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ObjectiveTo evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer.DesignPragmatic, cluster randomised trial.Setting20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care.ParticipantsAll patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires.InterventionsProactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle.Main outcome measuresThe primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life.ResultsBaseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively.ConclusionsProactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant.Trial registrationClinicalTrials.govNCT02485678.

OBJECTIVE--To assess the quality of preregistration house officer training in eight English regions. DESIGN--Postal questionnaire. SETTING--Thames, East Anglian, Mersey, Northern, and Wessex regions. PARTICIPANTS--1670 preregistration house officers. MAIN OUTCOME MEASURES--Education, hours of work, workload, conditions of work, and attitudes to job and medicine as a career. RESULTS--Response rate was 69% (1146 replies). Most house officers had attended induction courses (1036/1129 (92%)); 74% (757/1024) found them satisfactory. The proportions who had never received adequate guidance on how to break bad news and how to control pain were 59% (670/1135) and 56% (634/1136) respectively. There was much variation between regions. Overall, 65% (736/1138) reported confidence in performing cardiopulmonary resuscitation. Most respondents (95% (1089/1142)) worked an on call rota, 3% (36) a partial shift, and 0.6% (seven) a full shift; 19% (202) were on duty for average weekly hours that exceeded the targets for 1 April 1993. House officers had a median of 20 patients under their care and clerked a median of 10 emergency cases, six routine cases, and two day cases a week. Over half (690/1128 (61%)) could not obtain hot food after 8 pm, 20% (223/1095) did not always have clean sheets available in their on call room, and 45% (462/1036) did not consider the protection of staff against violence to be adequate at their hospital. The most important problems with the preregistration year were inappropriate or non-medical tasks (ranked first by 360 respondents), hours of work (359), and pay for out of hours work (167). Overall 57% (646/1125) would encourage a friend to apply for their post, but only 24% (266/1112) would encourage a friend to take up medicine and 44% (494/1112) would discourage the idea. CONCLUSIONS--House officers' training is deficient in important respects, with inappropriate tasks and heavy clinical workloads impeding the provision of proper education.

While acknowledging the severe harm done by smoking, there are reasons to discourage a complete ban on smoking in hospital grounds.1 In 2008, implementation of a total smoking ban was associated with a sharp increase in the number of fires on psychiatric units.2 In October 2008 a major fire at the secure unit …

(a) Swenson operation-end to end anastomosis intussuscepting aganglionic and ganglionic bowel through anus and resection and anastomosis along dotted line. (b) Duhamel operation -anterior aganglionic and posterior ganglionic bowel. The dotted line indicates the staple closure and knife division between the two portions of bowel. (c) Soave operation-mucosa is removed, a muscular cuff of the aganglionic bowel is left and ganglionic bowel is pulled through to hang from the anus.

We need to ensure that equity exists for access to effective and expensive treatments I n an era when encouraging headlines for the treatment of cancer seem to come and go, the results of randomised trials of adjuvant trastuzumab for treating breast cancers that overexpress human epidermal growth factor receptor 2 (HER2) have been rightly viewed as “stunning.”1 The implications are relevant not only to patients with respect to significantly reducing the risk of cancer recurrence and death but also to all involved in the delivery of health care. We need to ensure that the process for funding of these highly effective treatments remains equitable not only between patients with different types of cancer but also between patients in different countries. HER2 normally helps in the regulation of cell proliferation. Amplification of the HER2/neu oncogene occurs in 25-30% of human primary breast cancers and portends a poorer prognosis.2 Trastuzumab is a recombinant humanised monoclonal antibody directed against HER2. The success of trastuzumab is an example of true …

