Lack Of Difference In Outcome Research Articles

Postoperative hand therapy in Dupuytren's disease

Background. Postoperative hand therapy in patients after surgery for Dupuytren's contracture is common medical practice to improve outcomes. Until now, patients are referred for postoperative hand rehabilitation on an empirical basis.Purpose. To evaluate whether referral criteria after surgery because of Dupuytren's disease were actually adhered to, and, to analyse differences in outcomes between patients who were referred according to the criteria (correctly referred) and those who were not referred but should have been (incorrectly not referred).Methods. Referral pattern was evaluated prospectively in 46 patients. Total active/passive range of joint motion (TAM/TPM), sensibility, pinch force, Disability Arm Shoulder Hand questionnaire (DASH) and Michigan Hand outcomes Questionnaire (MHQ) were used as outcome measures preoperatively and 10 months postoperatively.Results. In total 21 patients were referred correctly and 17 patients were incorrectly not referred. Significant improvements on TAM/TPM, DASH and MHQ were found at follow-up for the total group. No differences in outcomes were found between patients correctly referred and patients incorrectly not referred for postoperative hand therapy.Conclusion. Referral criteria were not adhered to. Given the lack of differences in outcomes between patients correctly referred and patients incorrectly not referred, postoperative hand therapy in Dupuytren's disease should be reconsidered.

Accelerated versus conventional fractionated postoperative radiotherapy for advanced head and neck cancer: Results of a multicenter Phase III study

To determine whether, in the postoperative setting, accelerated fractionation (AF) radiotherapy (RT) yields a superior locoregional control rate compared with conventional fractionation (CF) RT in locally advanced squamous cell carcinomas of the oral cavity, oropharynx, larynx, or hypopharynx. Patients from four institutions with one or more high-risk features (pT4, positive resection margins, pN >1, perineural/lymphovascular invasion, extracapsular extension, subglottic extension) after surgery were randomly assigned to either RT with one daily session of 2 Gy up to 60 Gy in 6 weeks or AF. Accelerated fractionation consisted of a "biphasic concomitant boost" schedule, with the boost delivered during the first and last weeks of treatment, to deliver 64 Gy in 5 weeks. Informed consent was obtained. The primary endpoint of the study was locoregional control. Analysis was on an intention-to-treat basis. From March 1994 to August 2000, 226 patients were randomized. At a median follow-up of 30.6 months (range, 0-110 months), 2-year locoregional control estimates were 80% +/- 4% for CF and 78% +/- 5% for AF (p = 0.52), and 2-year overall survival estimates were 67% +/- 5% for CF and 64% +/- 5% for AF (p = 0.84). The lack of difference in outcome between the two treatment arms was confirmed by multivariate analysis. However, interaction analysis with median values as cut-offs showed a trend for improved locoregional control for those patients who had a delay in starting RT and who were treated with AF compared with those with a similar delay but who were treated with CF (hazard ratio = 0.5, 95% confidence interval 0.2-1.1). Fifty percent of patients treated with AF developed confluent mucositis, compared with only 27% of those treated with CF (p = 0.006). However, mucositis duration was not different between arms. Although preliminary, actuarial Grade 3+ late toxicity estimates at 2 years were 18% +/- 4% and 27% +/- 6% for CF and AF, respectively (p = 0.10). Accelerated fractionation does not seem to be worthwhile for squamous cell carcinoma of the head and neck after resection; however, AF might be an option for patients who delay starting RT.

The crossover approach to switching antipsychotics: What is the evidence?

Clinicians frequently use a crossover approach in switching antipsychotics, although historically there has been a lack of data addressing the question of switch strategies. To establish if there is now empiric evidence that may guide clinicians in this regard, a MEDLINE search to April 2004 was carried out to identify published, randomized and controlled trials that have addressed this topic. A total of 404 articles were identified in the search, which resulted in the identification of four reports meeting the criteria. The four studies evaluated switching strategies to one of three atypical antipsychotics: aripiprazole, olanzapine (two reports), and ziprasidone. The switching process itself could be subdivided as follows: discontinuation (abrupt vs. gradual); and, replacement (abrupt vs. gradual). Meta-analyses confirmed a lack of difference in outcome, regardless of approach. While a crossover approach does not appear to increase adverse events, the available empiric evidence does not support its clinical superiority on various outcome measures. The existing data therefore argue against the position that a crossover approach in switching antipsychotics represents a ‘safer’ means of preventing clinical deterioration during the switch.

