Development of the Knee Quality of Life (KQoL-26) 26-item questionnaire: data quality, reliability, validity and responsiveness

Background This article describes the development and validation of a self-reported questionnaire, the KQoL-26, that is based on the views of patients with a suspected ligamentous or meniscal injury of the knee that assesses the impact of their knee problem on the quality of their lives. Methods Patient interviews and focus groups were used to derive questionnaire content. The instrument was assessed for data quality, reliability, validity, and responsiveness using data from a randomised trial and patient survey about general practitioners' use of Magnetic Resonance Imaging for patients with a suspected ligamentous or meniscal injury. Results Interview and focus group data produced a 40-item questionnaire designed for self-completion. 559 trial patients and 323 survey patients responded to the questionnaire. Following principal components analysis and Rasch analysis, 26 items were found to contribute to three scales of knee-related quality of life: physical functioning, activity limitations, and emotional functioning. Item-total correlations ranged from 0.60–0.82. Cronbach's alpha and test retest reliability estimates were 0.91–0.94 and 0.80–0.93 respectively. Hypothesised correlations with the Lysholm Knee Scale, EQ-5D, SF-36 and knee symptom questions were evidence for construct validity. The instrument produced highly significant change scores for 65 trial patients indicating that their knee was a little or somewhat better at six months. The new instrument had higher effect sizes (range 0.86–1.13) and responsiveness statistics (range 1.50–2.13) than the EQ-5D and SF-36. Conclusion The KQoL-26 has good evidence for internal reliability, test-retest reliability, validity and responsiveness, and is recommended for use in randomised trials and other evaluative studies of patients with a suspected ligamentous or meniscal injury

Evidence for models of diagnostic service provision in the community: literature mapping exercise and focused rapid reviews

Background Current NHS policy favours the expansion of diagnostic testing services in community and primary care settings. Objectives Our objectives were to identify current models of community diagnostic services in the UK and internationally and to assess the evidence for quality, safety and clinical effectiveness of such services. We were also interested in whether or not there is any evidence to support a broader range of diagnostic tests being provided in the community. Review methods We performed an initial broad literature mapping exercise to assess the quantity and nature of the published research evidence. The results were used to inform selection of three areas for investigation in more detail. We chose to perform focused reviews on logistics of diagnostic modalities in primary care (because the relevant issues differ widely between different types of test); diagnostic ultrasound (a key diagnostic technology affected by developments in equipment); and a diagnostic pathway (assessment of breathlessness) typically delivered wholly or partly in primary care/community settings. Databases and other sources searched, and search dates, were decided individually for each review. Quantitative and qualitative systematic reviews and primary studies of any design were eligible for inclusion. Results We identified seven main models of service that are delivered in primary care/community settings and in most cases with the possible involvement of community/primary care staff. Not all of these models are relevant to all types of diagnostic test. Overall, the evidence base for community- and primary care-based diagnostic services was limited, with very few controlled studies comparing different models of service. We found evidence from different settings that these services can reduce referrals to secondary care and allow more patients to be managed in primary care, but the quality of the research was generally poor. Evidence on the quality (including diagnostic accuracy and appropriateness of test ordering) and safety of such services was mixed. Conclusions In the absence of clear evidence of superior clinical effectiveness and cost-effectiveness, the expansion of community-based services appears to be driven by other factors. These include policies to encourage moving services out of hospitals; the promise of reduced waiting times for diagnosis; the availability of a wider range of suitable tests and/or cheaper, more user-friendly equipment; and the ability of commercial providers to bid for NHS contracts. However, service development also faces a number of barriers, including issues related to staffing, training, governance and quality control. Limitations We have not attempted to cover all types of diagnostic technology in equal depth. Time and staff resources constrained our ability to carry out review processes in duplicate. Research in this field is limited by the difficulty of obtaining, from publicly available sources, up-to-date information about what models of service are commissioned, where and from which providers. Future work There is a need for research to compare the outcomes of different service models using robust study designs. Comparisons of ‘true’ community-based services with secondary care-based open-access services and rapid access clinics would be particularly valuable. There are specific needs for economic evaluations and for studies that incorporate effects on the wider health system. There appears to be no easy way of identifying what services are being commissioned from whom and keeping up with local evaluations of new services, suggesting a need to improve the availability of information in this area. Funding The National Institute for Health Research Health Services and Delivery Research programme

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

Background: Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. Methods: 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Results: Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084). Conclusions: Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research. Trial registration: The trial is registered with http://www.isrctn.org/ and ID is ISRCTN76616358.Medicine, Department ofPopulation and Public Health (SPPH), School ofNon UBCMedicine, Faculty ofReviewedFacult

