Late Genitourinary Toxicity Outcomes in 300 Prostate Cancer Patients Treated With Dose-escalated Image-guided Intensity-modulated Radiotherapy.

AIMS: To quantify and qualify late genitourinary toxicity in a cohort of patients with localised prostate cancer treated with image-guided intensity-modulated radiotherapy (IMRT) to doses ≥78 Gy. MATERIALS AND METHODS: The cohort consisted of 300 patients treated with definitive dose-escalated IMRT between 2007 and 2013. Ninety-seven patients received 78-80 Gy in 38 fractions, and 203 received 82-84 Gy in 40 fractions. International Prostate Symptoms Score (IPSS) and supplemental quality of life data were recorded at baseline, weekly during treatment and at follow-up. Genitourinary toxicities were recorded using modified Radiation Therapy Oncology Group criteria during weekly treatment review and at each follow-up. Kaplan-Meier curves were used to assess the cumulative incidence of grade ≥ 2 genitourinary toxicity at 3 years. Baseline patient characteristics and symptoms were then used in univariate and multivariate analyses to identify predictors of late urinary toxicity. RESULTS: The median follow-up was 58 months (range 9-109 months). The actuarial cumulative 3 year rates of grade ≥ 2 and grade 3 genitourinary toxicity were 14.9% and 2.8%, respectively. There was no grade 4 toxicity. History of transurethral resection of the prostate (TURP), alpha blocker use before radiation, any hormone use, baseline IPSS ≥ 14 and pre-existing incontinence or nocturia were significantly associated with late ≥ 2 genitourinary toxicity on univariate analysis. On multivariate analysis, only previous TURP retained significance, with a hazard ratio of 2.54 (P=0.002). CONCLUSION: Our study showed acceptable levels of late grade 2 genitourinary toxicity and low rates of late grade 3 genitourinary toxicity in a cohort of patients with prostate cancer treated with image-guided IMRT to doses between 78 and 84 Gy. Variables associated with increased late ≥ 2 genitourinary toxicity include previous TURP, alpha blocker use, hormone use and pre-existing urinary dysfunction.

Stereotactic Ablative Body Radiotherapy for the Treatment of Spinal Oligometastases.

AIMS: To report multicentre outcomes of patients with spinal oligometastases treated with stereotactic ablative body radiotherapy (SABR). The primary objective was to estimate the widespread failure-free survival (WFFS) at 2 years - defined as freedom from metastases not amenable to local salvage therapy and death. MATERIALS AND METHODS: Patients with one to three metastases treated with spinal SABR between January 2010 and July 2014 at four academic institutions were included in this retrospective review. The median dose/fractionation was 24 Gy (range 16-52.5 Gy) in two fractions (range one to three) and the median biologically effective dose (α/ß=10) was 52.5 Gy (range 40-144.4 Gy). The WFFS, overall survival, freedom from local progression and toxicity rates were described using Kaplan-Meier statistics. RESULTS: In total, 60 patients with 72 spinal metastases were analysed. The median follow-up was 21 months. Patients had a median age of 66 years, Eastern Cooperative Oncology Group performance 0-1 in 97% and metachronous oligometastases in 85%. The 1 and 2 year WFFS rates were 67% (95% confidence interval 55-80) and 59% (95% confidence interval 47-75), respectively. The 1 and 2 year overall survival rates were 90% (95% confidence interval 83-98) and 76% (95% confidence interval 64-91), respectively. The 1 and 2 year freedom from local progression were 92% (95% confidence interval 85-99) and 86% (95% confidence interval 75-99), respectively. There were four cases (6.7%) of vertebral compression fracture and no cases of radiation myelopathy. CONCLUSION: Despite the use of relatively low biological doses respecting spinal cord constraints, SABR results in excellent 2 year local control rates with low morbidity. Through careful selection of patients with oligometastases, most patients are alive and free from widespread metastases at 2 years. This cohort warrants further investigation in clinical trials of SABR.

SpaceOAR Hydrogel in Dose-escalated Prostate Cancer Radiotherapy: Rectal Dosimetry and Late Toxicity.