Randomized Phase II Evaluation of 6 g/m2 of Ifosfamide Plus Doxorubicin and Granulocyte Colony-Stimulating Factor (G-CSF) Compared With 12 g/m2 of Ifosfamide Plus Doxorubicin and G-CSF in the Treatment of Poor-Prognosis Soft Tissue Sarcoma

The relative value of increasing ifosfamide dose in combination chemotherapy for patients with soft tissue sarcoma (STS) is unclear. The purpose of this study was to compare the efficacy and toxicity of doxorubicin with high-dose (HD) ifosfamide or standard-dose (SD) ifosfamide in patients with STS. Chemotherapy-naive patients with STS were randomly assigned to receive doxorubicin 60 mg/m(2) and either SD ifosfamide (1.5 g/m(2)/d, days 1 through 4) or HD ifosfamide (3.0 g/m(2), days 1 through 4) every 21 days. Patients were stratified by the presence or absence of metastatic disease. End points were overall survival (OS), 1-year disease-free survival (DFS), and toxicity. The study group consisted of 79 patients (52 patients with localized disease and 27 patients with metastases). Both groups were well-balanced with respect to known prognostic factors. There was no significant difference in 1-year DFS comparing SD ifosfamide with HD ifosfamide (55% v 52%; P = .81). For SD ifosfamide, 2- and 3-year OS were 73% and 52% versus 57% and 49% for HD ifosfamide (P = .34). The incidence of grade 3/4 neutropenia, anemia, and thrombocytopenia were 49%, 23%, and 10%, respectively, on the SD ifosfamide arm, compared with 88%, 58%, and 63%, respectively, on the HD ifosfamide arm. There were five early deaths, all on the HD ifosfamide arm. When combined with doxorubicin, HD ifosfamide did not improve 1-year DFS and OS. Toxicity was clearly greater with the HD ifosfamide arm, and lack of outcome differences might be explained by toxicities with HD ifosfamide. These results suggest that HD ifosfamide combination regimens should not be used as first-line therapy for patients with STS.

The Selection of Hormonal Therapy in Prostate Cancer: Who, When, and for How Long?

Androgen deprivation is the foundation for the systemic therapy of advanced prostate cancer. Multiple trials have tested combined androgen blockade versus androgen deprivation alone in patients with advanced disease. These studies suggest a slight advantage to the combined approaches that contain flutamide and bicalutamide, but the lack of dramatic differences in outcome makes monotherapy reasonable, especially in patients with more indolent disease. Intermittent androgen deprivation is an alternative that may allow patients to reduce the total time on androgen suppression as well as possibly delay the onset of androgen independence. A number of secondary hormonal therapies, including deferred and secondary antiandrogens, ketoconazole, and estrogens have shown modest response proportions. Patients with less advanced disease such as a rising prostate-specific antigen have varied outcomes, and no standard approach exists. In this group, noncastrating forms of hormonal therapy are being evaluated. Patients undergoing definitive local therapy who have high-risk features may benefit from early, as opposed to deferred, androgen deprivation. This review examines the evidence for the current state of the art in hormonal therapy in patients with prostate cancer and focuses, in particular, on treatment composition and timing as well as the rationale for the use of hormonal therapy in early stage disease.

