Written patient information materials used in general practices fail to meet acceptable quality standards.

BACKGROUND: Patient information materials and decision aids are essential tools for helping patients make informed decisions and share in decision-making. The aim of this study was to investigate the quality of the written patient information materials available at general practices in Styria, Austria. METHODS: We asked general practitioners to send in all patient information materials available in their practices and to answer a short questionnaire. We evaluated the materials using the Ensuring Quality Information for Patients (EQIP-36) instrument. RESULTS: A total of 387 different patient information materials were available for quality assessment. These materials achieved an average score of 39 out of 100. The score was below 50 for 78% of all materials. There was a significant lack of information on the evidence base of recommendations. Only 9 % of the materials provided full disclosure of their evidence sources. We also found that, despite the poor quality of the materials, 89% of general practitioners regularly make active use of them during consultations with patients. CONCLUSION: Based on international standards, the quality of patient information materials available at general practices in Styria is poor. The vast majority of the materials are not suitable as a basis for informed decisions by patients. However, most Styrian general practitioners use written patient information materials on a regular basis in their daily clinical practice. Thus, these materials not only fail to help raise the health literacy of the general population, but may actually undermine efforts to enable patients to make shared informed decisions. To increase health literacy, it is necessary to make high quality, evidence-based and easy-to-understand information material available to patients and the public. For this, it may be necessary to set up a centralized and independent clearinghouse.

[Quality Indicators of Primary Health Care Facilities in Austria]. / Qualitätsindikatoren für Primary-Health-Care-Einrichtungen in Österreich.

BACKGROUND: The strengthening of primary health care is one major goal of the current national health reform in Austria. In this context, a new interdisciplinary concept was developed in 2014 that defines structures and requirements for future primary health care facilities. OBJECTIVE: The aim of this project was the development of quality indicators for the evaluation of the scheduled primary health care facilities in Austria, which are in accordance with the new Austrian concept. METHODS: We used the RAND/NPCRDC method for the development and selection of the quality indicators. We conducted systematic literature searches for existing measures in international databases for quality indicators as well as in bibliographic databases. All retrieved measures were evaluated and rated by an expert panel in a 2-step process regarding relevance and feasibility. RESULTS: Overall, the literature searches yielded 281 potentially relevant quality indicators, which were summarized to 65 different quality measures for primary health care. Out of these, the panel rated and accepted 30 measures as relevant and feasible for use in Austria. Five of these indicators were structure measures, 14 were process measures and the remaining 11 were outcome measures. Based on the Austrian primary health care concept, the final set of quality indicators was grouped in the 5 following domains: Access to primary health care (5), quality of care (15), continuity of care (5), coordination of care (4), and safety (1). CONCLUSION: This set of quality measures largely covers the four defined functions of primary health care. It enables standardized evaluation of primary health care facilities in Austria regarding the implementation of the Austrian primary health care concept as well as improvement in healthcare of the population.

Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial.

BACKGROUND: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. METHODS: We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. FINDINGS: 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. INTERPRETATION: Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.

Long-term effects of weight-reducing diets in people with hypertension.

