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PubMed2006

The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France.

INTRODUCTION: Because of design, objectives and number of included subjects, clinical studies are insufficient to assess the safety of new drugs. Sometimes, serious adverse drug reactions (ADRs) led to withdrawal of the drug from the market after their approval. The objective of our study was to determine the scientific evidences leading to drug withdrawal for pharmacovigilance reasons in France. METHODS: Data coming from French Health Products Safety Agency, literature and Toulouse Pharmacovigilance Center allowed to identify all drugs withdrawn from the French market for pharmacovigilance reasons from 1998 to 2004. We classified data according to their study design (Randomized Clinical Trial [RCT], case serie or case report, case-control study, cohort study, observational study, animal study), the organ/system affected and the type of ADR. RESULTS: A total of 21 drugs were withdrawn for safety reasons between 1998 and 2004 in France. The most frequent ADRs were hepatic (n = 7), cardiovascular (n = 4) or neurological (n = 3) ones. Eleven withdrawals were due to type-B ('unexpected') reactions (52%). For 19 out of 21 drugs, scientific evidence leading to drug withdrawal came from spontaneous case reports (or case series). Among these, case reports were the sole evidence in 12 cases. Withdrawals were based on evidence from case reports in combination with case-control or cohort study in four cases, in combination with observational study in two cases or in combination with animal study in two other cases. In only one case, a RCT supported the decision. CONCLUSIONS: This study underlines the importance of spontaneous case reports in detecting signals and supporting withdrawal of drug for pharmacovigilance reasons in France. Health authorities suffer from lack of comparative data resource. In this perspective, a pharmaco-epidemiological population-based database could represent a helpful tool to both generate and test safety hypotheses.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Rethinking research on psychosocial interventions in biopsychosocial oncology: an essay written in honor of the scholarly contributions of Bernard H. Fox.

In his best known contribution to the field of psychooncology, the late Dr Bernard H. Fox applied his breadth of scholarship in biopsychosocial cancer epidemiology to address the question of whether and to what extent stress and other psychosocial factors may contribute to cancer risk. Less well known but equally important to the field is his incisive critique of the 1989 study by Spiegel et al. on survival time of patients with metastatic breast cancer following a psychosocial intervention. This essay represents an attempt to take Fox's line of thought to the next logical level of rethinking research on psychosocial interventions in biopsychosocial oncology. Following an analysis of the inadequacy of randomized clinical trials (RCT) to evaluate the causal effects of psychosocial interventions on cancer outcomes and distinguish these from mere prediction, an integrated RCT design is suggested to take into account the psychogenicity of a given intervention, potential mediating mechanisms, and individual differences that could help illuminate hypothesized causal processes linking an experimental intervention and cancer outcomes.

Biomedical Research↗
PubMed2006

Factors that influence Spanish- and English-speaking participants' decision to enroll in cancer randomized clinical trials.

Cancer randomized clinical trial (RCT) participation is low, particularly among ethnic and racial minorities. Hispanic enrollment is far below their representation in the US population, yet their cancer burden is higher. Little is known from the patient perspective about factors which influence the decision to enroll in RCTs. We asked Spanish- and English-speaking individuals what factors influence decisions about cancer RCT participation. Eight focus groups were conducted with 55 participants (25 Spanish and 30 English-speaking). The groups were taped, transcribed, and analyzed for themes. Six major themes emerged: patient-provider communication, personal relationship with provider, involvement of significant others in decision making, role of faith, need for information, and impact of discrimination on decision making. Both similarities (e.g. need for comprehensive information) and differences (e.g. need for provider acknowledgement of emotional and spiritual concerns) were found between Spanish- and English-speaking participants. Among Spanish-speaking participants, level of education was differentially related to decision-making themes. Implications for providers are discussed.

Adult↗
PubMed2005

Medical management of parapneumonic pleural disease.