Accelerated versus conventional fractionated postoperative radiotherapy for advanced head and neck cancer: results of a multicenter phase III study

Purpose/Objective: To determine whether, in the postoperative setting, accelerated radiotherapy (AF) yields superior locoregional control rate compared to conventional fractionated (CF) radiotherapy (RT) in locally advanced squamous cell carcinomas of the oral cavity, oropharynx, larynx or hypopharynx.Materials/Methods: Patients from 4 Institutions with one or more high-risk features (pT4, positive resection margins, pN>1, perineural/lymphovascular invasion, extracapsular extension, subglottic extension) after surgery were randomly assigned to either RT with one daily session of 2 Gy up to 60 Gy in 6 weeks or AF. This consisted in a “biphasic concomitant boost” schedule with the boost delivered both during the first and the last week of treatment to deliver 64 Gy in 5 weeks as previously reported (Sanguineti et al. IJROBP 1994). Informed consent was obtained. Primary endpoint of the study was locoregional control (LRC). Analysis is on intention-to-treat basis.Results: From March 1994 until August 2000, 226 patients were randomized. At a median follow-up time of 27 months (range: 0–99 months), 2-yr LRC estimates are 79±4% for CF and 77±5% for AF (p=0.44) and 2-yr overall survival estimates are of 68±5% for CF and of 63±4% for AF, respectively (p=0.68). The lack of difference in outcome between the two treatment arms was confirmed at multivariate analysis. However, subgroup analysis using median values as cut-off did show a trend for improved better LRC control for those patients who had a delay in starting RT and were treated with AF compared to those with a similar delay but who were treated with CF (HR=0.5, 95% CI: 0.2–1.1, p=0.08). Fifty percent of patients treated with AF developed confluent mucositis compared to only 27% of those treated with CF (p=0.006). However, mucositis duration was not different between arms. Although preliminary, actuarial grade 3+ late toxicity estimates at 2 yrs are 18±4% and 27±6% for CF and AF (p=0.10).Conclusions: Accelerated fractionation does not seem to be worthwhile for HN-SCC after resection; however, AF may be an option for patients who delay RT start. Purpose/Objective: To determine whether, in the postoperative setting, accelerated radiotherapy (AF) yields superior locoregional control rate compared to conventional fractionated (CF) radiotherapy (RT) in locally advanced squamous cell carcinomas of the oral cavity, oropharynx, larynx or hypopharynx. Materials/Methods: Patients from 4 Institutions with one or more high-risk features (pT4, positive resection margins, pN>1, perineural/lymphovascular invasion, extracapsular extension, subglottic extension) after surgery were randomly assigned to either RT with one daily session of 2 Gy up to 60 Gy in 6 weeks or AF. This consisted in a “biphasic concomitant boost” schedule with the boost delivered both during the first and the last week of treatment to deliver 64 Gy in 5 weeks as previously reported (Sanguineti et al. IJROBP 1994). Informed consent was obtained. Primary endpoint of the study was locoregional control (LRC). Analysis is on intention-to-treat basis. Results: From March 1994 until August 2000, 226 patients were randomized. At a median follow-up time of 27 months (range: 0–99 months), 2-yr LRC estimates are 79±4% for CF and 77±5% for AF (p=0.44) and 2-yr overall survival estimates are of 68±5% for CF and of 63±4% for AF, respectively (p=0.68). The lack of difference in outcome between the two treatment arms was confirmed at multivariate analysis. However, subgroup analysis using median values as cut-off did show a trend for improved better LRC control for those patients who had a delay in starting RT and were treated with AF compared to those with a similar delay but who were treated with CF (HR=0.5, 95% CI: 0.2–1.1, p=0.08). Fifty percent of patients treated with AF developed confluent mucositis compared to only 27% of those treated with CF (p=0.006). However, mucositis duration was not different between arms. Although preliminary, actuarial grade 3+ late toxicity estimates at 2 yrs are 18±4% and 27±6% for CF and AF (p=0.10). Conclusions: Accelerated fractionation does not seem to be worthwhile for HN-SCC after resection; however, AF may be an option for patients who delay RT start.

Rehabilitation for distal radial fractures in adults.

Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. To examine the evidence for effectiveness of rehabilitation intervention(s) for adults with conservatively or surgically treated distal radial fractures. We searched the Cochrane Musculoskeletal Injuries Group specialised register (January 2002), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), the Cochrane Rehabilitation and Related Therapies Field database, MEDLINE (1966 to January 2002), EMBASE (1988 to 2001 Week 50), CINAHL (1982 to December Week 2 2001), Current Controlled Trials (December 2001), AMED, PEDro, conference proceedings and reference lists of articles. Randomised or quasi-randomised clinical trials evaluating rehabilitation as part of the management of fractures of the distal radius sustained by skeletally mature patients. Rehabilitation interventions such as active and passive mobilisation exercises, and training for activities of daily living, could be used on their own or in combination, and be applied in various ways by various clinicians. All trials meeting the selection criteria were independently assessed by all three reviewers for methodological quality. Data were extracted independently by two reviewers. The trials were grouped into categories relating to the main comparisons, and to when the intervention(s) commenced (for example, during or after plaster cast immobilisation). Quantitative data are presented using relative risks or mean differences together with 95 per cent confidence limits. Twelve trials, involving 601 mainly female and older patients, were included. Initial treatment was conservative, involving plaster cast immobilisation, in all but 20 patients whose fractures were fixed surgically. Though some trials were well conducted, others were methodologically compromised. No trial provided definitive evidence. Only very limited pooling of results from comparable trials was possible. During immobilisation, there was weak evidence of improved hand function in the short term, but not in the longer term, for early occupational therapy (1 trial), and of a lack of differences in outcome between supervised and unsupervised exercises (1 trial). Post-immobilisation, there was weak evidence of a lack of clinically significant differences in outcome in patients receiving formal rehabilitation therapy (3 trials), passive mobilisation (2 trials) or whirlpool immersion (1 trial) compared with no intervention. There was weak evidence of a short-term benefit of continuous passive motion (post external fixation) (1 trial), intermittent pneumatic compression (1 trial) and ultrasound (1 trial). There was weak evidence of better short-term hand function in patients given physiotherapy than in those given instructions for home exercises by a surgeon (1 trial). The available evidence from randomised trials is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius.

Thymidylate synthase expression in stage II and III colon cancer: a retrospective review.

This study is a retrospective analysis of thymidylate synthase (TS) levels in patients with stage II (T3 or T4) and III colon cancer. Two groups of patients were identified: one undergoing surgery alone (98 patients) and the second receiving adjuvant 5-fluorouracil chemotherapy (112 patients). TS analyses were carried out using the 106 monoclonal antibody and a published grading system dividing staining into high and low intensity. The distribution of patients with low versus high TS levels was similar in the two groups. There was no association between TS staining intensity and grade, stage or location of primary. Seventy-nine patients have relapsed: 46 (48%) in the surgery only group, 33 (30%) in the adjuvant therapy group (median follow-up: 51 and 61 months). Similar proportions relapsed when analyzed according to TS: in the surgery only group, 41% of patients with low TS, 48% with high TS; in the adjuvant group, 31% with low TS, 30% with high TS. In the surgery only group, a trend toward improved disease-free survival (DFS) was seen in the low TS group (84 versus 63% at 2 years, p = 0.08). No difference was seen in overall survival. There were no differences in DFS or overall survival in patients receiving adjuvant therapy according to TS intensity. The trend for worse outcome in patients with high TS is consistent with previous reports. The lack of difference in outcome for patients with low and high TS receiving chemotherapy suggests that high TS levels may predict greater benefit from adjuvant treatment.

Myocardial infarction in men and women under 65 years of age: no evidence of gender bias.

We examined short and long term outcomes of MI in a consecutive series of 169 men and 50 women who were followed for an average of 3.5 years. Similar percentages of men and women were admitted to medical intensive care, received in-patient cardiac rehabilitation, quit smoking at one year, were still smoking, were taking a lipid lowering drug or had returned to work at one year, underwent coronary angiography at 3.5 years or had died by 3.5 years. The lack of gender difference in outcome may reflect an absence of gender bias in the management of men and women with MI in southwest Scotland.