AIM: To investigate the feasibility, dosimetric benefits and late toxicity of a temporary hydrogel spacer between the rectum and the prostate for prostate intensity-modulated radiotherapy. MATERIALS AND METHODS: Thirty patients with prostate cancer were enrolled on a phase I/II study. All patients underwent magnetic resonance imaging before and after placement of 10 cm(3) of hydrogel. The first 10 patients had an additional magnetic resonance imaging after the completion of radiation treatment. SpaceOAR hydrogel was injected under general anaesthetic using a transperineal approach with transrectal ultrasound guidance. Primary end points were perioperative toxicity and comparison of rectal dosimetry. Secondary end points included cute and late radiation toxicity. All patients were planned on both pre- and post-hydrogel scans to a D95 of 80 Gy in 40 fractions. A contemporary control group of 110 prostate cancer patients treated with the same prescription was identified for comparison. RESULTS: There were no perioperative complications. Rectal doses were significantly lower for the post-hydrogel plans, especially above 65 Gy (V82 = 0.2% versus 1.3%; V80 = 0.8% versus 5.3%; V75 = 2.2% versus 9.5%; V70 = 3.7% versus 12.3%; V65 = 5.4% versus 14.7%; V40 = 22.9% versus 32% and V30 = 42.7% versus 49.4%). There was no significant difference in acute grade 1 and 2 gastrointestinal toxicity, which was 43% versus 51% and 0% versus 4.5% in the hydrogel and control groups, respectively. Late grade 1 was significantly less frequent in the hydrogel group (16.6% versus 41.8%, P = 0.04). CONCLUSION: SpaceOAR hydrogel was inserted with minimal side-effects. Dosimetric benefits were greatest at higher rectal doses (V65 to V82). Late grade 1 gastrointestinal toxicity was significantly lower than that seen in patients treated without hydrogel.

Validation of a new patient-reported outcome instrument of health-related quality of life specific to patients with alcohol use disorder: the Alcohol Quality of Life Scale (AQoLS).

PURPOSE: The Alcohol Quality of Life Scale (AQoLS) is a new patient-reported outcome 34-item questionnaire measuring health-related quality of life (HRQOL), specific to patients with an alcohol use disorder, developed from the patients' perspective. This is the first report establishing evidence in support of measurement reliability and validity of the AQoLS. METHODS: A total of 285 randomly selected patients receiving interventions for alcohol use disorder in addiction specialised care settings in France were included in the study (response rate 80.1 %). Exploratory factor analysis was conducted to evaluate the hypothesised-during-development-stage dimensional structure of the AQoLS. Internal consistency of the total score and the dimensions subscores were assessed through Cronbach's alpha coefficients. Construct validity was tested through correlations with the Short-Form 36 Health Survey (SF-36) and EuroQol 5 dimensions (EQ-5D). RESULTS: Exploratory analysis indicated seven observed dimensions which differed slightly from the 7 dimensions defined a priori in the framework hypothesised during the scale development: activities, relationships, living conditions, negative emotions, self-esteem, control and sleep. A major common factor allows the summing of the 34 items to obtain a total score. All the 34 items were acceptable. Cronbach's alpha for the AQoLS total score was 0.96 and ranged from 0.8 to 0.9 for the dimensions subscores. Negative correlations between AQoLS and all dimensions of the SF-36, but general health and positive correlations between AQoLS and all items of the EQ-5D were shown. As expected, the correlations were mostly moderate in magnitude, low with scores referring to physical areas and the highest with the SF-36 MSC. CONCLUSION: This study provides evidence of the measure's psychometric properties in terms of construct validity and internal consistency. The "control" and "self-esteem" dimensions are of particular interest as these concepts are not captured in existing HRQOL. Further longitudinal validation of the scale is necessary to assess sensitivity to change.

Promising results with image guided intensity modulated radiotherapy for muscle invasive bladder cancer.

