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The first issue of Current Researches in Anesthesia and Analgesia appeared in August 1922 as a bimonthly publication of the National Anesthesia Research Society (NARS), the organizational precursor (1919-1925) of the International Anesthesia Research Society (IARS). The linear descendent, Anesthesia & Analgesia, now produced monthly, is the oldest active publication devoted specifically to the specialty of anesthesiology. The 75th anniversary of Anesthesia & Analgesia provides an opportunity to review its history, as well as that of the IARS, and to celebrate the achievements of both. The early history of the Journal and the Society was documented by Dr. T. H. Seldon on the occasion of the 50th anniversary of the Journal, then titled Anesthesia and Analgesia…Current Researchers [1]. Enough of that earlier information is included in this article to provide continuity for the more recent history. Also recalled is the key role played by the IARS in the creation of the World Federation of Societies of Anaesthesiologists (WFSA) and in the first WFSA Congress. Several newer programs of the Journal and Society include the 1983 establishment of the IARS Research Awards Program, affiliations beginning in 1994 between Anesthesia & Analgesia and several subspecialty societies in anesthesiology, and the 1996 development of The Electronic Anesthesiology Library (TEAL) project. A tentative look at the future concludes this historical review. Anesthesia & Analgesia 1922-1997 In the 75 years since 1922, Anesthesia & Analgesia has had only five Editors, plus an interim Editor who was responsible for the final three Journal issues of 1939. It is convenient to examine the history of Anesthesia & Analgesia and of the NARS/IARS within the time periods coinciding with the terms of the five Editors. Francis Hoeffer McMechan, MD (1922-1939) The early years of the NARS/IARS and the Journal were dominated by one man, Francis McMechan. A 1903 graduate of the College of Medicine of the University of Cincinnati, Ohio, he was the third generation of his family to practice medicine in southwestern Ohio. Early in his career, he had shown unusual skill in administering anesthetics, perhaps as the result of assisting his physician father in the care of patients. When the demands of colleagues for McMechan's anesthesia services rapidly engulfed the remainder of his general practice, he became one of the first full-time anesthetists in the country. Less than 2 years after his 1909 marriage to the vivacious and energetic actress, Laurette VanVarsveld, McMechan developed severe rheumatoid arthritis that stiffened and deformed him sufficiently to confine him to a wheelchair, rapidly making him dependent on others for his every need. This skeletal deformity caused McMechan to learn to sleep sitting in a chair, so that his eventually fused body could always be accommodated in the wheelchair that offered him the mobility to travel the world. As a result, his wheelchair was described as a device that contained, but never confined, Francis McMechan. Deprived of the ability to practice medicine, McMechan's boundless energies shifted to managing and promoting the literature of the fledgling specialty of anesthesia and assisting with the development of its organizations. Throughout his life, he was a major catalyst in the evolution of our profession. In 1908, a group of interested anesthetists began to meet regularly with McMechan to discuss current problems and interests. At the 1912 meeting of the American Medical Association (AMA), those present from the discussion groups established the American Association of Anesthetists (AAA), whose first formal meeting held in Minneapolis, Minnesota, at the time of the 1913 meeting of the AMA. After the onset of World War I, McMechan became secretary of the AAA. A dearth of research in anesthesia prompted a group of practitioners of anesthesia, researchers involved with the specialty, and representatives of related industries to meet at the Union Club in Cleveland, Ohio, on December 18, 1919 [1]. There they formed the NARS. As time passed, however, the presence of industry representatives in the NARS provoked such controversy among the membership that the group failed to thrive. Consequently, at a 1925 meeting in Cleveland, Ohio, the NARS was reorganized as the IARS, with a new constitution that excluded industry representatives. McMechan became the Secretary General of the revised organization as well as the Editor of its journal. Before World War I, increasing literature in the field had prompted McMechan to seek assistance from his friend, Dr. Joseph MacDonald, Jr., the Managing Editor of the American Journal of Surgery. Together they developed within the American Journal of Surgery the Quarterly Supplement of Anesthesia and Analgesia, with McMechan as its Editor. The Supplement was first published in October 1914, with a subtitle indicating that it was the American Journal of Anesthesia and Analgesia (Figure 1). Initially, it was the official organ of the American Association of Anesthetists and the Scottish Society of Anesthetists [2]. In time, the society linkages changed and expanded so that by July 1921, the Supplement served as the official organ of the AAA, the NARS, the Inter-State Association of Anesthetists, the New York Society of Anesthetists, and the Providence (RI) Society of Anesthetists. Quarterly publication continued until 1926, when the American Journal of Surgery changed management and the Supplement was discontinued.Figure 1: Cover page from the first issue of the Quarterly Supplement of Anesthesia and Analgesia of the American Journal of Surgery.The death of Dr. MacDonald in 1922 apparently catalyzed McMechan's concerns about existing publications in the new specialty and whetted his desire to establish a major scientific periodical independent of the parental influence of another journal. As a result, he originated Current Researches in Anesthesia and Analgesia, the first issue of which was published in August 1922 (Figure 2) under the sponsorship of the NARS. The Quarterly Supplement of Anesthesia & Analgesia continued with McMechan as Editor but was no longer the official publication of the NARS. The British Journal of Anaesthesia started publication in 1923, making Current Researches in Anesthesia and Analgesia (and its lineage of renamed descendants; Anesthesia and Analgesia…Current Researches and the current Anesthesia & Analgesia) the oldest dedicated publication in the specialty. With the demise of the NARS in 1925, Current Researches in Anesthesia and Analgesia became the official organ of its successor, the current IARS.Figure 2: Cover of the first issue of Current Researches in Anesthesia and Analgesia, August 1922.The cover page of the initial issue of Current Researches in Anesthesia and Analgesia lists the six-man Board of Governors of the NARS and its 30-member Research Committee (Figure 3). Membership was open to physicians, dentists, and researchers holding doctor of philosophy degrees. McMechan was Executive Secretary of the Society, Chairman of its Research Committee, and Editor of its journal.Figure 3: Early organization of the National Anesthesia Research Society with Dr. F. H. McMechan as Executive Secretary, Editor, and Chairman of the Research Committee. From August 1922 issue of Current Researches in Anesthesia and Analgesia.Comments in the editorial foreword of the initial issue of Current Researches in Anesthesia and Analgesia (Figure 4) remain relevant today. From the outset, the mission of the NARS/IARS has been apolitical, with its focus being the advancement of the specialty of anesthesia through the publication of a journal, the support of research, and the conduct of annual Congresses. The new publication was intended to link the many small anesthesia societies that had evolved. The current affiliation of three other societies with the IARS in support of Anesthesia & Analgesia reaffirms that objective. Emphasis on international aspects of the specialty was an important role of the NARS and remains so with the IARS of today, as its early involvement with the WFSA indicates [3,5]. Support by the IARS of ongoing research currently constitutes a major program that is described later in this article.Figure 4: Editorial Foreword of the first issue of Current Researches in Anesthesia & Analgesia, August 1922.Dr. McMechan was very active in establishing and managing a number of anesthesia organizations during the 1920s and 1930s [1,4]. He was the originator and promoter of organized anesthesia. The AAA lasted until 1926, when it became part of the Association of Anesthetists of the United States and Canada, a group that eventually blended into the IARS early in the years during World War II. The Canadian Society of Anaesthetists appeared in 1920. Participating in the evolution of these and other societies despite his uncompromising physical limitations, McMechan and his ever-present wife/nurse/companion, Laurette, traveled the world as enthusiastic, widely respected ambassadors of the specialty. During the 1930s, Dr. McMechan's health deteriorated further. Because of their extensive travels together throughout North America, Europe, and Australia, Laurette McMechan had become a widely known and admired figure. Almost by default, she became an increasingly prominent influence in the affairs of the IARS and the Journal. The death of Dr. McMechan in June 1939 removed from the evolving specialty of anesthesia one of its most forceful and dynamic early leaders. Dr. Emanuel Klaus of Cleveland, Ohio, a member of the IARS Board, was appointed the interim Editor and was responsible for the final three issues of 1939. At a meeting of the IARS Board of Governors on October 16, 1939, the Board voted to "constitute themselves as a Board of Editors of the Publication of this Society Current Researches in Anesthesia and Analgesia reserving to themselves the power to review all manuscripts and copy to be published in the magazine." The Board also confirmed an earlier resolution (July 1, 1939) to appoint Laurette McMechan as Assistant Editor, and they made formal the appointment of the next Editor. Howard Dittrick, MB, MD (1940-1954) Dr. Howard Dittrick, a Cleveland gynecologist with strong interests in medical history and library activities, was appointed Directing Editor of Current Researches in Anesthesia and Analgesia effective with the first issue of 1940. A Canadian who received his medical degree at the University of Toronto in 1900 and his gynecological training in Cleveland, Ohio, and at Johns Hopkins Hospital in Baltimore, Maryland, Dittrick had practiced gynecology in the Cleveland area for several decades. From 1943 to 1947, he served as Head of the Department of Education at the Cleveland Clinic as well as its Director of Publications. Mrs. McMechan remained with the Journal as Assistant Editor and apparently became the major force in the maintenance of the publication. With the rapid maturation of the new journal, Anesthesiology, the official publication of the fledgling American Society of Anesthesiologists (ASA), competition for manuscripts was increasingly difficult for Current Researches in Anesthesia and Analgesia. Under less than vigorous direction from the Editor and the Board of Governors, it languished and lost readership. Dr. Dittrick continued as Directing Editor until his own death in 1954 at age 77. Despite his lack of professional connection to clinical anesthesiology, he frequently opined editorially in the Journal on a variety of subjects. Thomas Harry Seldon, MD (1954-1976) After Dr. Dittrick's death, Dr. Thomas Harry Seldon (always addressed as Harry), an anesthesiologist at the Mayo Clinic and a member of the IARS Board of Trustees since approximately 1949, volunteered for the editorship. Seldon had earned his medical degree from Queen's University in Kingston, Ontario, Canada, in 1929. He was a general practitioner in nearby Sharbot Lake until recruited by his friend, anesthesiologist Ralph Tovell, to Rochester, Minnesota, and a residency in anesthesiology at the Mayo Clinic. He remained a Consultant in Anesthesiology at Mayo until his retirement at age 65. Having been assigned to supervise the new transfusion service at St. Mary's Hospital, his innovative leadership earned him national recognition and leadership positions in blood banking. His editorship of Current Researches in Anesthesia and Analgesia was accomplished in addition to his full-time clinical responsibilities. Never slighting either task, he became known to neighbors as the gentleman whose study lights were on until the wee hours of most mornings. Harry was active in the American Medical Writers' Association, an organization from which he gleaned many new ideas for his meticulous process of rebuilding the Journal. With many innovative features designed to attract articles and readership, the publication gradually recovered its usefulness. To permit more appropriate referencing, in 1957 the IARS Board of Trustees approved the request of the Editor to change the name of the Journal to Anesthesia and Analgesia…Current Researches. Also in 1957, the Journal was enlarged from its historic pocket size to a 7 x 10 inch page that would be more useful for copy and could more The their but article appeared in for the first in the affairs of the Society had in the early Mrs. McMechan continued as Assistant Editor of the Journal with an annual from the IARS Board of Trustees until death in and throughout Harry as Editor, the IARS Trustees had as Editors and had the Editorial Board of the journal. In Dr. Seldon that his age by years of retirement from clinical practice, increasingly with his editorial He the at age an energetic as Editor. Harry in his of and innovative to the affairs of the Journal had its and its MD Dr. was appointed Editor in and began a new for the publication and the Dr. from The College of & of New in began a residency at Hospital, and served 2 years as a medical at Hospital, After from the he in anesthesiology with Dr. at General Hospital, and then with Dr. at the After a at he was appointed and Chairman of Anesthesiology at the University of Rochester, New of Medicine and in with an appointment in the Department of He was with the of the residency training program in the Department of years he to University to the Department of Anesthesiology as its and Chairman and also to be Director of the Department of Anesthesiology at the Medical New He remained in that for the next years to more time to other aspects of anesthesiology. During a career, his as a and He however, as an served first on the editorial Board of Anesthesiology from to and then as its from to When he was appointed of Anesthesia and Analgesia…Current Researches in to the a of and as an and as a His but always very and on the of the Journal it in new and to new its and its to become a member of the IARS Board of The Editorial Board were Editors, and most were of the Board of As a result of these the Journal became independent of but remained responsible to the IARS In the Journal a and was renamed Anesthesia & Analgesia. the the increasing number of manuscripts that it received that it In for publication was by the that had been for its and plus influence on the scientific of Anesthesia & Analgesia, to expanded and From the to and IARS research support for the specialty. Dr. remained until his retirement in a and well publication. Dr. for achievements been the in the T. H. Seldon at the IARS in the at the annual meeting of the and appointment as an of the College of Anaesthetists MD to The current Dr. was appointed in at a time of rapid of subspecialty societies in anesthesiology, as well as increasing of anesthesia specialty and these of developed the of a subspecialty its own within the of a general of anesthesiology. As a result, subspecialty of Anesthesia & Analgesia were with Editors for This to the scientific of their and to a within a new were established between several of the subspecialty societies and the Journal. New international were from Editor later to and Under Anesthesia & Analgesia is to the international influence of anesthesiology. In were by & in Baltimore, Anesthesia & Analgesia is to be in the of other of an important new in with The British Journal of Anesthesiology, and the Canadian Journal of was in Dr. is a graduate of the University of His anesthesia training and a in were at the University of in After 2 years in the United States during which he earned a with a for service in he to he has had a very In he became of and and in was appointed and Chairman of the Department of He served on the Editorial Board of Anesthesiology from to and was appointed of Anesthesia & Analgesia in he has been a member of the Editorial Board of the British Journal of Dr. has been the of many and as an of the College of Anaesthetists of the United and of the of Anaesthetists of the College of of he is the Editor of the of anesthesia. The of the IARS in the of the WFSA In an to anesthesiology the IARS held its with the Association of Anaesthetists of and in and 2 later at an anesthesia meeting in organized by about the of a organization to in which anesthesia was The received an was and Dr. of Canada, then also the Chairman of the IARS Board of was made its The IARS the of an expanded meeting in during which it was to with the establishment of the When to the the IARS in of the as the United States the the The first WFSA was held in in the in with Dr. as societies were by approximately The IARS the publication of the of the meeting and a copy to Harry Seldon of the and the extensive editorial With the leadership of Dr. the editorial of Dr. Seldon, and the IARS played a major role in the of the World of the involvement of the IARS, the United States would had no part in the initial development of the WFSA The WFSA membership as the United States until years several the IARS support for WFSA programs World the of the IARS has its as a WFSA it played a role in the development of the IARS The first of the NARS after the of its Journal, Current Researches in Anesthesia and Analgesia, was held at the in Ohio, from October to 1, successor, now the and of the IARS, was held at the in The World War caused the of the IARS from to and the was in of the first WFSA but of the IARS been held in the United in it was held in in in in and in The size and of IARS in the The review an and the of scientific as and Also were a and scientific The and the Journal the major programs of the Society, and with the Research Awards Program, to the mission of the IARS to advancement in the specialty. IARS Research Awards From the outset, the mission of the NARS/IARS included and support of research in anesthesia (Figure It was until 1983 that the of the Society became to that by support to the history of the IARS Research Awards that began with a in 1: IARS Research Awards three IARS Awards 2 been to support clinical research by Also in the IARS established the in Anesthesia Research of years and intended to and by an in the field of anesthesiology. The first was in to Dr. of the University of Ontario, the was in to Dr. of University of With this the IARS has to the support of anesthesia research since Society The McMechan included many between the NARS/IARS and other societies [1,4]. During the 1930s, those and with the of the with the WFSA the IARS continued on its own independent until the Several important new then developed between the IARS and the Canadian Society the IARS and the Society for Anesthesia then between Anesthesia & Analgesia and the British Journal of most recent affiliations with three subspecialty The IARS and the had a that was by a in that provides for IARS sponsorship of the for under the for for at annual and for among many other less formal but strong between the of the IARS and the Society for Anesthesia at the of the WFSA to a meeting that would between in and the The result was creation of the Anesthesia which first in in and has since held in the The American Anesthesia in for 2 the IARS Congress. The British Journal of Anaesthesia is the of the College of Anesthesia & Analgesia and the British Journal of Anaesthesia for and on Dr. of Anesthesia & Analgesia is a member of the Editorial Board of the British Journal of In the Society of Anesthesiologists with the IARS in Anesthesia & Analgesia, and the Journal became the official publication of societies This was in 1996 by the Society for Anesthesia and by the Society for Anesthesia & Analgesia is now the official publication of the IARS, Society of Society for and Society for The Editorial Board of the Journal from of the but it remains independent from The result of these important is a Journal that is published annual meeting and to approximately and In addition to the the IARS has a of less with other organizations. the WFSA provides the IARS with a of societies in whose library is As many as of these with a copy of the IARS in New New is a that to to care to in for at the is one of their programs been established in several the IARS has with of Anesthesia & Analgesia, and The Canadian Society International in Ontario, Canada, has the of to the Library of the Department of at the University of in In support of that the IARS to the Canadian Society International in 1996 that being to a for the and a to the project. is an new that years of from of the anesthesia & Analgesia, Anesthesiology, the British Journal of and the Canadian Journal of a It and by for in and be to include the most recent years of publication from of its This new the of Anesthesia & Analgesia that has been for a number of years from the and The most in North American medicine at this time, future for the IARS in than in The of a of and and continued on health care of the next to of the next to With that the IARS its for new and more innovative to support research and in anesthesiology. As for research become more and more continued support of the IARS in Anesthesia Research be increasingly There be an on in anesthesiology. The new Anesthesiology first at the IARS is one is on of and of Anesthesia & Analgesia into is a The and research with the societies that currently with the Journal be and the IARS remain open to with other specialty national organizations. At the time, the Society remain and As the and The with the assistance of F. Executive Chairman of the IARS Board of and Dittrick of Medical Cleveland Cleveland, Ohio.

