Impact of COVID-19 on mortality in coastal Kenya: a longitudinal open cohort study.

The mortality impact of COVID-19 in Africa remains controversial because most countries lack vital registration. We analysed excess mortality in Kilifi Health and Demographic Surveillance System, Kenya, using 9 years of baseline data. SARS-CoV-2 seroprevalence studies suggest most adults here were infected before May 2022. During 5 waves of COVID-19 (April 2020-May 2022) an overall excess mortality of 4.8% (95% PI 1.2%, 9.4%) concealed a significant excess (11.6%, 95% PI 5.9%, 18.9%) among older adults ( ≥ 65 years) and a deficit among children aged 1-14 years (-7.7%, 95% PI -20.9%, 6.9%). The excess mortality rate for January 2020-December 2021, age-standardised to the Kenyan population, was 27.4/100,000 person-years (95% CI 23.2-31.6). In Coastal Kenya, excess mortality during the pandemic was substantially lower than in most high-income countries but the significant excess mortality in older adults emphasizes the value of achieving high vaccine coverage in this risk group.

A phase II, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of VT-1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail.

BACKGROUND: Onychomycosis is a fungal disease that affects the fingernails and toenails and is predominantly caused by dermatophytes. VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of lanosterol demethylase, and has demonstrated potent activity against Trichophyton rubrum and Trichophyton mentagrophytes. OBJECTIVES: To evaluate the safety and efficacy of four dosing regimens of orally administered VT-1161 compared with placebo in patients with moderate-to-severe distal and lateral subungual onychomycosis of the toenail. METHODS: This was a phase II, randomized, double-blind, placebo-controlled, multicentre study (ClinicalTrials.gov identifier NCT02267356). Patients aged 18-70 years (n = 259) who had 25-75% mycotic involvement were randomized to five treatment groups. They received 300 mg VT-1161 as a 2-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks, or 600 mg VT-1161 as a 2-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks. All treatments were followed by a nontreatment period of 36 weeks. A matching placebo arm was included. RESULTS: In the intent-to-treat population, at week 48 the complete cure rates were 0% in the placebo group and ranged from 32% to 42% in the VT-1161 treatment groups (P < 0·001 vs. placebo). VT-1161 was well tolerated, with no evidence of an adverse effect on liver function or QT intervals. CONCLUSIONS: VT-1161 treatment led to high nail clearance rates and a favourable safety profile. VT-1161 exhibits characteristics that appear promising for the treatment of this chronic and difficult-to-treat condition and warrants further evaluation in larger studies.

Assessing physical activity in people with mental illness: 23-country reliability and validity of the simple physical activity questionnaire (SIMPAQ).

BACKGROUND: Physical inactivity is a key contributor to the global burden of disease and disproportionately impacts the wellbeing of people experiencing mental illness. Increases in physical activity are associated with improvements in symptoms of mental illness and reduction in cardiometabolic risk. Reliable and valid clinical tools that assess physical activity would improve evaluation of intervention studies that aim to increase physical activity and reduce sedentary behaviour in people living with mental illness. METHODS: The five-item Simple Physical Activity Questionnaire (SIMPAQ) was developed by a multidisciplinary, international working group as a clinical tool to assess physical activity and sedentary behaviour in people living with mental illness. Patients with a DSM or ICD mental illness diagnoses were recruited and completed the SIMPAQ on two occasions, one week apart. Participants wore an Actigraph accelerometer and completed brief cognitive and clinical assessments. RESULTS: Evidence of SIMPAQ validity was assessed against accelerometer-derived measures of physical activity. Data were obtained from 1010 participants. The SIMPAQ had good test-retest reliability. Correlations for moderate-vigorous physical activity was comparable to studies conducted in general population samples. Evidence of validity for the sedentary behaviour item was poor. An alternative method to calculate sedentary behaviour had stronger evidence of validity. This alternative method is recommended for use in future studies employing the SIMPAQ. CONCLUSIONS: The SIMPAQ is a brief measure of physical activity and sedentary behaviour that can be reliably and validly administered by health professionals.

Dopaminergic and serotonergic modulation of social reward appraisal in zebrafish (Danio rerio) under circumstances of motivational conflict: Towards a screening test for anti-compulsive drug action.

