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 /

Vertebroplasty : letter to the editor

In separate letters the authors debate whether the promotion of vertebroplasty in routine care is both premature and potentially dangerous as there are no completed RCTs. <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

Parsimonious and efficient assessment of health-related quality of life in osteoarthritis research: validation of the Assessment of Quality of Life (AQoL) instrument

BACKGROUND: The Assessment of Quality of Life (AQoL) utility instrument was psychometrically developed for the general population. This study aimed to explore its potential as an osteoarthritis (OA) outcome measure. METHODS: WOMAC, Lequesne index, SF-36, Visual analogue scales and the AQoL were administered to 222 people with OA. The ability of each questionnaire to detect differences between groups was based on (i) self-rated health (SRH) and, (ii) differences between people on an orthopedic waiting list (WL) vs people with OA in the community (C). Comparisons included effect size, relative efficiency and receiver operator characteristic curves. RESULTS: All instruments detected differences between groups; however no one instrument exhibited superior efficiency. The AQoL demonstrated strong psychometric properties. CONCLUSION: The AQoL has equivalent performance to comparator questionnaires commonly used in OA research and would be a useful adjunct to well-established disease specific scales. The AQoL has important advantages; brevity (12 items), facilitates comparisons between disease groups, and delivers a utility score that can be used in health economic evaluations

Field-Testing and Refinement of the Organisational Health Literacy Responsiveness Self-Assessment (Org-HLR) Tool and Process

Health literacy refers to the skills and knowledge that influence a person&rsquo;s ability to access, understand and use information to make health-related decisions, which are influenced by the complexity of their health needs and the demands health services place on them. The aim of this study was to field-test the Organisational Health Literacy Responsiveness (Org-HLR) tool and process to determine their utility in assessing health literacy responsiveness and for supporting organisations to plan health literacy-related improvement activities. Four organisations in Victoria, Australia, field-tested the Org-HLR tool. Data were collected through direct observation, participant feedback, and focus groups. Forty-three individuals participated in field-testing activities, and 20 took part in focus group meetings. Themes relating to the applicability and utility of the Org-HLR self-assessment tool and process were identified. Field-testing resulted in a number of refinements to the tool and process. Twenty-eight indicators were removed, 29 were rephrased to improve their clarity, and four new indicators were added. The revised Org-HLR self-assessment tool contains six dimensions, 22 sub-dimensions and 110 performance indicators. The Org-HLR tool and process were perceived as useful for assessing health literacy responsiveness, prioritising improvement activities, and establishing a benchmark for monitoring and evaluation of improvements over time. Testing generated an improved Org-HLR tool and assessment process that are likely to have utility across a broad range of health and social service sector organisations

Magnitude and meaningfulness of change in SF-36 scores in four types of orthopedic surgery

Background: The Medical Outcomes General Health Survey (SF-36) is a widely used health status measure; however, limited evidence is available for its performance in orthopedic settings. The aim of this study was to examine the magnitude and meaningfulness of change and sensitivity of SF-36 subscales following orthopedic surgery.Methods: Longitudinal data on outcomes of total hip replacement (THR, n = 255), total knee replacement (TKR, n = 103), arthroscopic partial meniscectomy (APM, n = 74) and anterior cruciate ligament reconstruction (ACL, n = 62) were used to estimate the effect sizes (ES, magnitude of change) and minimal detectable change (sensitivity) at the group and individual level. To provide context for interpreting the magnitude of changes in SF-36 scores, we also compared patients\u27 scores with age and sex-matched population norms. The studies were conducted in Sweden. Follow-up was five years in THR and TKR studies, two years in ACL, and three months in APM.Results: On average, large effect sizes (ES&ge;0.80) were found after orthopedic surgery in SF-36 subscales measuring physical aspects (physical functioning, role physical, and bodily pain). Small (0.20&ndash;0.49) to moderate (0.50&ndash;0.79) effect sizes were found in subscales measuring mental and social aspects (role emotional, vitality, social functioning, and mental health). General health scores remained relatively unchanged during the follow-up. Despite improvements, post-surgery mean scores of patients were still below the age and sex matched population norms on physical subscales. Patients\u27 scores on mental and social subscales approached population norms following the surgery. At the individual level, scores of a large proportion of patients were affected by floor or ceiling effects on several subscales and the sensitivity to individual change was very low.Conclusion: Large to moderate meaningful changes in group scores were observed in all SF-36 subscales except General Health across the intervention groups. Therefore, in orthopedic settings, the SF-36 can be used to show changes for groups in physical, mental, and social dimensions and in comparison with population norms. However, SF-36 subscales have low sensitivity to individual change and so we caution against using SF-36 to monitor the health status of individual patients undergoing orthopedic surgery.<br /

Health-related quality of life advantage of long-acting injectable antipsychotic treatment for schizophrenia: a time trade-off study

<p>Abstract</p> <p>Background</p> <p>This study was undertaken to estimate utility values for alternative treatment intervals for long acting antipsychotic intramuscular injections for the treatment of schizophrenia.</p> <p>Methods</p> <p>Vignettes were developed using the published literature and an iterative consultation process with expert clinicians and patient representative groups. Four vignettes were developed. The first was a vignette of relapsed/untreated schizophrenia. The other three vignettes presented a standardised picture of well-managed schizophrenia with variations in the intervals between injections: once every 2-weeks, 4-weeks and 3-months. A standardised time trade off (TTO) approach was used to obtain utility values for the vignettes. As a societal perspective was sought, a representative sample of individuals from across the community (Sydney, Australia) was recruited. Ninety-eight people completed the TTO interview. The vignettes were presented in random order to prevent possible ordering effects.</p> <p>Results</p> <p>A clear pattern of increasing utility was observed with increasing time between injections. Untreated schizophrenia was rated as very poor health-related quality of life with a mean (median) utility of 0.27 (0.20). The treated health states were rated at much higher utilities and were statistically significantly different (<it>p </it>< 0.001) from each other: (1) 2-weekly: mean (median) utility = 0.61 (0.65); (2) 4-weekly: mean (median) utility = 0.65 (0.70); (3) 3-monthly: mean (median) utility = 0.70 (0.75).</p> <p>Conclusions</p> <p>This study has provided robust data indicating that approximately a 0.05 utility difference exists between treatment options, with the highest utility assigned to 3-monthly injections.</p