ABSTRACT
OBJECTIVES: The objective of this study is to develop classification criteria for overall hand osteoarthritis (OA), interphalangeal OA and thumb base OA based on self-reported data and radiographic features. METHODS: The classification criteria sets were developed in three phases. In phase 1, we identified criteria that discriminated hand OA from controls. In phase 2, we used a consensus-based decision analysis approach to derive a clinician-based evaluation of the relative importance of the criteria. In phase 3, we refined the scoring system, determined the cut-offs for disease classification and compared the sensitivity and specificity of the European Alliance of Associations for Rheumatology (EULAR) criteria with the 1990 American College of Rheumatology (ACR) criteria. RESULTS: In persons with hand symptoms and no other disease (including psoriasis) or acute injury that can explain the hand symptoms (mandatory criteria), hand OA can be classified based on age, duration of morning stiffness, number of joints with osteophytes and joint space narrowing, and concordance between symptoms and radiographic findings. Using a sum of scores based on each diagnostic element, overall hand OA can be classified if a person achieves 9 or more points on a 0-15 scale. The cut-off for interphalangeal OA and thumb base OA is 8 points. While the EULAR criteria demonstrated better sensitivity than the ACR criteria in the phase 1 data set, the performance of the two criteria sets was similar in two external cohorts. CONCLUSIONS: International experts developed the EULAR criteria to classify overall hand OA, interphalangeal OA and thumb base OA in clinical studies using a rigorous methodology.
ABSTRACT
BACKGROUND: Multimorbidity is increasingly the norm; however, primary care remains focused on single diseases. Osteoarthritis, anxiety, and depression are frequently comorbid with other long-term conditions (LTCs), but rarely prioritized by clinicians. OBJECTIVES: To test the feasibility of a randomized controlled trial (RCT) of an intervention integrating case-finding and management for osteoarthritis, anxiety, and depression within LTC reviews. METHODS: A pilot stepped-wedge RCT across 4 general practices recruited patients aged ≥45 years attending routine LTC reviews. General practice nurses provided usual LTC reviews (control period), then, following training, delivered the ENHANCE LTC review (intervention period). Questionnaires, an ENHANCE EMIS-embedded template and consultation audio-recordings, were used in the evaluation. RESULTS: General practice recruitment and training attendance reached prespecified success criteria. Three hundred and eighteen of 466 (68%) of patients invited responded; however, more patients were recruited during the control period (206 control, 112 intervention). Eighty-two percent and 78% returned their 6-week and 6-month questionnaires, respectively. Integration of the ENHANCE LTC review into routine LTC reviews varied. Case-finding questions were generally used as intended for joint pain, but to a lesser extent for anxiety and depression. Initial management through referrals and signposting were lacking, and advice was more frequently provided for joint pain. The stepped-wedge design meant timing of the training was challenging and yielded differential recruitment. CONCLUSION: This pilot trial suggests that it is feasible to deliver a fully powered trial in primary care. Areas to optimize include improving the training and reconsidering the stepped-wedge design and the approach to recruitment by targeting those with greatest need. TRIAL REGISTRATION: ISRCTN registry (ISRCTN: 12154418). Date registered: 6 August 15. Date first participant was enrolled: 13 July 2015. https://www.isrctn.com/ISRCTN12154418?q=depression%20schizophrenia&filters=conditionCategory:Not%20Applicable&sort=&offset=5&totalResults=9&page=1&pageSize=20&searchType=basic-search.
