2017

Patient and public involvement for a surgical trial in rectal prolapse (2017)

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Type of publication:
Conference abstract

Author(s):
Lee M.; Blackwell S.; Brown S.; Sayers A.; Heywood N.; Fearnhead N.; *Lacy-Colson J.; Cornish J.

Citation:
Colorectal Disease; Sep 2017; vol. 19 ; Supplement S2 ; p. 39

Abstract:
Aim: An integral part of trial design is Patient and Public Involvement (PPI) to incorporate patient views and preferences. The aim of this study is to describe the conduct and findings of early PP for a trial in surgical treatment of rectal prolapse. Method: Participants were invited directly by research collaborators and through social media. Only women were invited due to nature of trial. A modified deliberate engagement process was followed. Patients provided expertise on patient experience of the condition, potential recruitment strategies, and outcome measures. Results: 13 patients attended the PPI meeting. Most were recruited by clinicians. Broad representation of age and demographic origin was achieved. Patients agreed with equipoise, and were willing tobe randomised to posterior or ventral rectopexy. Several qualities of life tools were discussed when selecting appropriate outcomes. With respect to sexual function, older patients preferred FSFI and younger patients preferred PISQ-IR. Final consensus was that PISQ-IR was the best compromise for all. Conclusion: Patients with rectal prolapse are willing to engage in PPI for researchers and discuss intimate details on how treatments have affected their personal lives. The PPI exercise confirmed equipoise and modified the outcome measure of sexual function.

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Functional outcomes of achilles tendon minimally invasive repair using 4- and 6-strand nonabsorbable suture: A cohort comparison study (2017)

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Type of publication:
Journal article

Author(s):
*Carmont M.R.; Brorsson A.; Olsson N.; Nilsson-Helander K.; Karlsson J.; Zellers J.A.; Silbernagel K.G.

Citation:
Orthopaedic Journal of Sports Medicine; Jan 2017; vol. 5 (no. 8)

Abstract:
Background: The aim of management of Achilles tendon rupture is to reduce tendon lengthening and maximize function while reducing the rerupture rate and minimizing other complications. Purpose: To determine changes in Achilles tendon resting angle (ATRA), heel-rise height, patient-reported outcomes, return to play, and occurrence of complications after minimally invasive repair of Achilles tendon ruptures using nonabsorbable sutures. Study Design: Cohort study; Level of evidence, 3. Methods: Between March 2013 and August 2015, a total of 70 patients (58males, 12 females) with amean age of 42 +/- 8 years were included and evaluated at 6 weeks and 3, 6, 9, and 12 months after repair of an Achilles tendon rupture. Surgical repair was performed using either 4-strand or 6-strand nonabsorbable sutures. After surgery, patients were mobilized, fully weightbearing using a functional brace. Early active movement was permitted starting at 2 weeks. Results: There were no significant differences in the ATRA, Achilles Tendon Total Rupture Score (ATRS), and Heel-Rise Height Index (HRHI) between the 4- and 6-strand repairs. The mean (SD) relative ATRA was -13.1degree (6.6degree) (dorsiflexion) following injury; this was reduced to 7.6degree (4.8degree) (plantar flexion) directly after surgery. During initial rehabilitation at 6 weeks, the relative ATRA was 0.6degree (7.4degree) (neutral) and -7.0degree (5.3degree) (dorsiflexion) at 3 months, after which ATRA improved significantly with time to 12 months (P = .005). At 12 months, the median ATRS was 93 (range, 35-100), and the mean (SD) HRHI and Heel-Rise Repetition Index were 81% (0.22%) and 82.9% (0.17%), respectively. The relative ATRA at 3 and 12 months correlated with HRHI (r = 0.617, P < .001 and r = 0.535, P < .001, respectively). Conclusion: Increasing the number of suture strands from 4 to 6 does not alter the ATRA or HRHI after minimally invasive Achilles tendon repair. The use of a nonabsorbable suture during minimally invasive repair when used together with accelerated rehabilitation did not prevent the development of an increased relative ATRA. The ATRA at 3months after surgery correlated with heel-rise height at 12 months.

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Partial breast radiotherapy after breast conservation: 5 year outcomes from the IMPORT LOW (CRUK/06/003) phase III trial (2017)

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Type of publication:
Conference abstract

Author(s):
Coles C.; Griffin C.; Bhattacharya I.; Emson M.; Haviland J.; Hopwood P.; Kaggwa R.; Bliss J.; Kirby A.; Donovan E.; *Agrawal R.; Alhasso A.; Brunt A.M.; Ciurlionis L.; Chan H.; Harnett A.; Sawyer E.; Sybdikus I.; Tsang Y.; Wheatley D.; Wilcox M.; Yarnold J.; Jefford M.

