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At least 19 recordsLinked to original sources
PubMed2000

The minor oral surgery outcome scale: a multi-attribute patient-derived outcome measure.

PURPOSE: The purpose of this study was to produce a clinically useful, patient-derived, minor oral surgery outcome scale. PATIENTS AND METHODS: Seventy-seven consecutive patients scheduled for minor oral surgery were interviewed using semistructured interview techniques to identify those areas of life (domains) that patients believed will be affected by minor oral surgery. These interviews were analyzed by a multidisciplinary panel and a scale based on 5 domains, each with 4 outcome statements was constructed. The domains and outcome statements were weighted in terms of importance by a further consecutive sample of 100 patients using resource allocation and visual analog tasks. An additive mathematical formula was applied to the mean weights for each domain and outcome states to produce the final weighted scale. RESULTS: Five domains were identified from the interviews and weighted according to their order of importance (0 to 100 scale; 0 = least important). These were general health and well-being (24.6); impact on home/social life (20.8); health and comfort of the mouth, teeth, and gums (20.0); appearance (18.8); and impact on job/studies (15.8). CONCLUSION: A clinically applicable, multi-attribute outcome scale has been produced that takes into account all determinants of health outcome as perceived by the patient in the context of minor oral surgery. It is completed by selecting a weighted statement from each domain, the sum of which constitutes the patient's health state utility score. The scale has potentially extensive application to both clinical care and research.

Adolescent↗
PubMed2003

Comparison of mortality outcomes derived from survival curves calculated by the mean covariates and corrected group prognosis methods.

As creators of mortality abstracts, we assume the mortality and survival curves from source articles have been created by the appropriate methodology. Two methods can be used to generate adjusted curves--the mean of covariates and the group prognosis methods. The use of the former, although simple to implement, may be mathematically problematic. A comparative mortality analysis is created from a study population using curves adjusted by both methods. For this cohort, utilizing data from direct measurement of enlarged survival curves produced no difference in mortality outcomes. Small differences in percent cumulative survival derived from each method do not translate into important differences in mortality ratios and excess deaths.

Cardiac Catheterization↗
PubMed2003

Validation of a Japanese patient-derived outcome scale for assessing total knee arthroplasty: comparison with Western Ontario and McMaster Universities osteoarthritis index (WOMAC).

We have developed a Japanese self-administered questionnaire based on an English version of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) to measure subjective function and pain status of patients who undergo a total knee arthroplasty procedure. Using multiple international cohorts, the performance of the developed Japanese scale was compared to the results of the WOMAC in the United Kingdom, United States, Canada, and Australia. The developed scale showed a comparable level of internal consistency and construct/criterion validity. The responsiveness of the scale was superior to the concurrently measured MOS Short Form 36 Physical Function scale. These results suggest that the developed scale is reliable, valid, and responsive for assessing the effectiveness of total knee arthroplasty in the Japanese context despite the cultural life style differences from Western countries.

Arthroplasty, Replacement, Knee↗
PubMed2006

Psychosocial outcomes derived from an acid burned population in Bangladesh, and comparison with Western norms.

Assault by acid burns typically results in severe disfigurement, yet the psychosocial impact of this injury is so far unreported. This study provides the first empirical data using standardised assessment scales, from 44 acid burns survivors in Bangladesh. Compared with published norms, individuals show high levels of psychological distress including social anxiety and avoidance, anxiety and depression. Consistent with the published literature, there is no relationship between severity of injury and level of psychological distress. One interesting feature of this population is the relative preservation of perceived self-concept, and this is discussed with relation to the supportive and therapeutic environment of the clinic where this group were studied. We also note an interesting sub-group who were attacked by members of their own family and for whom psychological morbidity seems particularly pronounced.

Acids↗
PubMed1997

Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: use of pain intensity and visual analogue scales.