In contrast to pharmaceuticals, new surgical and other invasive procedures often enter clinical practice without assessment of their safety and efficacy. There is usually no guidance on their use. As a result, patients are offered treatments without access to adequate information on the nature and likelihood of benefits and harms; clinicians are left uncertain as to which innovations to adopt; and hospitals and healthcare systems have difficulty managing the risks that these procedures pose.1 Why does this happen? A fundamental reason is the poor evidence base for new interventional procedures, which has a number of causes. Unlike new pharmaceuticals, procedures do not usually have a commercial sponsor, which makes research harder to fund. When procedures entail a medical device, manufacturers have some incentive to fund evaluations, but differences in the regulatory regimes for drugs and devices, and in manufacturers' priorities for investment in research, mean that randomised trials are scarce. For example, novel designs of hip prostheses came to market with limited evaluation of their clinical performance.2 When research exists, widespread reliance on study designs without randomisation or even controls makes it hard to assess the validity of a procedure's apparent benefits. Follow up is commonly too short to show how often the condition relapses or late complications arise. Patients in evaluations are sometimes highly selected and the researchers are particularly skilled pioneers, limiting the results' generalisability and making reporting bias a concern. Particularly important is the fact that evaluations often have too few patients to detect important but less frequent complications of treatment. For example, the available evidence on laparoscopic helium plasma coagulation for endometriosis consists of three case series, none of which has been published in peer reviewed journals; they report on fewer than 100 patients in total. Uncertainties may prevail about the meaning and value of the outcomes reported in studies of new interventional procedures. Data on outcomes that matter to patients and their doctors are of prime importance but often elusive. For example, radiofrequency ablation shrinks liver tumours, but little research exists on its effects on patients' symptoms and survival.3 Another difficulty is that a procedure's clinical impact is often highly dependent on the skill of the clinician doing it. Clinicians working in settings less favourable than those from which major series have been reported will have to climb the learning curve and may not even then achieve such good results. Also, procedures may evolve and change appreciably, especially when they are new. There may also be cultural and educational reasons why interventional clinicians do not find rigorous evaluation attractive. These may include the clinicians' decisive approach to clinical practice and their personal involvement in procedures.4 They may then be less willing to recognise the existence of uncertainty and undertake research to reduce it. The problem is not confined to new interventional procedures: more widely, treatments in general surgery are half as likely as treatments in general medicine to be based on randomised controlled trials.5,6 The benefits and harms of new interventional procedures need to be considered together, and compared with existing treatments and no treatment. For example, laser in situ keratomileusis (LASIK) is used to treat myopia, a usually minor impairment corrected with great safety and effectiveness with spectacles or contact lenses. Even a low rate of complications might lead some patients to have qualms about the procedure. By contrast, people with an otherwise untreatable and rapidly fatal cancer might accept a procedure with a high immediate mortality after which survivors are likely to be cured. Many innovations bring positive advantages which patients, clinicians, and healthcare systems value. However, lack of information on their benefits and harms brings unnecessary risk and may militate against their widespread use. What can be done? Firstly, clinicians need to do better research, from their first use of a new procedure. They need more training in how to evaluate their innovations, more collaboration with researchers skilled in evaluating health technologies, and more funding. Secondly, manufacturers of medical devices need to do more than the minimum required by their regulators and to show by research if their products change patients' outcomes. Thirdly, healthcare systems need to support responsible clinical innovation by providing guidance, not least to ensure that patients are fully informed before deciding whether to accept an interventional procedure. In the United Kingdom, the National Institute for Clinical Excellence (NICE) has an interventional procedures programme (www.nice.org.uk/ip), which aims to improve care for patients by specifying the conditions under which a new interventional procedure should be used.7 For procedures with uncertain safety and efficacy, these include actively managing the uncertainty in a way that minimises risk. This means enhancing consent arrangements for patients so that they understand what is known and what is not; working with hospital clinical governance staff to manage the risks that the procedures may create; and monitoring outcomes by clinical audit or research. NICE guidance describes the limitations in the existing evidence, and, for selected procedures, NICE commissions systematic reviews and primary research. No clinical guidance can remedy the underlying reasons for the limited attention given to evaluating procedures. Their potential for helping and harming patients is similar to that of pharmaceuticals, yet investment in gauging their benefits and harms is much less. Until this is addressed patients will continue be exposed to poorly understood risks, and uncertainty will continue to hamper the safe introduction of interventional procedures into routine clinical practice.