Citation:
Radiotherapy and Oncology; May 2017; vol. 123

Abstract:
Background: Local cancer relapse rates after breast conservation surgery followed by radiotherapy have fallen sharply in many countries with risk influenced by patient age and clinico-pathological factors. In women at lower than average risk of local relapse, partial breast radiotherapy restricted to the vicinity of the original tumour is hypothesised to improve the balance of beneficial versus adverse effects compared with whole breast radiotherapy. Methods: The IMPORT LOW trial (ISRCTN12852634) recruited women aged >=50 years after breast conserving surgery for invasive ductal adenocarcinoma pT<=3cm, pN0- 3, G1-3 and >=2mm resection margins. Using 15 daily treatments, patients were randomly allocated (1:1:1) to 40 Gy whole breast radiotherapy (control), 36 Gy whole breast plus 40 Gy to partial breast (reduced dose) or 40 Gy partial breast only (partial breast). Primary endpoint was ipsilateral local relapse rate (80% power to exclude a +2.5% noninferiority margin at 5 years for each test group). Findings: Between May 2007 and October 2010, 2018 women were recruited (control n=675, reduced dose: n=674, partial breast: n=669). With a 72.2 month median followup (IQR 61.7-83.2), 5-year local relapse rates were 1.1% (95%CI 0.5-2.3), 0.2% (0.02-1.2) and 0.5% (0.2-1.4) in control, reduced dose and partial breast groups. Absolute differences in local relapse rate compared with the control group were -0.73% (-0.99, 0.22) for the reduced dose and -0.38% (-0.84, 0.90) for the partial breast groups, demonstrating non-inferiority for both test groups. Photographs, patients and clinicians reported similar or lower levels of adverse effects after reduced dose or partial breast radiotherapy compared with whole breast radiotherapy (see Table 1). (Table presented) Interpretation: At 5 years, partial breast and reduced
dose radiotherapy showed local relapse rates non-inferior to that observed following whole breast radiotherapy and produced equivalent or milder late normal tissue side effects. This simple radiotherapy technique is implementable in radiotherapy centres worldwide.

Surgery for constipation: systematic review and practice recommendations: Results II: Hitching procedures for the rectum (2017)

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Type of publication:
Systematic Review

Author(s):
Grossi U.; Knowles C.H.; Mason J.; *Lacy-Colson J.; Brown S.R.; Campbell K.; Chapman M.; Clarke A.; Cruickshank

Citation:
Colorectal Disease; Sep 2017; vol. 19 ; p. 37-48

Abstract:
Aim: To assess the outcomes of rectal suspension procedures (forms of rectopexy) in adults with chronic constipation. Method: Standardised methods and reporting of benefits and harms were used for all Capacity reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. Results: Eighteen articles were identified, providing data on outcomes in 1238 patients. All studies reported only on laparoscopic approaches. Length of procedures ranged between 1.5 to 3.5 h, and length of stay between 4 to 5 days. Data on harms were inconsistently reported and heterogeneous, making estimates of harm tentative and imprecise. Morbidity rates ranged between 5-15%, with mesh complications accounting for 0.5% of patients overall. No mortality was reported after any procedures in a total of 1044 patients. Although inconsistently reported, good or satisfactory outcome occurred in 83% (74-91%) of patients; 86% (20-97%) of patients reported improvements in constipation after laparoscopic ventral mesh rectopexy (LVMR). About 2-7% of patients developed anatomical recurrence. Patient selection was inconsistently documented. As most common indication, high grade rectal intussusception was corrected in 80-100% of cases after robotic or LVMR. Healing of prolapse-associated solitary rectal ulcer syndrome occurred in around 80% of patients after LVMR.
Conclusion: Evidence supporting rectal suspension procedures is currently derived from poor quality studies. Methodologically robust trials are needed to inform future clinical decision making.

Surgical assessment clinic - One stop emergency out-patient clinic for rapid assessment, reduced admissions and improved acute surgical service: A quality improvement study (2017)

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Type of publication:
Journal article

Author(s):
*Macano C.A.W.; *Lake B.; *Clarke R.; Kirby G.C.; Nyasavajjala S.M.

