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Therapeutic ultrasound for venous leg ulcers.

BACKGROUND: Ultrasound therapy is commonly used with the aim of improving the healing of chronic wounds such as pressure ulcers and venous leg ulcers. OBJECTIVES: To assess the effectiveness of therapeutic ultrasound in the treatment of venous leg ulcers. SEARCH STRATEGY: The Cochrane Wounds Group search strategy was used (see Scope) to search for randomised controlled trials (RCTs) of therapeutic ultrasound for the treatment of venous leg ulcers. SELECTION CRITERIA: Randomised controlled trials comparing therapeutic ultrasound with sham ultrasound, or other (standard) treatment DATA COLLECTION AND ANALYSIS: Results of searches were scrutinised by one reviewer (and checked by a second) to identify possible RCTs and full reports of these were obtained. Details of eligible studies were extracted and summarised using a data extraction sheet. Attempts were made to obtain missing data by contacting authors. Data extraction was checked by a second reviewer. MAIN RESULTS: A total of seven eligible RCTs were identified. Four trials compared ultrasound therapy with sham ultrasound, three trials compared ultrasound therapy with standard treatment. None of the trials found a difference in healing rates between any of the therapies, though it is noteworthy that the direction of treatment effect was consistently in favour of ultrasound (though this did not reach significance in the individual studies). REVIEWER'S CONCLUSIONS: There is no good evidence of a benefit of ultrasound therapy in the healing of venous leg ulcers.

Humans↗

Orthotic devices for treating patellofemoral pain syndrome.

BACKGROUND: Patellofemoral pain syndrome is a frequently reported condition in active adults. A wide variety of conservative treatment strategies have been described. As yet, no optimal strategy has been identified. Application of orthotic devices e.g. knee braces, knee straps, forms of taping of the knee, active training devices, knee sleeves and in-shoe orthotics to support the foot have been advocated to treat this condition. OBJECTIVES: To assess the effectiveness of foot and knee orthotics for treatment of patellofemoral pain syndrome. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (December 2001), the Cochrane Controlled Trials register (Issue 2, 2000), MEDLINE (January 1966 to March 2000; EMBASE (January 1988 to March 2000); CINAHL (January 1982 to March 2000) and PEDro (up to March 2000). Relevant orthotic companies were contacted. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing the effectiveness of knee or foot orthotics for treatment of patellofemoral pain syndrome were selected. Trials describing the use of orthotic devices in conjunction with operative treatment were excluded. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed methodological quality of the identified trials by use of a modified version of the Cochrane Musculoskeletal Injuries Group assessment tool, consisting 11 items. Two reviewers extracted data without blinding. Trialists were contacted to obtain missing data. MAIN RESULTS: Five trials involving 362 participants were included in this review. Five other trials await possible inclusion if further information can be obtained and one awaits further assessment. Due to clinical heterogeneity, we refrained from statistical pooling and conducted analysis by grading the strength of scientific evidence. The level of obtained research-based evidence was graded as limited as all trials were of low methodological quality. This limited research-based evidence showed the Protonics orthosis at six week follow-up was significantly more effective for decrease in pain (weighted mean difference (WMD) between groups 3.2; 95% confidence interval (CI) 2.8 to 3.6), functional improvement on the Kujala score (WMD 45.6; 95% CI 43.4 to 47.7) and change in patellofemoral congruence angle (WMD 17.2; 95% CI 14.1 to 20.3) when compared to no treatment. A comprehensive programme including tape application was significantly superior to a monitored exercise programme without tape application for decrease in worst pain (WMD 1.6; 95% CI 0.4 to 2.8) and usual pain (WMD 1.2; 95% CI 0.2 to 2.1), and clinical change and functional improvement questionnaire scores (WMD 10, 95% CI 2.07 to 17.93) at four weeks follow-up. The trials reported statistically significant differences in patient satisfaction after applied therapy (WMD 3.3; 95% CI 0.5 to 6.1) in favour of the McConnell regimen compared with the Coumans bandage at six weeks follow-up. REVIEWER'S CONCLUSIONS: The evidence from randomised controlled trials is currently too limited to draw definitive conclusions about the use of knee and foot orthotics for the treatment of patellofemoral pain. Future high quality trials in this field are warranted.

