Apr

Introduction

Lichtenstein tension-free mesh repair has been the standard practice in open inguinal hernia repair for many years. The procedure involves suture fixation of the mesh via an anterior approach to the inguinal canal. It is hypothesised that this invasive fixation contributes to the development chronic postoperative inguinal pain (CPIP), a condition which can cause significant morbidity.

A sound repair should restore the groin anatomy whilst minimising recurrence and not adversely affecting the patient quality of life. Considering the large number of these operations performed each year, reducing complications such as chronic postoperative pain will have a significant impact on healthcare resources.

The introduction of anatomical self-adhesive meshes such as Parietx ProGrip^TM addresses this concern in theory by obviating the need for mesh fixation. This mesh is a macro porous polyester mesh that utilizes polylactic acid micro grips (PLA) to aid placement within 60 seconds¹ without the need for additional fixation. The manufacturer does suggest, however, that additional fixation is left to the discretion of the operating surgeon.

We conducted a review of the literature to evaluate the reported outcomes of using this mesh in open inguinal hernia repair.

Methods

We conducted a PUBMED/MEDLINE search using the search words “Self-adhesive mesh”, “Lichtenstein repair”, “Open inguinal hernia repair” and “Self-gripping mesh” .We looked primarily at the outcomes of postoperative pain and recurrence. The result highlighted five well-structured meta-analyses and several RCTs and retrospective reviews.

Results

In a retrospective review of 211 patients who underwent open inguinal hernia repair with self-adhesive mesh, Tarchi P et al reported a recurrence rate of 0.5% at 1 year and 2.4% at 2 years. They incidence of chronic pain was less than 3%. There were no cases of seroma, testicular complications or mesh infection at 1, 2 and 3-year follow-up. The report highlighted the shorter operative duration with no effect on recurrence rates as a point in favour of self-adhesive mesh. The authors acknowledged the limitation of the study design and the need for randomised trials to address the issue.⁸ A few other small non-randomised trials draw similar conlusions.⁹

A randomised blinded trial from the Danish Multicentre DANGRIP Study Group allocated 163 vs 171 patients to self-adhesive and suture fixation respectively. There were no significant differences between the groups in postoperative complications (33.7 versus 40.4 %; P = 0·215), rate of recurrent hernia within 1 year (1.2 % in both groups) or quality of life. The 12 month prevalence of moderate or severe symptoms was 17.4 and 20.2% respectively (P = 0.573).

The study concluded that the avoidance of suture fixation using a self-gripping mesh was not accompanied by a reduction in chronic symptoms after inguinal hernia repair. ⁵

The FinnMesh trial is a randomised multicentre trial from Finland that Compared glue fixation, self-gripping mesh, and suture fixation of mesh. 625 patients were randomised to cyanoacrylate glue (Histoacryl, n = 216), self-gripping mesh (Parietex ProGrip, n = 202), or conventional non absorbable sutures (Prolene 2-0, n = 207) There was no significant differences postoperatively in pain response or need for analgesics between the study groups at 1 year follow up. The mean operative duration was lower in the self-adhesive mesh group.⁶

The HIPPO trial is a randomised double-blinded trial of 165 patients. The reported hernia recurrence rate after 24 months was 2.4% for the ProGrip mesh and 1.8% for the sutured mesh (P = 0.213).

The incidence of CPIP was 7.3% at 3 months declining to 4.6% at 24 months and did not differ between both groups. ⁷ The mean duration of surgery was significant shorter with the ProGrip mesh (44 vs 53 minutes, P < 0.001).

In a systematic review of 7 studies comparing self-gripping versus sutured mesh for inguinal hernia repair totalling 1353 patients, Zhang C et al found no difference in recurrence (risk difference -0.02 [95% confidence interval -0.07 to 0.03], P = 0.40) or chronic pain (risk difference -0.00 [95% confidence interval -0.01 to 0.01], P = 0.57). ² This review found no difference in wound infection, hematoma, and seroma formation. Self-adhesive mesh was again associated with a shorter mean operative duration. In its conclusion, the authors surmised that both mesh types are comparable in outcome but further long term analysis might be needed.

Pandanaboyana S published a meta-analysis of 5 RCTs and 1170 patients, that also found no significant difference in recurrence or chronic pain. Wound infection was lower in the self-gripping mesh group compared to sutured mesh but this was not statistically significant (risk ratio (RR) 0.57, 95% confidence interval 0.30-1.06, P = 0.08). The duration of operation was significantly shorter with self-gripping mesh compared to sutured mesh with a mean difference of -5.48 min [-9.31, -1.64] Z = 2.80 (P = 0.005).³

In another meta-analysis, Li J et al included 5 RCTs and 2 prospective comparative studies and 1353 patients. Statistically, there was no difference in the incidence of chronic pain [odds ratio = 0.74, 95% confidence interval (CI) (0.51-1.08)]. There was no statistical difference in the incidence of acute postoperative pain [odds ratio = 1.32, 95% CI (0.68-2.55)], hematoma or seroma [odds ratio = 0.89, 95% CI (0. 56-1.41)], wound infection [risk difference = -0.01, 95% CI (-0.02 to 0.01)], and recurrence [risk difference = 0.00, 95% CI (-0.01 to 0.01)]. The self-gripping mesh group was associated with a shorter operating time (1-9 minutes).¹⁰

In Ismail A et al’s meta-analysis of 12 randomized controlled trials and 5 cohort studies, 3722 patients were included in the final analysis. The two groups, using self-gripping mesh or sutured mesh fixation, did not differ significantly in terms of recurrence rate (odds ratio = 0.66, 95% confidence interval 0.18-2.44; P = 0.54) or postoperative chronic groin pain (odds ratio = 0.75, 95% confidence interval 0.54-1.05; P = 0.09). The operative time was less in the self-gripping mesh group (mean difference = -7.85, 95% confidence interval -9.94 to -5.76; P < .0001). There were comparable risks between self-gripping mesh and sutured mesh fixation groups in terms of postoperative infection (odds ratio = 0.81, 95% confidence interval 0.53-1.23; P = 0.32), postoperative hematoma (odds ratio = 0.97, 95% confidence interval 0.7-1.36; P = 0.9), and urinary retention (odds ratio = 0.66, 95% confidence interval 0.18-2.44; P =0.54).¹¹

A more recent meta-analysis including 10 RCTs and 2541 patients also draws similar conclusions, with no significant difference in the incidence of chronic pain (odds ratio = 0.93; 95% confidence interval, 0.74-1.18), recurrence (odds ratio = 1.34; 95% confidence interval, 0.82-2.19), or foreign body sensation (odds ratio = 0.82; 95% confidence interval, 0.65-1.03).⁴ The mean operating time was significantly shorter (odds ratio = -7.58; 95% confidence interval, -9.58 to -5.58) in the self-gripping mesh group which is consistent with the reported literature.

Discussion

Open inguinal hernia repair is a routinely performed operation and chronic postoperative inguinal pain is a significant cause of morbidity that can impact negatively on patients’ quality of life. Eliminating the need for suture fixation seems theoretically a step in the right direction.

The published literature, however, seems to arrive at similar conclusions. Whilst using self-adhesive mesh results in a shorter operative duration and seemingly does not affect the outcome negatively otherwise, there is no evidence that it reduces postoperative chronic pain and therefore should not be advocated on this merit. A shortened operative time coupled with a non-inferior outcome does seem like a more reasonable evidence-based argument for its proponents.

The decision of which mesh fixation technique to use can be left to the discretion of the operating surgeon. Further long-term follow up data is required to arrive at more definitive conclusions as the mean follow up duration in the reviewed studies ranged from 4 months to 3 years. The cost implications involved in the choice of mesh used should also be taken into account in future studies.

Summary points

• The non-vitamin K antagonist oral anticoagulants have demonstrated favourable benefit–risk profiles in large phase III trials, and these findings have been supported by real-world studies involving unselected patients representative of those encountered in routine clinical practice and including those deemed ‘challenging-to-treat’
• Accurate detection of atrial fibrillation and assessment of stroke and bleeding risk is crucial in identifying patients who should receive anticoagulation
• Elderly populations represent a significant proportion of patients seen in general practice, and advanced age should not be regarded as a contraindication to treatment; acetylsalicylic acid is not considered an effective treatment option to reduce the risk of stroke in patients with non-valvular atrial fibrillation (except for those declining oral anticoagulation), particularly in fragile elderly patients, for whom this drug was historically prescribed
• The frequency of follow-up visits, in particular to check compliance, should be tailored according to patients’ clinical characteristics and needs, but there is no requirement for routine coagulation monitoring, unlike vitamin K antagonists

Atrial fibrillation: a clinical and economic burden to society

Atrial fibrillation (AF) is the most frequently encountered sustained cardiac arrhythmia, with a prevalence of about 1.5–2% in the general population^1,2. Its incidence is predicted to rise sharply over the coming years as a consequence of the ageing population and increased life expectancy in those with ischaemic and other structural heart disease². In addition to being associated with significantly increased rates of mortality³, AF is also associated with significantly increased rates of heart failure, which is both a common cause and consequence of AF and greatly worsens the prognosis⁴. However, it is stroke that is the most devastating consequence of AF, with an average fivefold increased risk⁵.

AF-related strokes are often more severe than other strokes^6,7because the clots that embolise from the left atrium or left atrial appendage are often much larger⁸than from other sources of emboli. These clots usually lodge in large cerebral vessels, commonly the middle cerebral artery, resulting in huge neurological and functional deficits and increased mortality compared with other stroke types. Moreover, the strokes suffered by patients with AF are more likely to lead to extended hospital care than strokes in patients without AF, thus impacting on patients’ quality of life⁷.