BACKGROUND: All major guidelines for antihypertensive therapy recommend weight loss. Thus dietary interventions that aim to reduce body weight might be a useful intervention to reduce blood pressure and adverse cardiovascular events associated with hypertension. OBJECTIVES: Primary objectivesTo assess the long-term effects of weight-reducing diets in people with hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events). Secondary objectivesTo assess the long-term effects of weight-reducing diets in people with hypertension on change from baseline in systolic blood pressure, change from baseline in diastolic blood pressure, and body weight reduction. SEARCH METHODS: We obtained studies from computerised searches of the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Hypertension Specialised Register, Ovid MEDLINE, and Ovid EMBASE, and from searches in reference lists, systematic reviews, and the clinical trials registry ClinicalTrials.gov (status as of 2 February 2015). SELECTION CRITERIA: We included randomised controlled trials (RCTs) of at least 24 weeks' duration that compared weight-reducing dietary interventions to no dietary intervention in adults with primary hypertension. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data. We pooled studies using fixed-effect meta-analysis. In case of moderate or larger heterogeneity as measured by Higgins I(2), we used a random-effects model. MAIN RESULTS: This review update did not reveal any new studies, so the number of included studies remained the same: 8 studies involving a total of 2100 participants with high blood pressure and a mean age of 45 to 66 years. Mean treatment duration was 6 to 36 months. We judged the risk of bias as unclear or high for all but two trials. No study included mortality as a predefined outcome. One RCT evaluated the effects of dietary weight loss on a combined endpoint consisting of the necessity of reinstating antihypertensive therapy and severe cardiovascular complications. In this RCT, weight-reducing diet lowered the endpoint compared to no diet: hazard ratio 0.70 (95% confidence interval (CI), 0.57 to 0.87). None of the studies evaluated adverse events as designated in our protocol. There was low-quality evidence for a blood pressure reduction in participants assigned to weight loss diets as compared to controls: systolic blood pressure: mean difference (MD) -4.5 mm Hg (95% CI -7.2 to -1.8 mm Hg) (3 of 8 studies included in analysis), and diastolic blood pressure: MD -3.2 mm Hg (95% CI -4.8 to -1.5 mm Hg) (3 of  8  studies included in analysis). There was moderate-quality evidence for weight reduction in dietary weight loss groups as compared to controls: MD -4.0 kg (95% CI -4.8 to -3.2) (5 of 8 studies included in analysis). Two studies used withdrawal of antihypertensive medication as their primary outcome. Even though we did not consider this a relevant outcome for our review, the results of these studies strengthen the finding of reduction of blood pressure by dietary weight loss interventions. AUTHORS' CONCLUSIONS: In this update, the conclusions remain the same, as we found no new trials. In people with primary hypertension, weight loss diets reduced body weight and blood pressure, however the magnitude of the effects are uncertain due to the small number of participants and studies included in the analyses. Whether weight loss reduces mortality and morbidity is unknown. No useful information on adverse effects was reported in the relevant trials.

Long-term effects of weight-reducing drugs in people with hypertension.

BACKGROUND: All major guidelines on antihypertensive therapy recommend weight loss; anti-obesity drugs may be able to help in this respect. PRIMARY OBJECTIVES: To assess the long-term effects of pharmacologically induced reduction in body weight in adults with essential hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events). SECONDARY OBJECTIVES: To assess the long-term effects of pharmacologically induced reduction in body weight in adults with essential hypertension on change from baseline in systolic blood pressure, change from baseline in diastolic blood pressure, and body weight reduction. SEARCH METHODS: We obtained studies using computerised searches of the Cochrane Hypertension Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid EMBASE, the clinical trials registry ClinicalTrials.gov, and from handsearches in reference lists and systematic reviews (status as of 13 April 2015). SELECTION CRITERIA: Randomised controlled trials in hypertensive adults of at least 24 weeks' duration that compared long-term pharmacologic interventions for weight loss with placebo.  DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted data. Where appropriate and in the absence of significant heterogeneity between studies (P > 0.1), we pooled studies using fixed-effect meta-analysis. When heterogeneity was present, we used the random-effects method and investigated the cause of heterogeneity. MAIN RESULTS: After updating the literature search, which was extended to include four new weight-reducing drugs, we identified one additional study of phentermine/topiramate, bringing the total number of studies to nine that compare orlistat, sibutramine, or phentermine/topiramate to placebo and thus fulfil our inclusion criteria. We identified no relevant studies investigating rimonabant, liraglutide, lorcaserin, or naltrexone/bupropion. No study included mortality and cardiovascular morbidity as predefined outcomes. Incidence of gastrointestinal side effects was consistently higher in those participants treated with orlistat versus those treated with placebo. The most frequent side effects were dry mouth, constipation, and headache with sibutramine, and dry mouth and paresthaesia with phentermine/topiramate. In participants assigned to orlistat, sibutramine, or phentermine/topiramate body weight was reduced more effectively than in participants in the usual-care/placebo groups. Orlistat reduced systolic blood pressure as compared to placebo by -2.5 mm Hg (mean difference (MD); 95% confidence interval (CI): -4.0 to -0.9 mm Hg) and diastolic blood pressure by -1.9 mm Hg (MD; 95% CI: -3.0 to -0.9 mm Hg). Sibutramine increased diastolic blood pressure compared to placebo by +3.2 mm Hg (MD; 95% CI: +1.4 to +4.9 mm Hg). The one trial that investigated phentermine/topiramate suggested it lowered blood pressure. AUTHORS' CONCLUSIONS: In people with elevated blood pressure, orlistat and sibutramine reduced body weight to a similar degree, while phentermine/topiramate reduced body weight to a greater extent. In the same trials, orlistat and phentermine/topiramate reduced blood pressure, while sibutramine increased it. We could include no trials investigating rimonabant, liraglutide, lorcaserin, or naltrexone/bupropion in people with elevated blood pressure. Long-term trials assessing the effect of orlistat, liraglutide, lorcaserin, phentermine/topiramate, or naltrexone/bupropion on mortality and morbidity are unavailable and needed. Rimonabant and sibutramine have been withdrawn from the market, after long-term trials on mortality and morbidity have confirmed concerns about the potential severe side effects of these two drugs. The European Medicines Agency refused marketing authorisation for phentermine/topiramate due to safety concerns, while the application for European marketing authorisation for lorcaserin was withdrawn by the manufacturer after the Committee for Medicinal Products for Human Use judged the overall benefit/risk balance to be negative.