The aim of this study was to examine whether mean data from categorical pain intensity and visual analogue scales for both pain intensity and relief could be used reliably to derive dichotomous outcome measures for meta-analysis. Individual patient data from randomised controlled trials of single-dose analgesics in acute postoperative pain were used. The methods used were as follows: data from 132 treatments with over 4700 patients were used to calculate mean %maxSPID (categorical pain intensity), %maxVAS-SPID (visual analogue pain intensity) and %maxVAS-TOTPAR (visual analogue pain relief); these were used to derive relationships with the number of patients who achieved at least 50% pain relief (%maxTOTPAR). Good agreement was obtained between the actual number of patients with > 50%maxTOTPAR and the number calculated for all three measures. For SPID, verification included independent data sets. For calculations involving each measure, summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of less than 0.25 patients per treatment arm. Reports of randomised trials of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events, such as number of proportion of patients obtaining at least 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining such mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean SPID, VAS-SPID and VAS-TOTPAR as well as TOTPAR data in previously published acute pain studies makes much more information accessible for meta-analysis.

Analgesics↗
PubMed2004

Clinical examination, endosonography, and MR imaging in preoperative assessment of fistula in ano: comparison with outcome-based reference standard.

PURPOSE: To prospectively evaluate the relative accuracy of digital examination, anal endosonography, and magnetic resonance (MR) imaging for preoperative assessment of fistula in ano by comparison to an outcome-derived reference standard. MATERIALS AND METHODS: Ethical committee approval and informed consent were obtained. A total of 104 patients who were suspected of having fistula in ano underwent preoperative digital examination, 10-MHz anal endosonography, and body-coil MR imaging. Fistula classification was determined with each modality, with reviewers blinded to findings of other assessments. For fistula classification, an outcome-derived reference standard was based on a combination of subsequent surgical and MR imaging findings and clinical outcome after surgery. The proportion of patients correctly classified and agreement between the preoperative assessment and reference standard were determined with trend tests and kappa statistics, respectively. RESULTS: There was a significant linear trend (P < .001) in the proportion of fistula tracks (n = 108) correctly classified with each modality, as follows: clinical examination, 66 (61%) patients; endosonography, 87 (81%) patients; MR imaging, 97 (90%) patients. Similar trends were found for the correct anatomic classification of abscesses (P < .001), horseshoe extensions (P = .003), and internal openings (n = 99, P < .001); endosonography was used to correctly identify the internal opening in 90 (91%) patients versus 96 (97%) patients with MR imaging. Agreement between the outcome-derived reference standard and digital examination, endosonography, and MR imaging for classification of the primary track was fair (kappa = 0.38), good (kappa = 0.68), and very good (kappa = 0.84), respectively, and fair (kappa = 0.29), good (kappa = 0.64), and very good (kappa = 0.88), respectively, for classification of abscesses and horseshoe extensions combined. CONCLUSION: Endosonography with a high-frequency transducer is superior to digital examination for the preoperative classification of fistula in ano. While MR imaging remains superior in all respects, endosonography is a viable alternative for identification of the internal opening.

Abscess↗
PubMed2005

Tissue regeneration and in loco administration of platelet derivatives: clinical outcome, heterogeneous products, and heterogeneity of the effector mechanisms.

BACKGROUND: In loco administration of platelet (PLT) derivatives is a relatively new auxiliary treatment for tissue regeneration to be hastened. Enthusiastic reports are faced by more critical ones. The more obvious rationale for the in vivo administration of PLT derivatives resides in their growth factor content. STUDY DESIGN AND METHODS: The relevant literature was systematically reviewed. Close scrutiny of the technical details was carried out to find out the procedural differences accounting for conflicting results. RESULTS: An impressively vast heterogeneity of conduct was found in both in vitro and in vivo studies. Major outcome-affecting variables were recognized such as those associated with PLT preparation; growth factor measurement; proliferation test; dose, timing, and administration of the PLT derivatives; study design; and primary endpoints. CONCLUSIONS: So many variables were found making standardization or confrontation of the in vitro and the in vivo studies barely conceivable or manageable. The mechanisms of action are very complex. The attribution of tissue regeneration capacity of PLT derivatives solely to the PLT-derived growth factors is simplistic. The results obtained through in vitro experiments are indicative for general mechanisms. Their simplistic hold to the complex in vivo environment may be misleading.

Animals↗
PubMed2005

Measuring improvement following total hip and knee arthroplasty using patient-based measures of outcome.

