Responsiveness and interpretability of incontinence severity scores and FIQL in patients with fecal incontinence: a secondary analysis from a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: This study aims to assess the responsiveness and interpretability of the Vaizey score, Wexner score, and the Fecal Incontinence Quality of Life Scale (FIQL) for use in the evaluation of patients with fecal incontinence (FI). METHODS: Eighty patients with FI with a mean age of 59.3 (SD ± 11.9) were enrolled in a randomized controlled trial. The patient-reported outcomes were tested for internal and external responsiveness, longitudinal construct validity, and interpretability. RESULTS: All total scores proved to have both adequate to excellent responsiveness and longitudinal construct validity, and changes were in agreement with subjective improvement. Due to variability in minimally important change estimates (Vaizey score -5 to -3, Wexner score -3 to -2, FIQL 1.1 to 1.2), they should be used as indicators. All patient-reported outcomes showed psychometric or practical limitations. CONCLUSIONS: The instruments available to date to evaluate severity and quality of life in FI do not yet attain the highest levels of psychometric soundness. As the focus of patients may differ from that of physicians, it is recommended that several measures should be included for evaluation. So far, there are suggestions that the Wexner score is most suitable for severity assessment and the FIQL for evaluating quality of life.

WITHDRAWN: Pelvic floor muscle training for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training is the most commonly recommended physical therapy treatment for women with stress leakage of urine. It is also used in the treatment of women with mixed incontinence, and less commonly for urge incontinence. Adjuncts, such as biofeedback or electrical stimulation, are also commonly used with pelvic floor muscle training. The content of pelvic floor muscle training programmes is highly variable. OBJECTIVES: To determine the effects of pelvic floor muscle training for women with symptoms or urodynamic diagnoses of stress, urge and mixed incontinence, in comparison to no treatment or other treatment options. SEARCH STRATEGY: Search strategy: We searched the Cochrane Incontinence Group trials register (May 2000), Medline (1980 to 1998), Embase (1980 to 1998), the database of the Dutch National Institute of Allied Health Professions (to 1998), the database of the Cochrane Rehabilitation and Related Therapies Field (to 1998), Physiotherapy Index (to 1998) and the reference lists of relevant articles. We handsearched the proceedings of the International Continence Society (1980 to 2000). We contacted investigators in the field to locate studies. Date of the most recent searches: May 2000. SELECTION CRITERIA: Randomised trials in women with symptoms or urodynamic diagnoses of stress, urge or mixed incontinence that included pelvic floor muscle training in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. Sensitivity analysis on the basis of diagnosis was planned and undertaken where appropriate. MAIN RESULTS: Forty-three trials met the inclusion criteria. The primary or only reference for 15 of these was a conference abstract. The pelvic floor muscle training programs, and comparison interventions, varied markedly. Outcome measures differed between trials, and methods of data reporting varied, making the data difficult to combine. Many of the trials were small. Allocation concealment was adequate in five trials, and nine trials used assessors masked to group allocation. Thirteen trials reported that there were no losses to follow up, seven trials had dropout rates of less than 10%, but in the remaining trials the proportion of dropouts ranged from 12% to 41%. Pelvic floor muscle training was better than no treatment or placebo treatments for women with stress or mixed incontinence. 'Intensive' appeared to be better than 'standard' pelvic floor muscle training. PFMT may be more effective than some types of electrical stimulation but there were problems in combining the data from these trials. There is insufficient evidence to determine if pelvic floor muscle training is better or worse than other treatments. The effect of adding pelvic floor muscle training to other treatments (e.g. electrical stimulation, behavioural training) is not clear due to the limited amount of evidence available. Evidence of the effect of adding other adjunctive treatments to PFMT (e.g. vaginal cones, intravaginal resistance) is equally limited. The effectiveness of biofeedback assisted PFMT is not clear, but on the basis of the evidence available there did not appear to be any benefit over PFMT alone at post treatment assessment.Long-term outcomes of pelvic floor muscle training are unclear. Side effects of pelvic floor muscle training were uncommon and reversible. A number of the formal comparisons should be viewed with caution due to statistical heterogeneity, lack of statistical independence, and the possibility of spurious confidence intervals in some instances. AUTHORS' CONCLUSIONS: Pelvic floor muscle training appeared to be an effective treatment for adult women with stress or mixed incontinence. Pelvic floor muscle training was better than no treatment or placebo treatments. The limitations of the evidence available mean that is difficult to judge if pelvic floor muscle training was better or worse than other treatments. Most trials to date have studied the effect of treatment in younger, premenopausal women. The role of pelvic floor muscle training for women with urge incontinence alone remains unclear. Many of the trials were small with poor reporting of allocation concealment and masking of outcome assessors. In addition there was a lack of consistency in the choice and reporting of outcome measures that made data difficult to combine. Methodological problems limit the confidence that can be placed in the findings of the review. Further, large, high quality trials are necessary.

The development of a clinical practice stroke guideline for physiotherapists in The Netherlands: a systematic review of available evidence.