Effects of task shifting from primary care physicians to nurses: a protocol for an overview of systematic reviews.

INTRODUCTION: Task-shifting from primary care physicians (PCPs) to nurses is one option to better and more efficiently meet the needs of the population in primary care and to overcome PCP shortages. This protocol outlines an overview of systematic reviews to assess the effects of delegation or substitution by nurses of PCPs' activities regarding clinical, patient-relevant, professional and health services-related outcomes. METHODS AND ANALYSIS: We will conduct a systematic literature search for secondary literature in PubMed/MEDLINE, EMBASE, CINAHL and Cochrane databases. Systematic reviews, meta-analyses and Health Technology Assessments in German and English comprising randomised controlled trials and prospective controlled trials will be considered for inclusion. Search terms will include Medical Subject Headings combined with free text words. At least one-third of abstracts and full-text articles are reviewed by two independent reviewers. Methodological quality will be assessed using the Overview Quality Assessment Questionnaire. We will only consider reviews if they include controlled trials, if the profession that substituted or delegated tasks was a nurse, if the profession of the control was a PCP, if the assessed intervention was the same in the intervention and control group and if the Overview Quality Assessment Questionnaire score is ≥5. The corrected covered area will be calculated to describe the degree of overlap of studies in the reviews included in the study. We will report the overview according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. ETHICS AND DISSEMINATION: The overview of secondary literature does not require the approval of an Ethics Committee and will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020183327.

Palliative Care Survey: Awareness, Knowledge and Views of the Styrian Population in Austria.

BACKGROUND: No population-based data on awareness and knowledge of palliative care currently exist in Austria. We therefore conducted a survey to determine the general awareness and knowledge of palliative care in Styria, a federal state in Austria. We also asked participants to imagine what services they would need as a patient or family member, where they themselves would like to receive such services, and what fears they imagined patients with a terminal illness would have. METHODS: A descriptive cross-sectional survey consisting of 18 questions that address several aspects of palliative care was carried out in the adult population of Styria, Austria, from October 2019 to March 2020. RESULTS: A total of 419 questionnaires were analyzed, whereby 70.3% of respondents had at least heard of palliative care. Of these, significantly more were female, had a university degree and were aged 50 to 64. The main goal of palliative care was chosen correctly by 67.1% of participants, with the proportion of correct answers increasing in line with education and reaching 82.0% among university graduates. Overall, 73.2% believed that the greatest need of terminally ill persons was a reduction in physical suffering, whereas the greatest perceived need of relatives was the availability of specialist care around the clock. About one-third believed that the greatest fear of palliative patients was that of death, which was chosen significantly more often by men than women. If terminally ill, some 39% of respondents would wish to be looked after at home by professional carers, and women and people that had completed high school chose this answer significantly more often. The most desired service that should be provided to patients and relatives was home pain management at 69.9%, followed by time off for family caregivers at 58.0%. This item was chosen significantly more often by women. CONCLUSIONS: To facilitate the care of severely ill patients at home, it would make sense to develop targeted information campaigns. These should also attempt to deliver targeted information to less informed groups of people, such as young, poorly educated men, in order to raise their awareness of the difficulties and challenges of providing care to terminally ill patients and thus increase the acceptance of support options.