Siontis and colleagues’ conclusion that comparison of risk prediction models for cardiovascular disease “would benefit from standardised reporting and formal, consistent statistical comparisons” is only part of the story.1 …

This article is published under a Creative Commons Attribution Non Commercial (CC BY-NC 3.0) licence that allows reuse subject only to the use being non-commercial and to the article being fully attributed (http://creativecommons.org/licenses/by-nc/3.0). Objective - To evaluate current risk models and scores for type 2 diabetes and inform selection and implementation of these in practice. Design - Systematic review using standard (quantitative) and realist (mainly qualitative) methodology. Inclusion - criteria Papers in any language describing the development or external validation, or both, of models and scores to predict the risk of an adult developing type 2 diabetes. Data sources - Medline, PreMedline, Embase, and Cochrane databases were searched. Included studies were citation tracked in Google Scholar to identify follow-on studies of usability or impact. Data extraction - Data were extracted on statistical properties of models, details of internal or external validation, and use of risk scores beyond the studies that developed them. Quantitative data were tabulated to compare model components and statistical properties. Qualitative data were analysed thematically to identify mechanisms by which use of the risk model or score might improve patient outcomes. Results - 8864 titles were scanned, 115 full text papers considered, and 43 papers included in the final sample. These described the prospective development or validation, or both, of 145 risk prediction models and scores, 94 of which were studied in detail here. They had been tested on 6.88 million participants followed for up to 28 years. Heterogeneity of primary studies precluded meta-analysis. Some but not all risk models or scores had robust statistical properties (for example, good discrimination and calibration) and had been externally validated on a different population. Genetic markers added nothing to models over clinical and sociodemographic factors. Most authors described their score as “simple” or “easily implemented,” although few were specific about the intended users and under what circumstances. Ten mechanisms were identified by which measuring diabetes risk might improve outcomes. Follow-on studies that applied a risk score as part of an intervention aimed at reducing actual risk in people were sparse. Conclusion - Much work has been done to develop diabetes risk models and scores, but most are rarely used because they require tests not routinely available or they were developed without a specific user or clear use in mind. Encouragingly, recent research has begun to tackle usability and the impact of diabetes risk scores. Two promising areas for further research are interventions that prompt lay people to check their own diabetes risk and use of risk scores on population datasets to identify high risk “hotspots” for targeted public health interventions. Tower Hamlets, Newham, and City and Hackney primary care trusts and National Institute of Health Research.

We recently admitted a man in his 80s with poor glycaemic control and osmotic symptoms. His medical history included chronic kidney disease, macrocytic anaemia, hypothyroidism, hypertension, osteoarthritis, and splenectomy. Glycaemic control was managed by twice daily insulin. On admission, creatinine concentration was 147 µmol/L, urea 8.5 mmol/L, and potassium 5.1 mmol/L while taking lisinopril. He was taking no other drugs …

The present system by which new drugs enter the National Health Service is failing doctors and patients. It leads to prescribing and funding decisions being made on inadequate information, causes duplication of effort, and creates geographical inequities in the availability of drugs. We need a new approach which takes account of relative effectiveness and cost utility. Drugs in Britain are licensed on the basis of the applicant's evidence of efficacy, acceptable toxicity, and proper manufacture. Much of the information on which the decision is based is unpublished at the time of licensing, although the European licensing body, the Committee for Proprietary Medicinal Products, now publishes summaries of its opinions. Doctors then have to decide whether to prescribe the (often expensive) new drug and health authorities to allow or resist its use. They turn for help to local sources of advice such as drug and therapeutics committees. The doctors and pharmacists who provide advice at local level suffer from several handicaps. The published evidence is all they …

EDITOR—It is unfortunate that the remarkable life and achievements of Hamilton Naki were so inaccurately reported in the BMJ .1 He did not participate in the first heart transplant, did not ever operate on humans, nor ever work in Groote Schuur Hospital. Christiaan Barnard sequentially performed both historic donor and …

