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Biomedical subjects

J Kirwan

Publications and source records attributed to J Kirwan.

At least 19 recordsLinked to original sources

Chemotherapy for advanced, recurrent or metastatic endometrial cancer: a systematic review of Cochrane collaboration.

BACKGROUND: Cytotoxic chemotherapy has a limited place in the management of advanced or recurrent endometrial cancer. Commonly used agents include cisplatin and doxorubicin, but the side-effect profile may be unacceptable for many patients. The feasibility of administration of combination chemotherapy is limited in many patients on account of significant co-morbidity. While early-stage endometrial adenocarcinoma is a common gynaecological cancer with a favourable prognosis, advanced or recurrent disease presents a difficult management problem. The platinum and anthracycline compounds have been widely used for many years, but their impact on progression-free survival (PFS) and overall survival (OS) is not clear. This systematic review aimed to evaluate both the benefits and adverse effects of cytotoxic chemotherapy in these women. PATIENTS AND METHODS: We carried out systematic searches for randomised controlled trials (RCTs) comparing chemotherapy with another intervention. Data were extracted from trial reports or supplied by investigators. Where possible, hazard ratios (HRs) were calculated for OS and PFS and odds ratios (ORs) were calculated for acute toxicity. The impact of more versus less intensive chemotherapy on OS, PFS and acute toxicity was assessed in a meta-analysis. RESULTS: Eleven eligible RCTs were identified that recruited 2288 patients. A meta-analysis of six of these trials found that PFS [HR = 0.80, 95% confidence interval (CI) 0.71-0.90; P = 0.004], but not OS (HR = 0.90, 95% CI 0.80-1.03; P = 0.12), was significantly improved when more intensive chemotherapy was compared with less intensive chemotherapy. OS was improved when doxorubicin, cisplatin and other drugs were compared with doxorubicin and cisplatin. Toxicity was generally higher with more chemotherapy. There was insufficient evidence to assess the effect of chemotherapy on symptom control or quality of life (QoL). Platinums, anthracyclines and taxanes were the most studied in phase II trials and combinations gave the best responses, but patient selection and pre-treatment was very variable. CONCLUSIONS: More intense combination chemotherapy significantly improves the disease-free survival and the data indicate a modest improvement in OS. The addition of anthracyclines (e.g. doxorubicin) or the taxanes [e.g. paclitaxel (Taxol)] to cisplatin increases the response rate. More intensive regimens are associated with the gain in survival. However, grade 3 and 4 myelosuppression and gastrointestinal toxicity are also increased. Future developments are likely to exploit specific molecular characteristics of endometrial cancers, including their hormone dependence, growth factor target overexpression and PTEN loss. While no one drug or regimen offers a clear benefit for women with advanced endometrial cancer, platinum drugs, anthracyclines and paclitaxel seem the most promising agents. Future trials should address the impact of such agents on QoL and symptom control in addition to survival. Chemotherapy and endocrine therapy need to be compared directly in an RCT.

Antineoplastic Agents↗

Outcome of ultrasound-guided sclerotherapy for varicose veins: medium-term results assessed by ultrasound surveillance.

OBJECTIVE: To estimate medium-term success after a technique for ultrasound-guided sclerotherapy for superficial chronic venous disease. DESIGN: A prospective study in a single unit with ultrasound surveillance after treatment. MATERIALS: Results after 1189 treatment sessions for 807 venous saphenous veins and related tributaries or non-saphenous tributaries in 489 patients. METHODS: Univariate life table analysis determined primary and secondary success rates. Multivariate Cox regression analysis detected covariates that affected outcome. RESULTS: Primary and secondary success rates at 36 months for all veins were 52.4% (95%CI 46-58%) and 76.8% (95%CI 71-82%). Cox regression analysis for primary success for all veins showed significantly worse results for saphenous veins compared to tributaries (HR 3.72 - 95%CI 1.9 to 7.3). Cox regression for all saphenous veins showed independently worse results for patients less than 40 years age (HR 2.16 - 95%CI 1.27-3.66), small compared to great saphenous veins (HR 1.58 - 95%CI 1.11-2.24), veins greater than 6mm diameter compared to smaller veins (HR 2.22 - 95%CI 1.40-3.50), liquid compared to foam sclerotherapy (HR 2.20 - 95%CI 1.28-3.78), lower volumes of sclerosant compared to volumes greater than 12 ml (HR 0.51 - 95%CI 0.33-0.81) and highly diluted compared to concentrated sclerosant (HR 2.05 - 95%CI 1.21-3.46) with worse results using highly diluted or undiluted 3% sclerosant compared to a 1.5% concentration. There were no significant differences for primary success for saphenous veins for date of procedure, sex, side, primary or recurrent varicose veins, or commercial type of sclerosant. CONCLUSIONS: Ultrasound-guided sclerotherapy gives satisfactory results if it is accepted that treatment may need to be repeated to achieve secondary success. Results provide a basis for further research to explore factors that might affect outcome. Younger patients with larger diameter saphenous veins may warrant alternative forms of treatment, particularly for small saphenous reflux.