Cognitive flexibility, shown to be impaired in patients presenting with compulsions, is dependent on balanced dopaminergic and serotonergic interaction. Towards the development of a zebrafish (Danio rerio) screening test for anti-compulsive drug action, we manipulated social reward appraisal under different contexts by means of dopaminergic (apomorphine) and serotonergic (escitalopram) intervention. Seven groups of zebrafish (n = 6 per group) were exposed for 24 days (1 h per day) to either control (normal tank water), apomorphine (50 or 100 µg/L), escitalopram (500 or 1000 µg/L) or a combination (A100/E500 or A100/E1000 µg/L). Contextual reward appraisal was assessed over three phases i.e. Phase 1 (contingency association), Phase 2 (dissociative testing), and Phase 3 (re-associative testing). We demonstrate that 1) sight of social conspecifics is an inadequate motivational reinforcer under circumstances of motivational conflict, 2) dopaminergic and serotonergic intervention lessens the importance of an aversive stimulus, increasing the motivational valence of social reward, 3) while serotoninergic intervention maintains reward directed behavior, high-dose dopaminergic intervention bolsters cue-directed responses and 4) high-dose escitalopram reversed apomorphine-induced behavioral inflexibility. The results reported here are supportive of current dopamine-serotonin opponency theories and confirm the zebrafish as a potentially useful species in which to investigate compulsive-like behaviors.

The Role of Movement Restrictions in Limiting the Economic Impact of Livestock Infections.

Movements are essential for the economic success of the livestock industry. These movements however bring the risk of long-range spread of infection, potentially bringing infection to previously disease-free areas where subsequent localised transmission can be devastating. Mechanistic predictive models usually consider controls that minimize the number of livestock affected without considering other costs of an ongoing epidemic. However, it is more appropriate to consider the economic burden, as movement restrictions have major consequences for the economic revenue of farms. Using mechanistic models of foot-and-mouth disease (FMD), bluetongue virus (BTV) and bovine tuberculosis (bTB) in the UK, we contrast the economically optimal control strategies for these diseases. We show that for FMD, the optimal strategy is to ban movements in a small radius around infected farms; the balance between disease control and maintaining 'business as usual' varies between regions. For BTV and bTB, we find that the cost of any movement ban is more than the epidemiological benefits due to the low within-farm prevalence and slow rate of disease spread. This work suggests that movement controls need to be carefully matched to the epidemiological and economic consequences of the disease, and optimal movement bans are often far shorter than existing policy.

Quantitative Study of the Beliefs and Attitudes Toward Organ Donation and the Opt-Out System Among the Sikh Community in the United Kingdom.

In the United Kingdom, there is a paucity donors from ethnic minorities; however, the number of recipients from ethnic minorities is increasing annually. Following implementation of the opt-out system (OOS) in Wales, a wider debate has started whether the system should be adopted elsewhere in the United Kingdom. We studied Sikh opinion with regard to organ donation and the OOS. METHODS: An anonymous survey was completed by Sikhs in phase 1 paper-based forms and in phase 2 online questionnaires. Data were analyzed using multinomial regression. RESULTS: A total of 268 responses were analyzed; 82.8% said they would donate an organ to anyone; however, 62.1% were not registered organ donors and of those not registered 57.6% did not have sufficient knowledge about the donation process. On multinomial regression, independent variables associated with acceptability of organ donation were awareness of organ shortage, knowing a donor in the immediate family, higher education level, and knowing a successful transplant recipient (all P < .05). Approximately 1 in 2 Sikhs do not understand presumed consent and a majority of 60.1% disagree with the OOS. CONCLUSIONS: Significant barriers exist to donation; there is lack of awareness of the OOS and donation process. Targeted intervention is required to address these barriers.

Strong and frequent T-cell responses to the minor allergen Phl p 12 in Spanish patients IgE-sensitized to Profilins.