Arthralgia↗

Electromagnetic therapy for the treatment of pressure sores.

BACKGROUND: Electromagnetic therapy is used with the aim of improving the healing of chronic wounds such as pressure sores and venous leg ulcers OBJECTIVES: To assess the effectiveness of electromagnetic therapy in the treatment of pressure sores SEARCH STRATEGY: The Cochrane Wounds Group search strategy was used (see Scope) to search for randomised controlled trials (RCTs) of electromagnetic therapy for the treatment of pressure sores SELECTION CRITERIA: Randomised controlled trials comparing electromagnetic therapy with sham electromagnetic therapy, or other (standard) treatment DATA COLLECTION AND ANALYSIS: Results of searches were scrutinised by one reviewer (and checked by a second) to identify possible RCTs and full reports of these were obtained. Details of eligible studies were extracted and summarised using a data extraction sheet. Attempts were made to obtain missing data by contacting authors. Data extraction was checked by a second reviewer. MAIN RESULTS: A total of two eligible RCTs were identified for inclusion in this review. The first of these studies (Comorosan 1993) was a three armed study comparing electromagnetic therapy, electromagnetic therapy in combination with standard therapy, and standard therapy alone. The second study (Salzburg 1995) was a comparison between electromagnetic therapy and sham therapy on 30 male patients with a spinal cord injury and a grade two or grade three pressure sore. Neither study found a statistically significant difference between the healing rates of electromagnetic therapy treated and control group patients. REVIEWER'S CONCLUSIONS: The results suggest no evidence of a benefit in using electromagnetic therapy to treat pressure sores. However the possibility of a beneficial or harmful effect cannot be ruled out due to the fact there were only two trials with methodological limitations and small numbers of patients.

Electromagnetic Phenomena↗

Electromagnetic therapy for treating pressure ulcers.

BACKGROUND: Pressure ulcers are defined as areas "of localized damage to the skin and underlying tissue caused by pressure, shear, friction and/or the combination of these". In the UK, pressure ulcers occur in 5 to 32% of District General Hospitals people and in 4 to 7% of people in community settings. Electromagnetic therapy, in which electrodes produce an electromagnetic field across the wound, may improve healing of chronic wounds such as pressure ulcers. OBJECTIVES: To assess the effects of electromagnetic therapy on the healing of pressure ulcers. SEARCH STRATEGY: For this first update, we searched the Cochrane Wounds Group Specialised Register (last searched October 2005); CENTRAL (The Cochrane Library 2005, Issue 4); MEDLINE (1966 to October 2005); EMBASE (1980 to October 2005); and CINAHL (1982 to October 2005). SELECTION CRITERIA: Randomised controlled trials comparing electromagnetic therapy with sham electromagnetic therapy, or other (standard) treatment. DATA COLLECTION AND ANALYSIS: For this first update, two authors independently scrutinized the results of the search to identify relevant RCTs and obtained full reports of potentially eligible studies. For the original review, details of eligible studies were extracted and summarised using a data extraction sheet. Attempts were made to obtain missing data by contacting authors. Data extraction was checked by a second author. Meta-analysis was applied to combine the results of trials when the interventions and outcome measures were sufficiently similar. MAIN RESULTS: This update identified no new trials. Two RCTs were identified for inclusion in the original review (total of 60 participants). One was a three-armed study comparing electromagnetic therapy with electromagnetic therapy in combination with standard therapy, and with standard therapy alone, on 17 female and 13 male with grade II and III pressure ulcers. The other study compared electromagnetic therapy with sham therapy in 30 male participants with a spinal cord injury and a grade II or grade III pressure ulcer.Neither study found a statistically significant difference between the healing rates of pressure ulcers in people treated with electromagnetic therapy compared with those in the control group. AUTHORS' CONCLUSIONS: The results provide no evidence of benefit in using electromagnetic therapy to treat pressure ulcers. However, the possibility of a beneficial or harmful effect cannot be ruled out, due to the fact that there were only two included trials both with methodological limitations and small numbers of participants. Further research is recommended.