Adult↗

Villoglandular adenocarcinoma of the cervix: clarity is needed on the histological definition for this difficult diagnosis.

BACKGROUND: Villoglandular adenocarcinoma (VGA) of the cervix is reported as a variant of a cervical adenocarcinoma with a good prognosis. CASES: We present two cases histologically reported as a villoglandular adenocarcinoma of the cervix that have recurred and progressed rapidly since initial treatment. External histopathological review suggested both had a prominent villoglandular pattern but with an associated underlying well-differentiated adenocarcinoma. CONCLUSION: The diagnosis of VGA is difficult. Current literature is not entirely consistent in the presented definition, and further clarity is needed. Because of the rarity of VGA and the difficulty but importance of the diagnosis, we would feel that a central review of all cases of VGA is warranted. This would assist in diagnosis and also in obtaining accurate follow-up data.

Adenocarcinoma↗

Chemotherapy for advanced, recurrent or metastatic endometrial carcinoma.

BACKGROUND: Endometrial adenocarcinoma is a common gynaecological cancer, but a comparatively small proportion of patients present with or develop recurrent or advanced disease. Progestogens are widely used, with little evidence of their efficacy. Co-morbidity including obesity and cardiac disease and concerns over toxicity have prevented more extensive studies of cytotoxic chemotherapy, although there are a number of active agents. OBJECTIVES: To assess any benefits or adverse effects of cytotoxic chemotherapy in women with advanced, recurrent or metastatic endometrial adenocarcinoma. SEARCH STRATEGY: The major medical literature databases were searched for all known randomised controlled trials (RCTs), as were trials registers and reference lists of relevant publications. SELECTION CRITERIA: RCTs comparing chemotherapy versus another intervention (including different chemotherapy) in advanced disease were considered. Trials of adjuvant treatment or for sarcomatous tumours were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted from the papers by reviewers and authors of included studies contacted for further information. MAIN RESULTS: Eleven eligible trials were identified which entered 2288 patients between 1974 and 2000. A meta-analysis of the 6 trials comparing more with less chemotherapy with combination was possible and included 1135 patients. Progression-free survival (PFS) was significantly improved (Hazard Ratio (HR) = 0.80, 95% Confidence Interval (CI) 0.71 to 0.90, p = 0.004), but there was only a trend toward improved survival (HR = 0.90, 95% CI 0.80 to 1.03). Toxicity was in general higher with the combination chemotherapy regimens. Only one trial showed a significant survival benefit from the addition of paclitaxel to combination chemotherapy, but this was at the expense of increased toxicity. There was insufficient evidence to assess whether there was any benefit from cytotoxic chemotherapy in terms of symptom control or QOL compared with best supportive care. There were no comparative trials of chemotherapy with endocrine therapy. AUTHORS' CONCLUSIONS: The optimum cytotoxic drug regimen for advanced endometrial adenocarcinoma has still to be defined although our review suggests that it may contain paclitaxel or platinum. These mainly North American and European trial populations represent a highly selected subgroup of the 10,000 women dying annually from this disease. Future trials should include measures of QOL and symptom control in addition to PFS and overall survival (OS). They should also consider comparison of endocrine therapy and cytotoxic chemotherapy in patients with no prior drug therapy. Stratification of patients should take into account other prognostic factors including co-morbidity and prior radiation treatment.