BACKGROUND: Profilins are dominant pan-allergens known to cause cross-sensitization, leading to clinical symptoms such as pollen-food syndrome. This study aimed to determine the T-cell response to Phl p 12 in profilin-sensitized patients, by measuring the prevalence, strength and cross-reactivity to clinically relevant profilins. METHODS: The release of Phl p allergens from pollen was determined by mass spectrometry and immunochemistry. T-cell responses, epitope mapping and cross-reactivity to profilins (Phl p 12, Ole e 2, Bet v 2 and Mal d 4) were measured in vitro using PBMCs from 26 Spanish grass-allergic donors IgE-sensitized to profilin. Cross-reactivity was addressed in vivo using 2 different mouse strains (BALB/c and C3H). RESULTS: Phl p 12 and Phl p 1 are released from pollen simultaneously and in similar amounts. Both T-cell response frequency (17/26 donors) and strength were comparable between Phl p 12 and Phl p 1. T-cell cross-reactivity to other profilins correlated with overall sequence homology, and 2 immunodominant epitope regions of Phl p 12 were identified. Data from mice immunized with Phl p 12 showed that cross-reactivity to Bet v 2 was mediated by conserved epitopes and further influenced by additional genetic factors, likely to be MHC II. CONCLUSION: The strength, prevalence and cross-reactivity of T-cell responses towards Phl p 12 are comparable to the major allergen Phl p 1, which supports the hypothesis that T cells to Phl p 12 can play an important role in development of allergic symptoms, such as those associated with pollen-food syndrome.

Impact of immunosuppressive therapy on therapy-neutralizing antibodies in transplanted patients with Fabry disease.

BACKGROUND: Inhibitory antibodies towards enzyme replacement therapy (ERT) are associated with disease progression and poor outcome in affected male patients with lysosomal disorders such as Fabry disease (FD). However, little is known about the impact of immunosuppressive therapy on ERT inhibition in these patients with FD. METHODS: In this retrospective study, we investigated the effect of long-term immunosuppression on ERT inhibition in male patients with FD (n = 26) receiving immunosuppressive therapy due to kidney (n = 24) or heart (n = 2) transplantation. RESULTS: No ERT-naïve transplanted patient (n = 8) developed antibodies within follow-up (80 ±72 months) after ERT initiation. Seven (26.9%) patients were tested ERT inhibition positive prior to transplantation. No de novo ERT inhibition was observed after transplantation (n = 18). In patients treated with high dosages of immunosuppressive medication such as prednisolone, tacrolimus and mycophenolate-mofetil/mycophenolate acid, ERT inhibition decreased after transplantation (n = 12; P = 0.0160). Tapering of immunosuppression (especially prednisolone) seemed to re-increase ERT inhibition (n = 4, median [range]: 16.6 [6.9; 36.9] %; P = 0.0972) over time. One ERT inhibition-positive patient required interventions with steroid therapy and increased doses of tacrolimus, which also lowered ERT inhibition. CONCLUSION: We conclude that the immunosuppressive maintenance therapy after transplantations seems to be sufficient to prevent de novo ERT inhibition in ERT-naïve patients. Intensified high dosages of immunosuppressive drugs are associated with decreased antibody titres and decreased ERT inhibition in affected patients, but did not result in long-term protection. Future studies are needed to establish ERT inhibition-specific immunosuppressive protocols with long-term modulating properties to warrant an improved disease course in ERT inhibition-positive males.

[Comparison of the cost-utility of direct oral anticoagulants for the prevention of stroke in patients with atrial fibrillation in Spain]. / Comparacion del coste-utilidad de los anticoagulantes orales de accion directa en la prevencion de ictus en la fibrilacion auricular no valvular en España.