MAPPinfo - mapping quality of health information: Validation study of an assessment instrument.

BACKGROUND: Health information is a prerequisite for informed choices-decisions, made by individuals about their own health based on knowledge and in congruence with own preferences. Criteria for development, content and design have been defined in a corresponding guideline. However, no instruments exist that provide reasonably operationalised measurement items. Therefore, we drafted the checklist, MAPPinfo, addressing the existing criteria with 19 items. OBJECTIVES: The current study aimed to validate MAPPinfo. METHODS: Five substudies were conducted subsequently at the Martin Luther University Halle-Wittenberg, Germany and the Medical University of Graz, Austria: (1) to determine content validity through expert reviews of the first draft, (2) to determine feasibility using 'think aloud' in piloting with untrained users, (3) to determine inter-rater reliability and criterion validity through a pretest on 50 health information materials, (4) to determine construct validity using 50 developers' self-declarations about development methods as a reference standard, (5) to determine divergent validity in comparison with the Ensuring Quality Information for Patients (EQIP) (expanded) Scale. The analyses used were qualitative methods and correlation-based methods for determining both inter-rater reliability and validity. RESULTS: The instrument was considered by experts to operationalise the existing guidelines convincingly. Health and nursing science students found it easy to understand and use. It also had good interrater reliability (mean of T coefficients = .79) and provided a very good estimate of the reference standard (Spearman's rho = .89), implying sound construct validity. Finally, comparison with the EQIP instrument revealed important and distinct areas of similarities and differences. CONCLUSIONS: The new instrument is ready for use as a screening instrument without the need for training. According to its underpinning concept the instrument exclusively comprises items which are justified by either ethics or research evidence, implying negligence of not yet evidence based, however, potentially important criteria. Further research is needed to complete the body of evidence-based criteria, aiming at an extension of the guideline and MAPPinfo. TRIAL REGISTRATION NUMBER: AsPredicted22546; date of registration: 24 July 2019.

[Factors promoting and hindering the use of an evidence-based clinical pathway for the management of overweight or obese children and adolescents]. / Förderliche und hinderliche Faktoren für den Einsatz eines evidenzbasierten Behandlungspfades zur Versorgung von übergewichtigen oder adipösen Kindern und Jugendlichen.

BACKGROUND/OBJECTIVE: Evidence-based clinical pathways can be a useful tool for guideline implementation. However, there seem to be barriers to the use of clinical pathways. The aim of the present questionnaire survey was to assess the perceived usability of the clinical pathway "Overweight/obesity in children and adolescents at primary care level" and to identify factors promoting and hindering the use of the clinical pathway. METHODS: In January 2020, an online questionnaire survey was sent out to 3,916 general practitioners and 470 pediatricians in Austria. The data collected were analysed descriptively. RESULTS: A total of 148 people took part in the questionnaire survey (response rate 3.7 %). The majority of respondents indicated that they, in general, perceive evidence-based clinical pathways as helpful (90 %) and also make use of them (57 %). Few respondents (9 %) felt well-informed about new clinical pathways developed in Austria. Most of the respondents considered the clinical pathway "Overweight/obesity in children and adolescents at primary care level" as a useful support (60 %), as a reference work (72 %) or as a facilitator for justifying their approach to their patients (68 %). However, a large proportion of the respondents stated that the clinical pathway is not easily applicable in everyday practice. The three most frequently cited barriers to using the clinical pathway were lack of time resources, lack of structures and lack of financial incentives. Other display and access options (e. g., individualisation, integration into practice software) were most frequently cited as factors that might promote the use of the pathway. CONCLUSION: Although the majority of the respondents had positive expectations regarding the use of the clinical pathway "Overweight/obesity in children and adolescents at primary care level", many of them still perceived its usability in everyday clinical practice as difficult. The necessary next steps to improve the use of evidence-based clinical pathways seem to be: an economic and practicable design, easy accessibility of clinical pathways and the creation of framework conditions that facilitate their use in everyday practice.

MAPPinfo, mapping quality of health information: study protocol for a validation study of an assessment instrument.