Considerable heterogeneity exists in the management of parapneumonic pleural disease. A randomized controlled trial (RCT) demonstrated the effectiveness of small-catheter drainage with fibrinolysis, but surgical devotees suggest this may only be applicable to "early" cases. We examined evidence-based medical management in "all-comers." We performed a retrospective database analysis of the management of all children with complex pleural effusion admitted to the John Radcliffe Hospital over the 7-year period 1996-2003. One hundred and ten children were admitted. Ten were excluded as they were part of a multicenter RCT and had received intrapleural saline instead of urokinase. Of the remaining 100, 51 were female and 49 male. Median age on admission was 5.8 years (range, 0.3-16.5). Symptoms preadmission averaged 11 days, with December the most common month for presentation. Ninety-six underwent chest ultrasound, confirming an effusion in all, described as loculated/septated (68) or echogenic (11). In 17 cases, no specific comment was made regarding the nature of the fluid seen on ultrasound. Ninety-five had subsequent chest tube drainage and then received intrapleural fibrinolysis with urokinase. An etiological organism was identified in 21 cases (21%) (Streptococcus pneumoniae in 10, group A Streptococcus in 5, Staphylococcus aureus in 4, Haemophilus influenzae in 1, and coliform in 1). In a further 9 cases (9%), Gram-positive organisms were seen on pleural fluid microscopy, but did not grow on culture. Two (2%) required surgery due to the persistence of symptoms and an inadequate response to medical management. Median duration of admission was 7 days (range, 2-21 days); median duration of stay from intervention was 5 days (range, 2-19 days). At median follow-up of 8 weeks (range, 3-20 weeks), all children were symptom-free, with minimal pleural thickening on chest X-ray. In conclusion, antibiotic therapy with chest drain insertion and intrapleural urokinase is effective in treating complex parapneumonic effusion and is associated with a good long-term outcome.

Adolescent↗
PubMed2003

Selective exclusion of treatment arms in multi-arm randomized clinical trials.

In this paper we discuss a design for multi-arm randomized clinical trials (RCTs) in which clinicians and their patients can selectively exclude one of the randomized treatment arms. This approach has the advantage that it should expedite protocol development, and allow easier and faster recruitment of patients into the trial. However, to preserve the randomized nature of treatment comparisons, not all recruited patients can be included in all treatment comparisons. This dictates that treatment arms are compared in a pairwise fashion, and that the numbers of patients included in different treatment comparisons may not be equal. The total trial size of a multi-arm RCT that allowed selective exclusion of arms would be greater than the size of an equivalent standard multi-arm RCT. However, the duration of time taken to recruit the study would be reduced. The implications for the design, monitoring and analysis of such RCTs are discussed.

Data Interpretation, Statistical↗
PubMed2001

NMR structure of the hRap1 Myb motif reveals a canonical three-helix bundle lacking the positive surface charge typical of Myb DNA-binding domains.

Mammalian telomeres are composed of long tandem arrays of double-stranded telomeric TTAGGG repeats associated with the telomeric DNA-binding proteins, TRF1 and TRF2. TRF1 and TRF2 contain a similar C-terminal Myb domain that mediates sequence-specific binding to telomeric DNA. In the budding yeast, telomeric DNA is associated with scRap1p, which has a central DNA-binding domain that contains two structurally related Myb domains connected by a long linker, an N-terminal BRCT domain, and a C-terminal RCT domain. Recently, the human ortholog of scRap1p (hRap1) was identified and shown to contain a BRCT domain and an RCT domain similar to scRap1p. However, hRap1 contained only one recognizable Myb motif in the center of the protein. Furthermore, while scRap1p binds telomeric DNA directly, hRap1 has no DNA-binding ability. Instead, hRap1 is tethered to telomeres by TRF2. Here, we have determined the solution structure of the Myb domain of hRap1 by NMR. It contains three helices maintained by a hydrophobic core. The architecture of the hRap1 Myb domain is very close to that of each of the Myb domains from TRF1, scRap1p and c-Myb. However, the electrostatic potential surface of the hRap1 Myb domain is distinguished from that of the other Myb domains. Each of the minimal DNA-binding domains, containing one Myb domain in TRF1 and two Myb domains in scRap1p and c-Myb, exhibits a positively charged broad surface that contacts closely the negatively charged backbone of DNA. By contrast, the hRap1 Myb domain shows no distinct positive surface, explaining its lack of DNA-binding activity. The hRap1 Myb domain may be a member of a second class of Myb motifs that lacks DNA-binding activity but may interact instead with other proteins. Other possible members of this class are the c-Myb R1 Myb domain and the Myb domains of ADA2 and Adf1. Thus, while the folds of all Myb domains resemble each other closely, the function of each Myb domain depends on the amino acid residues that are located on the surface of each protein.