Subject(s)
Depression , Osteoarthritis , Anxiety/therapy , Arthralgia , Depression/therapy , Humans , Osteoarthritis/therapy , Pilot Projects , Primary Health Care/methodsABSTRACT
BACKGROUND: To improve quality of care for patients with hip and knee osteoarthritis (OA), general practitioners (GPs) and physiotherapists (PTs) in a Norwegian municipality initiated an intervention. The intervention aimed to increase provision of core OA treatment (information, exercise, and weight control) prior to referral for surgery, rational use of imaging for assessing OA and improve communication between healthcare professionals. This study assessed the effectiveness of this intervention. METHODS: Forty-eight PTs and one hundred one GPs were invited to the intervention that included two interactive workshops outlining best practice and an accompanying template for PT discharge reports. Using interrupted time series research design, the study period was divided into three: pre-implementation, transition (implementation) and post-implementation. Comparing the change between pre- and post-implementation, the primary outcome was patient-reported quality of OA care measured with the OsteoArthritis Quality Indicator questionnaire. Secondary outcomes were number of PT discharge reports, information included in GP referral letters to orthopaedic surgeon, the proportion of GP referral letters indicating use of core treatment, and the use of imaging within OA assessment. Analyses involved linear mixed and logistic regression models. RESULTS: The PT workshop had 30 attendees, and 31 PTs and 33 GPs attended the multidisciplinary workshop. Two hundred eight and one hundred twenty-five patients completed the questionnaire during pre- and post-implementation, respectively. The adjusted model showed a small, statistically non-significant, increase in mean total score for quality of OA care (mean change = 4.96, 95% CI -0.18, 10.12, p:0.057), which was mainly related to items on OA core treatment. Patients had higher odds of reporting receipt of information on treatment alternatives (odds ratio (OR) 1.9, 95% CI 1.08, 3.24) and on self-management (OR 2.4, 95% CI 1.33, 4.32) in the post-implementation phase. There was a small, statistically non-significant, increase in the proportion of GP referral letters indicating prior use of core treatment modalities. There were negligible changes in the number of PT discharge reports, in the information included in the GP referral letters, and in the use of imaging for OA assessment. CONCLUSION: This study suggests that a primary care intervention including two inter-active workshops can shift the quality of care towards best practice recommendations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02876120 .
Subject(s)
General Practitioners , Osteoarthritis, Hip , Osteoarthritis, Knee , Humans , Norway/epidemiology , Osteoarthritis, Hip/diagnosis , Osteoarthritis, Hip/therapy , Osteoarthritis, Knee/diagnostic imaging , Osteoarthritis, Knee/therapy , Primary Health CareABSTRACT
BACKGROUND: There is no physiotherapy-specific quality indicator tool available to evaluate physiotherapy care for people with hip and/or knee osteoarthritis (OA). This study aimed to develop a patient-reported quality indicator tool (QUIPA) for physiotherapy management of hip and knee OA and to assess its reliability and validity. METHODS: To develop the QUIPA tool, quality indicators were initially developed based on clinical guideline recommendations most relevant to physiotherapy practice and those of an existing generic OA quality indicator tool. Draft items were then further refined using patient focus groups. Test-retest reliability, construct validity (hypothesis testing) and criterion validity were then evaluated. Sixty-five people with hip and/or knee OA attended a single physiotherapy consultation and completed the QUIPA tool one, twelve- and thirteen-weeks after. Physiotherapists (n = 9) completed the tool post-consultation. Patient test-retest reliability was assessed between weeks twelve and thirteen. Construct validity was assessed with three predefined hypotheses and criterion validity was based on agreement between physiotherapists and participants at week one. RESULTS: A draft list of 23 clinical guideline recommendations most relevant to physiotherapy was developed. Following feedback from three patient focus groups, the final QUIPA tool contained 18 items (three subscales) expressed in lay language. The test-retest reliability estimates (Cohen's Kappa) for single items ranged from 0.30-0.83 with observed agreement of 64-94%. The intraclass correlation coefficient (ICC) and 95% confidence interval (CI) for the Assessment and Management Planning subscale was 0.70 (0.54, 0.81), Core Recommended Treatments subscale was 0.84 (0.75, 0.90), Adjunctive Treatments subscale was 0.70 (0.39, 0.87) and for the total QUIPA score was 0.80 (0.69, 0.88). All predefined hypotheses regarding construct validity were confirmed. However, agreement between physiotherapists and participants for single items showed large measurement error (Cohen's Kappa estimates ranged from - 0.04-0.59) with the ICC (95% CI) for the total score being 0.11 (- 0.14, 0.34). CONCLUSIONS: The QUIPA tool showed acceptable test-retest reliability for subscales and total score but inadequate reliability for individual items. Construct validity was confirmed but criterion validity for individual items, subscales and the total score was inadequate. Further research is needed to refine the QUIPA tool to improve its clinimetric properties before implementation.