AIM: To describe the feasibility of image guided intensity modulated radiotherapy (IG-IMRT) using daily soft tissue matching in the treatment of bladder cancer. METHODS: Twenty-eight patients with muscle-invasive carcinoma of the bladder were recruited to a protocol of definitive radiation using IMRT with accelerated hypofractionation with simultaneous integrated boost (SIB). Isotropic margins of .5 and 1 cm were used to generate the high risk and intermediate risk planning target volumes respectively. Cone beam CT (CBCT) was acquired daily and a soft tissue match was performed. Cystoscopy was scheduled 6 weeks post treatment. RESULTS: The median age was 83 years (range 58-92). Twenty patients had stage II or III disease, and eight were stage IV. Gross disease received 66 Gy in 30 fractions in 11 patients (ten with concurrent chemotherapy) or 55 Gy in 20 fractions for those of poorer performance status or with palliative intent. All patients completed radiation treatment as planned. Three patients ceased chemotherapy early due to toxicity. Six patients (21 %) had acute Grade ≥ 2 genitourinary (GU) toxicity and six (21 %) had acute Grade ≥ 2 gastrointestinal (GI) toxicity. Five patients (18 %) developed Grade ≥2 late GU toxicity and no ≥2 late GI toxicity was observed. Nineteen patients underwent cystoscopy following radiation, with complete response (CR) in 16 cases (86 %), including all patients treated with chemoradiotherapy. Eight patients relapsed, four of which were local relapses. Of the patients with local recurrence, one underwent salvage cystectomy. For patients treated with definitive intent, freedom from locoregional recurrence (FFLR) and overall survival (OS) was 90 %/100 % for chemoradiotherapy versus 86 %/69 % for radiotherapy alone. CONCLUSION: IG- IMRT using daily soft tissue matching is a feasible in the treatment of bladder cancer, enabling the delivery of accelerated synchronous integrated boost with good early local control outcomes and low toxicity.

Comparison of Single-fraction and Multi-fraction Stereotactic Radiotherapy for Patients with 18F-fluorodeoxyglucose Positron Emission Tomography-staged Pulmonary Oligometastases.

AIM: To compare outcomes of single-fraction and multi-fraction stereotactic ablative body radiotherapy (SABR) for pulmonary metastases. MATERIALS AND METHODS: A retrospective review from two academic institutions of patients with one to three pulmonary metastases staged with (18)F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) scans. For single-fraction SABR, 26 Gy was prescribed for peripheral targets and 18 Gy for central targets. In the multi-fraction cohort, 48 Gy/4 or 50 Gy/5 was prescribed for peripheral targets and 50 Gy/5 was prescribed for central targets. Three-dimensional conformal radiotherapy (3D-CRT), intensity-modulated radiotherapy (IMRT) and volumetric-modulated arc therapy (VMAT) plans were delivered using heterogeneity corrections. Conformity indices at an intermediate dose (R50%) and at a high dose (R100%) were used to assess a relationship with the planning target volume (PTV). Overall survival, local and distant progression and toxicity rates were analysed from the date of treatment completion. RESULTS: Between February 2010 and June 2013, 65 patients with 85 pulmonary metastases were reviewed. The median follow-up was 2.1 years. Metastases most commonly originated from colorectal cancer (31%), followed by non-small cell lung cancer (25%). 3D-CRT was used in 52 targets, IMRT in 21 and VMAT in 12. 3D-CRT showed a lower median R50% (P=0.01), but a higher median R100% than IMRT/VMAT (P=0.04). The R50% index was inversely correlated to the PTV with all techniques (P=0.01). Overall survival at 1 and 2 years in all patients was 93% (95% confidence interval 87-100%) and 71% (95% confidence interval 58-86%), respectively. The 2 year freedom from local and distant progression was 93% (95% confidence interval 86-100%) and 38% (95% confidence interval 27-55%), respectively. There were no significant differences between overall survival (P=0 .14), time to distant progression (P=0.06) or toxicity rates (P=0.75) between single- and multi-fraction cohorts. CONCLUSION: We report comparable local control, overall survival and toxicity rates between single-fraction and multi-fraction SABR treatments in patients with FDG-PET-staged pulmonary oligometastases. We propose a guideline for R50% conformity incorporating 3D-CRT/IMRT/VMAT techniques with heterogeneity corrected planning algorithms.

Development of the Alcohol Quality of Life Scale (AQoLS): a new patient-reported outcome measure to assess health-related quality of life in alcohol use disorder.