Current evidence suggests that, in the UK, AF has a causative role in almost 20% of all strokes⁹. This is likely to represent a significant underestimate given that long term electrocardiogram (ECG) monitoring in patients who would previously have been diagnosed as having cryptogenic stroke has demonstrated a significant AF burden in these patients¹⁰.

With improved AF detection and stroke prevention, it is estimated that approximately 8000 strokes could be avoided and 2100 lives saved every year in the UK, resulting in substantial healthcare savings of £96 million^11,12.

A key objective of this short review is to provide primary care clinicians with the confidence to manage patients with AF in need of anticoagulation, including the safe and appropriate use of the non-vitamin K antagonist oral anticoagulants (NOACs) apixaban, dabigatran, rivaroxaban (approved in the EU, US and several other countries worldwide) and edoxaban (approved in the EU, US and Japan).^13-20The focus will be on how to accurately identify, risk-stratify and counsel patients on the risks and benefits associated with the different treatment options.

Who to treat. Accurate detection and assessment of stroke and bleeding risk

Many patients with AF are asymptomatic, particularly the elderly, less active patients who may not notice the reduction in cardiac performance associated with AF. Unfortunately, it remains the case that AF is undetected in up to 45% of patients²¹, and stroke is very often the first presentation of AF.

Both the National Institute for Health and Care Excellence (NICE) and the European Society of Cardiology (ESC) guidelines recommend opportunistic screening in patients aged ≥65 years by manual pulse palpation followed by ECG in patients found to have an irregular pulse^1,22. Opportunistic screening (manual pulse palpation) was shown to be as effective as systematic screening (ECG) in detecting new cases²³, and this simple strategy should be used to screen at-risk patient groups as often as possible. Hypertension and increasing age are the two leading risk factors for developing AF, but other high-risk groups include patients with obstructive sleep apnoea, morbid obesity or a history of ischaemic heart disease^24-26. In the context of proactive AF detection, many initiatives have been launched worldwide to encourage primary care clinicians to integrate manual pulse checks into their routine practice. The Know Your Pulse campaign was launched by the AF Association and Arrhythmia Alliance during Heart Rhythm Week in 2009 and was quickly endorsed by the Department of Health in the UK and by many other countries. This initiative has assisted in diminishing some of the gaps in AF detection²¹.

The most frequently used tools to evaluate stroke risk in patients with non-valvular AF (AF that is not associated with rheumatic valvular disease or prosthetic heart valves) are the CHADS₂²⁷ and CHA₂DS₂-VASc²⁸scores, with recent guidelines favouring the use of the latter and emphasising the need to effectively identify ‘truly low-risk’ patients¹. The CHA2DS2-VASc score is superior to CHADS₂ in identifying these truly low-risk patients, who should not be routinely offered anticoagulation¹. Patients with any form of AF (i.e. paroxysmal, persistent or permanent), and regardless of whether they are symptomatic, should be risk stratified in this way. The risk of stroke should also be assessed using CHA₂DS₂-VASc in patients with atrial flutter and probably for the majority of patients who have been successfully cardioverted in the past²². Unless the initial underlying cause has been removed (e.g. corrected hyperthyroidism) and there is no significant underlying structural heart disease, the risk of patients suffering from a recurrence of AF following ‘successful’ cardioversion remains high²⁹. The ESC guidelines recommend that anticoagulation should be offered to patients with a CHA₂DS₂-VASc score ≥1 based on assessment of risk of bleeding complications and the patient’s clinical features and preferences¹.

The new Quality and Outcomes Framework (QOF) for 2015–2016 now recommends the use of CHA₂DS₂-VASc for risk stratification and no longer recommends antiplatelet agents as a therapeutic option for stroke prevention in patients with non-valvular AF³⁰; this should result in significantly more patients receiving anticoagulation for this indication. The changes to QOF 2015–2016 compared with 2014–2015 are summarised in Table 1³⁰.

Table 1. Summary of changes to UK the Quality and Outcomes Framework (QOF) 2015–2016³⁰

Key: AF = atrial fibrillation; CHADS₂ = Congestive heart failure, Hypertension, Age ≥75 years, Diabetes, Stroke (doubled); CHA₂DS₂-VASc = Congestive heart failure or left ventricular dysfunction Hypertension, Age ≥75 years (doubled), Diabetes, Stroke (doubled)-Vascular disease, Age 65–74 years, Sex category (female); NICE = National Institute for Health and Care Excellence

The Guidance on Risk Assessment and Stroke Prevention in Atrial Fibrillation (GRASP-AF) clinical audit software detection tool is now very widely used in primary care to improve clinical outcomes in the AF population by identifying patients likely to benefit from anticoagulation. GRASP-AF systematically scans general practice software systems and calculates CHADS₂ and CHA₂DS₂-VASc scores in patients who are coded as having AF, thus enabling physicians to identify high-risk patients who are not adequately treated for stroke prevention³¹. Identification of AF patients who are poorly controlled on warfarin (defined as having a time in therapeutic range <65% or a labile international normalised ratio [INR], e.g. one INR value >8 or two INR values <1.5 or >5 within the past 6 months)²² is crucial because these patients are more likely to experience major bleeding or stroke. These patients should be reviewed and, if possible, the cause for the poor warfarin control should be identified. The Warfarin Patient Safety Audit tool is another software tool that has been developed to help identify patients with poor warfarin control³².

Primary care clinicians are being urged to objectively assess the bleeding risk of AF patients who are receiving, or about to receive, anticoagulation^1,22,32. HAS-BLED is the bleeding assessment scheme advocated by both NICE and the ESC^1,22, this has been validated in several independent cohorts and was shown to correlate well with the risk of major bleeding, in particular intracranial bleeding¹. The key aspect of HAS-BLED is that, unlike CHADS₂ and CHA₂DS₂-VASc, it consists of risk factors that are modifiable. It should, therefore, not be a tool to influence the decision of whether to anticoagulate, but instead to identify ways to reduce the risk of bleeding in patients receiving an anticoagulant; for example, optimising blood pressure control, stopping unnecessary antiplatelet or anti-inflammatory agents and reducing alcohol consumption can all significantly reduce HAS-BLED scores and bleeding risk¹. In addition, it needs to be emphasised that the absolute number of patients with AF experiencing a serious bleeding event while receiving anticoagulant therapy is low (~2–3%/year in the XANTUS, PMSS and Dresden NOAC Registry real-world studies) , with prospective real-world studies indicating that most bleeding events can be managed conservatively^33-35. Whilst concerns have been raised about not having a reversal agent to counter the anticoagulant action of NOACs in patients who experience serious bleeding, the low incidence of major bleeding in real-world and phase III studies and its conservative management in most cases demonstrate that such agents would not be required routinely. Despite these low rates of major bleeding, reversal agents have been developed and successfully completed phase III studies and undergone approval in some markets, including idarucizumab in the UK^36,37. Notably, high-risk patients with AF were shown to be more willing to endure bleeding events in order to avoid a stroke and its consequences³⁸, thus reinforcing the message that “we can replace blood but we cannot replace brain tissue”.

Adequate anticoagulation therapy should follow appropriate patient identification

Identifying the right treatment option for patients with AF is likely to improve clinical outcomes. Involving patients in the decision-making process and rationale, and ensuring they understand the net benefit–risk of treatment options, is likely to lead to better compliance and improved clinical outcomes. The ESC guidelines consider patients with valvular AF (patients with AF in the presence of either rheumatic mitral stenosis [very rare now in the UK] or prosthetic heart valves) to be at high risk, and these patients should be anticoagulated with a VKA regardless of the presence of any other risk factors¹. Warfarin is very effective at reducing the risk of stroke compared with acetylsalicylic acid (ASA)^39,40, but an unpredictable dose–response relationship and multiple drug and food interactions can be problematic for some patients, and many patients remain sub-optimally treated⁴¹. ASA is also not considered an effective treatment option to reduce the risk of stroke in patients with non-valvular AF especially in frail, elderly patients in whom ASA was historically prescribed. The GARFIELD-AF registry (10,614 patients enrolled in the first cohort) revealed that real-world anticoagulant prescribing in AF populations deviates substantially from guideline recommendations: 40.7% of patients with a CHA₂DS₂-VASc score ≥2 did not receive anticoagulant therapy, and a further 38.7% with a score of 0 received anticoagulant therapy. At diagnosis, 55.8% of patients overall were given a VKA, just over one quarter (25.3%) received an antiplatelet drug alone, and ~4.5% received a NOAC²⁴. Inappropriate prescribing was further confirmed by data from UK general practices (n=1857, representing a practice population of 13.1 million registered patients) using the GRASP-AF tool. Only 55% of patients with high-risk AF (CHADS₂ ≥2) were receiving oral anticoagulation (OAC) therapy, whereas a further 34% of patients with no known contraindication did not receive OAC therapy⁴².

The NOACs have altered the landscape in terms of stroke prevention management by increasing the available options for patients. These agents exhibit some important practical advantages over traditional therapy (e.g. no requirement for routine anticoagulation monitoring, simple fixed dosing oral regimens, fast onset of action, fewer drug reactions and no food interactions), leading to their increased uptake in primary care.