Antineoplastic Agents↗

Concomitant chemotherapy and radiation therapy for cancer of the uterine cervix.

BACKGROUND: The National Cancer Institute (USA) alert in February 1999 stated that concomitant chemoradiotherapy should be considered for all patients with cervical cancer, based on evidence from five randomised controlled trials (RCTs). OBJECTIVES: To review all known RCTs comparing concomitant chemotherapy and radiation therapy with radiotherapy for locally advanced cervical cancer. SEARCH STRATEGY: We searched electronic databases, trials registers and reference lists of published trial reports and review articles were also searched. SELECTION CRITERIA: This review includes RCTs in cervical cancer comparing concomitant chemoradiation with radiotherapy in the experimental arm. Trials allowing further adjuvant chemotherapy or hydroxyurea were included. Trials using radiosensitisers or radioprotectors in the experimental arm were excluded. DATA COLLECTION AND ANALYSIS: Two authors reviewed trials for inclusion and extracted data. For meta-analyses of time-to-event outcomes (survival, progression-free survival), a hazard ratio (HR) was extracted or estimated from trial reports, where possible. Only overall rates of local and distant recurrence were presented in many reports so only odds ratios (OR) of recurrence rates could be calculated, which takes no account of time to recurrence or censoring. Few trials reported acute toxicity adequately, but where possible ORs were calculated for the main types and severities of acute toxicity. The HRs and ORs for individual trials were combined across all trials, using the fixed effect model. Late toxicity was rarely described in sufficient detail so could only be reviewed qualitatively. MAIN RESULTS: The original review was based on nineteen trials (17 published and two unpublished) including 4580 patients. This update includes twenty four trials (21 published, 3 unpublished) and 4921 patients, although due to patient exclusion and differential reporting 61% to 75% were available for the analyses. The review strongly suggests chemoradiation improves overall survival and progression free survival, whether or not platinum was used with absolute benefits of 10% and 13% respectively. There was, however, statistical heterogeneity for these outcomes. There was some evidence that the effect was greater in trials including a high proportion of stage I and II patients. Chemoradiation also showed significant benefit for local recurrence and a suggestion of a benefit for distant recurrence. Acute haematological and gastrointestinal toxicity was significantly greater in the concomitant chemoradiation group. Late effects of treatment were not well reported and so the impact of chemoradiation on these effects could not be determined adequately. Treatment-related deaths were rare. AUTHORS' CONCLUSIONS: Concomitant chemoradiation appears to improve overall survival and progression-free survival in locally advanced cervical cancer. It also appears to reduce local and distant recurrence suggesting concomitant chemotherapy may afford radiosensitisation and systemic cytotoxic effects. Some acute toxicity is increased, but the long-term side effects are still not clear.

Combined Modality Therapy↗

Chemotherapy for advanced, recurrent or metastatic endometrial carcinoma.

BACKGROUND: Endometrial adenocarcinoma is a common gynaecological cancer, but a comparatively small proportion of patients present with or develop recurrent or advanced disease. Progestogens are widely used, with little evidence of their efficacy. Co-morbidity including obesity and cardiac disease and concerns over toxicity have prevented more extensive studies of cytotoxic chemotherapy, although there are a number of active agents. OBJECTIVES: To assess any benefits or adverse effects of cytotoxic chemotherapy in women with advanced, recurrent or metastatic endometrial adenocarcinoma. SEARCH STRATEGY: The major medical literature databases were searched for all known randomised controlled trials (RCTs), as were trials registers and reference lists of relevant publications. SELECTION CRITERIA: RCTs comparing chemotherapy versus another intervention (including different chemotherapy) in advanced disease were considered. Trials of adjuvant treatment or for sarcomatous tumours were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted from the papers by reviewers and authors of included studies contacted for further information. MAIN RESULTS: Eleven eligible trials were identified which entered 2288 patients between 1974 and 2000. A meta-analysis of the 6 trials comparing more with less chemotherapy with combination was possible and included 1135 patients. Progression-free survival (PFS) was significantly improved (Hazard Ratio (HR) = 0.80, 95% Confidence Interval (CI) 0.71 to 0.90, p = 0.004), but there was only a trend toward improved survival (HR = 0.90, 95% CI 0.80 to 1.03). Toxicity was in general higher with the combination chemotherapy regimens. Only one trial showed a significant survival benefit from the addition of paclitaxel to combination chemotherapy, but this was at the expense of increased toxicity. There was insufficient evidence to assess whether there was any benefit from cytotoxic chemotherapy in terms of symptom control or quality of life (QOL) compared with best supportive care. There were no comparative trials of chemotherapy with endocrine therapy AUTHORS' CONCLUSIONS: The optimum cytotoxic drug regimen for advanced endometrial adenocarcinoma has still to be defined although our review suggests that it may contain paclitaxel or platinum. These mainly North American and European trial populations represent a highly selected subgroup of the 10, 000 women dying annually from this disease. Future trials should include measures of QOL and symptom control in addition to PFS and overall survival (OS). They should should also consider comparison of of endocrine therapy and cytotoxic chemotherapy in patients with no prior drug therapy. Stratification of patients should take into account other prognostic factors including co-morbidity and prior radiation treatment.