BACKGROUND: Patient-derived outcome scales have become increasingly important to physicians and clinical researchers for measuring improvement in function after surgery. The goal of the present study was to evaluate the ability of health-status instruments to measure early functional recovery after total hip and total knee arthroplasty. METHODS: Four hundred and six patients undergoing total hip arthroplasty and 266 patients undergoing total knee arthroplasty completed health-status questionnaires preoperatively and six months postoperatively to determine the standardized response mean. In the second phase of the study, a group of patients undergoing knee and hip arthroplasty were evaluated with several instruments before and after surgery to test for postoperative ceiling effects. RESULTS: The standardized response mean at six months was 1.7 for the MODEMS Hip Core, 1.2 for the MODEMS Knee Core, and 1.5 and 1.1 for the Physical Component Summary of the SF-36 for patients managed with hip and knee replacement, respectively. A standardized response mean of 1.0 is generally satisfactory for measuring improvement in orthopaedic surgery. In Phase 2 of the study, the vast majority of patients who had a score of 95 to 100 (that is, a maximum or near-maximum score) on the joint-specific scales generally believed that the hip or knee was normal and could not be better. CONCLUSIONS: The MODEMS, Oxford, and WOMAC scales all demonstrated a ceiling effect following total knee and total hip arthroplasty. These scores likely reflected the patients' perception of the status of the knee or hip rather than an inability to measure their improvement beyond the highest possible score. The Physical Component Summary score of the SF-36 had similar standardized response means when compared with hip and knee-specific instruments, and, therefore, consideration should be given to using this scale without a joint-specific scale for the measurement of improvement following total knee and total hip replacement, as a way to decrease responder burden (that is, the time required to complete the questionnaires).

Adult↗
PubMed2025

Causal Inference for Genomic Data with Multiple Heterogeneous Outcomes.

With the evolution of single-cell RNA sequencing techniques into a standard approach in genomics, it has become possible to conduct cohort-level causal inferences based on single-cell-level measurements. However, the individual gene expression levels of interest are not directly observable; instead, only repeated proxy measurements from each individual's cells are available, providing a derived outcome to estimate the underlying outcome for each of many genes. In this paper, we propose a generic semiparametric inference framework for doubly robust estimation with multiple derived outcomes, which also encompasses the usual setting of multiple outcomes when the response of each unit is available. To reliably quantify the causal effects of heterogeneous outcomes, we specialize the analysis to standardized average treatment effects and quantile treatment effects. Through this, we demonstrate the use of the semiparametric inferential results for doubly robust estimators derived from both Von Mises expansions and estimating equations. A multiple testing procedure based on Gaussian multiplier bootstrap is tailored for doubly robust estimators to control the false discovery exceedance rate. Applications in single-cell CRISPR perturbation analysis and individual-level differential expression analysis demonstrate the utility of the proposed methods and offer insights into the usage of different estimands for causal inference in genomics.

Derived outcomes↗
PubMed1997

Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: verification from independent data.

A previously established relationship for deriving dichotomous from continuous information in randomised controlled trials (RCTs) of analgesics has been tested using an independent data set. Individual patient information from 18 RCTs of parallel-group design in acute postoperative pain (after abdominal, gynaecological and oral surgery) was used to calculate the percentage of the maximum possible pain relief score (%maxTOTPAR) and the proportion of patients with > 50%maxTOTPAR for the different treatments. The relationship between the measures was investigated in 85 treatments with over 3400 patients. In 80 of 85 treatments (94%) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 (85%) was within three (average of 40 patients per treatment, range 21-58 patients). Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm. Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events, such as number or proportion of patients with 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic reviews which require data in dichotomous form.

Acute Disease↗
PubMed1988

Relationships among structure, process, and outcome scores derived from evaluations of 300 general dental practices.

Analyses were undertaken to examine relationships among measures of structure, process, and outcome using data obtained during field testing of the Development of Evaluation Methods and Computer Applications in Dentistry (DEMCAD) office assessment instrument in 300 general dental practices. Correlation coefficients between scores for the structure dimension and scores for the process/outcome dimensions were 0.50 and 0.40, respectively, while process and outcome dimension scores were correlated at an even higher level (r = 0.79). Thus the DEMCAD instrument demonstrated a relatively high degree of interrelationship among these three major dimensions compared to other reports in the health care evaluation literature. Additional analyses were conducted to compare relationships between structure and process measures and various components of outcome, and to compare results across different types of practices (urban group, rural and urban nongroup). Correlations between the patient satisfaction component of outcome and scores for the structure/process dimensions were considerably lower than the corresponding correlations involving outcome components other than patient satisfaction. Ordinary least squares regression models demonstrated that structure scores were not significantly related to outcomes when controlling for process and that relationships were quite consistent across practice types.