PURPOSE: The development of patient-centred approaches and of reduction in consumption strategies in alcohol use disorder requires giving a larger place to qualitative assessments that are closer to patients' concerns and more clinically relevant than drinking outcomes and generic health-related quality of life instrument. Our purpose was to develop from patients input the Alcohol Quality of Life Scale (AQoLS), a disease-specific measure for alcohol use disorder (AUD). METHODS: Concept elicitation focus groups were conducted with AUD patients in the UK and France. Thematic analysis was used to identify key areas of impact of AUD, and draft items were developed to capture these issues. The draft items underwent expert review to ensure clinical and cross-cultural applicability. Two iterative rounds of cognitive debriefing interviews were conducted with AUD patients in both countries, to assess face and content validity. RESULTS: From focus groups conducted with 38 AUD patients, seven areas of impact emerged, forming the basis for the AQoLS: relationships, activities, looking after self, emotional impact, control, living conditions, and sleep. An initial pool of 90 items was reduced to 50 following the review process. In cognitive interviews, the measure took less than 10 min to complete, and patients reported that items were relevant to their experience. Following Round 1 interviews (n = 16), 14 items were removed because patients felt they were unclear or uneasy to respond to, 2 were combined, 7 were revised, and 4 new items were added. The recall period of 2 weeks was changed to 4 weeks, based on patient comments. Following Round 2 interviews (n = 15), 5 items were removed and 3 were modified to produce the 34-item AQoLS. CONCLUSION: As the only de novo measure of health-related quality of life developed specifically for AUD, the AQoLS offers the potential of increased sensitivity to show the effectiveness of therapeutic interventions from the patient's perspective.

The need to clot: a review of current management strategies for adverse bleeding events with new oral anticoagulants.

The new factor Xa inhibitors and direct thrombin inhibitors have offered alternatives to traditional anticoagulants, with benefits of no routine monitoring, less drug interactions, and oral administration. Current approved uses of these agents include prophylaxis of stroke in non-valvular atrial fibrillation and prevention of venous thromboembolism (VTE) following hip and knee arthroplasty. However, concern over bleeding risk in the context of having no specific antidotes available is a topic of focus for many physicians in an acute care setting. This manuscript examines the recent literature in the management of acute bleeding and the various methods of reversing anticoagulation in this setting. Literature published over the last 18 months (2011/07/01-present) was gathered from PubMed, Ovid, and Medline under a combined search strategy covering bleeding, reversal, and new oral anticoagulants, both factor Xa and direct thrombin inhibitors. The use of prothrombin complex concentrate, fresh frozen plasma, activated recombinant factor VII, activated prothrombin complex concentrate, as well as adjuncts of charcoal, hemodialysis, and antifibrinolytics are discussed. Recommendations are based on the determination of the severity of the bleed and physiological markers of anticoagulation, and involve the use of prothrombin complex concentrate, activated recombinant factor VII, and adjunctive therapy as appropriate.

The development of the L-QoL: a quality-of-life instrument specific to systemic lupus erythematosus.

OBJECTIVES: Complex diseases, such as systemic lupus erythematosus (SLE), present dilemmas over choice of outcome measures. Using a battery of instruments to capture the impact of different impairments or activity limitations experienced does not provide assessment of the wider impact on quality of life (QoL). This paper describes the development and testing of a new instrument to measure QoL in systemic lupus erythematosus (L-QoL). METHODS: The development combines theoretical strengths of the needs-based QoL model with statistical and diagnostic powers of the Rasch model. Content was derived from in-depth interviews with relevant patients. Cognitive debriefing interviews assessed face and content validity. Rasch analysis was applied to data from an initial postal survey to remove misfitting items. A second postal survey assessed scaling properties, reliability, internal consistency and validity. RESULTS: A 55-item questionnaire was derived from interview transcripts. Cognitive debriefing confirmed acceptability. Rasch analysis of postal survey data (n = 95) removed misfitting items. A second postal survey (n = 93), produced a 25-item version with good item fit and stability, excellent test-retest reliability (0.92), internal consistency (0.92) and strict unidimensionality. CONCLUSIONS: It is concluded that the L-QoL should prove a valuable instrument for assessing patient-based outcome in clinical trials and practice.

Treatment of paediatric atopic dermatitis with pimecrolimus (Elidel, SDZ ASM 981): impact on quality of life and health-related quality of life.