Antineoplastic Agents↗

A study to investigate women's experiences of radiation enteritis following radiotherapy for cervical cancer.

BACKGROUND: Radiotherapy remains the standard treatment for cervical cancer, especially for more advanced disease. It is estimated that the prevalence of chronic radiation enteritis (CRE) post-radiotherapy is in the region of 5-15%. However, preliminary studies at the study hospital suggest the problem to be more widespread (C. Israel, unpublished data). AIM: This qualitative study of 10 cervical cancer patients investigates experiences of CRE and its impact on quality of life. METHODS: Informed volunteers participated in one-to-one tape-recorded in-depth interviews exploring experiences following treatment. These interviews were transcribed verbatim and analysed using NUD*IST Nvivo. RESULTS: The majority of women reported side-effects from radiotherapy, predominantly diarrhoea. CRE had a significant impact upon the physical, psychological and social aspects of life of sufferers, enforcing some to be virtually housebound. Other sufferers were managing their symptoms with regular medication and/or self-imposed restricted diets. Few of these women had ever sought professional help in dealing with their problems because of embarrassment or reluctance to complain. CONCLUSIONS: If untreated the side-effects of CRE have a disabling affect on sufferers, who may be reluctant to seek help about their symptoms. Health professionals need to be more pro-active in identifying and caring for sufferers of CRE.

Adult↗

Welfare rights services for people disabled with arthritis integrated in primary care and hospital settings: set-up costs and monetary benefits.

OBJECTIVE: To quantify the set-up costs and monetary benefits of a welfare rights service integrated within an NHS service provider, that selects eligible patients using the Health Assessment Questionnaire (HAQ) and offers welfare rights advice to assist in application for Disability Living Allowance and Attendance Allowance. METHOD: (1) DESIGN: a cost evaluation of a social intervention, screening with the HAQ and welfare rights advice in primary care and hospital settings. (2) SETTING: Eight general practices and four hospital rheumatology out-patient departments were selected from four localities in the southwest of England. (3) PARTICIPANTS: Two hundred and sixty-eight eligible patients with arthritis accepted an interview with a welfare rights officer (WRO) from a sample of 1989 service users identified from GPs' records and hospital out-patient lists. Two hundred and forty two service users expressed an interest in take up of the social intervention. (4) Service users with a HAQ score >/=1.5 were contacted by telephone and offered an appointment with an experienced WRO to help them complete a welfare benefit application form. A 'micro-costing' study was undertaken with assessment of monetary benefits received. RESULTS: The indicative set-up costs of similar welfare rights services are pound 8125 in a GP setting and pound 9307 per annum in a hospital setting at 2002 prices. Total annual unclaimed Disability Living Allowance/Attendance Allowance granted to successful claimants was pound 184,382 in the GP setting (n = 84 from 137) and pound 169,309 in the hospital setting (n = 79 from 131). CONCLUSIONS: Welfare rights advice received during a visit to a GP practice or a hospital out-patient department can substantially reduce the level of unclaimed benefit in arthritic populations including the elderly; with mobility and care difficulties. A welfare rights service integrated within a GP practice or hospital that screens people with arthritis using HAQ scores and encourages those with scores >/=1.5 to see a WRO for help with welfare benefit confers monetary benefits for service users that substantially outweigh set-up costs.