NHS Evidence has accredited the process used by the British Association of Dermatologists to produce guidelines. Accreditation is valid for three years from May 2010 and is applicable to guidance produced using the processes described in the British Association of Dermatologists' guidelines development manual (Bell & Ormerod, 2009). More information on accreditation can be viewed at http://www.evidence.nhs.uk.Disclaimer These guidelines reflect the best published data available at the time the report was prepared. Caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations in this report. It may be necessary or even desirable to depart from the guidelines in the interests of specific patients and special circumstances. Just as adherence to the guidelines may not constitute defence against a claim of negligence, so deviation from them should not necessarily be deemed negligent. These guidelines are published simultaneously in the British Journal of Dermatology (DOI 10.1111/j.1365-2133.2010.09883.x) and the Journal of Plastic, Reconstructive & Aesthetic Surgery (DOI 10.1016/j.bjps.2010.07.006). These guidelines for the management of cutaneous melanoma present evidence-based guidance for treatment, with identification of the strength of evidence available at the time of preparation of the guidelines, and a brief overview of epidemiology, diagnosis, investigation and follow up. Contribution to these guidelines has been made by a large number of clinicians. They have also been endorsed by, or have had input from, representatives of the following groups or organizations: the U.K. Melanoma Study Group, the British Association of Dermatologists, the British Association of Plastic, Reconstructive and Aesthetic Surgeons, the Royal College of Physicians, London, the Association of Cancer Physicians, the Royal College of Radiologists, London, the Royal College of Surgeons of England, the Royal College of Pathologists (pathology section only), the Royal College of General Practitioners, London, and the Department of Health. These consensus guidelines have been drawn up by a multidisciplinary working party with membership drawn from a variety of groups and coordinated by the U.K. Melanoma Study Group and the British Association of Dermatologists. The guidelines deal with aspects of the management of melanoma from its prevention, through the stages of diagnosis and initial treatment to palliation of advanced disease. PubMed literature searches for this guidelines revision were carried out to identify publications from 2000 to April 2010, with search terms including: melanoma genetics, epidemiology, early diagnosis, risk factors, clinical features, pathology, surgery, chemotherapy and clinical trials. Relevant materials were also isolated from reviews and other publications identified from the PubMed searches, independent searches carried out by the authors, as well as materials collected by the authors as part of their ongoing professional interest in the latest developments in this clinical area. Levels of evidence to support the guidelines are quoted according to the criteria stated in Appendix 1. The consultation process for British Association of Dermatologists guidelines and their compliance with guideline recommendations have been published elsewhere.1, 2 There are arguments in favour of newer guideline grading methods, such as those of GRADE,3 but the authors believe that the system used here allows greater potential for consensus in areas of conflicting evidence or where evidence sources are not directly comparable. In some instances, this is not due to an absence of high quality (Level Ib) trials but because different entry criteria or endpoints preclude direct comparison of results; in other cases interpretation of the clinical significance of results has been challenged. To assist production of unified guidelines taking account of these issues, the ‘quality of evidence’ grading used in these guidelines differs slightly from that used in other British Association of Dermatologists current guidelines; the ‘strength of recommendations’ grading is the same as used in many other publications. Where no level is quoted the evidence is to be regarded as representing Level IV (i.e. a consensus statement). The intention of the working party was to agree best practice for the management of melanoma in the belief that this will promote good standards of care across the whole country. However, they are guidelines only. Care should be individualized wherever appropriate. These guidelines will be revised as necessary to reflect changes in practice in light of new evidence. Multidisciplinary care of the patient is held to be the most desirable model, as recommended in the Calman/Hine report.4 This has been defined by the National Institute for Health and Clinical Excellence (NICE) Improving Outcomes for People with Skin Tumours including Melanoma.5 Core services will be provided within each Cancer Network by Local Skin Cancer Multidisciplinary Teams (LSMDTs). Specialist services will be provided by Specialist Skin Cancer Multidisciplinary Teams (SSMDTs). For melanoma there is a clear demarcation of care such that more advanced primary melanoma, rare subtypes of melanoma, melanoma in children, and patients eligible for trial entry or sentinel lymph node biopsy (SLNB) should be promptly referred for investigation and treatment from an LSMDT to an SSMDT (Table 1). Individuals, and particularly children, should not get sunburnt (Level I).6-9 Meta-analysis of case–control studies provides good evidence that melanoma is caused predominantly by intermittent intense sun exposure; fair-skinned individuals should therefore limit their recreational exposure through life (Level I).10 People with freckles, red or blond hair, skin which burns in the sun, increased numbers of naevi, and those with a family history of melanoma are at increased risk and should heed this advice. Adequate sun exposure to allow vitamin D synthesis, or sufficient dietary intake of vitamin D3, is essential to human health; insufficiency of vitamin D is now recognized to be common.11 It would therefore be inappropriate to greatly limit sun exposure in people without the risk factors listed above. Recent studies have shown that in the U.K. vitamin D levels are often suboptimal in melanoma patients, and are lower in fair-skinned people.12, 13 Fair-skinned people who avoid the sun rigorously to reduce the risk of melanoma should consider supplementing their intake of vitamin D3 in the absence of medical contraindications. There is evidence from a recent meta-analysis that sunbed usage does increase the risk of melanoma, particularly under the age of 35 years, and therefore it is recommended that this should be avoided (Level Ia).14 Melanoma remains relatively uncommon and therefore the opportunity to develop diagnostic skills is limited in primary care. All lesions suspicious of melanoma should be referred urgently under the 2-week rule to local screening services usually run by dermatologists. In England and Wales, this would be to an LSMDT. In Scotland, referral should be made to a local Rapid Access Cancer Clinic according to Scottish Cancer Referral Guidelines. The seven-point checklist or the ABCD rule may be helpful in the identification of melanomas although they are more sensitive than specific.15-18 Urgent referral to the LSMDT is indicated where there is: • A new mole appearing after the onset of puberty which is changing in shape, colour or size • A long-standing mole which is changing in shape, colour or size • Any mole which has three or more colours or has lost its symmetry • A mole which is itching or bleeding • Any new persistent skin lesion especially if growing, if pigmented or vascular in appearance, and if the diagnosis is not clear • A new pigmented line in a nail especially where there is associated damage to the nail • A lesion growing under a nail Lesions which are suspicious for melanoma should not be removed in primary care. This is because clinicopathological correlation is vital for diagnostic accuracy, which in turn determines prognosis and defines adjuvant treatment options, and because diagnostic surgery requires specialist training. Early recognition of melanoma presents the best opportunity for cure15, 19-22 (Level III, Grade A). All patients presenting with an atypical melanocytic lesion or a large number of moles should have a complete skin examination and assessment of risk factors. The dermoscope is a useful tool for the trained clinician screening pigmented lesions, as it can increase diagnostic accuracy.23 It is also useful for monitoring multiple pigmented lesions where photography of dermoscopic images provides a record of change (Level Ia, Grade A). Recommendations for LSMDT record keeping of clinical features are provided in Table 2. There are some individuals at higher risk of melanoma who should be considered for referral to specialist clinics. These individuals can be divided broadly into two groups based upon the degree of risk: 1 Individuals at moderately increased risk (approximately 8–10 times that of the general population) should be counselled about this risk and taught how to self-examine for changing naevi, but long-term follow up is not usual. Such patients are those with either a previous primary melanoma or large numbers of moles, some of which may be clinically atypical (Level Ia, Grade B).24-28 Organ transplant recipients are also at this level of increased risk (Level III, Grade B).29, 30 2 Those at greatly increased risk of melanoma (more than 10 times that of the general population). Patients with a giant congenital pigmented hairy naevus (definitions include ‘20 cm or more in diameter’ and ‘5% of body surface area’) should be monitored by an expert for their life time because of the risk of malignant change, which is significant but poorly quantified (Level III, Grade B).31, 32 Excision biopsy of suspicious areas in large congenital naevi may be necessary but requires expert histopathological review. Patients with a strong family history of melanoma are also at greatly increased risk. In some families, most clearly in mainland Europe and North America, families at risk of melanoma are also at increased risk of pancreatic cancer.33 Those with three or more cases of melanoma or pancreatic cancer in the family should be referred to appropriate clinics managing inherited predisposition to cancer (involving dermatologists and/or clinical geneticists) for counselling. It is the consensus of the Melanoma Genetics Consortium (http://www.genomel.org) that it is premature to suggest gene testing routinely but this may change as more is known of the genes predisposing to melanoma.34 The risk to families associated with the presence of two family members affected with melanoma is lower. In these families, if affected individuals also have the atypical mole syndrome, or if there is a history of multiple primary melanomas in an individual or pancreatic cancer, then referral should also be made for counselling; otherwise family members should probably be considered at moderately increased risk. All of the above individuals at increased risk of melanoma should be advised on the specific changes that suggest melanoma and encouraged to undertake monthly skin self-examination (Level III, Grade B). Close-up and distant photography may be a useful adjunct to detecting early melanoma in either of these high-risk groups (Level III). They should be given written information and access to images of moles and melanomas. Such images are available at: http://www.genomel.org or http://www.rcplondon.ac.uk/pubs/contents/f36b1656-cc74-4867-8498-cc94b378312a.pdf. Recommendations for screening and surveillance of high-risk individuals are summarized in Table 3. A lesion suspected to be melanoma, or where melanoma needs to be excluded, should be photographed, and then excised completely. The axis of excision should be orientated to facilitate possible subsequent wide local excision; generally on the limb this will be along the long axis. If uncertain, direct referral to the multidisciplinary team (MDT) will allow appropriate