Citation:
Annals of Medicine and Surgery; Nov 2017; vol. 23 ; p. 28-31

Abstract:
Background There is increasing pressure on emergency services within the NHS requiring efficient, rapid assessment and management of patients. A subsequent reduction in hospital admissions reduces overall costs with an aim to improve quality of care. At the Royal Shrewsbury Hospital we run a one stop emergency surgical clinic. With strict criteria for admission to this clinic we have established a care pathway for those patients requiring urgent surgical review but not necessarily hospital admission. Materials and methods We reviewed our initial referral pathway to the emergency surgical assessment clinic. New guidelines were distributed to the local Care Coordination Centre (CCC) through which GP referrals to the clinic were made. A re-audit carried out 6 weeks later assessed change in clinical practice. Results With the introduction of guidelines for referral we significantly increased the percentage of appropriate referrals to the one stop emergency surgical clinic (42.9%-79.4%, p = 0.000017). The majority (75.8%) of appropriate referrals can be successfully managed on an urgent outpatient basis. Appropriate referrals unsuitable for discharge from clinic had genuine reasons for admission such as abnormal results on assessment, or a need for surgery. 97.8% of referrals not deemed appropriate for the clinic were admitted for inpatient management. Conclusion By providing suitable guidance for referring practitioners we have optimised our clinic use significantly and improved our acute ambulatory surgical care. We have reduced admissions, provided rapid treatment and have established a service that helps address the ever increasing demand on acute services within the NHS.

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Study on Lithium Monitoring amongst Patients in a Community Mental Health and Primary Care Setting in Rural England (2017)

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Type of publication:
Journal article

Author(s):
*Nicholas Savage , Jessica Green, Madhavan Seshadri, Madhusudan Deepak Thalitaya

Citation:
Psychiatria Danubina, 2017; Vol. 29, Suppl. 3, pp 481-486

Abstract:
Background: Lithium is widely used as a mood stabilizer in managing Bipolar Disorder. It is also licensed as an augmenting agent for recurrent depression and treatment resistant depression. However, it has a narrow therapeutic index with potentially significant side effects and adverse drug interactions. Toxicity is one of the main concerns for prescribers and serum levels should be checked regularly. Also, due to the adverse effects on Kidneys and Thyroid, there are strict guidelines to monitor the kidney as well as thyroid functions periodically. Whilst the need to monitor blood biochemistry is well established, less well recognized is the need to monitor patients’ physical health by means of annual checks of Body Mass Index (BMI) and waist circumference.
Aim: The purpose of this study was to investigate compliance against the NICE CG185 guidelines. Hereford is a rural town in England with a population of about 180000. Currently, the Herefordshire part of 2gether Mental Health NHS Foundation Trust does not have clearly agreed shared care protocols for Lithium monitoring. Lithium monitoring is done by GPs as part of QOF targets. As Psychiatrists recommend treatment with lithium, they have the responsibility to have an updated results and act on these appropriately. Therefore, an important aspect of this audit was to identify monitoring gaps that may result from the dual ownership of patient care.
Results: We found that 80% of cases complied with NICE guidance as regards blood monitoring however, only 40% of cases were compliant as regards checks on the physical health parameters of BMI and weight.
Conclusion: The blood biochemistry of patients on lithium is generally well monitored however, physical health assessment is rarely completed with the required annual frequency and, waist circumference is almost never measured; either on initiation of lithium therapy or, on an on-going basis. More needs to be done to promote awareness of the need to monitor the physical health of
patients on lithium and, in particular, to ensure that these checks include measurement of waist circumference. We believe that to improve monitoring of patients on lithium, shared care protocols should be developed between mental health services and GP services.

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Osteonecrosis of the jaw and oral health-related quality of life after adjuvant zoledronic acid: An adjuvant zoledronic acid to reduce recurrence trial subprotocol (BIG01/04) (2017)

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Type of publication:
Journal article

Author(s):
Rathbone E.J.; Brown J.E.; Coleman R.E.; Marshall H.C.; Collinson M.; Liversedge V.; Murden G.A.; Cameron D.; Spensley S.; *Agrawal R.; Jyothirmayi R.; Chakraborti P.; Yuille F.; Bell R.