Amino Acid Motifs↗
PubMed1989

Successive histochemical differentiation steps during postnatal development of the collecting duct in rabbit kidney.

Immunohistochemical experiments with monoclonal antibodies (mabs) on the kidney of neonatal rabbits revealed that the primary expression of collecting duct typic structures does not occur in a continuous and parallel, but in a subsequent developmental process. Only mabs RCT-30 A, and CD 4-V revealed immunoreactivity at the ontogenetically oldest parts of the collecting duct, the ampullae, while the other used markers (CD 1-3, CD 5-V, RCT-30 and RMCX) did not. In contrast, all of the tested antibodies showed positive reactions at the medullary and cortical collecting duct of the neonatal kidney as well as of the adult kidney. Additional incubations with wheat-germ agglutinin (WGA) a marker of terminal-differentiated collecting duct cells demonstrated weak-labelled ampulla cells beside intensively labelled ampullary neck and medullary collecting duct cells. With peanut agglutinin (PNA) labelling a 3 step transition could be illuminated: weak-labelled ampulla cells were found beside continuously bright labelled ampullary neck cells and finally a punctuate pattern downwards to the papilla. If the ampullary neck is the zone of proliferation, our findings of WGA- and PNA-co-labelling in this zone indicate, that in early developmental stages characteristic structures of different mature cells, probably principal and intercalated cells, are co-expressed within one single cell type. Thus intercalated cells might derive from principal cells.

Animals↗
PubMed1986

Inhibition of experimental pulmonary metastasis in mice by beta-cyclodextrin-benzaldehyde.

The effect of beta-cyclodextrin-benzaldehyde (CDBA) on experimental pulmonary metastasis in C3H/He mice was examined. In an in vitro assay, the growth of RCT(+) cells was inhibited by 1200 micrograms/ml CDBA using unrenewed media, and by 600 micrograms/ml CDBA in that using daily renewed media. When mice were treated daily with CDBA, 3 weeks later the number of lung nodules developing after i.v. injection of 1 X 10(6) RCT(+) cells was significantly decreased in a dose-dependent manner, i.e., 73.8%, 85.6%, and 95.7% inhibition was observed following 0.5, 5, and 25 mg CDBA/mouse per day p.o. administration, respectively. The same mice showed almost as much natural killer (NK) activity as normal mice. Therefore, experiments were designed to evaluate the effect of CDBA on the NK activity of tumor-free mice whose immunity had been suppressed by 5-fluorouracil (5FU). Injections of 5FU only suppressed this activity to about 50% of normal mice, but the combined treatment with CDBA negated the suppressive effect of 5FU on NK activity. The results suggested that the inhibition of experimental pulmonary metastasis might be induced by the possible combined effects of CDBA; that is, the direct inhibition of tumors and the augmentation of NK cell activity.

Animals↗
PubMed1988

Rotator cuff tear--relationship between clinical and anatomopathological findings.