planning for future surgery. The excision biopsy should include the whole tumour with a clinical margin of 2 mm of normal skin, and a cuff of fat. This allows confirmation of the diagnosis by examination of the entire lesion, such that subsequent definitive treatment can be based on Breslow thickness.35-37 Diagnostic shave biopsies should not be performed as they may lead to incorrect diagnosis due to sampling error, and make accurate pathological staging of the lesion impossible (Level III). For the same reasons partial removal of naevi for diagnosis must be avoided and partial removal of a melanocytic naevus may result in a clinical and pathological picture very like melanoma (pseudomelanoma). This gives rise to needless anxiety and is avoidable. Incisional or punch biopsy is occasionally acceptable, for example in the differential diagnosis of lentigo maligna (LM) on the face or of acral melanoma, but there is no place for either incisional or punch biopsy outside the skin cancer MDT (Level III). It is acceptable in certain circumstances to excise the lesion entirely but without repair, and to dress the wound while awaiting definitive pathology. Biopsies of possible subungual melanomas should be carried out by surgeons regularly doing so. The nail should be removed sufficiently for the nail matrix to be adequately sampled: clinically obvious tumour should be biopsied if present. Prophylactic excision of naevi, or of small (< 5 cm diameter) congenital naevi in the absence of suspicious features is not recommended (Level III, Grade D). Full clinical details should be supplied on the histopathology form, including history of the lesion, relevant previous history, site and differential diagnosis. All melanocytic lesions excised for whatever reason must be sent for histopathological review to the pathologist associated with the LSMDT or SSMDT. The diagnosis of melanoma, both in situ and invasive, should be given or supervised by doctors who have received advanced communication skills training, following local policies for breaking bad news. A skin cancer trained nurse should be present to provide continuing support. The Royal College of Pathologists has produced a minimum dataset which should be included in the histopathology report.38 Double reporting is recommended for all melanomas and all naevi showing severe dysplasia if resources allow this to be achieved within 14 days.5 The report should include the following: • Site of the tumour • Type of surgical procedure: excision or re-excision, incision biopsy, punch biopsy • Any other relevant clinical information Contour, colour and size of the tumour and the excised skin specimen in millimetres. Presence or absence of ulceration Ulceration has prognostic value, and its presence should be confirmed microscopically as full-thickness loss of epidermis with reactive changes which include a fibrinous exudate and attenuation or acanthosis of the adjacent epidermis. These distinguish true ulceration from artefact.39 Thickness The tumour should be measured from the granular layer of the overlying epidermis to the deepest cells in the dermis judged to be malignant, to the nearest 0·1 mm. Ulcerated tumours should be measured from the base of the ulcer. Tumour forming a sheath around appendages should be excluded when measuring thickness except when the melanoma extends out into the adjacent reticular dermis when it should be measured in the conventional manner. In the presence of histological regression thickness measurements should be of the residual melanoma. Microsatellites should not be included in thickness measurements (Level III, Grade B). Mitotic count The number of mitoses has prognostic value and is now included in the American Joint Committee on Cancer (AJCC) staging system for melanomas ≤ 1·0 mm.40, 41 It should be recorded as number of mitoses mm−2 in the area of greatest number of mitoses in the vertical growth phase (VGP). It has prognostic value at all thicknesses. Histological subtypes Desmoplastic melanoma with or without neurotropism should be recorded because of its different biological behaviour and clinical outcome.42 The subtypes superficial spreading, nodular, LM and acral lentiginous melanomas have good clinicopathological correlation, but their prognostic value has not been established. Margins of excision This indicates whether excision is complete and the minimum margin of excision to peripheral and deep aspects measured in millimetres. If the excision or re-excision is not complete, whether the tumour is in situ or invasive at the resection margin should be indicated. When possible a statement should be made of whether the lesion is primary or secondary melanoma. Pathological staging Staging using TNM and AJCC (Table 4), and coding, e.g. SNOMED, should be given.41 Growth phase Invasive melanoma without a VGP is termed microinvasion.43 The assessment of microstaging criteria should be applied to the VGP only. Regression The presence or absence of tumour regression has not been shown consistently to affect long-term outcome. Until its relevance is clear it should be reported as segmental replacement of melanoma by fibrosis, as this is subject to less observer variation.44 Tumour-infiltrating lymphocytes It remains unclear whether tumour-infiltrating lymphocytes have prognostic value.40 The categories absent, non-brisk and brisk are subject to wide observer variation. ‘Absent’ indicates no lymphocytes infiltrating among the tumour cells, but does not exclude lymphocytes in the surrounding dermis. ‘Non-brisk’ is a patchy or discontinuous infiltrate either among the peripheral cells or in the centre of the tumour, whereas ‘brisk’ is a continuous infiltrate but may be confined to peripheral cells. These are qualified as mild, moderate or severe in intensity. Lymphatic or vascular invasion Vascular or lymphatic infiltration has prognostic value, and its presence should be recorded even though it is infrequently observed.45 Perineural infiltration Perineural infiltration occurring beyond the main bulk of the tumour correlates with increased local recurrence. It is most commonly associated with desmoplastic melanoma.46 Microsatellites These are defined as islands of tumour mm in the the main invasive of melanoma, but from it by mm of normal (i.e. not tumour or of AJCC staging also requires that must be which has not been this may be subject to Microsatellites are of lymph node this is by naevus The presence of melanocytic naevus should be level of invasion This is a less of prognosis than thickness and is subject to observer It is not used to melanomas in the AJCC staging except that levels IV or may be used for melanoma in rare when count be in a melanoma. These are given in Table It may not be possible to distinguish a melanoma and a melanocytic Such patients must be referred to the SSMDT for clinical and pathological review. A to as a melanoma should be made by the SSMDT in with the Thickness should be measured as for melanoma. This needs to be in a so that are (Level III, Grade B). The should be either by or multiple although the is A minimum of should be but a higher of is by with at each The clinical relevance of the by these is of and and is and A are most but a such as is also appropriate. This gives prognostic The following are the of the from the of the sentinel lymph node the according to its either or measuring the of the of melanoma The pathological examination of following should include an to all lymph at at and count the number The presence of and of should be recorded with the size of the The of such as or A are not for patients with primary melanoma. are is not recommended for patients with and melanoma as this has a very of and high of Patients with particularly high-risk primary melanoma may staging if deemed appropriate by the SSMDT and/or as a to trial There is no for with other including and is not in detecting sentinel lymph and/or distant in patients with primary (Level Grade as has high and for lymph node and is the best but quoted from to with the higher achieved by sentinel node and of the sentinel node in all cases of staging by following a sentinel lymph and to has a very this should be after with an patient and the SSMDT (Level Grade D). In and IV melanoma, will be by the SSMDT. of the and will adequately exclude and is most relevant in melanoma planning lymph node and If patients are entry to an adjuvant following the of should be by the SSMDT to avoid When IV is suspected of the and whole body should be will be by clinical trial and for or of previous the of is to be clinically relevant in IV melanoma (Level III, Grade D). Where is may be useful in that make surgery should be measured in all patients with suspected IV melanoma. There is no for a in staging except where to possible disease. Staging are summarized in Table Surgery is the treatment for melanoma. excision for diagnosis and for of Breslow a and margin is to complete removal of the primary lesion, and to The of the excision has been to the or and there is no evidence to support this surgical excision for invasive melanoma on Breslow thickness and are based on trials including about patients, and a National of Health However, of these studies is adequately and two provide for detecting or due to exclude melanoma on the and and/or A recent review in favour of wide excision although the was not a but in wide and excision be trial evidence is to excision for primary cutaneous The recommended surgical are those measured clinically at the time of surgery, but of excision should be confirmed by review of re-excision an for of The about the size of the margin should be made by the after with the The should be made with of and of the margin All patients with primary melanoma and higher should be referred treatment to an SSMDT when this provides an When the SSMDT does not provide all primary melanomas or should be There are no data for margin size for LM or other in situ melanoma. LM and other in situ melanomas have no potential for and the should be to excise the lesion with a clear histological although margin size remains treatment is then LM is best by complete excision because of the risk of This may be on incisional biopsy due to sampling The risk of to invasive melanoma is poorly and in the very may be within their for some clinical treatment by other such as or may be There is evidence to support the of and this treatment may make subsequent to treatment with is as of value so should be used in the of a clinical If the patient with LM is by then the reason for this should be and clearly by the Local of LM in about of patients by 2 Excision with of surgical should be although histological is often to situ melanoma on acral and skin is also associated with a higher risk of local but this is less in other of in situ melanoma. In in situ melanoma should not but cases This may be due to histological regression a more advanced tumour, or after removal of in situ disease. There have been three of patients with melanomas in this thickness The recommended surgical are based on the Health Melanoma Group This trial 1 and cm for melanomas up to 2 mm local and were in patients with melanomas 1 mm in with either excision However, this was based on of data from The and studies 2 cm with 5 cm and the included patients with melanomas mm or more in thickness in this A 1 cm margin is deemed for this (Level Grade A). There have been studies that have included patients in this The a small of local as site of in the 1 cm There was no in 1 and cm but the was to The Melanoma 2 cm of excision for lesions of mm in was the two groups in either local or other studies have included patients with melanomas up to 2 also with either 2 or 5 cm There was no in the The 1 2 cm and 2 5 cm studies be but no using 2 cm as has shown of than However, trials of have either not been performed 1 2 cm or have been and not a that a 1 cm margin is Evidence to that a minimum margin of 1 cm is although 2 cm are appropriate. The will be by MDT and after with an patient (Level Grade A). The Melanoma no in of local patients with 2 and those with cm However, follow up in the 2 cm although this

