|
| 1 | +> **Illustrative teaching example.** The trial, setting, and every number below are **fictional** and |
| 2 | +> exist only to demonstrate NEJM house style for a clinical-trial abstract and introduction. No real-trial |
| 3 | +> facts are stated and no clinical recommendation is implied. Corresponding skills: |
| 4 | +> [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md), [`nejm-writing`](../../skills/nejm-writing/SKILL.md), |
| 5 | +> [`nejm-study-design`](../../skills/nejm-study-design/SKILL.md), [`nejm-reporting`](../../skills/nejm-reporting/SKILL.md), |
| 6 | +> [`nejm-statistics`](../../skills/nejm-statistics/SKILL.md), and [`nejm-ethics`](../../skills/nejm-ethics/SKILL.md). |
| 7 | +
|
| 8 | +# Worked Example: An NEJM-Style Abstract + Introduction (before → after) |
| 9 | + |
| 10 | +This demonstrates two things at once, drawn **only** from this pack's own skill files: |
| 11 | + |
| 12 | +1. The **structured abstract** required by [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md) — four headed |
| 13 | + sections (**Background / Methods / Results / Conclusions**), ≤250 words, primary outcome led with an |
| 14 | + **effect size + 95% CI** (not a bare P value), the **intention-to-treat** population and per-group n stated, |
| 15 | + ending with the **trial registration number** and **funding source**. |
| 16 | +2. The **terse IMRAD Introduction** required by [`nejm-writing`](../../skills/nejm-writing/SKILL.md) — the |
| 17 | + clinical problem, the gap, the specific question, ending with the objective; no mini-review. |
| 18 | + |
| 19 | +It also shows the **CONSORT-aligned** reporting expectations from |
| 20 | +[`nejm-reporting`](../../skills/nejm-reporting/SKILL.md) (participant flow that reconciles with the analysis |
| 21 | +population), the **prospective registration** non-negotiable from |
| 22 | +[`nejm-study-design`](../../skills/nejm-study-design/SKILL.md), and the statistical reporting discipline from |
| 23 | +[`nejm-statistics`](../../skills/nejm-statistics/SKILL.md) (CI over bare P, ITT primary, absolute risk + NNT |
| 24 | +alongside relative measures). |
| 25 | + |
| 26 | +**Illustrative trial (fictional):** *"Early High-Flow Oxygen versus Standard Oxygen in Adults Hospitalized |
| 27 | +with Community-Acquired Pneumonia (the FICTIONAL OXYGEN-CAP Trial)."* Every figure is invented for teaching. |
| 28 | + |
| 29 | +--- |
| 30 | + |
| 31 | +## Before (an unstructured abstract that buries the result) |
| 32 | + |
| 33 | +> Community-acquired pneumonia remains a major cause of hospitalization worldwide and has been studied |
| 34 | +> extensively. Oxygen therapy is a cornerstone of management, and there has been much interest in whether |
| 35 | +> more aggressive oxygenation strategies are beneficial. We performed a study using high-flow oxygen and |
| 36 | +> found interesting and robust results suggesting that this novel approach may be helpful. Patients did |
| 37 | +> better on the new treatment, which was statistically significant (P<0.05). High-flow oxygen could |
| 38 | +> represent a promising new standard of care for pneumonia and should be widely adopted. Further work is |
| 39 | +> needed. |
| 40 | +
|
| 41 | +**What's wrong (against this pack's skills):** |
| 42 | + |
| 43 | +- **Not a structured abstract.** [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md) requires four headed |
| 44 | + sections (Background / Methods / Results / Conclusions); this is one unheaded paragraph. |
| 45 | +- **No effect size and no 95% CI** for the primary outcome — only "P<0.05," which |
| 46 | + [`nejm-statistics`](../../skills/nejm-statistics/SKILL.md) explicitly forbids as the sole result. |
| 47 | +- **No design, no population, no per-group n, no ITT** — the Methods content |
| 48 | + [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md) and [`nejm-study-design`](../../skills/nejm-study-design/SKILL.md) require is absent. |