INTRODUCTION: Apixaban, dabigatran and rivaroxaban are three new direct oral anticoagulants (DOACs) used in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) in Spain. AIM: To assess the relative cost-utility of the three DOACs compared with vitamin K antagonists. PATIENTS AND METHODS: A Markov model with 3-month cycles was used to simulate NVAF patients starting with treatment and followed up for their lifetime from the perspective of the National Health System. The model included 36 health states including treatment combinations, disability and events history and considered a hypothetical cohort of 10,000 NVAF patients. Relative efficacy was calculated from a formal indirect treatment comparison using data from the pivotal trials of each DOAC. RESULTS: Dabigatran was associated with the highest number of quality-adjusted life years (QALY) (8.40 QALY), followed by apixaban (8.33 QALY), rivaroxaban (8.15 QALY) and acenocoumarol (8.03 QALY). Patients taking acenocoumarol had the lowest total costs (€22,230), followed by dabigatran (€24,564), apixaban (€24,655) and rivaroxaban (€25,900). Incremental cost-utility ratios compared to vitamin K antagonists, were €6,397, €8,039 and €29,957/QALY for dabigatran, apixaban and rivaroxaban, respectively. If compared together, dabigatran dominated apixaban and rivaroxaban. Sensitivity analyses confirmed the robustness of the baseline case. CONCLUSIONS: All three direct anticoagulants are cost-effective against acenocoumarol. Dabigatran is economically dominant over rivaroxaban and apixaban in the Spanish setting, as it is more effective and cheaper.

TITLE: Comparacion del coste-utilidad de los anticoagulantes orales de accion directa en la prevencion de ictus en la fibrilacion auricular no valvular en España.Introduccion. El apixaban, el dabigatran y el rivaroxaban son tres anticoagulantes orales de accion directa (ACOD) indicados para la prevencion del ictus y la embolia sistemica en pacientes con fibrilacion auricular no valvular (FANV) en España. Objetivo. Comparar el coste-utilidad de los tres ACOD frente a los antivitamina K. Pacientes y metodos. Se utilizo un modelo Markov con ciclos trimestrales para simular pacientes con FANV desde que inician su tratamiento hasta el resto de su vida desde la perspectiva del Sistema Nacional de Salud. El modelo incorporo 36 estados de salud, incluyendo combinaciones de tratamientos, discapacidad y antecedentes de eventos, y considero una cohorte hipotetica de 10.000 pacientes con FANV. La eficacia relativa se calculo a partir de una comparacion indirecta formal de los tratamientos segun los datos de los ensayos pivotales de cada ACOD. Resultados. El dabigatran se asocio al valor maximo de años de vida ajustados por calidad (AVAC) (8,40 AVAC), seguido del apixaban (8,33 AVAC), el rivaroxaban (8,15 AVAC) y el acenocumarol (8,03 AVAC). Los costes totales fueron menores con el acenocumarol (22.230 €), seguido del dabigatran (24.564 €), el apixaban (24.655 €) y el rivaroxaban (25.900 €). La ratio coste-utilidad incremental frente a los antivitamina K fue de 6.397, 8.039 y 29.957 €/AVAC para el dabigatran, el apixaban y el rivaroxaban, respectivamente. Comparados entre ellos, el dabigatran domino al apixaban y al rivaroxaban. Los analisis de sensibilidad confirmaron la robustez del caso base. Conclusiones. Los tres ACOD son coste-efectivos frente al acenocumarol. El dabigatran es economicamente dominante frente al rivaroxaban y al apixaban en España, al ser mas efectivo y menos costoso.

[Tendinopathies of the hip : Treatment recommendations according to evidence-based medicine]. / Tendinopathien der Hüfte : Behandlungsempfehlungen nach der Evidence-based Medicine.

Tendinopathies of the hip are a differential diagnostic challenge. The spatial proximity of these structures is challenging and many of the structures are located in very deep positions in an individual-specific manner and are covered by other tissues resulting in difficult accessibility for a clinical examination. Furthermore, the definition of the different syndromes is not consistent in the literature, which makes a comparability and assessment difficult. This article demonstrates the most frequent tendinopathies and associated syndromes with their typical clinical presentation, diagnostics and therapy options. Finally, a critical assessment of these aspects is presented based on the current literature.

[Increasing Number of Road Traffic Fatalities in Germany - Turnaround or Snap-Shot]. / Warum wieder mehr Menschen im Straßenverkehr sterben ­ Trendwende oder Ausreißer?