Effectiveness of GP access to magnetic resonance imaging of the knee: a randomised trial

BACKGROUND: GPs commonly see patients with knee problems. Magnetic resonance imaging (MRI) of the knee is an accurate diagnostic test for meniscus and ligament injuries of the knee, but there is uncertainty about the appropriate use of MRI and when it should enter the diagnostic pathway for patients with these problems. AIM: To assess the effectiveness of GP referral to early MRI and a provisional orthopaedic appointment, compared with referral to an orthopaedic specialist without prior MRI for patients with continuing knee problems. Design of study: Pragmatic multicentre randomised trial with two parallel groups. SETTING: A total of 553 patients consulting their GP about a continuing knee problem were recruited from 163 general practices at 11 sites across the UK. METHOD: Patients were randomised to MRI within 12 weeks of GP referral including a provisional orthopaedic appointment, or orthopaedic appointment without prior MRI within a maximum of 9 months from GP referral. The primary outcome measures were the Short Form 36-item (SF-36) physical functioning scale and the Knee Quality of Life 26-item Questionnaire (KQoL-26) at 6, 12, and 24 months. RESULTS: Patients randomised to MRI improved mean SF-36 physical functioning scores by 2.81 (95% confidence interval [CI] = -0.26 to 5.89) more than those referred to orthopaedics (P = 0.072). Patients randomised to MRI improved mean KQoL-26 physical functioning scores by 3.65 (95% CI = 1.03 to 6.28) more than controls (P = 0.007). There were no other significant differences. CONCLUSION: GP access to MRI yielded small, but statistically significant, benefits in patients' knee-related quality of life but non-significant improvements in physical functioning

Cost-effectiveness of magnetic resonance imaging of the knee for patients presenting in primary care

BACKGROUND: Musculoskeletal problems generate high costs. Of these disorders, patients with knee problems are commonly seen by GPs. Magnetic resonance imaging (MRI) of the knee is an accurate diagnostic test, but there is uncertainty as to whether GP access to MRI for these patients is a cost-effective policy. AIM: To investigate the cost-effectiveness of GP referral to early MRI and a provisional orthopaedic appointment, compared with referral to an orthopaedic specialist without prior MRI for patients with continuing knee problems. Design of study: Cost-effectiveness analysis alongside a pragmatic randomised trial. SETTING: Five-hundred and thirty-three patients consulting their GP about a knee problem were recruited from 163 general practices at 11 sites across the UK. METHOD: Two-year costs were estimated from the NHS perspective. Health outcomes were expressed in terms of quality-adjusted life years (QALYs), based on patient responses to the EQ-5D questionnaire administered at baseline, and at 6, 12, and 24 months' follow-up. RESULTS: Early MRI is associated with a higher NHS cost, by pound 294 ($581; euro 435) per patient (95$11,538; euro 8642). At a cost per QALY threshold of pound 20,000, there is a 0.81 probability that early MRI is a cost-effective use of NHS resources. CONCLUSION: GP access to MRI for patients presenting in primary care with a continuing knee problem represents a cost-effective use of health service resources

DAMASK Trial Team. Influence of MRI of the knee on general practitioners' decisions: a randomised trial

BACKGROUND: Magnetic resonance imaging (MRI) of the knee for meniscus and ligament injuries is an accurate diagnostic test. Early and accurate diagnosis of patients with knee problems may prevent the onset of chronic problems such as osteoarthritis, a common cause of disability in older people consulting their GP. AIM: To assess the effect of early access to MRI, compared with referral to an orthopaedic specialist, on GPs' diagnoses and treatment plans for patients with knee problems. DESIGN OF STUDY: A multi-centre, pragmatic, randomised controlled trial. SETTING: Five hundred and fifty-three patients with knee problems were recruited from 163 general practices across the UK from November 2002 to October 2004. METHOD: Eligible patients were randomised to MRI or consultation with an orthopaedic specialist. GPs made a concomitant provisional referral to orthopaedics for patients who were allocated to imaging. GPs recorded patients' diagnoses, treatment plans, and their confidence in these decisions at trial entry and follow-up. Data were analysed as intention to treat. RESULTS: There was no significant difference between MRI and orthopaedic groups for changes in diagnosis (P = 0.79) or treatment plans (P = 0.059). Significant changes in diagnostic and therapeutic confidence were observed for both groups with a greater increase in diagnostic confidence (P<0.001) and therapeutic confidence (P = 0.002) in the MRI group. There was a significant increase in within-group changes in diagnostic and therapeutic confidence. CONCLUSION: Access to MRI did not significantly alter GPs' diagnoses or treatment plans compared with direct referral to an orthopaedic specialist, but access to MRI significantly increased their confidence in these decisions