What is Artificial Intelligence? Artificial intelligence (AI) refers to a computer mimicking “intellectual processes characteristic of humans, such as the ability to reason, discover meaning, generalize, or learn from past experience” to achieve goals without being explicitly programmed for specific action. There is no consensus on what constitutes AI. Different criteria for intelligence proposed have not satisfied everyone leading to the famous aphorism, “AI is whatever hasn’t been done yet.” For example, optical character recognition and translation has now been relegated from “artificial intelligence” because of the routine nature of their use.[12] The broad agreement is that any device which uses reason, devises strategy, solves puzzles, and makes “judgments under uncertainty representing knowledge, including commonsense knowledge, plans, learns, communicates in natural language and integrates all these skills towards common goals” demonstrates intelligence. Currently, in 2018, we can safely place activities such as understanding human speech, competing at the highest level in strategic game systems (such as chess and Go), driving autonomous cars, planning intelligent routing in content delivery network, and military simulations in the realm of AI.[3] Some famous authors mentioned different benchmarks. The most famous was the “Turing-Test” (1950) by Alan Turing where a human who converses with an unseen machine and an unseen human must guess which of the two is the machine. The machine passes this test if it fools the evaluator for 30% of the time. In 2014, a program called Eugene Goostman cleared this test.[4] Edward Feigenbaum in 2003 tweaked the “Turing-Test” to create “Subject-Matter-Expert-Turing-Test” or the “Feigenbaum-Test” where a machine's response cannot be distinguished from an expert in a given field. These are examples of “narrow-artificial intelligence.” The next higher goal is “artificial-general-intelligence,” where a model trained on one task can be re-purposed on a second related task, a concept called transfer learning.[3] We are some distance from it today. Artificial Intelligence and Strategy Games In 1997, IBM DeepBlue became the first computer chess-playing system to beat a reigning world chess champion, Garry Kasparov, in a full series. In 2011, IBM's Watson was crowned champion for beating the two greatest Jeopardy champions, Brad Rutter and Ken Jennings. In 2016, DeepMind's AlphaGo defeated Go champion Lee Sedol in an ancient strategy game played on a “19 × 19-board,” winning 4 out of 5 games, becoming the first computer to beat a professional Go player without handicaps. In 2017, AlphaGo won a three-game match with world No. 1 ranked Ke Jie. Till now, the DeepMind was trained by human experts.[5] DeepMind AI then developed a completely self-taught program without any human intervention and called it AlphaGo Zero (AGZ). This AlphaGo Zero gained tremendous human knowledge around the game Go in just 72 hours and was called AlphaGo Zero (3 days). It beat the version of the original AlphaGo that had defeated human champion Lee Sedol with a score of 100 to 0. It did so without any human data, which usually provided the baseline to train the AI. It used spontaneous data depending only on the rules and constraints while playing repeatedly. In December 2017, another program Alpha Zero trained within 24 hours to demonstrate superhuman capabilities in Chess, Go, and Shogi together. With mere 34 hours of self-learning of Go, AlphaZero defeated its predecessor AlphaGoZero 60 wins to 40 losses. In chess, AlphaZero gave a fantastic 28 wins, 0 losses, and 72 draws. In Shogi, it recorded 90 wins, 8 losses, and 2 draws. Thus, we now had “a bot that defeated the bot that defeated the world champion human.”[5] Artificial Intelligence in Medicine AI applications have become common, e.g. Siri, Alexa, and Cortana. In medicine, IBM Watson-Oncology has picked up drugs for treatment of cancer patients with equal or better efficiency than human experts. Microsoft's Hanover Project at Oregan has analyzed medical research to tailor personalized cancer treatment option.[6] United Kingdom's National Health Service (NHS) used Google's DeepMind platform for detecting health risks by analyzing mobile app data and medical images collected from NHS patients.[7] Stanford's radiology algorithm picked up pneumonia better than human radiologists,[8] while in diabetic retinopathy challenge, the computer was as good as expert ophthalmologists in making a referral decision.[9] In 2018, Krause et al. trained an automated algorithm for diabetic retinopathy (DR) grading while working on quantifying errors in DR grading based on individual graders and the majority decision using adjudication. They retrospectively analyzed Health Insurance Portability and Accountability Act Safe Harbor deidentified images labeled by American board-certified ophthalmologists and retinal specialists in addition to the “developed and tuned” algorithm. The retinal fundus images were contributed by EyePACS-affiliated clinics, Aravind Eye Hospital, Sankara Nethralaya, Narayana Nethralaya, and Messidor-2 dataset from Brest University Hospital supported Laboratory of Medical Information Processing and the original images from Gulshan et al. Ethics review and institutional review board exemption was granted to the project by Quorum Review Institutional Review Board. These results were rated against the consensus of the retinal specialists as the reference standard. The commonly used International Clinical Diabetic Retinopathy (ICDR) disease severity scale consisting of a five-point grade for DR: no, mild, moderate, severe, and proliferative was used by three ophthalmologists. Three grading types were used in development, including grading by EyePACS graders, grading by ophthalmologists, and adjudicated consensus grading by retinal specialists. The quadratic-weighted kappa score to assess agreement between different graders demonstrated a high degree of correlation in moderate or worse DR with following scores among individual retinal specialists (Kappa = 0.82 to 0.91), ophthalmologists (Kappa = 0.80 to 0.84), and algorithm (Kappa = 0.84). Thus, a small number of adjudicated consensus grades in the tuning dataset and higher resolution images in the input resulted in improved AUC from 0.934 to 0.986 for moderate or worse DR for the algorithm. The algorithm performed at par with the recommendations of American board-certified ophthalmologists and retinal specialists.[10] Why Should India be Concerned? There are no explicit laws covering data transfer for processing in India. Humongous amount of data was processed by an indirect third party by service providers, recoding the data according to US laws. A similar deal between Google DeepMind and the Royal Free London NHS Foundation Trust lead to much debate in 2017.[7] That agreement was criticized on grounds of violating the Caldicott Principles by transferring more data than necessary and blurring of the line between the data controllers and data processors. Legal obligations and liabilities are associated with each. The UK has mechanisms such as Information Commissioner's Office (responsible for enforcing the Data Protection Act and Health Research Authority (responsible for governance framework for health research) and Confidentiality Advisory Group (method for confidential health information in absence of explicit consent), which were not consulted before beginning data-transfer, which was done after using a “self-assessment information governance toolkit” used to validate the security of technical infrastructure to handle NHS data.[7] What Can be Done? The direct care providers need to be careful when sharing data with a third party which is not in a direct care relationship with the patient in question. Direct care is defined as “activity concerned with the prevention, investigation and treatment of illness and the alleviation of suffering of an identified individual.” A notice for use of such data must be given to the patient/subject who is in-the-care. If explicit consent and notice have not been given, then all de-identified (labelled or unlabelled) data should come into public domain and be published by a statutory body. This will keep a check on illegal proprietary exploitation of the data and force the data processor to seek limited amounts of data for exchange. Such publicly available public/peer scrutinized datasets such as Messidor will aid independent development of algorithms and processes. Because in the absence of consent such de-identified datasets should be considered community resource, there is logic in placing it in the hands of the community, thereby enabling policing of these data exchanges at a level which is not possible for any government. In India, we need to have statutory regulation such as section 251 in UK, which brings the government and statutory control for such transfers.[7] In fact, the ownership and custodial responsibility of such data are often never discussed in our country.[11] With AI tool use on such datasets, there is no specific brief of how the data will be manipulated by the machine. With transfer learning and AGI, humans may not even be able to understand how the machine handled the data like people found some of the lines of play in AlphaZero “alien” but effective. Justice BN Srikrishna Committee has made welcome progress by empowering patients.[11] However, it will be foolhardy to expect general protection to address extremely convoluted bioethical concerns in the development of medical AI. The medical fraternity needs to insist on specific “dos-and-don’ts,” which if followed will keep it safe from litigation in case of any data breach because India is not only the largest producer and the cheapest source of such data (by admission of the authors in the Google Diabetic Retinopathy Project),[10] it will be the largest market for the algorithms derived from it in future. There is a need for a strong bioethical and computational ethics framework to ensure that this is hardwired into the rules we give to the machines for recursive self-improvement. The clichéd aphorism, “ First, do no harm,” needs to be carried from medical ethics into the domain of computational bioethics. We may be like parents here; beyond a stage of development we may not be in control of these algorithms any further or may not understand them at all. AlphaZero mastered Go, chess, and Shogi without any human guidance, except the game rules. Within 24 hours, it was able to defeat all state-of-the-art AI programs such as Stockfish, Elmo, and AlphaGo (3 day).[5] AI development is now shifting focus from “supervised” learning (which required large amounts of labeled examples to train the machine to recognize similar patterns) to “unsupervised-learning” (form of learning in which the machine trains without labeled data). Clearly, AI is becoming powerful, and will continue to do so on the back of higher computational power, thereby raising legitimate concerns about a scenario with this power finding its way into the wrong hands – human or artificial. The former will evolve at our human pace of evolution, allowing us a window of opportunity to reclaim our lives but not so for latter as the AlphaGo experience has shown us. More caution is necessary in case of medicine and medical research because the person affected by each decision is a sentient human being. Why Teaching Machines what is Right is Important for the Human Race? Humans were at the top of the food chain because of their intelligence. They could control dangerous snakes and tigers with cages. Today we are training machines to be smarter than us. Do we need to protect the humans and make these machines slaves to humans? Do we want them to be like friendly Siri, Cortana, and Alexa or like rogue heuristically programmed algorithmic computer (HAL) of “2001: A Space Odyssey” who killed the crew of the spaceship for the sake of his program?[12] To prevent the latter, we must ensure that human physicians are informed of all reasons and decisions taken by the machine. This human operator must also possess a veto power or a manual override. Futuristic dystopian extreme of machines displacing human knowledge workers appears unlikely. Throughout recorded history, technological advances have consistently made majority of workers richer and provided them extra leisure time. When Kelman invented phacoemulsification and when we started using computers to sculpt corneas, everyone gained – the patient, the practitioner, and the industry. History is replete with examples of “man-with-machine” progress. In medical application AI, the “healthcare-domain-experts” acted only as “raters and dataset-providers” for number crunching. They did not become integral to guiding the process of development of AI algorithms in healthcare. Failure of public institutions and oversight mechanisms in protecting the vulnerable is an irrevocable mistake. We may be teaching these machines disdain for human ordained rules. That may prove to be the costliest failure of mankind. The “big-red-switch” needs to firmly remain in the hands of human operator/s or agencies even if the machine becomes artificially superintelligent surpassing the human in all cognitive domains. AI, like fire, is a great slave but a poor master. Beyond one stage of development, we may not be able to control it, so we need to inculcate in them the rules, the respect for benefiecience and lives of humans. The need for strong computational/AI bioethics framework in consultation with the medical fraternity cannot be overemphasized. About the author The author is an Ophthalmologist by training. He has been working on computers and allied areas since 1984. His instruction courses on “ Use of Computers for Managing Patient Data and Conducting Research” and “Do-It-Yourself Statistics for the Practitioner” have been well received by the community at national and international levels. He has an MBA in Operations Research with specialization in Information Systems and Technology Management. He was formerly the Member Secretary of the Institutional Ethics Committee and the Nodal Officer (Information Technology) of a thousand bedded medical college hospital with integrated healthcare information system in the national capital. He has been Assistant DNB Co-ordinator and Member Secretary of Hospital Scientific Committee. He has been Chief Instructor at World Ophthalmology Congress and invited international faculty for Asia Pacific Academy of Ophthalmology and American Academy of Ophthalmology. He has been faculty for Delhi Ophthalmological Society and has chaired sessions in seven All India Ophthalmological Society Conferences on research, statistics and computer-related issues. He has been a peer reviewer for British Journal of Ophthalmology, Journal of Venomous Animals and Toxins, Canadian Medical Journal, Singapore Medical Journal, Indian Journal of Ophthalmology, Annals of Health and Medical Research, Journal of Clinical Research and Ophthalmology, Saudi Journal of Ophthalmology and a host of other publications. He has been on the editorial board of different journals. He has authored two books including one on “Basics of Biostatistics: A Manual for Medical Practitioners”. He is currently the Chairman of DOS Subcommittee for Information Technology, Practice Automation and Clinical Informatics set up by the Delhi Ophthalmology Society.