Key patient groups who are likely to benefit from the NOACs include patients poorly controlled on VKAs, those predicted to require medications that interact with VKAs (e.g. patients who require frequent antibiotics), those without severe renal impairment or those with a prior ischaemic stroke while receiving a VKA with an adequate INR. These agents could also be a good choice for patients living a considerable distance from their local hospital or surgery and commuters. The NICE guidelines state that primary care clinicians should consider clinical features and patient preference before deciding on the most appropriate option for patients²². In addition, cost may be important in some settings. All of the NOACs have demonstrated cost-effectiveness versus warfarin, and although cost models vary by country, there is little doubt that these agents provide cost-effectiveness largely through the number of adverse events avoided and their associated costs⁴³.

Choice of anticoagulant: which to choose?

The demonstration of a favourable benefit–risk profile (stroke prevention vs bleeding events) in large phase III studies involving over 70,000 patients has resulted in the regulatory approval of apixaban, dabigatran, edoxaban and rivaroxaban^44-47for the prevention of stroke and systemic embolism in patients with non-valvular AF and one or more risk factors.

Overall, NOACs have demonstrated an improved benefit compared with warfarin, with lower rates of intracranial haemorrhage (for all NOACs) and similar or superior efficacy for stroke prevention^44-48. Statistically significant relative risk reductions (RRRs) in the incidence of fatal bleeding events were seen with low-dose dabigatran (110 mg twice daily [bd]; RRR=42%), both tested doses of edoxaban (30 mg once daily [od] and 60 mg od; RRR=65% and 45%, respectively) and rivaroxaban (20 mg od; RRR=50%)^46,47,49; rates of fatal bleeding were also lower in patients treated with apixaban compared with warfarin (34 patients vs 55 patients, respectively)⁴⁴. These data are promising, especially considering the current lack of a specific antidote for any of the NOACs, and it is likely that the very short half-life of these drugs play an important role in mitigating the bleeding risk.

Owing to a lack of head-to-head comparisons between the NOACs in phase III clinical trials, patient characteristics, drug compliance, tolerability issues and cost may be important considerations¹. In addition, subanalyses of phase III trial data for rivaroxaban, apixaban and dabigatran indicate that the challenging-to-treat patient groups often encountered by primary care clinicians can be treated effectively and safely with the NOACs (Table 2). A recent meta-analysis showed a similar treatment effect for almost all subgroups encountered in clinical practice; NOACs appeared to be at least as effective as VKAs in reducing the risk of stroke and systemic embolism and no more hazardous in relation to the risk of major bleeding events, irrespective of patient co-morbidities⁵⁰.

Table 2.Novel oral anticoagulants studied in key patient subgroups*

*No subgroup analyses have been presented for edoxaban Key: AF = atrial fibrillation; ARISTOTLE = Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation; CAD = coronary artery disease; CHADS₂= Congestive heart failure, Hypertension, Age ≥75 years, Diabetes, Stroke (doubled); MI = myocardial infarction; PAD = peripheral artery disease; PK/PD = pharmacodynamics/pharmacokinetics; RE-LY = Randomized Evaluation of Long-term anticoagulation therapy; ROCKET AF = Rivaroxaban Once daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation; VKA = vitamin K antagonist

Because patient selection in clinical trials is based on strict inclusion/exclusion criteria, patient populations in such studies are not always representative of patients routinely seen in real-world practice. In addition, bleeding events may be managed differently in clinical trials versus routine clinical practice. Real-world data are, therefore, needed to help validate drug safety and effectiveness in unselected patient populations. Following phase III clinical trials and the widespread approval of the NOACs in stroke prevention in patients with non-valvular AF, real-world experience has been steadily accumulating. The current real-world data for rivaroxaban, apixaban and dabigatran have been very reassuring and bridge the evidence gap between clinical studies and real-world experience^33-35,51-57.

The lack of routine coagulation monitoring with NOACs does not remove the necessity for regular follow-up. Instead, the frequency of visits can be tailored according to patients’ clinical characteristics and needs. NOACs are all partially eliminated by the kidneys; therefore, regular monitoring of renal function is important either to use a lower recommended dose of these drugs or to avoid them. For example, renal function should be monitored every 6 months in patients who have stage III chronic kidney disease (creatinine clearance [CrCl] 30–60 ml/min)⁵⁸. Apixaban, rivaroxaban and edoxaban are not recommended in patients with CrCl <15 ml/min, and dabigatran is contraindicated in patients with CrCl <30 ml/min^13,15,17,19. Reduced-dose regimens of NOACs are recommended for patients at higher risk of bleeding events, including those with reduced renal function. For example, a reduced apixaban dose of 2.5 mg bd is indicated in patients with at least two of the following characteristics: age ≥80 years, body weight ≤60 kg or serum creatinine ≥1.5 mg/dl (133 μmol/l); a reduced rivaroxaban dose of 15 mg od is indicated in patients with CrCl 15‒49 ml/min⁵⁸; edoxaban is recommended at a reduced dose of 30 mg od in patients with CrCl 15‒50 ml/min and contraindicated in patients with CrCl >95 ml/min⁵⁸; and a reduced dose of 110 mg bd dabigatran should be considered in patients with CrCl 30‒50 ml/min who are at a high risk of bleeding⁵⁸. Follow-up visits should also systematically document patient compliance, thromboembolic and bleeding events, side-effects, co-medications and blood test results⁵⁸.

Conclusions

The NOACs have demonstrated favourable benefit–risk profiles in large phase III trials, and these findings have been supported by real-world studies involving unselected patients, including those deemed challenging to treat. The NOACs also address many of the limitations associated with VKA use, thus assisting with their integration into clinical practice for stroke prevention in patients with non-valvular AF. In addition, the results from subgroup analyses should provide primary care clinicians with the confidence to manage stroke-prevention strategies in a wide variety of patients with AF.

Introduction

Routine pulse palpation is the recommended screening method to detect asymptomatic atrial fibrillation (AF) in clinical practice¹. Since this is part of the blood pressure (BP) measurement technique when using the Riva Rocci (mercury) device or the aneroid device, most patients are evaluated for rhythm irregularity while checking their BP, and, if pulse isn’t palpated, heart rhythm can be evaluated through auscultation of Koroktoff’ sounds. According to the European Community law (2007/51 CE; 2007 September 27^th), the mercury sphygmomanometers should not be sold any more, therefore aneroid or automatic devices will replace them in a few years. Recently new devices with embedded algorithms to detect irregular heart beat and possible AF have been commercialised. Whether the switch from Riva-Rocci or aneroid sphygmomanometer to this device will affect detection of AF in usual care is unknown. We explored this issue using a retrospective, naturalistic observation of a group of GPs who abandoned the “old” Riva-Rocci or the aneroid sphygmomanometer and adopted this new device.

Methods

In September 2011 the members of the Italian College of General Practitioners based in Bologna (a medium size city in Central Italy) decided to standardize their office BP measurements. They received an unconditional grant for 30 automatic upper arm blood pressure monitors (Microlife- Afib ®) to be used in office by the GP him/herself. This device embeds an algorithm that calculates the irregularity index (standard deviation divided by mean) based on interval times between heartbeats; if the irregularity index is above a certain threshold value, atrial fibrillation is likely to be present and an atrial fibrillation icon is displayed on the screen. The 30 general practitioners who received the device agreed to a later proposal to examine their database to evaluate detection of new AF patients. They all had the same professional software (Millewin®), and used an automatic extraction. All the patients with recorded diagnosis of hypertension were identified, then BP recording and AF diagnosis were extracted before (365 days preceding the use of Microlife) and after (4 months since starting the use of Microlife) the adoption of the automatic devices. The proposal to examine AF detection was made after four months after they received the devices, therefore the GPs weren’t aware of this study during the usual professional activity. This study was also neither planned nor known by Microlife. Fourteen other GPs, who were using the traditional device, volunteered to provide the same data extraction from their personal database.

Results
The 30 participants GPs cared for 48,184 individuals, 12,294 (25.5%) of whom had hypertension (mean age 69.9±13.4). The 16 control GPs cared for 23,218 patients, 5,757 (24.8%) with hypertension (mean age 69.7±13.6). The four-monthly AF detection rate for the original group and the control group is reported in table 1. All the new detected AF were then confirmed on ECG. Statistical analysis was made with the chi-square (χ²) test.

Table 1: Four-monthly AF detection rate in the original GP group and in the control group*

*‡ Use of the traditional device: original group vs controls: p NS ( χ² = 3.0421, df 1)
** use of the automatic device (other quarters use of traditional device)
**‡‡ Original group: use of the automatic device vs traditional device in AF detection: p < 0.005 (χ ² = 9.487, df 1)

Discussion

Atrial fibrillation can be difficult to diagnose as it is often asymptomatic and intermittent (paroxysmal). The irregularity of heart rhythm can be detected by palpation of the pulse. It may therefore be detected in patients who present with symptoms such as palpitations, dizziness, blackouts and breathlessness, but may also be an incidental finding in asymptomatic patients during routine examination. The diagnosis must be confirmed with an ECG, which should be performed in all patients, whether symptomatic or not, in whom atrial fibrillation is suspected due to the detection of an irregular pulse. Heart rhythm should be evaluated while measuring BP with traditional sphygmomanometers, while this information may be lost with automatic devices, therefore the use of automatic devices with algorithms which can detect possible AF is an appealing choice. The hypothesis that these devices are equal or superior to systematic pulse palpation is currently under investigation by NICE². At the moment the consequences of switching from the classical Riva-Rocci devices to these new ones in usual care isn’t known. The AF opportunistic screening in people aged > 65 leads to a 1.63% detection rate while usual care has a detection rate of 1.04%, very similar to that observed in our hypertensive population (1.13%)³. Our data show that, at least in the short term, switching from the usual device to an automatic device with algorithm for irregular beat detection increases the identification rate of previously unknown AF in the hypertensive population. While waiting for a formal appraisal, GPs who wish or must renounce to their “old” Riva-Rocci can use this device implementing their “usual care” performances.