Aged↗

Concomitant hydroxyurea plus radiotherapy versus radiotherapy for carcinoma of the uterine cervix.

BACKGROUND: A number of randomised studies suggest hydroxyurea given alongside radiotherapy improves survival in patients with locally advanced cervix cancer. Following publication of five large randomised trials in 1999 and 2000 concomitant chemoradiotherapy has become standard treatment for these patients. In two of the studies hydroxyurea was given to patients in both control and experimental arms. The precise role of this orally administered cytotoxic drug is not known. OBJECTIVES: To assess the effectiveness (survival and toxicity) of concomitant radiation and hydroxyurea compared with radiotherapy alone in treating locally advanced cervix cancer. SEARCH STRATEGY: We searched the following:Cochrane Gynaecological Cancer Group's Specialised RegisterCENTRAL (Cochrane Library on CD ROM, issue 4, 2002) MEDLINE (Silver Platter, from 1970 to 2001) EMBASE (from 1980 to 2001) CANCERLIT (from 1970 to 2001) PDQ (search for open and closed trials) LILACSMeta-register (ongoing trials)Searches were not language or publication restricted. Investigators of relevant trials were contacted for further information. SELECTION CRITERIA: Randomized controlled trials comparing concomitant radiotherapy (+/- surgery) with hydroxyurea versus radiotherapy (+/- surgery) for locally advanced cervix cancer. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed trials for inclusion and extracted data. Discussions on all aspects of data collection and analysis took place among all the authors at regular intervals. MAIN RESULTS: Seven studies were found to be suitable for inclusion from 33 identified as relevant. None of the trials provided adequate evidence to support the use of hydroxyurea owing to small sample size, large numbers of post-randomisation exclusions and questionable rules for censoring, particularly a failure to include treatment-related deaths in the survival analysis. Details of statistical analysis were limited and often confusing, and we felt meta-analysis would lead to unreliable and invalid conclusions. Most studies appeared to be double blind placebo-controlled studies but none give details of power calculations or reasons for stopping recruitment. Only two studies had more than 50 patients. Patients were excluded from analysis in most trials for treatment-related reasons; in one, less than half those recruited were used in the analysis, the remainder having been excluded because of tumour progression or treatment-related conditions e.g. septicaemia, worsening renal/hepatic function. In another trial five out of 20 in the hydroxyurea group died of treatment-related complications but the five-year survival group was presented as 94%. REVIEWER'S CONCLUSIONS: We found no evidence to support the use of hydroxyurea in addition to radiotherapy in the routine treatment of cervix cancer.

Antineoplastic Agents↗

Concomitant hydroxyurea plus radiotherapy versus radiotherapy for carcinoma of the uterine cervix: a systematic review.

We identified eight randomised control trials of hydroxyurea and radiation versus radiotherapy alone (six published in full and two abstracts). Most concluded that outcomes were improved by use of hydroxyurea. However, methodological problems associated with these trials included small sample size, a large number of patient exclusions post randomisation, differing outcome definitions, subgroup analyses of already small numbers of patients and questionable rules for censoring, particularly a failure to include treatment related deaths in the survival analysis. All but two studies were of less than 50 patients. Patients were excluded from some analyses for treatment related reasons. The exclusion of such patients undoubtedly altered the conclusions of the studies. Even if there was a survival advantage attributed to hydroxyurea, overall survival was somewhat poor. We found the evidence regarding the use of hydroxyurea and radiotherapy to be inadequate for assessing its role in the treatment of cervical cancer.

Antineoplastic Agents↗

Standardised nomenclature for glucocorticoid dosages and glucocorticoid treatment regimens: current questions and tentative answers in rheumatology.

In rheumatology and other medical specialties there is a discrepancy between the widespread use and the imprecise designation of glucocorticoid treatment regimens. Verbal descriptions of glucocorticoid treatment regimens used in various phases of diseases vary between countries and institutions. Given this background, a workshop under the auspices of the EULAR Standing Committee on International Clinical Studies including Therapeutic Trials was held to discuss this issue and to seek a consensus on nomenclature for glucocorticoid treatment. This report summarises the panel's discussion and recognises that answers derived from consensus conferences are not definitive. Nevertheless, recommendations on glucocorticoid treatment are presented that (1) reflect current and best knowledge available and (2) take into account current clinical practice. A question-answer rationale presentation style has been chosen to convey the messages, to summarise the meeting in a readable format, and to avoid dogmatism.

