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PubMed2001

Expression of cholesteryl ester transfer protein in human atherosclerotic lesions and its implication in reverse cholesterol transport.

Reverse cholesterol transport (RCT) is the major protective system against atherosclerosis. In this system, cholesteryl ester transfer protein (CETP) is known to facilitate the transfer of neutral lipids between lipoproteins in plasma. We reported the pathophysiological significance of CETP by clinical studies with genetic CETP deficiency, showing that this protein plays a crucial role in the RCT system. However, information about the expression of this protein in the initial step of RCT, macrophages (Mphi) in the blood vessels, is still very limited. In the present study, we have performed immunohistochemical analyses on the expression of CETP in human atherosclerotic lesions. The immunoreactive mass of CETP was abundantly detected in foam cells in human aortic and coronary atherosclerotic lesions, but not in the normal arterial wall. A double immunostaining showed that the majority of CETP-positive foam cells were derived from Mphi and a minor population appeared to derive from smooth muscle cells. Transient transfection of CETP cDNA into COS-7 cells showed that high density lipoprotein (HDL)-mediated efflux of free cholesterol from the cells expressing CETP was much higher than that from mock-transfected cells, while uptake of HDL-lipids was not affected in cells transfected with CETP cDNA. Efflux of free cholesterol from the Mphi obtained from CETP deficiency was significantly decreased compared with that from normal subjects. These data indicate that CETP is expressed in Mphi in the atherosclerotic lesions and may possess an anti-atherogenic function to remove cholesterol from the cells, suggesting another role of CETP at the initial step of RCT.

Adult↗
PubMed2003

P27 does not predict histopathological response to radiochemotherapy in rectal cancer.

BACKGROUND: Tumor response to radiochemotherapy (RCT) varies considerably, even among patients treated in accordance with the same protocol. The aim of the present study was to test the predictive value of the cell-cycle inhibitor p27kip1 with regard to neoadjuvant RCT response in rectal cancer. MATERIALS AND METHODS: P27kip1 was evaluated by immunohistochemistry in pretreatment biopsy material obtained from 42 patients with rectal cancer treated uniformly in accordance with an identical prospective neoadjuvant RCT protocol (CAO/AIO/ARO-94). Four expression patterns (staining intensity [-,+,++,+++] and the percentage of positive cells, evaluated separately for nuclei and cytoplasm) of p27kip1 were investigated for correlation with tumor response, which was assessed in the resected surgical specimen using a histopathological five-point grading system. Additionally, p27(kip1) expression was investigated for correlation with several pathological features, overall survival, and disease-free survival. RESULTS: p27kip1 expression was as follows: nuclear intensity: -: 8, +: 19, ++: 11, +++: 4 cases, median percentage of positive cells: 18.75%; cytoplasmic intensity: -: 0, +: 25, ++: 12, +++: 3 cases, median percentage of positive cells: 70%. Histopathological tumor regression was acceptable in 30 patients (3 complete; 27 good) and inadequate in 12 patients (7 moderate; 5 minimal). No tumor failed to show some regression. No significant correlation was found between any of the p27kip1 expression patterns and RCT response, tumor differentiation (low grade versus high grade), cT- and ypT-category, UICC stage, overall survival, and disease-free survival. CONCLUSIONS: p27kip1 cannot aid the individualization of multimodal treatment strategies in rectal cancer, nor can it serve as a predictor of survival.

Adenocarcinoma↗
PubMed1999

Desialylation of human apolipoprotein E decreases its binding to human high-density lipoprotein and its ability to deliver esterified cholesterol to the liver.

Apolipoprotein E (apoE) plays a significant role in the delivery of high-density lipoprotein (HDL) cholesterol to the liver via the apoB/E receptor. The roles of the apoE sialylation status in its association with HDL and in the reverse cholesterol transport (RCT) function of HDL have not been well defined. Furthermore, long-term ethanol treatment impairs apoE sialylation and leads to its decreased content in HDL. Therefore, we investigated the association of either sialo apoE (SapoE) or desialo apoE (DSapoE) with HDL and its effect on the RCT function of HDL. The dextran sulfate precipitation method showed that [125I]DSapoE binding to HDL was 27.3% (P < .02) to 35.5% (P < .001) lower versus [125I]SapoE. Scatchard analysis of the specific binding data showed that [125I]SapoE had 11.2 times more affinity for HDL than [125I]DSapoE based on size-exclusion chromatography (Kd = 89.7 v 1,010 nmol/L). Similarly, [1251]HDL had 4.5 times more affinity for SapoE compared with DSapoE based on solid-phase binding (Kd = 21.9 v 104.4 nmol/L). Furthermore, esterified cholesterol uptake from reconstituted HDL particles (rHDLs) by HepG2 cells increased over basal uptake up to 153% when rHDLs contained SapoE, versus only 37% with DSapoE. Enzymatic resialylation of DSapoE completely restored its HDL-binding and RCT properties, identical to those of SapoE. It is therefore concluded that desialylation of apoE decreases its binding to plasma HDL, leading to an impaired RCT function.