PURPOSE: To develop a clinical practice guideline for the physiotherapy management of patients with stroke as support for the clinical decision-making process, especially with respect to the selection of appropriate interventions, prognostic factors and outcome measures. INTRODUCTION: Physiotherapists have a high caseload of patients with stroke, so there is a need to identify effective evidence-based physiotherapy procedures. The availability of a guideline that includes information about prognostic factors, interventions, and outcome measures would facilitate clinical decision-making. METHOD: A systematic computerized literature search was performed to identify evidence concerning the use of: (i) prognostic factors related to functional recovery; (ii) physiotherapy interventions in patients with stroke; and (iii) outcome measures to assess patients' progress in functional health. Experts, physiotherapists working in the field of stroke rehabilitation, and a multidisciplinary group of health professionals reviewed the clinical applicability and feasibility of the recommendations for clinical practice and their comments were used to compose the definitive guideline. RESULTS: Of 9482 relevant articles, 322 were selected. These were screened for methodological quality. Seventy-two recommendations for clinical practice were retrieved from these articles and included in the guideline: Six recommendations concerned the prediction of functional recovery of activities of daily living (ADL), including walking ability and hand/arm use; 65 recommendations concerned the choice of physiotherapy interventions; and 1 recommendation concerned the choice of outcome instrument to use. A core set of seven reliable, responsive, and valid outcome measures was established, to determine impairments and activity limitations in patients with stroke. CONCLUSIONS: The guideline provides physiotherapists with an evidence-based instrument to assist them in their clinical decision making regarding patients with stroke. As most of the recommendations included in the guideline came from studies of patients in the post acute and chronic phase of stroke, and in general involved patients with less severe and uncomplicated stroke, more needs to be learned about the more complex cases.

Development of quality indicators for physiotherapy for patients with PAOD in the Netherlands: a Delphi study.

OBJECTIVES: The aim of the study was to develop quality indicators (QIs) for physiotherapy management of patients with intermittent claudication (IC) in the Netherlands. DESIGN: As part of an international six-step method to develop QIs, an online survey Delphi-procedure was completed. After two Delphi-rounds a validation round was performed. PARTICIPANTS: Twenty-six experts were recruited to participate in this study. Twenty-four experts completed two Delphi-rounds. A third round was conducted inviting 1200 qualified and registered physiotherapists of the Dutch integrated care network 'Claudicationet' to validate a draft set of quality indicators. RESULTS: Out of 83 potential QIs in the Dutch physiotherapy guideline on 'Intermittent claudication', consensus among the experts selected nine indicators. All nine quality indicators were validated by 300 physiotherapists. CONCLUSION: A final set of nine indicators was derived from (1) a Dutch evidence-based physiotherapy guideline, (2) an expert Delphi procedure and (3) a validation by 300 physiotherapists. This set of indicators should be validated in clinical practice.

Effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain: a cluster randomised controlled trial.

OBJECTIVES: To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain. DESIGN: A cluster randomised controlled trial comparing an active strategy with standard dissemination. SETTING: Primary care physiotherapy practices. PARTICIPANTS: 113 physiotherapists were randomly allocated to receive the guidelines by mail (control group) or to receive an additional active strategy (intervention group) which consisted of a multifaceted programme including education, discussion, role playing, feedback, and reminders. MAIN OUTCOME MEASURES: Adherence to the guidelines was measured by means of individual patients' forms recording the treatment completed by the physiotherapist. The forms were assessed using an algorithm based on the number of treatment sessions, treatment goals, interventions, and patient education. RESULTS: Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain (OR 2.39; 95% CI 1.12 to 5.12), more often set functional treatment goals (OR 1.99; 95% CI 1.06 to 3.72), more often used mainly active interventions (OR 2.79; 95% CI 1.19 to 6.55), and more often gave adequate patient education (OR 3.59; 95% CI 1.35 to 9.55). They also adhered more to all four criteria (OR 2.05; 95% CI 1.15 to 3.65). CONCLUSIONS: The active strategy moderately improved adherence to the guidelines. Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain.

The impact of physical therapy on functional outcomes after stroke: what's the evidence?

OBJECTIVE: To determine the evidence for physical therapy interventions aimed at improving functional outcome after stroke. METHODS: MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, DARE, PEDro, EMBASE and DocOnline were searched for controlled studies. Physical therapy was divided into 10 intervention categories, which were analysed separately. If statistical pooling (weighted summary effect sizes) was not possible due to lack of comparability between interventions, patient characteristics and measures of outcome, a best-research synthesis was performed. This best-research synthesis was based on methodological quality (PEDro score). RESULTS: In total, 151 studies were included in this systematic review; 123 were randomized controlled trials (RCTs) and 28 controlled clinical trials (CCTs). Methodological quality of all RCTs had a median of 5 points on the 10-point PEDro scale (range 2-8 points). Based on high-quality RCTs strong evidence was found in favour of task-oriented exercise training to restore balance and gait, and for strengthening the lower paretic limb. Summary effect sizes (SES) for functional outcomes ranged from 0.13 (95% Cl 0.03-0.23) for effects of high intensity of exercise training to 0.92 (95% Cl 0.54-1.29) for improving symmetry when moving from sitting to standing. Strong evidence was also found for therapies that were focused on functional training of the upper limb such as constraint-induced movement therapy (SES 0.46; 95% Cl 0.07-0.91), treadmill training with or without body weight support, respectively 0.70 (95% Cl 0.29-1.10) and 1.09 (95% Cl 0.56-1.61), aerobics (SES 0.39; 95% Cl 0.05-0.74), external auditory rhythms during gait (SES 0.91; 95% Cl 0.40-1.42) and neuromuscular stimulation for glenohumeral subluxation (SES 1.41; 95% Cl 0.76-2.06). No or insufficient evidence in terms of functional outcome was found for: traditional neurological treatment approaches; exercises for the upper limb; biofeedback; functional and neuromuscular electrical stimulation aimed at improving dexterity or gait performance; orthotics and assistive devices; and physical therapy interventions for reducing hemiplegic shoulder pain and hand oedema. CONCLUSIONS: This review showed small to large effect sizes for task-oriented exercise training, in particular when applied intensively and early after stroke onset. In almost all high-quality RCTs, effects were mainly restricted to tasks directly trained in the exercise programme.