It seems that psychiatry is gradually losing its allure for future doctors.  All around, one can detect an air of pessimism from colleagues about the creeping 'socialisation' of this important field of medicine. There is no longer the breadth of interest in the subject and each sub-branch, for want of a better expression, has its followers and adherents. Proponents of one particular facet of treatment are zealous in the pursuit of their own interests. Psychotherapy is pitched against the neurobiological, rehabilitation and social psychiatry against the pharmacologists, all trying to mark out their own piece of territory, with some yearning for a place in the history books, or at the very least, an acronym. Some psychiatrists do not believe in diagnoses; others ridicule the concept of personality disorder, autistic spectrum disorder, or drug treatment; some believe psychiatric illness is the fault of governments, and there are probably a few who do not believe in psychiatry at all! 'Research' studies are cherry-picked by all sides to illustrate the ineffectiveness of 'alternative' treatments. The full picture or perspective of ill health is blurred and narrowed by a minority who believe they alone know what is right for patients, and psychiatry is 'intellectualised' by others to give it an air of authority and profundity it does not possess. Morale and training are suffering and, if this state of chaos and insanity continues, the discipline itself will implode and cease to be of interest to anyone, save the warring factions in the profession itself.

Once upon a time it was considered that a reasonably broad mixture of community and hospital services would provide benefit for patients with mental illness. Staff involved in their care, who have the rather cumbersome and oxymoronic description of being called 'mental' health professionals, would also widen their experience because of the continuity of care provided.  It was hoped patients who clearly did not need to be in hospital (for example, waiting for appropriate accommodation) could be discharged. Clinical need would determine those who required further rehabilitation/treatment in hospital, and would not be swayed by pressures, often financial, to discharge. Now, with the setting up of Home Treatment and other teams the situation has ironically worsened, because there is an implicit opinion in this arrangement that hospital admission, even for the seriously ill or indeed violent patients, is the least desirable option and something to avoid at all cost, even when care in the community is not immediately available or adequate. Care provision for the elderly is a separate concern and is not under discussion here.

In the domain of general adult psychiatry those patients who are in need of care, be it medical or social, are languishing at home, desperate for help, being offered assessment after assessment by disparate teams. There are not enough care professionals to cope with the demand. Home Treatment Teams in particular, are under considerable sustained pressure and stress to ensure further reduction in beds. Rehabilitation beds are being closed. 'It is cheaper to keep patients in the community', we are told. Or, if that does not suit, the liberal stance might be, 'What does hospital admission achieve'? That's fine if the problem is not on your doorstep. Psychiatrists who oversee inpatient care are also pressurised to discharge patients as soon as possible, so the very old notion of 'incarceration' (that worn-out cliché from the antipsychiatry lobby) seems facile, to say the least. On the contrary, doctors now have the added worry of prematurely discharging partially treated ('we need the beds') as well as more vulnerable patients who cannot cope. Most patients who take up psychiatric hospital beds do not want to be in hospital in the first place as they often, rightly or wrongly, do not see themselves as ill. Many hospital beds are now occupied by 'Section patients', and conversely, many very ill patients are left to go it alone because they refuse hospital admission and do not want community team involvement, yet are not 'sectionable'. The inference seems to be, 'If not sectionable or under CPA (Care Programme Approach) it is not our concern.'

Where there are sufficient provisions for outpatient care, some of the damage may be mitigated. Overworked staff including community psychiatric nurses (CPNs), support time recovery workers (STRs) and occupational therapists (OTs) often have the thankless task and enormous responsibility of seeing patients at home, some of whom are threatening and potentially dangerous, others erratic with their outpatient clinics attendance not always through deliberate evasion but often the result of the very condition causing the problem, for example, lack of insight. Other patients do not engage either through hostility or loss of motivation induced by the underlying problem, say, drug and alcohol misuse. Chronic patients are not ill enough to be on CPA and diagnostic 'conundrums' are left to others to sort out. With the introduction of the New Ways of Working,¹ the traditional outpatient clinics are being abolished and replaced with community clinics ('short-term' outpatients really). Ideally a community clinic should be run by CPNs as they usually understand the medical, psychiatric, psychological, and social needs of patients. In the authors' opinion the clinics should be Consultant-led because despite the tendency to classify everyone as 'clinicians' many staff feel uncomfortable with this role as it implies or infers a degree of clinical responsibility for which they are not qualified. Psychiatric nurses (especially those with a general nursing background) are ideally placed to carry out this function by virtue of their wide experience; also they are aware when to seek medical help when needed. Often they are more informed about patients than the primary physician or indeed the psychiatrist because of more frequent contact, either via liaison with the hospital wards or through home visits in their role as CPNs.  Nurses and other staff (for example, social workers) are involved in patients' discharge from hospital (usually determined at pre-discharge meetings) and are therefore an essential link in the continuity of patient care before patients are eventually seen in the 'community clinics'. Requests for domiciliary visits from general practitioners (GPs) to physicians themselves have become a thing of the past, with the exception of those psychiatrists working with Home Treatment Teams and Assertive Outreach Teams. Nowadays it is not uncommon for patients to be waiting months on end (more assessments) before being deemed 'appropriate' to see a Consultant Psychiatrist.

Certainly there are patients who do not need to continue seeing a Consultant Psychiatrist for years on end and should be discharged back to the GP to reduce unnecessary costs and to avoid a dependency culture, in the same way a patient with mild arthritis does not need to see a rheumatologist or a patient with anaemia does not always need the expertise of a haematologist, to use simple analogies. However, sometimes GPs are unwilling to reciprocate or feel out of depth with 'psychiatry' that this is not always possible. The chronicity of many psychiatric disorders perhaps harnesses the belief that new treatments may emerge which only a psychiatrist, with his/her specialized knowledge, can implement and deal with. This type of scenario is seen with many other illnesses in all fields of medicine (chronic psoriasis, rheumatoid arthritis, multiple sclerosis) yet no one is suggesting that GPs solely should be left to manage these conditions. It seems the clinical risk to patient care is not thought through and this no doubt will lead to serious repercussions later. In our estimation, physical and mental illnesses are so often intertwined that their management should be equally shared by physicians and psychiatrists.²   

Swings and Roundabouts

Such is the pressure by management (under the thumb of civil servants) and 'those in the know', reverentially referred to as ‘Commissioners’, that health professionals in psychiatry have to defend their clinical judgment and carry out numerous risk assessments (defensive medicine) of patients who are to be discharged from the outpatient clinic back to the GP in any event. Patients may be fortunate enough to receive a few last appointments with the Community Clinic (when they are up and running: some are at the time of writing) before they are shown the door and sent back to the GP, all to save money. Packages of care will not disguise the fact that vulnerable patients are being left to fend for themselves, just as they were in the past when the large  institutions closed down without any forward planning as to how and where patients would survive. Yet ‘management training’ and ‘mandatory courses’ continue inexorably, often provided by 'expert' outside speakers, costing Trusts considerable amounts of hours lost, let alone the  expense, instead of employing more nursing staff to cope with the ever-increasing workload. We are led to believe that reducing 'outpatient numbers' will lead to less pressurised work on staff, which really does not fit. All that will be happening to the extent that 'outpatients' will now be filling to the brim with CPA patients (read 'psychoses') instead of a good case-mix of patients required for general experience and training. It seems to be forgotten that there are patients who feel very unwell and are unable to cope, yet are not suffering from major psychiatric disorders.

The next scenario will be the revolving door ‘GP - Access/Assessment Team - possible Consultant Psychiatrist advice and at most two follow-up appointments (if one is really ill) - Community Clinic - discharge to GP system’, to replace the premature hospital discharge-readmission system which failed miserably in the past. When the patient relapses (or rather, when the illness remains static) the GP refers back into the system and the whole process begins again. In this way the Trusts receive money by reaching their targets (discharging patients) and are paid a second time when GPs 'purchase' more care. Those patients with 'minor problems' (not in their GP's estimation) will whittle away and remain unhappy. 'They can always see a counsellor' is the unspoken passive riposte. Furthermore, there will be less clinical variety for doctors and students, as their work will amount to prescribing 'powerful drugs' (we are told by the antipsychiatrists), monitoring serum lithium (and other drug) levels or checking blood results and clozapine dosages, because the Talking Therapies will be curing all and sundry. If only. We are reverting to the bad old days of pseudomedicine and pseudoscience.