Apolipoproteins E↗
PubMed1998

Neural conduction in visual pathways in newly-diagnosed IDDM patients.

OBJECTIVES: Visual evoked potentials (VEPs) show abnormal responses in newly-diagnosed insulin-dependent diabetic (IDDM) patients. Electrophysiological methods allow one to dissect and explore different structures contributing to neural conduction in the visual pathways. The aim of our work was to assess whether the VEP abnormalities are due to impaired function of the retinal layers and/or a delayed conduction in the postretinal visual pathways. METHODS: Simultaneous recordings of VEP and pattern-electroretinogram (PERG) were performed at two intervals (at entry of the study and after 3 months) in 14 newly-diagnosed IDDM patients (age: 24.8+/-6.8 years; duration of disease: 3+/-1.5 months), and in 14 age-matched control subjects. RESULTS: In comparison with control subjects, IDDM patients showed: VEP P100 latencies significantly delayed (P < 0.01), a significant impairment of all PERG parameters (P < 0.01) and retinocortical time (RCT, difference between VEP P100 and PERG P50 latencies) and latency window (LW, difference between VEP N75 and PERG P50 latencies) also significantly increased (P < 0.01). All electrophysiological parameters were not significantly changed when retested after 3 months. No correlations were found between VEP P100 latency, RCT, LW and PERG parameters. CONCLUSIONS: Impaired PERG indicates an involvement of the innermost retinal layers; increased values of RCT and LW represent an index of delayed neural conduction in the postretinal visual pathways. Therefore two sources, one retinal (impaired PERG) and one postretinal (delayed RCT and LW), may independently contribute in to the abnormal responses of VEP observed in newly-diagnosed IDDM patients. Three months of relatively-stable metabolic control have not normalized the VEP and PERG impairment.

Adolescent↗
PubMed2003

Power analysis in randomized clinical trials based on item response theory.

Patient relevant outcomes, measured using questionnaires, are becoming increasingly popular endpoints in randomized clinical trials (RCTs). Recently, interest in the use of item response theory (IRT) to analyze the responses to such questionnaires has increased. In this paper, we used a simulation study to examine the small sample behavior of a test statistic designed to examine the difference in average latent trait level between two groups when the two-parameter logistic IRT model for binary data is used. The simulation study was extended to examine the relationship between the number of patients required in each arm of an RCT, the number of items used to assess them, and the power to detect minimal, moderate, and substantial treatment effects. The results show that the number of patients required in each arm of an RCT varies with the number of items used to assess the patients. However, as long as at least 20 items are used, the number of items barely affects the number of patients required in each arm of an RCT to detect effect sizes of 0.5 and 0.8 with a power of 80%. In addition, the number of items used has more effect on the number of patients required to detect an effect size of 0.2 with a power of 80%. For instance, if only five randomly selected items are used, it is necessary to include 950 patients in each arm, but if 50 items are used, only 450 are required in each arm. These results indicate that if an RCT is to be designed to detect small effects, it is inadvisable to use very short instruments analyzed using IRT. Finally, the SF-36, SF-12, and SF-8 instruments were considered in the same framework. Since these instruments consist of items scored in more than two categories, slightly different results were obtained.

Health Status↗
PubMed2002

[Interpretation of results of clinical trials in benign prostatic hyperplasia].

The random clinical trial (RCT) is the most suitable study to evaluate the treatment effectiveness in the benign prostatic hyperplasia (BPH). Although most of the urologists will not collaborate in a RCT development, they will treat BPH patients, so it is very important to know if a CRT in BPH is well designed and their conclusions are correct. The aim of this article is to give the basic elements of analysis that urologists need in order to evaluate the quality and the level of evidence of a RCT in BPH. This article emphasizes the three main elements of a RCT: to check if the study has been correctly performed (internal validity), to evaluate if the treatment achieves an important clinical improvement (relevance of the results) and the applicability of the results in our patients (external validity). The article shows that to analyse these elements common sense and clinical judgment are needed rather than statistical knowledge.