Subject(s)
Osteoarthritis, Hip/rehabilitation , Osteoarthritis, Knee/rehabilitation , Patient Reported Outcome Measures , Physical Therapy Modalities/standards , Quality Indicators, Health Care , Aged , Female , Guideline Adherence/standards , Humans , Male , Middle Aged , Practice Guidelines as Topic , Quality of Life , Reproducibility of ResultsABSTRACT
BACKGROUND: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. METHODS: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. FINDINGS: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference -0·32; 95% CI -0·48 to -0·16; p=0·0001). No adverse events were reported. INTERPRETATION: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. FUNDING: Arthritis Research UK.
Subject(s)
Anti-Inflammatory Agents/administration & dosage , Carpal Tunnel Syndrome/therapy , Injections , Methylprednisolone/analogs & derivatives , Splints , Adult , Aged , Carpal Tunnel Syndrome/economics , Cost-Benefit Analysis , Female , Humans , Male , Methylprednisolone/administration & dosage , Methylprednisolone Acetate , Middle Aged , Severity of Illness Index , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Since publication of the European League Against Rheumatism (EULAR) recommendations for management of hand osteoarthritis (OA) in 2007 new evidence has emerged. The aim was to update these recommendations. EULAR standardised operating procedures were followed. A systematic literature review was performed, collecting the evidence regarding all non-pharmacological, pharmacological and surgical treatment options for hand OA published to date. Based on the evidence and expert opinion from an international task force of 19 physicians, healthcare professionals and patients from 10 European countries formulated overarching principles and recommendations. Level of evidence, grade of recommendation and level of agreement were allocated to each statement. Five overarching principles and 10 recommendations were agreed on. The overarching principles cover treatment goals, information provision, individualisation of treatment, shared decision-making and the need to consider multidisciplinary and multimodal (non-pharmacological, pharmacological, surgical) treatment approaches. Recommendations 1-3 cover different non-pharmacological treatment options (education, assistive devices, exercises and orthoses). Recommendations 4-8 describe the role of different pharmacological treatments, including topical treatments (preferred over systemic treatments, topical non-steroidal anti-inflammatory drugs (NSAIDs) being first-line choice), oral analgesics (particularly NSAIDs to be considered for symptom relief for a limited duration), chondroitin sulfate (for symptom relief), intra-articular glucocorticoids (generally not recommended, consider for painful interphalangeal OA) and conventional/biological disease-modifying antirheumatic drugs (discouraged). Considerations for surgery are described in recommendation 9. The last recommendation relates to follow-up. The presented EULAR recommendations provide up-to-date guidance on the management of hand OA, based on expert opinion and research evidence.
Subject(s)
Antirheumatic Agents/standards , Disease Management , Osteoarthritis/rehabilitation , Physical Therapy Modalities/standards , Rheumatology/standards , Analgesics/standards , Anti-Inflammatory Agents, Non-Steroidal/standards , Glucocorticoids/standards , Hand , HumansABSTRACT
OBJECTIVE: The Joint Effort Initiative was endorsed by Osteoarthritis Research Society International (OARSI) in 2018 as a collaboration between international researchers and clinicians with an interest in the implementation of osteoarthritis management programs (OAMPs). This study aimed to identify and prioritise activities for future work of the Joint Effort Initiative. DESIGN: A survey was emailed to delegates of the 2018 OARSI World Congress attending a pre-conference workshop or with a known interest in OAMPs (n = 115). Delegates were asked about the most important issues regarding OAMP implementation. The top 20 issues were synthesised into 17 action statements, and respondents were invited to participate in a priority ranking exercise to determine the order of importance of the statements. RESULTS: Survey respondents (n = 51, 44%) were most commonly female (71%), with an allied health background (57%), affiliated with universities (73%) from Oceania (37%), and Europe/UK (45%). The five highest ranked action statements were: CONCLUSION: Prioritising statements will bring focus to the future work of the Joint Effort Initiative in the future and provide a basis for longer-term actions.