Academicians and those who sit on government advisory bodies with grandiose names would have us believe there are far more effective ways to support people at home, or if they have no home, a crisis house will do. Meaningless, empty statements such as 'randomised controlled trials' (given the complexity of the issues under study) often with some reference to National Institute for Health and Clinical Excellence (NICE) guidelines, are used to support questionable findings. Despite all the 'new ways of working' national stress levels are at their highest because of rising unemployment, unexpected redundancies, increasing debt through credit card borrowing, and suicide rates are going up. New ways of Working is not working and any 'ad hoc survey' (note we did not say 'research') will reveal the depth of disillusionment all professionals in the discipline of psychiatry are experiencing, and not just the hallowed psychiatrists. Rudderless multidisciplinary teams are not the answer: teams require management. The term 'leadership' is becoming redundant (one only has to look at successive governments) and is often merely a spur for making money out of meaningless and time-wasting leadership courses which seem to be sprouting everywhere. Among the many qualities 'leadership' embraces are a sense of humour, assertiveness, fairness, creativity, openness, integrity and dedication, all to be found in one individual; presumably! Hierarchical structures may work, contrary to the sweeping statements of some,³ because people who are experienced in medical, academic and management matters (with perhaps a sense of humour) tend to command respect from team members. It is not enough to be an expert in cognitive behavioural therapy (CBT).

No place like home

How does one establish trust and rapport with patients when there will be less opportunity to do so because their care and progress are determined by market forces?  Instead of decreasing outpatient volume or confining this aspect of care to CPA patients only, outpatient departments should cater for the mounting levels of stress in the community (poverty, debts, redundancies, threatened job losses) through increased staffing levels and training/supervision of more social workers, CPNs and occupational health workers. Where possible such staff should attend as many clinics as possible (not just CPAs) to offer a more holistic approach to patient care. If anything, policy makers, clinicians, managers, carers and user groups need to collaborate and clamour for a more integrative mental health service, not fracture the already fragile set-up.  Community clinics are seen as a stepping stone to discharging from the mental health services (those who set them up don't like this analogy), which in theory is a good idea. The problem lies in the precipitous nature of transfer from outpatient to community clinics. Some very ill patients with chronic conditions are ironically not a burden to the system, in that they do not need to be seen frequently nor do they not require repeated admissions to hospital, yet if left to their own devices and discharged back to Primary Care would soon find life unmanageable as they rely on the expertise of health professionals to remain reasonably stable. Many patients have physical problems, some partly the result of the very treatments given to alleviate their underlying condition (obesity, hypertension, ECG disturbances, Type 2 diabetes and so forth), and need careful monitoring and supervision which is best provided by CPNs and other staff, in the same way a Health Visitor, Practice Nurse, or Diabetes Nurse Specialist might offer his/her expertise to a GP practice.

There will always be patients who need to be seen in the outpatient department with the emotional security and staff support this provides.  We are aware that some 20% of patients miss their mental health appointments but then people miss appointments for other interviews and not always because they are unwell.⁴ Some people miss appointments because they feel better. This is surely not a reason for abandoning the outpatient system, which serves the remainder of the patient population quite well.  We have experienced an unprecedented expression of worry and disappointment by patients who have been told they are not ill enough to be followed up at the outpatient department. Now mental health professionals are also frustrated, because they perceive their remit is to refer back to the GP as swiftly as possible, without having thoroughly assessed a patient over a period of time. First on the target list will be those patients who have not been seen by a psychiatrist for several months (‘We don't see them very often, therefore what is the point?') yet many chronically unwell patients may not want to attend outpatients, or have sufficient insight to realize they need to attend, for reasons outlined above. Will Outreach Teams in every Trust be abandoned to save money? Was it not their role in the first place to help those reluctant to receive treatment? What messages are we giving to patients other than being 'just a number, a hospital statistic’'? Those who have had the ‘luxury’ of a hospital admission usually comprise the very psychotic, and the personality disordered, and of the latter some consider they should not be in hospital anyway. The gains that have been made over the past decade in early intervention and engagement with patients by Assertive Outreach Teams will be lost. Yet, there is a continuing demand from patients and their carers to be seen by doctors.⁵

Here is how the 'new' system works. New Ways of Working, set up some years ago 1  and imposed on us,  was  meant to be an innovative approach to consultants' contracts by encouraging multidisciplinary teamwork ('When did consultants ever not consult their fellow professionals'?), reviewing the continued necessity for outpatient clinics, advocating more scheduled time for carers (colleagues we have spoken to cannot ever recall not seeing relatives or carers!) and more prominent roles for all team members, encouraging further education and training. Unfortunately we have gone to the other extreme and are being bombarded by all sorts of courses to the extent that much time is lost not seeing patients. Team members may and should undertake postgraduate studies. For doctors, continued professional development is mandatory. We are the only profession that requires revalidation every five years. Nothing can substitute for the medical training doctors undergo and it is a shame that the expertise of psychiatrists is diluted and devalued by their current roles as medication gatekeepers. It is a curious state of affairs or perhaps conveniently forgotten that when Trusts or 'Health Care Reformers' talk nowadays about working in teams and 'shared responsibility', the Consultant-led team concept is dismissed. Where there are Consultants who do not feel up to the role of leading a team, or are uncomfortable making assertive decisions and would rather take a back-seat thus avoiding the responsibility of being in charge of a team, then a Specialist Registrar nearing the end of training could fill this position. Multidisciplinary means 'several' not 'equal' disciplines of learning, ideally each discipline contributing a part to the whole. The medical member of the team is nowadays confronted with the added indignity of having his/her patients described in management-speak as customers, consumers, clients, service users, in fact any title that does not describe the ill person as a patient. It also reflects a creeping normalisation of 'political correctness' thrust upon us by the social engineers and should be resisted. We want patients to be treated with respect not as 'service users’, waiting for the next bus or train. Trusts are now seen  to promote a business approach to health care, thereby gaining the approval of their masters, the civil servants and politicians.⁶ Lots of tick boxes and targets, with subtle threats of redundancies or talks about 'natural wastage'. Meanwhile, the College sits idly by.  

Another concern is the training of future psychiatrists which is slip-shod and bureaucratic (lots of forms and assessments). There is hardly any room to accommodate medical students. Junior doctors who practice psychiatry are not receiving the continuity of supervision which existed years ago. The 'junior doctor' is less visible because of European working time directives, on-call commitments with days off in lieu, study leave, annual leave, and the inevitable sick leave. Passing the Member of the Royal College of Psychiatrists (MRCPsych) exams nowadays does not necessarily equate with clinical experience anymore. Even the nomenclature is confusing - not just to doctors and management (‘CT1’, ‘ST1’ and so forth) but also to staff, and reduces the profession to an anomalous set of categories no outsider understands, not to mention the loss of identity it creates in the individual doctor. What was wrong with Senior House Officer (SHO), Registrar, Senior Registrar, and Consultant? Unfortunately, we believe it is now too late to revert this shambles born out of the chaotic modernisation of medical careers. ⁷

The future is bleak and many doctors (and indeed nurses) are becoming disenchanted by psychiatry, feeling let down by a Royal College which seems to accommodate every new social trend rather than concentrating on improving the status of a once fascinating field of medicine. Lots of wake-up calls, but no-one is getting out of bed.⁸ Strange having a 'trade union' that ignores its members! Could someone inform the College that nowadays most General Adult Psychiatrists are almost reduced to measuring lithium levels, advising on clozapine doses, and attending meetings. No wonder the numbers of potential psychiatrists are falling. How would this dilution of responsibility work in a surgical unit? Would the team members decide how an operation is to be carried out because one of them is trained in resuscitation? Contrary to reports³ consultants are not happy with the present set-up, though it is unlikely our Royal College hierarchy will do anything about it. Many psychiatrists nowadays have an extensive academic knowledge of medicine, psychology, sociology, and neuropsychiatry, and no longer want to be minor players in the game, or undermined by a system that encourages power without responsibility.

Fragmentation breeds disinterest

What is the answer?    The previous system, though not perfect, worked well. This had its shortcomings too (oversized catchments areas, Consultants in charge of many wards, and so forth)7 but the continuity of care was there. Patients discharged from hospital were seen by the same team. GPs could refer directly to Consultants (as is the case in other medical specialties) and patients were then seen in the outpatient clinic. However, often the patient would attend such clinics for years because GPs were reluctant to resume care. Nowadays the training and education of GPs is exemplary and most are more than capable and indeed willing, to continue to provide support for their patients provided there is a back-up plan. The academic training of psychiatrists has never been better but their clinical skills are suspect. Therefore there needs to be an overhaul in the examination system as well. Actors are not patients. Simulated psychiatry is not the same as simulated surgery. Simulation is a technique not a technology, we are told. It is not a substitute for doctors examining real patients in real contexts. The same applies to nurses. All nurses (CPNs) could easily be trained to do ECGs, act as phlebotomists, and arrange routine tests. Many already do. Give back to nurses the skills they enjoy in other fields of medicine. For psychiatrists there are numerous courses one can attend to broaden their medical knowledge. Most GPs take an interest in a holistic approach to their patients (social, psychological, physical). As matters stand GPs now refer to a borough 'Access and Allocation Team' with no one held accountable, and even though requested by the GP, a Consultant Psychiatrist's opinion is not always provided. Responsibility is the province of senior doctors and management and should not be diluted by putting pressure on the Team as a whole whose individual experience varies considerably. Doctors (and nursing staff) should have mandatory training in psychological therapies (cognitive and behaviour therapies specifically). A fixed number of sessions in addition to their usual duties could be part of the job plan for those doctors interested in the psychotherapies per se, or put another way, a holistic approach to patient care, which is what most doctors do in any event. Patients would then have the benefit of medical and psychological input simultaneously (let's call it a cognitive-medical model). Waiting lists would be dramatically reduced at a stroke and Trusts would no longer have the responsibility of finding and employing unqualified (in medicine or psychology) 'talking therapists'. People who are generally physically well and who do not have serious psychosocial problems or psychiatric illnesses could receive treatment elsewhere through their GP, counsellors or other psychotherapists (those with no medical or psychology degrees) of their own volition. There is no need to clog up the system with 'customers'. We are not a supermarket!