BACKGROUND: Randomized controlled trials are being used increasingly to evaluate the effectiveness of health care interventions, including those in primary care. AIM. A study was undertaken to document the topic areas addressed by randomized controlled trials conducted in primary care and the methodological characteristics of these, based on a historical review of all trials published in the British Journal of General Practice (formerly the Research Newsletter and Journal of the Royal College of General Practitioners) between 1953 and 1991 inclusive. METHOD. Trials were identified by systematically hand searching all back issues. RESULTS. A total of 90 randomized controlled trials were identified, 78% of which were undertaken in general practice. The trials covered a wide range of topics; 62% examined pharmacological interventions, 21% non-pharmacological interventions, and 16% an intervention related to provision of an aspect of health service. Among the randomized controlled trials published there was a significant trend towards more reports on non-pharmacological trials in recent years (P &lt; 0.001). The quality of trials, judged by the extent to which bias was controlled, varied considerably. Trials of pharmacological interventions generally controlled for selection bias at entry and at assessment of outcome more effectively than trials of non-pharmacological interventions. CONCLUSION. Some imaginative solutions to the logistic difficulties of conducting randomized trials in general practice were noted. These may serve as an incentive to those undertaking such studies in the future.

BACKGROUND: The PARiHS framework (Promoting Action on Research Implementation in Health Services) has proved to be a useful practical and conceptual heuristic for many researchers and practitioners in framing their research or knowledge translation endeavours. However, as a conceptual framework it still remains untested and therefore its contribution to the overall development and testing of theory in the field of implementation science is largely unquantified. DISCUSSION: This being the case, the paper provides an integrated summary of our conceptual and theoretical thinking so far and introduces a typology (derived from social policy analysis) used to distinguish between the terms conceptual framework, theory and model - important definitional and conceptual issues in trying to refine theoretical and methodological approaches to knowledge translation. Secondly, the paper describes the next phase of our work, in particular concentrating on the conceptual thinking and mapping that has led to the generation of the hypothesis that the PARiHS framework is best utilised as a two-stage process: as a preliminary (diagnostic and evaluative) measure of the elements and sub-elements of evidence (E) and context (C), and then using the aggregated data from these measures to determine the most appropriate facilitation method. The exact nature of the intervention is thus determined by the specific actors in the specific context at a specific time and place. In the process of refining this next phase of our work, we have had to consider the wider issues around the use of theories to inform and shape our research activity; the ongoing challenges of developing robust and sensitive measures; facilitation as an intervention for getting research into practice; and finally to note how the current debates around evidence into practice are adopting wider notions that fit innovations more generally. SUMMARY: The paper concludes by suggesting that the future direction of the work on the PARiHS framework is to develop a two-stage diagnostic and evaluative approach, where the intervention is shaped and moulded by the information gathered about the specific situation and from participating stakeholders. In order to expedite the generation of new evidence and testing of emerging theories, we suggest the formation of an international research implementation science collaborative that can systematically collect and analyse experiences of using and testing the PARiHS framework and similar conceptual and theoretical approaches. We also recommend further refinement of the definitions around conceptual framework, theory, and model, suggesting a wider discussion that embraces multiple epistemological and ontological perspectives.