Rotator cuff tears (RCT) are frequent and increase with age. Why do only a relatively small percentage cause a permanent severe handicap justifying surgery? Is there a relationship between size and site of the tear and the clinical symptoms? How do they influence the postoperative result? These questions were answered in a prospective study of 76 operated patients. We adopted D. Patte's classification of the RCT into four groups according to the site and size of the lesion. Our figures were compared with those obtained by Patte in an analogous study of 256 cases. Of the tears in our series, 56.5% belonged to groups I and II, which means that only the supraspinatous and occasionally also the subscapular muscles were involved. In 100% of the cases in group I we found only pain, whereas a pure symptomatology with pain alone was presented in only 51% of group II, in 48% of group III, and in 0% of group IV. Groups III (35.5%) and IV (8%) represent more extensive tears, involving not only the anterior part of the rotator cuff, e.g., the supraspinatous tendon, but also to a more or less severe extent, the infraspinatous and sometimes even the teres minor. In group IV the extensive tear is combined with osteoarthritic changes. In both groups a mixed symptomatology (pain and pseudoparalysis) is the rule. The result of operative treatment is satisfactory in all groups as far as pain relief is concerned. The improvement of active ROM is not as evident and seems, as expected, to be related to the severity of the lesion.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1997

Neural conduction in the visual pathways in ocular hypertension and glaucoma.

BACKGROUND: The aim of our work was to evaluate neural conduction in visual pathways in subjects with ocular hypertension and glaucoma. METHODS: We assessed simultaneous recordings of pattern electroretinograms (PERG) and visual evoked potentials (VEP) in 16 subjects with ocular hypertension (OHT), in 16 subjects with primary open-angle glaucoma (POAG) and in 15 age-matched controls. The visual stimuli were checkerboard patterns (the check edges subtend 15 min of visual arc; contrast 70%) reversed at the rate of 2 reversals/s. RESULTS: In OHT and POAG patients we found PERG and VEP latencies significantly longer than in controls. The P50-N95 PERG amplitudes were significantly reduced in OHT and POAG eyes. VEP amplitudes were significantly reduced in POAG eyes, while in OHT they were similar to controls. The retinocortical time (RCT; difference between VEP P100 latency and PERG P50 latency) was longer in POAG patients than in controls; no differences between patients with OHT and controls were observed. Moreover, we observed that in POAG the longer RCT was inversely related to the PERG amplitude. CONCLUSION: Our results suggest that involvement of the innermost retinal layers in POAG is accompanied by slowed neural conduction in the visual pathways.

Electroretinography↗
PubMed1980

[The National Research Program 1A: a community-oriented intervention study. Methodological considerations on various types of studies].

Intervention tricals can principally be classified into community or clinically oriented designs. The clinical approach of the randomized controlled trial (RCT) implies the individual randomization of a volunteer population into a study and a control group. In community-oriented trials, however, the study and control group are not composed of individuals, but rather of total population groups (e.g. communities, factories). The paper gives first an overview over the historial development of epidemiological methods as the basis for both study types. Shortcomings and advantages both of RCT's and of community trials are discussed, using the examples of the "diet-heart" hypothesis and of the National Research Program 1A design, respectively. The two study types uses as primary endpoints for the analysis changes in risk factor distribution, morbidity and/or mortality. A recent alternative is presented, too: advances in angiography allow direct measurements of changes in vessels with atherosclerotic disease. The different study types available complement one another in trying to understand the mechanisms involved in disease of multifactorial origin.

Cardiovascular Diseases↗
PubMed1996

Treatment of chronic hepatitis C by interferon for longer duration than six months.