Electric Stimulation Therapy↗

Electromagnetic therapy for the treatment of venous leg ulcers.

BACKGROUND: Electromagnetic therapy is used with the aim of improving the healing of chronic wounds such as pressure sores and venous leg ulcers OBJECTIVES: To assess the effectiveness of electromagnetic therapy in the treatment of venous leg ulcers SEARCH STRATEGY: The Cochrane Wounds group search strategy was used (see Scope) to search for randomised controlled trials (RCTs) of electromagnetic therapy for the treatment of venous leg ulcers SELECTION CRITERIA: Randomised controlled trials comparing electromagnetic therapy with sham electromagnetic therapy or other (standard) treatment DATA COLLECTION AND ANALYSIS: Results of searches were scrutinised by one reviewer (and checked by a second) to identify possible RCTs and full reports of these were obtained. Details of eligible studies were extracted and summarised using a data extraction sheet. Attempts were made to obtain missing data by contacting authors. Data extraction was checked by a second reviewer. MAIN RESULTS: A total of three eligible RCTs were identified. Two trials compared the use of electromagnetic therapy to sham (Ieran 1990; Kenkre 1996) and one trial (Stiller 1992) compared it with standard topical treatments. One of the trials found a difference in healing rates of borderline statistical significance between electromagnetic therapy and sham, although the direction of treatment effect was consistently in favour of electromagnetic therapy the difference was not statistically significant. REVIEWER'S CONCLUSIONS: There is currently no reliable evidence of benefit of electromagnetic therapy in the healing of venous leg ulcers.

Electromagnetic Phenomena↗

Electromagnetic therapy for treating venous leg ulcers.

BACKGROUND: Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called stasis, or varicose ulcers) comprise 80 to 85% of all leg ulcers. Electromagnetic therapy is sometimes used as a treatment to assist the healing of chronic wounds such as venous leg ulcers. OBJECTIVES: To assess the effects of electromagnetic therapy on the healing of venous leg ulcers. SEARCH STRATEGY: For this first review update, we searched the Cochrane Wounds Group Specialised Register (last searched October 2005); CENTRAL (The Cochrane Library 2005, Issue 4); MEDLINE (1966 to October 2005); EMBASE (1980 to October 2005); and CINAHL (1982 to October 2005). SELECTION CRITERIA: Randomised controlled trials comparing electromagnetic therapy with sham electromagnetic therapy or other treatments. DATA COLLECTION AND ANALYSIS: For the original review, details of eligible studies were extracted and summarised using a data extraction sheet. Attempts were made to obtain missing data by contacting authors. A second reviewer checked data extraction. Meta-analysis was applied to combine the results of trials where the interventions and outcome measures were adequately similar. For this first update, two reviewers independently scrutinized the results of the search to identify relevant RCTs and obtained full reports of potentially eligible studies. In the case of disagreements, a final decision was made either after discussion between two reviewers or consultation with a third party (a member of the Cochrane Wounds Group). MAIN RESULTS: This update identified no new trials. A total of three eligible RCTs were identified by the original review. Two trials compared the use of electromagnetic therapy with sham therapy and one trial compared it with standard topical treatments. One trial found a difference in healing rates of borderline statistical significance between electromagnetic therapy and sham therapy, although the direction of treatment effect was consistently in favour of electromagnetic therapy, the difference was not statistically significant. AUTHORS' CONCLUSIONS: There is currently no reliable evidence of benefit of electromagnetic therapy in the healing of venous leg ulcers. Further research is needed.

Electric Stimulation Therapy↗

Acupuncture for acute stroke.