EDITOR—As a gynaecological teaching associate (GTA) myself, I'd like to respond to some of Syed Sohaib's comments in Lucy Cowdrey's article.1 “Using GTAs is only partially beneficial to students as these women all have normal anatomy. ” The most common criticism of the programme is that we have normal bodies and are unable to teach pathology. I do not think …

Preventing suicide and reducing excessive drinking are both priorities in the Health of the Nation.1 Chronically excessive alcohol consumption is common among patients attempting suicide, many of whom also take alcohol as part of a self poisoning episode.2 Questioning patients admitted to hospital with self poisoning about their alcohol consumption is therefore important, both to the management of their overdose and to identify excessive drinkers for later advice and follow up. We surveyed inpatients' notes to assess whether patients who had poisoned themselves had had their alcohol intake assessed. As part of the evaluation of a training intervention to improve the management of excessive alcohol consumption among inpatients, we examined the medical and nursing notes and discharge summaries of consecutive patients admitted over 28 weeks to four general medical wards at a …

To examine the possibility that cytotoxic drugs may cause sterility or congenital malformations in the offspring of women of childbearing age who are cured of cancer a study was conducted of the obstetric histories of 445 long term survivors treated in this unit with chemotherapy for gestational trophoblastic tumours between 1958 and 1978. After completing treatment 97% of those who wished for a pregnancy (49% of all women studied) conceived and 86% had at least one live birth. All these women had received methotrexate. Of the 47 women who wished to conceive and whose combination therapy included cyclophosphamide, 37 (79%) had a live birth. Women who received three or more drugs were less likely to have a live birth than those who received methotrexate alone or with only one other drug (p less than 0.001). There was no statistically significant excess of congenital malformations. These results are strong evidence that the cytotoxic drug regimens used in this unit for treating gestational trophoblastic tumours are compatible with the preservation of fertility in most women and not associated with any increase in congenital abnormalities.

To try to establish whether mechanical stress and muscular activity in earlier life influence the incidence and severity of spinal osteoporosis in old age lateral x-ray films of the lumbar vertebrae were obtained from three matched groups, each of 100 women 50 to 90 years old. Group A was of rural Bantu accustomed to carrying heavy loads on their heads. Group B was of urban Bantu, mainly in domestic service. Group C was of women of European origin. Severe osteoporosis occurred in three cases from group A, two from group B, and 14 from group C. Lesser degrees of osteoporosis could not be assessed precisely enough for inclusion in these figures. Evenly biconcave vertebral bodies, strongly suggestive of osteomalacia, were seen in 10 from group A, five from group B, and one from group C. In many Bantu subjects the fifth lumbar vertebra appeared flattened though of good radiodensity and with no marked changes in the other vertebrae. Twenty-eight of these were from group A, 16 from group B, and none from group C. About a third of each group showed severe degenerative changes in the spine; another third showed milder changes. More cases of spondylolisthesis occurred in the Bantu groups than in the white group. Severe calcification in the abdominal aorta was noted in 24 women in group C. Mild signs occurred in 35 further women from group C, in six from group B, and in only one from group A.

In our first 200 cases of primary hyperparathyroidism confirmed by operation 12 were also shown to have a long history either of a malabsorption syndrome or of chronic renal-glomerular failure. We consider that they first went through a phase of secondary hyperparathyroidism, during which one or more of the glands became autonomous adenamata. This then produced the biochemical changes of "primary" hyperparathyroidism, necessitating excision of the adenoma. This condition is best described as "tertiary" hyperparathyroidism. The transition from secondary to tertiary hyperparathyroidism occurred in four of the 12 patients while under our observation. We think the same process can be traced retrospectively in the other eight cases. The concept of tertiary hyperparathyroidism may help to explain the high incidence of other diseases in association with primary hyperparathyroidism.The behaviour of the parathyroid glands provides a valuable model for the investigation of tumour formation in man. All states occurred in our patients with primary hyperparathyroidism, from normal through hyperplasia to adenoma formation and finally to parathyroid carcinoma.