Subject(s)
Osteoarthritis/therapy , Congresses as Topic , Consensus , Female , Health Priorities , Humans , Male , Models, Organizational , Program DevelopmentABSTRACT
A number of controversies and challenges exist for the management of OA in health care. This paper describes the challenges and gaps in OA care, particularly in relation to population health management, complex interventions and outcomes. It sets this in the context of competing health priorities and multimorbidity, access to high quality conservative care, non-pharmacological therapies, resource limitations and models of care. The overuse of some therapies and neglect of others are discussed, as well as the potential for self-management. The roles of patient and public involvement and the healthcare team are highlighted in enhancing best care for OA and providing solutions for closing the evidence-to-practice gap. Implementation of models of care offer one solution to the challenges and progress of such implementation is described. Areas for further research are highlighted.
Subject(s)
Disease Management , Evidence-Based Medicine/methods , Health Priorities/standards , Osteoarthritis/therapy , Patient Care Team/standards , Quality of Health Care , HumansABSTRACT
BACKGROUND: Osteoarthritis (OA) is a leading cause of pain and disability. NICE OA guidelines (2008) recommend that patients with OA should be offered core treatments in primary care. Assessments of OA management have identified a need to improve primary care of people with OA, as recorded use of interventions concordant with the NICE guidelines is suboptimal in primary care. The aim of this study was to i) describe the patient-reported uptake of non-pharmacological and pharmacological treatments recommended in the NICE OA guidelines in older adults with a self-reported consultation for joint pain and ii) determine whether patient characteristics or OA diagnosis impact uptake. METHODS: A cross-sectional survey mailed to adults aged ≥45 years (n = 28,443) from eight general practices in the UK as part of the MOSAICS study. Respondents who reported the presence of joint pain, a consultation in the previous 12 months for joint pain, and gave consent to medical record review formed the sample for this study. RESULTS: Four thousand fifty-nine respondents were included in the analysis (mean age 65.6 years (SD 11.2), 2300 (56.7%) females). 502 (12.4%) received an OA diagnosis in the previous 12 months. More participants reported using pharmacological treatments (e.g. paracetamol (31.3%), opioids (40.4%)) than non-pharmacological treatments (e.g. exercise (3.8%)). Those with an OA diagnosis were more likely to use written information (OR 1.57; 95% CI 1.26,1.96), paracetamol (OR 1.30; 95% CI 1.05,1.62) and topical NSAIDs (OR 1.30; 95% CI 1.04,1.62) than those with a joint pain code. People aged ≥75 years were less likely to use written information (OR 0.56; 95% CI 0.40,0.79) and exercise (OR 0.37; 95% CI 0.25,0.55) and more likely to use paracetamol (OR 1.91; 95% CI 1.38,2.65) than those aged < 75 years. CONCLUSION: The cross-sectional population survey was conducted to examine the uptake of the treatments that are recommended in the NICE OA guidelines in older adults with a self-reported consultation for joint pain and to determine whether patient characteristics or OA diagnosis impact uptake. Non-pharmacological treatment was suboptimal compared to pharmacological treatment. Implementation of NICE guidelines needs to examine why non-pharmacological treatments, such as exercise, remain under-used especially among older people.
Subject(s)
Arthralgia/therapy , Guideline Adherence/standards , Osteoarthritis/therapy , Practice Guidelines as Topic/standards , Practice Patterns, Physicians'/standards , Primary Health Care/standards , Adult , Age Factors , Aged , Arthralgia/diagnosis , Arthralgia/epidemiology , Cross-Sectional Studies , Disability Evaluation , Female , Health Care Surveys , Humans , Male , Middle Aged , Osteoarthritis/diagnosis , Osteoarthritis/epidemiology , Pain Measurement , Self Report , United Kingdom/epidemiologyABSTRACT
OBJECTIVE: To evaluate the effectiveness of oral glucosamine in subgroups of people with hip or knee osteoarthritis (OA) based on baseline pain severity, body mass index (BMI), sex, structural abnormalities and presence of inflammation using individual patient data. METHODS: After a systematic search of the literature and clinical trial registries, all randomised controlled trials (RCTs) evaluating the effect of any oral glucosamine substance in patients with clinically or radiographically defined hip or knee OA were contacted. As a minimum, pain, age, sex and BMI at baseline and pain as an outcome measure needed to be assessed. RESULTS: Of 21 eligible studies, six (n=1663) shared their trial data with the OA Trial Bank. Five trials (all independent of industry, n=1625) compared glucosamine with placebo, representing 55% of the total number of participants in all published placebo-controlled RCTs. Glucosamine was no better than placebo for pain or function at short (3 months) and long-term (24 months) follow-up. Glucosamine was also no better than placebo among the predefined subgroups. Stratification for knee OA and type of glucosamine did not alter these results. CONCLUSIONS: Although proposed and debated for several years, open trial data are not widely made available for studies of glucosamine for OA, especially those sponsored by industry. Currently, there is no good evidence to support the use of glucosamine for hip or knee OA and an absence of evidence to support specific consideration of glucosamine for any clinically relevant OA subgroup according to baseline pain severity, BMI, sex, structural abnormalities or presence of inflammation.