Citation:
Journal of Clinical Oncology; Jul 2013; vol. 31 (no. 21); p. 2685-2691

Abstract:
Purpose: In patients with early breast cancer, adjuvant zoledronic acid (zoledronate) may reduce recurrence and improve survival. However, zoledronate is associated with the occasional development of osteonecrosis of the jaw (ONJ). We report on the frequency of ONJ and investigate oral health-related quality of life (Oral-QoL) in a large randomized trial (Adjuvant Zoledronic Acid to Reduce Recurrence [AZURE]). Patients and Methods: Three thousand three hundred sixty women with stage II or III breast cancer were randomly assigned to receive standard adjuvant systemic therapy alone or with zoledronate administered at a dose of 4 mg for 19 doses over 5 years. All potential occurrences of ONJ were reported as serious adverse events and centrally reviewed. Additionally, we invited 486 study participants to complete the Oral Health Impact Profile-14 (OHIP-14) to assess Oral-QoL around the time the patients completed 5 years on study. Multivariable linear regression was used to calculate mean scores and 95% CIs in addition to identifying independent prognostic factors. Results: With a median follow-up time of 73.9 months (interquartile range, 60.7 to 84.2 months), 33 possible cases of ONJ were reported, all in the zoledronate-treated patients. Twenty-six cases were confirmed as being consistent with a diagnosis of ONJ, representing a cumulative incidence of 2.1% (95% CI, 0.9% to 3.3%) in the zoledronate arm. Three hundred sixty-two patients (74%) returned the OHIP-14 questionnaire. Neither the prevalence nor severity of impacts on Oral-QoL differed significantly between zoledronate patients and control patients. Conclusion: Adjuvant zoledronate used in the intensive schedule studied in the AZURE trial is associated with a low incidence of ONJ but does not seem to adversely affect Oral-QoL.

Tendon end separation with loading in an Achilles tendon repair model: comparison of non-absorbable vs. absorbable sutures (2017)

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Type of publication:
Journal article

Author(s):
*Carmont M.R.; Kuiper J.H.; Gravare Silbernagel K.; Karlsson J.; Nilsson-Helander K.

Citation:
Journal of Experimental Orthopaedics; Dec 2017; vol. 4 (no. 1)

Abstract:
Background: Rupture of the Achilles tendon often leads to long-term morbidity, particularly calf weakness associated with tendon elongation. Operative repair of Achilles tendon ruptures leads to reduced tendon elongation. Tendon lengthening is a key problem in the restoration of function following Achilles tendon rupture. A study was performed to determine differences in initial separation, strength and failure characteristics of differing sutures and numbers of core strands in a percutaneous Achilles tendon repair model in response to initial loading. Methods: Nineteen bovine Achilles tendons were repaired using a percutaneous/minimally invasive technique with a combination of a modified Bunnell suture proximally and a Kessler suture distally, using non-absorbable 4-strand 6-strand repairs and absorbable 8-strand sutures. Specimens were then cyclically loaded using phases of 10 cycles of 100 N, 100 cycles of 100 N, 100 cycles of 190 N consistent with early range of motion training and weight-bearing, before being loaded to failure. Results: Pre-conditioning of 10 cycles of 100 N resulted in separations of 4 mm for 6-strand, 5.9 mm for 4-strand, but 11.5 mm in 8-strand repairs, this comprised 48.5, 68.6 and 72.7% of the separation that occurred after 100 cycles of 100 N. The tendon separation after the third phase of 100 cycles of 190 N was 17.4 mm for 4-strand repairs, 16.6 mm for 6-strand repairs and 26.6 mm for 8-strand repairs. There were significant differences between the groups (p < 0.0001). Four and six strand non-absorbable repairs had significantly less separation than 8-strand absorbable repairs (p = 0.017 and p = 0.04 respectively). The mean (SEM) ultimate tensile strengths were 4-strand 464.8 N (27.4), 6-strand 543.5 N (49.6) and 8-strand 422.1 N (80.5). Regression analysis reveals no significant difference between the overall strength of the 3 repair models (p = 0.32) (4 vs. 6: p = 0.30, 4 vs. 8: p = 0.87; 6 vs. 8: p = 0.39). The most common mode of failure was pull out of the Kessler suture from the distal stump in 41.7% of specimens. Conclusion: The use of a non-absorbable suture resulted in less end-to-end separation when compared to absorbable sutures when an Achilles tendon repair model was subject to cyclical loading. Ultimate failure occurred more commonly at the distal Kessler suture end although this occurred with separations in excess of clinical failure. The effect of early movement and loading on the Achilles tendon is not fully understood and requires more research.