AIM: To report on quality of life (QoL) and health-related quality of life (HRQL) impacts of pimecrolimus (Elidel, Novartis A.G., Basel, Switzerland, SDZ ASM 981) 1% cream in the long-term treatment of paediatric atopic dermatitis. METHODS: QoL and HRQL data are presented from two 12-month international clinical trials evaluating the efficacy and safety of pimecrolimus 1% cream. Both trials were randomized and double blinded and compared two treatment strategies, one involving the use of emollients, pimecrolimus and topical corticosteroids, the other is 'usual care' (emollients plus topical corticosteroids) with a vehicle cream to maintain study blinding. The first trial (the infant trial) involved patients between ages 3 months and 2 years, whereas the children trial included patients aged 2-17 years. In both trials, QoL of the affected child's parent was evaluated with the parent's index of quality of life in atopic dermatitis (PIQoL-AD). HRQL was assessed in the children trial only with the children's dermatology life quality index (CDLQI). QoL and HRQL assessments were conducted at baseline, 6 weeks, 6 months and 12 months. RESULTS: Generalized linear modelling of PIQoL-AD scores at each post-baseline visit showed a greater impact on parent's QoL for pimecrolimus compared with control at all time-points in both trials. HRQL scores showed a greater improvement from baseline for children in the pimecrolimus group compared with those in the control group at all time-points. CONCLUSIONS: The results show a beneficial impact of pimecrolimus on parents' QoL in paediatric atopic dermatitis, confirming findings from earlier shorter term trials. There was also a clear benefit to the HRQL of the children treated.

A new instrument for assessing quality of life in atopic dermatitis: international development of the Quality of Life Index for Atopic Dermatitis (QoLIAD).

BACKGROUND: Atopic dermatitis (AD) is a chronic or chronically relapsing inflammatory skin condition that can have a considerable impact on those affected. There are a number of instruments available to measure outcome in dermatological conditions but none have been developed specifically for AD. In addition, most measure symptoms and/or daily functioning, which are potential influences on quality of life (QoL) rather than assessments of the construct itself. OBJECTIVES: The aim of the current study was to develop a new instrument specifically designed to measure QoL in adults with AD-the Quality of Life Index for Atopic Dermatitis (QoLIAD). METHODS: The instrument was developed based on the needs-based model of QoL and was produced in several different countries simultaneously. Its content was derived from 65 in-depth interviews with relevant patients in the U.K., Italy and the Netherlands. The initial version of the measure was produced in U.K. English and translations were produced for the Netherlands, Italy, Germany, France and the U.S.A. using a dual translation panel methodology. A Spanish version was developed using the same adaptation process after the instrument was finalized. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. The instrument [in addition to the Dermatology Life Quality Index (DLQI) and the Psychological General Well-Being Schedule (PGWB)] was then administered to up to 300 AD patients in each country at two time points to finalize the instrument and test its psychometric properties. RESULTS: The initial version of the QoLIAD had 56 items that reflected the areas of need fulfillment identified in the qualitative interviews as having been affected by AD: mental and emotional stimulation, physical and emotional stability, security, sharing and belonging, self-esteem, personal development and fulfillment. Comments from patients in field-test interviews resulted in the removal of 14 items, to leave a 42-item instrument that was considered relevant and acceptable. The number of patients participating in the survey were 286 in the U.K., 46 in the Netherlands, 213 in France, 187 in Germany, 178 in the U.S.A. and 83 in Spain. Application of the Rasch model to these data identified the final 25-item QoLIAD. Unidimensionality was confirmed, with deviation of the total scale from the Rasch model evident at a single time point in one country only (the U.K.). All language versions, with the exception of the Dutch measure, had test-retest reliability coefficients in excess of 0.85. The test-retest in the Netherlands was 0.80. However, this country had the smallest sample size and the corresponding reliability for the DLQI was only 0.40. The QoLIAD had adequate internal consistency and the initial indications of construct validity were good. The levels of association with the DLQI indicated that the two instruments measure related but distinct constructs. CONCLUSIONS: The QoLIAD is a practical, reliable, valid and culturally applicable instrument for measuring the impact of AD and its treatment on QoL in clinical trials or in routine clinical practice.

Development of the PsAQoL: a quality of life instrument specific to psoriatic arthritis.