Subject(s)
Anti-Inflammatory Agents/administration & dosage , Glucosamine/administration & dosage , Osteoarthritis, Hip/drug therapy , Osteoarthritis, Knee/drug therapy , Administration, Oral , Adult , Aged , Arthralgia/drug therapy , Arthralgia/etiology , Body Mass Index , Female , Hip Joint/drug effects , Hip Joint/pathology , Humans , Knee Joint/drug effects , Knee Joint/pathology , Male , Middle Aged , Osteoarthritis, Hip/complications , Osteoarthritis, Hip/pathology , Osteoarthritis, Knee/complications , Osteoarthritis, Knee/pathology , Randomized Controlled Trials as Topic , Severity of Illness Index , Sex Factors , Treatment OutcomeABSTRACT
BACKGROUND: Research into musculoskeletal conditions often focusses on pain at single sites, such as the knee, yet several studies have previously reported the high prevalence of multiple sites of musculoskeletal pain. The most common form of musculoskeletal condition is arthritis, with osteoarthritis (OA) the most common cause of joint pain in adults 45 years and over. However, there is limited recognition of the prevalence of multisite peripheral joint pain in those either living with or at risk of OA, therefore this study set out to estimate the prevalence of multisite peripheral joint pain in adults 45 years and older, and its impact on several dimensions of health. METHODS: A cross-sectional population survey was mailed to adults (n = 28,443) aged 45 years and over from eight general practices in the North West Midlands, United Kingdom (UK). Prevalence rates were established for multisite peripheral joint pain (pain in two or more sites; hands, hips, knees, feet). Impact was measured for general health (SF-12 MCS & PCS), QoL (EQ-5D), pain intensity (0-10 numerical ratings scale) and the number of consultations with a range of health care professionals. RESULTS: Of 15,083 responders (53%), multisite peripheral joint pain was reported by 54%. Peripheral joint pain was present in n = 11,928, of which 68% reported pain in multiple sites. Multisite peripheral joint pain was shown to be significantly associated with reduced physical (Mean difference = -5.9 95% CI -6.3,-5.5) and mental (-2.8 95% CI -3.2,-2.4) components of the SF-12, reduced QoL (-0.14 95% CI -0.15, -0.13), increased pain (+0.70 95% CI 0.62, 0.79) and increased odds of consultations with GPs (OR 2.4 95% CI 2.2, 2.6) and practice nurses (OR 2.6 (95% CI 2.1, 3.2) when compared to single site pain. CONCLUSIONS: Multisite peripheral joint pain is prevalent in the population in adults 45 years and over and has a significant negative impact on several dimensions of health. Health care professionals should consider joint pain beyond the index site in order to address holistic management.