INTRODUCTION: Health information is a prerequisite of informed decision-making. Criteria for development, content and presentation have recently been published in a corresponding guideline. Within a systematic search, 27 relevant checklists were identified, none of them, however, complying with the guideline or providing reasonably operationalised measurement items. Therefore, a draft of a checklist with 19 criteria was drafted. The current study aims at developing and validating this measure of quality. METHODS AND ANALYSIS: The validation design consists of five single studies to be conducted at the University of Halle-Wittenberg/Germany and Graz/Austria. (1) Achieving content validity through expert reviews of the first draft, (2) achieving feasibility using 'think aloud' in piloting with untrained users, (3) pretesting the instrument applied to health information materials without use of secondary sources: determining inter-rater reliability and criterion validity, (4) determining construct validity using information on proceedings and methods in the development process provided by the developers and (5) determining divergent validity in comparison with the Ensuring Quality Information for Patients (EQUIP) (expanded) Scale. The substudies will use varying samples of experts, students and developers and will apply the instrument to materials of various domains. Sample sizes will be adjusted to the particular research designs and questions. Analyses will employ qualitative methods, such as content analyses and discourse within the expert panel, and correlation-based methods both for determining inter-rater reliability and validity. ETHICS AND DISSEMINATION: The project is approved by the ethics committee of the Martin Luther University Halle-Wittenberg (approval number: 2019 115). Results will be published, and the instrument made accessible on public health platforms. It is meant to become a certification standard. MAPPinfo can be used as a screening instrument without training or secondary sources. Although developed in the German language, the instrument will be applicable also in other languages. TRIAL REGISTRATION NUMBER: AsPredected22546; date of registration: 24 July 2019. PROTOCOL VERSION: July 2020.

Choosing Wisely: assessment of current US top five list recommendations' trustworthiness using a pragmatic approach.

OBJECTIVES: Identification of sufficiently trustworthy top 5 list recommendations from the US Choosing Wisely campaign. SETTING: Not applicable. PARTICIPANTS: All top 5 list recommendations available from the American Board of Internal Medicine Foundation website. MAIN OUTCOME MEASURES/INTERVENTIONS: Compilation of US top 5 lists and search for current German highly trustworthy (S3) guidelines. Extraction of guideline recommendations, including grade of recommendation (GoR), for suggestions comparable to top 5 list recommendations. For recommendations without guideline equivalents, the methodological quality of the top 5 list development process was assessed using criteria similar to that used to judge guidelines, and relevant meta-literature was identified in cited references. Judgement of sufficient trustworthiness of top 5 list recommendations was based either on an 'A' GoR of guideline equivalents or on high methodological quality and citation of relevant meta-literature. RESULTS: 412 top 5 list recommendations were identified. For 75 (18%), equivalents were found in current German S3 guidelines. 44 of these recommendations were associated with an 'A' GoR, or a strong recommendation based on strong evidence, and 26 had a 'B' or a 'C' GoR. No GoR was provided for 5 recommendations. 337 recommendations had no equivalent in the German S3 guidelines. The methodological quality of the development process was high and relevant meta-literature was cited for 87 top 5 list recommendations. For a further 36, either the methodological quality was high without any meta-literature citations or meta-literature citations existed but the methodological quality was lacking. For the remaining 214 recommendations, either the methodological quality was lacking and no literature was cited or the methodological quality was generally unsatisfactory. CONCLUSIONS: 131 of current US top 5 list recommendations were found to be sufficiently trustworthy. For a substantial number of current US top 5 list recommendations, their trustworthiness remains unclear. Methodological requirements for developing top 5 lists are recommended.

[Breast cancer screening in Austria: Key figures, age limits, screening intervals and evidence]. / Brustkrebs-Screening in Österreich: Kennzahlen, Altersgrenzen, Screening-Intervalle und Evidenzbasis.