Complaints will inevitably follow when patient dissatisfaction begins to emerge, which is only a matter of time. More serious incidents will be a consequence of too many bed closures and staff shortages. Dilution of responsibility means that no one person seems to be accountable when things go wrong and patients are left stranded (read the Francis Report ⁹). Already GPs are frustrated by the lack of informal contact with psychiatrists who are once again seen to be retreating to their ivory towers, having been overwhelmed by lots of courses, lots of training, lots of meetings, lots of empty rhetoric. Too much emphasis nowadays is placed on the sociological/psychological aspects of patients' illness and so serious conditions are missed. GPs should be able to refer directly to their colleagues where there are immediate concerns and not have to wait for triage meetings which delay this process. After all, GPs know their patients best. Community clinics could take the bulk of moderate conditions (which are causing undue stress) and see patients for as long as necessary (not a determined number of appointments) before deciding the GP can resume responsibility. 'Packages of Care' and other outdated expressions should be confined to the dustbin. Patients are not fooled by promises of cardboard boxes with little pink ribbons. Continuity of patient care requires a flexible approach which encompasses easy access to information and a direct pathway to services and medical care when needed.

Knowledge in the making

Psychiatrists should concentrate on more difficult and complicated cases (as was the case in the past) as well as routine moderate conditions, enabling them to use their broad skills more efficiently and effectively. Some psychiatrists see too few patients and this should be changed. Perhaps there is a case for psychiatrists rotating through some specialties say, every five years, for example, between Rehabilitation and General Adult Psychiatry. There are many patients who are not on mood stabilisers or clozapine who require intensive input and combined medical expertise and rotating between posts would offer valuable experience. A more varied approach is thus needed but do we really need all those subspecialties? What ever happened to the general psychiatrist with a special interest? In our view at least one year of neurology training should be mandatory for psychiatrists during their training. No formal examinations, just certificates to prove the courses have been completed; otherwise the system grinds to a halt. Under this system a doctor could still theoretically become a consultant after nine years postgraduate training (three years in foundation training and neurology), and six years Psychiatry (to include neurology, psychology and sociology) which is not unreasonable. Equal emphasis on neuromedical, sociological and psychological factors causing health problems would foster a healthier and friendlier relationship between disciplines which deal with mental illness and primary care providers. As it stands, with the fragmented role of general adult psychiatric services and the emphasis on e-learning and internet training for junior doctors (no hands-on clinical experience) we are facing yet another era of overemphasis on social psychiatry (or rather reverting to ancient belief systems) with its 'neutral' politically correct denigrating sound bites (customers, clients, service users). All will be well if we can just sort out the social problems! The simplistic notion that problems will disappear if we do not smoke, drink, take illicit drugs, keep our weight down, and have a home to go to, is the stuff of social engineering by the 'experts in living,' and alas by doctors who have lost touch with medicine.

Doctors need reminding that psychiatry is that branch of medicine that is concerned with the study, treatment, and prevention of mental illness using medical and psychological therapies as well as paying special attention to social hardship and isolation where present. It is not philosophy or social science. It is to medicine what metaphysics is to philosophy. Psychiatrists need to broaden their horizons and take their heads out of the therapy books to witness the advances in neuroscientific techniques and genetic advancements that have already transformed the nature of medicine. To develop their psychological skills they need to take on board that patients want more than drugs to alleviate distress. Therefore practical techniques such as CBT or DBT (dialectical behaviour therapy) will further heighten their expertise as physicians. Many doctors are already familiar with applying CBT and other therapies. However, doctors should also be aware of the limitations of psychotherapies in general, recognizing and acknowledging that such therapies do not always work either and indeed in some instances may be harmful. Psychiatrists should be part of separate Wellbeing Clinics (perhaps one session per week) to becoming better acquainted and proficient again with physical examinations, investigations, routine procedures (ECGs for example) and interpretation of results (not just screen, but to intervene). This overseeing of the physical health of patients is not always possible in a busy outpatient clinic. Many potentially serious conditions would be revealed and information to the GP or tertiary services made known immediately. Psychiatrists are not 'stuck in a medical model' no more than a physician believes all myocardial infarcts are caused by psychosocial factors or life style. But to ignore the medical advances in molecular biology and neuroscientific diagnostic techniques portrays a profound  ignorance of biological psychiatry and is insulting to those scientists who work  tirelessly, often without much recognition, to further our understanding of 'brain disorders'. It is all very well to talk about art, philosophy, social sciences and literature as having a great bearing on our interest in psychiatry and congratulate ourselves as 'lateral thinkers' but an understanding of the philosophy of say, Bertrand Russell or indeed the school of Zen Buddhism, will not eliminate mental disorder. Romantic as it might sound in retrospect, Vincent Van Gogh did not enjoy cutting his ear off, nor did Robert Schumann feel ecstatic when jumping into the Rhine before being carted off to the asylum.

If we do not embrace a holistic view of mental ill-health we risk not only throwing the baby out with the bath water but the bath itself, thereby causing further dissatisfaction and low morale among doctors with an inevitable negative impact on patient care. Psychiatrists are not bemoaning their loss of hegemony - a favourite word and another myth propagated by the antipsychiatry lobby; rather, it is only too obvious to them (as qualified medical doctors) that patients will suffer in the long term by not being referred appropriately to those who have the expertise to recognize and distinguish between human difficulties and illness. There is also a need to re-examine the impact of psychological therapies and not succumb to the popular and naive notion that they are all evidence-based in scientific terms. In the meantime the 'worried well' can indulge themselves with all the peripheral talking therapies and current fads they desire. Likewise, performance management, outcome measures and payment by results have become relentless tick-box exercises creating unnecessary stress among health care professionals (threats of job losses) who 'must meet targets at all costs', all for a slice of the Commissioners' cake. What a way to run a health service! Patients become meaningless statistics in the meantime. No! The wake-up call should be aimed at those who are intent on destroying the good will and values of the very same people they purport to support, through their social engineering and outdated attitudes.

INTRODUCTION:

People with intellectual disabilities are a heterogeneous group, who can pose a challenge to services in terms of meeting a wide range of needs. Following the closure of large institutions, the optimum means of service provision for people with intellectual disabilities with additional mental illness and challenging behaviour has been a matter of debate.

Challenging behaviour can be defined as a ‘culturally abnormal behaviour of such an intensity, frequency or duration that the physical safety of the person or others is likely to be placed in serious jeopardy, or behaviour which is likely to seriously limit use of, or result in the person being denied access to, ordinary community facilities’ – Emerson, 1995¹. Examples of challenging behaviours include self-injury, aggressive outbursts, destruction of property and socially inappropriate behaviour.

The credit-crunch of recent years has led to an increased use of private sector services delivering care to NHS funded patients. The Winterbourne Scandal unearthed by BBC Panorama in June 2011 (an investigation into the physical abuse and psychological abuse suffered by people with learning disabilities and challenging behaviour at this private hospital in South Gloucestershire), highlighted that whist this maybe an economically viable option, fundamental questions were raised about whether private sector services’ safeguards and monitoring protocols were as robust as the NHS in protecting vulnerable patients. It also reawakened longstanding disputes around the way people with complex needs are cared for in residential settings. The discussions centred around ‘institutional’ versus ‘community’ care styles; specialist intellectual disabilities services versus generic adult psychiatric services; local versus specialist expertise congregated around a single unit; and also financial questions regarding how best to meet the needs of this population at a time of austerity. Opinions vary widely, and at times are even polarised, as a result of several factors including position within this competitive and complex system, personal and cultural politics and also personal experience. As a result of the government review, subsequent to the Winterbourne investigation, a number of recommendations have been made which will affect the future of care of this vulnerable group of patients. These include, “by June 2013, all current placements will be reviewed, everyone in hospital inappropriately will move to community-based support as quickly as possible, and no later than June 2014… as a consequence, there will be a dramatic reduction in hospital placements for this group of people”²

The Department of Health Policy, Valuing People³, set out ‘ambitious and challenging programme of action for improving services’, based on four important key principles – civil rights, independence, choice and inclusion. Government Policy as detailed in both Valuing People and the Mansell Report^{3, 4} recognises that NHS specialist inpatient services are indeed necessary on a short-term basis for some people with intellectual disabilities and complex mental health needs. Inpatient facilities for people with Intellectual Disability have been described as highly specialised services that are a valuable, but also expensive, component of mental health services⁵. The Enfield Specialist Inpatient unit - the Seacole Centre - is one such service.

The Seacole Centre consists of two inpatient units, with a total of 12 inpatient beds, for people with intellectual disabilities with acute mental illness and/or challenging behaviour. It is located within Chase Farm Hospital in Enfield, Greater London. The Seacole Centre has a multidisciplinary team consisting of nurses, psychologists, psychiatrists, a resident GP, occupational therapists, intensive support team staff, physiotherapists, speech and language therapists, a physical exercise coach and administrative staff. Patients are admitted from a variety of sources, including general psychiatric wards, general medical wards and community intellectual disability teams. Since patients are often referred from other boroughs, in addition to this multidisciplinary team, each patient has their own community and social care team based within their own borough. The use of out-of-area units faces similar challenges to out-of-area placements, use of which has been increasing in the UK, and it is important to explore ways in which service users, out-of-area, can be supported effectively⁶.

