other women's personal experiences was strongly emphasised

A systematic review of interventions to improve knowledge and self-management skills concerning contraception, pregnancy and breastfeeding in people with rheumatoid arthritis

This systematic review aimed to determine the effectiveness of interventions for improving knowledge and/or self-management skills concerning contraception, pregnancy and breastfeeding in people with rheumatoid arthritis (RA). We searched four databases (MEDLINE, CINAHL, Cochrane Trials, PsycINFO) using a comprehensive search strategy. Studies were eligible if they were prospective, published in English from 2004 to 2015, included participants with RA and tested an intervention designed to improve knowledge and/or self-management skills relating to family planning, pregnancy or breastfeeding. As no studies met the latter criterion, the search strategy was expanded to include all prospective studies evaluating RA educational and/or self-management interventions. Data on study characteristics, participant characteristics and programme content were extracted to summarise the evidence base for interventions to support people with RA during their reproductive years. Expanded literature searches identified 2290 papers, of which 68 were eligible. Of these, nine papers (13 %) specifically excluded pregnant women/breastfeeding mothers or recruited only older people.Only one study (1 %) explicitly evaluated pregnancy-focused education via a motherhood decision aid, while eight studies (12 %) incorporated relevant (albeit minor) components within broader RA educational or self-management interventions. Of these, three studies provided methotrexate education in relation to conception/pregnancy/breastfeeding; three incorporated discussions on RA and relationships, impact of RA on the family or sexual advice; one provided information regarding contraception and fertility; and one issued a warning regarding use of biologic therapy in pregnancy/breastfeeding. In conclusion, information regarding family planning, pregnancy or breastfeeding represents a negligible part of published RA educational interventions, with scope to develop targeted resources

Five insights from the Global Burden of Disease Study 2019

The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 provides a rules-based synthesis of the available evidence on levels and trends in health outcomes, a diverse set of risk factors, and health system responses. GBD 2019 covered 204 countries and territories, as well as first administrative level disaggregations for 22 countries, from 1990 to 2019. Because GBD is highly standardised and comprehensive, spanning both fatal and non-fatal outcomes, and uses a mutually exclusive and collectively exhaustive list of hierarchical disease and injury causes, the study provides a powerful basis for detailed and broad insights on global health trends and emerging challenges. GBD 2019 incorporates data from 281 586 sources and provides more than 3·5 billion estimates of health outcome and health system measures of interest for global, national, and subnational policy dialogue. All GBD estimates are publicly available and adhere to the Guidelines on Accurate and Transparent Health Estimate Reporting. From this vast amount of information, five key insights that are important for health, social, and economic development strategies have been distilled. These insights are subject to the many limitations outlined in each of the component GBD capstone papers

Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017

Background How long one lives, how many years of life are spent in good and poor health, and how the population's state of health and leading causes of disability change over time all have implications for policy, planning, and provision of services. We comparatively assessed the patterns and trends of healthy life expectancy (HALE), which quantifies the number of years of life expected to be lived in good health, and the complementary measure of disability-adjusted life-years (DALYs), a composite measure of disease burden capturing both premature mortality and prevalence and severity of ill health, for 359 diseases and injuries for 195 countries and territories over the past 28 years. Methods We used data for age-specific mortality rates, years of life lost (YLLs) due to premature mortality, and years lived with disability (YLDs) from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2017 to calculate HALE and DALYs from 1990 to 2017. We calculated HALE using age-specific mortality rates and YLDs per capita for each location, age, sex, and year. We calculated DALYs for 359 causes as the sum of YLLs and YLDs. We assessed how observed HALE and DALYs differed by country and sex from expected trends based on Socio-demographic Index (SDI). We also analysed HALE by decomposing years of life gained into years spent in good health and in poor health, between 1990 and 2017, and extra years lived by females compared with males. Findings Globally, from 1990 to 2017, life expectancy at birth increased by 7·4 years (95% uncertainty interval 7·1–7·8), from 65·6 years (65·3–65·8) in 1990 to 73·0 years (72·7–73·3) in 2017. The increase in years of life varied from 5·1 years (5·0–5·3) in high SDI countries to 12·0 years (11·3–12·8) in low SDI countries. Of the additional years of life expected at birth, 26·3% (20·1–33·1) were expected to be spent in poor health in high SDI countries compared with 11·7% (8·8–15·1) in low-middle SDI countries. HALE at birth increased by 6·3 years (5·9–6·7), from 57·0 years (54·6–59·1) in 1990 to 63·3 years (60·5–65·7) in 2017. The increase varied from 3·8 years (3·4–4·1) in high SDI countries to 10·5 years (9·8–11·2) in low SDI countries. Even larger variations in HALE than these were observed between countries, ranging from 1·0 year (0·4–1·7) in Saint Vincent and the Grenadines (62·4 years [59·9–64·7] in 1990 to 63·5 years [60·9–65·8] in 2017) to 23·7 years (21·9–25·6) in Eritrea (30·7 years [28·9–32·2] in 1990 to 54·4 years [51·5–57·1] in 2017). In most countries, the increase in HALE was smaller than the increase in overall life expectancy, indicating more years lived in poor health. In 180 of 195 countries and territories, females were expected to live longer than males in 2017, with extra years lived varying from 1·4 years (0·6–2·3) in Algeria to 11·9 years (10·9–12·9) in Ukraine. Of the extra years gained, the proportion spent in poor health varied largely across countries, with less than 20% of additional years spent in poor health in Bosnia and Herzegovina, Burundi, and Slovakia, whereas in Bahrain all the extra years were spent in poor health. In 2017, the highest estimate of HALE at birth was in Singapore for both females (75·8 years [72·4–78·7]) and males (72·6 years [69·8–75·0]) and the lowest estimates were in Central African Republic (47·0 years [43·7–50·2] for females and 42·8 years [40·1–45·6] for males). Globally, in 2017, the five leading causes of DALYs were neonatal disorders, ischaemic heart disease, stroke, lower respiratory infections, and chronic obstructive pulmonary disease. Between 1990 and 2017, age-standardised DALY rates decreased by 41·3% (38·8–43·5) for communicable diseases and by 49·8% (47·9–51·6) for neonatal disorders. For non-communicable diseases, global DALYs increased by 40·1% (36·8–43·0), although age-standardised DALY rates decreased by 18·1% (16·0–20·2). Interpretation With increasing life expectancy in most countries, the question of whether the additional years of life gained are spent in good health or poor health has been increasingly relevant because of the potential policy implications, such as health-care provisions and extending retirement ages. In some locations, a large proportion of those additional years are spent in poor health. Large inequalities in HALE and disease burden exist across countries in different SDI quintiles and between sexes. The burden of disabling conditions has serious implications for health system planning and health-related expenditures. Despite the progress made in reducing the burden of communicable diseases and neonatal disorders in low SDI countries, the speed of this progress could be increased by scaling up proven interventions. The global trends among non-communicable diseases indicate that more effort is needed to maximise HALE, such as risk prevention and attention to upstream determinants of health. Funding Bill & Melinda Gates Foundation