Data Interpretation, Statistical↗
PubMed1998

Comparison between enzyme-linked immunosorbent assay, indirect fluorescent antibody and rapid conglutination tests in detecting antibodies against Babesia bovis.

The performance of an enzyme-linked immunosorbent assay (ELISA), an indirect fluorescent antibody test (IFAT) and a rapid conglutination test (RCT) for the detection of antibodies against Babesia bovis, was evaluated with 462 cattle sera from Bahia State; Brazil. The results showed a concordance of 96.6% between the ELISA and IFAT, 90.5% between the ELISA and RCT, and 91.8% between the IFAT and RCT. Although the prevalence rates determined by ELISA (97.2%) and IFAT (96.8%) were higher than that indicated by the RCT (92.9%), performances of the three serological tests were very similar and characterized the region studied as enzootically stable to B. bovis.

Animals↗
PubMedDate not supplied

The influence of acromioclavicular joint morphology on rotator cuff tears.

A detailed anatomic study of 123 shoulders was performed to define the location of the acromioclavicular (AC) joint within the supraspinatus outlet and to determine the correlation of AC joint morphologic characteristics with the presence of full-thickness rotator cuff tears (RCTs). The presence, location, and extent of RCTs were first documented for each shoulder, and 2 anatomic landmarks consisting of the anterolateral acromial corner and the inferior midpoint of the AC joint were identified and their positions digitized in 3 dimensions to calculate outlet space and clearance and AC joint locations. High resolution x-ray films were then obtained to determine the extent of degenerative changes including the location and size of inferior osteophytes and joint space. These specimens were cleaned of all soft tissues, and additional measurements were made. All data were entered into a computerized database and analyzed with respect to age, sex, and the presence of RCT. Comparison of age-matched RCT versus non-RCT groups revealed no significant differences in the position of the AC joint within the supraspinatus outlet. When AC joint morphologic characteristics were compared with those of a nontear, age-matched group, no significant differences with regard to joint space narrowing were found, but significantly larger and greater number of osteophytes were identified on both sides of the joint in the RCT group. In conclusion, the position of the AC joint is fairly constant within the supraspinatus outlet and does not appear to predispose to RCTs. The morphology of the AC joint contribution of the tears seems to be acquired in nature rather than inherent in its location within the outlet.

Acromioclavicular Joint↗
PubMed2003

Methodological issues and complementary therapies: researching intangibles?

The increasing drive to adopt evidence-based practice within the mainstream health service creates a sense of urgency for high quality, rigorous research to support CAM. The RCT is seen as the gold standard for allopathic research. However, the tenets of the RCT cannot simply be just picked up and applied to CAM research. Critics of the RCT propose that it fractures and fragments the essence of many complementary therapies. Challenges including standardisation, blinding, randomisation, practitioner influence, placebos, and controls are explored and some possible solutions are presented. CAM researchers need to be creative so that they capture some of the intangibles that currently slip through the reductionist net of the RCT.

Complementary Therapies↗
PubMed2006

GnRH-antagonists in ovarian stimulation for IVF in patients with poor response to gonadotrophins, polycystic ovary syndrome, and risk of ovarian hyperstimulation: a meta-analysis.

This article is a systematic review of the literature on utilization of gonadotrophin-releasing hormone antagonists (GnRH-ant) for ovarian stimulation for IVF in special patient groups. Summarized by meta-analysis are the data from randomized controlled trials (RCT) in which GnRH-agonist (GnRH-a) and GnRH-ant were compared (eight RCT for poor response, four RCT for PCOS). Also reviewed are the data from two RCT and 13 retrospective or observational trials in which patients at risk of ovarian hyperstimulation syndrome (OHSS) were triggered with GnRH-agonist instead of HCG. For poor responders, no differences in clinical outcomes were found, except a significantly higher number of cumulus-oocyte complexes in GnRH-antagonist multiple dose protocol as compared to GnRH-agonist long protocol (P=0.05). For PCOS patients, no differences in outcomes were found, except a significantly shorter duration of stimulation, when GnRH-antagonist multiple dose protocol and GnRH-agonist long protocol are compared (P<0.01). However, sample sizes are still small and power to detect subtle differences is therefore limited. For OHSS risk patients triggered with GnRH-agonist, reports on the efficacy of this measure vary in the literature. GnRH-agonist triggering appears to be associated with a reduction in the incidence of mild and moderate OHSS. For prevention of severe OHSS, as yet, only very limited evidence is available.