Introduction: For the first time since 20 years, the number of road accident fatalities in 2011 increased on German roads compared to earlier periods. Methods and Results: The presented paper submitted by the expert group for accident prevention investigates and discusses possible reasons for the observed increase in road traffic fatalities. Results: Climate changes as well as changes in economic environment, and technological progress in car and passenger safety are identified as possible reasons for the observed increase. Discussion: Mentioning the "Decade of Action for Road Safety" initiated by the UNO and coordinated by the WHO, the overall goal is a worldwide reduction of accident related road fatalities. But prognostic calculations predict an asymptotic approximation to a limit of road fatalities. To achieve a reduction by half until 2020 intense collaboration and disproportional expenditure are necessary. Conclusion: From the authors' point of view the current increase of traffic fatalities in Germany is rated as a snapshot rather than a turnaround.

Non-Operative Management of Rotator Cuff Tears.

BACKGROUND: The role of nonoperative management for rotator cuff tears remains a matter of debate. Clinical results reported in the literature mainly consist of level IV studies, oftentimes combining a mixed bag of tear sizes and configurations, and are contradictory to some extent. METHODS: A selective literature search was performed and personal surgical experiences are reported. RESULTS: Most studies show an overall success rate of around 75% for nonoperative treatment. However, the majority of studies also present a progression of tear size and fatty muscle infiltration over time, with however debatable clinical relevance for the patient. Suggested factors associated with progression of a rotator cuff tear are an age of 60 years or older, full-thickness tears, and fatty infiltration of the rotator cuff muscles at the time of initial diagnosis. CONCLUSION: Non-operative management is indicated for patients with lower functional demands and moderate symptoms, and/or of course for those refusing to have surgery. Close routinely monitoring regarding development of tear size should be performed, especially in patients that remain symptomatic during nonoperative treatment. To ensure judicious patient counseling, it has to be taken into account that 1) tears that are initially graded as reparable may become irreparable over time, and 2) results after secondary surgical therapy after failed nonoperative treatment are usually reported to be inferior to those who underwent primary tendon repair.

Physical Exercise in Patients with Fabry Disease - a Pilot Study.

The aim of this study was to assess the extent of exercise intolerance in Fabry disease (FD) patients and to report individual effects of physical exercise. Exercise capacity and strength of 14 patients (mean age 46 years, 6 females) were determined using cycle ergometry and isokinetic measurements. Patients performed a strength/circuit exercise training protocol for 12 months. The mean relative maximum performance of the group was low at baseline and increased by 12.1% (baseline: 1.9 [0.9-3.4] W·kg-1vs. re-test: 2.1 [1.1-3.8] W·kg-1; p=0.035) during the study. Patients' mean baseline maximum performance blood lactate of 5.4 [1.3-9.9] mmol·L-1 increased to a mean of 7.2 (2.4-10.2) mmol·L-1 (p=0.038). Mean strength of the lower limbs (left/right extensors and flexors, total work of 5 sets) changed from 2269 (1017-2913) kg·m2·s - 2 to 2325 (1359-3107) kg·m2·s-2 (not significant). Patients reported increased well-being, daily activity and reduced fatigue during the study. Our results indicate that exercise intolerance in FD patients often results from physical inactivity. FD patients may perform exercise training to improve exercise capacity and muscle strength. Future studies will address the clinical benefits of exercise in FD.

[Development and Evaluation of the Work-Related Intervention "Perspective Job" for the Oncological Rehabilitation]. / Entwicklung und Bewertung der beruflich-orientierten Intervention "Perspektive Job" für die onkologische Rehabilitation.

AIMS OF THE STUDY: The knowledge about contents and arrangement of work-related measures in oncological rehabilitation is limited. The aim of the study was to develop a multimodal work-related module called Perspective Job for the oncological rehabilitation as well as to evaluate the process of development and the module itself. METHODS: Perspective Job was developed within a rehabilitation team. For an examination of the process of development and of the module expert interviews with clinic employees and group interviews with patients were conducted. Group interviews were conducted before as well as after the implementation of Perspective Job to demonstrate changes in the rehabilitation from the patients point of view. Participants were oncological patients with substantial work-related problems. RESULTS: The module Perspective Job consists of work-related therapies as well as job trainings. The expert interviews illustrates: The process of development is valued as positive and meaningful by the rehabilitation team. Furthermore synergetic effects were used and the exchange of information and the communication within the team were promoted. The interviews with the patient emphasized that most perspective job therapies were classified as work-related and that an individual occupation-oriented care took place. The promoting exchanges of experience between the participants has been positively evaluated. In addition, they seemed to be well-prepared for the return to work. CONCLUSION: The development of a work-related module in the rehabilitation team is possible. The process was valued by the team members positively and promoted the multiprofessional cooperation. An occupationally oriented arrangement of the rehabilitation was solely perceived by the participants of Perspective Job, which felt better prepared to reintegrate into working life. The results emphasize the importance of teamwork for the development and implementation of work-related therapy modules for the oncological rehabilitation.