An unusual case of breathlessness and a dry cough (2017)

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Type of publication:
Conference abstract

Author(s):
*Iftikhar S.; *Green N.J.; *Perks W.

Citation:
American Journal of Respiratory and Critical Care Medicine; 2017; vol. 195

Abstract:
A 77 year old female presented with new onset breathlessness over the previous four weeks. The patient described symptoms of fatigue and one episode of near fainting. Previously she had been active with good exercise tolerance. There was a history of gastro-oesophageal reflux. Medication included omeprazole, zopiclone and citalopram on a regular basis. The patient was a life long smoker, smoking ten cigarettes daily. Alcohol intake was up to 20 units per week. The patient's mother had died of breast cancer and father of pulmonary emphysema. On examination, the patient looked unwell. Blood pressure was 120/60 mm Hg; pulse 120 bpm; and oxygen saturation 97% by pulse oximetry. The patient weighed 60 Kg and denied any weight loss. Cardiovascular, respiratory and abdominal examination was unremarkable. A resting ECG showed sinus tachycardia with first degree heart block. A 24 hour ECG tape and 24 hour blood pressure monitoring showed no significant abnormality. Blood results showed low haemoglobin at 96 g/dl with normal red cell morphology, platelets 675 x 109 /L, white cell count 12.9 x 109 /L (with slightly elevated neutrophils, lymphocytes, monocytes and eosinophils), ESR 88 mm/hour, serum sodium 128 mmol/L, albumin 32 g/L, alkaline phosphatase 135 u/L, AST 55 u/L, ALT 122 u/L, GGT 70 u/L, calcium 2.2 mmol/L and glucose 7.5 mmol/L. A vasculitic screen was negative. Urinalysis revealed proteinuria. A CT scan, that showed marked ground glass change and mosaic attenuation, was discussed at a weekly X-ray meeting. The diagnosis of post viral pneumonitis was made. The patient died suddenly at home two weeks later just prior to a follow up hospital appointment. Post mortem examination revealed interstitial pneumonia (UIP) with focal pulmonary fibrosis and small areas of honeycomb change (fig. 1 & 2). The heart was morphologically normal, but showed myocarditis in which the infiltrate consisted of small T lymphocytes and eosinophil polymorphs (fig. 3). We postulate an association between UIP and lymphocytic myocarditis, which has rarely been described in the literature before.

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Analysis of doctors and nurses confidence with the use of in and out urinary catheters for collection of urine samples (2017)

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Type of publication:
Conference abstract

Author(s):
*Fox H.; *Gupta M.

Citation:
Archives of Disease in Childhood; May 2017; vol. 102, Suppl. 1

Abstract:
Background NICE recommends collecting urine by a clean catch sample to diagnose urinary tract infection (UTI), but if not possible or practical, to use urinary catheters (UC) to collect urine. Despite a policy to obtain clean catch urine, we have noticed high contamination rates, especially in infants. This creates diagnostic uncertainty, leading to unnecessary investigations and overuse of antibiotics. Using a UC to obtain urine can reduce rates of contamination, but experience among staff is low in our department as UC are not commonly used for this purpose. In this survey we explore the confidence, competence and training of staff with UC for collection of urine samples. Methods A survey of medical and nursing staff was undertaken during a typical working week in October 2016. We asked about their experience, confidence and competence with insertion of UC to obtain urine samples in children. Results were analysed using Microsoft Excel. Results 30 staff completed the questionnaire including 12 nurses, 3 advanced paediatric nurse practitioners (APNP), 9 tier 1 doctors (Foundation, GP and CT1-3 paediatrics trainees) and 6 tier 2 doctors (CT4 and above). 33% of Band 5 nurses, 67% of band 6 nurses, 75% of Tier 1 paediatric trainees and none of the foundation and GP trainees have inserted a UC in children. 50% of junior doctors and 53% nurses have never received training on UC insertion in children. 7% of all nurses and 67% of all doctors feel competent with insertion of UC in boys, whereas 40% of all nurses and 53% of all doctors surveyed feel competent with insertion of UC in girls. Conclusion This survey identified that experience of UC insertion is low among nursing and junior medical staff, which is reflected in their perceived competence. This may be due to infrequent use of this procedure. Most staff identified the need for more training. Therefore we recommend using a standard operating procedure to allow structured training of junior medical and nursing staff. Considering UC more often in clinical practice will improve confidence and maintain competency of staff, and reduce the incidence of contaminated urine samples, especially in infants.

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