BACKGROUND: Acupuncture-like sensory stimulation activates multiple efferent (nerve) pathways leading to altered activity in numerous neural systems. Acupuncture is widely accepted by Chinese people and it is increasingly requested by patients and their relatives in Western countries. OBJECTIVES: To assess the effectiveness and safety of acupuncture in patients with acute stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched August 2003), the Chinese Stroke Trials Register (August 2003) and the Chinese Acupuncture Trials Register (August 2003). Electronic searches were performed in the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2003), MEDLINE (1966 to 2003), EMBASE (1980 to 2003), Alternative Medicine Database (1985 to 2003), CINAHL (1982 to 2003) and the Chinese Biological Medicine Database (1981 to 2003). Reference lists of systematic reviews and identified trials were handsearched. SELECTION CRITERIA: Randomised and quasi-randomised trials of acupuncture started within 30 days of stroke onset, compared with placebo/sham acupuncture or open control in patients with acute ischaemic and/or haemorrhagic stroke. Needling into skin was required for acupuncture. DATA COLLECTION AND ANALYSIS: Two reviewers selected trials for inclusion, assessed trial quality, and extracted the data independently. Authors of trials were contacted for missing data. MAIN RESULTS: Fourteen trials involving 1208 patients were included. Ten trials included patients with only ischaemic stroke. When acupuncture was compared with sham acupuncture or open control, there was a borderline significant trend towards fewer patients being dead or dependent (Odds ratio (OR) 0.66, 95% confidence interval (CI) 0.43 to 0.99), and significantly fewer being dead or needing institutional care (OR 0.58, 95% CI 0.35 to 0.96) in the acupuncture group after three months or more. There was also a significant difference favouring acupuncture in the mean change of global neurological deficit score during the treatment period (standardized mean difference (SMD) 1.17, 95% CI 0.30 to 2.04). Comparison of acupuncture with sham acupuncture only showed a statistically significant difference on death or requiring institutional care (OR 0.49, 95% CI 0.25 to 0.96), but not on death or dependency (OR 0.67, 95% CI 0.40 to 1.12), or change of global neurological deficit score (SMD 0.01, 95% CI -0.55 to 0.57). Severe adverse events with acupuncture (dizziness, intolerable pain and infection of acupoints) were rare (6/386, 1.55%). AUTHORS' CONCLUSIONS: Acupuncture appeared to be safe but without clear evidence of benefit. The number of patients is too small to be certain whether acupuncture is effective for treatment of acute ischaemic or haemorrhagic stroke. Larger, methodologically-sound trials are required.

Acupuncture Therapy↗

National Audit of Thrombolysis for Acute Leg Ischemia (NATALI): clinical factors associated with early outcome.

OBJECTIVE: The National Audit of Thrombolysis for Acute Leg Ischemia (NATALI) database is a consecutive series of patients who underwent intra-arterial thrombolysis to treat acute leg ischemia in one of 11 centers in the United Kingdom. The purpose of the study was to analyze the factors associated with outcome after 30 days. METHODS: The data were collected over 10 years on standard pro formas, and registration was completed at the end of 1999. Since then, data from each unit have been verified and missing data included when available. Univariate and multivariate analyses were performed, with the outcomes of amputation-free survival (AFS), amputation with survival, and death. RESULTS: A total of 1133 thrombolytic events were included. Outcome results at 30 days for the entire group were AFS, 852 (75.2%); amputation, 141 (12.4%); and death, 140 (12.4%). Results for the entire group improved from the first half of the database, when AFS ranged from 65% to 75%, to almost 80% for the last few years of the study, although this was not statistically significant. Preintervention factors associated with lower AFS at multivariate analysis included diabetes (P =.002), increasing age (P <.001), short-duration ischemia (P =.027), Fontaine grade (P =.001), and ischemia with neurosensory deficit (P =.004). AFS was improved in patients receiving warfarin sodium at the time of the arterial occlusion (P =.04). Mortality was higher in women (P =.006) and in older patients (P <.001), and in patients with native vessel occlusion (P <.001), emboli (P =.02), or a history of ischemic heart disease (P <.001). Amputation risk was greatest in younger men (P <.001) and in patients with more severe ischemia (P =.02), graft occlusion (P <.001), or native vessel thrombotic occlusion (P =.02). CONCLUSION: Experienced surgeons and radiologists can achieve an AFS of about 80% in selected patients with acute leg ischemia. Information from the NATALI database can be used in selection of an appropriate intervention in the individual patient.

