corso di clinical writing

Corso di clinical writing

What to expect today?

Core modules

• IntroductionIntroduction

• Correction of abstracts submitted by participantsCorrection of abstracts submitted by participants

• Practical session 2Practical session 2 – Abstract drafting – Abstract drafting

• Results draftingResults drafting

• Discussion draftingDiscussion drafting

• Tables and Figures draftingTables and Figures drafting

• Peer review and publicationPeer review and publication

• Synthetic example Synthetic example – database creation, analysis and – database creation, analysis and

Results draftingResults drafting

AbstractAbstract

What makes a good abstract?

First you need to ask yourself what an abstract is for!

AbstractAbstract

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

AbstractAbstract

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 rulesFollowing the rules

Concise as possible, but brisk!Concise as possible, but brisk!

– Body length determinedBody length determined

• ~175 Words (shorter)~175 Words (shorter)

• ~300 Words (longer?)~300 Words (longer?)

– It may be difficult to comply, especially if very It may be difficult to comply, especially if very

structuredstructured (eg JAMA, Annals of Internal Medicine) (eg JAMA, Annals of Internal Medicine)

IMRAD algorithmIMRAD algorithm

Introduction (± Aim) 2-3 phrases

Methods 2-3 phrases

Results 3-5 phrases

And

Conclusions 1-3 phrases

Details of hypothetical trialDetails 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


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


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


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.


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.


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.

Remember: 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…

corso di clinical writing

Documents

pain unchanged

degree of pain

pain scores

month pain assessment

remarkable reduction

original pain dairy

good abstract

abstractthe abstract