In January 2014, the first nationwide quality-assured breast cancer screening program addressing women aged ≥ 40 years was introduced in Austria. As part of the process of developing a patient information leaflet, the Evidence Based Medicine (EBM) Review Center of the Medical University of Graz was charged with the task of assessing the potential benefits and harms of breast cancer screening from the available evidence. Based on these results, key figures were derived for mortality, false-positive and false-negative mammography results, and overdiagnosis, considering Austria-specific incidence rates for breast cancer and breast cancer mortality. Furthermore, the current evidence regarding age limits and screening interval, which were the subjects of controversial public discussions, was analyzed. A systematic search for primary and secondary literature was performed and additional evidence was screened, e. g., evaluation reports of European breast cancer screening programs. On the basis of the available evidence and of the Austrian breast cancer mortality and incidence rates, it can be assumed that - depending on the age group - 1 to 4 breast cancer deaths can be avoided per 1,000 women screened in a structured breast cancer screening program, while the overall mortality remains unchanged. On the other hand, 150 to 200 of these 1,000 women will be affected by false-positive results and 1 to 9 women by overdiagnosis due to the structured breast cancer screening. Therefore, the overall benefit-harm balance is uncertain. If women from 40 to 44 or above 70 years of age are considered, who can also participate in the Austrian screening program, even a negative benefit-harm balance seems possible. However, with the implementation of quality standards in breast cancer screening and the dissemination of a patient information leaflet, an improvement in the medical treatment situation, specifically in terms of informed decision-making, can be expected.

Clinical effectiveness of stress-reduction techniques in patients with hypertension: systematic review and meta-analysis.

OBJECTIVE: A systematic review and meta-analysis focusing on patient-relevant outcomes and blood pressure was conducted to assess the clinical effectiveness of stress-reduction techniques in adults with essential hypertension. METHODS: Systematic reviews and randomized controlled trials (RCTs) were identified as part of a systematic search in six electronic databases ending September 2012. RCTs comparing stress-reduction techniques versus no such techniques with a follow-up of at least 24 weeks and published in English or German were included. Outcomes of interest were death, cardiovascular morbidity/mortality, end-stage renal disease, health-related quality of life, adverse events, changes in blood pressure, and changes in antihypertensive medication. When appropriate, meta-analyses were used to combine data. RESULTS: Seventeen RCTs analyzing different stress-reduction techniques such as biofeedback, relaxation or combined interventions were identified. Data were not reported for most of the patient-relevant outcomes, and meta-analyses could only be used to evaluate effects on blood pressure. The data indicated a blood pressure-lowering effect, but the studies had methodological shortcomings and heterogeneity between them was high. Mean group differences for DBP ranged from -10 to 1 mmHg and for SBP from -12 to 10 mmHg. In terms of antihypertensive medication, no favorable effects of stress-reduction techniques could be identified. CONCLUSIONS: The available RCTs on stress-reduction techniques used for at least 24 weeks appeared to indicate a blood pressure-lowering effect in patients with essential hypertension, but this should be interpreted with caution because of major methodological limitations. A benefit of specific stress-reduction techniques in hypertensive patients remains unproven.

[Pyoderma gangrenosum following breast surgery]. / Pyoderma gangrenosum na mammachirurgie.

Pyoderma gangrenosum is a rare, destructive ulcerative condition of the skin. The painful ulcers may occur spontaneously, or result from a minor injury or surgery. The clinical presentation can mimic a necrotizing bacterial infection; however, no micro-organisms can be cultured from the skin lesions and the ulcers fail to respond to antibiotic therapy. Surgical interventions can aggravate the disease process. We describe 2 patients, a 22-year-old woman and a 45-year-old woman, with ulcerative wound abnormalities after breast surgery. After failure of antibiotic therapy and standard wound care, tissue biopsy of the wounds confirmed the clinical diagnosis 'pyoderma gangrenosum'. Wound healing began after systemic steroid treatment. Delays in diagnosis and treatment of pyoderma gangrenosum may result in extensive ulceration and scarring. It is, therefore, important to recognise the characteristic clinical features at an early stage and to start appropriate treatment immediately.

Functional and aesthetic outcome and survival after double free flap reconstruction in advanced head and neck cancer patients.