BACKGROUND: Patient reported outcome measures used in studies of psoriatic arthritis (PsA) have been found to be inadequate for determining the impact of the disease from the patient's perspective. OBJECTIVE: To produce the PsAQoL, a PsA-specific quality of life (QoL) instrument, employing the needs based model of QoL that would be relevant and acceptable to respondents, valid, and reliable. METHODS: Content was derived from qualitative interviews conducted with patients with PsA. Face and content validity were assessed by field test interviews with a new sample of patients with PsA. A postal survey was conducted to improve the scaling properties of the new measure. Finally, a test-retest postal survey was used to identify the final measure and to test its scaling properties, reliability, internal consistency, and validity. RESULTS: Analysis of the qualitative interview transcripts identified a 51 item questionnaire. Field test interviews confirmed the acceptability and relevance of the measure. Analysis of data from the first postal survey (n = 94) reduced the questionnaire to 35 items. Rasch analysis of data from the test-retest survey (n = 286) identified a 20 item version of the PsAQoL with good item fit. This version had excellent internal consistency (alpha = 0.91), test-retest reliability (0.89), and validity. CONCLUSIONS: The PsAQoL is a valuable tool for assessing the impact of interventions for PsA in clinical studies and trials. It is well accepted by patients, taking about three minutes to complete, is easy to administer, and has excellent scaling and psychometric properties.

Development of the PSORIQoL, a psoriasis-specific measure of quality of life designed for use in clinical practice and trials.

BACKGROUND: Patients with psoriasis have significant impairment in their quality of life (QoL). Several patient-completed instruments are available to measure outcome in dermatological conditions but these primarily focus on severity of disease rather than on QoL. OBJECTIVES: To develop a new instrument specifically designed to measure QoL in psoriasis-the Psoriasis Index of Quality of Life (PSORIQoL). METHODS: The content of the instrument was derived from qualitative interviews with 62 psoriasis patients in the U.K., Italy and the Netherlands. Content analysis of the interview transcripts from the three countries identified potential items for the questionnaire. All further stages of the project were conducted in the U.K. only. Face and content validity were determined by means of a focus group held with seven psoriasis patients and face-to-face interviews with a further 21 patients. A new draft version of the PSORIQoL, together with the Dermatology Life Quality Index (DLQI) and the General Well-Being Index (GWBI), were completed by a new sample of psoriasis patients contacted by mail, in order to determine construct validity. A subsample of the respondents completed a similar package 2 weeks later, to assess reproducibility (reliability). RESULTS: The first version of the PSORIQoL consisted of 61 items covering the needs identified in the interviews as having been affected by psoriasis or its treatment. These included fear of negative reactions from others, self-consciousness and poor self-confidence, problems with socialization, physical contact and intimacy, limitations on personal freedom and impaired relaxation, sleep and emotional stability. Following the focus group and field-test interviews, a new draft measure consisting of 45 items was completed by 148 patients, 88 of whom completed and returned a similar package 2 weeks later. Application of Rasch analysis identified a final 25-item version of the PSORIQoL. This version had a test-retest reliability coefficient of 0.89, indicating good reproducibility. The levels of association with the DLQI and PGWB indicated that the PSORIQoL measures a related but distinct construct. CONCLUSIONS: The PSORIQoL appears to be a practical, reliable and valid instrument for measuring the impact of psoriasis on QoL. It remains necessary to establish the instrument's responsiveness to changes in QoL associated with treatment.

Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis.

BACKGROUND: Although disease-specific health status measures are available for ankylosing spondylitis (AS), no instrument exists for assessing quality of life (QoL) in the condition. OBJECTIVE: To produce an AS-specific QoL measure that would be relevant and acceptable to respondents, valid, and reliable. METHODS: The ASQoL employs the needs-based model of QoL and was developed in parallel in the UK and the Netherlands (NL). Content was derived from interviews with patients in each country. Face and content validity were assessed through patient field test interviews (UK and NL). A postal survey in the UK produced a more efficient version of the ASQoL, which was tested for scaling properties, reliability, internal consistency, and validity in a further postal survey in each country. RESULTS: A 41 item questionnaire was derived from interview transcripts. Field testing interviews confirmed acceptability. Rasch analysis of data from the first survey (n=121) produced a 26 item questionnaire. Rasch analysis of data from the second survey (UK: n=164; NL: n=154) showed some item misfit, but showed that items formed a hierarchical order and were stable over time. Problematic items were removed giving an 18 item scale. Both language versions had excellent internal consistency (alpha=0.89-0.91), test-retest reliability (r(s)=0.92 UK and r(s)=0.91 NL), and validity. CONCLUSIONS: The ASQoL provides a valuable tool for assessing the impact of interventions for AS and for evaluating models of service delivery. It is well accepted by patients, taking about four minutes to complete, and has excellent scaling and psychometric properties.