Subject(s)
Arthralgia/epidemiology , Arthralgia/psychology , Health Status , Pain Measurement/methods , Quality of Life/psychology , Referral and Consultation , Aged , Arthralgia/diagnosis , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Prevalence , Referral and Consultation/trends , United Kingdom/epidemiologyABSTRACT
BACKGROUND: Despite a lack of service provision for people with osteoarthritis (OA), each year 1 in 5 of the general population consults a GP about a musculoskeletal condition such as OA. Consequently this may provide an opportunity for practice nurses to take an active role in helping patients manage their condition. A nurse led clinic for supporting patients with OA was developed for the MOSAICS study investigating how to implement the NICE 2014 OA Guideline core recommendations. This paper has two main objectives, firstly to provide an overview of the nurse-led OA clinic, and secondly to describe the development, key learning objectives, content and impact of the training to support its delivery. METHODS: A training programme was developed and delivered to provide practice nurses with the knowledge and skill set needed to run the nurse-led OA clinic. The impact of the training programme on knowledge, confidence and OA management was evaluated using case report forms and pre and post training questionnaires. RESULTS: The pre-training questionnaire identified a gap between what practice nurses feel they can do and what they should be doing in line with NICE OA guidelines. Evaluation of the training suggests that it enabled practice nurses to feel more knowledgeable and confident in supporting patients to manage their OA and this was reflected in the clinical management patients received in the nurse-led OA clinics. CONCLUSIONS: A significant gap between what is recommended and what practice nurses feel they can currently provide in terms of OA management was evident. The development of a nurse training programme goes some way to develop a system in primary care for delivering the core recommendations by NICE. TRIAL REGISTRATION: The cluster trial linked to this training was conducted from May 2012 through February 2014 by the Arthritis Research UK Primary Care Centre, Keele University, UK (Trial registration number ISRCTN06984617 ).
Subject(s)
Education, Nursing, Continuing , General Practice/organization & administration , Nurse's Role , Osteoarthritis/therapy , Practice Patterns, Nurses' , Clinical Competence , Curriculum , Humans , Middle Aged , Practice Guidelines as Topic , Self Efficacy , Surveys and QuestionnairesABSTRACT
BACKGROUND: The National Institute for Health and Care Excellence's Osteoarthritis (OA) guidelines recommended that future research should consider the benefits of combination therapies in people with OA across multiple joint sites. However, the clinical effectiveness of such approaches to OA management is unknown. This systematic review therefore aimed to identify the clinical and cost effectiveness of multidisciplinary approaches targeting multiple joint sites for OA in primary care. METHODS: A systematic review of randomised controlled trials. Computerised bibliographic databases were searched (MEDLINE, EMBASE, CINAHL, PsychINFO, BNI, HBE, HMIC, AMED, Web of Science and Cochrane). Studies were included if they met the following criteria; a randomised controlled trial (RCT), a primary care population with OA across at least two different peripheral joint sites (multiple joint sites), and interventions undertaken by at least two different health disciplines (multidisciplinary). The Cochrane 'Risk of Bias' tool and PEDro were used for quality assessment of eligible studies. Clinical and cost effectiveness was determined by extracting and examining self-reported outcomes for pain, function, quality of life (QoL) and health care utilisation. The date range for the search was from database inception until August 2015. RESULTS: The search identified 1148 individual titles of which four were included in the review. A narrative review was conducted due to the heterogeneity of the included trials. Each of the four trials used either educational or exercise interventions facilitated by a range of different health disciplines. Moderate clinical benefits on pain, function and QoL were reported across the studies. The beneficial effects of exercise generally decreased over time within all studies. Two studies were able to show a reduction in healthcare utilisation due to a reduction in visits to a physiotherapist or a reduction in x-rays and orthopaedic referrals. The intervention that showed the most promise used educational interventions delivered by GPs with reinforcement by practice nurses. CONCLUSIONS: There are currently very few studies that target multidisciplinary approaches suitable for OA across multiple joint sites, in primary care. A more consistent approach to outcome measurement in future studies of this nature should be considered to allow for better comparison.
