Corso di clinical writing

What to expect today? Core modules IntroductionIntroduction Correction of abstracts submitted by participantsCorrection of abstracts submitted by participants Practical session 2 – Abstract draftingPractical session 2 – Abstract drafting Results draftingResults drafting Discussion draftingDiscussion drafting Tables and Figures draftingTables and Figures drafting Peer review and publicationPeer review and publication Synthetic example – database creation, analysis and Results draftingSynthetic example – database creation, analysis and Results drafting

Abstract What makes a good abstract? First you need to ask yourself what an abstract is for!

Abstract The abstract is like the whole body of a woman It may mislead, but it is decisive in making the choice for reading the full-text of the article

Abstract A good abstract should : 1.State the principal objectives and scope of the investigation 2.Describe the methods employed 3.Summarize the results 4.State the principal conclusions

Following the rules Concise as possible, but brisk! –Body length determined ~175 Words (shorter)~175 Words (shorter) ~300 Words (longer?)~300 Words (longer?) –It may be difficult to comply, especially if very structured (eg JAMA, Annals of Internal Medicine)

IMRAD algorithm Introduction (± Aim) 2-3 phrases Methods 2-3 phrases Results 3-5 phrases And Conclusions 1-3 phrases

Details of hypothetical trial Design: prospective Population: patients with persistent or recurrent righ lower-quadrant pain (>3 months), either continuous or with at least one attack in the month before inclusion, excluding those with a history of chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopy or a laparoscopic sterilization), specific gastrointestinal disorders (such as inflammatory bowel disease) and gynecological disease (all female patients had consulted a gynecologist) Intervention: elective laparoscopic appendicectomy Comparison: no surgery Allocation: randomized Setting: single center Time: September 1994 to November 2004

Details of hypothetical trial Primary outcomes: the primary outcome measure was pain scored by the patient at 6 months after operation in the presence of the surgical resident. At each follow-up appointment patients were instructed to score pain on a three-point scale, comparing the current situation with the degree of pain before surgery based on the patient's own original pain dairy notes. Pain scores were: 1, pain unchanged (or even worse); 2, improvement with a remarkable reduction of pain, but not completely pain free; and 3, completely pain free, no more right lower abdominal complaints. After the 6-month pain assessment, the operation carried out was revealed to the patient. Those who still experienced abdominal complaints and had the appendix in situ were offered a second laparoscopic procedure for intended appendicectomy

Details of hypothetical trial Secondary outcomes: the secondary outcome investigated was the relationship between clinical improvement and histopathological findings of the removed appendices. A scoring system for the histological investigation of the appendices was developed. Appendices had either signs of acute (endo)appendicitis (infiltration of granulocytes into the epithelial mucosal layer or deeper), or signs thought to be compatible with chronic or recurrent appendicitis. The presence of fecostasis or fecoliths was noted. Finally, based on the overall findings, the pathologist scored the appendix as normal or having signs of appendicopathy. Cases that showed inconsistencies between pathology scoring and the final conclusion were re-evaluated by both pathologists, and a consensus reached

Details of hypothetical trial Results (1): Eighty-eight patients with chronic or recurrent right lower- quadrant pain of unknown origin were evaluated. Forty-six patients were excluded. Remarkably, during the 3-month observation period before inclusion in the trial, two potential candidates had surgery for suspected acute appendicitis. Forty-two patients signed a consent form but, during the diagnostic part of the laparoscopy, two were judged to have convincing pathology explaining the chronic pain syndrome and were not included in the trial. Of 40 patients finally randomized, 18 patients (14 female and four male), of median age 25 (range 17-40) years, were allocated to appendicectomy. Twenty-two patients (19 female and three male) with a median age of 29 (range 15-45) years were allocated to inspection without removal of the appendix.

Details of hypothetical trial Results (2): Pain scores 6 months after operation showed that a significantly higher proportion of patients in the appendicectomy group than in the inspection-only group had an improvement in pain (14 of 18 versus seven of 22; P = 0.005). The relative risk was 2.4 (95 per cent confidence interval 1.3 to 4.0, p<0.05), indicating that patients who had an appendicectomy had a 2.4-fold greater chance of experiencing an improvement in pain. The number needed to treat was 2.2 (95 per cent confidence interval 1.5 to 6.5, p<0.05). One man in the inspection-only group, who had a pain score of 1 at 3-month follow-up, underwent emergency laparotomy for an acutely perforated gangrenous appendix 4 months after investigative laparoscopy. Eleven patients with ongoing or recurrent complaints opted for a second laparoscopic procedure with removal of the appendix. Appendicectomy was carried out more than a year after diagnostic laparoscopy in one of these patients. Eight patients reported that they had become pain free.

Details of hypothetical trial Results (3): Postoperative complications comprised one urinary tract infection and one superficial wound infection in two patients in the appendicectomy group. There were no complications after the trial laparoscopy in the inspection-only group. However, one of the 11 patients who eventually had a laparoscopic appendicectomy developed intra-abdominal abscesses, and had a protracted and complicated postoperative course.

Details of hypothetical trial

Remember: Introduction (± Aim) 2-3 phrases Methods 2-3 phrases Results 3-5 phrases And Conclusions 1-3 phrases

And now let’s move on…