The efficacy of various regimens using interferon-alpha (IFN-alpha) in the treatment of hepatitis C virus (HCV) infection was analyzed in a meta-analysis of 33 randomized clinical trials (RCTs). The results of the meta-analysis showed increased complete and sustained ALT response rates in patients receiving IFN 3 MU three times a week for six months compared with patients receiving placebo or no treatment. The dose effect (6 MU three times a week versus 3 MU three times a week) on complete ALT response rate at the end of treatment was significant, with a mean 10% improvement at both six and 12 months. There also was a significant dose effect on sustained response for 12 months treatment, with a mean 17% improvement. There was a significant treatment duration effect on sustained response rate at 3 MU three times a week and 6 MU three times a week, with a mean improvement of 16% (> or = 12 months vs six months) with 3 MU three times a week. Due to adverse events, we conclude that the best efficacy-risk ratio favors IFN treatment with 3 MU three times a week for at least 12 months. The results of our RCT comparing three IFN regimens showed that patients receiving 3 MU three times a week for up to 18 months exhibited significant improvements in histological activity score, normalization of serum ALT concentrations, and sustained response compared with patients receiving a lower dose or shorter duration of treatment with IFN. Together, these results support the conduct of another RCT to evaluate the hypothesis that long-term, continuous IFN treatment may significantly reduce the incidence of cirrhosis in patients with HCV infection.

Chronic Disease↗
PubMed1999

Concomitant radiochemotherapy with 5-FU and cisplatin for invasive bladder cancer. Acute toxicity and first results.

PURPOSE: To evaluate acute toxicity and efficacy of simultaneous radiochemotherapy for invasive urothelial cancer of the bladder. PATIENTS AND METHODS: From September 1993 to July 1997, 61 patients with invasive bladder cancer were treated with a transurethral resection (TURB) followed by radiochemotherapy (RCT). Twenty-five received a combination of 5-FU and cisplatin. The prescribed doses were 600 mg/m2 5-FU daily as continuous infusion over 5 days each in the 1st and 5th treatment week and 20 mg/m2 cisplatin daily at the same days as a short infusion. The pelvis was irradiated with 54 Gy, the bladder with 59.4 Gy and the paraaortic nodes in 7 cases with 45 Gy, respectively. Six to 8 weeks after RCT a second TURB was performed for reasons of restaging. RESULTS: Twenty out of 25 patients received at least 80% of the prescribed chemotherapy, in 13 cases the full dose could be given. Gastrointestinal toxicity of Grade I and II occurred in 10 cases, 1 patient developed severe diarrhea (Grade VI). After the 1st course of chemotherapy 7 patients had leuko- or thrombopenia of Grade III. One patient had a leucopenia of Grade IV. After the 2nd course 4 patients developed Grade III leuko- and thrombopenia, 1 of Grade IV. Two Grade II anemia were found. All more severe toxicities and necessary dose reductions were related to radiation of the paraaortic nodes. No life threatening infections, bleedings or cardiotoxicity was found. Restaging TURBs resulted in 22 complete remissions, 1 patient had a de-novo-carcinoma (Tis) at this time, 2 were non-responders (8%). After a median follow-up of 38 months 20 patients are alive (80%). CONCLUSIONS: 1. If irradiation of paraaortic nodes is necessary, 5-FU should not be applied, because the gastrointestinal toxicity is too extensive. In all other cases side effects are tolerable and can be managed by supportive care. 2. The first results are promising and should be evaluated in a prospective study.

Adult↗
PubMed1999

[Neoadjuvant radiochemotherapy in soft tissue sarcomas. Optimization of local functional tumor control].