From Cognitive Behavior Therapy to Psychotherapy Integration: An Evolving View

Mapping the Journey: Evolution of a Story From Cognitive Behavior Therapy to Psychotherapy Integration: An Evolving View Marvin R. Goldfried. New York: Springer Publishing Company, 1995, 304 pp., $42.95 (hardcover). With the ever increasing proliferation of schools of psychotherapy, the lack of significant differences in outcome among diverse models of therapy, and the increasing need for accountability from a more informed consumer base, the move toward psychotherapy integration has gained momentum in recent years. One of the leaders of this movement has been Marvin Goldfried, a distinguished behavior therapist and long-time proponent of psychotherapy integration. In this volume, using a broad sampling of his previous writings, Goldfried takes us on a fascinating journey, documenting in a vivid way his own sense of theoretical evolution. Following a new introduction, Goldfried begins this book with his first article on behavior therapy and then lays out for the reader the trajectory of his professional development, using articles he generated over the years as the road map by which we may understand his professional journey. Though not strictly chronological, the flow of the book moves from his earlier to later writings. Traditionally, there have been three avenues toward psychotherapy integration: technical eclecticism, theoretical integration, and a common factors approach (Norcross & Newman, 1992). The common factors approach represents the core of Goldfried's efforts toward collaboration and integration: the understanding that there are common principles of change which may be delineated across theoretical orientations. These common therapeutic principles include: (1) an expectation that therapy will be helpful, (2) the availability of an optimal therapeutic relationship, (3) the use of feedback to increase patients' awareness, (4) the facilitation of corrective experiences, and (5) the opportunity to engage in ongoing reality testing. From Cognitive Behavior Therapy to Psychotherapy Integration is divided into five sections: an introduction; sections on cognitive-behavioral assessment, facilitating coping skills, expanding the scope of cognitive-behavior therapy, and a final section detailing the challenges and opportunities of psychotherapy integration. In Part I, Goldfried presents an overview of his thinking as concerns the essentials of psychotherapy, and argues for the study of psychotherapy integration for two primary reasons. First, it is clear that professionals from all orientations are moving toward more eclectic/integrated models of practice. Goldfried cites a number of studies that document this phenomenon, and maintains that as scientist-practitioners, our clinical practice must be supported by empirical research. Second, he rejects the uniformity myth that all models of therapy are basically equivalent, and argues that different models of therapy may have differential effects depending on presenting concern and client characteristics. Although he does not accept the uniformity myth, Goldfried's focus is not on differences among therapies, but on commonalities, or "therapeutic strategies or principles" (p. 8). By doing so, integrationists hope to arrive at clinically robust phenomena which will lead to a better understanding of the change process itself. Part II (Assessment) represents some of Goldfried's earliest work, and the behavioral emphases are most evident in this section. In it, he documents procedures for behavioral assessment, delineates between traditional and behavioral modes of assessment, and discusses the emergence of cognitive variables in cognitive-behavioral models. In Part III Goldfried develops the theme of facilitating client coping skills. In this chapter he uses language that is vaguely constructivist, as he reframes the teaching of coping skills as an active process by which clients are able to gain a new sense of perspective over stressful or problematic life situations. …

Lack of apparent difference in outcome between clinically staged IIIA and IIIB non-small-cell lung cancer treated with radiation therapy.

The current American Joint Committee on Cancer (AJCC) staging system for bronchogenic carcinoma, which divides stage III M0 cases into stages IIIA and IIIB, is based on the observation that selected patients with IIIA disease (T3 or N2) can undergo complete surgical resection, in distinction to IIIB patients (T4 or N3). To understand the value of this system when applied to clinically staged (CS) patients treated with a standard nonoperative approach, the records of patients with squamous cell, large-cell, and adenocarcinoma of the lung treated with radiation therapy (RT) at the Fox Chase Cancer Center from 1978 to 1987 were reviewed. Three hundred sixteen patients were identified as having CS III M0 disease treated with single daily fraction RT without chemotherapy or sensitizers. Of these, the distinction between IIIA (166) and IIIB (140) could be made for 306 patients. The median survival time (MST) for all CS III patients was 9.6 months, and the 2-year survival was 17%. No difference was observed in MST between CS IIIA and IIIB patients (9.4 v 9.8 months, P = .78), in 2-year survival (17% v 18%), or in rate of first failure within the RT field (43% v 44%). MSTs for the 157 CS IIIA and IIIB patients with less than 5% weight loss and Zubrod performance status (PS) 0 to 1 were 13.0 and 15.8 months (P = .29), respectively. This lack of difference in outcome for CS IIIA and IIIB patients receiving RT has important implications in the design and stratification of future nonoperative trials for stage III lung cancer.