Drug Administration Schedule↗
PubMed2002

The choice of hormone replacement therapy or statin therapy in the treatment of hyperlipidemic postmenopausal women.

Evidence based treatment of cardiovascular risk factors on outcome in women is still inconclusive given the very large numbers needed to achieve a significant difference in cardiovascular event. Although numerous studies of the effect of hormone replacement therapy (HRT) on risk factors have suggested benefit, the only data from a randomised control trial of HRT in secondary prevention was neutral. Coronary disease-primary prevention: (a) Statins: Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TEX CAPS). The only randomised controlled trial (RCT) to include women. There were fewer coronary heart disease (CHD) events in women but no difference in mortality. (b) HRT: no completed RCT-the results from Womens Health Initiative (WHI) and Women Intervention Study of Long Duration of Oestrogen in the Menopause (WISDOM) are awaited, the former likely to complete in 2004. There are numerous reports of positive observational epidemiological studies for HRT. There is little evidence for statin use in women who will probably not qualify for treatment on global CHD risk assessment, familial hypercholesterolemia and type 2 diabetes excepted. HRT is, therefore, not only appropriate for its multiple effects on lipoproteins, vascular function and insulin sensitivity but also for prevention of osteoporosis. Coronary disease- SECONDARY PREVENTION: (a) Statins: the major measurable effect of these drugs is to reduce total and LDL cholesterol. In RCT trials, the Scandanavian Simvastatin Survival Study (4S), the Cholesterol and Recurrent Event (CARE) and Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID), approximately 20% of subjects were female, in whom CHD events, but not CHD or total mortality were reduced. (b) HRT: there is data available from a single RCT of continuous combined premarin and medroxyprogesterone acetate (MPA) against placebo, The Heart Estrogen Replacement Study (HERS). A study of 2763 women and mean duration of 4.1 years. This study was neutral, with no reduction in CHD events or mortality. There were more events in the first year, and fewer in years 3-5. Other studies of HRT have been observational and positive for HRT. The effects of treatment on lipoproteins with statins, HRT and combination of statin and HRT have been investigated. In secondary prevention for hyperlipidemic women to achieve cholesterol <5, low density lipoprotein (LDL)<3 mmol/l statins will be first choice, possibly with HRT additionally for its other benefits on cardiovascular risk factors.

Coronary Disease↗
PubMed2000

Is long-term weight loss possible?

Any intervention which causes negative energy balance is guaranteed to be efficacious in producing weight loss, which will continue while there is negative energy balance or be maintained as long as the new energy balance is maintained. In clinical practice compliance is rarely 100% so the efficiency of even the most efficacious treatment is usually low. However, recent evidence-based guidelines have recognized the clinical benefits of moderate (5-10%) weight loss, which is achievable using a variety of interventions. Long-term studies of 'weight loss' are, in reality, combinations of weight loss (usually completed in 1-6 months) followed by variable weight maintenance, set in the context of progressive adult weight gain in an obesogenic environment. Few studies have adopted specific and separate strategies for weight loss and weight maintenance. Meta-analyses conducted by non-expert methodologists have failed to recognize these distinctions, and have criticized the available research without understanding the different needs of studies with weight change as the outcome variable, which require randomized controlled trials (RCT), and those with weight loss as the treatment, intended to improve metabolic or biomedical outcome measures. An RCT design is inapplicable to studies of biomedical end points (e.g. cardiac risk factors) when weight loss is the treatment. Because fixed weight loss cannot be prescribed there is always a range of weight changes in any study, and single-sample studies with regression analysis provide the best design. An RCT study design does not give useful information about clinical value as the control group is always 'treated' to some extent. Placebo- (or control)-subtracted differences are misleading because in an RCT all subjects recruited to active treatment, including non-responders, are continued on treatment for the full duration of the study. In routine clinical practice, treatments are changed in the light of early experience as a therapeutic trial to optimize the results for each individual, and audit is required to evaluate 'long term weight loss'.

Adult↗
PubMed2006

Randomized and non-randomized evidence for the effect of compulsory community and involuntary out-patient treatment on health service use: systematic review and meta-analysis.