In 2002, a review of admissions to the unit was completed to describe the management of mental illness and challenging behaviour. Since then there have been several service reconfigurations within the trust, in order to accommodate national, political and financial recommendations. However, despite these changes, it was observed clinically that certain clinical problems including delayed discharges continue to occur. We decided to complete a similar review, to describe current admission trends in further detail, in order to enable us to identify areas of improvement, and also to ascertain the nature and severity of ongoing problems to focus future recommendations.

METHOD:

A retrospective review of the case records of all inpatient admissions to the Seacole Centre was completed over a three-year period – from 1^st January 1999 to 31^st December 2001.

Data collected included age on admission, gender, borough, diagnosis, psychotropic medication on discharge, date of admission and discharge, length of stay, legal status on admission, delays on discharge, and reason for delay, and living arrangements prior to and after discharge

A successful outcome of admission was discharge from hospital to community care. We used the following definition of the delayed discharge:

"A delayed transfer occurs when a patient is ready for transfer from a general and acute hospital bed but is still occupying such a bed. A patient is ready for transfer when:

• a clinical decision has been made that the patient is ready for transfer
• a multi-disciplinary team decision has been made that the patient is ready for transfer
• the patient is safe to discharge/transfer.⁷

The review was repeated during a further three-year period between 1^st January to 2009 and 31^st December 2011.

RESULTS:

Characteristics of 1999-2001 cohort, and comparison with 2009-2011

The basic demographic details can be seen in Table 1.

Table 1 - Demographic details

Trends in Admission Rates

As seen in Tables 1 and 2, there has been a reduction in the total number of admissions between the studies. There has also been a marked reduction in re-admissions. The average length of stay has increased, and although the number of delayed discharges has slightly decreased, it can be seen that this is still a factor in a significant proportion of the admissions.

Table 2 - Trends in admission

Reason for admission

The trends in reason for admission are shown in Figure 1.

Figure 1 – Trends in Reason for Admission, 1999-2001 compared to 2009-2011

In both time periods, the most frequent reason for admission is challenging behaviour (62%, n=37 between 1999-2001; 63%, n=29, between 2009-2011), followed by psychosis (22%, n=13 between 1999-2001; 11%, n=5, between 2009-2011. Social admissions were the third most common reason for admission in the recent study (0% between 1999-2001; 4%, n=2 between 2009-2011). The range of psychiatric presentations was widest during the original time period.

Patterns on discharge

As shown in Figure 2, most patients in the original study were discharged to either the same residential home or back to the family home, where as in the latter time period patients were most frequently discharged to either a different residential home or to supported living. Figure 3 summarises this effect, demonstrating the change in discharging the majority of patients to a different place of residence.

Figure 2 – A graph to show the place of discharge, 1999-2001 compared to 2009-2011

Figure 3 – A Graph to Demonstrate Trends in Place of Discharge – comparing 1999-2001 and 2009-2011

Delayed discharges

The primary cause for delay in both studies was finding appropriate placement, although this was more marked in the recent cohort.

One of the major factors contributing to delayed discharges was lack of identification of suitable placement, which was identified as a major contributing factor to delayed discharges in 69% of cases in 2009-2011 and in 44% in 1999-2001, and apparent delays in the role played by social services (table 2).

DISCUSSION:

Throughout this study spanning 10 years, challenging behaviour followed by psychotic disorder remained the most common cause for admission. Interestingly, by 2008-2011, the third most common cause for admission was related to social reasons (4%). There were no admissions in the original study for this reason. Between 1999 and 2001, there were a wider range of reasons for admission across the mental illness spectrum compared to 10 years on. In previous studies, the largest diagnostic group for all admissions was schizophrenia spectrum disorders^7,8. However, between 2009-2011, more than a quarter of patients admitted to the Seacole Centre did not have any psychiatric diagnosis on admission. It is important to keep in mind that individuals with intellectual disabilities accessing specialist inpatient services are more likely to present with complex clusters of symptoms and behavioural problems that may span several diagnostic categories.

The most significant improvement from the original review and the re-review is that the number of re-admissions significantly reduced from 24% (14 patients) to 2% (1 patient). Of interest to note is that during 1999-2001 a large proportion of patients were discharged to their original place of accommodation (often the family home) whereas in 2009-2011, it was more common for patients to be discharged to a new place of living, more suited to managing increasing complex needs and behaviours. This may account for some of the reduction in re-admission rates.

The length of stay over the 10-year period has slightly increased from an average of 198.6 days up to 244.6 days, which demonstrate that admissions are considerably longer than in more generic medical settings. The findings are in keeping with a number of other studies regarding patients with intellectual disability who are admitted to a specialist unit and continue as inpatients for significantly longer periods. One study showed a mean length of stay 23.2 weeks for a specialist unit versus 11.1 weeks in generic settings ⁸. Another study in South London revealed similar finds of 19.3 weeks compared with generic unit stays of 5.5. weeks⁹. An exploratory national survey of intellectual disability inpatient services in England has shown that 25% of residents had been in the units for more than two years. Only 40% of residents had a discharge plan, and only 20% had both this and the type of placement considered ideal for them in their home area¹⁰. Reasons for length of stay are not fully understood in any of these studies. They may include fear of taking risks, lack of local safe or competent amenities, lack of experience or authority amongst those charged with sourcing bespoke services for complex people with challenging needs, and also a potential lack of such resource in terms of time available to see people, read reports, meet with stake holders and find the right services. The results of another retrospective study comparing the generic and specialist models in two districts in the UK by Alexander et al¹¹ suggested that, within the same district, patients do stay longer in the specialist unit, but they are less likely to be discharged to an out of area placement.

There is no evidence to suggest that comprehensive care for people with intellectual disabilities can be provided by community services alone. Likewise, there is also no clear evidence to suggest that a balanced system of mental health care can be provided without acute beds¹². There is, however, clear evidence that services created by the private sector are used very widely and seen as at time as an economically viable option in the current climate of credit crunches.

The different models of inpatient service provision that have been suggested range from mainstream adult mental health services; alternatively an integrated inpatient scheme whereby people with Intellectual disabilities with additional mental illness or severe challenging behaviour are admitted to adult mental health beds, with provision for extra support from a multidisciplinary learning disabilities team; ranging across to specialist assessment and treatment units^13,14.

Inpatient care is known to consume most of the mental health budget¹⁵ and specialist inpatient units are an expensive component of these services. Cost containment and cost minimisation of inpatient beds within the current economic recession presents a real challenge for those charged with responsibility to provide high-quality, effective, specialist care for adults with intellectual disability. Such cost reduction could be approached in a number of ways, through the reduction of length of stay, optimising drug budgets, reducing rates of re-admissions, and establishment of projects in association with the voluntary and statutory sector to facilitate prompt and safe discharge.

Reducing the average length of stay where possible can reduce the cost, and the resources and budget freed up in this way could be used for other service components¹⁵. However, this single agenda can lead to problems of pressured early discharge to unsuitable placements. It is known that resource consumption is most intense during the early stages of admission. As such, we observe a position whereby reducing length of stay requires proactive planning throughout the whole process of care, as well as active discharge planning, with a need for clearly defined pathways of care.

A crucial aspect of the patient's transition through inpatient placement to life in the community is efficient and regular communication between the relevant professionals and teams who form part of continuity of on-going care back in the community. This can at times be particularly challenging owing to differences in values and perceptions about patient need and problem, and also varying pressures. Understanding and resolving problems for individuals with complex and severe challenging behaviour or mental illness that requires a period of containment in a specialist service also requires specialist on-going work and risk management to ensure that when the problems are contained and understood, they remain contained and understood on discharge and thereafter so long as the individual remains vulnerable to the point of requiring any care giving. Many people from the general population who develop a serious mental illness requiring hospitalisation, have capacity once well, to make decisions for themselves and articulate a need or otherwise for specific care or intervention. This is rarely completely the case for people with Intellectual disabilities. Collaborative approaches together with those involved in community care is crucial to getting the right care at the right financial cost for this relatively small but very complex and vulnerable group of individuals.

Malaria is caused by obligate intra-erythrocytic protozoa of the genus Plasmodium. Humans can be infected with one (or more) of the following five species: P. falciparum, P. vivax, P. ovale, and P. malariae and P. knowlesi. Plasmodia are transmitted by the bite of an infected female Anopheles mosquito and these patients commonly present with fever, headache, fatigue and musculoskeletal symptoms.

Diagnosis is made by demonstration of the parasite in peripheral blood smear. The thick and thin smears are prepared for identification of malarial parasite and genotype respectively. Rapid diagnosis of malaria can be done by fluorescence microscopy with light microscope and interference filter or by polymerase chain reaction.

We report a complicated case of P. ovale malaria without fever associated with Hepatitis B virus infection, pre-excitation (WPW pattern), and secondary adrenal insufficiency.

Case Report:

A 23 year old African American man presented to the emergency department with headache and dizziness for one week. He had 8/10 throbbing headaches associated with dizziness, nausea and ringing sensation in the ears and also complained of sweating but denied any fever. He had loose, watery bowel movements 3 times a day for a few days and had vomited once 5 days ago. He denied any past medical history or family history. He was a chronic smoker and smoked 1PPD for 8 years and denied alcohol or drug use. He had travelled to Africa 9 months before presentation and had stayed in Senegal for 1 month though he did not have any illnesses during or after returning from Africa.

On examination: T: 97.6, HR: 115/min, BP: 105/50, no orthostasis, SPO₂: 100% in room air and RR: 18/min. Head, neck and throat examinations were normal and respiratory and cardiovascular system examinations were unremarkable except for tachycardia. Abdominal examination revealed no organomegaly and his CNS examination was unremarkable.