| 49 | +- **No registration number and no funding source** in the Conclusions, both mandated by |
| 50 | + [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md) and [`nejm-study-design`](../../skills/nejm-study-design/SKILL.md). |
| 51 | +- **Over-claiming** ("should be widely adopted," "new standard of care") — exactly the over-reach |
| 52 | + [`nejm-writing`](../../skills/nejm-writing/SKILL.md) flags as a top rejection reason. |
| 53 | +- **Filler adjectives** ("interesting," "robust," "novel," "promising") that |
| 54 | + [`nejm-writing`](../../skills/nejm-writing/SKILL.md) bans; "numbers, not adjectives." |
| 55 | + |
| 56 | +--- |
| 57 | + |
| 58 | +## After — the structured abstract (NEJM house style) |
| 59 | + |
| 60 | +> **BACKGROUND** |
| 61 | +> Hospitalized adults with community-acquired pneumonia commonly receive supplemental oxygen, but the |
| 62 | +> standard low-flow approach may not relieve hypoxemia quickly. It is unknown whether early high-flow nasal |
| 63 | +> oxygen, as compared with standard oxygen, reduces the need for escalation to mechanical ventilation. |
| 64 | +> |
| 65 | +> **METHODS** |
| 66 | +> We conducted a multicenter, randomized, open-label trial. We randomly assigned 1,200 adults hospitalized |
| 67 | +> with community-acquired pneumonia and hypoxemia (oxygen saturation <92%) in a 1:1 ratio to early high-flow |
| 68 | +> nasal oxygen (600 patients) or standard oxygen (600 patients), with randomization in permuted blocks |
| 69 | +> stratified by site. The pre-specified primary outcome was escalation to invasive mechanical ventilation |
| 70 | +> within 14 days. The secondary outcome was 28-day all-cause mortality. Analyses followed the |
| 71 | +> intention-to-treat principle; outcome assessors were blinded. |
| 72 | +> |
| 73 | +> **RESULTS** |
| 74 | +> The primary outcome occurred in 66 of 600 patients (11.0%) in the high-flow group and in 108 of 600 |
| 75 | +> (18.0%) in the standard-oxygen group (absolute difference, −7.0 percentage points; 95% CI, −11.1 to −2.9; |
| 76 | +> relative risk, 0.61; 95% CI, 0.46 to 0.81; P=0.001), corresponding to a number needed to treat of 15. |
| 77 | +> At 28 days, all-cause mortality was 7.5% versus 9.0% (absolute difference, −1.5 percentage points; 95% CI, |
| 78 | +> −4.5 to 1.5). Serious adverse events occurred in 4.2% versus 3.8% of patients. |
| 79 | +> |
| 80 | +> **CONCLUSIONS** |
| 81 | +> Among adults hospitalized with community-acquired pneumonia and hypoxemia, early high-flow nasal oxygen |
| 82 | +> reduced escalation to mechanical ventilation within 14 days as compared with standard oxygen. (Funded by |
| 83 | +> the Fictional National Institute for Respiratory Research; OXYGEN-CAP ClinicalTrials.gov number, |
| 84 | +> NCT00000000.) |
| 85 | +
|
| 86 | +**Why this clears the bar (mapped to the skills):** |
| 87 | + |
| 88 | +| Requirement | Skill | How the rewrite satisfies it | |
| 89 | +| --- | --- | --- | |
| 90 | +| Four headed sections, ≤250 words | [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md) | Background / Methods / Results / Conclusions present; tight prose. | |
| 91 | +| Primary outcome led with effect + 95% CI | [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md), [`nejm-statistics`](../../skills/nejm-statistics/SKILL.md) | Absolute difference **and** relative risk, each with a 95% CI, plus exact P. | |
| 92 | +| ITT + per-group n | [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md), [`nejm-statistics`](../../skills/nejm-statistics/SKILL.md) | "intention-to-treat"; 600 vs 600 stated. | |
| 93 | +| Absolute risk + NNT alongside relative | [`nejm-statistics`](../../skills/nejm-statistics/SKILL.md) | Absolute difference and NNT (15) given, not relative risk alone. | |
| 94 | +| Registration number + funding source in Conclusions | [`nejm-abstract`](../../skills/nejm-abstract/SKILL.md), [`nejm-study-design`](../../skills/nejm-study-design/SKILL.md) | NCT number and funder named in the final sentence. | |