BACKGROUND: Extensive composite defects in the head and neck area may require the use of double free flap reconstructions. These reconstructions are not only surgically challenging but also challenging to patients. A realistic perspective on general outcome for the patient seems important. METHODS: From January of 2002 to August of 2003, double free flap reconstructions were used in 12 patients with extensive composite head and neck defects following malignant tumor (n = 7) and osteoradionecrosis (n = 5) resection. Six patients had a standardized interview, physical examination, and clinical photographs. RESULTS: All reconstructions were performed using an osteocutaneous fibula flap in combination with an anterolateral thigh flap (n = 8), a radial forearm flap (n = 1), or a lateral thigh flap (n = 1). The total flap survival rate was 96 percent. Mean mandibular bone defects were 10 cm. Mean skin island sizes of osteocutaneous fibula flaps were 67 cm. Mean external skin reconstruction flap sizes were 117 cm. Mean overall survival time was 20 months in patients with malignant tumors. Patients with osteoradionecrosis reconstruction survived free of disease for an average period of 38 months. Three patients (50 percent) were very satisfied, one was neutral, and two were very dissatisfied with their functional and aesthetic results. Objective evaluation of function showed mainly deteriorated speech (83 percent) and oral incontinence (67 percent). Objective evaluation of aesthetics showed mainly color mismatch (67 percent) and flap contracture of external flaps (50 percent). CONCLUSIONS: Reconstruction of these major composite through-and-through defects will often result in a modest functional and aesthetic outcome. Because selected patients require these procedures, the authors give information that matches with realistic expectations.

The facial artery perforator flap for reconstruction of perioral defects.

BACKGROUND: The concept of the facial artery perforator flap was developed to gain more freedom for reconstruction of perioral defects. Single perforators of the facial artery should supply a large area of facial skin for a pedicled perforator flap. METHODS: Five fresh cadavers yielding 10 facial arteries were dissected after Microfil vascular injection to study distribution, number, length, and diameter of facial artery perforators. Five clinical cases with cancer-related perioral defects were reconstructed with facial artery perforator flaps. In two cases, additional regional flaps were used. Surgical technique was governed by the aesthetic unit principle and Doppler identification of the facial artery, which was used as a guideline for identification of suitable facial artery perforators. RESULTS: Cadaver dissection showed a large number of evenly distributed facial artery perforators (average, 5.7; range, three to nine). The average perforator length was 25.2 mm (range, 13 to 51 mm). The average perforator diameter was 1.2 mm (range, 0.6 to 1.8 mm). In all clinical cases, a suitable facial artery perforator was identified to meet reconstructive demands. Flaps were rotated up to 180 degrees. Four flaps survived completely. One flap showed minor distal necrosis. CONCLUSIONS: The facial artery perforator flap offers a versatile tailor-made flap, because of the reliable presence of perforators, with a large arc of rotation and an aesthetically pleasing donor site. The thin pedicle makes it an ideal flap for one-stage reconstruction without secondary revisions.

Anterolateral thigh flap reconstruction of large external facial skin defects: a follow-up study on functional and aesthetic recipient- and donor-site outcome.

BACKGROUND: The purpose of this study was to investigate the subjective and the objective functional and aesthetic follow-up results of the recipient and donor sites after reconstruction of extensive facial defects with the anterolateral thigh flap. METHODS: Between December of 2001 and April of 2003, the anterolateral thigh flap was used to reconstruct large facial skin defects after malignant tumor resection in 23 white patients. All patients had a standardized interview, physical examination, and clinical photographs. RESULTS: The mean flap size was 108 cm2. Fasciocutaneous anterolateral thigh flaps were used in 15 patients and musculocutaneous flaps were used in eight patients with exposed dura, open sinuses, or orbital defects. An extra free osteocutaneous fibula flap was necessary to reconstruct the affected mandible in 10 patients. The donor site was skin grafted in 18 patients. The flap survival rate was 96 percent. At follow-up, color mismatch (71 percent) and flap bulkiness (50 percent) were encountered most often. Four of five patients with speech problems had received an additional free osteocutaneous fibula flap. Three flap contractures were seen in the neck region. A contour defect of the upper leg was encountered in five patients. Sensory disturbances of the upper leg were observed in 12 patients. Cold intolerance occurred three times after skin grafting. No significant impairment was found in range of motion and muscle strength of the donor leg. CONCLUSIONS: Careful patient selection may further improve aesthetic outcome of the anterolateral thigh flap. The versatility in design and composition of the anterolateral thigh flap and the low donor-site morbidity and satisfactory recipient-site outcome make it a valuable option in reconstruction of external skin defects in the head and neck region.