BACKGROUND: There is limited randomized controlled trial (RCT) evidence for compulsory community treatment. Other study methods may clarify their effectiveness. We reviewed RCT and non-RCT evidence for the effect of compulsory community treatment on hospital admissions, bed-days, compliance and out-patient contacts. METHOD: A systematic review of RCTs, controlled before-and-after (CBA) studies, and interrupted time series (ITS) analyses. Meta-analysis of RCTs. RESULTS: Eight papers covering five studies (two RCTs and three CBAs) met inclusion criteria (total n=1108). There was no statistical difference in 12-month admission rates between subjects on involuntary out-patient treatment and controls. Survival analyses of time to admission were equivocal. All five studies reported decreases in the number of bed-days following involuntary out-patient treatment but this only reached statistical significance in one situation; patients receiving the intervention were less likely to have admissions of over 100 days. There was no difference in treatment adherence between the intervention and control groups in either RCT or two of the CBA studies. However, the third CBA study reported a statistically significant increase of nearly five visits in the mean number of overall contacts in the involuntary out-patient treatment group. CONCLUSIONS: The evidence for involuntary out-patient treatment in reducing either admissions or bed-days is very limited. It therefore cannot be seen as a less restrictive alternative to admission. Other effects are uncertain. Evaluation of a wide range of outcomes should be included if this type of legislation is introduced.

Ambulatory Care↗
PubMed2003

Hormone replacement therapy after treatment for breast cancer: physicians' attitudes towards randomized trials.

PURPOSE: Physician support is required for successful patient recruitment to a large randomized controlled trial (RCT) designed to determine the safety and benefits of short-term hormone replacement therapy (HRT) after breast cancer (BC). METHODS: A survey was mailed to 1899 Canadian gynaecologists, family physicians, medical, radiation and surgical oncologists to assess willingness to refer patients to an RCT of HRT after BC. RESULTS: Of 538 physicians, 420 (78%) reported that they would be willing to refer a woman after BC to an RCT of HRT versus placebo. Variables predicting willingness to refer included: support for HRT in well women (p = 0.04) and after BC (p = 0.0001); support for clinical trials (p = 0.0001); ongoing BC trials at the physicians' institution (p = 0.003); currently prescribing HRT to women after BC (p = 0.03); and beneficial results in ongoing RCTs of HRT in well women (p = 0.02). CONCLUSIONS: An RCT of short-term HRT after BC may be feasible among Canadian physicians.

Antineoplastic Agents, Hormonal↗
PubMed2004

Studies suggest alternatives to amalgam as a retrograde filling material for apicectomy.

DATA SOURCES: Sources were Medline and the Cochrane Library. STUDY SELECTION: Studies included were in vivo with human subjects, had experimental and control groups, and gave quantitative results in English, German or French. DATA EXTRACTION AND SYNTHESIS: Success and failure rates were derived from randomised controlled trials (RCT), clinical controlled trials (CCT), cohort studies (CS) and case-controlled studies (CCS). Qualitative synthesis of results was performed. RESULTS: Two RCT, six CCT and 14 CCS were identified. The two RCT suggest that glass ionomer may be more effective than amalgam, conversely one CCT showed amalgam to be more effective. CCTs also suggest that EBA (reinforced zinc oxide eugenol) cement, composite with GLUMA (Bayer AG., Leverkusen, Germany) and gold leaf retrograde filling may be more effective than amalgam. A further CCT suggested that gutta-percha used as a retrograde filing is less effective than when used following an orthograde approach. CONCLUSIONS: Based on the outcome of two RCT, glass ionomer appears as effective as amalgam. EBA cement, composite with GLUMA and gold leaf and orthograde gutta-percha may also be as effective as amalgam. Evidence is limited, however, and further research is needed.

Comment↗
PubMed2005

Although leukoplakia responds to some treatments relapses and adverse effects are common.