Drug Administration Schedule↗

Concomitant chemotherapy and radiation therapy for cancer of the uterine cervix.

BACKGROUND: The National Cancer Institute (USA) alert in February 1999 stated that concomitant chemoradiotherapy should be considered for all patients with cervical cancer, based on evidence from five randomised controlled trials. OBJECTIVES: To review all known randomised clinical controlled trials (RCTs) comparing concomitant chemotherapy and radiation therapy with radiotherapy for locally advanced cervical cancer. SEARCH STRATEGY: We searched electronic databases, trials registers and reference lists of published trial reports and review articles were also searched. SELECTION CRITERIA: This review includes RCTs in cervical cancer comparing concomitant chemotherapy and radiotherapy with radiotherapy. In the experimental arm, further adjuvant chemotherapy was allowable. Hydroxyurea was considered inactive and allowable. Trials using radiosensitisers or radioprotectors in the experimental arm were excluded. DATA COLLECTION AND ANALYSIS: Two authors reviewed trials for inclusion and extracted data. For meta-analyses of time-to-event outcomes (survival, progression-free survival), a hazard ratio (HR) was extracted or estimated from trial reports, where possible. Only overall rates of local and distant recurrence were presented in many reports so only an odds ratios (OR) of recurrence rates could be calculated, which takes no account of time to recurrence or censoring. The HRs and ORs for individual trials were combined across all trials, using the fixed effect model. Few trials reported acute toxicity adequately. Data were therefore grouped and the number of toxic events was used to calculate a single OR for each site and grade. Late toxicity was rarely described so could only be reviewed qualitatively. MAIN RESULTS: Nineteen trials (17 published, two unpublished) were identified including 4580 patients, although due to patient exclusion and differential reporting 62-78% were available for the various analyses. The review strongly suggests chemoradiation improves overall survival and progression free survival, whether platinum was used or not with absolute benefits of 12% and 16% respectively. There was, however, statistical heterogeneity for these outcomes There was some evidence that the effect was greater in trials including a high proportion of stage I and II patients. Chemoradiation also showed significant benefit for both local and distant recurrence. Haematological and gastrointestinal toxicity was significantly greater in the concomitant chemoradiation group. Details of late morbidity were sparse. REVIEWER'S CONCLUSIONS: Concomitant chemotherapy and radiotherapy appears to improve overall survival and progression-free survival in locally advanced cervical cancer. It also reduces local and distant recurrence suggesting concomitant chemotherapy may afford cytotoxic and sensitisation effects. Some acute toxicity is increased, but data on long term side effects were sparse.

Combined Modality Therapy↗

Is there a place for intra-articular hyaluronate in osteoarthritis of the knee?

Viscosupplementation refers to the intra-articular injection of hyaluronic acid (HA) as a hyaluronate to relieve pain and improve function, usually in patients with knee OA. HA is the major constituent of a 1-2-micron layer on the surface of articular cartilage as well as a major constituent of synovial fluid (SF). Solutions of HA can act as lubricants when movements are slow and as shock absorbers when movements are fast. In arthritis, the molecular weight of HA is reduced, and so are its properties. Viscosupplementation has been advocated as a way of reversing this, but intra-articular HA has other properties, such as an anti-inflammatory effect, which may also contribute to any therapeutic effect. There is a large placebo effect from intra-articular injections, and the benefits of intra-articular glucocorticoids may be only slightly better than this effect. In only one randomised, placebo-controlled trial was the difference in response significant. Studies of intra-articular HA also show a marked placebo response (where it has been measured), but some have suggested a measurable benefit, which may be more prolonged that that of glucocorticoids. There is only a single study in which the effects of intra-articular therapy with placebo, glucocorticoids and viscosupplementation can be compared. Here, HA may have had a slightly longer period of benefit than triamcinolone hexacetonide or placebo. The very large placebo response after aspiration of the knee may seriously mislead those engaged in uncontrolled therapeutic evaluation of intra-articular therapy. Current evidence suggests that viscosupplements probably provide a similar level of pain relief to glucocorticoids and do so for several months, but the onset is slower, and there is the potential for local adverse reactions.