Subject(s)
Cost-Benefit Analysis , Exercise Therapy/economics , Osteoarthritis/therapy , Patient Education as Topic/economics , Primary Health Care/methods , Weight Reduction Programs/economics , Access to Information , Combined Modality Therapy/economics , Humans , Osteoarthritis/economics , Pain Management/methods , Pain Measurement , Patient Acceptance of Health Care/statistics & numerical data , Practice Guidelines as Topic , Primary Health Care/economics , Primary Health Care/statistics & numerical data , Quality of Life , Randomized Controlled Trials as Topic , Range of Motion, Articular , Self Report , Treatment OutcomeABSTRACT
BACKGROUND: Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints. Secondary objectives are to determine specified comparative clinical outcomes and cost effectiveness of corticosteroid injection over 6 and 24 months. METHOD/DESIGN: A multicentre, randomised, parallel group, clinical pragmatic trial will recruit 240 adults aged ≥18 years with mild to moderate CTS from GP Practices and Primary-Secondary Care Musculoskeletal Interface Clinics. Diagnosis will be by standardised clinical assessment. Participants will be randomised on an equal basis to receive either one injection of 20 mg Depo-Medrone or a night splint to be worn for 6 weeks. The primary outcome is the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. Secondary outcomes are the BCTQ symptom severity and function status subscales, symptom intensity, interrupted sleep, adherence to splinting, perceived benefit and satisfaction with treatment, work absence and reduction in work performance, EQ-5D-5L, referral to surgery and health utilisation costs. Participants will be assessed at baseline and followed up at 6 weeks, 6, 12 and 24 months. The primary analysis will use an intention to treat (ITT) approach and multiple imputation for missing data. The sample size was calculated to detect a 15 % greater improvement in the BTCQ overall score in the injection group compared to night-splinting at approximately 90 % power, 5 % two-tailed significance and allows for 15 % loss to follow-up. DISCUSSION: The trial makes an important contribution to the evidence base available to support effective conservative management of CTS in primary care. No previous trials have directly compared these treatments for CTS in primary care populations, reported on clinical effectiveness at more than 6 months nor compared cost effectiveness of the interventions. TRIAL REGISTRATION: Trial registration: EudraCT 2013-001435-48 (registered 05/06/2013), ClinicalTrials.gov NCT02038452 (registered 16/1/2014), and Current Controlled Trials ISRCTN09392969 (retrospectively registered 01/05/2014).
Subject(s)
Carpal Tunnel Syndrome/therapy , Cost-Benefit Analysis , Glucocorticoids/therapeutic use , Methylprednisolone/analogs & derivatives , Splints/economics , Adult , Carpal Tunnel Syndrome/economics , Glucocorticoids/administration & dosage , Glucocorticoids/economics , Hand , Humans , Injections , Methylprednisolone/administration & dosage , Methylprednisolone/economics , Methylprednisolone/therapeutic use , Methylprednisolone Acetate , Patient Satisfaction , Primary Health Care/methods , Surveys and Questionnaires , Treatment OutcomeABSTRACT
OBJECTIVE: The aims of this study were to determine the feasibility of introducing a computerized template for identifying quality of care during an OA consultation, describe quality of OA care in practices in which the template was introduced and assess the effect of the template on routinely recorded clinician behaviour in those practices. METHODS: A computerized template to assist the recording of care in consultations for patients with OA was installed in eight general practices. Eligible patients were those ≥45 years of age consulting for clinical OA during a 6 month period. The main outcomes were frequency of template triggering, achievement of quality indicators during the consultation (assessment of pain and function, assessment for first-line analgesics, provision of information, exercise advice, consideration of physiotherapy referral, weight loss advice) and change in routinely recorded clinician behaviour (diagnostic coding, prescribing, referral, use of radiography, weight records) compared with the 12 months prior to template installation. RESULTS: The template was triggered for 1730 patients. Achievement of indicators ranged from 36% (for consideration of physiotherapy referral) to 63% (for pain assessment), with substantial variability between clinicians. There was an increase in prescription of recommended first-line analgesics following the template installation: paracetamol [odds ratio (OR) 1.49 (95% CI 1.22, 1.82) compared with pre-template] and topical NSAIDs [OR 1.95 (95% CI 1.61, 2.35)]. CONCLUSION: This new template is a feasible tool for capturing data during OA consultations to aid assessment of quality of care. It was associated with significant improvements in recommended care processes. However, strategies are needed to ensure consistent approaches between clinicians. TRIAL REGISTRATION: http://www.controlled-trials.com/ISRCTN06984617/mosaics.
Subject(s)
Medical Records Systems, Computerized , Osteoarthritis/diagnosis , Osteoarthritis/therapy , Point-of-Care Systems , Quality of Health Care , Referral and Consultation , Aged , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Feasibility Studies , Female , Humans , Male , Middle Aged , Patient Education as Topic , Patient Outcome Assessment , Physical Therapy Modalities , Primary Health Care , Weight Reduction ProgramsABSTRACT
A multitude of factors can influence the uptake and implementation of complex interventions in health care. A plethora of theories and frameworks recognize the need to establish relationships, understand organizational dynamics, address context and contingency, and engage key decision makers. Less attention is paid to how theories that emphasize relational contexts can actually be deployed to guide the implementation of an intervention. The purpose of the article is to demonstrate the potential role of qualitative research aligned with theory to inform complex interventions. We detail a study underpinned by theory and qualitative research that (a) ensured key actors made sense of the complex intervention at the earliest stage of adoption and (b) aided initial engagement with the intervention. We conclude that using theoretical approaches aligned with qualitative research can provide insights into the context and dynamics of health care settings that in turn can be used to aid intervention implementation.
