Postnephrectomy pseudoaneurysm with arteriovenous fistula

Sonography detected a paraaortic pulsatile tubular mass in a patient 10 years after “stump” nephrectomy, which was subsequently confirmed as a renal artery-renal vein fistula by computed tomography, angiography, and laparotomy.     

Postnephrectomy pseudoaneurysm with arteriovenous fistula

Sonography detected a paraaortic pulsatile tubular mass in a patient 10 years after "stump" nephrectomy, which was subsequently confirmed as a renal artery-renal vein fistula by computed tomography, angiography, and laparotomy.     

A framework for considering the risk‐benefit trade‐off in designing noninferiority trials using composite outcome approaches

When a new treatment regimen is expected to have comparable or slightly worse efficacy to that of the control regimen but has benefits in other domains such as safety and tolerability, a noninferiority (NI) trial may be appropriate but is fraught with difficulty in justifying an acceptable NI margin that is based on both clinical and statistical input. To overcome this, we propose to utilize composite risk‐benefit outcomes that combine elements from domains of importance (eg, efficacy, safety, and tolerability). The composite outcome itself may be analyzed using a superiority framework, or it can be used as a tool at the design stage of a NI trial for selecting an NI margin for efficacy that balances changes in risks and benefits. In the latter case, the choice of NI margin may be based on a novel quantity called the maximum allowable decrease in efficacy (MADE), defined as the marginal difference in efficacy between arms that would yield a null treatment effect for the composite outcome given an assumed distribution for the composite outcome. We observe that MADE: (1) is larger when the safety improvement for the experimental arm is larger, (2) depends on the association between the efficacy and safety outcomes, and (3) depends on the control arm efficacy rate. We use a numerical example for power comparisons between a superiority test for the composite outcome vs a noninferiority test for efficacy using the MADE as the NI margin, and apply the methods to a TB treatment trial.     

Mother and clinician experiences of a trial of a video feedback parent–infant intervention for mothers experiencing difficulties consistent with ‘personality disorder’: A qualitative interview study

Objectives

We explored mothers' and clinicians' experiences of a video feedback intervention adapted for perinatal ‘personality disorder’ (VIPP-PMH) and the acceptability of a randomised controlled trial (RCT) examining its effectiveness.

Design

In-depth qualitative interviews with participants from a two-phase feasibility study of the VIPP-PMH intervention. Participants were mothers experiencing enduring difficulties in managing emotions and relationships, consistent with a ‘personality disorder’, and their 6- to 36-month-old children.

Methods

Forty-four qualitative interviews were conducted, including all nine mothers receiving VIPP-PMH during the pilot phase, 25 of the 34 mothers participating in the RCT (14 allocated to the VIPP-PMH arm and 9 from the control arm), 11 of the 12 clinicians delivering VIPP-PMH and one researcher. Interview data were thematically analysed.

Results

Mothers described feeling motivated to take part in the research and understood the need for randomisation. Research visits were largely experienced positively, with some suggestions for improvement in questionnaire timing and accessibility. Almost all mothers initially felt anxious about being filmed, but reported positive experiences of the intervention, particularly valuing its non-judgemental, positive and child-focussed nature, their supportive relationship with the therapist and the insights they gained on their child.

Conclusions

The findings indicate the likely feasibility and acceptability of undertaking a future definitive RCT of the VIPP-PMH intervention in this population. In designing a future trial, a positive and non-judgemental therapeutic relationship will be important to allay mothers' anxieties about being filmed, and careful consideration should be given to the timing and accessibility of questionnaires used.     

Ethical issues for the consultant in the general hospital

Medical practice has changed dramatically in the past 50 years since psychiatry first made inroads into the general hospital setting. The image of the wise, gentleman-psychiatrist in a tweed jacket, spreading pearls of wisdom to a train of eager students and house-officers has been gradually replaced by that of a harried consultant being summoned for triage and tranquilization. In her quest to be all things to all people, the consultation-liaison psychiatrist has to confront many an ethical dilemma. This article highlights some familiar conflicts and attempts to achieve resolution.