Is there a benefit for health care workers in testing HIV, HCV and HBV in routine before elective arthroplasty?

INTRODUCTION: Occupational infection of clinical health care workers with blood-borne viruses (BBVs) like human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) is a current and often emotionally discussed issue. HCV and especially HIV are still stigmatized. The consequence is a broad and maybe irrational fear of professional health care workers being infected occupationally. Therefore, we assessed preoperative screening to: (1) answer whether this can detect not previously diagnosed blood-borne virus infections to a great extent, (2) calculate a cost-benefit ratio to find out, if the screening's potential ability to prevent occupational transmission of BBVs to health care workers faces unjustifiable high costs. HYPOTHESIS: Preoperative routine screening is limited suitable for enhancement of detecting fomites compared to interview the patient. MATERIALS AND METHODS: Retrospective cohort study of preoperative screening for HIV, HBV and HCV (HBsAg, anti-HCV and HIV-Ab/Ag-Combination) for every patient who was admitted to the traumatologic department for elective arthroplasty between 01/01/1997 and 31/12/2008. RESULTS: Among the 1534 patients who underwent elective prosthetic surgery [total hip (879) and knee arthroplasty (508), followed by shoulder, elbow and upper ankle joint], 693 (45.2%) patients were male and 841 (54.8) female. Mean age was 64.2±13.8 years. Screening tests were available for 1373 patients (89.5%). Among all screened patients, we found 21 HCV, 10 HBV and 1 HIV infections. 5 HBV (0.5%) and 7 HCV infections (0.7%) were unknown before. Every newly detected infectious patient occasions screening costs about 7250€. Considering this data, the risk of HCV transmission from an index patient with unknown status of infectiousness to health care worker after percutaneous contact to blood is 0.08 ‰ and of HIV transmission is 0.00054 ‰ in our study population. DISCUSSION: Routine preoperative screening for BBVs of patients undergoing elective arthroplasty, who were asked for HBV, HCV and HIV, should be reconsidered and is, in times of sparse funds, overpriced. LEVEL OF EVIDENCE: IV.

Evaluation of the effect of nurse education on patient-reported foot checks and foot care behaviour of people with diabetes receiving haemodialysis.

AIMS: To assess whether a programme of nurse education increased the frequency with which nurses conducted foot checks on people with diabetes undergoing haemodialysis and to evaluate whether this influenced self-reported foot care behaviour. METHODS: A non-randomized stepped-wedge design was used to evaluate a nurse education programme implemented in four UK National Health Service dialysis units. People with diabetes undergoing haemodialysis were invited to complete a questionnaire on the frequency of foot examination by health professionals, on the presence of foot problems and on their own foot care behaviour, using the Nottingham Assessment of Functional Foot-care (NAFF). An education session for nurses, including procedures for foot examination, was conducted sequentially in each of four haemodialysis units. The questionnaire was repeated at 2-monthly intervals. RESULTS: The education session resulted in a significant increase in the reported number of foot examinations by nurses (P = 0.007). There was also a significant improvement in reported foot care behaviour (P < 0.001), but this occurred between the first and second 2-monthly assessments and was unrelated to the timing of the intervention. CONCLUSIONS: A single education session can improve the routine checking of the feet of people with diabetes undergoing haemodialysis. The administration of the Nottingham Assessment of Functional Foot-care questionnaire was associated with improved self-reported foot care behaviour, reflecting greater awareness of risk in this population.

Hydrothermally modified slow release corn starch: a potential new therapeutic option for treating hypoglycemia in autoimmune hypoglycemia (Hirata's disease).