Adjuvants, Immunologic↗

Development and validation of a self-efficacy scale for use in British patients with rheumatoid arthritis (RASE).

OBJECTIVE: Current arthritis self-efficacy scales have attracted some criticism. Therefore, the aim of this study was to develop and validate a measure of self-efficacy for use in British rheumatoid arthritis patients [Rheumatoid Arthritis Self-efficacy (RASE) scale]. METHODS: Phase I: item generation of self-management strategies by rheumatology professionals and patients to create a pilot RASE. Phase II: examination of the internal structure (n=88) using correlation coefficients and principal component analysis (PCA) to create the final RASE. Phase III: reliability in 23 patients. Phase IV: comprehension, construct validity and sensitivity to change in 48 rheumatoid arthritis patients undergoing a self-management programme, using correlation coefficients, PCA and inter-item correlation. RESULTS: Phase I: of 166 self-management items generated, 100 commonly cited items were selected for the pilot RASE. Phase II: using a correlation matrix and PCA, a 28-item RASE was created. Phase III: good 4-week reliability was seen (r=0.889, P<0.001). Phase IV: the final RASE was shown to be independent of mood, disease status and disability and weakly associated with other self-efficacy scales (r=0.313, P<0.05). The RASE was sensitive to change following an education programme (+5.167, P<0.025), and was associated with behaviour initiation (r=0.35, P<0.01). CONCLUSIONS: Careful construction means that the RASE examines beliefs in potential ability to perform tasks, rather than actual ability, performance or outcome expectancy. It shows good face validity and reliability, plus reasonable construct validity and sensitivity. Further studies are needed to support the validation of this new scale.

Adult↗

The relationship between soft tissue swelling, joint space narrowing and erosive damage in hand X-rays of patients with rheumatoid arthritis.

OBJECTIVES: To test the hypotheses that the progression of joint space narrowing behaves differently from the progression of erosions and that clinically and radiologically assessed soft tissue swelling relates more to diffuse cartilage loss than to erosive damage. METHODS: Radiographs and clinical data were obtained from 28 patients in a prospective, multicentre, randomized, placebo-controlled trial of prednisolone 7.5 mg daily over 2 yr. Radiographic scoring included the Larsen score, joint space narrowing and soft tissue swelling. Clinical joint inflammation in the hands was assessed every 3 months and cumulative synovitis score over the period of study was then calculated for each joint. The placebo-treated patients and the prednisolone-treated patients were analysed separately. The Larsen scores were compared after log transformation [transformed score=log(10) (original score+1)]. Changes in Larsen scores and joint space narrowing scores were compared with the cumulative presence of clinical synovitis and radiological soft tissue swelling using the correlation coefficient. RESULTS: There was a difference in the rate of progression in the Larsen score between placebo- and prednisolone-treated patients, but there was no significant difference in the rate of joint space loss. In placebo-treated patients, measures of synovitis correlated more strongly with progression of joint space narrowing than with changes in the Larsen score. In prednisolone-treated patients there was no correlation between clinical synovitis and change in Larsen score (r=0.029) and only a slight and non-significant correlation with joint space narrowing (r=0.127). Radiographic evidence of soft tissue swelling remained correlated with joint space narrowing (r=0.279, P:<0.001) but was not correlated with change in Larsen score (r=-0.113, P:<0.001 for difference between correlations). The correlation between Larsen score progression and joint space narrowing seen in the non-treated patients was completely abolished in the glucocorticoid-treated group (r=-0.003). CONCLUSIONS: The progression of joint space narrowing behaves differently from the progression of erosions. Prednisolone slows (or even stops) the progression of erosions (as assessed by the Larsen score) while making no difference to the progression of cartilage loss (as assessed by joint space narrowing). The results also suggest that synovitis, whether measured clinically or radiologically, is more closely related to diffuse cartilage loss than to erosion progression. Any link between synovitis and erosions is abolished by glucocorticoid therapy while the link between synovitis and cartilage loss is not, pointing to at least two different mechanisms for these observed radiological features.

Adolescent↗