UK audit of single photon emission computed tomography reconstruction software using software generated phantoms.

The purpose of this study was to undertake an audit of the quantitative characteristics of single photon emission computed tomography software using projection data from an analytically generated software phantom and a measured line source. The phantom consisted of three structures. A uniformly filled cylinder, a series of cylindrical rods of various diameters in a background activity with a rod to background ratio of 2:1 and lastly, a set of three concentric rings of activity in the ratio 1:0:1. The phantom contained no added statistical noise. No attenuation was imposed on the data. The phantom was generated analytically and projections were distributed at six different count densities. A single set of projections from a thin line source was also distributed. These data were distributed to centres throughout the UK. Centres were asked to reconstruct the data using a 'ramp only' reconstruction with no additional smoothing function applied. Data were requested for mean and standard deviation in the uniform cylinder, the maximum counts for each cylindrical rod and the mean counts in regions placed within the concentric rings. For the measured line source, centres were asked to measure the full width at half maximum and peak pixel counts for a profile through the reconstructed line. Results from 115 systems were obtained from 100 centres throughout the UK. These provided data from 12 software providers, 11 of these being commercial companies. Data were compared with the known input values and histograms of the distribution of results obtained. Significant differences in quantitative parameters were noted for the different input count densities as well as between suppliers and revisions of software from single suppliers.

Adaptation and validation of the rheumatoid arthritis quality of life scale for use in Canada.

OBJECTIVE: The Rheumatoid Arthritis Quality of Life questionnaire (RAQoL) was developed simultaneously in the UK and the Netherlands to measure quality of life in patients with RA. We adapted and validated the RAQoL for the English-Canadian and French-Canadian languages and culture. METHODS: The UK RAQoL was translated into French-Canadian by a bilingual translation panel. Separate lay panels were then used to ensure that this and the English-Canadian instruments were appropriate for use with Canadian patients. Interviews were conducted with 15 French-Canadian and 15 English-Canadian patients with RA to determine the content validity. Reliability and construct validity were established by means of test-retest mail surveys conducted with 92 French-Canadian and 87 English-Canadian RA patients. The survey consisted of the adapted RAQoL, the Health Assessment Questionnaire (HAQ), and a demographic questionnaire. RESULTS: The RAQoL was successfully adapted for both the French and English-Canadian cultures. Field testing showed both versions to be well received by respondents. Of the French-Canadian patients included in the postal survey, 52 responded at Time 1 and 50 at Time 2. For the English-Canadian sample, 54 responded at both time points. Missing data rates for the RAQoL were low and floor and ceiling effects were minimal. Test-retest reliability was good for both versions: 0.87 for the French-Canadian and 0.95 for the English-Canadian. Alpha coefficients (0.92 for the French-Canadian, 0.93 for the English-Canadian) showed the items to be adequately interrelated and scores on the measure showed moderate to high correlations with the HAQ, confirming construct validity. Both versions of the RAQoL were also able to distinguish patient groups that differed according to perceived health status and perceived severity of RA. In addition, the French-Canadian version was able to distinguish patients who rated today as bad or very bad from those who rated today as good or very good. CONCLUSION: The new versions of the RAQoL were well received by both French and English speaking Canadians. The psychometric quality of the adapted questionnaires means they are suitable for inclusion in clinical trials involving patients with RA.

Developing a disease-specific quality of life measure for people with multiple sclerosis.