We report the successful treatment of autoimmune hypoglycemia in an 82-year-old non-diabetic Caucasian male with hydrothermally modified slow release corn starch, a product which is used in other conditions associated with hypoglycemia, most typically glycogen storage disease type I. An 82-year-old-Caucasian male presented with recurrent spontaneous hypoglycemia as low as 30 mg/dl following in-patient treatment for community acquired pneumonia. During a fasting-test, symptomatic hypoglycemia occurred. Plasma concentrations of c-peptide and insulin were considerably elevated. Autoimmune hypoglycemia was confirmed by the presence of insulin autoantibodies. While dietary restriction alone did not result in sufficient glucose control in this patient with autoimmune hypoglycemia, treatment with hydrothermally modified slow release corn starch led to stable euglycemia. This easy, well tolerated and non-invasive treatment may constitute a new therapeutic option for hypoglycemia in patients with autoimmune hypoglycemia who do not achieve sufficient control of hypoglycemia by dietary restriction alone.

Using realist review to inform intervention development: methodological illustration and conceptual platform for collaborative care in offender mental health.

BACKGROUND: This paper reports how we used a realist review, as part of a wider project to improve collaborative mental health care for prisoners with common mental health problems, to develop a conceptual platform. The importance of offenders gaining support for their mental health, and the need for practitioners across the health service, the criminal justice system, and the third sector to work together to achieve this is recognised internationally. However, the literature does not provide coherent analyses of how these ambitions can be achieved. This paper demonstrates how a realist review can be applied to inform complex intervention development that spans different locations, organisations, professions, and care sectors. METHODS: We applied and developed a realist review for the purposes of intervention development, using a three-stage process. (1) An iterative database search strategy (extending beyond criminal justice and offender health) and groups of academics, practitioners, and people with lived experience were used to identify explanatory accounts (n = 347). (2) From these accounts, we developed consolidated explanatory accounts (n = 75). (3) The identified interactions between practitioners and offenders (within their organisational, social, and cultural contexts) were specified in a conceptual platform. We also specify, step by step, how these explanatory accounts were documented, consolidated, and built into a conceptual platform. This addresses an important methodological gap for social scientists and intervention developers about how to develop and articulate programme and implementation theory underpinning complex interventions. RESULTS: An integrated person-centred system is proposed to improve collaborative mental health care for offenders with common mental health problems (near to and after release) by achieving consistency between the goals of different sectors and practitioners, enabling practitioners to apply scientific and experiential knowledge in working judiciously and reflectively, and building systems and aligning resources that are centred on offenders' health and social care needs. CONCLUSIONS: As part of a broader programme of work, a realist review can make an important contribution to the specification of theoretically informed interventions that have the potential to improve health outcomes. Our conceptual platform has potential application in related systems of health and social care where integrated, and person-centred care is a goal.

Adjuvant Rosa Damascena has a Small Effect on SSRI-induced Sexual Dysfunction in Female Patients Suffering from MDD.

BACKGROUND: Treating major depressive disorders (MDD) with selective serotonin-reuptake inhibitors (SSRIs) may impact negatively on sexual function. On the other hand, a satisfying sexual life is associated with overall life satisfaction. Therefore, managing this negative side effect of SSRIs may have an important role in the treatment of MDD. In a former study, adjuvant Rosa damascena oil improved sexual dysfunction in male patients suffering from both MDD and SSRI-induced sexual dysfunction (SSRI-I SD). The aim of the present study was to test whether the same pattern of results would be observed among female patients suffering from both SSRI-I SD and MDD. METHOD: In a double-blind, randomized and placebo-controlled clinical trial, a total of 50 female patients (mean age: 34 years) treated with an SSRI and suffering from MDD and SSRI-I SD were randomly assigned either to the verum (Rosa damascena oil) or to the placebo condition. Patients completed self-ratings of depression and sexual function at baseline, 4 weeks later, and at the end of the study 8 weeks after its start. RESULTS: Sexual desire, sexual orgasms, and sexual satisfaction increased over time. Patients in the verum group reported decreased pain. Overall sexual score increased in the verum as compared to the placebo condition. CONCLUSIONS: Whereas in male patients suffering from both MDD and SSRI-I SD adjuvant Rosa damascena oil improved sexual function, data on female patients are less robust and suggest only modest effects on female sexual function.