Consumer Behavior↗
PubMed2004

Number needed to treat estimates incorporating effects over the entire range of clinical outcomes: novel derivation method and application to thrombolytic therapy for acute stroke.

BACKGROUND: Number needed to treat (NNT) is a useful measure of a treatment's clinical benefit or harm. However, NNT estimates for treatments for neurologic conditions have previously been generated only for dichotomized functional outcomes, which may underestimate clinically relevant treatment effects. OBJECTIVES: To develop a method for estimating NNTs for nonbinary outcomes from parallel design clinical trials and to illustrate its application to outcomes of fibrinolytic stroke therapy across the full range of the modified Rankin Scale (mRS) of disability. METHODS: Expert generation of joint distribution outcome tables in a model population affords a novel means to derive NNTs for nonbinary end points. Using mRS distributions from the National Institute of Neurological Disorders and Stroke-Tissue Plasminogen Activator trials, 10 neurologist and emergency physician acute stroke care experts independently specified the joint distribution of outcomes in model samples of 100 patients assigned to placebo and active therapy. RESULTS: The average estimated NNT for 1 additional patient to have a better outcome by 1 or more grades on the mRS as a result of treatment was 3.1 (95% confidence interval, 2.6-3.6). The estimated number needed to harm was 30.1 (95% confidence interval, 25.1-36.0). Expert estimates were robust across alternative stratifications of the mRS, with the NNT for benefit on 6- and 5-rank versions of 3.3 and 3.7 and the number needed to harm of 56.6 and 100.0, respectively. CONCLUSIONS: Expert generation of joint distribution outcome tables enables NNT estimation across a full spectrum of nonbinary outcomes. For every 100 patients with acute stroke treated with tissue plasminogen activator, approximately 32 have a better final outcome and 3 have a worse final outcome as a result of treatment.

Confidence Intervals↗
PubMed1996

Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics.

Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events--such as number or proportion of patients with 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean data, at least in acute pain models, indicates that more meaningful overviews or meta-analysis may be possible. This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data, and then used that relationship to derive dichotomous from continuous information in randomised controlled trials (RCTs) of analgesics. Individual patient information from 13 RCTs of parallel-group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score (%maxTOTPAR) and the proportion of patients with greater than 50% pain relief (> 50%maxTOTPAR) for the different treatments. The relationship between the measures was investigated in 45 actual treatments and 10,000 treatments simulated using the underlying actual distribution; 1283 patients had 45 separate treatments. Mean %maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR (r2 = 0.90). The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50% pain relief in 42 of 45 treatments, and 98.8% of 10,000 simulated treatments. For seven effective treatments, actual numbers-needed-to-treat (NNT) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data.

Analgesics↗
PubMed2002

Plasmapheresis in thrombotic microangiopathy-associated syndromes: review of outcome data derived from clinical trials and open studies.

Current reimbursement policy of health insurance for therapeutic plasmapheresis requires proof of efficacy using the concept of evidence-based medicine. The aim of this paper is to review the outcome of plasmapheresis used to treat thrombotic microangiopathy (TMA)-associated syndromes in the last decade to provide scientific evidence to back up reimbursement applications. The strength of evidence of each reviewed study was assessed using the five levels of evidence criteria as defined by the American Society of Hematology in 1996 for assessment of the treatment of immune thrombocytopenia. The level Experimental indication was added for situations where only case reports or small series supported by pathophysiological reasoning are available. The definitions of evidence used in this paper are as follows: Level I, randomized clinical trial with low rates of error (p < 0.01); Level II, randomized clinical trial with high rates of error (p < 0.05); Level III, nonrandomized studies with concurrent control group; Level IV, nonrandomized studies with historical control group; Level V, case series without a control group or expert opinion; and Experimental, case reports and pathophysiological reasoning. The results of this analysis based on the published data is summarized as follows: The indication of plasmapheresis is assigned to Level IV evidence for thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS); cancer/chemotherapy-associated TTP/HUS is assigned to Level V evidence; and TTP/HUS refractory to standard plasma exchange and post-bone marrow transplantation TTP/HUS are assigned to Experimental indication. For both subsets, protein A immunoadsorption is reportedly successful. The other TMA-associated syndromes, hemolysis elevated liver enzymes low platelets and HUS in early childhood, are no indication of plasmapheresis. Two randomized clinical trials were performed in order to demonstrate the superiority of plasma exchange/fresh frozen plasma (PEX/FFP) over plasma transfusion in the management of TTP/HUS. The results prove the greater clinical success of the latter type of plasma administration. Standard PEX/FFP has reduced the mortality of TTP/HUS from 94.5% to 13%.