In response to a review recently carried out by the Royal College of General Practitioners, the British Journal of General Practice is soon to be issued in a new and expanded format. While continuing to develop its primary role as a leading scientific journal of record, the journal will accommodate a monthly selection of integrated news, information and features. The editorial board welcomes the opportunities provided by these changes, but wishes to emphasize the continuing importance of general practice as a scientific discipline in its own right and to reaffirm its commitment to the publication of high-quality, peer-reviewed original research papers. It is hoped that the newlook journal will have a wide appeal. But, as the first-and still the foremost-journal of general practice in the world, it will continue to be a journal of record serving both its authors and the academic community worldwide.

Background Prioritisation is an increasing part of a GP's workload, though learning this skill is usually left to on-the-job training. Little is known about how experienced GPs prioritise their workload. Aim This study aimed to explore the factors that experienced GPs consider when prioritising their acute workload Design and Setting This qualitative research study used focus groups of GP educators based in central Scotland to explore the factors that they consider when prioritising their acute workload. Method Participants were recruited through convenience sampling. The key inclusion criterion was being involved in the supervision of GP Registrars. Five focus groups were carried out and transcripts were analysed using reflexive thematic analysis to identify the dilemmas that GPs face when prioritising their workload. Results Thirty-seven participants took part. Five themes emerged from the data; (1) GPs maintain an awareness of their work system and adapt their consultation style to demand. (2) They make decisions in an order which manages their time efficiently. (3) Their familiarity with patients and clinical experience enables them to make quick decisions about patient care, though this can lead to bias in decision-making. (4) They rely on their therapeutic relationships with patients and working relationships with colleagues when making decisions. (5) Their personal preferences are important, such as managing the simplest or the most complex presentations first. Conclusion Prioritisation is an increasingly important skill in modern General Practice. It is crucial that those involved in prioritisation are given the time and tools necessary to adequately develop this skill.

BACKGROUND: Detailed, comprehensive, and timely reporting on population health by underlying causes of disability and premature death is crucial to understanding and responding to complex patterns of disease and injury burden over time and across age groups, sexes, and locations. The availability of disease burden estimates can promote evidence-based interventions that enable public health researchers, policy makers, and other professionals to implement strategies that can mitigate diseases. It can also facilitate more rigorous monitoring of progress towards national and international health targets, such as the Sustainable Development Goals. For three decades, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) has filled that need. A global network of collaborators contributed to the production of GBD 2021 by providing, reviewing, and analysing all available data. GBD estimates are updated routinely with additional data and refined analytical methods. GBD 2021 presents, for the first time, estimates of health loss due to the COVID-19 pandemic. METHODS: The GBD 2021 disease and injury burden analysis estimated years lived with disability (YLDs), years of life lost (YLLs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries using 100 983 data sources. Data were extracted from vital registration systems, verbal autopsies, censuses, household surveys, disease-specific registries, health service contact data, and other sources. YLDs were calculated by multiplying cause-age-sex-location-year-specific prevalence of sequelae by their respective disability weights, for each disease and injury. YLLs were calculated by multiplying cause-age-sex-location-year-specific deaths by the standard life expectancy at the age that death occurred. DALYs were calculated by summing YLDs and YLLs. HALE estimates were produced using YLDs per capita and age-specific mortality rates by location, age, sex, year, and cause. 95% uncertainty intervals (UIs) were generated for all final estimates as the 2·5th and 97·5th percentiles values of 500 draws. Uncertainty was propagated at each step of the estimation process. Counts and age-standardised rates were calculated globally, for seven super-regions, 21 regions, 204 countries and territories (including 21 countries with subnational locations), and 811 subnational locations, from 1990 to 2021. Here we report data for 2010 to 2021 to highlight trends in disease burden over the past decade and through the first 2 years of the COVID-19 pandemic. FINDINGS: Global DALYs increased from 2·63 billion (95% UI 2·44-2·85) in 2010 to 2·88 billion (2·64-3·15) in 2021 for all causes combined. Much of this increase in the number of DALYs was due to population growth and ageing, as indicated by a decrease in global age-standardised all-cause DALY rates of 14·2% (95% UI 10·7-17·3) between 2010 and 2019. Notably, however, this decrease in rates reversed during the first 2 years of the COVID-19 pandemic, with increases in global age-standardised all-cause DALY rates since 2019 of 4·1% (1·8-6·3) in 2020 and 7·2% (4·7-10·0) in 2021. In 2021, COVID-19 was the leading cause of DALYs globally (212·0 million [198·0-234·5] DALYs), followed by ischaemic heart disease (188·3 million [176·7-198·3]), neonatal disorders (186·3 million [162·3-214·9]), and stroke (160·4 million [148·0-171·7]). However, notable health gains were seen among other leading communicable, maternal, neonatal, and nutritional (CMNN) diseases. Globally between 2010 and 2021, the age-standardised DALY rates for HIV/AIDS decreased by 47·8% (43·3-51·7) and for diarrhoeal diseases decreased by 47·0% (39·9-52·9). Non-communicable diseases contributed 1·73 billion (95% UI 1·54-1·94) DALYs in 2021, with a decrease in age-standardised DALY rates since 2010 of 6·4% (95% UI 3·5-9·5). Between 2010 and 2021, among the 25 leading Level 3 causes, age-standardised DALY rates increased most substantially for anxiety disorders (16·7% [14·0-19·8]), depressive disorders (16·4% [11·9-21·3]), and diabetes (14·0% [10·0-17·4]). Age-standardised DALY rates due to injuries decreased globally by 24·0% (20·7-27·2) between 2010 and 2021, although improvements were not uniform across locations, ages, and sexes. Globally, HALE at birth improved slightly, from 61·3 years (58·6-63·6) in 2010 to 62·2 years (59·4-64·7) in 2021. However, despite this overall increase, HALE decreased by 2·2% (1·6-2·9) between 2019 and 2021. INTERPRETATION: Putting the COVID-19 pandemic in the context of a mutually exclusive and collectively exhaustive list of causes of health loss is crucial to understanding its impact and ensuring that health funding and policy address needs at both local and global levels through cost-effective and evidence-based interventions. A global epidemiological transition remains underway. Our findings suggest that prioritising non-communicable disease prevention and treatment policies, as well as strengthening health systems, continues to be crucially important. The progress on reducing the burden of CMNN diseases must not stall; although global trends are improving, the burden of CMNN diseases remains unacceptably high. Evidence-based interventions will help save the lives of young children and mothers and improve the overall health and economic conditions of societies across the world. Governments and multilateral organisations should prioritise pandemic preparedness planning alongside efforts to reduce the burden of diseases and injuries that will strain resources in the coming decades. FUNDING: Bill & Melinda Gates Foundation.