BACKGROUND: Adequate local control rates > 90% and acceptable functional results are the paramount goals in the treatment of soft-tissue sarcoma. Purpose of this paper is to evaluate response, long-term control, functional outcome and toxicity following neoadjuvant radiochemotherapy (RCT) in advanced and recurrent soft tissue sarcoma. PATIENTS AND METHODS: Between 1992 and 1998, a total of 23 patients in whom primary curative limb and function sparing surgery seemed impossible entered the study. Sixteen patients had primary and 7 patients recurrent sarcoma. The stages according to AJCC/UICC 1997 were as follows: rIA (2), rIIA (5) IIA (4), IIB (2), III (7), IV (3). RCT consisted of an accelerated split-course radiation (1.5 to 1.6 Gy twice daily, median total dose 60 Gy, range 60 to 64 Gy, break of 1 week after 30 Gy) with concomitant chemotherapy using adriamycin (50 mg/m2/d on days 2 and 30) and ifosfamide (1.5 g/m2/d on days 1 to 5, 29 to 33). Median follow-up was 26 months (range 2 to 92 months). RESULTS: Twenty-two patients underwent surgery with a curative (R0) resection being achieved in 20/22 (91%) patients and gross residual (R2) tumor or unclear tumor margins (RX) in 1 patient, respectively. Effective tumor-downstaging was documented in 4/22 (18%) patients (ypT0: 3 patients, ypT1: 1 patient). Long-term local tumor control after R0/RX resection remained 100%. Without prognostic impact on tumor response and local control have been the variables primary vs. recurrent tumor, grading, stage and gender. Delayed wound healing was only noted in 1/22 (5%) patients. Four patients developed distant metastases. Overall-, NED- and distant-metastases-free survival rates were 83%, 64% and 68%, respectively, at 3 years. Grade 3/4 neutropenia (WHO) was seen after 21/46 (46%) cycles of chemotherapy with 1 patient dying of septicemia. The functional results were good to excellent in 18/22 (82%) patients. CONCLUSION: Accelerated split-course radiation with 60 to 64 Gy and concurrent chemotherapy using adriamycin/ifosfamide is a safe and effective treatment for soft tissue sarcoma. This regimen may be considered in all cases with recurrent and advanced disease not amenable to primary curative or limb sparing surgery.

Adult↗
PubMed1997

Quality and retrieval of obstetrical anaesthesia randomized controlled trials.

PURPOSE: Randomized controlled trials (RCTs) are suitable for meta-analysis and systematic reviews provided they are of high quality and are easy to retrieve. We determined these attributes of RCTs in obstetrical anaesthesia in a sample of available journals that are indexed in MEDLINE. SOURCE: Randomized controlled trials published between January 1985 and December 1994 in seven anaesthetic and three obstetric journals were identified by a MEDLINE search, and by handsearch of the same journals. Each RCT was assigned a quality score by a blinded rater using a reliable and validated scaled. The quality of each RCT was described and compared over time and by journal. The comparative yield of MEDLINE and hand-search was evaluated. PRINCIPAL FINDINGS: Three hundred and forty RCTs were retrieved by MEDLINE and handsearch. Two hundred and twenty seven (65%) were identified by the MEDLINE search and 333 by the handsearch (98%). The median quality score was 3/5. There was no difference in score over time. Anesthesiology had the highest median score, Anaesthesia had the lowest (P < 0.05). CONCLUSIONS: Care must be taken when reviewing obstetrical anaesthesia research. Strategies in addition to a MEDLINE search must be used to identify RCTs since more than one third were missed using MEDLINE alone. Poor quality RCTs are more likely to be biased in favour of a new treatment. Therefore, to increase the validity of reviews sensitivity analyses based on quality should be done.

Anesthesia, Obstetrical↗
PubMed2004

Cell salvage does not minimize perioperative allogeneic blood transfusion in abdominal vascular surgery: a systematic review.

PURPOSE: To determine whether the use of cell salvage reduces the proportion of patients receiving at least one unit of allogeneic packed red blood cells during the perioperative period of an elective vascular surgery. SOURCE: We identified all relevant articles through the combined use of electronic searches of the MEDLINE and EMBASE databases, the Cochrane library as well as hand searching of all randomized clinical trials and review articles. The electronic search included articles published between 1966 and April 2001. The search included textword searches using "autotransfusion," "cell salvage," "device," or Medical Subject Headings "autologous blood transfusion" or a "randomized controlled trials" filter. PRINCIPAL FINDINGS: Five randomized controlled trials (RCT) were identified involving cell salvage and vascular surgeries. In infra renal abdominal aortic aneurysm surgery the risk ratio (the risk of receiving at least one unit of allogeneic red cells) was 0.37 [95% confidence intervals (CI) of 0.06 to 2.36]. In elective aorto-femoral bypass surgery the risk ratio was 0.97 (95% CI of 0.66 to 1.42). The pooled risk ratio for cell salvage in vascular surgery was 0.67 (95% CI of 0.35 to 1.28). CONCLUSION: Cell salvage, a commonly used technique to recover red cells from the operative field, has been the subject of several studies in vascular surgery. There is insufficient evidence to recommend the routine use of cell salvage in elective abdominal aortic aneurysm and aorto-femoral bypass surgeries. A large RCT would elucidate whether cell salvage is effective as a blood conservation technique.