Clinical Trials as Topic↗
PubMed2006

Surgical treatment of vulvar vestibulitis syndrome: outcome assessment derived from a postoperative questionnaire.

INTRODUCTION: Vulvar vestibulitis syndrome (VVS) is the most common pathology in women with sexual pain. Surgery for VVS was first described in 1981. Despite apparently high surgical success rates, most review articles suggest that surgery should be used only "as a last resort." Risks of complications such as bleeding, scarring, and recurrence of symptoms are often used to justify these cautionary statements. However, there are little data in the peer-reviewed literature to justify this cautionary statement. AIMS: To determine patient satisfaction with vulvar vestibulectomy for VVS and the rate of complications with this procedure. METHODS: Women who underwent a complete vulvar vestibulectomy with vaginal advancement by one of three different surgeons were contacted via telephone by an independent researcher between 12 and 72 months after surgery. MAIN OUTCOME MEASURES: The primary outcome measurement of surgical success was overall patient satisfaction with surgery. Additional secondary outcome measurements included improvement in dyspareunia, changes in coital frequency, and occurrence of surgical complications. RESULTS: In total, 134 women underwent surgery in a 5-year period. An independent research assistant was able to contact 106 women, and 104 agreed to participate in the study. Mean duration since surgery was 26 months. A total of 97 women (93%) were satisfied, or very satisfied, with the outcome of their surgery. Only three patients (3%) reported persistently worse symptoms after surgery and only seven (7%) reported permanent recurrence of any symptoms after surgery. Prior to surgery, 72% of the women were completely apareunic; however, after surgery, only 11% were unable to have intercourse. DISCUSSION: In this cohort of patients, there was a high degree of satisfaction with surgery for VVS. In addition, the risks of complications with this procedure were low, and most complications were transient and the risk of recurrence after surgery was also found to be low.

Adult↗
PubMedDate not supplied

Comparing professional and patient outcomes for the same episode of care.

Following an acute hospital admission, patients' perceptions of the acceptability of their own outcomes were compared with professionally derived outcomes of care developed for the same patients by nurses. Professional opinion was obtained from the Nursing Practice--Casemix and Outcomes Project undertaken by the Sydney Metropolitan Teaching Hospitals Nursing Consortium, where patient outcomes were classified by nurses into three groups: Outcomes Acceptable; Outcomes Not Acceptable but Justified and Outcomes Not Acceptable and Not Justified. Fifteen male patients in the present study discussed their outcomes following recent orthopaedic surgery at a series of focus groups organised according to the three outcome categories. Findings from the study showed the majority of patients were satisfied with their outcomes. Patient agreement with nurses regarding the acceptability of outcomes was highest for patients from the Outcomes Acceptable group and lowest for those from the Outcomes Not Acceptable and Not Justified group. This work is significant in that it is one of the first nursing studies to compare outcomes developed by practitioners for a particular group of patients with actual outcomes experienced by the same group of patients.

Adult↗
PubMed2005

Combining information from multiple data sources to create multivariable risk models: illustration and preliminary assessment of a new method.

A common practice of metanalysis is combining the results of numerous studies on the effects of a risk factor on a disease outcome. If several of these composite relative risks are estimated from the medical literature for a specific disease, they cannot be combined in a multivariate risk model, as is often done in individual studies, because methods are not available to overcome the issues of risk factor colinearity and heterogeneity of the different cohorts. We propose a solution to these problems for general linear regression of continuous outcomes using a simple example of combining two independent variables from two sources in estimating a joint outcome. We demonstrate that when explicitly modifying the underlying data characteristics (correlation coefficients, standard deviations, and univariate betas) over a wide range, the predicted outcomes remain reasonable estimates of empirically derived outcomes (gold standard). This method shows the most promise in situations where the primary interest is in generating predicted values as when identifying a high-risk group of individuals. The resulting partial regression coefficients are less robust than the predicted values.

Journal Article↗