Laboratory examination revealed: WBC: 6.4, Hb: 14.4 and Hct: 41.3, Platelets: 43, N: 83.2, L: 7.4, M: 9.3, B: 0.1. His serum chemistry was normal except for a creatinine of 1.3 (BUN 14) and albumin of 2.6 (total protein 5.7). A pre-excitation (WPW Pattern) was seen on ECG and head CT and Chest X-ray were normal.

He was admitted to the telemetry unit to monitor for arrhythmia. Peripheral blood smear (PBS) was sent because of thrombocytopenia and mild renal failure and revealed malarial parasites later identified as P. ovale (Pic. 1 and 2).

He was treated with Malarone; yet after 2 days of treatment, he was still complaining of headache, nausea and dizziness. There were no meningeal signs. His blood pressure readings were low (95/53) and he was orthostatic. His ECG showed sinus tachycardia and did not reveal any arrhythmias or QTc prolongation. His morning serum cortisol was 6.20 and subsequent cosyntropin stimulation test revealed a serum cortisol of 13.40 at one hour after injection. His Baseline ACTH was<1.1 suggesting a secondary adrenal insufficiency. His IGF-1, TSH, FT4, FSH, LH were all within normal limits. His bleeding and coagulation parameters were normal, CD4 was 634(CD4/CD8: 1.46) and rapid oral test for HIV was negative.  His Hepatitis B profile was as follows: HBsAg: positive, HBV Core IgM: negative, HBV core IgG: positive, HBeAg: negative, HBeAb: positive, HBV DNA: 1000 copies/ml, Log10 HBV DNA: 3000 copies/ml.

His Blood cultures were negative, his G6PD levels and hemoglobin electrophoresis were normal, haptoglobin was<15 and LDH was 326. MRI of the brain was unremarkable. The abdominal sonogram revealed a normal echo pattern of the liver and spleen and spleen size was 12 cm. The secondary adrenal insufficiency was treated with dexamethasone resulting in gradual improvement of his nausea, vomiting and headache. Furthermore the platelet count improved to 309. Primaquine was prescribed to complete the course of malaria treatment and he was discharged home following 8 days of hospitalization. Unfortunately he did not return for follow up.

Discussion:

Malaria continues to be a major health problem worldwide. In 2007 the CDC received reports of 1,505 cases of malaria among person in the United States. 326 cases were reported from New York with all but one of these cases being acquired outside of the United States¹.

While Plasmodia are primarily transmitted through the bite of an infected female Anopheles mosquito, infections can also occur through exposure to infected blood products (transfusion malaria) or by congenital transmission. In industrialized countries most cases of malaria occur among travellers, immigrants, or military personnel returning from areas endemic for malaria (imported malaria). Exceptionally, local transmission through mosquitoes occurs (indigenous malaria). For non-falciparum malaria the incubation period is usually longer (median 15–16 days) and both P. Vivax and P. Ovale malaria may relapse months or years after exposure due to the presence of hypnozoites in the liver of which the longest reported incubation period for P. vivax being 30 years².

Malaria without fever has been reported in cases of Plasmodium falciparum malaria in non- immune people³. Hepatitis B infection associated with asymptomatic malaria has been reported in the Brazilian Amazon⁴.  This study was done in P. falciparum and P. vivax infected person with HBV co-infection though not in the P. ovale group. HBV infection leads to increased IFN-gamma levels^5,6 which are important for plasmodium clearance in the liver⁷, in addition to its early importance for malarial clinical immunity⁸. High levels of IFN gamma, IL6 and TNF alpha are detectable in the blood of malaria patients and in the spleen and liver in the rodents’ model of malaria^9,10. These inflammatory cytokines are known to suppress HBV replication in HBV transgenic mice⁹. This might explain the low levels of HBV viremia in our patient although human studies are required to confirm this finding.

The hypothalamic-pituitary- adrenocortical axis suppression and primary and secondary adrenal insufficiency has been reported in severe falciparum malaria¹⁰. In our case, the patient did not have any features to characterize severe malaria, and parasitaemia was <5%. Further, the MRI did not reveal any secondary cause for adrenal insufficiency. This might indicate that patients with malaria are more prone for hypothalamo-pituitary adrenocortical axis dysregulation yet further studies are required to prove this phenomenon in patients without severe malaria.

Cardiac complications after malaria have rarely been reported. In our patient pre-excitation on ECG disappeared after starting antimalarial treatment. Whether WPW pattern and its subsequent disappearance was incidental or caused by malarial infection that improved with treatment could not be determined. Lengthening of the QTc and severe cardiac arrhythmia has been observed, particularly after treatment with halofantrine for chloroquine resistant Plasmodium falciparum malaria¹¹. Post-infectious myocarditis can be associated with cardiac events especially in combination with viral infections¹².  A case of likely acute coronary syndrome and possible myocarditis was reported after experimental human malaria infection¹³. To date, except for cardiac arrhythmias that developed after treatment with halofantrine and quinolines, no other arrhythmias has been reported in patients with malaria before treatment.

Transient thrombocytopenia is very common in uncomplicated malaria in semi -immune adults¹⁴. A person with a platelet count <150 × 10⁹/l is 4 times more likely to have asymptomatic malarial infection than one with a count ≥150 × 10⁹/l¹⁵. In an observational study among 131 patients, patients with involvement of more than one organ system was found to have a lower mean platelet count compared to those with single organ involvement¹⁶.

Conclusions:

Our case highlights the need for further studies to understand the multi-organ involvement in patients without severe malaria as well as early recognition of potential complications to prevent mortality and morbidity in this subgroup of patients.

We present a case of a 48-year-old lady with a history of bony metastatic breast carcinoma who presented with abdominal pain, diarrhoea and bleeding per rectum. She had recently finished a course of chemotherapy 2 weeks ago.

On examination, she was febrile with a temperature of 38.4°C. Her blood pressure was 84/54mmHg and pulse rate was 130/min. She had lower abdominal tenderness with bowel sounds present and a small perineal haematoma. Per rectal examination revealed a small amount of fresh blood, but no surrounding crepitus or induration. Rectoscopic examination was not performed.

Initial haematological investigations revealed a haemoglobin of 11g/dl, white cell count 0.3x10⁹/litre, neutrophil count 0.05x10⁹/litre and a C-reactive protein of 171mg/L. A provisional diagnosis of neutropenic sepsis was made. She was managed with analgesia, intravenous fluids and broad spectrum intravenous antibiotics (piperacillin and tazobactam 4.5g 3-times per day). An urgent CT of abdomen and pelvis was arranged for that morning. It showed rectal wall thickening with air in the pelvis but no tumour or diverticulae (see figure 1).

Fig 1: CT scan of abdomen and pelvis showing free air around rectum 

Explanation:

Stercoral perforation of the colon is caused by progressive ischemic necrosis of the bowel wall by a faecal mass. It is the least likely diagnosis here as it usually occurs on the antimesenteric border of the sigmoid colon and is usually associated with a history of chronic constipation and megacolon.

Typhylitis is a potentially life threatening inflammatory bowel process that is a recognised complication of systemic chemotherapy. It can progress to bowel necrosis and perforation but is usually characterised by involvement of the caecum or ascending colon and the rectum is rarely involved.

Clostridial gas gangrene infection occurs with tissue inoculation in a low oxygen tension environment. Approximately 80% of patients without trauma  have a malignancy of which 40% are hematologic, however the vast majority of cases are preceded by trauma of which there was no history of in this case ¹.

Perineal Necrotizing fasciitis is a rare condition with an estimated 500 cases each year in the UK². It can affect healthy individuals of any age but carcinoma and immunosupression are known to increase susceptibility³. The initial lack of obvious skin findings make this condition difficult to diagnosis but exquisite pain, especially pain that is disproportionate to what would be expected from the clinical findings is seen ^2, 4. Where concurrent signs of sepsis exist, a high index of suspicion is required.

As the disease progresses, the skin may begin to appear smooth, shiny and swollen. Blistering and serous bullae may develop, and a haemorrhage into bullae may occur and giving the appearance of a haematoma as in our case. Crepitus, induration and foul smelling watery discharge secondary to liquefactive necrosis can also become apparent². On CT scans, fascial thickening, fat stranding and gas tracking may be seen in nearly 80%^2, 5 of cases, and was seen in this case as well.

Discussion

Necrotizing fasciitis is a lethal soft tissue infection characterised by rapidly progressive inflammation and necrosis of the subcutaneous fascial tissues. The adjacent skin and muscle are relatively spared until late in the course of the disease. Treatment with surgical debridement must be instigated without delay or the patient inevitably succumbs to sepsis and multi-organ failure².

A 24 hour delay in treatment has been shown to increase mortality by 18% and further surgery is usually indicated with an average of 3.8 debridements needed overall^5, 6. Surgical treatment should be instigated in conjunction with broad spectrum intravenous antibiotics and intensive care. The antibiotics selected should be effective against gram-positive, gram negative and anaerobic organisms. Adjuvant therapies like hyperbaric oxygen, intravenous immunoglobulin and activated protein C are of uncertain value.

Following surgery the patient is invariably left with a large tissue defect. Perineal wounds are particularly complex and present multiple challenges including the risk of infection from faecal contamination. Thus diverting colostomies are advised and a Vacuum Assisted Closure (VAC) system may facilitate wound healing ⁵.