DATA SOURCES: The Cochrane Oral Health Group's Trials Register, Cochrane Central Trials Register, Medline and Embase were searched, as well as the following journals: Cancer, Community Dentistry and Oral Epidemiology, European Journal of Oral Sciences, Journal of Dental Research, Oral Oncology, Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontics. The reference lists of included studies and reviews were checked, and oral medicine experts were contacted through a European mailing list (EURORALMED). STUDY SELECTION: Randomised controlled trials (RCT) were included if they had enrolled patients who had a diagnosis of oral leukoplakia and who were undergoing any surgical or medical (topical and systemic) treatment. The primary outcome considered was malignant transformation of leukoplakia demonstrated by histopathological examination. Other outcomes considered were clinical resolution, histological modification and frequency of adverse effects. DATA EXTRACTION AND SYNTHESIS: Data were collected using a specific extraction form. The validity of studies included was assessed by two reviewers, on the basis of the method of allocation concealment, blindness of the study and loss of participants. Data were analysed by calculating relative risk (RR). When valid and relevant data were collected, a meta-analysis of the data was undertaken. RESULTS: The possible effectiveness of surgical interventions, including laser therapy and cryotherapy, has never been studied by means of an RCT. Nineteen RCT of nonsurgical interventions were identified: seven were included. Vitamin A and retinoids were tested in five RCT (245 patients); the other drugs tested were bleomycin (one study), mixed tea (one study) and beta-carotene (one study). Malignant transformation was recorded in just two studies. None of the treatments tested showed a benefit compared with placebo. Treatment with beta-carotene and vitamin A or retinoids was associated with significant rates of clinical resolution, compared with placebo or absence of treatment. Whenever reported, a high rate of relapse was a common finding. Side effects of variable severity were often described but interventions were well accepted by patients, since dropout rates were similar between treatment and control. CONCLUSIONS: To date there is no evidence of effective treatment in preventing malignant transformation of leukoplakia. Treatments may be effective in the resolution of lesions, but relapses and adverse effects are common.

Comment↗
PubMed2003

Maintenance of exercise participation in individuals with spinal cord injury: effects on quality of life, stress and pain.

STUDY DESIGN: Follow-up study of seven individuals with spinal cord injury (SCI) who completed a 9-month randomized control trial (RCT) of exercise training. OBJECTIVE: In a 9-month RCT conducted in our lab, individuals with SCI who participated in a twice-weekly supervised exercise training reported greater perceived quality of life (PQOL), and less stress and pain than a nonexercising control cohort. The present follow-up study examined the voluntary continuation of exercise training after the study ended and the persistence of the accrued psychosocial benefits. SETTING: Centre for Health Promotion and Rehabilitation, McMaster University, Hamilton, Ontario, Canada. METHODS: Five men and two women (age 42.3+/-3.6 years) with SCI (C5-T12; ASIA A-D 12.7+/-8.2 years postinjury) were invited to continue supervised exercise training twice weekly at the completion of the 9-month RCT. Exercise adherence, PQOL, stress and bodily pain were measured at a 3-month follow-up and were compared to values obtained at baseline, and at 3, 6 and 9 months during the intervention. RESULTS: There was a significant decrease in adherence at the 3-month follow-up compared to the overall 9-month adherence rate (42.7 versus 80.6%, respectively; P<0.01). There was also a significant decrease in PQOL (P<0.05) and a trend for increased pain (P=0.07) and stress (P=0.12), at follow-up compared to the end of the 9-month trial. Finally, there was a significant negative correlation between pain at the conclusion of the RCT and exercise adherence over the 3-month follow-up period (r=-0.91; P<0.01). CONCLUSIONS: These findings emphasize the importance of continued exercise adherence to the maintenance of exercise-related increases in psychological well-being among individuals with SCI.

Adult↗
PubMed2002

A multimethod approach to the evaluation of community preschool speech and language therapy provision.

OBJECTIVES: The paper presents a research study investigating the effectiveness and acceptability of community speech and language therapy provision for preschool children with early speech/language delays. As a 'worked example', it demonstrates the value of a multimethod approach to evaluation. METHODS: The paper examines how the research findings of a pragmatic randomized controlled trial (RCT), a survey questionnaire and qualitative in-depth interviews, which were the methods used in the evaluation, overlap and complement each other. RESULTS: There was little evidence to establish the effectiveness of the speech and language therapy provided in the trial. This lack of difference was reflected in responses of parents to items on the questionnaire. The findings of the RCT, questionnaire and interviews all cast considerable doubt on the prospect of spontaneous resolution of the children's difficulties. Although the RCT showed few differences between the children allocated to immediate therapy or 'watchful waiting', the questionnaire and interviews revealed the circumstances in which the parents felt that these intervention strategies had been acceptable and unacceptable. CONCLUSIONS: Although the trial provided information about the progress of the children, the questionnaire and interview components highlighted the advantages and limitations of the intervention from the viewpoint of parents, thereby helping to explain the RCT findings. Thus, the study demonstrates how a multimethod approach to evaluation can yield useful information to explain the findings of RCTs.

Child Welfare↗