OBJECTIVES: To develop a patient-completed disease-specific measure of quality of life in multiple sclerosis and to validate the measure in a community-based population of people with multiple sclerosis. METHODS: The items in the scale were selected in focus group sessions of people with multiple sclerosis. The initial scale included 25 items and was tested in subgroups of 150 people from a population register of people with multiple sclerosis in Leeds. Following further developmental phases, a restructured 16-item scale was tested on a random sample of 200 people with multiple sclerosis from the population register, stratified according to disease course. This led to a final eight-item unidimensional scale, the Leeds Multiple Sclerosis Quality of Life (LMSQoL) scale. RESULTS: After initial development a 16-item scale was found to be both reliable and valid. Cronbach's alpha for the 16-item scale was 0.86. The test-retest correlation was 0.74, using a two-week retest interval. However, convergent validity with the General Well Being Index was 0.67 and with the SF-36 Physical Function Scale was 0.68. This suggested that the scale straddled these two concepts and was confirmed by fit of the data to the Rasch measurement model. This revealed the potential for a reduced eight-item version of the scale. The eight-item scale had a closer association to well-being (0.83) than to physical function (0.39), had good internal consistency (0.79) and test-retest reliability (0.85). There were virtually no floor or ceiling effects for the scale. CONCLUSIONS: The study presents a disease-specific measure of quality of life in multiple sclerosis, the Leeds Multiple Sclerosis Quality of Life (LMSQoL) scale. The instrument is brief, easy to use and practical to administer in clinic or as a postal questionnaire. It measures a construct related to well-being, and provides an important adjunct to the measurement of outcome in multiple sclerosis.

Epidural anesthesia-analgesia shortens length of stay after laparoscopic segmental colectomy for benign pathology.

BACKGROUND: Aggressive postoperative care plans after open colectomy may allow earlier discharge, especially in conjunction with preoperative thoracic epidural anesthesia-analgesia using a local anesthetic and narcotic. The purpose of this study was to evaluate the role of thoracic epidural anesthesia-analgesia using bupivacaine and fentanyl citrate in reducing lengths of stay after laparoscopic colectomy (LAC). METHODS: A consecutive cohort of patients who underwent LAC and who received perioperative thoracic epidural anesthesia-analgesia (TEG) was compared with a standard group of patients (STD) undergoing LAC during the 2 months preceding the implementation of the epidural management protocol. Patients with TEG received 6 to 8 mL bupivacaine (0.25%) and fentanyl citrate (100 microg) through a T8-9 or a T9-10 epidural catheter before the incision was made and a postoperative infusion of bupivacaine (0.1%) and fentanyl citrate (5 microg/mL) at 4 to 6 mL/h for 18 hours. STD patients had supplemental intravenous morphine. The postoperative care plan was otherwise identical between the 2 groups. Patients were matched by sex, age, and type of segmental resection. Discharge criteria included tolerance of 3 general diet meals, passage of flatus or stool, and adequate oral analgesia. Length of stay was defined as the time from admission for the surgical procedure to discharge from the hospital. Statistical analysis included a Student t test, Wilcoxon rank sum test, chi-square trend test, and Fisher exact test where appropriate. Data are presented as mean +/- SEM. RESULTS: Procedures performed were: right hemicolectomy-ileocolectomy (TEG, n = 5; STD, n = 5); or sigmoid colectomy-rectopexy (TEG, n = 17; STD, n = 17). There was no significant difference with respect to operating room (OR) time (TEG, 102 +/- 12 minutes; STD, 87 +/- 17 minutes), body mass index (TEG, 26 +/- 2; STD, 26 +/- 2), or American Society of Anesthesiologists class (I-III) distribution (TEG, 3/12/10; STD, 4/11/7), or mean incision length (TEG, 3.5 +/- 0.4 cm; STD, 3.7 +/- 0.3 cm.) No postoperative complications or readmissions occurred in either group. The length of stay decreased in the TEG group (TEG, 2.8 +/- 0.2 days; STD, 3.9 +/- 0.3; P <.001) and the median length of stay for the 2 groups was similarly less (TEG, 2 days; STD, 3 days). CONCLUSIONS: These data suggest that thoracic epidural anesthesia-analgesia has a significant and favorable impact on dietary tolerance and length of stay after LAC. A thoracic epidural appears to be an important component of a postoperative care protocol, which adds further advantage to LAC without the need for labor-intensive and costly patient care plans.