The bibliographical references of original articles published during 1988 in four primary care magazines from diverse cultural backgrounds were analysed: Canadian Family Physician (Canada), Journal of Family Practice (United States), Atención Primaria (Spain), and Journal of the Royal College of General Practitioners (United Kingdom). There are 4,225 bibliographical references used in the 328 original reviewed articles. These references had been published in 725 different magazines, of which the ten most oft-quoted account for 38% of the total references. In addition to the four magazines included in our review, the list includes the following: British Medical Journal, New England Journal of Medicine, Journal of the American Medical Association, Lancet, Canadian Medical Association Journal, Annals of Internal Medicine, and American Journal of Obstetrics and Gynecology.

Funding based on population need is key to equitable healthcare. The formula for general practice capitation payments in England has not been updated for over twenty years and is based on crude workload weights. To estimate and describe the uplifts in payments required to bring practices in line with updated and more precise needs-based workload weights. All 6,213 general practices in England in 2024. We applied updated workload weights to publicly available practice data on patient age and gender, new registration, ethnicity, deprivation and prevalence of 20 long-term conditions. We removed the practice payment provided for input price variation and calculated the current workload payment per weighted-patient for each practice and the funding required to uplift all practices to minimum thresholds. Workload payment per-patient was &#xa3;92.66 on average, varying from &#xa3;86.72 in the lowest to &#xa3;99.91 in the highest deprivation decile. Workload payment per-weighted-patient varied from &#xa3;81.40 (5th percentile) to &#xa3;107.10 (95th percentile) and from &#xa3;89.69 in the lowest to &#xa3;96.40 in the highest deprivation decile. Uplifting payments to a minimum of &#xa3;102.46 per-weighted-patient (90th percentile value) would increase total payments by 11.6% (&#xa3;677.77M per year) and payments per-patient to &#xa3;99.75 in the lowest and &#xa3;108.18 in the highest deprivation decile. The workload element of the general practice funding formula should use updated weights. Additional concerns related to equity in outcomes and under-funding of practices in deprived areas should be addressed by adjustments or revisions of other elements of the funding formula.

Background Patients later diagnosed with cancer may first be diagnosed with another 'interim' diagnosis based on their clinical presentation. In some cases, interim diagnoses may be missed opportunities to diagnose cancer. Aim To explore healthcare professionals' perspectives of when interim non-cancer diagnoses occur, how they impact a cancer diagnosis, and what could trigger their prompt review. Design and setting Interviews were conducted between March and November 2024 with 35 General Practitioners (GPs), 3 other clinicians, and 3 practice administrators from 31 general practices in Southern England, UK. Method Semi-structured interviews via videocall. Interviews were analysed using Framework Analysis. Results Participants reported that interim diagnoses occurred in cases of diagnostic uncertainty, especially when non-specific symptoms were attributed to common differential diagnoses. Remote consultations were thought to increase the likelihood of interim diagnosis by limiting information gathering. Interim diagnoses were suggested to delay cancer diagnoses, although this was not always seen as avoidable. Clinicians hoped to facilitate opportunities to make a cancer diagnosis by using safety-netting to encourage reattendance, and an informal rule of "three strikes and you're in". Colleagues providing a "fresh pair of eyes", discussing diagnostic uncertainty in the clinical team, and using past cases as learning opportunities were suggested approaches to facilitate prompt review of interim diagnoses. Conclusion Consistent safety-netting is required to ensure timely review of non-cancer 'interim' diagnoses when there is a possible underlying cancer diagnosis. The range of interim diagnoses and their impact on cancer diagnosis requires further quantification to inform interventions to mitigate their effect.

Background Heart failure (HF) is a global public health priority. HF diagnosis in primary care is linked to improved outcomes, but most patients are diagnosed in hospital. The pathway to HF diagnosis in primary care is poorly understood. Aim To gain deeper understanding of the patient experience of missed opportunities for HF diagnosis. Design and Setting Qualitative study with patients recruited through general practice and community nurse clinics. Method We conducted, remote, semi-structured interviews with 24 patients who had a diagnosis of HF. Data were analysed using reflexive thematic analysis. Results Three themes were developed: diagnostic liminality and suffering at the threshold of HF diagnosis (when participants were unwell but not yet diagnosed or were unaware of their diagnosis); meaning and framing in the diagnostic moment; and truth-telling and sense-making facilitating the escape from liminality. Although receiving the diagnosis brought relief, it also came as a shock due to the meanings associated with the term. Some thought HF meant imminent death and was incompatible with living. Participants also described not being properly informed about their diagnosis. Conclusion While life was disrupted by a HF diagnosis, the diagnosis did not enable the transition from liminality. It was truth telling, in combination with careful explanation that facilitated the shift from diagnostic liminality. Through sense-making, participants were able to build an understanding of what HF diagnosis actually meant for them and their future. Clinicians have a vitally important role in guiding patients away from diagnostic liminality through prompt HF diagnosis and thoughtful communication.

Background It is widely recognised that continuity of GP care should be improved. This requires a continuity measure, applicable in all practices. Previous measures have limitations. Aim To develop an improved measure of continuity and compare its performance with established measures. Design and Setting One-year pilot in two general practices using audit data. Method The modified SLICC (mSLICC) was developed, calculated monthly and compared with the St Leonard's Index of Continuity of Care (SLICC), the 1-year Bice-Boxerman (BB) and Usual Provider of Care Index (UPC). Proportions of patients and appointments included were calculated with patients grouped by age, 3-year appointment numbers and frailty categories. Results In the two practices, the mSLICC included 19,840 out of 29,127 (68.1%) appointments and a mean of 65.2% (SD 6.4%) of patients with appointments. The UPC/BB included 21032 (72.2%) appointments and 4096 (41.2%) of 9924 patients with appointments. In practice A the mSLICC was 52.0%, SLICC 57.1%, mean UPC 0.63 (95% CI 0.62 to 0.64), and mean BB 0.41 (95% CI 0.40 to 0.43). In Practice B the mSLICC was 25.7%, SLICC 25.1%, mean UPC 0.50 (95% CI 0.49 to 0.51), and mean BB 0.23 (95% CI 0.22 to 0.25). The mSLICC correlated with the SLICC [(r)=0.98, p<0.001]. Conclusion The mSLICC is a new monthly measure of continuity. It has fewer limitations than the BB and UPC and does not require a named GP. With sufficient IT resource, the mSLICC could be used by practices without personal lists to measure continuity of care.