Acute Disease↗

Advances in statistical methods for substance abuse prevention research.

The paper describes advances in statistical methods for prevention research with a particular focus on substance abuse prevention. Standard analysis methods are extended to the typical research designs and characteristics of the data collected in prevention research. Prevention research often includes longitudinal measurement, clustering of data in units such as schools or clinics, missing data, and categorical as well as continuous outcome variables. Statistical methods to handle these features of prevention data are outlined. Developments in mediation, moderation, and implementation analysis allow for the extraction of more detailed information from a prevention study. Advancements in the interpretation of prevention research results include more widespread calculation of effect size and statistical power, the use of confidence intervals as well as hypothesis testing, detailed causal analysis of research findings, and meta-analysis. The increased availability of statistical software has contributed greatly to the use of new methods in prevention research. It is likely that the Internet will continue to stimulate the development and application of new methods.

Humans↗

[Consumer satisfaction trajectories of adolescents during in-patient psychiatric treatment].

OBJECTIVE: Patient satisfaction with in-patient treatment and other aspects of process quality is usually examined cross-sectionally (e.g. at discharge). Therefore, the knowledge about changes in patient satisfaction and related issues, such as participation and motivation during the treatment period, is limited. This study describes the development of a questionnaire covering these topics and the course and variability in these domains for different subgroups. METHOD: The study group comprises 88 adolescents (48 females, 40 males; aged 13 to 18 years) who delivered altogether 1,003 data points (median per person is 8). The questionnaire consisted of 16 items that were administered to them by computer twice a week at adolescent wards in two psychiatric departments. Statistical analysis was done using hierarchical linear modeling (growth curve models), which is well suited for the analysis of data with different numbers of assessment points and missing data. RESULTS: Psychometric properties of the questions were good. The trajectories for all items are very heterogeneous with regard to the level.. The trends (slope of the growth curves) are around 0 in general satisfaction, i.e. the adolescents stay on their different levels during the treatment period. Concerning participation, however, there are diverging trends, in particular between the two departments, which may reflect the difference in the treatment experience of the teams, whereas age, gender and diagnosis (internalizing vs. externalizing) play a minor role. CONCLUSION: Evaluation of process characteristics has turned out to be feasible in clinical routine and promising for further insights into process quality.

Adolescent↗

Patients with a longer duration of symptoms of acute asthma are more likely to require admission to hospital.

OBJECTIVE: To determine whether, for patients with moderate or severe asthma presenting to emergency departments, there is a difference in need for hospitalization between those with a duration of symptoms less than 6 h and those with a longer duration of symptoms. METHODS: This prospective, observational study investigated a sample of patients presenting with acute asthma between 21 August and the 3 September 2000, attending study emergency departments and classified as having moderate or severe asthma according to the National Asthma Guidelines. Data collected included duration of symptoms (less than 6 h or greater than 6 h) and disposition following emergency department treatment (home, ward, intensive care unit, high dependency unit, transfer). Data analysis was by Chi square analysis. RESULTS: Of 381 eligible patients, 348 had sufficient data for entry into this study (33 had missing data). Patients with duration of symptoms more than 6 h were more likely to require hospital admission (P < 0.0001). The relative risk for hospital admission or transfer as opposed to discharge from the emergency department for the group with a duration of symptoms of more than 6 h was 2.2. CONCLUSION: Patients presenting with moderate or severe asthma and a duration of symptoms of more than 6 h are more likely to require hospital admission or transfer for further treatment than patients with a shorter duration of symptoms. This has implications for decision making regarding asthma management and disposition in the emergency department.

Acute Disease↗

Conception and development of a bibliographic database of blood nutrient fluxes across organs and tissues in ruminants: data gathering and management prior to meta-analysis.

In the organism, nutrient exchanges among tissues and organs are subject to numerous sources of physiological or nutritional variation, and the contribution of individual factors needs to be quantified before establishing general response laws. To achieve this, meta-analysis of data from publications is a useful tool. The objective of this work was to develop a bibliographic database of nutrient fluxes across organs and tissues of ruminant animals (Flora) under Access using the Merise method. The most important criteria for Flora were the ease to relate the various information, the exhaustivity and the accuracy of the data input, a complete description of the diets, taking into account the methods of the methodological procedures of measurement and analysis of blood nutrients and the traceability of the information. The conceptual data model was built in 6 parts. The first part describes the authors and source of publication, and the person in charge of data input. It clearly separates and identifies the experiments, the groups of animals and the treatments within a publication. The second part is concerned with feeds, diets and their chemical composition and nutritional value. The third and fourth parts describe the infusion of any substrates and the methods employed, respectively. The fifth part is devoted to the results of blood flows and nutrient fluxes. The sixth part gathers miscellaneous experimental information. All these parts are inter-connected. To model this database, the Merise method was utilised and 26 entities and 32 relationships were created. At the physical level, 93 tables were created, corresponding, for the majority, to entities and relationships of the data model. They were divided into reference tables (n = 65) and data tables (n = 28). Data processing was developed in Flora and included the control of the data, generic calculations of unknown data from given data, the automation of the estimation of the missing data or the chemical composition of the diets. It also included the construction of tables for meta-analyses and the study of the variations of several factors within publications (pre-coding of meta-analyses). Overall, the system was built to facilitate the gathering, input, validation, management and retrieval of data from publications.

Animal Feed↗

A systematic overview of the use of diary cards, quality-of-life questionnaires, and psychometric tests in treatment trials of Helicobacter pylori-positive and -negative non-ulcer dyspepsia.

BACKGROUND: Our aim was to evaluate the use of diary cards, quality-of-life questionnaires, and psychometric tests in treatment trials of non-ulcer dyspepsia. METHODS: Data sources were a Medline search (up to 1966) and a manual search of five gastrointestinal journals (up to 1980) for original, randomized, double-blind, placebo-controlled trials with at least 20 patients which evaluated treatment regimens for non-ulcer dyspepsia. RESULTS: Of the 67 eligible studies, 31 used diary cards. Diary cards were used alone in 15 of the 31 studies (48%), whereas the others (52%) also used a physician assessment. The symptoms assessed by diary cards were epigastric pain (100%), nausea/vomiting (65%), heartburn (52%), belching (39%), regurgitation (29%), fullness (29%), and bloating (23%). Forty-five per cent also recorded antacid use. Severity of outcome measures was assessed by a visual analogue scale in 5 of the 31 studies (16%), Likert scales in 17 studies (55%), and unclear methods in 3 studies (10%). For statistical analysis daily averages of symptoms were used in 5 of the 31 studies (16%), weekly averages in 11 studies (35%), and 2-week intervals during the treatment period in the rest, with some studies using a combination (such as daily and weekly averages). Only 3 of the 31 studies (8%) checked for compliance with diary card data. None of the studies mention anything about missing data and how this was handled. One study evaluated quality of life questionnaires and one evaluated a psychometric test. CONCLUSIONS: Non-ulcer dyspepsia treatment trials frequently use diary cards but need to be much clearer about how information was obtained and how it was used in the statistical analysis. Not much information is available to comment on the use of quality-of-life questionnaires or psychometric tests for evaluation of outcome measures.

Dyspepsia↗

Assessment of quality of life during chemotherapy.

Increasingly more aggressive chemotherapy together with expected small differences between treatments with respect to objective endpoints has heightened awareness about the importance of addressing how patients experience and value the impact that treatment has had on their overall life situation. Assessment of a patient's quality of life (QoL) is now conceptually viewed as an important complement to traditional objective evaluation measures. It was therefore considered important to review the basis for the assessment of this endpoint when The Swedish Council of Technology Assessment in Health Care (SBU) performed a systematic overview of chemotherapy effects in several tumour types. The group came to the following conclusions: QoL assessments, mostly by patient self-reporting in questionnaires, have come increasingly into use during the past decade. A number of general, cancer-specific and cancer diagnosis-specific instruments have been developed. There is at present little need for development of new cancer instruments, although specific treatment modalities and tumour types may need new additional modules. A predefined hypothesis should determine the instrument to be used. Since the selection of a QoL instrument in a specific study influences both the results and the conclusions, it is essential to carefully select the instrument or instruments that have the greatest likelihood of identifying relevant differences between treatment alternatives. Interpretation of QoL data is more difficult than interpretation of objective endpoints such as survival time, objective response rates or toxicity. Despite these difficulties, QoL analyses have provided new insights into the advantages and disadvantages of various treatments not provided by traditional end-points. Some palliative treatments seemingly increase patients' QoL despite side-effects or the lack of, or marginal, increases in survival. When using potentially curative chemotherapy, it is not a matter of when the treatment should be started, but rather when it should be concluded. When using less active chemotherapy, the expected small therapeutic gains must be weighed against the QoL costs of using the therapy: does the toxicity and/or the inconvenience of the proposed treatment justify the expected gain? When it is found that the strain on the patient is greater than the effects of the cancer, treatment must be discontinued. It is not possible to determine whether or not the advantages of palliative chemotherapy are worth their costs without knowledge about patients' personal values regarding the influence on factors of relevance for QoL. The mostly used QoL questionnaires do not consider individual preferences, which therefore need to be addressed in the dialogue with the patient. QoL assessment is clearly in need of further methodological improvement before this endpoint can be regarded as fully established with respect to ability to provide unequivocally useful data in clinical trials. The multitude of questionnaires, missing data, lack of pre-study hypotheses of relevant differences between treatments and data multiplicity giving a risk for chance findings are examples of serious methodological problems. Patient response-shifts over time further complicate the interpretation of the data. Thus, QoL data, also from seemingly well-performed clinical trials, have to be interpreted cautiously. The international development during recent years has aimed at creating increased standardization of QoL measures. This has created greater possibilities to compare results from different trials. Hopefully, this also implies that it will be possible to draw firmer conclusions from QoL measurements in recently completed or ongoing trials than has been the case previously. QoL assessments are resource demanding even when short standardized questionnaires are used. Since cancer patients also generally give priority to anticancer effects over toxicity and convenience, QoL assessments in clinical trials are motivated mainly in study settings comparing treatments without expected major differences of outcome in objective endpoints.

Antineoplastic Agents↗

Race and delayed kidney allograft function.

BACKGROUND: Allograft survival among black recipients is poorer than among whites. Delayed allograft function is associated with a significant reduction in renal allograft survival. The relationship between delayed allograft function and black race is incompletely specified and was the focus of this investigation. METHODS: A non-concurrent study of 325 recipients of cadaveric allografts followed for the occurrence of delayed allograft function defined as dialysis during the first week following transplantation for the principal analysis. A secondary definition of delayed allograft function was formulated based on the serum creatinine 2 weeks after transplantation. Unadjusted and adjusted logistic regression analysis were used to examine the unconfounded relationship between race and delayed allograft function. RESULTS: Fifty-seven of 91 (62.6%) black recipients experienced delayed allograft function compared to 113 of 234 (48.3%) whites. The odds ratio for black race as a predictor of delayed allograft function was 1.80, P=0.02, (95% CI, 1.09, 2.95). This finding was stable despite adjustment for other predictors of delayed allograft function in a multivariate model, but the precision of this estimate was less (P=0.10) because of missing data. Additionally, adjusted models with imputed values for missing covariates, models using a secondary definition of delayed allograft function, and models excluding patients whose cyclosporin therapy was delayed, all consistently demonstrated a similar association between black race and delayed allograft function. CONCLUSIONS: This study demonstrated an increased risk of delayed allograft function among black recipients. This relationship may play a role in the poorer allograft outcomes experienced by black recipients. Given the negative effect of delayed allograft function on allograft survival, efforts to identify its modifiable risk factors should be a high priority.

