Comparison of two recruitment strategies for patients with chronic shoulder complaints.

BACKGROUND: Recruiting adequate numbers of participants represents a major problem to the completion of randomised clinical trials in primary care. Information on different recruitment strategies applied in one trial is scarce. AIM: To evaluate the application of two recruitment strategies in one trial. DESIGN OF STUDY: The study was performed within the framework of a randomised clinical trial on the effectiveness of a behavioural treatment for patients with chronic shoulder complaints. SETTING: Thirty-two general practices in the Netherlands. METHOD: Patients recruited during a consultation with their GP for chronic shoulder complaints were compared with patients recruited by advertisement in a local newspaper as regards baseline characteristics, withdrawals (drop-outs and losses to follow-up) and post-treatment clinical outcomes. RESULTS: Patients recruited by the GPs (n = 83) were similar to those recruited by advertisement (n = 83) in terms of demographic characteristics and clinical outcome measures at baseline, but differed slightly in disease characteristics and treatment preferences. Recruitment strategy was not related to reasons for or numbers of withdrawals. Improvements on outcome measures were greater in patients recruited by the GPs, irrespective of allocated treatment. Results on the clinical effectiveness of treatments at the end of the treatment period or during follow-up were neither modified by recruitment strategy, nor by differences between the two strategy groups in patient characteristics found at baseline. CONCLUSION: Using two recruitment strategies did not influence the outcomes on clinical effectiveness in this trial.However, recruitment strategy should be considered as a putative modifying factor in the design of a study.

Implications of process evaluation for clinical effectiveness and clinical practice in a trial on chronic shoulder complaints.

OBJECTIVE: The intervention process was evaluated in a randomised clinical trial on the effectiveness of a behavioural Graded Exercise Therapy (GET) programme for patients with chronic shoulder complaints in primary care settings. This process evaluation was done for three reasons: first, to know whether the programme was performed as planned; second, to know whether or not this treatment is feasible in normal practice; third, to identify needs for improvement of the protocol to facilitate implication. METHODS: We evaluated the extent to which the programme is being applied according to protocol, patient adherence to the programme and the suitability of the programme according to patients and physiotherapists. Twenty participating physiotherapists and 87 patients allocated to GET were asked to evaluate the intervention process. Furthermore, a sample of 10 patients, taken from the total number of 87 patients allocated to GET, was invited to take part in a focus group interview at the end of the study. We evaluated the intervention process using a treatment registration form filled in by the physiotherapists during treatment, evaluation forms filled in independently by physiotherapists and patients 26 weeks after the start of the treatment period, and information gathered during the focus group interview at the end of the study. RESULTS: GET was applied according to protocol to an acceptable extent, and participating patients showed satisfactory adherence to the programme. CONCLUSIONS: Clinical effectiveness of GET in this trial is not influenced by flaws in the application of the programme or by lack of patient adherence. PRACTICE IMPLICATIONS: The programme could be improved in terms of the process of goal-setting, and the implementation of GET could be facilitated if the programme is embedded in a multidisciplinary approach in primary care.

Effectiveness of a graded exercise therapy program for patients with chronic shoulder complaints.

An operant behavioural and time-contingent graded exercise therapy program was developed to improve functional ability irrespective of pain experience in patients with chronic shoulder complaints. The clinical effectiveness of graded exercise therapy compared to usual care was evaluated in a randomised clinical trial. Assessments were carried out before and after 12 weeks of treatment. Performance of daily activities was measured by two outcome measures: the main complaints instrument and the Shoulder Disability Questionnaire (SDQ). Patients were eligible for participation if they had suffered from shoulder complaints for at least three months. Patients suffering from systemic diseases, referred pain or severe biomedical or psychiatric disorders were excluded. Patients (n = 176) were randomised and allocated either to graded exercise therapy (n = 87) or usual care (n = 89). Graded exercise therapy led to greater improvement in the performance of daily activities than usual care. However, only mean differences between groups in performance of activities related to the main complaints reached statistical significance (p = 0.049; 95% CI 0.0 to 15.0). The observed beneficial effects were considered to be small to moderate (calculated effect sizes: 0.30 for the main complaints instrument and 0.07 for the SDQ). Subgroup analysis showed larger improvements on the mean complaints instrument in patients not reporting pain reduction over time. Graded exercise therapy seems to be less effective in restoring performance of daily activities as assessed by the SDQ in patients showing a painful arc during physical examination. Results showed that graded exercise therapy is more effective in restoring the ability to daily activities in patients with chronic shoulder complaints than usual care, although beneficial effects are small.

A behavioural treatment for chronic shoulder complaints: concepts, development, and study design.

This paper discusses the rationale for and content of a newly developed treatment for shoulder complaints, and describes a randomised study which is currently being conducted to test effectiveness of the treatment. In current practice, approximately 50% of all patients with shoulder complaints mention limitations in the performance of daily activities and persisting pain after six months. To improve the functional ability of patients with chronic shoulder complaints, despite their pain, we have developed an operant behavioural and time-contingent graded exercise therapy programme for use in a primary care setting. We present the theory and conceptual model underlying this programme, report on its development and content, and describe the design of a randomised clinical trial to evaluate the programme's effectiveness and cost-effectiveness. One hundred and thirty-two patients who suffer from shoulder complaints for at least 3 months are being recruited in general practice. After inclusion in the study, patients are allocated randomly to the graded exercise therapy programme or to usual care. Questionnaires will be used to measure factors like severity of the main complaint, functional limitations of daily activities, perceived recovery, global health status, shoulder pain, generic health-related quality of life, and costs. These factors will be assessed at baseline, during treatment (6 weeks), and after treatment (12, 26, and 52 weeks).

Cost-effectiveness of a graded exercise therapy program for patients with chronic shoulder complaints.

OBJECTIVES: The present study evaluated the cost-effectiveness of a behavioral graded exercise therapy (GET) program compared with usual care (UC) in terms of the performance of daily activities by patients with chronic shoulder complaints in primary care. METHODS: A total of 176 patients were randomly assigned either to GET (n=87) or to UC (n=89). Clinical outcomes (main complaints, shoulder disability [SDQ] and generic health-related quality of life [EQ-5D], and costs [intervention costs, direct health care costs, direct non-health-related costs, and indirect costs]) were assessed during the 12-week treatment period and at 52 weeks of follow-up. RESULTS: Results showed that GET was more effective than UC in restoring daily activities as assessed by the main complaints instrument after the 12-week treatment period (p = .049; mean difference, 7.5; confidence interval [CI], 0.0-15.0). These effects lasted for at least 52 weeks (p = .025; mean difference 9.2; CI, 1.2-17.3). No statistically significant differences were found on the SDQ or EQ5D. GET significantly reduced direct health care costs (p = .000) and direct non-health care costs (p = .029). Nevertheless, total costs during the 1-year follow-up period were significantly higher (p = .001; GET = Euro 530 versus UC = Euro 377) due to the higher costs of the intervention. Incremental cost-effectiveness ratios for the main complaints (0-100), SDQ (0-100), and EQ-5D (-1.0-1.0) were Euro 7, Euro 74, and Euro 5278 per unit of improvement, respectively. CONCLUSIONS: GET proved to be more effective in the short- and long-term and reduces direct health care costs and direct non-health care costs but is associated with higher costs of the intervention itself.