BACKGROUND: In an era of shifting global agendas and expanded emphasis on non-communicable diseases and injuries along with communicable diseases, sound evidence on trends by cause at the national level is essential. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) provides a systematic scientific assessment of published, publicly available, and contributed data on incidence, prevalence, and mortality for a mutually exclusive and collectively exhaustive list of diseases and injuries. METHODS: GBD estimates incidence, prevalence, mortality, years of life lost (YLLs), years lived with disability (YLDs), and disability-adjusted life-years (DALYs) due to 369 diseases and injuries, for two sexes, and for 204 countries and territories. Input data were extracted from censuses, household surveys, civil registration and vital statistics, disease registries, health service use, air pollution monitors, satellite imaging, disease notifications, and other sources. Cause-specific death rates and cause fractions were calculated using the Cause of Death Ensemble model and spatiotemporal Gaussian process regression. Cause-specific deaths were adjusted to match the total all-cause deaths calculated as part of the GBD population, fertility, and mortality estimates. Deaths were multiplied by standard life expectancy at each age to calculate YLLs. A Bayesian meta-regression modelling tool, DisMod-MR 2.1, was used to ensure consistency between incidence, prevalence, remission, excess mortality, and cause-specific mortality for most causes. Prevalence estimates were multiplied by disability weights for mutually exclusive sequelae of diseases and injuries to calculate YLDs. We considered results in the context of the Socio-demographic Index (SDI), a composite indicator of income per capita, years of schooling, and fertility rate in females younger than 25 years. Uncertainty intervals (UIs) were generated for every metric using the 25th and 975th ordered 1000 draw values of the posterior distribution. FINDINGS: Global health has steadily improved over the past 30 years as measured by age-standardised DALY rates. After taking into account population growth and ageing, the absolute number of DALYs has remained stable. Since 2010, the pace of decline in global age-standardised DALY rates has accelerated in age groups younger than 50 years compared with the 1990-2010 time period, with the greatest annualised rate of decline occurring in the 0-9-year age group. Six infectious diseases were among the top ten causes of DALYs in children younger than 10 years in 2019: lower respiratory infections (ranked second), diarrhoeal diseases (third), malaria (fifth), meningitis (sixth), whooping cough (ninth), and sexually transmitted infections (which, in this age group, is fully accounted for by congenital syphilis; ranked tenth). In adolescents aged 10-24 years, three injury causes were among the top causes of DALYs: road injuries (ranked first), self-harm (third), and interpersonal violence (fifth). Five of the causes that were in the top ten for ages 10-24 years were also in the top ten in the 25-49-year age group: road injuries (ranked first), HIV/AIDS (second), low back pain (fourth), headache disorders (fifth), and depressive disorders (sixth). In 2019, ischaemic heart disease and stroke were the top-ranked causes of DALYs in both the 50-74-year and 75-years-and-older age groups. Since 1990, there has been a marked shift towards a greater proportion of burden due to YLDs from non-communicable diseases and injuries. In 2019, there were 11 countries where non-communicable disease and injury YLDs constituted more than half of all disease burden. Decreases in age-standardised DALY rates have accelerated over the past decade in countries at the lower end of the SDI range, while improvements have started to stagnate or even reverse in countries with higher SDI. INTERPRETATION: As disability becomes an increasingly large component of disease burden and a larger component of health expenditure, greater research and development investment is needed to identify new, more effective intervention strategies. With a rapidly ageing global population, the demands on health services to deal with disabling outcomes, which increase with age, will require policy makers to anticipate these changes. The mix of universal and more geographically specific influences on health reinforces the need for regular reporting on population health in detail and by underlying cause to help decision makers to identify success stories of disease control to emulate, as well as opportunities to improve. FUNDING: Bill & Melinda Gates Foundation.

Functional abdominal pain (FAP) and irritable bowel syndrome (IBS) are associated with anxiety, depression, school absenteeism and reduced quality of life in children. In secondary care, hypnotherapy is often available. To determine the effectiveness of home-based guided hypnotherapy for children with FAP or IBS in primary care. A pragmatic randomised controlled trial in Dutch primary care with a follow-up of 12 months. Children aged 7-17 years with FAP or IBS diagnosed by a general practitioner were included. The intervention group received home-based guided hypnotherapy via a website for 3 months in addition to care as usual. The control group received care as usual only. The primary outcome was adequate relief of abdominal pain and/or discomfort at 12 months. Adjusted odds ratios (aOR) and 90% confidence intervals (90%CI) are reported. In total, 152 children were included. No significant differences were observed in adequate relief at 12 months (79.5% in the intervention group (58/73 children) versus 74.3% in the control group (52/70 children); aOR 1.47, 90%CI 0.74-2.93), but more children in the intervention group had adequate relief compared to the control group at 3 months (aOR 2.74, 90%CI 1.22-6.13) and 6 months (aOR 4.26, 90%CI 1.81-10.04). The intervention group also showed reductions in abdominal pain severity, intensity, frequency, and threat, and higher proportions of fast sleep onset. While adequate relief after 12 months is high in both groups, adding hypnotherapy to care as usual may help achieve earlier relief and reduce pain.

Background Personal continuity -having a GP who knows and follows the patient- is a core value of general practice, yet changes in society and healthcare have challenged its provision. Therefore, we developed TOOL-kit, a multi-component intervention aimed to optimise personal continuity for patients aged 65 or above. Aim to evaluate TOOL-kit's implementation and identify barriers and facilitators influencing its delivery. Design and setting Mixed-methods study embedded in the main effect trial (August 2020 - April 2022). Method Implementation was assessed via 3-monthly surveys, 93 interviews with GPs and practice staff (n=221) from 32 general practices. Based on Saunders paradigm, it was evaluated on the process indicators of recruitment and reach, fidelity (adherence to protocol), dose delivered (extent of improvement plans), and dose received (goal achievement, sustained organisational change). Barriers and facilitators were evaluated on the intervention, staff, organisational, and socio-political levels. Results Of 32 practices, 23 adhered to protocol. TOOL-kit was delivered at a (very) low dose in 17 of 31 practices. At study end, 55% of practice goals were met. After 24 months, 19 practices had observed sustained positive effects regarding personal continuity. A good quality improvement infrastructure facilitated TOOL-kit implementation, while work pressure and staff shortages, exacerbated by COVID-19, were seen as the main barriers for implementation. Conclusion Despite implementation challenges, TOOL-kit was able to enhance work procedures and improve the focus on personal continuity within practice. Fostering practices' quality improvement infrastructure and decision-making processes could improve implementation. Keywords General Practice, Continuity of care, Implementation Science, Physician-Patient Relations.

Background Domestic and family violence (DFV) is common worldwide and general practitioners (GPs) are not immune. DFV survivors frequently present to primary care where GP DFV survivors often encounter them. Little literature and no qualitative studies look at the emotional and professional effects that these encounters have on survivor GPs, including how it affects their ability to care for survivor patients. Aim This study asked the question, "what are the experiences of survivor GPs when working with patient survivors of DFV?" Design/Setting This study used a phenomenological qualitative approach to gain a deep understanding of Australian GP DFV survivors' experiences when working with survivor patients. Method Participants were Australian GPs self-identifying as survivors of all forms of DFV. Participants were recruited from two Australian GP online groups using purposive sampling. Semi-structured interviews took place and were audio recorded and transcribed verbatim. Reflexive thematic analysis was undertaken. Results Participants (20) were female and worked in a range of locations throughout Australia. Four themes were identified: 'My experiences can be my superpower' (encompassing the subthemes: 'Having a sixth sense' and 'Going above and beyond'); 'Connecting with survivor's stories'; 'Wearing a cloak'; and 'My experiences give me purpose'. Conclusion Although GP DFV survivors commonly experienced difficult emotions when working with survivor patients, they had a commitment to this work which stemmed from personal DFV experiences. This increased their empathy for survivors and gave them a deep understanding of their circumstances, allowing them to work powerfully with survivors, aiming to improve their situation.

Structured Medication Reviews (SMRs) were introduced into primary care in England for patients living with multiple long-term conditions (MLTCs), polypharmacy, increased frailty, in care homes or at risk of medicines-related harm. SMRs aim to optimise the therapeutic potential of medication and reduce medicine-related harms through holistic reviews. To explore the day-to-day work being undertaken with, and by, clinical pharmacists to implement, embed and integrate SMRs into practice, and consider how to optimise SMRs. Qualitative one-to-one interviews with clinical pharmacists undertaking SMRs and SMR service leaders/managers (SMR leads) in England between February 2023 and November 2024. Participants were recruited as part of a wider evaluation of the roll-out of SMRs in England. Interview topic guides and qualitative data analysis were informed by Normalization Process Theory (NPT). Eighteen clinical pharmacists and five SMR leads participated. Participants reported often having to explain the purpose of SMRs and clinical pharmacists' roles to patients, partly due to patients not being informed about SMRs. Participants valued SMRs and expressed that trust-building and tailored consultations were important for optimising medications. Integration varied due to high workload, inconsistent leadership support, inadequate administrative/pharmacist technician resource and lack of training. However, participants described SMRs as valuable for identifying and addressing unmet needs and supporting holistic, person-centred care across MLTC pathways. The findings demonstrate the need for improved information on SMRs for patients and primary care teams, adequate and appropriate resource allocation, and enhanced support for consultation skills training to optimise medicines use.

Background Chronic kidney disease (CKD) affects approximately 10% of adults in England. <1% progress to end stage-kidney disease (ESKD), significantly impacting health-related quality of life with high healthcare costs. CKD is associated with increased cardiovascular disease risk. New therapies to improve outcomes highlight the need for effective risk stratification. Aim To explore primary care teams' views and experiences of CKD risk stratification. Design and Setting Qualitative interview and focus group study with GP practices in South England, South London and Yorkshire. Method 26 semi-structured interviews with GPs, pharmacists and practice nurses, and 4 focus groups (31 participants) with practice teams including clinical, administration and management staff, February 2024 to January 2025 across 20 practices, informed by normalisation process theory (NPT), using thematic analysis. Results We identified 4 key themes: 1) Awareness of diagnostic criteria and risk stratification tools, 2) Value of coding CKD and discussion of risk, 3) Barriers to CKD risk stratification, 4) Improving CKD risk stratification. Despite universal awareness of diagnostic criteria, there was low awareness of risk stratification tools. Coding was perceived as valuable for health professionals but not for patients. Concerns included increasing patient anxiety and over-medicalisation. Time pressures and lack of incentivisation were perceived as key barriers. Improved healthcare professional education, guidelines, pathways and technology/automation were highlighted as areas of potential improvement. Conclusion Primary care awareness of CKD is high, but workload, time pressures, and concerns regarding patient anxiety/over-medicalisation may contribute to incomplete risk stratification. Refining processes and effective patient communication could improve care.