Subject(s)
Evidence-Based Practice/standards , Health Services Research/standards , Qualitative Research , Translational Research, Biomedical/standards , Decision Theory , Evidence-Based Practice/methods , Exercise Therapy , Health Services Research/methods , Humans , Information Dissemination/methods , Osteoarthritis/therapy , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , State Medicine/standards , Translational Research, Biomedical/methods , United Kingdom , Weight LossABSTRACT
BACKGROUND: Written information can be of benefit to both practitioners and patients and the provision of quality information is emphasised as a core intervention by United Kingdom National Institute of Clinical Excellence (NICE) OA guidelines. Researchers, patients and HCPs developed an 'OA guidebook' to provide; a) a balanced source of information for patients; b) a resource to aid practitioners when discussing self-management. This study aimed to evaluate the acceptability and usefulness of the OA guidebook as part of complex intervention to deliver NICE OA guidelines in General Practice. METHODS: The intervention comprises a series of consultations with GPs and practice nurses in which supported self-management is offered to patients. Eight practices in the West Midlands and North West of England were recruited to take part: four control practices and four intervention practices. Semi-structured interviews were undertaken with patients (n = 29), GPs (n = 9) and practice nurses (n = 4) from the intervention practices to explore experiences of the intervention and use of the guidebook. Data were analysed using thematic analysis and constant comparison of data within and across interviews. RESULTS: GPs thought the guidebook helped provide patients with information about OA aetiology, prognosis and self-management. Thus, it backed up key messages they provided patients during consultations. GPs also found the guidebook helped them 'close off' consultations. Nurses also thought the guidebook helped them describe OA disease processes in consultations. Patients valued the explanations of disease onset, process and prognosis. The use of 'real' people and 'real life' situations contained within the guidebook made self-management strategies seem more tangible. A sense of inclusion and comfort was obtained from knowing other people encountered similar problems and feelings. CONCLUSION: An OA specific written information guidebook was deemed acceptable and useful to practitioners and patients alike as part of the MOSAICS study. Findings reinforce the utility of this model of patient information as a resource to support patients living with chronic illnesses. An OA guidebook featuring a mixture of lay and professional information developed by professionals and lay people is useful and could effectively be used more widely in usual care.
Subject(s)
Attitude of Health Personnel , Disease Management , Osteoarthritis/therapy , Pamphlets , Patient Education as Topic/standards , Qualitative Research , Aged , Female , Humans , Male , Middle Aged , Osteoarthritis/diagnosis , Patient Education as Topic/methods , Patient Participation , Practice Guidelines as Topic/standardsABSTRACT
STUDY QUESTION: Which types of exercise intervention are most effective in relieving pain and improving function in people with lower limb osteoarthritis? SUMMARY ANSWER: As of 2002 sufficient evidence had accumulated to show significant benefit of exercise over no exercise. An approach combining exercises to increase strength, flexibility, and aerobic capacity is most likely to be effective for relieving pain and improving function. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Current international guidelines recommend therapeutic exercise (land or water based) as "core" and effective management of osteoarthritis. Evidence from this first network meta-analysis, largely based on studies in knee osteoarthritis, indicates that an intervention combining strengthening exercises with flexibility and aerobic exercise is most likely to improve outcomes of pain and function. Further trials of exercise versus no exercise are unlikely to overturn this positive result.
ABSTRACT
BACKGROUND: Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported. AIMS: To enhance the design of a future clinical trial of hand splints for thumb-base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process. DESIGN: Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb-base OA were approached about involvement by Occupational Therapy (OT) practitioners. CONTENT OF THE FORA: A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group ('arm') was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint. CONCLUSION AND DISCUSSION: This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability.