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Having a dream. A research strategy for DSM-IV.

Psychiatric research has had a major impact on both DSM-III and its revision (DSM-III-R). We propose a strategy to maximize the impact of psychiatric research on DSM-IV. This strategy is an elaboration of a study design that was particularly helpful in developing criteria for several of the problematic diagnostic categories of DSM-II-R. The strategy, called a "multiplex study design," employs (1) multiple collaborating centers, (2) multiple experts in the diagnoses being studied at each site, and (3) multiple diagnostic criteria sets so that alternative definitions of disorders can be compared in terms of (4) multiple external validity criteria, such as familial aggregation, course, and differential response to treatment. This strategy is a particularly efficient method for providing an empiric base for further revisions in our official classification of mental disorders.

Autistic Disorder↗

Nasogastric intubation after abdominal surgery: a meta-analysis of recent literature.

OBJECTIVE: To determine whether refraining from nasogastric intubation (NGI) in patients after abdominal surgery will result in the same therapeutic effectiveness as using NGI. Data Source We identified randomized trials from the Cochrane Central Register of Controlled Trials published between January 1990 and January 2005. STUDY SELECTION: Two of us independently selected trials based on randomization, abdominal surgery in patients, early vs late removal of the NGI, and reporting at least 1 of the following end points: hospital stay, gastrointestinal function, and postoperative complications. DATA EXTRACTION: Two of us independently performed trial quality assessment and data extraction. Trials were judged using a structured list that included factors relating to internal and external validity. Data were entered and analyzed by means of dedicated software from the Cochrane Collaboration. DATA SYNTHESIS: Seventeen randomized trials met the inclusion criteria. Meta-analysis showed that NGI does not offer any clinically relevant benefits for patients after abdominal surgery, such as recovery of gastrointestinal function or reduction of postoperative complications (relative risk, 1.18; 95% confidence interval, 0.98-1.42). Moreover, NGI showed some undesired effects, such as discomfort (in 60% of the NGI patients) and a later return to a liquid diet (weighted mean difference, 0.65 days; 95% confidence interval, 0.38-0.92 days) or a regular diet, whereas hospital stay was not shortened. CONCLUSIONS: Routine NGI seems to serve no beneficial purpose and may even be harmful in patients after modern abdominal surgery; also, it is uncomfortable. Therefore, NGI is recommended only as a therapeutic approach.

Digestive System Surgical Procedures↗

Clinical similarities in siblings with schizophrenia.

Three symptom groups, identified by factor analysis of schizophrenic symptoms, together with other clinical variables, were compared among 80 sibships (169 individuals) containing two or more members affected with schizophrenia. The three factors, which were labelled negative symptom disorganization, and reality distortion, all showed a moderate but significant degree of correlation between siblings. Age at onset was also significantly correlated. Such a familial pattern of clinical heterogeneity suggests underlying common familial aetiologies that influence the clinical form of the disorder. Whether these are genetic or environmental requires further investigation. This finding confers some external validation on the three factor model. It may be feasible to develop familial symptom patterns as the basis for an a priori approach to linkage heterogeneity.

Adult↗

Direct measurement of high-energy phosphate compounds in patients with neuromuscular disease.

Several neuromuscular disorders are associated with reductions in intramuscular adenosine triphosphate (ATP) and/or phosphocreatine (PCr). These alterations have been primarily characterized using (31)P-magnetic resonance spectroscopy ((31)P-MRS). We prospectively measured total creatine, PCr, and ATP in muscle biopsies from 81 patients: normal controls (n = 33), mitochondrial cytopathy (n = 8), neuropathic (n = 3), dystrophy/congenital myopathies (n = 7), inflammatory myopathy (n = 12), and miscellaneous myopathies (n = 18) using direct biochemical analysis. Intramuscular concentrations of PCr and ATP were lower for the dystrophy/congenital myopathy, inflammatory myopathy, and mitochondrial disease patients with ragged red fiber (RRF) as compared with normal controls (P < 0.05). Total creatine was lower for the dystrophy/congenital myopathy group as compared with the normal control group (P < 0.05). These values compare favorably to results from other studies using (31)P-MRS and provide external validation for the values obtained using that method. Given the reductions in high-energy phosphate compounds in these patients, there is the potential for therapeutic intervention with creatine monohydrate supplementation.

Adenosine Triphosphate↗

Nonsampling measurement error in administrative data: implications for economic evaluations.

Administrative databases are increasingly being used to measure resource use in economic evaluations. Traditionally, it is assumed that any measurement error within the resource data source is stochastic and uncorrelated with group assignment. If the error is correlated with characteristics of the service delivery system and/or correlated by group, the estimated differences in consumption between groups may be reflecting errors in measurement rather than treatment effects. This paper is concerned with the effect of nonsampling measurement error on the internal and external validity of cost estimates based on data drawn from administrative record systems. Two service delivery characteristics, ownership form and financial incentives, are likely to influence systemically an agency's data collection effort. Using data from three community mental health centres located in three different states, evidence of systematic differences in data quality was found; private agencies with reimbursement property rights had higher quality data than public agencies without property rights. Simple tests for detecting variation in service use and costs data and cost-effective solutions for managing these problems are proposed.

Bias↗

Prediction of self-disclosure from objective personality assessment techniques.

Prior theory and research have suggested that self-disclosure may have a curvilinear relationship with psychological disturbance. The present study investigated the hypothesis using the CPI, MMPI, and Bipolar Psychological Inventory and employing Ss (N = 28) from a correctional institution. Analyses involved correlational, multiple regression and discriminant analysis techniques. The results offer partial support for the hypothesis and add substantially to the external validity of prior research.

Humans↗

Relationship between contrived in vivo and role-play assertive behavior.

Used a 2 (High or Low Assertive) x 2 (Role-Play or Contrived In Vivo) design to investigate the external validity of role-play (N = 32). The Conflict Resolution Inventory was used as the selection device. Results indicated a positive relationship between self-report scores and role-play behavior. They also indicated that self-report scores were not predictive of behavior in the contrived in vivo condition; moreover, assertion was enhanced in the role-play condition, while the converse occurred in the contrived in vivo condition. The results indicate that generalizations to more naturalistic settings based upon role-play or self-report scores must be made with caution.

Affect↗

Prophylactic anastomotic drainage for colorectal surgery.

BACKGROUND: There is little agreement on prophylactic use of drains in anastomoses in elective colorectal surgery despite many randomized clinical trials. Results of these trials are contradictory, quality and statistical power of these individual studies have been questioned. Once anastomotic leakage has occurred it is generally agreed that drains should be used for therapeutic purposes. However, on prophylactic use no such agreement exists. OBJECTIVES: Comparison of safety and effectiveness of routine drainage and non-drainage regimes after colorectal surgery. The following hypothesis was tested: The use of prophylactic anastomotic drainage after elective colorectal surgery does not prevent development of complications. SEARCH STRATEGY: The studies were identified from CINAHL, EMBASE, LILACS, MEDLINE, Controlled Clinical Trials Database, Trials Register of the Cochrane Colorectal Cancer Group, reference lists. SELECTION CRITERIA: Randomized controlled trials comparing drainage with non-drainage regimes after anastomoses in elective colorectal surgery were reviewed. Outcome measures were: 1. mortality; 2. clinical anastomotic dehiscence; 3. radiological anastomotic dehiscence; 4. wound infection; 5. reoperation; 6. extra-abdominal complications. DATA COLLECTION AND ANALYSIS: Data were independently extracted and cross-checked by the two reviewers. The methodological quality of each trial was assessed. Details of the randomization (generation and concealment), blinding, and the number of patients lost to follow-up were recorded. The RCTs were stratified based on experimental group, according to clinical homogeneity (external validity). MAIN RESULTS: Of the 1140 patients enrolled (6 RCTs), 573 were allocated for drainage and 567 for no drainage. The patients assigned to the drainage group compared with the ones assigned to non-drainage group showed: a) Mortality: 3% (18 of 573 patients) compared with 4% (25 of 567 patients); b) Clinical anastomotic dehiscence: 2% (11 of 522 patients) compared with 1% (7 of 519 patients); c) Radiological anastomotic dehiscence: 3% (16 of 522 patients) compared with 4% (19 of 519 patients); d) Wound infection: 5% (29 of 573 patients) compared with 5% (28 of 567 patients); e) Reintervention: 6% (34 of 542 patients) compared with 5% (28 of 539 patients); f) Extra abdominal complications: 7% (34 of 522 patients) compared with 6% (32 of 519 patients). REVIEWERS' CONCLUSIONS: There is insufficient evidence showing that routine drainage after colorectal anastomoses prevents anastomotic and other complications.

Anastomosis, Surgical↗

Stapled versus handsewn methods for colorectal anastomosis surgery.

BACKGROUND: Randomized controlled trials comparing stapled with handsewn colorectal anastomosis have not shown either technique to be superior, perhaps because individual studies lacked statistical power. A systematic review, with pooled analysis of results, might provide a more definitive answer. OBJECTIVES: To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications. SEARCH STRATEGY: The RCT register of the Cochrane Review Group was searched for any trial or reference to a relevant trial (published, in-press, or in progress). All publications were sought through computerised searches of EMBASE, LILACS, MEDLINE, the Cochrane Controlled Clinical Trials Database, and through letters to industrial companies and authors. There were no limits upon language, date, or other criteria. SELECTION CRITERIA STUDIES: All randomized clinical trials (RCTs) in which stapled and handsewn colorectal anastomosis were compared. PARTICIPANTS: Adult patients submitted electively to colorectal anastomosis. INTERVENTIONS: Endoluminal circular stapler and handsewn colorectal anastomosis. OUTCOMES: a) Mortality b) Overall Anastomotic Dehiscence c) Clinical Anastomotic Dehiscence d) Radiological Anastomotic Dehiscence e) Stricture f) Anastomotic Haemorrhage g) Reoperation h) Wound Infection i) Anastomosis Duration j) Hospital Stay. DATA COLLECTION AND ANALYSIS: Data were independently extracted by the two reviewers (SASL, DM) and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomization (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up were recorded. The results of each RCT were summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by characteristics of the participants, the interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The Risk Difference method (random effects model) and NNT for dichotomous outcomes measures and weighted mean difference for continuous outcomes measures, with the corresponding 95% confidence interval, were presented in this review. Statistical heterogeneity was evaluated by using funnel plot and chi-square testing. MAIN RESULTS: Of the 1233 patients enrolled ( in 9 trials), 622 were treated with stapled, and 611 with manual, suture. The following main results were obtained: a) Mortality: result based on 901 patients; Risk Difference - 0.6% Confidence Interval -2.8% to +1.6%. b) Overall Dehiscence: result based on 1233 patients; Risk Difference 0.2%, 95% Confidence Interval -5.0% to +5.3%. c) Clinical Anastomotic Dehiscence : result based on 1233 patients; Risk Difference -1.4%, 95% Confidence Interval -5.2 to +2.3%. d) Radiological Anastomotic Dehiscence : result based on 825 patients; Risk Difference 1.2%, 95% Confidence Interval -4.8% to +7.3%. e) Stricture: result based on 1042 patients; Risk Difference 4.6%, 95% Confidence Interval 1.2% to 8.1%. Number needed to treat 17, 95% confidence interval 12 to 31. f) Anastomotic Hemorrhage: result based on 662 patients; Risk Difference 2.7%, 95% Confidence Interval - 0.1% to +5.5%. g) Reoperation: result based on 544 patients; Risk Difference 3.9%, 95% Confidence Interval 0.3% to 7.4%. h) Wound Infection: result based on 567 patients; Risk Difference 1.0%, 95% Confidence Interval -2.2% to +4.3%. i) Anastomosis duration: result based on one study (159 patients); Weighted Mean Difference -7.6 minutes, 95% Confidence Interval -12.9 to -2.2 minutes. j) Hospital Stay: result based on one study (159 patients), Weighted Mean Difference 2.0 days, 95% Confidence Interval -3.27 to +7.2 days. REVIEWER'S CONCLUSIONS: The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis, regardless of the level of anastomosis.

Adult↗

Dressings and topical agents for surgical wounds healing by secondary intention.

BACKGROUND: Many different wound dressings and topical applications are used to cover surgical wounds healing by secondary intention. It is not known whether these dressings heal wounds at different rates. OBJECTIVES: To assess the effectiveness of dressings and topical agents on surgical wounds healing by secondary intention SEARCH STRATEGY: We sought relevant trials from the Cochrane Central Register of Controlled Trials, Cochrane Wounds Group Specialised Trials Register, MEDLINE, EMBASE, and CINAHL databases in March 2002. SELECTION CRITERIA: All randomised controlled trials (RCTs) evaluating the effectiveness of dressings and topical agents for surgical wounds healing by secondary intention. DATA COLLECTION AND ANALYSIS: Eligibility for inclusion was confirmed by two reviewers who independently judged the methodological quality of the trials according to the Dutch Cochrane Centre list of factors relating to internal and external validity. Two reviewers summarised data from eligible studies using a data extraction sheet, any disagreements were referred to a third reviewer. MAIN RESULTS: Fourteen reports of 13 RCTs on dressings or topical agents for postoperative wounds healing by secondary intention were identified. WOUND HEALING: Whilst a single small trial of aloe vera supplementation vs gauze suggests delayed healing with aloe vera, the results of this trial are un interpretable since there was a large differential loss to follow up. A plaster cast applied to an amputation stump accelerated wound healing compared with elastic compression, WMD -25.60 days, 95% CI -49.08 to -2.12 days (1 trial). There were no statistically significant differences in healing for other dressing comparisons (e.g. gauze, foam, alginate; 11 trials). PAIN: Gauze was associated with significantly more pain for patients than other dressings (4 trials). PATIENT SATISFACTION: Patients treated with gauze were less satisfied compared with those receiving alternative dressings (3 trials). COSTS: Gauze is inexpensive but its use is associated with the use of significantly more nursing time than foam (2 trials). LENGTH OF HOSPITAL STAY: Four trials showed no difference in length of hospital stay. One trial found shorter hospital stay in people after amputation when plaster casts were applied compared with elastic compression (WMD -30.10 days; 95% CI -49.82 to -10.38). REVIEWERS' CONCLUSIONS: We found only small, poor quality trials; the evidence is therefore insufficient to determine whether the choice of dressing or topical agent affects the healing of surgical wounds healing by secondary intention. Foam is best studied as an alternative for gauze and appears to be preferable as to pain reduction, patient satisfaction and nursing time.

Bandages↗

Antibiotic regimens for secondary peritonitis of gastrointestinal origin in adults.

BACKGROUND: Secondary peritonitis is associated with a high mortality rate and if not treated successfully leads to development of abscesses, severe sepsis and multi-organ failure. Source control and adjunctive antibiotics are the mainstay of treatment. However, no conclusive evidence suggest that one antibiotic regimen is better than any other but at the same time have a lower toxicity. OBJECTIVES: To ascertain the efficacy and adverse effects of different antibiotic regimens in treating intra-abdominal infections in adults. Outcomes were divided into primary (clinical success and effectiveness in reducing mortality) and secondary (microbiological success, preventing wound infection, intra-abdominal abscess, clinical sepsis, remote infection, superinfection, adverse reactions, duration of treatment required, effectiveness in reducing hospitalised stay, and time to defervescence). SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library, Issue 4, 2004), MEDLINE (from 1966 to November 2004), EMBASE (from 1980 to November 2004) and Cochrane Colorectal Cancer Group specialised register SR-COLOCA. Bibliographies of identified studies were screened for further relevant trials. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing different antibiotic regimens in the treatment of secondary peritonitis in adults were selected. Trials reporting gynaecological or traumatic peritonitis were excluded from this review. Ambiguity regarding suitability of trials were discussed among the review team. DATA COLLECTION AND ANALYSIS: Six reviewers independently assessed trial quality and extracted data. Data collection was standardised using data collection form to ensure uniformity among reviewers. Statistical analyses were performed using the random effects model and the results expressed as odds ratio for dichotomous outcomes, or weight mean difference for continuous data with 95% confidence intervals. MAIN RESULTS: Fourty studies with 5094 patients met the inclusion criteria. Sixteen different comparative antibiotic regimens were reported. All antibiotics showed equivocal comparability in terms of clinical success. Mortality did not differ between the regimens. Despite the potential high toxicity profile of regimens using aminoglycosides, this was not demonstrated in this review. The reason for this could be the inherent bias within clinical trials in the form of patient selection and stringency in monitoring drug levels. AUTHORS' CONCLUSIONS: No specific recommendations can be made for the first line treatment of secondary peritonitis in adults with antibiotics, as all regimens showed equivocal efficacy. Other factors such as local guidelines and preferences, ease of administration, costs and availability must therefore be taken into consideration in deciding the antibiotic regimen of choice. Future trials should attempt to stratify patients and perform intention-to-treat analysis to allow better external validity.

Anti-Bacterial Agents↗

Imaging&#x2011;based models for predicting cerebrovascular complications of carotid stenosis.

This is a protocol for a Cochrane review (prognosis). The objectives are as follows: Primary objective To systematically review and critically appraise multivariable prognostic models developed for adults (&#x2265;&#x202f;18&#x202f;years) with carotid stenosis in which imaging biomarkers (e.g. plaque characteristics derived from magnetic resonance imaging (MRI), computed tomography (CT), or ultrasound) constitute the core predictors. The primary focus is to evaluate the predictive performance of these models for cerebrovascular complications - specifically ipsilateral ischaemic stroke and transient ischaemic attack (TIA) - which are the clinical outcomes to be predicted. Where feasible, we will summarise and compare the models' discrimination (C&#x2011;statistic/area under the curve (AUC)) and calibration (calibration&#x2011;in&#x2011;the&#x2011;large, calibration slope, observed&#x2011;to&#x2011;expected ratio) across studies, and assess their potential for clinical application and external validation. For the purpose of defining symptomatic carotid stenosis as an eligibility criterion and subgroup variable, we will include studies that also considered retinal ischaemia (e.g. retinal embolism, amaurosis fugax) as a qualifying event. Secondary objectives To describe the combinations of imaging markers, modelling techniques, sample sizes, and variable&#x2011;selection strategies used in the development of the included models To evaluate the performance of these models for additional secondary clinical outcomes: plaque progression or regression, incident high&#x2011;risk imaging features, and the transition from asymptomatic to symptomatic disease To explore whether predictive performance differs according to imaging modality (MRI versus CT versus contrast&#x2011;enhanced ultrasound (CEUS)) or technical protocol (e.g. 3&#x202f;T versus 1.5&#x202f;T, spectral CT versus conventional CT) For studies that report both cerebrovascular and broader cardiovascular outcomes (major adverse cardiovascular events, myocardial infarction, etc.), we will only extract the performance metrics relating to cerebrovascular events for the primary analysis. Performance metrics for cardiovascular outcomes will be considered exploratory and will not form part of the main synthesis.

Humans↗

Recidivism as a follow-up methodology.

Issues surrounding posttreatment follow-up research are examined in terms of internal and external validity. Because of the problems involved in other types of follow-up research, recidivism is proposed as the most reliable methodology for follow-up research. Problems and solutions in recidivism research, as well as implications for aftercare, are discussed.

Follow-Up Studies↗

Ranking of phenols for abiotic oxidation in aqueous environment: a QSPR approach.

The limited availability and variability of data related to the overall degradation of compounds in the environment is a very relevant issue in studies related to environmental fate and chemical behavior. The studied phenol data set consists of reaction rate constants of different oxidation reactions in surface waters, available either experimentally or, to fill the data gap, from our QSAR models reported herein. A PCA (Principal Component Analysis) model based on these oxidative degradations has been proposed to evaluate the degradability of chemicals. The score of the first Principal Component is modelled by theoretical molecular descriptors to obtain a multiple linear regression (MLR) model with high predictive power, both internally and externally validated. This modeling approach allows a fast and preliminary ranking of phenols according to their tendency to be degraded by oxidants in water, starting only from knowledge of their molecular structure.

Chlorine Compounds↗

Male lifespan and the secondary sex ratio.

Literature speculating on the fetal origins of later life morbidity often invokes the "damaged cohort" theory, i.e., that maternal responses to exogenous shocks induce "stress reactivity" in fetuses and thereby shorten the lifespan of males in utero during stressful times. A rival, or "culled cohort," theory posits that exogenous shocks to gravid females induce spontaneous abortions of frail male fetuses, leaving relatively hardy survivors who enjoy, on average, lifespans longer than males in less stressed birth cohorts. A recent test based on archival data from Sweden supported the culled cohort theory. Several characteristics of the Swedish data, however, raise questions regarding the external validity of the findings. We repeat the test with data from Denmark, Iceland, and England and Wales. We use time-series methods that control for trends, seasonal cycles, and other forms of autocorrelation that could confound the test. None of the results supports the "damaged cohort" theory. Consistent with the Swedish findings and with evolutionary theory, we find support in Iceland and England and Wales for the "culled cohort" theory. We discuss the implications of our findings for basic research as well as for public health.

Abortion, Spontaneous↗

Secondary sex ratio variation during stressful times: the impact of the French revolutionary wars on a German parish (1787-1802).

The observation that declines in the human secondary sex ratio (SSR) may be linked to stressful periconceptional periods has received considerable attention (Catalano [2003] Hum Reprod 18:1972-1975; Catalano et al. [2005] Int J Epidemiol 34:944-948, [2005] Hum Reprod 20:1221-1227, [2005] Paediatr Perinat Epidemiol 19:413-420). For the purpose of testing the external validity of this phenomenon, birth records from four German village genealogies (N = 1,048) were analyzed to study the impact of the French Revolutionary Wars (1787-1802) on the proportion of male births. All births were subdivided into three cohorts (prewar, 1787-1792; war, 1792-1797; and postwar, 1797-1802). Differences in SSR between cohorts achieved statistical significance (chi2= 7.695; df = 2; P = 0.021). In addition, changes in SSR before, during, and after the wars were monitored by risk analysis. Using the SSR of the prewar period as a control, the results of the war cohort failed to achieve statistical significance (regression coefficient, -0.257; ExpB= 0.773; P = 0.118), while the odds reduction of 32.3% in the postwar period proved to be statistically significant (regression coefficient, -0.390; ExpB= 0.677; P = 0.006). It is hypothesized that the experience of postwar economic hardship (attributable to lowered food availability paired with dietary changes) represents the most likely proximate cause. The study also finds evidence of a parental sex ratio manipulation strategy meant to offset the female-biased SSR after the wars. It is argued that from an evolutionary perspective both the decline in SSR in response to stress as well as parental manipulation of the tertiary sex ratio convey reproductive advantages.

Birth Rate↗

Suicidal disorders: a nosological entity per se?

An extensive body of data has repeatedly shown in the past decades that suicidal behaviors are associated with several external validators such as low serotonergic activity in body fluids and in brains of suicide victims, genetic transmission of suicide risk independently of transmission of associated major psychiatric disorders, and more recently association with several serotonin-related genes. Despite these concordant findings, suicidal behaviors are still not considered as a nosological entity per se in standardized classification. The aim of this study is to review the existing literature establishing the validity of this entity through clinical, genetic, biochemical, and therapeutic arguments all leading to the need to recognizing suicidal behavior as an independent and possibly dimensional clinical entity.

Brain↗

Learned helplessness in systemic lupus erythematosus: analysis using the Rheumatology Attitudes Index.

The Rheumatology Attitudes Index (RAI) was administered to 138 patients with systemic lupus erythematosus (SLE) to determine its reliability and to examine the construct of learned helplessness in patients with this disease. The internal consistency of the RAI was indicated by Cronbach's standardized alpha value (alpha = 0.70). Significant correlations were observed between RAI scores and the Modified Health Assessment Questionnaire Activities of Daily Living difficulty (r = 0.34, P less than or equal to 0.001) and dissatisfaction (r = 0.32, P less than or equal to 0.001) scores, the 10-cm visual analog pain scale (r = 0.42, P less than or equal to 0.001), and the Psychosocial Adjustment to Illness Scale raw total (r = 0.63, P less than or equal to 0.01). These findings support the external validity of the RAI in SLE. In addition, these data suggest that the learned helplessness construct might be relevant to the outcomes of morbidity and mortality in patients with SLE.

Activities of Daily Living↗