| 95 | +| Conclusion calibrated, names the comparator | [`nejm-writing`](../../skills/nejm-writing/SKILL.md) | "as compared with standard oxygen"; no "new standard of care" over-reach. | |
| 96 | + |
| 97 | +> Note: the registered primary outcome must match the reported one |
| 98 | +> ([`nejm-study-design`](../../skills/nejm-study-design/SKILL.md)). In a real submission, the open-label design |
| 99 | +> would carry a justification and a blinded-outcome-assessment note in the Methods |
| 100 | +> ([`nejm-study-design`](../../skills/nejm-study-design/SKILL.md)). |
| 101 | +
|
| 102 | +--- |
| 103 | + |
| 104 | +## After — the Introduction (terse IMRAD, NEJM house style) |
| 105 | + |
| 106 | +> Community-acquired pneumonia is among the most frequent reasons for hospital admission, and hypoxemia at |
| 107 | +> presentation marks patients at risk for clinical deterioration. Supplemental oxygen is standard care, but |
| 108 | +> the conventional low-flow approach can be slow to correct hypoxemia, and some patients progress to invasive |
| 109 | +> mechanical ventilation. |
| 110 | +> |
| 111 | +> High-flow nasal oxygen delivers heated, humidified oxygen at high flow rates and can be started early on the |
| 112 | +> ward. Whether beginning high-flow oxygen early — rather than after deterioration — reduces the need for |
| 113 | +> mechanical ventilation in this population is not established; prior data come largely from intensive-care |
| 114 | +> settings and other diagnoses. |
| 115 | +> |
| 116 | +> We therefore conducted the OXYGEN-CAP trial to determine whether early high-flow nasal oxygen, as compared |
| 117 | +> with standard oxygen, reduces escalation to invasive mechanical ventilation within 14 days among adults |
| 118 | +> hospitalized with community-acquired pneumonia and hypoxemia. |
| 119 | +
|
| 120 | +**Why this is NEJM-shaped (mapped to [`nejm-writing`](../../skills/nejm-writing/SKILL.md)):** |
| 121 | + |
| 122 | +- **Two to three short paragraphs**: the clinical problem, the gap, then the specific question — ending on the |
| 123 | + objective. No exhaustive background; detail would move to references and the protocol. |
| 124 | +- **Question, not method, leads.** It opens with the clinical problem, not the apparatus. |
| 125 | +- **Plain, terse sentences; past tense for what was done** ("We therefore conducted…"); present tense for |
| 126 | + established facts ("Supplemental oxygen is standard care"). |
| 127 | +- **No over-claim and no filler.** No "novel," "robust," or practice recommendation — the Discussion, not the |
| 128 | + Introduction, weighs implications soberly. |
| 129 | + |
| 130 | +--- |
| 131 | + |
| 132 | +## CONSORT and ethics reminders this example assumes (not shown above) |
| 133 | + |
| 134 | +Per [`nejm-reporting`](../../skills/nejm-reporting/SKILL.md) and |
| 135 | +[`nejm-ethics`](../../skills/nejm-ethics/SKILL.md), a real OXYGEN-CAP write-up would also carry: |
| 136 | + |
| 137 | +- A **CONSORT 25-item checklist** and a **participant flow diagram** (Enrollment → Allocation → Follow-up → |
| 138 | + Analysis) whose denominators reconcile with the 600-vs-600 ITT populations and Table 1. |
| 139 | +- **Prospective registration before first enrollment**, with the registered primary outcome matching the |
| 140 | + reported one; the **protocol and statistical analysis plan** submitted as a supplement. |
| 141 | +- **IRB/ethics approval and informed consent** per the Declaration of Helsinki, **ICMJE COI disclosures**, a |
| 142 | + **role-of-the-funding-source** statement, and a **data-sharing statement** — all stated in the Methods/end |
| 143 | + matter, not the abstract. |
| 144 | + |
| 145 | +> **All numbers above are fictional teaching values. Do not cite them. To benchmark against real NEJM trials |
| 146 | +> by design, see [`../exemplars/library.md`](../exemplars/library.md).** |
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