Lack of difference in outcome between clinically staged IIIA and IIIB bronchogenic carcinoma treated with radiation therapy

The current AJCC staging system for bronchogenic carcinoma, which divides Stage III M-O cases into Stages IIIA and IIIB, is based on the observation that certain patients with pathologically staged IIIA disease (T-3 or N-2) can undergo complete surgical resection, in distinction to IIIB patients (T-4 or N-3). To understand the value of this system when applied to clinically staged (CS) patients treated with a standard nonoperative approach, the records of patients with squamous cell, large cell, and adenocarcinoma of the lung treated with radiation therapy (RT) at the Fox Chase Cancer Center from 1978-1987 were reviewed. 316 patients were identified as having CS III M-O disease treated with single daily fraction RT without chemotherapy or sensitizers. Of these, the distinction between IIIA (166) and IIIB (140) could be made for 306 patients. The median survival for all Stage III patients was 9.6 months, and the 2-year survival was 17%. No difference was observed in median survival between Stages IIIA and IIIB patients (9.4 vs. 9.8 mo., p=O.78), in 2-year survival (17 vs. 18%), or in percentage of patients with first failure within the RT field (44 vs. 46%). These results do differ from those for CS II (38 pts) treated with RT during the same period, with a median survival of 18.6 mo. and 2-year survival of 38% (p=O.O09). Median survival times for the 181 CS IIIA and IIIB patients with <5% weight loss and ECOG Performance Status (PS) 0 or 1 were 13.0 and 15.8 mo. (p=O.29), respectively. Multivariate regression analysis of the pretreatment patient factors of age, sex, weight loss, PS, cell type, and histologic grade revealed only PS to have a marginal influence on survival among Stage III patients (p=O.O7). This lack of difference in outcome for CS IIIA and IIIB patients receiving RT has significant implications in the design and stratification of future operative and nonoperative trials for Stage III lung cancer. 157

Comparison of critical care provided by family physicians and general internists

Privilege conflicts and credentialing issues involving family physicians' care of hospitalized patients are controversial areas. This study compares the process and outcome of critical care provided by family physicians and general internists. We studied 523 patients admitted by these specialists to the medical intensive and cardiac care units of a large regional hospital over a one-year period. The length of stay and readmission rate in the intensive care unit and hospital, severity of illness, discharge diagnosis, proportion who died, time until death of those who died, consultation rate, and hospital charges did not differ significantly between patients cared for by physicians in the two specialties. Application of Cox's proportional hazard model to the data indicated the risk of death to be significantly related to patient race, age, and severity of illness, but not to physician specialty. Regression analysis of several morbidity variables showed no relationship to physician specialty. Lack of differences in outcome and process in the hospital studied leads us to believe that both family physicians and general internists are entitled to have equal access to the care of patients in critical care units. (<i>JAMA</i>1988;260:354-358)

Comparison of Critical Care Provided by Family Physicians and General Internists

Privilege conflicts and credentialing issues involving family physicians' care of hospitalized patients are controversial areas. This study compares the process and outcome of critical care provided by family physicians and general internists. We studied 523 patients admitted by these specialists to the medical intensive and cardiac care units of a large regional hospital over a one-year period. The length of stay and readmission rate in the intensive care unit and hospital, severity of illness, discharge diagnosis, proportion who died, time until death of those who died, consultation rate, and hospital charges did not differ significantly between patients cared for by physicians in the two specialties. Application of Cox's proportional hazard model to the data indicated the risk of death to be significantly related to patient race, age, and severity of illness, but not to physician specialty. Regression analysis of several morbidity variables showed no relationship to physician specialty. Lack of differences in outcome and process in the hospital studied leads us to believe that both family physicians and general internists are entitled to have equal access to the care of patients in critical care units.