Adult↗

Effects of obesity on breast cancer stage at diagnosis in Korean women.

This study was carried out to test the hypothesis that palpation for lumps may be more difficult in large breasts than in small breasts, resulting in a delay in the detection and diagnosis of breast cancer, and to determine whether this hypothesis is confirmed in Asian women. Of 833 new breast cancer patients registered in the Daegu Cancer Registry in 1997-1999, 579 were used in the final data analysis, after excluding patient records containing many missing data on study variables related with cancer staging. There was no difference in means of body mass index (BMI) according to tumour, either in all cases or in those under 49 years of age. In the 50+ age group, the means+/-standard deviations of BMI of T1, T2 and T3 were 23.7+/-2.8, 24.2+/-3.0, and 26.2+/-4.3, respectively (P=0.01). In univariate logistic regression of tumour characteristics with BMI, no statistically significant odds ratios were found either by continuous or quartiles of BMI. In conclusion, these results suggest that the hypothesis is partially confirmed in Korean breast cancer patients and further studies are needed to clarify the relationship between BMI and tumour stage at diagnosis.

Adolescent↗

Clinical features of suicide attempts after traumatic brain injury.

This study documents demographic, clinical and temporal parameters for suicide attempts after traumatic brain injury (TBI). Clinical interviews and a medical file review were conducted with an outpatient sample (N = 172), identifying 45 clients (26.2%) who had collectively made a lifetime total of 80 suicide attempts. Data were collected on postinjury psychopathology, current hopelessness, and suicide ideation, as well as historical data about the attempts. The sample (N = 43, missing data N = 2) had a lifetime prevalence of 1.86 attempts, with 19 clients (44.2%) making repeat attempts. The majority (70%) of the attempts were made postinjury. Medical attention was provided in 60.7% of attempts. The odds ratio found that respondents with a comorbid postinjury history of psychiatric/emotional disturbance and substance abuse were 21 times more likely to have made an attempt post-TBI compared with respondents with no such history. The findings can inform suicide prevention initiatives among people with TBI.

Adolescent↗

Schatzki ring, statistically reexamined.

In the article by Schatzki published in 1963, data about the lower esophageal ring relate ring diameter to presence of dysphagia. Statistical analysis of these measurements was performed to quantify conclusions of Schatzki and to extract additional information from the data. Ring diameters in 332 patients with and without dysphagia are described in a histogram in the original article of Schatzki. Data were evaluated with analysis of variance, logistic regression, and receiver operating characteristic (ROC) analysis to quantify the relationship between ring diameter and dysphagia. Follow-up information was available in 36 symptomatic and 30 asymptomatic patients of Schatzki. Logistic regression indicated that there was a highly significant difference in ring diameter between the asymptomatic group and patients with recurrent dysphagia (P <.001) but not in patients who had a single episode of dysphagia at presentation (P =.229). Odds ratio of 0.686 indicated that a 1-mm increase in ring diameter decreased the likelihood of dysphagia by 31%; conversely, a 1-mm decrease in ring diameter increased the likelihood of dysphagia by 46%. ROC curve of sensitivity and specificity of ring diameter and symptoms showed that the 20-mm cutoff of Schatzki had a 96% (104 of 108) sensitivity and a 58% (130 of 224) specificity, with area under the ROC curve of 0.888. Retrospective statistical analysis of original data of Schatzki validated his major conclusions about the data. Some important questions remain unanswered because of missing data in the study of Schatzki.

Analysis of Variance↗