Abdomen↗
PubMedDate not supplied

The ryanodine contracture test may help diagnose susceptibility to malignant hyperthermia.

PURPOSE: The ryanodine contracture test (RCT) using the plant alkaloid ryanodine as the triggering agent has been proposed to reduce equivocal results of the in vitro caffeine-halothane-contracture test (IVCT), which is the accepted and standardized procedure to diagnose malignant hyperthermia (MH). However, the response of skeletal muscle of non-MH affected patients (controls) to ryanodine has not yet been characterized. METHODS: Skeletal muscle biopsies were studied in 33 controls and in six patients with a history of fulminant MH. Following the IVCT, the RCT was performed in all specimens using ryanodine 1 micro M. Onset time of contracture and time to reach a contracture level of 10 mN above lowest resting tension and above predrug tension were calculated. RESULTS: With the standard IVCT, all controls were labelled MH non-susceptible; all clinically diagnosed MH patients were labelled MH susceptible. With ryanodine, control muscle differed from MH susceptible muscle regarding onset time of contracture (26 vs 3.8 min, P < 0.05) and time to reach a contracture of 10 mN (49 vs 12.5 min, P < 0.05; all median). Tissue viability and patient's age significantly influenced contracture times. CONCLUSIONS: Despite the highly specific binding of ryanodine at the myocytic sarcoplasmic reticulum, the wide range of contracture times of the controls points toward heterogeneity of ryanodine receptors within physiologic limits. This may also be caused in part by tissue viability and the patients' age. The ryanodine contracture test performed in addition to the IVCT may add clarity into diagnosing a patient as MH-susceptible or not.

Adult↗
PubMed2003

[Evaluation of quality of life of patients with oral squamous cell carcinoma. Comparison of two treatment protocols in a prospective study-first results].

BACKGROUND: The treatment of oral cancer has a strong impact on the quality of life. In recent years different therapeutic concepts have been developed, these include preoperative simultaneous "neoadjuvant" radiochemotherapy (RCT) and one-stage surgery with tumor ablation and reconstruction. When considering long-term survival, there is substantial evidence that evidenced modality treatment including neoadjuvant RCT is superior to the primary surgical approach with postoperative radiation. PATIENTS AND METHODS: This longitudinal study prospectively evaluates quality of life in two groups consisting of 53 neoadjuvant and primarily surgically treated patients with oral cancer, using the quality-of-life core questionnaire (QLQ-C30) and the head and neck cancer module (H and N 35) of the European Organization for Research and Treatment of Cancer (EORTC). RESULTS: Postoperatively both groups showed a marked reduction in quality of life. 1 year later quality of life had equalized between the two groups to such an extent that the quality of life scores had almost reached the preoperative level. Both groups showed specific impairments in the symptom scales. In the neoadjuvant therapy group however, global health and the emotional status were reduced to a greater degree than in the other group. CONCLUSION: Temporary limitations in quality of life can be expected after tumor treatment of oral cancer as presented here. Neoadjuvant therapy concept is more aggressive and might result in a longer disease-free survival, but the restriction in quality of life is more severe. Primary goal is the eradication of the tumor. Nevertheless preservation or reconstruction of a maximum of function is essential for a high level of quality of life.

Adult↗